21
One Casper Street MannKind Corporation Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 www.mannkindcorp.com r-. ..) .- March 8,2011 o Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission, Region 1 475 Allendale Road - .. - Ki ng of Prussia, PA 19406-1415 Re: Termination of Mannkind Corp. License 06-30720-01 To Whom It May Concern: Enclosed please find NRC Form 314 requesting the termination our Radioactive Materials License 06-30720-01 for our Danbury, CT facility, along with on site waste Decay in Storage disposal documentation, shipped off site waste disposal manifest and room survey documentation. Mannkind Corp. has not used nor had on site any radioactive material in several years and as required by NRC regulations we would like to terminate our license. Please do not hesitate to contact me (203-796-3556) if you have any questions or need any additional information. rRegaro')L /y:ti?' Grimardi, MS, CHMM, RSO Associate Director Environmental, Health and Safety MannKind Corporation 57y...61« NMSSJRGN1 MA"rERIALS-002

Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

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Page 1: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

One Casper Street ~ MannKind Corporation Danbury CT 06810

Main 203-798-8000 Fax 203-798-7740

wwwmannkindcorpcom r- ) ~-shy

March 82011

oLicensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road - -Ki ng of Prussia P A 19406-1415

Re Termination of Mannkind Corp License 06-30720-01

To Whom It May Concern

Enclosed please find NRC Form 314 requesting the termination our Radioactive Materials License 06-30720-01 for our Danbury CT facility along with on site waste Decay in Storage disposal documentation shipped off site waste disposal manifest and room survey documentation

Mannkind Corp has not used nor had on site any radioactive material in several years and as required by NRC regulations we would like to terminate our license

Please do not hesitate to contact me (203-796-3556) if you have any questions or need any additional information

rRegaro)L yti ~Grimardi MS CHMM RSO

Associate Director Environmental Health and Safety MannKind Corporation

57y61laquo NMSSJRGN1 MArERIALS-002

NRC FORM 314 US NUCLEAR REGULATORY COMMISSION APPROVED BY OMB NO 31600lt128 EXPIRES 103112013 (122010) Estimated burden per response to comply with this mandatory collection request 30 minutes10 CFR 30360)(1) 40420)(1) 70380)(1) and 7254(k)(5)(1)(1) This submittal is used by NRC as part of the basis for lIS determination that the facility Is

released lor unresl11cted use Send comments regarding burden estimate to the Information Services Branch (H F53) US Nuclear Regulatory Commission Washington DC 20555-0001 or by Intemet e-maU to InfocclleclSResourcenrcgov and to the Desk OI1icer Office 01CERTIFICATE OF DISPOSITION OF MATERIALS Informatlon and Regulatory Affairs NEOBmiddot10202 (3150middot0028) OI1ice of Manegernent and Budget Washington DC 20503 If a means used to Impose an Inlormatlon collectlon does not display a currenUy valid OMB control number the NRC may not conduct or sponsor and a person is not required to respond to the information collection

LICENSEE NAME AND ADDRESS LICENSE NUMBER DOCKET NUMBER Mannkind Corporation 06-30720-01 03035937 1 Casper Street

LICENSE EXPIRATION DATE Danbury Ct 06810 03312012

A LICENSE STATUS (Check the appropriate box)o This license has expired [] This license has not yet expired please terminate it

B DISPOSAL OF RADIOACTIVE MATERIAL (Check the appropriate boxes and complete as necessary If additional space is needed provide attachments) The licensee or any individual executing this certificate on behalf of the licensee certifies that

1 No radioactive materials have ever been procured or possessed by the licensee under this license

[l] 2 All activities authorized by this license have ceased and all radioactive materials procured andor possessed by the licensee under this license number cited above have been disposed of in the following manner

Oa Transfer of radioactive materials to the licensee listed below

[l] b Disposal of radioactive materials

0 1 Directly by the licensee

Decay in Storage of I 125 waste - please see attached decay in storage dates records and survey at time of disposal

2 By licensed disposal site

o 3 By waste contractor Radiac Research Corporation - please see attached disposal manifests 261 Kent Avenue Brooklyn NY 11211

c All radioactive materials have been removed such that any remaining residual radioactivity is within the limits of 10 CFR Part 20 Subpart E and is ALARA

C SURVEYS PERFORMED AND REPORTED

[l] 1 A radiation survey was conducted by the licensee The survey confirms

a the absence of licensed radioactive materials

b that any remaining residual radioactivity is within the limits of 10 CFR 20 Subpart E and is ALARA

[l] 2 A copy of the radiation survey results

a is attached or b is not attached (Provide explanation) orJ c was forwarded to NRC on Dale

3 A radiation survey is not required as only sealed sources were ever possessed under this license and

a The results of the latest leak test are attached andor Db No leaking sources have ever been identified

The person to be contacted regarding the information provided on this form INAME TITLE i TELEPHONE (Include Are Code) tMAIL ADDRESS

John B Grimardi Associate Director EHS I 203-796-3556 jgrimardimannkindcorpcom Mail all future correspondence regarding thisllcen to 1 Casper Street Danbury a 06810

C CERTIFYING OFFICIAL I CERTIFY UNDER PENALTV OF PERJURY THAT THE FOREGOINgJS ~UE AND CORRECT

PRiNTED NAME AND TITLE DATE ISI(RE

John B Grimardi Associate Director EHS C75(middotmiddot2~raquo 3 - ltis - d-Ol (

WARNING FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT~OR CRIMINAL PENALTIES NRC REGULATIONS REQUIRE THAT SUBMISSIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MA TERI R CT 18 USC SECTION 1001 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT R AGENCY OF THE UNITED STATES AS TO ANY MATIER WITHIN ITS JURISDICTION

NRC FORM 314 (12-2010)

MannKind BioPharmaceuticals A Division of MannKind Corporation

DECAY-IN-STORAGE LOG

Activity Initial Surface Scheduled FinalContainer Storage Decay Nuclide Surveyor RSO InitialEntered Reading Disposal Reading Location Entry Date Initial ampDate ampDate(mCi) (mRlHr) Date (mRlHr)

B001 06052002 - 5 IJCi lt 002 mRHr 03512004 Background ~frS ~)16 Jpound6dar B002 12172002 I - 5 IJCi lt 002 mRlHr 091172004 Background 1JG )-kt~Hf6focf

B003 03172003 -51-1Ci lt 002 mRlHr 121712004 Background (-JJ6 JJJO rlJ6dJJ)oshyB004 04212003 - 5 IJCi lt 002 mRlHr 01212005 Background~~amp5 -)~PJ lbgiJjfd P001 06052002 -75 IJCi lt 002 mRlHr 04052004 Background j1G))ytbf6jbJk P002 03172002 - 26IJCi

- I (V I I

i

I I

~PkQltshy

FORM 540 S SHlPPEl - NAME INl) FACIlJll SHIPMENT LD NUMllER a MANIFEST NUMeER MANNKINO IiUO PHARMACeUTICAL NA 7 FoRM 5laquo) INl) 5-IOA PAGE 1 01 1 PAGEts) (Usa this tmnbct on all ~Wllion

UNIFORM LOW-LEVEL RADIOACTIVE 1 CASPER STREET FoRM 5411Nl)SIA 1 PAGES) COLLECTOR FORM52AND~ None PAGEtSI

RADIAC RESEARCH CORP

-76081 WASTE MANIFEST DANIlURY c1 061110 AOOIT1ONIL IlIFORMA11O~j No PAGE(S)

FRoassoR SHIPPING PAPER GENERATOR 9 coNSIGNEemiddot Nad FacillIy Addr_ CONTACTI Pmm~---shy

NA J IPMEHT NJMlER x Speltfj M JOSEPH SPEKTOfl

1 EMERGeNCY TEEPHOIE NUMBER (InlJUdfgt AIH CotIo RAOIAC RESEARCH CORP 1844)1 424middot900 CONTACT (__Coda) TELEPHONE NlIMBERlndudD 11TEIElIiONE NJLIeR Codo)

ROORlGO LAUREAND 261 KENT AVENUE ORGNIIZATION 2Q37ISs 718 963 - p33x 205B~~N~11~11 ~_

CHEMmEC 6 CARRlJR - NrmlWiAdd EPA 10 NUMBER

2 1SlHISANEXClUSlVEUSESHlPMEN17 3 TOTAL NUMBER OF _ RAOIACIlESEARCHCORl Truckt ND04t1T821tl ~~e~~_~ DATE ~U~I oY ~~D lSI KENT AVE TIII SHlPPIIIIG0A1E ~- 10 CER11FICATlOIl

==gt SRCIOKIYNNY 11211 3IfGlQ4 ThIs ~rItltY thot d _Is PlParl)ltdaHilltd dellCtlbodpadolgodnJ nd 10_uodI-IAJ~________I-________L______+-___________________~=----=---li~OIIfor_polta _OIdmglol11OapjgtIicobIol_oIhe~ntolT~_aIso

ooeSEPAREGUlATEO YES EPAfllANlFESTNllMBpoundR CONTACT TE(1rrlSHcgtNENUMBER 11iIibullbull he-~d_po9edm_d_andIn_dillonfor~dWASTE REQUIRlNG A 1 __ __lICCO=r_=IiIn=IhraquImm==_=--D_CfR ParI1I O_nd_SI~_or____middot_a1o_sIa_le-_-_IIoN_____AA_Tl-IUR G_REEH_--___________+---r-~18_-~~~~)--+=-pS~d=~in _____MANIFEST ACCOMPANY NO ~ bull THIS SHIPMENT NA SlGllATlJIIi- _~trilgtdlI()wIlaquodglng(lpI 01151 I T1TlE or I Ypr_Motdflflurngtlt= ~~ -- _ 3ibO-J $r rd~J A-ltS 3jitjOlj

11 U_S_DEPARTMErrOFTRANS~TATIOIIOESCRlPTION 12 13- V 14- 15 16 17 18 TOTAl WEIGHT 19IDENl1fICATION (Including pntp shlPPino MmO hozatd dan tJN 10 number OOTlABEl TRANSPORT I PHYSlCAl1Nl) INDMDUAL T01ALPACIltAGE ACTMn LSMIOO OR VOLUME NUMeEROF

and MYoddlQorusllnforrnalion 11ADlOACTIE INDEX CHEMICAl FOAM RAllIONUCLIOES MIkI mCl CIASS (Use _prIala unl PACKAGE

RildiQacuvemat8r1al e1ltcepted package4imited quantity of NA IA H-3 4000E+01 rOOOOE+OO NA rllN LaS 5 6081-01Solid ~ Q~J B

material 7 UN2910 r GAL)0 101 l~ltgttilt~ u

I I

20 CerllllltotIM Igt lItIteby made to __nh C41plhotlhls oNgtmontOl _1__I_unobely d_in Iho -monlfegtl TIIo_ d_bod __FOR CONSIGNEE USE ONY llM _red In bull __bull __1RAlMAC IIoce CriIotl _lind _JOgUIatioMlncludlna_ oflho NRC OOT EPA andappllcablbullbullJUIIIIfIl bullIl- Unless sclllally cltJdnd OI luded in wriIIng1ho gthlp OLoC 10 _tho best authltXizad anlt I 0lt lt111111_

Ogtlo 3~I Oi-j r phono ampS-1CCJ~~

FORM so (10911)

__

-FORM 540 s SHtPPSR -NAMeMIO FACILITY SHlPMSNT t P NUMBER 6 WJlIFESllrulolaERGTSDURATEK

RAQtAC RESeAACH CORP 1735 7 FORM 540 AtlD S40A PAGE OF 15 PMlE(S~ (USt lhilli nuneer onon =ntJrwUicn UNIFORM LOW-LEVEL RADIOACTIVE FORM 541 AND SUA U PAGElS)

HI KEllT AIf II COLLECTOR FORM 542 MID 5421 a PAGE(S) TkRTK-1 WASTE MANIFEST BROOKY NY 11211 AOOrTIONAL tt4jORP~iION UQrIC PAGES)

PROCSSOfl

SHIPPING PAPER (lEJIERATORTYPE 9 CONstGteemiddot ttame aM Facility AdWMIO COtlTACTISHMerr 11011_ T-NYOl1-1J1( W SfffiJy) Ed Kolski I Donnie alllc~elt

1 EMERGEtlCVTEtEPHOHE UUfWER I_AmlIQuir) GTSOurotek laquo00_-1gt00 COHTACT TpoundEPHONEtlUMllER Bear Creek Operations TELEPHOtlE NIJIWEl1(lndudo MIa C4gtdol

(lndoaCOltlo) 1560 Bear Creek Road QRGAlZATlOtlt IllIOII4U-7511 Oak Ridge TN 3783D (865) 220-1629

ClIEfITREC CARRtal-Nsrrenl M4r~ ElAIlltlUlJIIER SlGt(lll2E ~- 2 IS THIS A-CXCUJSM USE _n 3 IWlIAC IWIIARCH COlii NtlI4t17Im DA~qAdTOTAL IIUMSEI OF TtUtk

FACKAGES IOEtIrIFIED I T~t ~JJfLIl ( nd-ipound 7euroi011 THIS IAAIIFEST 170 2M I(lJl1AIIl SHlPl1tl(l DArE 10 CEf11ICATlOII~~ =====gt BRODKLYHUY 1t211 041_

flO ThtilloOClrify lha~ 1M NlAtiIWlamed DGletfalsarapropctf daUifitd d~bea~ mal1leG It1d~ aMQ~ IllproperccrulJIi(mIorImtlloportaIion~to~oppfimblUaltcnsaf1h~~clT~on Thi$dzt ePAMANlFpoundSTWJMBSR COITACT TElS1IIONE IlUBER cenlfies Ih31Il1e murIaIoiRClmi1iIedfII~ fllHXed Imdtabated and am Inprcpet~lionioffIUItlipCftiiIIiOlJMl4(Iu Area Code)~~~~~~ b]vss ARTIUI GREeJ disposal as cfacrlbed In a~ idllhe requirttMnl5 at to CFR PaIb ~t)tId 61 creQU1~ state I~7bullbull tn-allIMNIlFEST ACCOMPANY K NO

llilS SHIPMam IA OAT DATSnV pnM~MrII_=====gt TInE tQu-~- -~~O~ ~~O~rv-~ l( I~ middotOt~-1 us DEPARTerr 01 TlW1SIORTATlOII DESClUPTlOIJ z y13 14 1$ 17 18 TOTAL WEIGIiT 19IOEHTlFICATlOtl

(lnCIudina_J1IpplngnamollUInt U O DOT LABEl TRANSORT PHSICAIAND ItlDMDUAL J TOTAl PP~AtJM1Y LSMiCO ORVOWIdE IIUM8IROF

oodanyaddlticnal_ IIIIDIOACT1VE INDX CHEMICAl FORM MOIOtlUCIlOJS Mlq mCgt ClASS PACKAGEtu s_I Radloacliv8 material excepted package-limited quantity of IIA [lA Solid SOUDIFIEO UQUID Csmiddot137 H-3 92101+01 33DOE+OQ RG LSS 401 321D5A material 7 UN2910 I COMPACTIBLE TRASH (3 JARS) ampGlASS m Radloacllve material excepted packageflmfted quantity of NA NA Solid PAPER PlASTIC amp10 CI-36 H-3 Namiddot22 1100E+OO 1OO0E-01 Nil 31 LBS 401 32106 material 7 UN2910 JCOMBUSTIBLE TRASH GlASS VIALS m Radioacllve material excepted packagefimlted quanUty of NA rlA Solid PlASTIC PAPER Thmiddot232 7oo0e-02 Doooe-03 Nil 76 LBS41 32112 material 7 IIN2910 JCOMBUSTIBLE TRASH PLYWOOD m Radloactive material excepled package-lImlted quanlity of IIA ~A Solid PAPER PLASTIC 1-125 3690E+01 Nil 131 LBS 75 33762

matllfllll 7 UN2910 JCOMPACTIBLE TRASH GlASS m rmiddot700DE-Il1

~~~Radloacllve matarla~ low specific activlty nos 7 UW2912 NA 1 SoUd PLASTIC FOIU Th-232 9600E+01 OOODE-01 LSA-It 147 LBS 75 34Bll1 I COMPACTIBLE TRASH Thorium fluoride FT3

Radioactive material low specific activity noo5bull 1 UIII2912 Nil ~1 Solid PlASTIC FOIU Th-232 9600E+01 ISA-li 110 LBS 75 134892l0ooOE-01 I COMPACTIBLE TRASH Thorium fluoride m FOR CONSIGNEE USE DIlLY 2ll GEllERATORCERTlFICATlOti STAT6IpoundIIT

A) Ra$uadlve Malldab Ceruficauon is hereby made lD GTS Ourntellne Uta lhl5 Shi~t oJ IOH-I~ rJdioadivamp teIta~ has Igtftrt Jlepared in ~ TSNIIESSa I1CIiI1SE FCft DElIIERI IlO t4bmQlODdiloeW$lCrnJNgement~~trabecn~bythtNudeil(~CormISSIonorDIJtqeemerltStatef~ltwyagenty3rdWib

1btamml ~CII afUlIltGTSOundek MaAertsl ~ CtUerie

SOUTH CAIlOUjA TlWlSFOfIT FERMIT NO 8) ~OU$ tIlUIriaftl ~klr ttercbycertib$hat ItU rrotertal does mtI co=taio a t1atanbus Vozte as dlsfinedirt 4liCrn 26~

C) 00 sn_Iltgty_ lhotolldalll kmlllllllgt IUNIfORMlOW-tEJELRADIOAClIVI~JId=jnUS ECOLOGY GaIEflTOR 110

3S~(middotmiddotS~~Qrui-~2J~~-~I~-= ~ tlf O~ US ECOLOGY PERMIT 00

pw -ltQfllgtlut DaI _____---------_

FORM 540 (111-911)

5uweyltc( 1-17-00 ~k-

--

-----

-----

----- -----

F~ Duratek Inc - Commercial Processing 2 MANgt NUMBERUNIFORM LOW-LEVEL RADIOACTIVE O4-ORTKmiddot1

WASTE MANIFEST 3 PAGE 7 OF 26 PAGE(S)CONTAINER AND WASTE DESCRIPTION (CONTINUATION)

DISPOSAL CONTAINER DESCRIPTION WASTE DESCRIPTION FOR EACH WASTE TYPE IN CONTAINER 16 WASTE ~~~~ 7

5 8~ 9~ 10~ PHYSICAL OESCRIPTION 14 CHEMICAL OESCRJPTION lS~ RADIOLOGICAl OESCRIPTlON CLAssIFImiddot 6 CONTAINER OESCRIPTiON CATION

CONTAiNER WASTE SURFACE SJRFAC~~ - 12 13 WEfGHT(See 1) AS-CIaraquoIDENTIFICATION AND RADIATION _10PROCESS REQUESTED VOLUME WASTE APPROXIMATE CHEMICAL FORMI NUMBERI CONTAiNER LEVL ~ Maqiloo2~)

DESCRIPTOR WASTE O~JI3~~~~NOF CHELATING AGENT ~HELATING INDIVIDUAL RADIONUCLIDES AND ACTIVITY (MBq) AND AlJClasASee Note 1A GENERATOR 10 VVEIGHT ImSvJhr) CONTAINER TOTAL OR CONTAINER TOTAL ACTfVlTY(dpml00m2) VOLUMIS) IN MEDIA Unstable

NUMBER BURlALJD1SPOSjTI0N mremlhr) AGENT ANO AADIONucUOe PERCENT (kg) S~Not~2) CONTAINER QClassB(Sbullbull Not 2A)

BETA-gt (m3) (See Note 3 IF gt01 CclanC(ib) ALPHA GAMMA Iffij RADIONUCUDES M9q mG

H-3 21460E+Ol 58000E-Ol76000-1348721SUNVsT 4 3 100 PAPER PLASTIC ~ AU 8RooK C 02124 51709$ ltSOOOOEo3 lt334005-06 lt334QOpound-O$ 02124 GLASSJNP 1hiMNY E 214sect)E+01 58009Ej1

~ ~~~ -~~~~-1--- ~-- I-----~~- Total 21460E+01 58000E-Ol

75000 10000 lt50000Eo1 lt20000E+02 lt200005+03 75000

7S08()141730ISUNY-ST 4 3 100 PAPERPLASTIC NP AUHmiddot3 31080E+OO 84000E-02BROOK C 02124 530103 lt50000El3 lt33400E-C16 lt33400E-ltl5 02124 GLASSINP NY ISuhlotal 31080E+OO 84000B2E 1 ~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ I~~ ~~ ~~~~~~~~~~~~~~~~~ i ~~ ~~~~~

Total 31080E+OO 84000E-OZ75000 1170000 lt50000Eo1 lt200005+02 lt20000euro+03 75000

760S1-1RW 3 39 100 JNATCH PARTSINP NP Hmiddot3 90650E+03 24500E+02 ~~ NY C 00193 72575 ltSOOOOED3 lt33400E-06 lt33400E-05 00193

E ISubtotal 90659E+03 24599E+02 ~~-~-~~~-~

Total 90650E+03 24500E+02 06800 160000 lt50000E-01 lt20000E+02 lt200005+03 06800

760B1~2IRW 3 39 100 WATCH PARiSJNP I----w AUH-3 90650E+03 24500E+02Ilf C 00193 60039 lt50000eo3 lt33400E-OO lt33400Eos 00193 1h~1 90650E+03E 24599E+02

