avara Avara Shannon Pharmaceutical Services Ltd.

€nvir~nmentaI External Reports

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EPA Export 08-04-2019:03:41:19

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EPA Export 08-04-2019:03:41:19

Document Nu.: UCIRTU103.218 / 2018766 EPA Licence No.: POD20-U2 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Seruices Ltd Year: 2028 Facility location: Avara Shannon Pharmaceutical Services Ltd, Shannon Facility Office: Trim Rev.No: 1

Air L Scientific

Reporttpproved by

Stack Testing Team

Report Date Report Type

I Report Title

Dr. John Casey Dr. John Casey, Dr. Brian Sheridan

Test Report Compliance MonirorinFi 24/01/2019

Company address 1

Version

Stack Emissions Testing Report Commissioned by

Facility Name

1

Dates of the Monltoring Campaign

Job Reference Number

Report Wrltten By

Air Emissions Compliance Monitoring Emissions Report Air Scientific Ltd., 32 DeGranville CourtJ Dublin road,

Trim, Co. Meath Avara Shannon Pharmaceutical Services Ltd

Avara Shannon Pharmaceutical Services Ltd, Shannon Facility

Ms. Lourda Molaney POO20-02

Avara Shannon Pharmaceutical Services Ltd VE135

10/12/201& UCIRTL1101218 / 2QIX766

Dr. Brian Sheridan

.tohn cssey Managing Director

Sfgdature of Agprover

Page 1 of 24

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EPA Export 08-04-2019:03:41:19

Document No. . UCIRTL1101218 / 2018766 EPA Licence No . . POO20-02 Visit No: 4 Licence Holder; Avara Shannon Pharmaceutical Services Ltd Year: 2018 Facility Location: Avasa Shannon Pharmaceutical Services Ltd. Shannon Facility Office: Trim Rev. No. 1

Contents la Executive Summary ............................................................................................................................

Overall Aim of the monitoring Campaign ....................................................................................... Special Requirements ........................................................................................................................ Target Parameters .............................................................................................................................. Emission Limit Values ...... .._ ............................................................................................................... Reference Conditions ........................................................................................................................ Overall Results ...................................................................................................................................... Acciditation details .......................................................................................................................... Monitoring Dates & Times ._ ............................................................................................................. Monitoring, Equipment & Analytical Methods ..................................... .......................................... Sampllng Deviations ........................................................................................................................... Reference Documents ........................................................................................................................ Suitability of sampling location .......................................................................................................... Prooess details ...................................................................................................................................... Stack diagram ......................................................................................................................................

2. APPENDICES ......................................................................................................................................... II . App.endix I - Monitoiing Personnel & Equipment ........................................................................

Stack Em issisns Monitoring Personnel ............................................................................................ 111. Appendix II - Stack Details &flaw characteristics ........................................................................

IV . Appendix Ill - Individual parameter sampling details and results .............................................

I . Monitoring Objectives ........... ...........".. ............................................................................................

Preliminary r;tack survey calculations ..............................................................................................

API: sampling details and resutts ................................................................. API Quality Assurance ...............................................................................................

3 3 3 3 3 4 4 5 6 7 8

9 11 11 12 13 14 14 14 15 15 23 23 26

p

Opinions and intep@kbns expressed herem are outside the scope NAir ScleMr7c Limited /NAB acereditation . 7711s test regod shall not be reproduced, without the wtfffen approval of Alr Sct@nfh% Limited . Afl sampling

and reporting is mmpl8ted in accordance wifh Erwimrnenfai Protectfort Agency Air Guidance Note 2 requknwfs .

Page 2 of 24

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EPA Export 08-04-2019:03:41:19

Drrcunlent No.; UCIRTLI101218 / 2048766 EPA Licence No.: PO020-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Sewices Ltd Year: 2018 Facility Location: Avara Shannon Pharmaceutical Services Ltd, Shannon Facility Office: Trtm Rev.No: 1

- API

Stack Gas Temaerature

Overall Aim of the monitoring Campaign The aTm 5f the monitoring campalgn was to demonstrate cornpllance with a set of emission tlmit values a5 specified in the site Ilceflce.

