7
Pfizer Ireland Fharmaceuticals Ringaskiddy Active Pharmaceutical Ingredient Plant PO Box 140, Co. Cork, Ireland Tel: +353-214378791 Website: PfEer IreIand Pharmaceuticals Enforcement Team B, Office of Environment81 Enformment, SouthlSouthwest Region, Environmental Protection Agency, Inniscarra, Co. Cork, P31 XW9 Ref: Re : IE Licence register number POOl3-04 For Agency Information: Effluent toxlclty tests: report for 2H-2018 Oear Sirmadarn, 1, Effluent toxicity tests: report for 2H-2018 Pursuant to Condition 8.10.2 and Schedule C.3.2 of the above referenced IE Licmce, please find attached a copy of the results derived from emtoxicological testing of a sample of the emission to sewer from this facility, which being emlssion point TE1 . The sample was collected by the facility on the OB-Sep-18 as a flow-proportional 24hr composite of treated effluent from the 05 Sep2018. Testing was performed by City Analysts Limited at their Shannon Aquatic Toxicity Laboratory [SATL], in accordance with the following scheme. A. Compliance Species The species Crangon crengon [brown shrimp] and Vibrfo ffschefi [microtox] are specified test specie6 in Schedule 6.3 of the faciMy IE Licence register number PO01 3-04. Final results for these species were: Pher Ireland PharmaEeutids Registmed in Ireland - Company Number: 4909% -VAT Number: IE 976783oC Registwed Office: Options Support Group, Rjngaskiddy, Ca. Cork Directors Paul Duffy, Colm Hggh For inspection purposes only. Consent of copyright owner required for any other use. EPA Export 15-12-2018:04:04:08

PfEer IreIand Pharmaceuticals

Embed Size (px)

Citation preview

Pfizer Ireland Fharmaceuticals Ringaskiddy Active Pharmaceutical Ingredient Plant PO Box 140, Co. Cork, Ireland Tel: +353-214378791 Website:

PfEer IreIand Pharmaceuticals

Enforcement Team B, Office of Environment81 Enformment,

SouthlSouthwest Region,

Environmental Protection Agency,

Inniscarra,

Co. Cork,

P31 X W 9

Ref:

Re :

IE Licence register number POOl3-04 For Agency Information: Effluent toxlclty tests: report for 2H-2018

Oear Sirmadarn,

1, Effluent toxicity tests: report for 2H-2018

Pursuant to Condition 8.10.2 and Schedule C.3.2 of the above referenced IE Licmce, please find attached a copy of the results derived from emtoxicological testing of a sample of the emission to sewer from this facility,

which being emlssion point TE1 .

The sample was collected by the facility on the OB-Sep-18 as a flow-proportional 24hr composite of treated

effluent from the 0 5 Sep2018.

Testing was performed by City Analysts Limited at their Shannon Aquatic Toxicity Laboratory [SATL], in

accordance with the following scheme.

A. Compliance Species

The species Crangon crengon [brown shrimp] and Vibrfo ffschefi [microtox] are specified test specie6 in Schedule

6.3 of the faciMy IE Licence register number PO01 3-04. Final results for these species were:

P h e r Ireland PharmaEeutids Registmed in Ireland - Company Number: 4909% -VAT Number: IE 976783oC

Registwed Office: O p t i o n s Support Group, Rjngaskiddy, Ca. Cork Directors Paul Duffy, Colm H g g h

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 15-12-2018:04:04:08

e 1.8TU

2.2 TU [30 minute data]

B. Information Species

In accordance with CondHion 6.10.2 and Schedule C.3.2 of the IE Licence, and as outlined in our EDEN submission on 1 I Jan-18, reference LR032813, the facility proposed to also determine the aquatic toxicity of final

effluent from emission point TEI to f i s h battagliai [a marine crustacean]. risbe fmftagliaiwas included in the current 2H-2018 test suite, with final results as follows, tested using the same sample :

Tisbe battagliai e 3.1 TU

Each of the above tests were performed in the SATL facility on the same sample referenced above. Copy of the

final test report is enclosed herein.

We trust that this is to the satJsfactibn of the Agency.

Yours Sincerely,

Pfizer Ireland Pharmaceuticals Ringaskiddy Active Pharrnaceutkal Ingredient Plant

Ggldine Rooney Environment, tleatth and Safety Department

&er Irelmd Pharmaceulids Regist& in Ireland - Company Number: 490938 - VAT Number: IE W6783LK:

Regisbred Office: Operations Support Group, Ringaskiddy, Co. Cork Directors: Paul Duffy, colm Higgim

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 15-12-2018:04:04:08

Customer Jenny Cotter Pfizer Ringaskiddy API PO Box 140 Ringaskiddy Cork

City Anal- Limited, Pigeon House Road, Ringsend, Dublln 4.