~~~

Total 90650E+03 24500E+0206800 150000 ltS0000EQ1 lt200001+02 lt2aOODE+03 06800

7$08SAo1NYCBOE 3 59-S0LlOIFIED LlaUID IN 100 SOLIDIFIED NP AUCmiddot14 92SOOE+OO 25000E-OlWliHS C Ot)193 31751 ltSOOOOEo3 I lt334OOEQ6 ltJ3400EoS PLASTIC JUG 00193 UQUIDINP NY E Co-6Q 14000E-02 20000E-03

~-I-~~ ------- shy Ihntal ~ ~2JIIl+R9 Zli~IIlll06800 70000 lt50000E4)1 lt20000E+02 lt20000E+03 06800 Total 93240E+OO 25200E-Ol

S9--S0LlOIFrEO LIQUID IN 100 SOLIDIFIED NP AU CT C 00193 31751 lt50000pound03 lt33400Eos lt3340oe05 PLASTIC JUG 00193 LfOlJIDINP 76087-0iIMBP~ 3 H-3 74000E+01 20000E+OO

1htnt1E 14909E+01 200001l+90 ~~~ ~~~~ Total 74000E+Ol 20000E+OO ~ os800 70000 lt50000Eo1 lt20000E+02 lt20000E+03 06800

~~~~-

16058-01NA-NVC AU NY 0~2124 46nOO lt50000Eo3 lt33400E-OO lt330400E()S

I~~~~-----~ --- __ rI~ -~-~~ ~ -~~~ --~~---- ~ -~~~-

75000 1030000 lt5OOOOE-01 lt20000E+02 lt200D0E+03

~~~~ ~~-~~---~~ ---- shyNA-NVC 100 NP~~~~ASTIC Cmiddot14 84268E+OO 22775E-Ol

NY 02115 H-3 53669E+01 1450SE+OO---___----~~-- ---~ ~-~~~~~ ~ ~~~~~~~

1middot125 18500E-Ol 50000E-03 74700 P-32 74000E+01 20000E+OO

Subtotal 13amp26E+02 36amp33E+OO ~~~~-

--- I-~---

FORM 541A10-95)

~UKMb42A 2 MANIFEST NUMBeuroRDuratek Incmiddot Commercial Processing O4-ORTKmiddot1UNIFORM LOW-LEVEL RADIOACTIVE WASTE MANIFEST

3 MANIFEST INDEX AND REGIONAL COMPACT TABULATION (CONTINUATION) PAGE 3 OF 7 PAGE(S)

11 AS PRocesseOCOLLECTED TOTAL 5 bull 1 PREPROCESSEO 9 10 MANIFEST NUMBER(S) UNDERWASTEGENERATOR ORtG1NATING A SOURCE B SNM CACTIVITY O VOLUME

GENERATOR NAME GENERATOR (OR MATERIAL) VvHfCH WASTE (OR MATERIAl) WASTE CODEIDENTIFICATION MATERIAL NUMBER PERMIT NUMBER (IF APPtICABLEj FACILIIY VOLUME REceIVED AND DATE P =PROCESSED ~I~W

AND TELEPHONE NUMBER ADDRESS OF RECEIPT CCOIIECTED OR STATE (k9J (Ib) Ill) (mba) (mCi) (m3) (ft3)

(m3) (ft3)

KCHC KINGS COUNTy HOSPITAL Pathology m$titute 25800E-01 568795(11 000005+00 51202E+02 113838E+01 17400 CENTER 451 CLARKSON AVE NVO180904613 BROOKLYN NY 11203 63176-1592 i-

Lot LASER OPTICS INC 111 WOOSTER STREET 60000pound+01 13228E+02 OOooOE+oo 29600E+02 16J)OOOE+OO 75000 203 144 ~ 4160 BETHEL CT 06801

I

i I yn Lort9 Island UniVefSitragt OooooeOO jOooooe+oo OOOOOeuro+OO 5693OE+01 1S400E+OO 02271 bull0200

NY0073130742 TtS 4Sa160a SROOKLYNON~~ I7

I -- shy

MBPOO MANNKINO 1 CASPER STREiff OoooOE+oo OooooE+oo OOOOOE+OO 7AOOOE-01 i2DOOOE00 06800 810PHARMACEUTICALDanbury DANBURY CT 06810 CT~ 203--7~ ) ___m

I I MBPOE MANNKIND 10OOOOE00 0OOOOE+00 00000pound+00 94720E+01 rlsaoOE+OO 15000shy

BIOPKARMACEUTICAL SUITE 405 Elmsford NY ELMSFORO NY 10523 I

91+$1)6615 I I ~ I I

MRI ~NC 150MA~O OOOOOE+oo aOOOOE+OO OooooE+oo 37000e+01 00005 00 0212 75000 91 TUCKAHOE 01 I

I

I i

I I

MSKCC-R MEMORIAL SLOAN KETTERING ROCKEFELLER BLDG 10000E+00 22046E+00 00000pound+00 35Q76E+02 f94800E+OO 4361$I NYD075265157 NEW YORK NY 10065 CANCER CeNTER~ 430 EAST 61 STREET I 212 639 ~ 1391 I I

I I I

PC MEMORY PHARMACEUTICAL 100 PHILLIPS PARKWAY 03398 119999 7S090 (0410712004) C NJ OOOOOE+OO 100000E+00 00000pound00 31635e+01ja5500eo1 03115 110000 CORP MONTIVAlE NJ 07645 201-802-1229 j

I I

I I

I MC270A MILLENNIUM PHARM 270 210 ALBANY STREeT OOOOOeOO OOOooE+OO QOOOOE+OO 48314E+02 130$ampE+01 150000 Albany St CAMBRIDGE MA 02139 IMAROOO500843 617 679 ~ 70n I

I I FORM 542A (1Q96)

Page 1

DUIatek

Monday April 19 2004

Arthur F Green Radlae Research Corp

261 Kent AVenue Brooklyn NY 11211

Dear Mr Green

The attached signed shipping manifest copies are your notice of receipt of the radioactive waste materials shipment specified on the manifest number below

Manifest Number Date Received

1735-04middotDRTKmiddot1 0411912004

Thank you for your business

Sincerely

Shipping and Receiving

cc Manifest File Shipping and Receiving file

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Prepared by

Antkowiak and Mahoney Ente rprises Inc

3 Valley Court Chester NY 10918

845406-1917

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Survey Date April 19 2006

Survey performed by

Joel Antkowiak

Report prepared by

Robert Mahoney

Reviewed and Approved by ~=-=- Date s)- 1shy

Antkowiak and Mahoney Enterprises Inc

II

Table of Contents

II Approval

Table of Contents 1

I Introduction 2

II Survey Instrumentation 2-3

II III Survey Methodology 4

II IV Summary of Survey Results 5

V List of Rooms Surveyed 6

Appendix Diagrams of Areas Surveyed and Smear Results

II

I I I I I I

1

Antkowiak and Mahoney Ente rprises Inc

I Introduction

This report has been prepared by Antkowiak amp Mahoney Enterprises Inc for MannKind Corp to summarize the results of the monthly radiation safety surveys performed in the radioactive materials use areas at the facility in Danbury Connecticut The purpose of the survey was to identify and define the extent of fixed and removable radioactive contamination in the rooms where radioactive materials are used so that the researchers will be able to decontaminate the areas as soon as possible

The surveys were performed on April 192006 by Joel Antkowiak

II Survey Instrumentation

Table 2-1 provides a description of the instrumentation used to perform the routine monthly surveys

Instrument Use Serial Calibration Number Date

Ludlum Model 12 Direct measurements for beta 195030 072205 and gamma radiation

WModel 43-68 probe PR 178541

Beckman Model Liquid scintillation counting of 7040372 At time of 5000TD Liquid samples for removable use

Scintillation Analyzer radioactive contamination

All meters and instrumentation used for this survey have been calibrated within the past twelve months to standards traceable to the National Institute of Standards and Testing (NIST) The hand held meters response to a dedicated check source was verified prior to use The liquid scintillation counter was calibrated prior to use by running the manufacturers calibration protocol allowing the machine to adjust the gain

Minimum Detectable Activity Calculations

Equation

MDA = 271 + 465 Br x t tx E xA100

where 2MDA = activity in dpm 100 cm

Br = background rate in counts per minute t = counting time in minutes E = detector efficiency in counts per disintegration (41t)

A = probe area or area wiped in cm2

11 II

2

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 2: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

NRC FORM 314 US NUCLEAR REGULATORY COMMISSION APPROVED BY OMB NO 31600lt128 EXPIRES 103112013 (122010) Estimated burden per response to comply with this mandatory collection request 30 minutes10 CFR 30360)(1) 40420)(1) 70380)(1) and 7254(k)(5)(1)(1) This submittal is used by NRC as part of the basis for lIS determination that the facility Is

released lor unresl11cted use Send comments regarding burden estimate to the Information Services Branch (H F53) US Nuclear Regulatory Commission Washington DC 20555-0001 or by Intemet e-maU to InfocclleclSResourcenrcgov and to the Desk OI1icer Office 01CERTIFICATE OF DISPOSITION OF MATERIALS Informatlon and Regulatory Affairs NEOBmiddot10202 (3150middot0028) OI1ice of Manegernent and Budget Washington DC 20503 If a means used to Impose an Inlormatlon collectlon does not display a currenUy valid OMB control number the NRC may not conduct or sponsor and a person is not required to respond to the information collection

LICENSEE NAME AND ADDRESS LICENSE NUMBER DOCKET NUMBER Mannkind Corporation 06-30720-01 03035937 1 Casper Street

LICENSE EXPIRATION DATE Danbury Ct 06810 03312012

A LICENSE STATUS (Check the appropriate box)o This license has expired [] This license has not yet expired please terminate it

B DISPOSAL OF RADIOACTIVE MATERIAL (Check the appropriate boxes and complete as necessary If additional space is needed provide attachments) The licensee or any individual executing this certificate on behalf of the licensee certifies that

1 No radioactive materials have ever been procured or possessed by the licensee under this license

[l] 2 All activities authorized by this license have ceased and all radioactive materials procured andor possessed by the licensee under this license number cited above have been disposed of in the following manner

Oa Transfer of radioactive materials to the licensee listed below

[l] b Disposal of radioactive materials

0 1 Directly by the licensee

Decay in Storage of I 125 waste - please see attached decay in storage dates records and survey at time of disposal

2 By licensed disposal site

o 3 By waste contractor Radiac Research Corporation - please see attached disposal manifests 261 Kent Avenue Brooklyn NY 11211

c All radioactive materials have been removed such that any remaining residual radioactivity is within the limits of 10 CFR Part 20 Subpart E and is ALARA

C SURVEYS PERFORMED AND REPORTED

[l] 1 A radiation survey was conducted by the licensee The survey confirms

a the absence of licensed radioactive materials

b that any remaining residual radioactivity is within the limits of 10 CFR 20 Subpart E and is ALARA

[l] 2 A copy of the radiation survey results

a is attached or b is not attached (Provide explanation) orJ c was forwarded to NRC on Dale

3 A radiation survey is not required as only sealed sources were ever possessed under this license and

a The results of the latest leak test are attached andor Db No leaking sources have ever been identified

The person to be contacted regarding the information provided on this form INAME TITLE i TELEPHONE (Include Are Code) tMAIL ADDRESS

John B Grimardi Associate Director EHS I 203-796-3556 jgrimardimannkindcorpcom Mail all future correspondence regarding thisllcen to 1 Casper Street Danbury a 06810

C CERTIFYING OFFICIAL I CERTIFY UNDER PENALTV OF PERJURY THAT THE FOREGOINgJS ~UE AND CORRECT

PRiNTED NAME AND TITLE DATE ISI(RE

John B Grimardi Associate Director EHS C75(middotmiddot2~raquo 3 - ltis - d-Ol (

WARNING FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT~OR CRIMINAL PENALTIES NRC REGULATIONS REQUIRE THAT SUBMISSIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MA TERI R CT 18 USC SECTION 1001 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT R AGENCY OF THE UNITED STATES AS TO ANY MATIER WITHIN ITS JURISDICTION

NRC FORM 314 (12-2010)

MannKind BioPharmaceuticals A Division of MannKind Corporation

DECAY-IN-STORAGE LOG

Activity Initial Surface Scheduled FinalContainer Storage Decay Nuclide Surveyor RSO InitialEntered Reading Disposal Reading Location Entry Date Initial ampDate ampDate(mCi) (mRlHr) Date (mRlHr)

B001 06052002 - 5 IJCi lt 002 mRHr 03512004 Background ~frS ~)16 Jpound6dar B002 12172002 I - 5 IJCi lt 002 mRlHr 091172004 Background 1JG )-kt~Hf6focf

B003 03172003 -51-1Ci lt 002 mRlHr 121712004 Background (-JJ6 JJJO rlJ6dJJ)oshyB004 04212003 - 5 IJCi lt 002 mRlHr 01212005 Background~~amp5 -)~PJ lbgiJjfd P001 06052002 -75 IJCi lt 002 mRlHr 04052004 Background j1G))ytbf6jbJk P002 03172002 - 26IJCi

- I (V I I

i

I I

~PkQltshy

FORM 540 S SHlPPEl - NAME INl) FACIlJll SHIPMENT LD NUMllER a MANIFEST NUMeER MANNKINO IiUO PHARMACeUTICAL NA 7 FoRM 5laquo) INl) 5-IOA PAGE 1 01 1 PAGEts) (Usa this tmnbct on all ~Wllion

UNIFORM LOW-LEVEL RADIOACTIVE 1 CASPER STREET FoRM 5411Nl)SIA 1 PAGES) COLLECTOR FORM52AND~ None PAGEtSI

RADIAC RESEARCH CORP

-76081 WASTE MANIFEST DANIlURY c1 061110 AOOIT1ONIL IlIFORMA11O~j No PAGE(S)

FRoassoR SHIPPING PAPER GENERATOR 9 coNSIGNEemiddot Nad FacillIy Addr_ CONTACTI Pmm~---shy

NA J IPMEHT NJMlER x Speltfj M JOSEPH SPEKTOfl

1 EMERGeNCY TEEPHOIE NUMBER (InlJUdfgt AIH CotIo RAOIAC RESEARCH CORP 1844)1 424middot900 CONTACT (__Coda) TELEPHONE NlIMBERlndudD 11TEIElIiONE NJLIeR Codo)

ROORlGO LAUREAND 261 KENT AVENUE ORGNIIZATION 2Q37ISs 718 963 - p33x 205B~~N~11~11 ~_

CHEMmEC 6 CARRlJR - NrmlWiAdd EPA 10 NUMBER

2 1SlHISANEXClUSlVEUSESHlPMEN17 3 TOTAL NUMBER OF _ RAOIACIlESEARCHCORl Truckt ND04t1T821tl ~~e~~_~ DATE ~U~I oY ~~D lSI KENT AVE TIII SHlPPIIIIG0A1E ~- 10 CER11FICATlOIl

==gt SRCIOKIYNNY 11211 3IfGlQ4 ThIs ~rItltY thot d _Is PlParl)ltdaHilltd dellCtlbodpadolgodnJ nd 10_uodI-IAJ~________I-________L______+-___________________~=----=---li~OIIfor_polta _OIdmglol11OapjgtIicobIol_oIhe~ntolT~_aIso

ooeSEPAREGUlATEO YES EPAfllANlFESTNllMBpoundR CONTACT TE(1rrlSHcgtNENUMBER 11iIibullbull he-~d_po9edm_d_andIn_dillonfor~dWASTE REQUIRlNG A 1 __ __lICCO=r_=IiIn=IhraquImm==_=--D_CfR ParI1I O_nd_SI~_or____middot_a1o_sIa_le-_-_IIoN_____AA_Tl-IUR G_REEH_--___________+---r-~18_-~~~~)--+=-pS~d=~in _____MANIFEST ACCOMPANY NO ~ bull THIS SHIPMENT NA SlGllATlJIIi- _~trilgtdlI()wIlaquodglng(lpI 01151 I T1TlE or I Ypr_Motdflflurngtlt= ~~ -- _ 3ibO-J $r rd~J A-ltS 3jitjOlj