Special Requirements There were no sp&a[ requirements.

Page 3 of 24

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EPA Export 08-04-2019:03:41:19

BOcUment No.; UClRTL1ZB1218 / 2018766 Visit No: 4 Year: 2018 Office: Trim

API

EPA Licence No,: POO20-02 Licence Holder: Avara Shannon Pharmaceutical Services Ltd

Facility Location: Avara Shannon Pharmaceutical Sewices Ltd, Shannon Facility Rev.No: 1

0.15 I -

Emission Limit Values

~ ~~

Stack Gas Temperature

Volume {m3.h-') 52,000

Reference Condition

Oxvuen Reference %

W u e

No Owaen Ref

I Temoeralure K 1 273.15 ~

Total Pressure kPa

Moisture 56

___ ~

101.3

NO

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EPA Export 08-04-2019:03:41:19

E?& licence No.: P0020-02 llcence Holder: Avara Shannon Charfflaceutlcal Sewlces ltd

Faclhty Location: Avam Shannan PharmamtlcalSewitm ltd, Shannon Fadlity Rev.Rlo: 2

Executive Summary

Overall R&ulB

Run I

“:[‘I Wnlts Result Umit

Conoentr Mass I allan Emission

Parameter Dsbs Unik Result MUM- Blanks Limlt

Page5 of24

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EPA Export 08-04-2019:03:41:19

Document No,: UCIRTtllt01218 / 2013766 EPA Licence Nh,; POD20-02 Visit No: 4 Licence Holder: Auara Shannon Pharmaceutical Services Ltd Year: 2018 Facility Location: Avan Shannon Pharmaceutical Services Ltd, Shannon Facillty QfFIce; Trim Rev.No: 1

Execuflve Summary

Monitoring Dates & Times

Page 6 of 24

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EPA Export 08-04-2019:03:41:19

Document No.: UQRTLILPOIZIB / XI18766 Vislt No: 4 Year: 2018

EPA licence No.: POD20-02 Licence Holder: Avara Shannon Pharmaceutical Services Ltd

Facility Location: Avara Shannon Pharmaceutical Services Ltd, Shannon FaciIity Office: Trim Rev.No: 1

Executive Summa*

Page 7 of 24

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EPA Export 08-04-2019:03:41:19

EPA Licence NO.: P002W2 Licence Holder: Avara Shannon Pharmaceutkal Servfcs Ltd

Fadgty Lacatkm Auara Shannon Phermaceutklcal Services ltd, Shannan Facility RevAo: 1

Page 8 of24

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EPA Export 08-04-2019:03:41:19

Document No.: UCIRTLllOlZI8 / 201766 Writ No: 4 Year: 20.018 Olfftce! Trim

EPA Ucence WO.: POBZO-02 licence Holder: Avara Shannon Pharmatmtical Services Ltd

facility Lacotlon: Avara Shaman Pharmacedtical Sewlees Ltd, Shanmn Fadlity Rev.No! 1

List of Equipment

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EPA Export 08-04-2019:03:41:19

Document No.: UCIRTU101218 / 2013766 EPA Licence No,: POD20-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Services Ltd Year: 2018 Facility Location: Avara Shannon Pharmaceutical Services Ltd, Shannon Facility Office: Trim Rev.No: 1

Standard ID

Standard ID

Standard ID

Sampling Deviations

EN16911:2013-flnw rates in accordancewith MlDB9ll-I

I Parameter 1 Deviation I

Risk Assessment (RA)

Site Review [SR)

Site Specific Protocol (SSP) SOP1D15

I Standard ID I I

soP1011

SOP1 015

f

Page 10 of 24

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EPA Export 08-04-2019:03:41:19

Rocument No.: LJCIRTLllOlZlX / 2018766 EPA Licence No.: POO20-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Serwices Ltd Yeas: 2098 Facility Location: Avwa Shannon Pharmaceutical Scrviws Ltd, Shannon Facility offlce: Trim Rev.No; 1