Tel: (01 ) 613 6003 I Fax: (01)6136008

i- ---Ilm,ri Ernail: [email protected]

www.cityanalysts.ie

Certificate Of Analysis Job Number: 18-46553 Issue Number: 1 Report Date: 3 October 201 8

SI te: Ringaskidd y PO Number: 8501 901 888 Date Samples Received: 061091201 8

Please find amched the results for the samples received at our laboratory on 06/09/2018.

ShouId you have any queries regarding the report or require any further services, we would be happy to discuss your requirements. For additional information about the company please log-on to our website at the above address.

Thank you for choosing City Anatysts Limited. We look forward to assisting you again.

Authorlsed By:

Sent By:

Caitln Quinn Deputy Quality Manager

Sent Date: 3 October 201 8

Caitlin Quinn Deputy Quality Manager

Notes: Results relate only to the items tested. Information on methods of analysis and performance characteristics is availde on request. Any opinions or interpretations indicated are outside the scope of our INAB accredltathn. This test report shall not be reproduced except in full or with written approval of City Analysts Limitd.

Page 1 of 5 Template: 1146 Rwision: 018

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 15-12-2018:04:04:08

Customer Jenny Cotter Pfizer Ringaskiddy API PO Box 140 Ringaskiddy Cork

Slte I Method Ref.

Certificate Of Analysis

An a I y s k Fa rn m et e r Result Unlts St8rt Date

Slte: Ringaskddy

Sample Deswiptlon:

Sample Type: Eff luerrt (Final)

Lab Reference Number: 409967

FA966 WED 05 SEW 201 8

StS3239#

SJS3238#

0 - 1 I r n l

1 01091201 8 Inhibitory effsct to Vibrio fischeri A5% giving d . 2 Toxic Units %vol/vol

121091201 8 48 h LC50 to Tisbe battagllal s329b giving 4 . 1 TOXIC Unh %wl/vol

A

City Analysts Limited, Pigeon House Road, Ringsend, Dublin 4.

SE3240

Tel: (01) 613 6003 Fax: (01) 613 6008

[email protected] f -LHFw-,#- Ernail:

281O912Q18 96 h LCSO to Crangon crangon 256% giving cl .8 Toxic Units %vol/vol

Report Reference: 1846553

Repm Version: 1

SIS3011#

SlSl M33#

S/S I 04 1 #

US301 1

Date of Sampling: 06/09/2018

Date Sample Received: 06/09/2018

0#0912018 Conductivity @ 20°C 959.0 uwcm 920%

07109!2018 Dissolved Oxygen 8.34 mgn 02

06/09/20 1 8 PH 8.32 pH Unlt 0710912018 Salinity 0.5 PPt

# = INAB Accredlted, U = UKAS Accredited, = Subconlracted

Note: PV Value is the parametric value, taken from Eu- Communities, (Drinking Water) Rqulatlons, 2014. S.I. No. I22 ol2014 and relates only to drinking water sa m p I e 8. For queries on results, please contact ua within two weeks of the report data to ensure that we can acwmmadata your query as aamplw cennot be stored indefinitely. NAC & ATC - No abnormal change and acceptabb to wstorners. TVG -Total viable cmnt ate D = Analysed at City Analysts Dublin. S i S = Analysed at Ciiy Adalysts Shannon

Page 2 of 5

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 15-12-2018:04:04:08

Custamer Jenny Cotter Pfizer Ringaskiddy AP I PO Box 140 Ri rtgas kiddy Cork

Tesl Parameter Concentration Toxic Unltr M% Confidence Method of Calculatlon % vol. I vol. Limits % vprt.lvol.

Marlne Bacterium A.5 c2.2 Microtox

Marine Copepod a32 <3-1 +.

Certificate Of Analysis

She: Ringaskiddy

Sample Description:

Sample Type: Effluent (Final)

Lab Refemnce Number: 409967

F A W WED 05 SEPT 2018

City Analysts Limited, Pigeon House Road, Ringsend, Dublin 4.

Tel: tol) 81 3 go03 Fax: (61 61 3 6008

L- mall: [email protected]

www.cityanalysts.ie

R~por t Referenw: 18-46553

Repod Version: I

Date of Sampllng: OWO~2018

Date Sample Received: 06/09/2018

Comments

Maine Bacterium 30 min EGO to Vibrio fischori No Light lnhlbdlon oecuned at 45% VOUVOI. -Cornpared to the control.