11 U_S_DEPARTMErrOFTRANS~TATIOIIOESCRlPTION 12 13- V 14- 15 16 17 18 TOTAl WEIGHT 19IDENl1fICATION (Including pntp shlPPino MmO hozatd dan tJN 10 number OOTlABEl TRANSPORT I PHYSlCAl1Nl) INDMDUAL T01ALPACIltAGE ACTMn LSMIOO OR VOLUME NUMeEROF

and MYoddlQorusllnforrnalion 11ADlOACTIE INDEX CHEMICAl FOAM RAllIONUCLIOES MIkI mCl CIASS (Use _prIala unl PACKAGE

RildiQacuvemat8r1al e1ltcepted package4imited quantity of NA IA H-3 4000E+01 rOOOOE+OO NA rllN LaS 5 6081-01Solid ~ Q~J B

material 7 UN2910 r GAL)0 101 l~ltgttilt~ u

I I

20 CerllllltotIM Igt lItIteby made to __nh C41plhotlhls oNgtmontOl _1__I_unobely d_in Iho -monlfegtl TIIo_ d_bod __FOR CONSIGNEE USE ONY llM _red In bull __bull __1RAlMAC IIoce CriIotl _lind _JOgUIatioMlncludlna_ oflho NRC OOT EPA andappllcablbullbullJUIIIIfIl bullIl- Unless sclllally cltJdnd OI luded in wriIIng1ho gthlp OLoC 10 _tho best authltXizad anlt I 0lt lt111111_

Ogtlo 3~I Oi-j r phono ampS-1CCJ~~

FORM so (10911)

__

-FORM 540 s SHtPPSR -NAMeMIO FACILITY SHlPMSNT t P NUMBER 6 WJlIFESllrulolaERGTSDURATEK

RAQtAC RESeAACH CORP 1735 7 FORM 540 AtlD S40A PAGE OF 15 PMlE(S~ (USt lhilli nuneer onon =ntJrwUicn UNIFORM LOW-LEVEL RADIOACTIVE FORM 541 AND SUA U PAGElS)

HI KEllT AIf II COLLECTOR FORM 542 MID 5421 a PAGE(S) TkRTK-1 WASTE MANIFEST BROOKY NY 11211 AOOrTIONAL tt4jORP~iION UQrIC PAGES)

PROCSSOfl

SHIPPING PAPER (lEJIERATORTYPE 9 CONstGteemiddot ttame aM Facility AdWMIO COtlTACTISHMerr 11011_ T-NYOl1-1J1( W SfffiJy) Ed Kolski I Donnie alllc~elt

1 EMERGEtlCVTEtEPHOHE UUfWER I_AmlIQuir) GTSOurotek laquo00_-1gt00 COHTACT TpoundEPHONEtlUMllER Bear Creek Operations TELEPHOtlE NIJIWEl1(lndudo MIa C4gtdol

(lndoaCOltlo) 1560 Bear Creek Road QRGAlZATlOtlt IllIOII4U-7511 Oak Ridge TN 3783D (865) 220-1629

ClIEfITREC CARRtal-Nsrrenl M4r~ ElAIlltlUlJIIER SlGt(lll2E ~- 2 IS THIS A-CXCUJSM USE _n 3 IWlIAC IWIIARCH COlii NtlI4t17Im DA~qAdTOTAL IIUMSEI OF TtUtk

FACKAGES IOEtIrIFIED I T~t ~JJfLIl ( nd-ipound 7euroi011 THIS IAAIIFEST 170 2M I(lJl1AIIl SHlPl1tl(l DArE 10 CEf11ICATlOII~~ =====gt BRODKLYHUY 1t211 041_

flO ThtilloOClrify lha~ 1M NlAtiIWlamed DGletfalsarapropctf daUifitd d~bea~ mal1leG It1d~ aMQ~ IllproperccrulJIi(mIorImtlloportaIion~to~oppfimblUaltcnsaf1h~~clT~on Thi$dzt ePAMANlFpoundSTWJMBSR COITACT TElS1IIONE IlUBER cenlfies Ih31Il1e murIaIoiRClmi1iIedfII~ fllHXed Imdtabated and am Inprcpet~lionioffIUItlipCftiiIIiOlJMl4(Iu Area Code)~~~~~~ b]vss ARTIUI GREeJ disposal as cfacrlbed In a~ idllhe requirttMnl5 at to CFR PaIb ~t)tId 61 creQU1~ state I~7bullbull tn-allIMNIlFEST ACCOMPANY K NO

llilS SHIPMam IA OAT DATSnV pnM~MrII_=====gt TInE tQu-~- -~~O~ ~~O~rv-~ l( I~ middotOt~-1 us DEPARTerr 01 TlW1SIORTATlOII DESClUPTlOIJ z y13 14 1$ 17 18 TOTAL WEIGIiT 19IOEHTlFICATlOtl

(lnCIudina_J1IpplngnamollUInt U O DOT LABEl TRANSORT PHSICAIAND ItlDMDUAL J TOTAl PP~AtJM1Y LSMiCO ORVOWIdE IIUM8IROF

oodanyaddlticnal_ IIIIDIOACT1VE INDX CHEMICAl FORM MOIOtlUCIlOJS Mlq mCgt ClASS PACKAGEtu s_I Radloacliv8 material excepted package-limited quantity of IIA [lA Solid SOUDIFIEO UQUID Csmiddot137 H-3 92101+01 33DOE+OQ RG LSS 401 321D5A material 7 UN2910 I COMPACTIBLE TRASH (3 JARS) ampGlASS m Radloacllve material excepted packageflmfted quantity of NA NA Solid PAPER PlASTIC amp10 CI-36 H-3 Namiddot22 1100E+OO 1OO0E-01 Nil 31 LBS 401 32106 material 7 UN2910 JCOMBUSTIBLE TRASH GlASS VIALS m Radioacllve material excepted packagefimlted quanUty of NA rlA Solid PlASTIC PAPER Thmiddot232 7oo0e-02 Doooe-03 Nil 76 LBS41 32112 material 7 IIN2910 JCOMBUSTIBLE TRASH PLYWOOD m Radloactive material excepled package-lImlted quanlity of IIA ~A Solid PAPER PLASTIC 1-125 3690E+01 Nil 131 LBS 75 33762

matllfllll 7 UN2910 JCOMPACTIBLE TRASH GlASS m rmiddot700DE-Il1

~~~Radloacllve matarla~ low specific activlty nos 7 UW2912 NA 1 SoUd PLASTIC FOIU Th-232 9600E+01 OOODE-01 LSA-It 147 LBS 75 34Bll1 I COMPACTIBLE TRASH Thorium fluoride FT3

Radioactive material low specific activity noo5bull 1 UIII2912 Nil ~1 Solid PlASTIC FOIU Th-232 9600E+01 ISA-li 110 LBS 75 134892l0ooOE-01 I COMPACTIBLE TRASH Thorium fluoride m FOR CONSIGNEE USE DIlLY 2ll GEllERATORCERTlFICATlOti STAT6IpoundIIT

A) Ra$uadlve Malldab Ceruficauon is hereby made lD GTS Ourntellne Uta lhl5 Shi~t oJ IOH-I~ rJdioadivamp teIta~ has Igtftrt Jlepared in ~ TSNIIESSa I1CIiI1SE FCft DElIIERI IlO t4bmQlODdiloeW$lCrnJNgement~~trabecn~bythtNudeil(~CormISSIonorDIJtqeemerltStatef~ltwyagenty3rdWib

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SOUTH CAIlOUjA TlWlSFOfIT FERMIT NO 8) ~OU$ tIlUIriaftl ~klr ttercbycertib$hat ItU rrotertal does mtI co=taio a t1atanbus Vozte as dlsfinedirt 4liCrn 26~

C) 00 sn_Iltgty_ lhotolldalll kmlllllllgt IUNIfORMlOW-tEJELRADIOAClIVI~JId=jnUS ECOLOGY GaIEflTOR 110

3S~(middotmiddotS~~Qrui-~2J~~-~I~-= ~ tlf O~ US ECOLOGY PERMIT 00

pw -ltQfllgtlut DaI _____---------_

FORM 540 (111-911)

5uweyltc( 1-17-00 ~k-

--

-----

-----

----- -----

F~ Duratek Inc - Commercial Processing 2 MANgt NUMBERUNIFORM LOW-LEVEL RADIOACTIVE O4-ORTKmiddot1

WASTE MANIFEST 3 PAGE 7 OF 26 PAGE(S)CONTAINER AND WASTE DESCRIPTION (CONTINUATION)

DISPOSAL CONTAINER DESCRIPTION WASTE DESCRIPTION FOR EACH WASTE TYPE IN CONTAINER 16 WASTE ~~~~ 7

5 8~ 9~ 10~ PHYSICAL OESCRIPTION 14 CHEMICAL OESCRJPTION lS~ RADIOLOGICAl OESCRIPTlON CLAssIFImiddot 6 CONTAINER OESCRIPTiON CATION

CONTAiNER WASTE SURFACE SJRFAC~~ - 12 13 WEfGHT(See 1) AS-CIaraquoIDENTIFICATION AND RADIATION _10PROCESS REQUESTED VOLUME WASTE APPROXIMATE CHEMICAL FORMI NUMBERI CONTAiNER LEVL ~ Maqiloo2~)

DESCRIPTOR WASTE O~JI3~~~~NOF CHELATING AGENT ~HELATING INDIVIDUAL RADIONUCLIDES AND ACTIVITY (MBq) AND AlJClasASee Note 1A GENERATOR 10 VVEIGHT ImSvJhr) CONTAINER TOTAL OR CONTAINER TOTAL ACTfVlTY(dpml00m2) VOLUMIS) IN MEDIA Unstable

NUMBER BURlALJD1SPOSjTI0N mremlhr) AGENT ANO AADIONucUOe PERCENT (kg) S~Not~2) CONTAINER QClassB(Sbullbull Not 2A)

BETA-gt (m3) (See Note 3 IF gt01 CclanC(ib) ALPHA GAMMA Iffij RADIONUCUDES M9q mG

H-3 21460E+Ol 58000E-Ol76000-1348721SUNVsT 4 3 100 PAPER PLASTIC ~ AU 8RooK C 02124 51709$ ltSOOOOEo3 lt334005-06 lt334QOpound-O$ 02124 GLASSJNP 1hiMNY E 214sect)E+01 58009Ej1

~ ~~~ -~~~~-1--- ~-- I-----~~- Total 21460E+01 58000E-Ol

75000 10000 lt50000Eo1 lt20000E+02 lt200005+03 75000

7S08()141730ISUNY-ST 4 3 100 PAPERPLASTIC NP AUHmiddot3 31080E+OO 84000E-02BROOK C 02124 530103 lt50000El3 lt33400E-C16 lt33400E-ltl5 02124 GLASSINP NY ISuhlotal 31080E+OO 84000B2E 1 ~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ I~~ ~~ ~~~~~~~~~~~~~~~~~ i ~~ ~~~~~

Total 31080E+OO 84000E-OZ75000 1170000 lt50000Eo1 lt200005+02 lt20000euro+03 75000

760S1-1RW 3 39 100 JNATCH PARTSINP NP Hmiddot3 90650E+03 24500E+02 ~~ NY C 00193 72575 ltSOOOOED3 lt33400E-06 lt33400E-05 00193

E ISubtotal 90659E+03 24599E+02 ~~-~-~~~-~

Total 90650E+03 24500E+02 06800 160000 lt50000E-01 lt20000E+02 lt200005+03 06800

760B1~2IRW 3 39 100 WATCH PARiSJNP I----w AUH-3 90650E+03 24500E+02Ilf C 00193 60039 lt50000eo3 lt33400E-OO lt33400Eos 00193 1h~1 90650E+03E 24599E+02

~~~

Total 90650E+03 24500E+0206800 150000 ltS0000EQ1 lt200001+02 lt2aOODE+03 06800

7$08SAo1NYCBOE 3 59-S0LlOIFIED LlaUID IN 100 SOLIDIFIED NP AUCmiddot14 92SOOE+OO 25000E-OlWliHS C Ot)193 31751 ltSOOOOEo3 I lt334OOEQ6 ltJ3400EoS PLASTIC JUG 00193 UQUIDINP NY E Co-6Q 14000E-02 20000E-03

~-I-~~ ------- shy Ihntal ~ ~2JIIl+R9 Zli~IIlll06800 70000 lt50000E4)1 lt20000E+02 lt20000E+03 06800 Total 93240E+OO 25200E-Ol

S9--S0LlOIFrEO LIQUID IN 100 SOLIDIFIED NP AU CT C 00193 31751 lt50000pound03 lt33400Eos lt3340oe05 PLASTIC JUG 00193 LfOlJIDINP 76087-0iIMBP~ 3 H-3 74000E+01 20000E+OO

1htnt1E 14909E+01 200001l+90 ~~~ ~~~~ Total 74000E+Ol 20000E+OO ~ os800 70000 lt50000Eo1 lt20000E+02 lt20000E+03 06800

~~~~-

16058-01NA-NVC AU NY 0~2124 46nOO lt50000Eo3 lt33400E-OO lt330400E()S

I~~~~-----~ --- __ rI~ -~-~~ ~ -~~~ --~~---- ~ -~~~-

75000 1030000 lt5OOOOE-01 lt20000E+02 lt200D0E+03

~~~~ ~~-~~---~~ ---- shyNA-NVC 100 NP~~~~ASTIC Cmiddot14 84268E+OO 22775E-Ol

NY 02115 H-3 53669E+01 1450SE+OO---___----~~-- ---~ ~-~~~~~ ~ ~~~~~~~

1middot125 18500E-Ol 50000E-03 74700 P-32 74000E+01 20000E+OO

Subtotal 13amp26E+02 36amp33E+OO ~~~~-

--- I-~---

FORM 541A10-95)

~UKMb42A 2 MANIFEST NUMBeuroRDuratek Incmiddot Commercial Processing O4-ORTKmiddot1UNIFORM LOW-LEVEL RADIOACTIVE WASTE MANIFEST

3 MANIFEST INDEX AND REGIONAL COMPACT TABULATION (CONTINUATION) PAGE 3 OF 7 PAGE(S)

11 AS PRocesseOCOLLECTED TOTAL 5 bull 1 PREPROCESSEO 9 10 MANIFEST NUMBER(S) UNDERWASTEGENERATOR ORtG1NATING A SOURCE B SNM CACTIVITY O VOLUME

GENERATOR NAME GENERATOR (OR MATERIAL) VvHfCH WASTE (OR MATERIAl) WASTE CODEIDENTIFICATION MATERIAL NUMBER PERMIT NUMBER (IF APPtICABLEj FACILIIY VOLUME REceIVED AND DATE P =PROCESSED ~I~W

AND TELEPHONE NUMBER ADDRESS OF RECEIPT CCOIIECTED OR STATE (k9J (Ib) Ill) (mba) (mCi) (m3) (ft3)

(m3) (ft3)

KCHC KINGS COUNTy HOSPITAL Pathology m$titute 25800E-01 568795(11 000005+00 51202E+02 113838E+01 17400 CENTER 451 CLARKSON AVE NVO180904613 BROOKLYN NY 11203 63176-1592 i-

Lot LASER OPTICS INC 111 WOOSTER STREET 60000pound+01 13228E+02 OOooOE+oo 29600E+02 16J)OOOE+OO 75000 203 144 ~ 4160 BETHEL CT 06801

I

i I yn Lort9 Island UniVefSitragt OooooeOO jOooooe+oo OOOOOeuro+OO 5693OE+01 1S400E+OO 02271 bull0200

NY0073130742 TtS 4Sa160a SROOKLYNON~~ I7

I -- shy

MBPOO MANNKINO 1 CASPER STREiff OoooOE+oo OooooE+oo OOOOOE+OO 7AOOOE-01 i2DOOOE00 06800 810PHARMACEUTICALDanbury DANBURY CT 06810 CT~ 203--7~ ) ___m

I I MBPOE MANNKIND 10OOOOE00 0OOOOE+00 00000pound+00 94720E+01 rlsaoOE+OO 15000shy

BIOPKARMACEUTICAL SUITE 405 Elmsford NY ELMSFORO NY 10523 I

91+$1)6615 I I ~ I I

MRI ~NC 150MA~O OOOOOE+oo aOOOOE+OO OooooE+oo 37000e+01 00005 00 0212 75000 91 TUCKAHOE 01 I

I

I i

I I

MSKCC-R MEMORIAL SLOAN KETTERING ROCKEFELLER BLDG 10000E+00 22046E+00 00000pound+00 35Q76E+02 f94800E+OO 4361$I NYD075265157 NEW YORK NY 10065 CANCER CeNTER~ 430 EAST 61 STREET I 212 639 ~ 1391 I I

I I I

PC MEMORY PHARMACEUTICAL 100 PHILLIPS PARKWAY 03398 119999 7S090 (0410712004) C NJ OOOOOE+OO 100000E+00 00000pound00 31635e+01ja5500eo1 03115 110000 CORP MONTIVAlE NJ 07645 201-802-1229 j

I I

I I

I MC270A MILLENNIUM PHARM 270 210 ALBANY STREeT OOOOOeOO OOOooE+OO QOOOOE+OO 48314E+02 130$ampE+01 150000 Albany St CAMBRIDGE MA 02139 IMAROOO500843 617 679 ~ 70n I

I I FORM 542A (1Q96)

Page 1

DUIatek

Monday April 19 2004

Arthur F Green Radlae Research Corp

261 Kent AVenue Brooklyn NY 11211

Dear Mr Green

The attached signed shipping manifest copies are your notice of receipt of the radioactive waste materials shipment specified on the manifest number below

Manifest Number Date Received

1735-04middotDRTKmiddot1 0411912004

Thank you for your business

Sincerely

Shipping and Receiving

cc Manifest File Shipping and Receiving file

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Prepared by

Antkowiak and Mahoney Ente rprises Inc

3 Valley Court Chester NY 10918

845406-1917

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Survey Date April 19 2006

Survey performed by

Joel Antkowiak

Report prepared by

Robert Mahoney

Reviewed and Approved by ~=-=- Date s)- 1shy

Antkowiak and Mahoney Enterprises Inc

II

Table of Contents

II Approval

Table of Contents 1

I Introduction 2

II Survey Instrumentation 2-3

II III Survey Methodology 4

II IV Summary of Survey Results 5

V List of Rooms Surveyed 6

Appendix Diagrams of Areas Surveyed and Smear Results

II

I I I I I I

1

Antkowiak and Mahoney Ente rprises Inc

I Introduction

This report has been prepared by Antkowiak amp Mahoney Enterprises Inc for MannKind Corp to summarize the results of the monthly radiation safety surveys performed in the radioactive materials use areas at the facility in Danbury Connecticut The purpose of the survey was to identify and define the extent of fixed and removable radioactive contamination in the rooms where radioactive materials are used so that the researchers will be able to decontaminate the areas as soon as possible

