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Table of Contents
Introduction . . . . . . . . . . . . . . . . .3Diaphragm Selection . . . . . . . . . .4Diaphragm Design . . . . . . . . . . . .5Grade TM17 PTFE . . . . . . . . . . .6-7Grade 17 EPDM . . . . . . . . . . . . . .8Qualification Testing . . . . . . . . . .9Pressure Equipment Directive . . .10Service Recommendations . . . . .11Traceability . . . . . . . . . . . . . . . .12Validation . . . . . . . . . . . . . . . . . .13Packaging . . . . . . . . . . . . . . . . . .14Application . . . . . . . . . . . . . . . .15
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3
Introduction
ITT has manufactured diaphragmvalves for nearly 50 years and takesgreat pride in its reputation forsupplying the highest qualityhygienic diaphragm valves to theBiopharm industry.
The diaphragm is the most criticalcomponent of a diaphragm valve.Diaphragms are the valve compo-nent that provide positive shut-offbetween process fluids, protectsthe process from the environmentand in some cases protects theenvironment from the process.
Genuine ITT diaphragms feature:
• Engineered safety• Reliability• Industry proven performance• Reduced total cost of ownership• Complete product range• Pure-Flo Topworks compatibility• Material traceability• Original Equipment Manufacturer
(OEM) materials and specifica-tions
• Global availability• Global technical support• Preventative maintenance pro-
gram development assistance
Regulatory Compliance to:
• FDA 21CFR Part 177 • US Pharmacopea 28 Class VI • Pressure Equipment Directive
97/23/EC • EMEA/410/01 - TSE/BSE
(Transmitting Animal SpongiformEncephalopathy)
ITT Pure-Flo diaphragms are quali-fied and approved for use withPure-Flo diaphragm valves. Othermakes of diaphragms are notrecommended and/or guaranteedby Pure-Flo for use with Pure-Flovalves.
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4
Diaphragm Type ComplianceGrade Material FDA USDA 3A USP
B Black Butyl Rubber17 EPDMP Buna N **
TM17 PTFE *R2 PTFEW1 White Butyl Rubber
DiaphragmSelection
The Pharmaceutical and Biotechindustries consider a number offactors to determine the bestdiaphragm solution for a givenprocess or application.
Key factors include:• Regulatory Compliance
• FDA• USP 28• 3A
• Biocompatability• Material extractibles • Application temperatures• Cleaning in place• Steaming in place• Passivation• Failure mode
Applications within the Biotechindustry are particularly sensitive todiaphragm materials because ofthe fact that many of the processeswithin the industry utilize livingorganisms. A balance or compro-mise must be struck between all ofthe key factors listed. Regulatorycompliance in most cases is notsufficient by itself to guarantee aproperly functioning system.
The worldwide network of ITTPure-Flo technical resources areavailable to assist in determiningthe proper diaphragm for yourapplication.
* Class I applications** Class III applications
Grade R2 PTFE limited availability, replaced by Grade TM17 PTFE
Pure-Flo® FDA Compliant Diaphragms shown clock-wise: Buna N Grade P, White Butyl Grade W1, BlackButyl Grade B, Pure Gum Rubber Grade A, Grade 17,Grade TM17 PTFE
Diaphragm Type Size TemperatureGrade Material Inch DN °F °C
B Black Butyl Rubber 1/4–12 6–300 -20–250 -29–12117 EPDM 1/4–4 6–100 -30–300 -34–149P Buna N 1/2–12 15–300 10–180 -12–82
TM17 PTFE 1/4–6 6–150 -30–350 -34–176R2 PTFE 1/4–10 6–250 -30–350 -34–176W1 White Butyl Rubber 1/2–8 15–200 0–225 -18–107
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5
Diaphragm Design
Pure-Flo’s two-piece PTFEdiaphragms have proven throughyears of outstanding service to bea robust and forgiving design. Thetwo-piece construction eliminatesthe delamination problems inher-ent in competitive “PTFE faced”diaphragms.
PTFE diaphragms utilize a floatingtube nut connection. The floatingtube nut design assures that down-ward closing forces will beabsorbed by the elastomer backingcushion and evenly distributedacross the closing surface (weir) inthe valve body.
Design Benefits:• Reduced cold flow• Improved sealability• Longer diaphragm life• Reduced point loading• Eliminates stud pullout
ElastomerDiaphragmConstruction
Pure-Flo elastomer diaphragms areproduced by a compressionmolding process. The completedelastomer diaphragm is of a one-piece design. The diaphragm isconstructed with layers of polymermaterial and a high performancewoven fabric reinforcement formaximum strength and durability.
Elastomer diaphragms utilize athreaded connection to the valvecompressor. PTFE and Elastomerdiaphragm threads are not inter-changeable.
