Document No.: UClRTLl1605 - 20t7723 VMt No: 2 Year: 2017 Ofice; Trhn

IPPC Licence No.: POO2U-02 Licence Holder: Avara Shannon Pharrnaceutlcal Services Ltd

Facllity Locatlon: Avara Shannon Pharmaceutical Se&= Ltd Rev.No: 1

I Air Emtsfons Comdiance Mpnitorina Emissions b w r t Report Title I 7

AirSGfantlc Ltd., 32 DeGranville Court, Dublin road, T h , Co. Company address Manth

I Stack Emfssions Testing Re~ort GommlssiQned by I Avara Shannon Pharmaceutical SeMccts Ltd Facility Name Avara Shannon Pharmaceutical Services Ltd

Contact Person Ms. Lourda Molotl~y €PA Licence Number PQQ20-02

Licence Holder Avara Ehanrton PhamaceuElcal Services Ltd Seck Reference Number VEI35

Dates of the Monitoring Campaign 1 stoslaol7 UGIRTLI 1605 - 201 7723 doh Reference Number .

Report Written BY Qr. Brian Sheridan

Report Approved by I Dr. John Casey -~ Stack Testing Team Dr. Br$n Sheridan, Dr. John Casey

Report Date 07/06Y2017

Report Type Test Repart Gomplfance Monitoring Verslon 1

John casey signature of Approver

Managing Director

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EPA Export 20-09-2017:03:20:11

Document No . . UCIRTL11605 . 2D-IJ123 Visit No: 2 Year: 201 7 Office: Trfm

IPPC Licence No . . POOZO-02 Licence Holder: Avara Shannon Pharmaceutical Selvl~es ltcf

FaFlllty @x+b~. . A%-% Shahno? Phymace@al services Ltd * kv.No: I

Contents 1 .

I . Executive Summary ........................................................................................................ .. ...................... 4

Monitoring Objectives ................................................................................................................ 4 Overall Aim of the monitoring Campaign ........................................................................................ 4 Target Parameters ......................................................................................................................... ~~4 Emission Limit Values ............................................................................. ......,... ................. ...... 4 Reference Conditions ........................................................................................................................ 4 Overall Resuki ................................................................................................................................... 5 Asrreditatim ckta i IS ......................................................................................................................... 5 Monitoring Dafes & Times ............................................................................................................... 6 Process detatls ............................ .....-.. .................................................................. 1.,,11.7 .................. 7 MonitWing. Equipment & Analytical Methods ............................................................................... X Sampling Deviations.. ..................................................................................................................... 10 Reference Documents.. ................................................................................................................. 10 Suitability of sampling location.. ................................................................................................... 11 Stack diagram ................................................................................................................................... 12

2 . APPENDICES .................................................................................................................................. 13 Appendix I - Monitoring Personn.el & Equipment .................... ....r..ll........rl....I.~I..i.I.. .................. 13

Stack Emlssions Monitoring Pcrsonne 1 .......................................................................................... 13 Preliminary stack survey calculations ............................................................................................ 14

Appendix Ill -Individual parameter sampling details and results ........................................ 21 Active Pharmaceutical Ingredient {API) : Sampling details and results .......... Error! Bookmark not

defined . Active Pha.rmaceutical ingredient (API) Quality Assurance ............. Error1 Bookmark not defined .

Speclal Requirements ...................................................................................................................... 4

. .

II . 111 .

[V . Appendix II -$tack Dezai15 8i flow characteristics ................................................................. 14

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EPA Export 20-09-2017:03:20:11

Oocument Noi: UCIRTLI 1605 - 2017723 Vislt MO: 2 Year: 2017 Ofice: Tdm

IPPC L b n c e No.: POOZO-112 Llcence Holder: Avara Shannon Pharinaceutbal Servlces Ltd

Faclllty Looation: Avara Shannon Pharmaaeufical Sewbes Ltd Rev.No: 1

Oplnluns mdintepmtations expresses her& are ohhide tile scope of Air Scfetttific Limited INAB accreditafidn, fhis test mpmf shall not be repmduced, without the wrlten approval of Air Sdentifia Limited. All sampling and reporting ts completed in

acctxdancce WM Envlranmental Pmtecfiion Agency Air Guidance Note 2 requtremenfs,

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EPA Export 20-09-2017:03:20:11

Documen? No.: UCIRTLI 1605 - 2017723 Visit No: 2 Year: eo 1 a Off ice! trtm

Stack Gas Temperature

Volume (m?h l)

lPPC Licence No.: POc-t;rO-oZ Licence Hol&r. Avara Shannwtl Fharrnaceukd Services Ltd

Faclllty Locatton: h a m Shannon F'harmaceUtfcd %rVlces Ltd Rev. No; 1

52,000

1. Executhre Summary

Oxygen Reference % Temperature K

Overall Am of the manitoring Campalgn The aim of th8 mnltorlhg campaim was to demonstrate complfancawith a se1 of emission h i l t values as speGifled In the site

licence.