The surveys were performed on April 192006 by Joel Antkowiak

II Survey Instrumentation

Table 2-1 provides a description of the instrumentation used to perform the routine monthly surveys

Instrument Use Serial Calibration Number Date

Ludlum Model 12 Direct measurements for beta 195030 072205 and gamma radiation

WModel 43-68 probe PR 178541

Beckman Model Liquid scintillation counting of 7040372 At time of 5000TD Liquid samples for removable use

Scintillation Analyzer radioactive contamination

All meters and instrumentation used for this survey have been calibrated within the past twelve months to standards traceable to the National Institute of Standards and Testing (NIST) The hand held meters response to a dedicated check source was verified prior to use The liquid scintillation counter was calibrated prior to use by running the manufacturers calibration protocol allowing the machine to adjust the gain

Minimum Detectable Activity Calculations

Equation

MDA = 271 + 465 Br x t tx E xA100

where 2MDA = activity in dpm 100 cm

Br = background rate in counts per minute t = counting time in minutes E = detector efficiency in counts per disintegration (41t)

A = probe area or area wiped in cm2

11 II

2

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 3: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

MannKind BioPharmaceuticals A Division of MannKind Corporation

DECAY-IN-STORAGE LOG

Activity Initial Surface Scheduled FinalContainer Storage Decay Nuclide Surveyor RSO InitialEntered Reading Disposal Reading Location Entry Date Initial ampDate ampDate(mCi) (mRlHr) Date (mRlHr)

B001 06052002 - 5 IJCi lt 002 mRHr 03512004 Background ~frS ~)16 Jpound6dar B002 12172002 I - 5 IJCi lt 002 mRlHr 091172004 Background 1JG )-kt~Hf6focf

B003 03172003 -51-1Ci lt 002 mRlHr 121712004 Background (-JJ6 JJJO rlJ6dJJ)oshyB004 04212003 - 5 IJCi lt 002 mRlHr 01212005 Background~~amp5 -)~PJ lbgiJjfd P001 06052002 -75 IJCi lt 002 mRlHr 04052004 Background j1G))ytbf6jbJk P002 03172002 - 26IJCi

- I (V I I

i

I I

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FORM 540 S SHlPPEl - NAME INl) FACIlJll SHIPMENT LD NUMllER a MANIFEST NUMeER MANNKINO IiUO PHARMACeUTICAL NA 7 FoRM 5laquo) INl) 5-IOA PAGE 1 01 1 PAGEts) (Usa this tmnbct on all ~Wllion

UNIFORM LOW-LEVEL RADIOACTIVE 1 CASPER STREET FoRM 5411Nl)SIA 1 PAGES) COLLECTOR FORM52AND~ None PAGEtSI

RADIAC RESEARCH CORP

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FRoassoR SHIPPING PAPER GENERATOR 9 coNSIGNEemiddot Nad FacillIy Addr_ CONTACTI Pmm~---shy

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ROORlGO LAUREAND 261 KENT AVENUE ORGNIIZATION 2Q37ISs 718 963 - p33x 205B~~N~11~11 ~_

CHEMmEC 6 CARRlJR - NrmlWiAdd EPA 10 NUMBER

2 1SlHISANEXClUSlVEUSESHlPMEN17 3 TOTAL NUMBER OF _ RAOIACIlESEARCHCORl Truckt ND04t1T821tl ~~e~~_~ DATE ~U~I oY ~~D lSI KENT AVE TIII SHlPPIIIIG0A1E ~- 10 CER11FICATlOIl

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11 U_S_DEPARTMErrOFTRANS~TATIOIIOESCRlPTION 12 13- V 14- 15 16 17 18 TOTAl WEIGHT 19IDENl1fICATION (Including pntp shlPPino MmO hozatd dan tJN 10 number OOTlABEl TRANSPORT I PHYSlCAl1Nl) INDMDUAL T01ALPACIltAGE ACTMn LSMIOO OR VOLUME NUMeEROF

and MYoddlQorusllnforrnalion 11ADlOACTIE INDEX CHEMICAl FOAM RAllIONUCLIOES MIkI mCl CIASS (Use _prIala unl PACKAGE

RildiQacuvemat8r1al e1ltcepted package4imited quantity of NA IA H-3 4000E+01 rOOOOE+OO NA rllN LaS 5 6081-01Solid ~ Q~J B

material 7 UN2910 r GAL)0 101 l~ltgttilt~ u

I I

20 CerllllltotIM Igt lItIteby made to __nh C41plhotlhls oNgtmontOl _1__I_unobely d_in Iho -monlfegtl TIIo_ d_bod __FOR CONSIGNEE USE ONY llM _red In bull __bull __1RAlMAC IIoce CriIotl _lind _JOgUIatioMlncludlna_ oflho NRC OOT EPA andappllcablbullbullJUIIIIfIl bullIl- Unless sclllally cltJdnd OI luded in wriIIng1ho gthlp OLoC 10 _tho best authltXizad anlt I 0lt lt111111_

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FORM so (10911)

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-FORM 540 s SHtPPSR -NAMeMIO FACILITY SHlPMSNT t P NUMBER 6 WJlIFESllrulolaERGTSDURATEK

RAQtAC RESeAACH CORP 1735 7 FORM 540 AtlD S40A PAGE OF 15 PMlE(S~ (USt lhilli nuneer onon =ntJrwUicn UNIFORM LOW-LEVEL RADIOACTIVE FORM 541 AND SUA U PAGElS)

HI KEllT AIf II COLLECTOR FORM 542 MID 5421 a PAGE(S) TkRTK-1 WASTE MANIFEST BROOKY NY 11211 AOOrTIONAL tt4jORP~iION UQrIC PAGES)

PROCSSOfl

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(lndoaCOltlo) 1560 Bear Creek Road QRGAlZATlOtlt IllIOII4U-7511 Oak Ridge TN 3783D (865) 220-1629

ClIEfITREC CARRtal-Nsrrenl M4r~ ElAIlltlUlJIIER SlGt(lll2E ~- 2 IS THIS A-CXCUJSM USE _n 3 IWlIAC IWIIARCH COlii NtlI4t17Im DA~qAdTOTAL IIUMSEI OF TtUtk

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flO ThtilloOClrify lha~ 1M NlAtiIWlamed DGletfalsarapropctf daUifitd d~bea~ mal1leG It1d~ aMQ~ IllproperccrulJIi(mIorImtlloportaIion~to~oppfimblUaltcnsaf1h~~clT~on Thi$dzt ePAMANlFpoundSTWJMBSR COITACT TElS1IIONE IlUBER cenlfies Ih31Il1e murIaIoiRClmi1iIedfII~ fllHXed Imdtabated and am Inprcpet~lionioffIUItlipCftiiIIiOlJMl4(Iu Area Code)~~~~~~ b]vss ARTIUI GREeJ disposal as cfacrlbed In a~ idllhe requirttMnl5 at to CFR PaIb ~t)tId 61 creQU1~ state I~7bullbull tn-allIMNIlFEST ACCOMPANY K NO

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(lnCIudina_J1IpplngnamollUInt U O DOT LABEl TRANSORT PHSICAIAND ItlDMDUAL J TOTAl PP~AtJM1Y LSMiCO ORVOWIdE IIUM8IROF

oodanyaddlticnal_ IIIIDIOACT1VE INDX CHEMICAl FORM MOIOtlUCIlOJS Mlq mCgt ClASS PACKAGEtu s_I Radloacliv8 material excepted package-limited quantity of IIA [lA Solid SOUDIFIEO UQUID Csmiddot137 H-3 92101+01 33DOE+OQ RG LSS 401 321D5A material 7 UN2910 I COMPACTIBLE TRASH (3 JARS) ampGlASS m Radloacllve material excepted packageflmfted quantity of NA NA Solid PAPER PlASTIC amp10 CI-36 H-3 Namiddot22 1100E+OO 1OO0E-01 Nil 31 LBS 401 32106 material 7 UN2910 JCOMBUSTIBLE TRASH GlASS VIALS m Radioacllve material excepted packagefimlted quanUty of NA rlA Solid PlASTIC PAPER Thmiddot232 7oo0e-02 Doooe-03 Nil 76 LBS41 32112 material 7 IIN2910 JCOMBUSTIBLE TRASH PLYWOOD m Radloactive material excepled package-lImlted quanlity of IIA ~A Solid PAPER PLASTIC 1-125 3690E+01 Nil 131 LBS 75 33762

matllfllll 7 UN2910 JCOMPACTIBLE TRASH GlASS m rmiddot700DE-Il1

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Radioactive material low specific activity noo5bull 1 UIII2912 Nil ~1 Solid PlASTIC FOIU Th-232 9600E+01 ISA-li 110 LBS 75 134892l0ooOE-01 I COMPACTIBLE TRASH Thorium fluoride m FOR CONSIGNEE USE DIlLY 2ll GEllERATORCERTlFICATlOti STAT6IpoundIIT

A) Ra$uadlve Malldab Ceruficauon is hereby made lD GTS Ourntellne Uta lhl5 Shi~t oJ IOH-I~ rJdioadivamp teIta~ has Igtftrt Jlepared in ~ TSNIIESSa I1CIiI1SE FCft DElIIERI IlO t4bmQlODdiloeW$lCrnJNgement~~trabecn~bythtNudeil(~CormISSIonorDIJtqeemerltStatef~ltwyagenty3rdWib

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FORM 540 (111-911)

5uweyltc( 1-17-00 ~k-

--

-----

-----

----- -----

F~ Duratek Inc - Commercial Processing 2 MANgt NUMBERUNIFORM LOW-LEVEL RADIOACTIVE O4-ORTKmiddot1

WASTE MANIFEST 3 PAGE 7 OF 26 PAGE(S)CONTAINER AND WASTE DESCRIPTION (CONTINUATION)

DISPOSAL CONTAINER DESCRIPTION WASTE DESCRIPTION FOR EACH WASTE TYPE IN CONTAINER 16 WASTE ~~~~ 7

5 8~ 9~ 10~ PHYSICAL OESCRIPTION 14 CHEMICAL OESCRJPTION lS~ RADIOLOGICAl OESCRIPTlON CLAssIFImiddot 6 CONTAINER OESCRIPTiON CATION

CONTAiNER WASTE SURFACE SJRFAC~~ - 12 13 WEfGHT(See 1) AS-CIaraquoIDENTIFICATION AND RADIATION _10PROCESS REQUESTED VOLUME WASTE APPROXIMATE CHEMICAL FORMI NUMBERI CONTAiNER LEVL ~ Maqiloo2~)

DESCRIPTOR WASTE O~JI3~~~~NOF CHELATING AGENT ~HELATING INDIVIDUAL RADIONUCLIDES AND ACTIVITY (MBq) AND AlJClasASee Note 1A GENERATOR 10 VVEIGHT ImSvJhr) CONTAINER TOTAL OR CONTAINER TOTAL ACTfVlTY(dpml00m2) VOLUMIS) IN MEDIA Unstable

NUMBER BURlALJD1SPOSjTI0N mremlhr) AGENT ANO AADIONucUOe PERCENT (kg) S~Not~2) CONTAINER QClassB(Sbullbull Not 2A)

BETA-gt (m3) (See Note 3 IF gt01 CclanC(ib) ALPHA GAMMA Iffij RADIONUCUDES M9q mG

H-3 21460E+Ol 58000E-Ol76000-1348721SUNVsT 4 3 100 PAPER PLASTIC ~ AU 8RooK C 02124 51709$ ltSOOOOEo3 lt334005-06 lt334QOpound-O$ 02124 GLASSJNP 1hiMNY E 214sect)E+01 58009Ej1

~ ~~~ -~~~~-1--- ~-- I-----~~- Total 21460E+01 58000E-Ol

75000 10000 lt50000Eo1 lt20000E+02 lt200005+03 75000

7S08()141730ISUNY-ST 4 3 100 PAPERPLASTIC NP AUHmiddot3 31080E+OO 84000E-02BROOK C 02124 530103 lt50000El3 lt33400E-C16 lt33400E-ltl5 02124 GLASSINP NY ISuhlotal 31080E+OO 84000B2E 1 ~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ I~~ ~~ ~~~~~~~~~~~~~~~~~ i ~~ ~~~~~

Total 31080E+OO 84000E-OZ75000 1170000 lt50000Eo1 lt200005+02 lt20000euro+03 75000

760S1-1RW 3 39 100 JNATCH PARTSINP NP Hmiddot3 90650E+03 24500E+02 ~~ NY C 00193 72575 ltSOOOOED3 lt33400E-06 lt33400E-05 00193

E ISubtotal 90659E+03 24599E+02 ~~-~-~~~-~

Total 90650E+03 24500E+02 06800 160000 lt50000E-01 lt20000E+02 lt200005+03 06800

760B1~2IRW 3 39 100 WATCH PARiSJNP I----w AUH-3 90650E+03 24500E+02Ilf C 00193 60039 lt50000eo3 lt33400E-OO lt33400Eos 00193 1h~1 90650E+03E 24599E+02

~~~

Total 90650E+03 24500E+0206800 150000 ltS0000EQ1 lt200001+02 lt2aOODE+03 06800

7$08SAo1NYCBOE 3 59-S0LlOIFIED LlaUID IN 100 SOLIDIFIED NP AUCmiddot14 92SOOE+OO 25000E-OlWliHS C Ot)193 31751 ltSOOOOEo3 I lt334OOEQ6 ltJ3400EoS PLASTIC JUG 00193 UQUIDINP NY E Co-6Q 14000E-02 20000E-03

~-I-~~ ------- shy Ihntal ~ ~2JIIl+R9 Zli~IIlll06800 70000 lt50000E4)1 lt20000E+02 lt20000E+03 06800 Total 93240E+OO 25200E-Ol

S9--S0LlOIFrEO LIQUID IN 100 SOLIDIFIED NP AU CT C 00193 31751 lt50000pound03 lt33400Eos lt3340oe05 PLASTIC JUG 00193 LfOlJIDINP 76087-0iIMBP~ 3 H-3 74000E+01 20000E+OO

1htnt1E 14909E+01 200001l+90 ~~~ ~~~~ Total 74000E+Ol 20000E+OO ~ os800 70000 lt50000Eo1 lt20000E+02 lt20000E+03 06800

~~~~-

16058-01NA-NVC AU NY 0~2124 46nOO lt50000Eo3 lt33400E-OO lt330400E()S

I~~~~-----~ --- __ rI~ -~-~~ ~ -~~~ --~~---- ~ -~~~-

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NY 02115 H-3 53669E+01 1450SE+OO---___----~~-- ---~ ~-~~~~~ ~ ~~~~~~~

1middot125 18500E-Ol 50000E-03 74700 P-32 74000E+01 20000E+OO

Subtotal 13amp26E+02 36amp33E+OO ~~~~-

--- I-~---

FORM 541A10-95)

~UKMb42A 2 MANIFEST NUMBeuroRDuratek Incmiddot Commercial Processing O4-ORTKmiddot1UNIFORM LOW-LEVEL RADIOACTIVE WASTE MANIFEST

3 MANIFEST INDEX AND REGIONAL COMPACT TABULATION (CONTINUATION) PAGE 3 OF 7 PAGE(S)

11 AS PRocesseOCOLLECTED TOTAL 5 bull 1 PREPROCESSEO 9 10 MANIFEST NUMBER(S) UNDERWASTEGENERATOR ORtG1NATING A SOURCE B SNM CACTIVITY O VOLUME

GENERATOR NAME GENERATOR (OR MATERIAL) VvHfCH WASTE (OR MATERIAl) WASTE CODEIDENTIFICATION MATERIAL NUMBER PERMIT NUMBER (IF APPtICABLEj FACILIIY VOLUME REceIVED AND DATE P =PROCESSED ~I~W

AND TELEPHONE NUMBER ADDRESS OF RECEIPT CCOIIECTED OR STATE (k9J (Ib) Ill) (mba) (mCi) (m3) (ft3)

(m3) (ft3)

KCHC KINGS COUNTy HOSPITAL Pathology m$titute 25800E-01 568795(11 000005+00 51202E+02 113838E+01 17400 CENTER 451 CLARKSON AVE NVO180904613 BROOKLYN NY 11203 63176-1592 i-

Lot LASER OPTICS INC 111 WOOSTER STREET 60000pound+01 13228E+02 OOooOE+oo 29600E+02 16J)OOOE+OO 75000 203 144 ~ 4160 BETHEL CT 06801

I

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I I MBPOE MANNKIND 10OOOOE00 0OOOOE+00 00000pound+00 94720E+01 rlsaoOE+OO 15000shy

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I I I

PC MEMORY PHARMACEUTICAL 100 PHILLIPS PARKWAY 03398 119999 7S090 (0410712004) C NJ OOOOOE+OO 100000E+00 00000pound00 31635e+01ja5500eo1 03115 110000 CORP MONTIVAlE NJ 07645 201-802-1229 j

I I

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I MC270A MILLENNIUM PHARM 270 210 ALBANY STREeT OOOOOeOO OOOooE+OO QOOOOE+OO 48314E+02 130$ampE+01 150000 Albany St CAMBRIDGE MA 02139 IMAROOO500843 617 679 ~ 70n I

I I FORM 542A (1Q96)

Page 1

DUIatek

Monday April 19 2004

Arthur F Green Radlae Research Corp

261 Kent AVenue Brooklyn NY 11211

Dear Mr Green

The attached signed shipping manifest copies are your notice of receipt of the radioactive waste materials shipment specified on the manifest number below

Manifest Number Date Received

1735-04middotDRTKmiddot1 0411912004

Thank you for your business

Sincerely

Shipping and Receiving

cc Manifest File Shipping and Receiving file

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Prepared by

Antkowiak and Mahoney Ente rprises Inc

3 Valley Court Chester NY 10918

845406-1917

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Survey Date April 19 2006

Survey performed by

Joel Antkowiak

Report prepared by

Robert Mahoney

Reviewed and Approved by ~=-=- Date s)- 1shy

Antkowiak and Mahoney Enterprises Inc

II

Table of Contents

II Approval

Table of Contents 1

I Introduction 2

II Survey Instrumentation 2-3

II III Survey Methodology 4

II IV Summary of Survey Results 5

V List of Rooms Surveyed 6

Appendix Diagrams of Areas Surveyed and Smear Results

II

I I I I I I

1

Antkowiak and Mahoney Ente rprises Inc

I Introduction

This report has been prepared by Antkowiak amp Mahoney Enterprises Inc for MannKind Corp to summarize the results of the monthly radiation safety surveys performed in the radioactive materials use areas at the facility in Danbury Connecticut The purpose of the survey was to identify and define the extent of fixed and removable radioactive contamination in the rooms where radioactive materials are used so that the researchers will be able to decontaminate the areas as soon as possible