PTFE Diaphragm Compressor AssemblyShowing Floating Tube Nut Design
High PerformanceWoven FabricReinforcement
Layer ofPolymer Material
ThreadedConnection
Layer ofPolymer Material
* 950 and 970 Manual Bonnets use a T-slot compressor
Stem*
Floating Tube Nut
Compressor
EPDM Backing Cushion
PTFE Diaphragm
Diaphragm Stud
Compressor
Pin
Backing Cushion
PTFE Diaphragm
Tube nut andDiaphragm stud “float”
along axis withoutvertical force
Downward forcetransmitted throughthrust collar to toparea of compressor
Downward forceon stem
Stem
Thrust Collar
Tube Nut
Compressor Pin
Compressor
Downward force on top of compressor by-passed bytube nut and transformed to distributed pressure onbottom area of compressor. Compressor pressesdiaphragm over weir area of valve body.
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Grade TM17 PTFE
ITT Pure-Flo has developed a modified PTFE diaphragm to betterwithstand the critical process protocols associated with thePharmaceutical and Bioprocessingindustries, resulting in increasedperformance and longer life.
Type: TM17
Size Range: BT–6” (DN6 - DN150)
Temperature Rating:-30°F to 350°F (-34°C to 176°C)
Pressure Rating:See Pressure & Temperature chart onpage 11
Material (2 Piece Construction):Product Contact Surface: ModifiedPTFE with PPVE*Backing Cushion: Grade 17 EPDM
Regulatory Compliance:21CFR 177.1550 (a)USP28 Class VI, Chapter <87>, <88>21CFR177.2600 (Backing cushion)
*TM17 Material is considered ahomopolymer according to ISO 12086, ASTM D-4894 due to < 1%perfluoropropyl vinyl ether (PPVE)modification
PTFE ProductContact Surface
EPDM BackingCushion
7 www.ittpureflo.com
Grade TM17 PTFE
The enhanced material of theTM17 diaphragm retains all ofindustry proven advantages ofconventional PTFE with severalsignificant enhancements.
Overall improved sealing and flexlife due to:• Reduced cold flow • Reduced permanent deformation
under cyclic load• Greater dimensional stability• Reduced embrittlement• Greater crack resistance
Improved steam life due to:• Reduced voids• Reduced permeation• Reduced permanent deformation
under cyclic load• Reduced embrittlement• Greater crack resistance
Improved cleanability due to:• Reduced permeation• Reduced voids, pore free surface• Non-stick properties
Permanent Deformation Under Load (1 Cycle)
Moisture PermeationVoid Content
Permanent Total Deformation at 23ºC/74ºFCyclic Loading
Permanent Total Deformation at 150ºC/302ºFCyclic Loading
TM Modified PTFEConventional PTFE
Unfilled Compound(25% glass fibers)
Compound(25% carbon)
Cycle
Cycle
% V
oid
Con
tent
Moi
stur
e C
onte
nt
(1) Per ASTM F1249 (2) Permanent deformation after 100 hours under load. Measured 24 hours afterload removal. Based on ASTM D621
See Note 2
See Note 2
See Note 2
g *
mm
m2
* da
yTM17 is comparable to25% carbon reinforcedconventional PTFE
See Note 1
8www.ittpureflo.com
Grade 17 EPDM
Grade #17 is comprised of a highmolecular weight EPDM elastomer,which provides increased mechan-ical properties while reducingcompression set. In addition, thediaphragm is peroxide cured*enhancing the biocompatibility ofthe material.
Type: Grade 17
Size Range: BT–6” (DN6 - DN150)
Temperature Rating:-30°F to 300°F (-34°C to 149°C)
Pressure Rating:See Pressure & Temperature charton page 11Consult factory for steam rating
Material:Ethylene Propylene Diene MonomerPeroxide Cured (EPDM)
Regulatory Compliance:
21CFR 177.2600USP 28 Class VI, Chapter <87>, <88>
Benefits:
• Improved biocompatability • Better mechanical properties• Reduced compression set• Improved steam resistance (inter-
mittent)
* Peroxide has replaced sulfur asthe preferred method of EPDMcuring as sulfur was found to bea biocide which could adverselyaffect sensitive bioprocesses.
Elastomer Diaphragms forVacuum ServiceThe standard Pure-Flo diaphragm valve is ideallysuited for vacuum service, providing dependableperformance and good service life from atmosphericpressure down to nearly full vacuum (-30 in Hg, 0 Bar A) The diaphragm is bi-directional and presentsa smooth face with no hidden voids on either side ofthe valve, whether open, closed or throttling.
9 www.ittpureflo.com
QualificationTesting
Quality, performance and reliabilityof all Pure-Flo diaphragms isassured through extensive testingand comprehensive controls on thediaphragm material manufacturingprocess. Pure-Flo has years of expe-rience in the development ofdiaphragm materials for use in thechallenging applications within thePharmaceutical and Bioprocessingindustries. This knowledge isapplied to each new materialdevelopment. Successful comple-tion of all appropriate regulatoryrequirements and operationalperformance benchmarks must bemet before any new diaphragmmaterial is released to the industry.