No Oxygen Ref

273.15

Special Requlrernents

Moisture ?&

There were no spedal requirements,

No

Target Parameters

Erniaslon Ltmlt Values

I Emission Limit Values/ Mass Emlssions Limit Values I rng.m-g I ka.h-' I I API I 0.15 1

Reference Conditions

I Reference Conditions I Value I

1- Tdml Pressure kPa I 101.3 I

I

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Document No.; UClRTLl11605 - 2017723 Visit No: 2 Year: 2017 Qffhe: Trim

Units

rna.tnV3

IPPC Licence No.: POO20-02 Licence Holder; Auara Shannon Pharmmacauttcal Services Ltd

Facillty Location; Avara Shannon Pharmacautical Services Ltd Rev.Na: 1

Executive Summary

Resat MU& Limit Campliant Units Result 0.01 0.12 a.is Yes kg.h-' 0.00048

I Parameter

m3.k1

API

Stack Gas Temperature

38,680 - 1 52,000 Yes I I Volumetric Row Rat@

Air Scientific Limited External Analytical Laboratory

nthar

Overall Results

I NAB3 1 9T UKASOGU5

1 Mass Emlssion Cancentration

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EPA Export 20-09-2017:03:20:11

Document No.; UClRTLl1605 - 2D17723

Year: 2017 Office: Trlm

visit NQ; 2

API

IPPC L i ~ n c ~ No.; POOZO-U2 Licence Holder; Avara Shannon Phamaceuticaf Services Lrd

Facllity Lbcatlon! Avara Shannon Fhamacauutiml Services Ltd Rw.No: 1

Executrve Summary

Run Location Samplingj Sampllng Ssmpltng Duration IO DFA€FIS Time On Time Off (mins.)

Rub' VE135 16/05/2017 10:47:00 llr49:00 0t:W:W Run 2 - - - - Run 3 - *

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EPA Export 20-09-2017:03:20:11

Doournent No.; UClATLI 1605 - 201 7723 Vislt No: 2 Year 20iT Offi~e: Tim

IPPC Ucenco No.: Paom-02 Llcence Holder: Avara Shannon Pharmactcsutbal Services LM

FaciUty Location: Avara Shannon Pharmaceutical SstviceS Ltd

Executive Summary Rev.No: 1

Process defaits

Parameter

I Process status I Normal

I Continuous or Batch Process I Continuous I Feedstock 1

~~

Filtered Air

I Abatement System I Yes Abatement SGtarns Running Status 1 ~ Normal

I Fuel 1 NIA No

Other htormalion 1 Nohe

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EPA Export 20-09-2017:03:20:11

Document No.: UMRTLi1805 - 2017723 IPPC Lleence No.: POO20-02 Visit No: 2 Licence Hotder: AV= Shannon Pharmaceutical Semices Ltd 'fear: 201 7 Facility Lacatinn; Awam Shannon Pharmaceulioal SmvIws Ltd Offfcs: Trtm Rev.Na: 1

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EPA Export 20-09-2017:03:20:11

Do~ument No.: UClRTtl1605 - 201 7723 Visit No: 2 Year: 2017 Office: Trim

Parameter

IPPG Licence NQ,: POMU-02 Licence Holder: Avara Shannon Pharmaceutical Services Ltd

Facility Location: Anta Shannon Pharmaceutical Services Ltd Rev.No: 1

Deviation I Standard 10 EN16911 -In accordance wRh MID6911-1

Standard ID

Standard ID

Reference Documents

Risk Assessment {RA) SOP1 01 1 Site Review {SR) SQP1015

SOP1 01 5 Sife Specific Plotocal IsSPl

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EPA Export 20-09-2017:03:20:11

Document No.: lJClffTLileO5 -2017723 Vi& No: 2 Year: mi7 Office; Trim

General Information

PermanmWemporary

Insidel Outsids

lPPC Ltmoe No.: PUOBO-02 Lfcenoe Hofdw: Avara Shannon Pharmaceulicrrl Services Ltd

Facility Location; Avara Shannon Pharmaceutical SeNlms Ltd Rev.No: I

Executive Summary

Value

Permanent

Outslde

Value Irish EPA Technical Guidance Nota AG1 I BS EN 15269 Platform RequSrements Comment

I Sufficient Workinn area to manipulate probe and measuring instnunenta I yes I Platform has 2 handrails (approx. 0.5m & 1 ..O m high)