M a ~ h Copepod 48 hr Tisbe bathgliai NoTisbs were immobilised I@ 32% vol/vol -cornpared to contral.

Test Method(s): (see Appendlx I)

Method 2: Marine Bacterium Method 3: Marine Copepod Method g: Estuarine Crustacean

# = INAB Accredited, U = UKAS Accredited, + = Submtracted

Note: PV Value is the parametric value, taken from European Communkjies, (Drlnklnp Water) Regulatlons, 2014. S.I. No. '122 d 2014 and dates only to drinkinp water samples. Fwquerim on results, p l e w contact us within twn weeks d the repod date to ensure hat we can acwmrndate your query 88 samples cannot IM stored indefinitely. NAC & ATC -No abnormal change and acceptable to customers. TVC -Total vlabls count Site D = Analysed at Ci Analysts DuMin. Site S = Analysed at City Analyst6 Shannon

Page 3 of 5

I

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 15-12-2018:04:04:08

Gw!mx Jenny Cotter Pf izer Ri ngaskidd y API PO Box 140 Ringaskiddy Cork

Certificate Of Analysis

Slte: Ringas kiddy

Sample Deserlption:

Sample Type: Effluent (Final)

Lab Reference Number: 409967

FA986 WED 05 SEPT 2018

:jty Analysts Limited, ligeon House Road, lingsend, lubtin 4.

'el: (01) 813 BOW :ax: (01) 613 6008

I.. _ I I

Report Reference: 18-4659

Report Version: 1

Date of %mpHng: ow09t21201 a Date Sample Received: 061W2018

Method 10: SarnplinQ

# = INAB Amredad, U = UKAS Accredited, = Subcontracted

Note: PV Value is the parametic value, t&n fmm Eumpan Communities, (Dhnking Water) Repulatlons, 2014.S.l. NO. I = d 2014 and rdatas only to drinking water sa m p I e 9. For queries on results, please contact u6 wlthln two weeks of the report date to ensure thatwes can accommalate your query as samples cannot be stored indelinitely. NCK: & ATC - No abnormal chanp and amptable to customers. TVC -Total viable count 3t.e D = Analysed at City Analysts Dublin. Slte S r Analysed at Clly Analpis Shannon

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 15-12-2018:04:04:08

Appendix I

Report Reference: 18-46553

Report Verslon: 3

Toxicity Test Methods and Procedures

I . Freshwater Crustacean

Methad 3235 based on IS0 6341 :2012: ‘Water quality - Determination of the inhibition of the mobility of Daphnia magna Straus (Cladocera, Crustacea)

3, Marine Copepod

Method 3238 based on IS0 14669:1999: ‘Water quality - Determtnation of acute lethal toxicity to marine copepods (Copepoda, Crustacea)’

2. Marlne Bacterium

Method 3239 based on IS0 11348-3:2007: ‘Water quality - Determination of the inhibitory effect of water samples on the light emlssion of Vibrio fischeri (Luminescent bacterla test) - Part 3: Method using freeze-dried bacteria’

4. Marlne Algae Method 3237 b a d on I S 0 10253:2006: ‘Water quality - Marine algal growth Inhibition test with Skeletonema costaturn and Phaeodactyium tricornutum’

5. Freshwater Algae

Method 3236 based on IS0 86922012: ‘Water quality - Freshwater algal gowth inhibition test with unicellular green algae’

6. Freshwater Plant

Based on I S 0 20079:2005: ’Water quality - Determination of the toxic efiect of water constituents and waste water to duckweed (Lemna mlnor) - Duckweed growth inhibition test’

7. Marine Fish

Method based on OECD 1992: Guideline 203: - ’Fish acute toxicity test’

8. Freshwater Fish

Based on OECD 1992: Guideline 203: - ‘Fish, acute toxicity test’

9. Estuarine Crustacean

Based on MAFF SOP No. BEG/030:1996: ‘Brown Shrimp (Crangon crangon) 96 h acute toxicity for liquid effluents and wastes’

10. Samptlng

Based on IS0 5667-1 6:1998: ’Water quality - Sampling - Part 16: Guidance on biotesting of samples’

11. Eluate Generatlon

Based on DIN 38 41 4 part 4, 1984: - ‘Sludge and Sediments (Group S) - Determination of leachability by water (54)

Page 5 of 5

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 15-12-2018:04:04:08