Typical conformance andperformance tests:• FDA extraction per
21CFR177.2600 (Elastomers)• FDA extraction per
21CFR177.1550 (PTFE)• USP28 Class VI Chapters <87>
and <88>• Cycle testing using air, water,
and/or steam• Cycle testing against vacuum and
positive pressure at 100% and0% P conditions
• Cycle testing at ambient and ele-vated temperatures
Note: ITT Pure-Flo diaphragms arequalified and approved for usewith Pure-Flo diaphragm valves.Other makes of diaphragms arenot recommended and/or guaran-teed by Pure-Flo for use withPure-Flo valves.
Diaphragm Development
Qualification Testing
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Pressure Boundary
The diaphragm is a critical pressure boundarycomponent of a typical diaphragm valve in conjunc-tion with the valve body, fasteners and manual oractuated bonnet. These components are designed,manufactured and tested to achieve specific pressureratings and performance criteria. Changes in mate-rials, dimensions or even tolerances of any of thesecomponents can have an adverse affect on theoverall performance and safety of the valve. ITT PureFlo conducts extensive testing to support theperformance of the valve and pressure boundary.
European PressureEquipmentDirective 97/23/EC
Diaphragm valves must complywith European Union PressureEquipment Directive 97/23/EC.Valves must meet certain EssentialSafety Requirements and designcriteria. This includes diaphragmsas they are an integral componentof the valve pressure boundary.
The PED requires the manufacturerto maintain a technical file prima-rily consisting of:• Design calculations or proof test• Material testing• Performance testing• Declaration of Compliance to the
PED 97/23/EC (available onrequest)
An excerpt from a guideline for thePressure Equipment Directive97/23/EC states:
“Pressure equipment which hasbeen subject to important modifi-cations that change its originalcharacteristics, purpose and/or typeafter it has been put into servicehas to be considered as a newproduct covered by the directive.”1
Note:The use of unauthorized and there-fore undocumented componentswithin the valve constitutes amajor modification to the valveand renders the original ITTDeclaration and compliance to theDirective invalid. The end user orthe supplier of the unauthorizedreplacement component must takethe responsibility for compliance to93/23/EC.
1 http://europa.eu.int/comm/enter-prise/pressure_equipment/ped
ValveBonnet
Valve Body
Pressure Boundary
Diaphragm
11 www.ittpureflo.com
Vac
uu
m (
Bar
A,
Bar
(g))
* This line shows the limitation of plastic bonnets including 950, 963, and the AdvantageActuators.Note: Elastomer diaphragms may be used in vacuum service within above temperaturerecommendations. For services exceeding charted pressure/temperature recommendations,consult factory. The chart does not pertain to steam or corrosive services. Consult ITT DV-01Technical Manual and Service Guide for specific recommendations.
1/2” - 1” (DN15 to 25) valves1 1/2” - 2” (DN32 to 50) valves
2 1/2” - 3” (DN65 to 80) valves
4” (DN100) valves
6” (DN150) valves
Temperature °C
Max
imu
m P
ress
ure
Lin
e P
ress
ure
(P
SIG
)
Temperature °F
Lin
e P
ress
ure
(B
ar(g
))
Pressure/Temperature Recommendations
Limitation of Plastic Bonnets*
PTFE Diaphragms for Vacuum Service
Notes:1. Service conditions falling to the right of these lines will require
bonnet evacuation.2. PTFE-Diaphragms, 6" (DN 150) size and larger, will not with-
stand full vacuum at any temperature unless bonnets are evac-uated.
3. With evacuated bonnets any size PTFE-Diaphragms can beused up to 350°F (176°C).
4. See page 8 for Elastomer Diaphragms for Vacuum Service
1/2”
- 2
” (D
N15
to
55)
valv
es
2 1/
2” (
DN
65)
valv
es
3” (
DN
80)
valv
es
4” (
DN
100)
val
ves
Temperature °C
Vac
uu
m (
in H
g)
Temperature °F
12www.ittpureflo.com
Validation andCompliance
ITT Pure-Flo recognizes the impor-tance of product and processvalidation to the Pharmaceutical andBioprocessing industries. A completeselection of documentation is avail-able to facilitate the validationprocess.