PermanenVTemporafy

Inside/ Outslde

Executive Summary

Suitability of sampling location

Permanent Ouktde

t

Irish EPA Techn[cal Guidance Note AG1 I BS EN 'I5259 PIatform Requirements

Sufficient Working area to manlpulate probe and measuring instruments

Platform has 2 handrails faDorox. 0.5m & 1 .O m hrsh)

I General Information I Value I

Value Comment

Yes

Yes

~ ~

Platform has chains / self closing gates at top of ladders

There are no obstructions present which hamper insertion of sampling equipment

Safe Access Avatlable

Yes

No

Y@S

I Platfarm has vertical base boards laaorox. 0.25 rn hiahl I Yes I I

- ~ ~

Capacity (perlhour) (If applicable) NIA

Continuous or Batch Process Gonlfnuous

Feedstock Pharmaceuflcal Dust

Abatement Systems Running Status

Fuel Plume Auwarance

I Easv Access Available I Yes I I

~

Normal None

NO

SampIihg Location I Platform Improvement Recommendations

None

~~ ~

BSEN 15259 Homogeneity Test Requirements

I: There is no requirement to perform a BSEN15259 Hornogenity Test on this stack

Process details

I Parameter I I r Process status1 Normal 1

I Abatement Svstaml Yes I

I Other information^

Page 11 of 24

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EPA Export 08-04-2019:03:41:19

Document No.: UCIRTLlPO1218 / 2018766 EPA Licence No.: POO20-02 Visit No: 4 Licence Hotder: Avara Shannon Pharmaceutical Sewices Ltd Year: 2018 Facflity Location: Avara Shannon Pharmaceutical Services Ltd, Shannon Facility Office: Trim Rev.No: 1

Llcensee

Reg. number POO20-02

Site Contact Ms. Lourda Molonev Contractor Air Scientific Ud.

Contradors contact Dr. Brian Shertdan

I Role 1 I Role I ~

I I 1 Signature Signature

Emissions point Type of process Load of process

Rotogravure Printing

Cement Plant I - I

Other

Page 12 of 24

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EPA Export 08-04-2019:03:41:19

Document No,: lJGIRTLfl01218 / 2018766 EPA Licence No,: P0020-02 Visit No: 4 Licence Holder; Avara Shannon Pharmaceutical Sw-vices Ltd Year: 2018 Facility Location: Auara Shannon Pharmaceutical Services Ltd, Shannon FaciIity Office: Trim Rev.Na: 1

Page 13 of 24

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EPA Export 08-04-2019:03:41:20

Dowment No.: UCIRTLllOlZlX / 2018766 EPA Licence No.: POU20-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Sewices Ltd Year: 2018 Facility Location; Avara Shannan Pharmaceutical Sewices t td, Shannon Facility Office: Trim Rev.No: 1

~ ~~ ~ ~

Qualificatlons System approval

PhD. (Eng.), MSc. (Agr.), B. &r. Sc.

Air Scientific Limited Approved

2. APPENDlCPS

II. AppendixJ - Monitoring Personnel & Eguiprnenf

Stack Emissions Monitoring Personnel

~~ ~

Qualifications

System approval

Team Leader IName /Or. John Casey I

~

PhD. (ens.), MSc. (Agr.), BSc. (Hons.)

Air Scientific Limited Approved

Team Leader INarne IDr. Brian Sheridan I

Page 14 of 24

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EPA Export 08-04-2019:03:41:20

I..