The surveys were performed on April 192006 by Joel Antkowiak

II Survey Instrumentation

Table 2-1 provides a description of the instrumentation used to perform the routine monthly surveys

Instrument Use Serial Calibration Number Date

Ludlum Model 12 Direct measurements for beta 195030 072205 and gamma radiation

WModel 43-68 probe PR 178541

Beckman Model Liquid scintillation counting of 7040372 At time of 5000TD Liquid samples for removable use

Scintillation Analyzer radioactive contamination

All meters and instrumentation used for this survey have been calibrated within the past twelve months to standards traceable to the National Institute of Standards and Testing (NIST) The hand held meters response to a dedicated check source was verified prior to use The liquid scintillation counter was calibrated prior to use by running the manufacturers calibration protocol allowing the machine to adjust the gain

Minimum Detectable Activity Calculations

Equation

MDA = 271 + 465 Br x t tx E xA100

where 2MDA = activity in dpm 100 cm

Br = background rate in counts per minute t = counting time in minutes E = detector efficiency in counts per disintegration (41t)

A = probe area or area wiped in cm2

11 II

2

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 4: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

~PkQltshy

FORM 540 S SHlPPEl - NAME INl) FACIlJll SHIPMENT LD NUMllER a MANIFEST NUMeER MANNKINO IiUO PHARMACeUTICAL NA 7 FoRM 5laquo) INl) 5-IOA PAGE 1 01 1 PAGEts) (Usa this tmnbct on all ~Wllion

UNIFORM LOW-LEVEL RADIOACTIVE 1 CASPER STREET FoRM 5411Nl)SIA 1 PAGES) COLLECTOR FORM52AND~ None PAGEtSI

RADIAC RESEARCH CORP

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ROORlGO LAUREAND 261 KENT AVENUE ORGNIIZATION 2Q37ISs 718 963 - p33x 205B~~N~11~11 ~_

CHEMmEC 6 CARRlJR - NrmlWiAdd EPA 10 NUMBER

2 1SlHISANEXClUSlVEUSESHlPMEN17 3 TOTAL NUMBER OF _ RAOIACIlESEARCHCORl Truckt ND04t1T821tl ~~e~~_~ DATE ~U~I oY ~~D lSI KENT AVE TIII SHlPPIIIIG0A1E ~- 10 CER11FICATlOIl

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11 U_S_DEPARTMErrOFTRANS~TATIOIIOESCRlPTION 12 13- V 14- 15 16 17 18 TOTAl WEIGHT 19IDENl1fICATION (Including pntp shlPPino MmO hozatd dan tJN 10 number OOTlABEl TRANSPORT I PHYSlCAl1Nl) INDMDUAL T01ALPACIltAGE ACTMn LSMIOO OR VOLUME NUMeEROF

and MYoddlQorusllnforrnalion 11ADlOACTIE INDEX CHEMICAl FOAM RAllIONUCLIOES MIkI mCl CIASS (Use _prIala unl PACKAGE

RildiQacuvemat8r1al e1ltcepted package4imited quantity of NA IA H-3 4000E+01 rOOOOE+OO NA rllN LaS 5 6081-01Solid ~ Q~J B

material 7 UN2910 r GAL)0 101 l~ltgttilt~ u

I I

20 CerllllltotIM Igt lItIteby made to __nh C41plhotlhls oNgtmontOl _1__I_unobely d_in Iho -monlfegtl TIIo_ d_bod __FOR CONSIGNEE USE ONY llM _red In bull __bull __1RAlMAC IIoce CriIotl _lind _JOgUIatioMlncludlna_ oflho NRC OOT EPA andappllcablbullbullJUIIIIfIl bullIl- Unless sclllally cltJdnd OI luded in wriIIng1ho gthlp OLoC 10 _tho best authltXizad anlt I 0lt lt111111_

Ogtlo 3~I Oi-j r phono ampS-1CCJ~~

FORM so (10911)

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-FORM 540 s SHtPPSR -NAMeMIO FACILITY SHlPMSNT t P NUMBER 6 WJlIFESllrulolaERGTSDURATEK

RAQtAC RESeAACH CORP 1735 7 FORM 540 AtlD S40A PAGE OF 15 PMlE(S~ (USt lhilli nuneer onon =ntJrwUicn UNIFORM LOW-LEVEL RADIOACTIVE FORM 541 AND SUA U PAGElS)

HI KEllT AIf II COLLECTOR FORM 542 MID 5421 a PAGE(S) TkRTK-1 WASTE MANIFEST BROOKY NY 11211 AOOrTIONAL tt4jORP~iION UQrIC PAGES)

PROCSSOfl

SHIPPING PAPER (lEJIERATORTYPE 9 CONstGteemiddot ttame aM Facility AdWMIO COtlTACTISHMerr 11011_ T-NYOl1-1J1( W SfffiJy) Ed Kolski I Donnie alllc~elt

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(lndoaCOltlo) 1560 Bear Creek Road QRGAlZATlOtlt IllIOII4U-7511 Oak Ridge TN 3783D (865) 220-1629

ClIEfITREC CARRtal-Nsrrenl M4r~ ElAIlltlUlJIIER SlGt(lll2E ~- 2 IS THIS A-CXCUJSM USE _n 3 IWlIAC IWIIARCH COlii NtlI4t17Im DA~qAdTOTAL IIUMSEI OF TtUtk

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flO ThtilloOClrify lha~ 1M NlAtiIWlamed DGletfalsarapropctf daUifitd d~bea~ mal1leG It1d~ aMQ~ IllproperccrulJIi(mIorImtlloportaIion~to~oppfimblUaltcnsaf1h~~clT~on Thi$dzt ePAMANlFpoundSTWJMBSR COITACT TElS1IIONE IlUBER cenlfies Ih31Il1e murIaIoiRClmi1iIedfII~ fllHXed Imdtabated and am Inprcpet~lionioffIUItlipCftiiIIiOlJMl4(Iu Area Code)~~~~~~ b]vss ARTIUI GREeJ disposal as cfacrlbed In a~ idllhe requirttMnl5 at to CFR PaIb ~t)tId 61 creQU1~ state I~7bullbull tn-allIMNIlFEST ACCOMPANY K NO

llilS SHIPMam IA OAT DATSnV pnM~MrII_=====gt TInE tQu-~- -~~O~ ~~O~rv-~ l( I~ middotOt~-1 us DEPARTerr 01 TlW1SIORTATlOII DESClUPTlOIJ z y13 14 1$ 17 18 TOTAL WEIGIiT 19IOEHTlFICATlOtl

(lnCIudina_J1IpplngnamollUInt U O DOT LABEl TRANSORT PHSICAIAND ItlDMDUAL J TOTAl PP~AtJM1Y LSMiCO ORVOWIdE IIUM8IROF

oodanyaddlticnal_ IIIIDIOACT1VE INDX CHEMICAl FORM MOIOtlUCIlOJS Mlq mCgt ClASS PACKAGEtu s_I Radloacliv8 material excepted package-limited quantity of IIA [lA Solid SOUDIFIEO UQUID Csmiddot137 H-3 92101+01 33DOE+OQ RG LSS 401 321D5A material 7 UN2910 I COMPACTIBLE TRASH (3 JARS) ampGlASS m Radloacllve material excepted packageflmfted quantity of NA NA Solid PAPER PlASTIC amp10 CI-36 H-3 Namiddot22 1100E+OO 1OO0E-01 Nil 31 LBS 401 32106 material 7 UN2910 JCOMBUSTIBLE TRASH GlASS VIALS m Radioacllve material excepted packagefimlted quanUty of NA rlA Solid PlASTIC PAPER Thmiddot232 7oo0e-02 Doooe-03 Nil 76 LBS41 32112 material 7 IIN2910 JCOMBUSTIBLE TRASH PLYWOOD m Radloactive material excepled package-lImlted quanlity of IIA ~A Solid PAPER PLASTIC 1-125 3690E+01 Nil 131 LBS 75 33762

matllfllll 7 UN2910 JCOMPACTIBLE TRASH GlASS m rmiddot700DE-Il1

~~~Radloacllve matarla~ low specific activlty nos 7 UW2912 NA 1 SoUd PLASTIC FOIU Th-232 9600E+01 OOODE-01 LSA-It 147 LBS 75 34Bll1 I COMPACTIBLE TRASH Thorium fluoride FT3

Radioactive material low specific activity noo5bull 1 UIII2912 Nil ~1 Solid PlASTIC FOIU Th-232 9600E+01 ISA-li 110 LBS 75 134892l0ooOE-01 I COMPACTIBLE TRASH Thorium fluoride m FOR CONSIGNEE USE DIlLY 2ll GEllERATORCERTlFICATlOti STAT6IpoundIIT

A) Ra$uadlve Malldab Ceruficauon is hereby made lD GTS Ourntellne Uta lhl5 Shi~t oJ IOH-I~ rJdioadivamp teIta~ has Igtftrt Jlepared in ~ TSNIIESSa I1CIiI1SE FCft DElIIERI IlO t4bmQlODdiloeW$lCrnJNgement~~trabecn~bythtNudeil(~CormISSIonorDIJtqeemerltStatef~ltwyagenty3rdWib

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3S~(middotmiddotS~~Qrui-~2J~~-~I~-= ~ tlf O~ US ECOLOGY PERMIT 00

pw -ltQfllgtlut DaI _____---------_

FORM 540 (111-911)

5uweyltc( 1-17-00 ~k-

--

-----

-----

----- -----

F~ Duratek Inc - Commercial Processing 2 MANgt NUMBERUNIFORM LOW-LEVEL RADIOACTIVE O4-ORTKmiddot1

WASTE MANIFEST 3 PAGE 7 OF 26 PAGE(S)CONTAINER AND WASTE DESCRIPTION (CONTINUATION)

DISPOSAL CONTAINER DESCRIPTION WASTE DESCRIPTION FOR EACH WASTE TYPE IN CONTAINER 16 WASTE ~~~~ 7

5 8~ 9~ 10~ PHYSICAL OESCRIPTION 14 CHEMICAL OESCRJPTION lS~ RADIOLOGICAl OESCRIPTlON CLAssIFImiddot 6 CONTAINER OESCRIPTiON CATION

CONTAiNER WASTE SURFACE SJRFAC~~ - 12 13 WEfGHT(See 1) AS-CIaraquoIDENTIFICATION AND RADIATION _10PROCESS REQUESTED VOLUME WASTE APPROXIMATE CHEMICAL FORMI NUMBERI CONTAiNER LEVL ~ Maqiloo2~)

DESCRIPTOR WASTE O~JI3~~~~NOF CHELATING AGENT ~HELATING INDIVIDUAL RADIONUCLIDES AND ACTIVITY (MBq) AND AlJClasASee Note 1A GENERATOR 10 VVEIGHT ImSvJhr) CONTAINER TOTAL OR CONTAINER TOTAL ACTfVlTY(dpml00m2) VOLUMIS) IN MEDIA Unstable

NUMBER BURlALJD1SPOSjTI0N mremlhr) AGENT ANO AADIONucUOe PERCENT (kg) S~Not~2) CONTAINER QClassB(Sbullbull Not 2A)

BETA-gt (m3) (See Note 3 IF gt01 CclanC(ib) ALPHA GAMMA Iffij RADIONUCUDES M9q mG

H-3 21460E+Ol 58000E-Ol76000-1348721SUNVsT 4 3 100 PAPER PLASTIC ~ AU 8RooK C 02124 51709$ ltSOOOOEo3 lt334005-06 lt334QOpound-O$ 02124 GLASSJNP 1hiMNY E 214sect)E+01 58009Ej1

~ ~~~ -~~~~-1--- ~-- I-----~~- Total 21460E+01 58000E-Ol

75000 10000 lt50000Eo1 lt20000E+02 lt200005+03 75000

7S08()141730ISUNY-ST 4 3 100 PAPERPLASTIC NP AUHmiddot3 31080E+OO 84000E-02BROOK C 02124 530103 lt50000El3 lt33400E-C16 lt33400E-ltl5 02124 GLASSINP NY ISuhlotal 31080E+OO 84000B2E 1 ~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ I~~ ~~ ~~~~~~~~~~~~~~~~~ i ~~ ~~~~~

Total 31080E+OO 84000E-OZ75000 1170000 lt50000Eo1 lt200005+02 lt20000euro+03 75000

760S1-1RW 3 39 100 JNATCH PARTSINP NP Hmiddot3 90650E+03 24500E+02 ~~ NY C 00193 72575 ltSOOOOED3 lt33400E-06 lt33400E-05 00193

E ISubtotal 90659E+03 24599E+02 ~~-~-~~~-~

Total 90650E+03 24500E+02 06800 160000 lt50000E-01 lt20000E+02 lt200005+03 06800

760B1~2IRW 3 39 100 WATCH PARiSJNP I----w AUH-3 90650E+03 24500E+02Ilf C 00193 60039 lt50000eo3 lt33400E-OO lt33400Eos 00193 1h~1 90650E+03E 24599E+02

~~~

Total 90650E+03 24500E+0206800 150000 ltS0000EQ1 lt200001+02 lt2aOODE+03 06800

7$08SAo1NYCBOE 3 59-S0LlOIFIED LlaUID IN 100 SOLIDIFIED NP AUCmiddot14 92SOOE+OO 25000E-OlWliHS C Ot)193 31751 ltSOOOOEo3 I lt334OOEQ6 ltJ3400EoS PLASTIC JUG 00193 UQUIDINP NY E Co-6Q 14000E-02 20000E-03

~-I-~~ ------- shy Ihntal ~ ~2JIIl+R9 Zli~IIlll06800 70000 lt50000E4)1 lt20000E+02 lt20000E+03 06800 Total 93240E+OO 25200E-Ol

S9--S0LlOIFrEO LIQUID IN 100 SOLIDIFIED NP AU CT C 00193 31751 lt50000pound03 lt33400Eos lt3340oe05 PLASTIC JUG 00193 LfOlJIDINP 76087-0iIMBP~ 3 H-3 74000E+01 20000E+OO

1htnt1E 14909E+01 200001l+90 ~~~ ~~~~ Total 74000E+Ol 20000E+OO ~ os800 70000 lt50000Eo1 lt20000E+02 lt20000E+03 06800

~~~~-

16058-01NA-NVC AU NY 0~2124 46nOO lt50000Eo3 lt33400E-OO lt330400E()S

I~~~~-----~ --- __ rI~ -~-~~ ~ -~~~ --~~---- ~ -~~~-

75000 1030000 lt5OOOOE-01 lt20000E+02 lt200D0E+03

~~~~ ~~-~~---~~ ---- shyNA-NVC 100 NP~~~~ASTIC Cmiddot14 84268E+OO 22775E-Ol

NY 02115 H-3 53669E+01 1450SE+OO---___----~~-- ---~ ~-~~~~~ ~ ~~~~~~~

1middot125 18500E-Ol 50000E-03 74700 P-32 74000E+01 20000E+OO

Subtotal 13amp26E+02 36amp33E+OO ~~~~-

--- I-~---

FORM 541A10-95)

~UKMb42A 2 MANIFEST NUMBeuroRDuratek Incmiddot Commercial Processing O4-ORTKmiddot1UNIFORM LOW-LEVEL RADIOACTIVE WASTE MANIFEST

3 MANIFEST INDEX AND REGIONAL COMPACT TABULATION (CONTINUATION) PAGE 3 OF 7 PAGE(S)

11 AS PRocesseOCOLLECTED TOTAL 5 bull 1 PREPROCESSEO 9 10 MANIFEST NUMBER(S) UNDERWASTEGENERATOR ORtG1NATING A SOURCE B SNM CACTIVITY O VOLUME

GENERATOR NAME GENERATOR (OR MATERIAL) VvHfCH WASTE (OR MATERIAl) WASTE CODEIDENTIFICATION MATERIAL NUMBER PERMIT NUMBER (IF APPtICABLEj FACILIIY VOLUME REceIVED AND DATE P =PROCESSED ~I~W

AND TELEPHONE NUMBER ADDRESS OF RECEIPT CCOIIECTED OR STATE (k9J (Ib) Ill) (mba) (mCi) (m3) (ft3)

(m3) (ft3)

KCHC KINGS COUNTy HOSPITAL Pathology m$titute 25800E-01 568795(11 000005+00 51202E+02 113838E+01 17400 CENTER 451 CLARKSON AVE NVO180904613 BROOKLYN NY 11203 63176-1592 i-

Lot LASER OPTICS INC 111 WOOSTER STREET 60000pound+01 13228E+02 OOooOE+oo 29600E+02 16J)OOOE+OO 75000 203 144 ~ 4160 BETHEL CT 06801

I

i I yn Lort9 Island UniVefSitragt OooooeOO jOooooe+oo OOOOOeuro+OO 5693OE+01 1S400E+OO 02271 bull0200

NY0073130742 TtS 4Sa160a SROOKLYNON~~ I7

I -- shy

MBPOO MANNKINO 1 CASPER STREiff OoooOE+oo OooooE+oo OOOOOE+OO 7AOOOE-01 i2DOOOE00 06800 810PHARMACEUTICALDanbury DANBURY CT 06810 CT~ 203--7~ ) ___m

I I MBPOE MANNKIND 10OOOOE00 0OOOOE+00 00000pound+00 94720E+01 rlsaoOE+OO 15000shy

BIOPKARMACEUTICAL SUITE 405 Elmsford NY ELMSFORO NY 10523 I

91+$1)6615 I I ~ I I

MRI ~NC 150MA~O OOOOOE+oo aOOOOE+OO OooooE+oo 37000e+01 00005 00 0212 75000 91 TUCKAHOE 01 I

I

I i

I I

MSKCC-R MEMORIAL SLOAN KETTERING ROCKEFELLER BLDG 10000E+00 22046E+00 00000pound+00 35Q76E+02 f94800E+OO 4361$I NYD075265157 NEW YORK NY 10065 CANCER CeNTER~ 430 EAST 61 STREET I 212 639 ~ 1391 I I

I I I

PC MEMORY PHARMACEUTICAL 100 PHILLIPS PARKWAY 03398 119999 7S090 (0410712004) C NJ OOOOOE+OO 100000E+00 00000pound00 31635e+01ja5500eo1 03115 110000 CORP MONTIVAlE NJ 07645 201-802-1229 j