• Diaphragm ingredients and processing aids are FDA compliant
• Physical properties, raw materials,compounding and moldingprocess are documented
• All diaphragms are available withFDA Certificate of Conformance
• 21CFR177.2600 - Elastomers• 21CFR177.1550 - Perflourocarbon
• All diaphragms are available withUSP 28 Class VI Certificate ofConformance
• Chapter 87 In-Vitro• Chapter 88 In-Vivo
• Certificate of Compliance toEMEA/410/01 "Guidance onMinimising the Risk ofTransmitting Animal SpongiformEncephalopathy Agents via Humanand Veterinary Medicinal Products"available upon request
• Certificate of Traceability to EN 10204 3.1 B available uponrequest
• Third party testing and in-houseperformance data available uponrequest
Note: ITT Pure-Flo diaphragms arequalified and approved for use withPure-Flo diaphragm valves. Othermakes of diaphragms are not recom-mended and/or guaranteed byPure-Flo for use with Pure-Flo valves.
Certificates of Compliance
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Date Codes
PTFEB3 = February 2003manufacture date
PTFE Code - MonthsA JanuaryB FebruaryC MarchD AprilE MayF JuneG JulyH AugustI SeptemberJ OctoberK NovemberL December
PTFE Code - YearYear Code1999 92000 02001 12002 22003 32004 42005 5etc. etc.
Diaphragm Tab CodesDate
Size
Material Grade*
Vendor ID
Front
Back
ElastomerTwo digit year code anddots corresponding tomonthsExample: 01 with 4 dots isApril 2001
*Hole in tab indicates TM for material grade. Other materialgrades are listed on page 4
DiaphragmTraceability
All diaphragm materials and phys-ical properties are batch traceablevia permanent codes molded intothe diaphragm tabs. The moldingdate, material type, and diaphragmsize provide traceability to originalbatch records.
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Packaging
All Pure-Flo diaphragms are sealedin individual tamper evident pack-ages to prevent damage andcontamination during transporta-tion, handling and storage.Tamper evident packaging providesan extra level of assurance that thediaphragm has not been exposedto potential contamination duringstorage or maintenance activitiesprior to installation.
All Pure-Flo Diaphragm packagescontain important informationnecessary for validation and main-tenance.
• Diaphragm part number• Description• Material• Pack date• Cure date• Installation graphic
European Market Packaging
Packaging Method of US based Pure-Flo Sites
15 www.ittpureflo.com
Application
Pure-Flo diaphragms are suitablefor a wide range of utility andprocess applications utilized in thePharmaceutical and Biotech indus-tries. However, not all diaphragmmaterials are suitable for allprocesses and conditions. Theaccompanying tables should beused as a reference.
The worldwide network of ITTPure-Flo technical resources areavailable to assist in determiningthe proper diaphragm for yourapplication.
Typical Process Applications:• WFI• Purified water• Product solutions• Buffer solutions• Cell culture solutions• Media• Solvents• Protein solutions• Ultra filtration
Typical Utility Applications:• Passivation protocols• Cleaning protocols• Sterilization protocols
Saturated Steam1
DryHeat2 Ozone320 psi
1.4 Bar(g)30 psi
2.1 Bar(g)40 psi
2.8 Bar(g)PTFE R R R R REPDM R* R* R* U RButyl R* R* R* U RSilicone U U U U R
1 20psi/1.4 Bar(g) = 259ºF/126ºC30psi/2.1 Bar(g) = 274ºF/135ºC40psi/2.8 Bar(g) = 286ºF/142ºC
Sterilization
NitricAcid15%1
Phosphoric10%1
CitricAcid15%1
MixedChelants2
PTFE R R R REPDM U R R RButyl R R R RSilicone U U R R
Passivation
R = ResistantU = Unsatisfactory
1 At 60ºC/140ºF2 Amonium citrate Base at 80ºC/176ºF
Sodi
umH
ydro
xide
NaO
H
Sodi
umH
ypoc
hlor
ite
NaO
CI
Pota
ssiu
mH
ydro
xide
KOH
Phos
phor
icA
cid
H3P
O4
Hyd
roge
nPe
roxi
deH
2O2
PTFE R R R R REPDM R R R R RButyl R R R R USilicone R R U U R
Cleaning
2 338ºF/170ºC3 3% at 80ºF/27ºC
* Limited life and undesirable failure mode
Consult factory for specific temperature and concen-tration limitations.
For more information, please contact:
Pure-Flo Headquarters33 Centerville RoadLancaster, PA 17603-2064 USAPhone +1 (800) 787-3561Phone +1 (717) 509-2200Fax +1 (800) 239-9402
Website: www.ittpureflo.comE-mail: [email protected]
Valve Office Locations:
Pure-Flo110-B West CochranSimi Valley, CA 93065 USAPhone +1 (800) 926-8884Phone +1 (805) 520-7200Fax +1 (805) 520-7205
Pure-FloRichards StreetKirkham, LancashirePR4 2HU, EnglandPhone +44-1772-682696Fax +44-1772-686006
16
PFDIAA4-06
© 2006 ITT CorporationIndustrial & BioPharm Group
8H.POD