Platform has vertical base boards [approx. 0.25 rn high) Y&3 YO-C

Platform has chains /self closing gates d top of ladders There are no obstructhns present which hamper insertion Qf sampling

equipment Safe Access Available

Easy Amess Waitable

Sampling Location I Platform Improvement Recommandations

None

Yes

No Yea

YES

I BSEN 15259 Homogeneity Test RequiremeM -

1 :There Is np requirement to perform a BSEN15259 Hornogenity Test oh this stack E.g. Select Option 5: There is no requirement tr, pertorm a BSEN15259 Homogenity Test on thia stack 2: Test results were obtained trom previous Homogeneityled curled nut by ASL 3: Test resuits were obtained from previous Homogeneity test carried out by Altarnatfve contractor U: Othwr: Enter Description

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EPA Export 20-09-2017:03:20:11

Document Nu,; UCIRTLI I605 - 201 7723 Vkit No; 2 Year; 2017 Office: M m

IPPC Licence No.: P00213-1)2 Lfcenm Holder: A v m Shannon Pharmaceutical Service3 Ltd

Facility Lacatlon: Avara Shannon Pharmaceutical Services Ltd Rw,No: 1

Executive Summary

Stack diagram

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EPA Export 20-09-2017:03:20:11

DoCUmW NO.: UCIRTLI 1605 - 2017723 Visit NQ: 2 Year; 2017 Office; Trlm

IPPC Licence No.: POO20-02 Ltcehce Holder: Avara Shannon Pharmaoeutisal Ser~lcw ltd

Fdtlty Location: Avara Eihhannon Pharmaceutical SeFvfcea Ltd %V.NQ: 1

APPENDICES

U. Appendlx / Monitoring Personnel i% Equipment

Stack Emissions Monitoring PersonneI

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DOCUhlBht NO,: UClRTLl I605 - 201 7723 Vtslt No: 2 Year: 2017 Office; Trim

Sample P ~ l t Size

Initld Pitot Leak Check

Ffnal Pitot Leak Check Oriehtatlnn of Duct

PbtTube Gp

Number of Lines Available

Number of Lines Used

IPPC Licence No.: POO20-02 Licence Holdet: Pivarh Shannon Phamtaoautic~ldces Ltd

Fadlity LocaUon: A w a Shannon Pharmaceutical Servtce:: Ltd Rev.No: 1

1 25

Pa 780

790 Pa

Vertical

I3.998

2

2

mrn

Pranminary stack survey calcu!ations

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Where KpI =Pbt lube calbrafion W k i e n l

Compressibilliy cosreaton lactor, ammed ai awnstant 0 . m

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a.@ 039&

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EPA Export 20-09-2017:03:20:11

c

PitotTube Leak Check Positjva Pressure

Neqatfve Pressure

Document MO.: UGlRTLl1605 - 2017723 Vislt No: 2 Year: 2017 Offlce: Trim

Result

Pass Pass

IPPG licence No.: POMO-02 IJcenoe Holder: Avara Shannon Pharrnaoeutical Services Ltd

Facility Location: Awra Shannon Pharmaceuticd ServIws Ltd Rev.No: 1

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EPA Export 20-09-2017:03:20:11

DOCMIEII~ No.: UClRTLll605 - 2P17723 Vfdt No: e Year: 2017

IPPC Licence No.: POO2Q-02 Lfcenoe Haldqr; Avara Shannon Pharmaceutlcal bwicw Ltd

Facility Locatian: Avera Shannon Pharhmeutioal Services Ltd

Blank (Filter and Front Wash Combined)

Sample I (Filter and Front Combined)

Volume of Air Sampled

Blank Result

Sample Result

Emissfon Limit Value

co,oo2 ms 0.046 rng

1.30 ma a.uoi5 ma.m3

O.lH23 rnn.m*

0.15 rng.m+

Standard R a% Blank as Percentage of ELV $0 Requirement ELV

Isaklnetlc Criterion Corn~l~ar~ce

lsukinetic Variation

Atlowab[e IsoKineflc Range

Is0 Kineftcity r4icceptable

96 0

Ya 951 15

YES - -

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EPA Export 20-09-2017:03:20:11

Document No.: UCIRTLI 1605-2017723 Visit MO: 2 Year: 2017 oftiw Trtm

Stack ID

IPPC Licence No.: POO20-02 Licenca Holder; Avara Shannon Pharmaceutical Services Ltd

SaclUty Looaffan: Avara Shannon Pharmacautical Services Ltd RwNo: 1

VEI 35

BP1 Quality Assurance

Filler Housing

filter, 8mm Filter Size and

Number of Sampling lines

Number of Sampling Points

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Executive SummaryMonitoring ObjectivesOverall Aim of the monitoring CampaignSpeclal RequirementsEmission Limit ValuesReference ConditionsOverall ResukiAsrreditatim ckta i ISMonitoring Dafes & TimesProcess detatls 1.,,11.7Sampling DeviationsReference DocumentsSuitability of sampling locationStack diagram

2 APPENDICESIIStack Emlssions Monitoring Pcrsonne 1

Appendix II -$tack Dezai15 8i flow characteristicsPreliminary stack survey calculations

[VAppendix Ill -Individual parameter sampling details and results2 of