I I

I I

I MC270A MILLENNIUM PHARM 270 210 ALBANY STREeT OOOOOeOO OOOooE+OO QOOOOE+OO 48314E+02 130$ampE+01 150000 Albany St CAMBRIDGE MA 02139 IMAROOO500843 617 679 ~ 70n I

I I FORM 542A (1Q96)

Page 1

DUIatek

Monday April 19 2004

Arthur F Green Radlae Research Corp

261 Kent AVenue Brooklyn NY 11211

Dear Mr Green

The attached signed shipping manifest copies are your notice of receipt of the radioactive waste materials shipment specified on the manifest number below

Manifest Number Date Received

1735-04middotDRTKmiddot1 0411912004

Thank you for your business

Sincerely

Shipping and Receiving

cc Manifest File Shipping and Receiving file

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Prepared by

Antkowiak and Mahoney Ente rprises Inc

3 Valley Court Chester NY 10918

845406-1917

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Survey Date April 19 2006

Survey performed by

Joel Antkowiak

Report prepared by

Robert Mahoney

Reviewed and Approved by ~=-=- Date s)- 1shy

Antkowiak and Mahoney Enterprises Inc

II

Table of Contents

II Approval

Table of Contents 1

I Introduction 2

II Survey Instrumentation 2-3

II III Survey Methodology 4

II IV Summary of Survey Results 5

V List of Rooms Surveyed 6

Appendix Diagrams of Areas Surveyed and Smear Results

II

I I I I I I

1

Antkowiak and Mahoney Ente rprises Inc

I Introduction

This report has been prepared by Antkowiak amp Mahoney Enterprises Inc for MannKind Corp to summarize the results of the monthly radiation safety surveys performed in the radioactive materials use areas at the facility in Danbury Connecticut The purpose of the survey was to identify and define the extent of fixed and removable radioactive contamination in the rooms where radioactive materials are used so that the researchers will be able to decontaminate the areas as soon as possible

The surveys were performed on April 192006 by Joel Antkowiak

II Survey Instrumentation

Table 2-1 provides a description of the instrumentation used to perform the routine monthly surveys

Instrument Use Serial Calibration Number Date

Ludlum Model 12 Direct measurements for beta 195030 072205 and gamma radiation

WModel 43-68 probe PR 178541

Beckman Model Liquid scintillation counting of 7040372 At time of 5000TD Liquid samples for removable use

Scintillation Analyzer radioactive contamination

All meters and instrumentation used for this survey have been calibrated within the past twelve months to standards traceable to the National Institute of Standards and Testing (NIST) The hand held meters response to a dedicated check source was verified prior to use The liquid scintillation counter was calibrated prior to use by running the manufacturers calibration protocol allowing the machine to adjust the gain

Minimum Detectable Activity Calculations

Equation

MDA = 271 + 465 Br x t tx E xA100

where 2MDA = activity in dpm 100 cm

Br = background rate in counts per minute t = counting time in minutes E = detector efficiency in counts per disintegration (41t)

A = probe area or area wiped in cm2

11 II

2

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 5: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

__

-FORM 540 s SHtPPSR -NAMeMIO FACILITY SHlPMSNT t P NUMBER 6 WJlIFESllrulolaERGTSDURATEK

RAQtAC RESeAACH CORP 1735 7 FORM 540 AtlD S40A PAGE OF 15 PMlE(S~ (USt lhilli nuneer onon =ntJrwUicn UNIFORM LOW-LEVEL RADIOACTIVE FORM 541 AND SUA U PAGElS)

HI KEllT AIf II COLLECTOR FORM 542 MID 5421 a PAGE(S) TkRTK-1 WASTE MANIFEST BROOKY NY 11211 AOOrTIONAL tt4jORP~iION UQrIC PAGES)

PROCSSOfl

SHIPPING PAPER (lEJIERATORTYPE 9 CONstGteemiddot ttame aM Facility AdWMIO COtlTACTISHMerr 11011_ T-NYOl1-1J1( W SfffiJy) Ed Kolski I Donnie alllc~elt

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(lndoaCOltlo) 1560 Bear Creek Road QRGAlZATlOtlt IllIOII4U-7511 Oak Ridge TN 3783D (865) 220-1629

ClIEfITREC CARRtal-Nsrrenl M4r~ ElAIlltlUlJIIER SlGt(lll2E ~- 2 IS THIS A-CXCUJSM USE _n 3 IWlIAC IWIIARCH COlii NtlI4t17Im DA~qAdTOTAL IIUMSEI OF TtUtk

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flO ThtilloOClrify lha~ 1M NlAtiIWlamed DGletfalsarapropctf daUifitd d~bea~ mal1leG It1d~ aMQ~ IllproperccrulJIi(mIorImtlloportaIion~to~oppfimblUaltcnsaf1h~~clT~on Thi$dzt ePAMANlFpoundSTWJMBSR COITACT TElS1IIONE IlUBER cenlfies Ih31Il1e murIaIoiRClmi1iIedfII~ fllHXed Imdtabated and am Inprcpet~lionioffIUItlipCftiiIIiOlJMl4(Iu Area Code)~~~~~~ b]vss ARTIUI GREeJ disposal as cfacrlbed In a~ idllhe requirttMnl5 at to CFR PaIb ~t)tId 61 creQU1~ state I~7bullbull tn-allIMNIlFEST ACCOMPANY K NO

llilS SHIPMam IA OAT DATSnV pnM~MrII_=====gt TInE tQu-~- -~~O~ ~~O~rv-~ l( I~ middotOt~-1 us DEPARTerr 01 TlW1SIORTATlOII DESClUPTlOIJ z y13 14 1$ 17 18 TOTAL WEIGIiT 19IOEHTlFICATlOtl

(lnCIudina_J1IpplngnamollUInt U O DOT LABEl TRANSORT PHSICAIAND ItlDMDUAL J TOTAl PP~AtJM1Y LSMiCO ORVOWIdE IIUM8IROF

oodanyaddlticnal_ IIIIDIOACT1VE INDX CHEMICAl FORM MOIOtlUCIlOJS Mlq mCgt ClASS PACKAGEtu s_I Radloacliv8 material excepted package-limited quantity of IIA [lA Solid SOUDIFIEO UQUID Csmiddot137 H-3 92101+01 33DOE+OQ RG LSS 401 321D5A material 7 UN2910 I COMPACTIBLE TRASH (3 JARS) ampGlASS m Radloacllve material excepted packageflmfted quantity of NA NA Solid PAPER PlASTIC amp10 CI-36 H-3 Namiddot22 1100E+OO 1OO0E-01 Nil 31 LBS 401 32106 material 7 UN2910 JCOMBUSTIBLE TRASH GlASS VIALS m Radioacllve material excepted packagefimlted quanUty of NA rlA Solid PlASTIC PAPER Thmiddot232 7oo0e-02 Doooe-03 Nil 76 LBS41 32112 material 7 IIN2910 JCOMBUSTIBLE TRASH PLYWOOD m Radloactive material excepled package-lImlted quanlity of IIA ~A Solid PAPER PLASTIC 1-125 3690E+01 Nil 131 LBS 75 33762

matllfllll 7 UN2910 JCOMPACTIBLE TRASH GlASS m rmiddot700DE-Il1

~~~Radloacllve matarla~ low specific activlty nos 7 UW2912 NA 1 SoUd PLASTIC FOIU Th-232 9600E+01 OOODE-01 LSA-It 147 LBS 75 34Bll1 I COMPACTIBLE TRASH Thorium fluoride FT3

Radioactive material low specific activity noo5bull 1 UIII2912 Nil ~1 Solid PlASTIC FOIU Th-232 9600E+01 ISA-li 110 LBS 75 134892l0ooOE-01 I COMPACTIBLE TRASH Thorium fluoride m FOR CONSIGNEE USE DIlLY 2ll GEllERATORCERTlFICATlOti STAT6IpoundIIT

A) Ra$uadlve Malldab Ceruficauon is hereby made lD GTS Ourntellne Uta lhl5 Shi~t oJ IOH-I~ rJdioadivamp teIta~ has Igtftrt Jlepared in ~ TSNIIESSa I1CIiI1SE FCft DElIIERI IlO t4bmQlODdiloeW$lCrnJNgement~~trabecn~bythtNudeil(~CormISSIonorDIJtqeemerltStatef~ltwyagenty3rdWib

1btamml ~CII afUlIltGTSOundek MaAertsl ~ CtUerie

SOUTH CAIlOUjA TlWlSFOfIT FERMIT NO 8) ~OU$ tIlUIriaftl ~klr ttercbycertib$hat ItU rrotertal does mtI co=taio a t1atanbus Vozte as dlsfinedirt 4liCrn 26~

C) 00 sn_Iltgty_ lhotolldalll kmlllllllgt IUNIfORMlOW-tEJELRADIOAClIVI~JId=jnUS ECOLOGY GaIEflTOR 110

3S~(middotmiddotS~~Qrui-~2J~~-~I~-= ~ tlf O~ US ECOLOGY PERMIT 00

pw -ltQfllgtlut DaI _____---------_

FORM 540 (111-911)

5uweyltc( 1-17-00 ~k-

--

-----

-----

----- -----

F~ Duratek Inc - Commercial Processing 2 MANgt NUMBERUNIFORM LOW-LEVEL RADIOACTIVE O4-ORTKmiddot1

WASTE MANIFEST 3 PAGE 7 OF 26 PAGE(S)CONTAINER AND WASTE DESCRIPTION (CONTINUATION)

DISPOSAL CONTAINER DESCRIPTION WASTE DESCRIPTION FOR EACH WASTE TYPE IN CONTAINER 16 WASTE ~~~~ 7

5 8~ 9~ 10~ PHYSICAL OESCRIPTION 14 CHEMICAL OESCRJPTION lS~ RADIOLOGICAl OESCRIPTlON CLAssIFImiddot 6 CONTAINER OESCRIPTiON CATION

CONTAiNER WASTE SURFACE SJRFAC~~ - 12 13 WEfGHT(See 1) AS-CIaraquoIDENTIFICATION AND RADIATION _10PROCESS REQUESTED VOLUME WASTE APPROXIMATE CHEMICAL FORMI NUMBERI CONTAiNER LEVL ~ Maqiloo2~)

DESCRIPTOR WASTE O~JI3~~~~NOF CHELATING AGENT ~HELATING INDIVIDUAL RADIONUCLIDES AND ACTIVITY (MBq) AND AlJClasASee Note 1A GENERATOR 10 VVEIGHT ImSvJhr) CONTAINER TOTAL OR CONTAINER TOTAL ACTfVlTY(dpml00m2) VOLUMIS) IN MEDIA Unstable

NUMBER BURlALJD1SPOSjTI0N mremlhr) AGENT ANO AADIONucUOe PERCENT (kg) S~Not~2) CONTAINER QClassB(Sbullbull Not 2A)

BETA-gt (m3) (See Note 3 IF gt01 CclanC(ib) ALPHA GAMMA Iffij RADIONUCUDES M9q mG

H-3 21460E+Ol 58000E-Ol76000-1348721SUNVsT 4 3 100 PAPER PLASTIC ~ AU 8RooK C 02124 51709$ ltSOOOOEo3 lt334005-06 lt334QOpound-O$ 02124 GLASSJNP 1hiMNY E 214sect)E+01 58009Ej1

~ ~~~ -~~~~-1--- ~-- I-----~~- Total 21460E+01 58000E-Ol

75000 10000 lt50000Eo1 lt20000E+02 lt200005+03 75000

7S08()141730ISUNY-ST 4 3 100 PAPERPLASTIC NP AUHmiddot3 31080E+OO 84000E-02BROOK C 02124 530103 lt50000El3 lt33400E-C16 lt33400E-ltl5 02124 GLASSINP NY ISuhlotal 31080E+OO 84000B2E 1 ~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ I~~ ~~ ~~~~~~~~~~~~~~~~~ i ~~ ~~~~~

Total 31080E+OO 84000E-OZ75000 1170000 lt50000Eo1 lt200005+02 lt20000euro+03 75000

760S1-1RW 3 39 100 JNATCH PARTSINP NP Hmiddot3 90650E+03 24500E+02 ~~ NY C 00193 72575 ltSOOOOED3 lt33400E-06 lt33400E-05 00193

E ISubtotal 90659E+03 24599E+02 ~~-~-~~~-~

Total 90650E+03 24500E+02 06800 160000 lt50000E-01 lt20000E+02 lt200005+03 06800

760B1~2IRW 3 39 100 WATCH PARiSJNP I----w AUH-3 90650E+03 24500E+02Ilf C 00193 60039 lt50000eo3 lt33400E-OO lt33400Eos 00193 1h~1 90650E+03E 24599E+02

~~~

Total 90650E+03 24500E+0206800 150000 ltS0000EQ1 lt200001+02 lt2aOODE+03 06800

7$08SAo1NYCBOE 3 59-S0LlOIFIED LlaUID IN 100 SOLIDIFIED NP AUCmiddot14 92SOOE+OO 25000E-OlWliHS C Ot)193 31751 ltSOOOOEo3 I lt334OOEQ6 ltJ3400EoS PLASTIC JUG 00193 UQUIDINP NY E Co-6Q 14000E-02 20000E-03

~-I-~~ ------- shy Ihntal ~ ~2JIIl+R9 Zli~IIlll06800 70000 lt50000E4)1 lt20000E+02 lt20000E+03 06800 Total 93240E+OO 25200E-Ol

S9--S0LlOIFrEO LIQUID IN 100 SOLIDIFIED NP AU CT C 00193 31751 lt50000pound03 lt33400Eos lt3340oe05 PLASTIC JUG 00193 LfOlJIDINP 76087-0iIMBP~ 3 H-3 74000E+01 20000E+OO

1htnt1E 14909E+01 200001l+90 ~~~ ~~~~ Total 74000E+Ol 20000E+OO ~ os800 70000 lt50000Eo1 lt20000E+02 lt20000E+03 06800

~~~~-

16058-01NA-NVC AU NY 0~2124 46nOO lt50000Eo3 lt33400E-OO lt330400E()S

I~~~~-----~ --- __ rI~ -~-~~ ~ -~~~ --~~---- ~ -~~~-

75000 1030000 lt5OOOOE-01 lt20000E+02 lt200D0E+03

~~~~ ~~-~~---~~ ---- shyNA-NVC 100 NP~~~~ASTIC Cmiddot14 84268E+OO 22775E-Ol

NY 02115 H-3 53669E+01 1450SE+OO---___----~~-- ---~ ~-~~~~~ ~ ~~~~~~~

1middot125 18500E-Ol 50000E-03 74700 P-32 74000E+01 20000E+OO

Subtotal 13amp26E+02 36amp33E+OO ~~~~-

--- I-~---

FORM 541A10-95)

~UKMb42A 2 MANIFEST NUMBeuroRDuratek Incmiddot Commercial Processing O4-ORTKmiddot1UNIFORM LOW-LEVEL RADIOACTIVE WASTE MANIFEST

3 MANIFEST INDEX AND REGIONAL COMPACT TABULATION (CONTINUATION) PAGE 3 OF 7 PAGE(S)

11 AS PRocesseOCOLLECTED TOTAL 5 bull 1 PREPROCESSEO 9 10 MANIFEST NUMBER(S) UNDERWASTEGENERATOR ORtG1NATING A SOURCE B SNM CACTIVITY O VOLUME

GENERATOR NAME GENERATOR (OR MATERIAL) VvHfCH WASTE (OR MATERIAl) WASTE CODEIDENTIFICATION MATERIAL NUMBER PERMIT NUMBER (IF APPtICABLEj FACILIIY VOLUME REceIVED AND DATE P =PROCESSED ~I~W

AND TELEPHONE NUMBER ADDRESS OF RECEIPT CCOIIECTED OR STATE (k9J (Ib) Ill) (mba) (mCi) (m3) (ft3)

(m3) (ft3)

KCHC KINGS COUNTy HOSPITAL Pathology m$titute 25800E-01 568795(11 000005+00 51202E+02 113838E+01 17400 CENTER 451 CLARKSON AVE NVO180904613 BROOKLYN NY 11203 63176-1592 i-

Lot LASER OPTICS INC 111 WOOSTER STREET 60000pound+01 13228E+02 OOooOE+oo 29600E+02 16J)OOOE+OO 75000 203 144 ~ 4160 BETHEL CT 06801

I

i I yn Lort9 Island UniVefSitragt OooooeOO jOooooe+oo OOOOOeuro+OO 5693OE+01 1S400E+OO 02271 bull0200

NY0073130742 TtS 4Sa160a SROOKLYNON~~ I7

I -- shy

MBPOO MANNKINO 1 CASPER STREiff OoooOE+oo OooooE+oo OOOOOE+OO 7AOOOE-01 i2DOOOE00 06800 810PHARMACEUTICALDanbury DANBURY CT 06810 CT~ 203--7~ ) ___m

I I MBPOE MANNKIND 10OOOOE00 0OOOOE+00 00000pound+00 94720E+01 rlsaoOE+OO 15000shy

BIOPKARMACEUTICAL SUITE 405 Elmsford NY ELMSFORO NY 10523 I

91+$1)6615 I I ~ I I

MRI ~NC 150MA~O OOOOOE+oo aOOOOE+OO OooooE+oo 37000e+01 00005 00 0212 75000 91 TUCKAHOE 01 I

I

I i

I I

MSKCC-R MEMORIAL SLOAN KETTERING ROCKEFELLER BLDG 10000E+00 22046E+00 00000pound+00 35Q76E+02 f94800E+OO 4361$I NYD075265157 NEW YORK NY 10065 CANCER CeNTER~ 430 EAST 61 STREET I 212 639 ~ 1391 I I

I I I

PC MEMORY PHARMACEUTICAL 100 PHILLIPS PARKWAY 03398 119999 7S090 (0410712004) C NJ OOOOOE+OO 100000E+00 00000pound00 31635e+01ja5500eo1 03115 110000 CORP MONTIVAlE NJ 07645 201-802-1229 j

I I

I I

I MC270A MILLENNIUM PHARM 270 210 ALBANY STREeT OOOOOeOO OOOooE+OO QOOOOE+OO 48314E+02 130$ampE+01 150000 Albany St CAMBRIDGE MA 02139 IMAROOO500843 617 679 ~ 70n I

I I FORM 542A (1Q96)

Page 1

DUIatek

Monday April 19 2004

Arthur F Green Radlae Research Corp

261 Kent AVenue Brooklyn NY 11211

Dear Mr Green

The attached signed shipping manifest copies are your notice of receipt of the radioactive waste materials shipment specified on the manifest number below