~

Sample Pot? Slze mm 1 25

lniffal Pitot Leak Check Pa w.7 Final Ptbt Leak Check Pa l a

Odentation of Duct Vertical

Pttot Tube Cp 0.998

Number of Unes Available 2 Numbef 07 Lines Used 2

Document No.: UCIRTL1201218 / 2018766 EPA ttcence No,: PQ020-02 Visjf No: 4 Llcence Holder: Avam Shannon Pharmaceutical Services Ltd Year: 201x Facility Location: Avara Shannon Pharmaceutical Sewices Ltd, Shannon Facility Office: Trim Rev.No: 1

Preliminary stack survey calclrlations

Page 15 of 24

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EPA Export 08-04-2019:03:41:20

Document No.: UCIRTC11012lS / 2018768

Year: 2018 Mftce: Trim

k&kNQ: 4 EPA Licence No.: PUOZ0-02

Licence Holderr Avara Shannon Pharmaceutical Serulces Lrd Facllkylocatlon: Avara Shannon Pharmaceutbl Services Ltd, Shannon FacIllty

Rev.No; I

1. D.W 5 0 a 7.6 4 6 2 a 0.2 59 7.8 Cl6 3 0~41 48 B 7.4 <I$ 4 046 a a wa x15

B t.T7 64 B 7.8 4 5

1. D.W 5 0 a 7.6 4 6 2 a 0.2 59 7.8 Cl6 3 0~41 48 B 7.4 <I$

I I x15

B t.T7 64 B 7.8 4 5

Page f C af A

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EPA Export 08-04-2019:03:41:20

Document NO.: UCIRTLZ101218 / 2018766 VMt No: 4 Year! 2018 Office: Trim

4

5

6 7 8

g

EPA Lkence No.: POOZO-DZ Licence Holder: Avara Shannon PharmaceutkaTServim Ltd

Fadlitty location: Avara Shannon Pharmmutical Services ltd, Shannon Facility R e m & : 1

(I 98 19 B 7.5 4 5

111 51 B 7.6 c15

1.17 56 8 a EM

I

Page 17 of 24

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EPA Export 08-04-2019:03:41:20

Drxcument No.: UCIRTLllO32.U / 2018766 visitPTa: 4 Year: 2018 Off&: Trlm

EPA Licence No.: POOXt-02 Licence Holder: Avara shafinQtl Pharmacgutkal Services Ltd

Facility location; Avara Shannon Pharmaceutical SentcesLtd, Shannon Pacilify Rev.&: i

a

Page 18 of 24

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EPA Export 08-04-2019:03:41:20

Tested Ely

Approved ay

Air Scientific (TM)

Adam Ossland Date

CerliROate No. WKI8-87H

hue No. 1

Fag% 2 of 2

RPS Laboratarks Ltd. Unit 12. Waters Edge Business Park. Modwen Road. SalfMd. M5 3E2 Tel; (0161) 8722443 Rx: (0161) 877 3959

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EPA Export 08-04-2019:03:41:20

Date 08/01/2019 Test Certificate

5-isosorbide Manonitrate

lsosorbide DinRrate

Client

e 1-'9 In house( N) 12 Irg In houseCN)

contact

Alr Scientific OM) Unit 32 De Granville Court

Dublin Road

Trim Go Meath

Ireland

Brim Sheridan

2 filters far tsosorbide dE- & momnibate

Order NO. UClRTLl lO't218

CertlRCate No. WK18-8754

Issue No. I

DahReceivad 14N'2/2018

Teehnlque HPLC

Sample No. 1024986 195

<2 PLl I In house(N) 5-ismorbide Mononifrale

lsosorbide Dinitrate I UQ In house(NI

Sample No, 1024987 Blt4lk Method

f

Page f of 2

RPS Lahoratarles LtU Unlt 12. Waters Edge Business Park. Medwm Road. Salford. M5 3 a

Tek (OlSl) 872 2443 Fax: (0161) 877 3859

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EPA Export 08-04-2019:03:41:20

Document No.: UCIRTL1101218 / 2018766 EPA Licence No.: POO20-02 VisRNo: 4 Licence Holder: Avara Shannon Pharmaceutical Serulces Ltd Year: 2018 Facility Location: Avara Shannon Pharmaceutical Services Ltd, Shannon Facility Offlee: Trim Rev.No: 1

API Quality Assurance

Page 24 of 24

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EPA Export 08-04-2019:03:41:20