Manifest Number Date Received

1735-04middotDRTKmiddot1 0411912004

Thank you for your business

Sincerely

Shipping and Receiving

cc Manifest File Shipping and Receiving file

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Prepared by

Antkowiak and Mahoney Ente rprises Inc

3 Valley Court Chester NY 10918

845406-1917

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Survey Date April 19 2006

Survey performed by

Joel Antkowiak

Report prepared by

Robert Mahoney

Reviewed and Approved by ~=-=- Date s)- 1shy

Antkowiak and Mahoney Enterprises Inc

II

Table of Contents

II Approval

Table of Contents 1

I Introduction 2

II Survey Instrumentation 2-3

II III Survey Methodology 4

II IV Summary of Survey Results 5

V List of Rooms Surveyed 6

Appendix Diagrams of Areas Surveyed and Smear Results

II

I I I I I I

1

Antkowiak and Mahoney Ente rprises Inc

I Introduction

This report has been prepared by Antkowiak amp Mahoney Enterprises Inc for MannKind Corp to summarize the results of the monthly radiation safety surveys performed in the radioactive materials use areas at the facility in Danbury Connecticut The purpose of the survey was to identify and define the extent of fixed and removable radioactive contamination in the rooms where radioactive materials are used so that the researchers will be able to decontaminate the areas as soon as possible

The surveys were performed on April 192006 by Joel Antkowiak

II Survey Instrumentation

Table 2-1 provides a description of the instrumentation used to perform the routine monthly surveys

Instrument Use Serial Calibration Number Date

Ludlum Model 12 Direct measurements for beta 195030 072205 and gamma radiation

WModel 43-68 probe PR 178541

Beckman Model Liquid scintillation counting of 7040372 At time of 5000TD Liquid samples for removable use

Scintillation Analyzer radioactive contamination

All meters and instrumentation used for this survey have been calibrated within the past twelve months to standards traceable to the National Institute of Standards and Testing (NIST) The hand held meters response to a dedicated check source was verified prior to use The liquid scintillation counter was calibrated prior to use by running the manufacturers calibration protocol allowing the machine to adjust the gain

Minimum Detectable Activity Calculations

Equation

MDA = 271 + 465 Br x t tx E xA100

where 2MDA = activity in dpm 100 cm

Br = background rate in counts per minute t = counting time in minutes E = detector efficiency in counts per disintegration (41t)

A = probe area or area wiped in cm2

11 II

2

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 6: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

--

-----

-----

----- -----

F~ Duratek Inc - Commercial Processing 2 MANgt NUMBERUNIFORM LOW-LEVEL RADIOACTIVE O4-ORTKmiddot1

WASTE MANIFEST 3 PAGE 7 OF 26 PAGE(S)CONTAINER AND WASTE DESCRIPTION (CONTINUATION)

DISPOSAL CONTAINER DESCRIPTION WASTE DESCRIPTION FOR EACH WASTE TYPE IN CONTAINER 16 WASTE ~~~~ 7

5 8~ 9~ 10~ PHYSICAL OESCRIPTION 14 CHEMICAL OESCRJPTION lS~ RADIOLOGICAl OESCRIPTlON CLAssIFImiddot 6 CONTAINER OESCRIPTiON CATION

CONTAiNER WASTE SURFACE SJRFAC~~ - 12 13 WEfGHT(See 1) AS-CIaraquoIDENTIFICATION AND RADIATION _10PROCESS REQUESTED VOLUME WASTE APPROXIMATE CHEMICAL FORMI NUMBERI CONTAiNER LEVL ~ Maqiloo2~)

DESCRIPTOR WASTE O~JI3~~~~NOF CHELATING AGENT ~HELATING INDIVIDUAL RADIONUCLIDES AND ACTIVITY (MBq) AND AlJClasASee Note 1A GENERATOR 10 VVEIGHT ImSvJhr) CONTAINER TOTAL OR CONTAINER TOTAL ACTfVlTY(dpml00m2) VOLUMIS) IN MEDIA Unstable

NUMBER BURlALJD1SPOSjTI0N mremlhr) AGENT ANO AADIONucUOe PERCENT (kg) S~Not~2) CONTAINER QClassB(Sbullbull Not 2A)

BETA-gt (m3) (See Note 3 IF gt01 CclanC(ib) ALPHA GAMMA Iffij RADIONUCUDES M9q mG

H-3 21460E+Ol 58000E-Ol76000-1348721SUNVsT 4 3 100 PAPER PLASTIC ~ AU 8RooK C 02124 51709$ ltSOOOOEo3 lt334005-06 lt334QOpound-O$ 02124 GLASSJNP 1hiMNY E 214sect)E+01 58009Ej1

~ ~~~ -~~~~-1--- ~-- I-----~~- Total 21460E+01 58000E-Ol

75000 10000 lt50000Eo1 lt20000E+02 lt200005+03 75000

7S08()141730ISUNY-ST 4 3 100 PAPERPLASTIC NP AUHmiddot3 31080E+OO 84000E-02BROOK C 02124 530103 lt50000El3 lt33400E-C16 lt33400E-ltl5 02124 GLASSINP NY ISuhlotal 31080E+OO 84000B2E 1 ~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ I~~ ~~ ~~~~~~~~~~~~~~~~~ i ~~ ~~~~~

Total 31080E+OO 84000E-OZ75000 1170000 lt50000Eo1 lt200005+02 lt20000euro+03 75000

760S1-1RW 3 39 100 JNATCH PARTSINP NP Hmiddot3 90650E+03 24500E+02 ~~ NY C 00193 72575 ltSOOOOED3 lt33400E-06 lt33400E-05 00193

E ISubtotal 90659E+03 24599E+02 ~~-~-~~~-~

Total 90650E+03 24500E+02 06800 160000 lt50000E-01 lt20000E+02 lt200005+03 06800

760B1~2IRW 3 39 100 WATCH PARiSJNP I----w AUH-3 90650E+03 24500E+02Ilf C 00193 60039 lt50000eo3 lt33400E-OO lt33400Eos 00193 1h~1 90650E+03E 24599E+02

~~~

Total 90650E+03 24500E+0206800 150000 ltS0000EQ1 lt200001+02 lt2aOODE+03 06800

7$08SAo1NYCBOE 3 59-S0LlOIFIED LlaUID IN 100 SOLIDIFIED NP AUCmiddot14 92SOOE+OO 25000E-OlWliHS C Ot)193 31751 ltSOOOOEo3 I lt334OOEQ6 ltJ3400EoS PLASTIC JUG 00193 UQUIDINP NY E Co-6Q 14000E-02 20000E-03

~-I-~~ ------- shy Ihntal ~ ~2JIIl+R9 Zli~IIlll06800 70000 lt50000E4)1 lt20000E+02 lt20000E+03 06800 Total 93240E+OO 25200E-Ol

S9--S0LlOIFrEO LIQUID IN 100 SOLIDIFIED NP AU CT C 00193 31751 lt50000pound03 lt33400Eos lt3340oe05 PLASTIC JUG 00193 LfOlJIDINP 76087-0iIMBP~ 3 H-3 74000E+01 20000E+OO

1htnt1E 14909E+01 200001l+90 ~~~ ~~~~ Total 74000E+Ol 20000E+OO ~ os800 70000 lt50000Eo1 lt20000E+02 lt20000E+03 06800