Document No.: UClRTL1101218 / 2018766 EPA Licence No.: POa20-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Servlces Ltd Year: 2018 Facility Location: Avara Shannon Pharmaceutical Services Ltd, Shannon Facility Office; Trim Rev.No: 1

Pitot Tube Leak Check

Positive Pressure

Result

Pass

Negative Pressure Pass I I

Number of Forts

Straiclht lenath before samole ooint

2

s 5 r 5 Hvdraulic Diameters

Sample Calculations I I 1 I

Page 23 of 24

Blank (Filter and Front Wash Combined)

Sample I {Filter and Front Combined)

Volume of Air Samaled

1 4.004 mg so.004 mg

4.63 Nma Blank Result

Sample Resuit

Emission Limit Value

~0.0009 r n g . ~ ~ ' ~

SO.OOUQ mg.m-3

0.15 m~g.rn-~

Blank as Percentage of ELV 0.6 96 I Standard Requlrernent 4 0 % ELV

lsokinetic Criterion Compliance

lsokinefc Variation % 0 Allowable Isokinetic Range

Is0 Kineticity Acceptabte

% 95-1 75

Yes

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EPA Export 08-04-2019:03:41:20

Document No.: UCIRTL1101218 / 2018766 EPA Licence No.: PQ020-02 Visit No: 4 licence Holder: Avara Shannon Pharmaceutical Services Ltd Year: 2018 Facility Location: Avara Shannon Pharmaceutical Servlces Ltd, Shannon Facility Office: Trim Rev.No: 1

lQOD.0

lopingm Weights 1

Iv. Append& 3 - individual paramotwsampljng defails and#sdts

9 Inltlal F h l Difference

API Sampling details and resutts

4

Volume of Air Sampled

Moisture Content (EN T4790)

I Balance Calibration I Weight I I

4 3 Nrn3

0 %

Standard Criteda to be Met Resu It

Angle of Flow .=I 5 Nagathe Flow In the Stack None Pttot Pressure Difference >5Pa

Ratia of Flow Measurement 1.27

Standard Requirement

115 Degrees None

~ 5 P a

- 3 1

Page 22 of 24

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EPA Export 08-04-2019:03:41:20

Dacument No.: UCIRTLllOi2i8 / 2018766 VBit Nu; 4 rear: 2018 Offlm: Trim

EPA Licence No.: POOZa-02 Licence Holder: Avara Shannon Pharmaceutical Services Ltd

Facilitylomtion; Avara Shannon Pharmaceut3cat Servkes Ltd, Shannon Faclllty Rev.No: 1

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EPA Export 08-04-2019:03:41:20

Document No.: WRTL1101238/1018766 WsitNo; 4 Year: 2018 Office: Trlm

Uelennlnant Units

k9.m' DIY Olnsity @TP)# P STO k 9 . d

We1 DaflSlr (STP). P S W

Diy DemW (Actual), P Aelual

A v e w e W e l DenslLy (AclUal), P AWsl W

ks.ni3 hg.m'l

SPA timce No.: PoO20-02 licence Holder AvamShannon Pharmaceutical Sewtces LEd

Facilin, Locatlon: Avara Shannon Pharmaceutiral Servtces Ltd, Shamon Facility Rev.No: 1

ReLUlt

1.288 1.291

1268

1.265

I Where I I P STD = sum or oomponm! concenmiam, iq~d (excluding wler vapour)

P STW = (P 3TD + pl of WO) / ( 1 + (pi ofHZ0 I0.8836))

P actual= P STO x KSTP I(? STP)) X (Pe t r a ) P aclusl W [at each ssmpllmq pmhl) = P W X (TS I Ps) x (Pa I Tal

t

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EPA Export 08-04-2019:03:41:20

EPA Lieme No,: PO02042 Litence Holder: Awara Shannon Pharmaceuticalservices Ltd

Fadllty Lacatfon: Avsra Shannon Pharmaceuttcal Servlces Ltd, Shannon Factllty R~v.ND: 1

where p=Mf22.41

pt-rxp

Page 19 of 24

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EPA Export 08-04-2019:03:41:20