~~~~-

16058-01NA-NVC AU NY 0~2124 46nOO lt50000Eo3 lt33400E-OO lt330400E()S

I~~~~-----~ --- __ rI~ -~-~~ ~ -~~~ --~~---- ~ -~~~-

75000 1030000 lt5OOOOE-01 lt20000E+02 lt200D0E+03

~~~~ ~~-~~---~~ ---- shyNA-NVC 100 NP~~~~ASTIC Cmiddot14 84268E+OO 22775E-Ol

NY 02115 H-3 53669E+01 1450SE+OO---___----~~-- ---~ ~-~~~~~ ~ ~~~~~~~

1middot125 18500E-Ol 50000E-03 74700 P-32 74000E+01 20000E+OO

Subtotal 13amp26E+02 36amp33E+OO ~~~~-

--- I-~---

FORM 541A10-95)

~UKMb42A 2 MANIFEST NUMBeuroRDuratek Incmiddot Commercial Processing O4-ORTKmiddot1UNIFORM LOW-LEVEL RADIOACTIVE WASTE MANIFEST

3 MANIFEST INDEX AND REGIONAL COMPACT TABULATION (CONTINUATION) PAGE 3 OF 7 PAGE(S)

11 AS PRocesseOCOLLECTED TOTAL 5 bull 1 PREPROCESSEO 9 10 MANIFEST NUMBER(S) UNDERWASTEGENERATOR ORtG1NATING A SOURCE B SNM CACTIVITY O VOLUME

GENERATOR NAME GENERATOR (OR MATERIAL) VvHfCH WASTE (OR MATERIAl) WASTE CODEIDENTIFICATION MATERIAL NUMBER PERMIT NUMBER (IF APPtICABLEj FACILIIY VOLUME REceIVED AND DATE P =PROCESSED ~I~W

AND TELEPHONE NUMBER ADDRESS OF RECEIPT CCOIIECTED OR STATE (k9J (Ib) Ill) (mba) (mCi) (m3) (ft3)

(m3) (ft3)

KCHC KINGS COUNTy HOSPITAL Pathology m$titute 25800E-01 568795(11 000005+00 51202E+02 113838E+01 17400 CENTER 451 CLARKSON AVE NVO180904613 BROOKLYN NY 11203 63176-1592 i-

Lot LASER OPTICS INC 111 WOOSTER STREET 60000pound+01 13228E+02 OOooOE+oo 29600E+02 16J)OOOE+OO 75000 203 144 ~ 4160 BETHEL CT 06801

I

i I yn Lort9 Island UniVefSitragt OooooeOO jOooooe+oo OOOOOeuro+OO 5693OE+01 1S400E+OO 02271 bull0200

NY0073130742 TtS 4Sa160a SROOKLYNON~~ I7

I -- shy

MBPOO MANNKINO 1 CASPER STREiff OoooOE+oo OooooE+oo OOOOOE+OO 7AOOOE-01 i2DOOOE00 06800 810PHARMACEUTICALDanbury DANBURY CT 06810 CT~ 203--7~ ) ___m

I I MBPOE MANNKIND 10OOOOE00 0OOOOE+00 00000pound+00 94720E+01 rlsaoOE+OO 15000shy

BIOPKARMACEUTICAL SUITE 405 Elmsford NY ELMSFORO NY 10523 I

91+$1)6615 I I ~ I I

MRI ~NC 150MA~O OOOOOE+oo aOOOOE+OO OooooE+oo 37000e+01 00005 00 0212 75000 91 TUCKAHOE 01 I

I

I i

I I

MSKCC-R MEMORIAL SLOAN KETTERING ROCKEFELLER BLDG 10000E+00 22046E+00 00000pound+00 35Q76E+02 f94800E+OO 4361$I NYD075265157 NEW YORK NY 10065 CANCER CeNTER~ 430 EAST 61 STREET I 212 639 ~ 1391 I I

I I I

PC MEMORY PHARMACEUTICAL 100 PHILLIPS PARKWAY 03398 119999 7S090 (0410712004) C NJ OOOOOE+OO 100000E+00 00000pound00 31635e+01ja5500eo1 03115 110000 CORP MONTIVAlE NJ 07645 201-802-1229 j

I I

I I

I MC270A MILLENNIUM PHARM 270 210 ALBANY STREeT OOOOOeOO OOOooE+OO QOOOOE+OO 48314E+02 130$ampE+01 150000 Albany St CAMBRIDGE MA 02139 IMAROOO500843 617 679 ~ 70n I

I I FORM 542A (1Q96)

Page 1

DUIatek

Monday April 19 2004

Arthur F Green Radlae Research Corp

261 Kent AVenue Brooklyn NY 11211

Dear Mr Green

The attached signed shipping manifest copies are your notice of receipt of the radioactive waste materials shipment specified on the manifest number below

Manifest Number Date Received

1735-04middotDRTKmiddot1 0411912004

Thank you for your business

Sincerely

Shipping and Receiving

cc Manifest File Shipping and Receiving file

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Prepared by

Antkowiak and Mahoney Ente rprises Inc

3 Valley Court Chester NY 10918

845406-1917

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Survey Date April 19 2006

Survey performed by

Joel Antkowiak

Report prepared by

Robert Mahoney

Reviewed and Approved by ~=-=- Date s)- 1shy

Antkowiak and Mahoney Enterprises Inc

II

Table of Contents

II Approval

Table of Contents 1

I Introduction 2

II Survey Instrumentation 2-3

II III Survey Methodology 4

II IV Summary of Survey Results 5

V List of Rooms Surveyed 6

Appendix Diagrams of Areas Surveyed and Smear Results

II

I I I I I I

1

Antkowiak and Mahoney Ente rprises Inc

I Introduction

This report has been prepared by Antkowiak amp Mahoney Enterprises Inc for MannKind Corp to summarize the results of the monthly radiation safety surveys performed in the radioactive materials use areas at the facility in Danbury Connecticut The purpose of the survey was to identify and define the extent of fixed and removable radioactive contamination in the rooms where radioactive materials are used so that the researchers will be able to decontaminate the areas as soon as possible

The surveys were performed on April 192006 by Joel Antkowiak

II Survey Instrumentation

Table 2-1 provides a description of the instrumentation used to perform the routine monthly surveys

Instrument Use Serial Calibration Number Date

Ludlum Model 12 Direct measurements for beta 195030 072205 and gamma radiation

WModel 43-68 probe PR 178541

Beckman Model Liquid scintillation counting of 7040372 At time of 5000TD Liquid samples for removable use

Scintillation Analyzer radioactive contamination

All meters and instrumentation used for this survey have been calibrated within the past twelve months to standards traceable to the National Institute of Standards and Testing (NIST) The hand held meters response to a dedicated check source was verified prior to use The liquid scintillation counter was calibrated prior to use by running the manufacturers calibration protocol allowing the machine to adjust the gain

Minimum Detectable Activity Calculations

Equation

MDA = 271 + 465 Br x t tx E xA100

where 2MDA = activity in dpm 100 cm

Br = background rate in counts per minute t = counting time in minutes E = detector efficiency in counts per disintegration (41t)

A = probe area or area wiped in cm2

11 II

2

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 7: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

~UKMb42A 2 MANIFEST NUMBeuroRDuratek Incmiddot Commercial Processing O4-ORTKmiddot1UNIFORM LOW-LEVEL RADIOACTIVE WASTE MANIFEST

3 MANIFEST INDEX AND REGIONAL COMPACT TABULATION (CONTINUATION) PAGE 3 OF 7 PAGE(S)

11 AS PRocesseOCOLLECTED TOTAL 5 bull 1 PREPROCESSEO 9 10 MANIFEST NUMBER(S) UNDERWASTEGENERATOR ORtG1NATING A SOURCE B SNM CACTIVITY O VOLUME

GENERATOR NAME GENERATOR (OR MATERIAL) VvHfCH WASTE (OR MATERIAl) WASTE CODEIDENTIFICATION MATERIAL NUMBER PERMIT NUMBER (IF APPtICABLEj FACILIIY VOLUME REceIVED AND DATE P =PROCESSED ~I~W

AND TELEPHONE NUMBER ADDRESS OF RECEIPT CCOIIECTED OR STATE (k9J (Ib) Ill) (mba) (mCi) (m3) (ft3)

(m3) (ft3)

KCHC KINGS COUNTy HOSPITAL Pathology m$titute 25800E-01 568795(11 000005+00 51202E+02 113838E+01 17400 CENTER 451 CLARKSON AVE NVO180904613 BROOKLYN NY 11203 63176-1592 i-

Lot LASER OPTICS INC 111 WOOSTER STREET 60000pound+01 13228E+02 OOooOE+oo 29600E+02 16J)OOOE+OO 75000 203 144 ~ 4160 BETHEL CT 06801

I

i I yn Lort9 Island UniVefSitragt OooooeOO jOooooe+oo OOOOOeuro+OO 5693OE+01 1S400E+OO 02271 bull0200

NY0073130742 TtS 4Sa160a SROOKLYNON~~ I7

I -- shy

MBPOO MANNKINO 1 CASPER STREiff OoooOE+oo OooooE+oo OOOOOE+OO 7AOOOE-01 i2DOOOE00 06800 810PHARMACEUTICALDanbury DANBURY CT 06810 CT~ 203--7~ ) ___m

I I MBPOE MANNKIND 10OOOOE00 0OOOOE+00 00000pound+00 94720E+01 rlsaoOE+OO 15000shy

BIOPKARMACEUTICAL SUITE 405 Elmsford NY ELMSFORO NY 10523 I

91+$1)6615 I I ~ I I

MRI ~NC 150MA~O OOOOOE+oo aOOOOE+OO OooooE+oo 37000e+01 00005 00 0212 75000 91 TUCKAHOE 01 I

I

I i

I I

MSKCC-R MEMORIAL SLOAN KETTERING ROCKEFELLER BLDG 10000E+00 22046E+00 00000pound+00 35Q76E+02 f94800E+OO 4361$I NYD075265157 NEW YORK NY 10065 CANCER CeNTER~ 430 EAST 61 STREET I 212 639 ~ 1391 I I

I I I

PC MEMORY PHARMACEUTICAL 100 PHILLIPS PARKWAY 03398 119999 7S090 (0410712004) C NJ OOOOOE+OO 100000E+00 00000pound00 31635e+01ja5500eo1 03115 110000 CORP MONTIVAlE NJ 07645 201-802-1229 j

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I I

I MC270A MILLENNIUM PHARM 270 210 ALBANY STREeT OOOOOeOO OOOooE+OO QOOOOE+OO 48314E+02 130$ampE+01 150000 Albany St CAMBRIDGE MA 02139 IMAROOO500843 617 679 ~ 70n I

I I FORM 542A (1Q96)

Page 1

DUIatek

Monday April 19 2004

Arthur F Green Radlae Research Corp

261 Kent AVenue Brooklyn NY 11211

Dear Mr Green

The attached signed shipping manifest copies are your notice of receipt of the radioactive waste materials shipment specified on the manifest number below

Manifest Number Date Received

1735-04middotDRTKmiddot1 0411912004

Thank you for your business

Sincerely

Shipping and Receiving

cc Manifest File Shipping and Receiving file

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Prepared by

Antkowiak and Mahoney Ente rprises Inc

3 Valley Court Chester NY 10918

845406-1917

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Survey Date April 19 2006

Survey performed by

Joel Antkowiak

Report prepared by

Robert Mahoney

Reviewed and Approved by ~=-=- Date s)- 1shy

Antkowiak and Mahoney Enterprises Inc

II

Table of Contents

II Approval

Table of Contents 1

I Introduction 2

II Survey Instrumentation 2-3

II III Survey Methodology 4

II IV Summary of Survey Results 5

V List of Rooms Surveyed 6

Appendix Diagrams of Areas Surveyed and Smear Results

II

I I I I I I

1

Antkowiak and Mahoney Ente rprises Inc

I Introduction

This report has been prepared by Antkowiak amp Mahoney Enterprises Inc for MannKind Corp to summarize the results of the monthly radiation safety surveys performed in the radioactive materials use areas at the facility in Danbury Connecticut The purpose of the survey was to identify and define the extent of fixed and removable radioactive contamination in the rooms where radioactive materials are used so that the researchers will be able to decontaminate the areas as soon as possible

The surveys were performed on April 192006 by Joel Antkowiak

II Survey Instrumentation

Table 2-1 provides a description of the instrumentation used to perform the routine monthly surveys

Instrument Use Serial Calibration Number Date

Ludlum Model 12 Direct measurements for beta 195030 072205 and gamma radiation

WModel 43-68 probe PR 178541

Beckman Model Liquid scintillation counting of 7040372 At time of 5000TD Liquid samples for removable use

Scintillation Analyzer radioactive contamination

All meters and instrumentation used for this survey have been calibrated within the past twelve months to standards traceable to the National Institute of Standards and Testing (NIST) The hand held meters response to a dedicated check source was verified prior to use The liquid scintillation counter was calibrated prior to use by running the manufacturers calibration protocol allowing the machine to adjust the gain

Minimum Detectable Activity Calculations

Equation

MDA = 271 + 465 Br x t tx E xA100

where 2MDA = activity in dpm 100 cm

Br = background rate in counts per minute t = counting time in minutes E = detector efficiency in counts per disintegration (41t)

A = probe area or area wiped in cm2

11 II

2

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 8: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

Page 1

DUIatek

Monday April 19 2004

Arthur F Green Radlae Research Corp

261 Kent AVenue Brooklyn NY 11211

Dear Mr Green

The attached signed shipping manifest copies are your notice of receipt of the radioactive waste materials shipment specified on the manifest number below

Manifest Number Date Received

1735-04middotDRTKmiddot1 0411912004

Thank you for your business

Sincerely

Shipping and Receiving

cc Manifest File Shipping and Receiving file

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Prepared by

Antkowiak and Mahoney Ente rprises Inc

3 Valley Court Chester NY 10918

845406-1917

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Survey Date April 19 2006

Survey performed by

Joel Antkowiak

Report prepared by

Robert Mahoney

Reviewed and Approved by ~=-=- Date s)- 1shy

Antkowiak and Mahoney Enterprises Inc

II

Table of Contents

II Approval

Table of Contents 1

I Introduction 2

II Survey Instrumentation 2-3

II III Survey Methodology 4

II IV Summary of Survey Results 5

V List of Rooms Surveyed 6

Appendix Diagrams of Areas Surveyed and Smear Results

II

I I I I I I

1

Antkowiak and Mahoney Ente rprises Inc

I Introduction

This report has been prepared by Antkowiak amp Mahoney Enterprises Inc for MannKind Corp to summarize the results of the monthly radiation safety surveys performed in the radioactive materials use areas at the facility in Danbury Connecticut The purpose of the survey was to identify and define the extent of fixed and removable radioactive contamination in the rooms where radioactive materials are used so that the researchers will be able to decontaminate the areas as soon as possible

The surveys were performed on April 192006 by Joel Antkowiak

II Survey Instrumentation

Table 2-1 provides a description of the instrumentation used to perform the routine monthly surveys

Instrument Use Serial Calibration Number Date

Ludlum Model 12 Direct measurements for beta 195030 072205 and gamma radiation

WModel 43-68 probe PR 178541

Beckman Model Liquid scintillation counting of 7040372 At time of 5000TD Liquid samples for removable use

Scintillation Analyzer radioactive contamination

All meters and instrumentation used for this survey have been calibrated within the past twelve months to standards traceable to the National Institute of Standards and Testing (NIST) The hand held meters response to a dedicated check source was verified prior to use The liquid scintillation counter was calibrated prior to use by running the manufacturers calibration protocol allowing the machine to adjust the gain

Minimum Detectable Activity Calculations

Equation

MDA = 271 + 465 Br x t tx E xA100

where 2MDA = activity in dpm 100 cm

Br = background rate in counts per minute t = counting time in minutes E = detector efficiency in counts per disintegration (41t)

A = probe area or area wiped in cm2

11 II

2

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 9: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Prepared by

Antkowiak and Mahoney Ente rprises Inc

3 Valley Court Chester NY 10918

845406-1917

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Survey Date April 19 2006

Survey performed by

Joel Antkowiak

Report prepared by

Robert Mahoney

Reviewed and Approved by ~=-=- Date s)- 1shy

Antkowiak and Mahoney Enterprises Inc

II

Table of Contents

II Approval

Table of Contents 1

I Introduction 2

II Survey Instrumentation 2-3

II III Survey Methodology 4

II IV Summary of Survey Results 5

V List of Rooms Surveyed 6

Appendix Diagrams of Areas Surveyed and Smear Results

II

I I I I I I

1

Antkowiak and Mahoney Ente rprises Inc

I Introduction

This report has been prepared by Antkowiak amp Mahoney Enterprises Inc for MannKind Corp to summarize the results of the monthly radiation safety surveys performed in the radioactive materials use areas at the facility in Danbury Connecticut The purpose of the survey was to identify and define the extent of fixed and removable radioactive contamination in the rooms where radioactive materials are used so that the researchers will be able to decontaminate the areas as soon as possible

The surveys were performed on April 192006 by Joel Antkowiak

II Survey Instrumentation

Table 2-1 provides a description of the instrumentation used to perform the routine monthly surveys

Instrument Use Serial Calibration Number Date

Ludlum Model 12 Direct measurements for beta 195030 072205 and gamma radiation

WModel 43-68 probe PR 178541

Beckman Model Liquid scintillation counting of 7040372 At time of 5000TD Liquid samples for removable use

Scintillation Analyzer radioactive contamination

All meters and instrumentation used for this survey have been calibrated within the past twelve months to standards traceable to the National Institute of Standards and Testing (NIST) The hand held meters response to a dedicated check source was verified prior to use The liquid scintillation counter was calibrated prior to use by running the manufacturers calibration protocol allowing the machine to adjust the gain

Minimum Detectable Activity Calculations

Equation

MDA = 271 + 465 Br x t tx E xA100

where 2MDA = activity in dpm 100 cm

Br = background rate in counts per minute t = counting time in minutes E = detector efficiency in counts per disintegration (41t)

A = probe area or area wiped in cm2

11 II

2

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 10: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

Antkowiak and Mahoney Enterprises Inc

Radiological Survey for

MannKind Corp Danbury CT

April 2006

Survey Date April 19 2006

Survey performed by

Joel Antkowiak

Report prepared by

Robert Mahoney

Reviewed and Approved by ~=-=- Date s)- 1shy

Antkowiak and Mahoney Enterprises Inc

II

Table of Contents

II Approval

Table of Contents 1

I Introduction 2

II Survey Instrumentation 2-3

II III Survey Methodology 4

II IV Summary of Survey Results 5

V List of Rooms Surveyed 6

Appendix Diagrams of Areas Surveyed and Smear Results

II

I I I I I I

1

Antkowiak and Mahoney Ente rprises Inc

I Introduction

This report has been prepared by Antkowiak amp Mahoney Enterprises Inc for MannKind Corp to summarize the results of the monthly radiation safety surveys performed in the radioactive materials use areas at the facility in Danbury Connecticut The purpose of the survey was to identify and define the extent of fixed and removable radioactive contamination in the rooms where radioactive materials are used so that the researchers will be able to decontaminate the areas as soon as possible

The surveys were performed on April 192006 by Joel Antkowiak

II Survey Instrumentation

Table 2-1 provides a description of the instrumentation used to perform the routine monthly surveys

Instrument Use Serial Calibration Number Date

Ludlum Model 12 Direct measurements for beta 195030 072205 and gamma radiation

WModel 43-68 probe PR 178541

Beckman Model Liquid scintillation counting of 7040372 At time of 5000TD Liquid samples for removable use

Scintillation Analyzer radioactive contamination

All meters and instrumentation used for this survey have been calibrated within the past twelve months to standards traceable to the National Institute of Standards and Testing (NIST) The hand held meters response to a dedicated check source was verified prior to use The liquid scintillation counter was calibrated prior to use by running the manufacturers calibration protocol allowing the machine to adjust the gain

Minimum Detectable Activity Calculations

Equation

MDA = 271 + 465 Br x t tx E xA100

where 2MDA = activity in dpm 100 cm

Br = background rate in counts per minute t = counting time in minutes E = detector efficiency in counts per disintegration (41t)

A = probe area or area wiped in cm2

11 II

2

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 11: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

Antkowiak and Mahoney Enterprises Inc

II

Table of Contents

II Approval

Table of Contents 1

I Introduction 2

II Survey Instrumentation 2-3

II III Survey Methodology 4

II IV Summary of Survey Results 5

V List of Rooms Surveyed 6

Appendix Diagrams of Areas Surveyed and Smear Results

II

I I I I I I

1

Antkowiak and Mahoney Ente rprises Inc

I Introduction

This report has been prepared by Antkowiak amp Mahoney Enterprises Inc for MannKind Corp to summarize the results of the monthly radiation safety surveys performed in the radioactive materials use areas at the facility in Danbury Connecticut The purpose of the survey was to identify and define the extent of fixed and removable radioactive contamination in the rooms where radioactive materials are used so that the researchers will be able to decontaminate the areas as soon as possible

The surveys were performed on April 192006 by Joel Antkowiak

II Survey Instrumentation

Table 2-1 provides a description of the instrumentation used to perform the routine monthly surveys

Instrument Use Serial Calibration Number Date

Ludlum Model 12 Direct measurements for beta 195030 072205 and gamma radiation

WModel 43-68 probe PR 178541

Beckman Model Liquid scintillation counting of 7040372 At time of 5000TD Liquid samples for removable use

Scintillation Analyzer radioactive contamination

All meters and instrumentation used for this survey have been calibrated within the past twelve months to standards traceable to the National Institute of Standards and Testing (NIST) The hand held meters response to a dedicated check source was verified prior to use The liquid scintillation counter was calibrated prior to use by running the manufacturers calibration protocol allowing the machine to adjust the gain

Minimum Detectable Activity Calculations

Equation

MDA = 271 + 465 Br x t tx E xA100

where 2MDA = activity in dpm 100 cm

Br = background rate in counts per minute t = counting time in minutes E = detector efficiency in counts per disintegration (41t)

A = probe area or area wiped in cm2

11 II

2

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 12: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

Antkowiak and Mahoney Ente rprises Inc

I Introduction

This report has been prepared by Antkowiak amp Mahoney Enterprises Inc for MannKind Corp to summarize the results of the monthly radiation safety surveys performed in the radioactive materials use areas at the facility in Danbury Connecticut The purpose of the survey was to identify and define the extent of fixed and removable radioactive contamination in the rooms where radioactive materials are used so that the researchers will be able to decontaminate the areas as soon as possible

The surveys were performed on April 192006 by Joel Antkowiak

II Survey Instrumentation

Table 2-1 provides a description of the instrumentation used to perform the routine monthly surveys

Instrument Use Serial Calibration Number Date

Ludlum Model 12 Direct measurements for beta 195030 072205 and gamma radiation

WModel 43-68 probe PR 178541

Beckman Model Liquid scintillation counting of 7040372 At time of 5000TD Liquid samples for removable use

Scintillation Analyzer radioactive contamination

All meters and instrumentation used for this survey have been calibrated within the past twelve months to standards traceable to the National Institute of Standards and Testing (NIST) The hand held meters response to a dedicated check source was verified prior to use The liquid scintillation counter was calibrated prior to use by running the manufacturers calibration protocol allowing the machine to adjust the gain

Minimum Detectable Activity Calculations

Equation

MDA = 271 + 465 Br x t tx E xA100

where 2MDA = activity in dpm 100 cm

Br = background rate in counts per minute t = counting time in minutes E = detector efficiency in counts per disintegration (41t)

A = probe area or area wiped in cm2

11 II

2

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 13: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

Antkowiak and Mahoney Ente rprises Inc

II Survey Instrumentation (cont)

Table 2-2 provides the lower limits of detection for the instrumentation used to perform the surveys The MDA for the Ludlum survey meter uses a background count rate of 300 cpm and an efficiency of 131 for carbon-14

Instrument Serial Number Minimum Detectable Activity

Ludlum Model 12 195030 635 dpmj 100 cm 2

W Mode1 43-68 probe

PR178541

Beckman Model 5000TD 7040372 Channell 102 dpmsample Liquid Scintillation

Analyzer Channel 2 46 dpmsample

Channel 3 33 dpmsample

III Survey Methodology

Wipe samples were obtained by wiping at least 100 cm2 with a 425 cm diameter dry fllter paper The samples were placed directly into plastic 7 milliliter vials in an LSC rack labeled with a unique identification number Upon returning to the AME laboratoryS milliliters of an ecologically safe liquid scintillation cocktail were added to each vial The vial was then capped shaken and returned to the rack All vials were allowed to sit for at least 15 minutes before counting was initiated so that any chemical reactions that may occur will progress to completion Wipes exhibiting activity above the MDA were recounted for five minutes and the results reported herein as the best estimate of removable radioactivity

Locations of the wipe samples are indicated on the room diagrams contained in this report Analytical results are presented with each diagram Results are reported as less than the Minimum Detectable Activity (MDA) of the instruments where appropriate The method used to calculate these values is included in the report

I The results of the liquid scintillation analyses are presented by channel number Channel 1 is set for optimum tritium efficiency (0-19 kev) channel 2 is set for optimum carbon-14 efficiency (19-156 kev) and channel 3 is set for all other higher energy beta emitters (156shy1000 kev)

I Benchtops sinks equipment and hood sashes were scanned with a 100 cm2 gas proportional detector using the audio output to identify areas of elevated radioactivity Contaminated areas are identified as areas greater than twice background Each contaminated area is identified on the corresponding room diagram along with the results of an integral measurement The reported results have been corrected for background and are based on the meters efficiency to Carbon-14

IJ 3

I

I

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 14: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

Antkowiak and Mahoney Enterprises Inc

IV Summary of Survey Results

ThefoZlowing summary includes all removable andfixed contamination found to be greater than the MDA

Removable Activity

Room Wipe Channel 1 Channe12 Channel 3 (dpmj 100 cm2) (dpm100 cm2) (dpm100 cm2)

None NA NA NA NA

Direct Activity

ILocation (cpm 100 cm2lI Room

None NA NA

4

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 15: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

Antkowiak and Mahoney Enterprises Inc

V List of Rooms Surveyed

Laboratory 233 Radioactive Waste Area

5

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 16: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

Antkowiak and Mahoney Enterprises Inc

Appendix

Diagrams of Areas Surveyed and Smear Results

6

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 17: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

Antkowiak IIIId Waholley Ellterprises IIIamp

Room Laboratory 233

Name

Notes Part 1

I

15 14 13~ 11

16 rn 12 Elisa

Reader

18

6 8

I 1010 ~I9

Microscope

5 19

4

22-P

1

Smear Analysis Results - Analysis by Liauid Scintillation CountinQ

SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3 I1 ltMDA ltMDA ltMDA 11 ltMDA ltMDA ltMDA

2 ltMDA ltMDA ltMDA 12 ltMDA ltMDA ltMDA 3 ltMDA ltMDA ltMDA 13 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 14 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 15 ltMDA ltMDA ltMDA 6 ltMDA ltMDA ltMDA 16 ltMDA ltMDA ltMDA1

7 ltMDA ltMDA ltMDA 17 ltMDA ltMDA ltMDA 8 ltMDA ltMDA ltMDA 18 ltMDA ltMDA ltMDA 9 ltMDA ltMDA ltMDA 19 ltMDA ltMDA ltMDA

10 ltMDA ltMDA ltMDA 20 ltMDA ltMDA ltMDA

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 18: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

Antkuwialc and Mahoney Enterprises Inc

Room Laboratory 233

Name

Notes Part 2

I

15 14 13[3[J

11

16 rn 12 Elisa

Reader

18

6 8

10 41 10 9 1

Microscope

5

19

bull 22-P

1

II Smear Analysis Results - Analysis by Liauid Scintillation Countina

I SmearlD Channel 1 Channel 2 Channel 3 SmearlD Channel 1 Channel 2 Channel 3

21 ltMDA ltMDA ltMDA 22-phone ltMDA ltMDA ltMDA 23-door ltMDA ltMDA ltMDA

I

II I I

I

II

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 19: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

I I I I I

LSC 4

I 5

I I 2 4 I I Gamma

CounterI 6 3

I I Cabinet

1 a-door

I I Smear Analysis Results - Analysis by Liauid Scintillation Countina

I Smear 10 Channel 1 Channel 2 Channel 3 Smear 10 Channel 1 Channel 2 Channel 3

1 ltMDA ltMDA ltMDA

I 2 ltMDA ltMOA ltMDA 3 ltMDA ltMDA ltMDA 4 ltMDA ltMDA ltMDA 5 ltMDA ltMDA ltMDA 6 ltMDA ltMOA ltMDA 7 ltMDA ltMDA ltMDA

8-doormiddot ltMDA ltMDA ltMDA

Anltowiak and Mahoney Enterprises Inc

Room New Radioactive Waste Area

Name

Notes

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 20: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

I)shy~

~ r)

I 4tlES~MannKind Corporation ~~~=-One Casper Street bull I~-- g -- PITNEY BOWES

Danbury CT 06810 7005 3110 0000 7475 7757 1P $ 005980bull 02 bull 0003890243 - MAR 08 2011bull

MAILED FROM ZIPCODE06810

Licensing Assistant Section Nuclear Materials Safety Branch Nuclear Regulatory Commission Region 1 475 Allendale Road King ofPrussia PA 19406-1415

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader

Page 21: Nuclear Regulatory Commission · 2019-12-21 · ~MannKind Corporation One Casper Street Danbury. CT 06810 Main: 203-798-8000 Fax: 203-798-7740 . r-. ..) ~-,;!. March 8,2011 . Licensing

This is to acknowledge the receipt of your letterapplication dated

JsectI~ f and to inform you that the initial processing which includes an administrative review has been performed

d -ZGAH(Nktt~ Of- - o77-t -0 ~There were no administrative omissions Your application was assigned to a

technical reviewer Please note that the technical review may identify additional omissions or require additional information

o Please provide to this office within 30 days of your receipt of this card

A copy of your action has been forwarded to our License Fee amp Accounts Receivable Branch who will contact you separately if there is a fee issue involved

Your action has been assigned Mail Control Number When calling to inquire about this action please refer to this control number You may call us on (610) 337-5398 or 337-5260

NRC FORM 532 (RIJ Sincerely (6middot96) Licensing Assistance T earn Leader