Report Title

Company address

Stack Emissions Testing Report Commissioned by

I Factlity Name I dvara Shannon Pharmaceutical Services Ltd

Air Ernissfons Compliance Monitoring Emissions Report Atr Scientific Ltd., 32 BeGranville Court. Dublin road, Tiim, Go.

Meath Avara Shannon Pharmaceutical SeMces Lid

I Contact Person

Job Reference Number

Report Writfen By

1 EPA Ltcertce Number

UCIRTLI 460518 / 2018262

DF. John Casey

Ms, Lourda Moloney

PQ02D-02

Report Date

Report Type

Version

I Llcenca Holder 1 Avara Shannon PhamamuZleal Services Ltd

-I 110~~2018

Test Report Comptiance Monitoring

7

I Stack Reference Number 1 YEI55

1 Dates of the Monitoring Garnaaian I 1610512018

I Report Approved by I Dr. Brian Sheridan

I StackTeding Team I Dr. BTiWI Sheridan & Dr. John Casey

Signature of Approver

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EPA Export 19-10-2018:03:54:30

Industrial Emissions Licence . . POOiiO@ Liceme Holder: Avara Shannon PhermawuHtcal Servfces Ltd

Facility Location: Avara Shannon Pharmaceuticat ServioeS Ltd Rev.No: i

Cohmnts 1 .

I . Execwtive Summary ...................................................................... ............................................. 4

Overall Aim of the monitoring Campaign ....................................................................................... 4 Special Requirements ..................................................................................................................... 4 Target Parameters ............................................ .-. ........................................................................... 4 Emfssion Llmk Values ....................................................................................................................... 4 Reference Conditions ....................................................................................................................... 4 Overall Results ........................................................................................................................... +.,, . 6 Accredltatlon detaits ....................................................................................................................... 6 Monitoring Dates &Times .............................................................................................................. 7 Process details ................................................................................................................................. 8 Monitoring. Equipment & Analytical Methods ..............................!............................................!.. 9 Sampling Deviations ...................................................................................................................... 11 Reference Documents .................................................................................................................... 11 Suitability of sampling location., .................................................................................................... 12 Stack diagram ................................................................................................................................ 13

APPENDICES ........,........................................... ....................................................................................... 13: Appendix I Monitoring Personnel & Equipment .................................................................... 14

Stack Emissions Monitoring Personnel ......................................................................................... 14 Ap.pendix H Stack Details &flow characteristics ................................................................... 15

Preliminary stack s w e y calculations .............................................................................................. 15 Appendix III Individual parameter Sampling details and results., ............................................ 22

Deterrnlnatlon aP Dioxins and Furans ............................................................................................................ 2~

Monitoring Objectives .............................................................................................................. 4

II .

Ill.

IV.

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Roournent Na,: UCiRT!-ll605?812018262 VisM No: 2 Year: ~0’18 Office: Trim

Opinions and irtteprefations expresses heretn a n outside the scope of Air SCientHc Limited /NAB accmditafhn. Thb test report shall not be reproduced, w&ouf the wfilten approval ofAir Sclenfinc Limited. All sampling and reporting is completed in

accordance wlth Envkmmenfal Protectfan Agency Air Goldance Note 2 requirements.

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EPA Export 19-10-2018:03:54:30

1. Executive Summary

Emlsskn Urnit Values I Mass Emissions Limft Values

Dfnxins $r Furans

Stack Gas Temperature

Volume (d.h-')

I. Monitorrhg Objectives

ng.m" kg -h' 0. I -

21,500 -

Overall Aim of the monitoring Campaign The aim of the monitoring campalgn was to demonstrate compliance with a set af emission limit values as specified in the site

licence.

Temperature K Total Pressure kPa

Moisture %

Thwe Were tip special requirements.

273" 15

10'1.3

Yes

Speclal Requirements

Target Parameters

I Dloxins & Furans I Stack Gas Temperature

Volume (m3.h-')

Emissian Limit Values

Reference Conditione

Reference Conditions 1 Value ~ r Oxygan Reference % I No Oxygen Ref 1

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EPA Export 19-10-2018:03:54:30

lnduslrial Emissions Ucence.: P(la20-02 Licence Holder: Avara Shannon Pham6eutlmi Serrvieeg Ud

facility to&onn: Avara Shanhon Phamceutical S e w b s Ltd Rev,No: T

Executive Summary

Dioxins & Furans

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Industrial Emlssions Licence.: POQ20-02 Llcenm? Holder: Avara Shannon Pharmaceutical Services Ltd

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

Executive Summary

Parameter Process status

Capacfty (perfhour) (if appllcabfe)

Contlnuous or Batch Process

Feedstock

Abatement System

Abatement Syst.=mS Running Status

Fuel

Plume Appearance

Other informatton

Normal

NIB Cantinuous

Sofvent Alr

Yes Nrrrmal

Gas

No

None

Licensee

Reg. number PO020 02

58e Contact Ms Lourda Mulonay

RUk

Signature

8 af 24

Cantractor Air Seiantific La.

Contractor's contact Dr. Brian Sheridan

Rnle

Signature

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Sarnnllnrr Deviations

Standard 1D

Standard ID

I Parameter I Deviation I EN16911 jn accordancewith MID 6991 1

-

Risk Assessment (RA) Site RevkW (SRI Site Specific Protocol (SSP)

Standard ID

Standard ID

SOP1 01 1 SOP1 01 5 SOP1 01 5

Reference Documents

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lndostrlal Emissions Lic%xGe.: PDO20-02 Licence Holder: Awra Shawn Pharmae&diml Senriceti l id

Facility Location: A w a Shnorr Pharmaceutical Services Lfd Rev.No: I

Executive Summary

Oeneral lnformatlon

PermamVTernpomry

InsJdeI OUtside

SuttabtltQ erf sampling location

Valua

Permanent

Outsitside

Platbrnl has vertkat base boards (approx. 0.25 m high)

Plaff~pn ha5 chains / self dosing gates at top of ladUer6 Thew aE no ubstmctians present which hamper Inseltton ddatnpltng

equitmw3-lt Safe Access Available

res Yea

No -

Yes

I Yes I I

BSEN 16259 Homogendty Test Requirements

1: There is no requirement to pei-brm a BSENl5259 HomogenUy Test cm this sbck E.g. Selsct option I: There L no requirement to perform a BIEN752BB ~omog6nI& Twt on Zhts stack a: Test results were obtained from prviaus Homogonetty test carried out by ASL 3: Test results were obtainad from grwiaus Hamcwnelty test wWxl wt by Altarnative Wi tWiCtw 4: Other: Enter Dsscriptfon

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Industrial Emlssbns Licence.: P0020-02 Licence Hdder: Ayara Shannon FharmaceuUcal Services Ud

Facllily Lomlinn: Avara Shetflnun Pi-?armacedcal Sew& Lid f?ew.No: I

Executive Summary

Stack dlagram

I-

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Industha1 Emlssfow Ucence.: POOZD-02 Licenee Holder: Avara Bhannan Pharmaceutical SeWice8 Ltd

Facllity Locafion: Avara Shannon Phzrrmaceutical Serv'rces Ltd Rev,No: 1

APPENDICES

J L fippendlx lh4anitorlng Personnel & Equipment

Stack Emissions MonNorlng Pe~onnel

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Preliminary stack survey cahlations

General Stack Uetails 1 I Units I Value

Dale of survey T@/05/201& Time of survey wm

Stack Diameter / Depth, D m 0.m

TYPe Circular

Stack Width, W m 31 Average Stack Gas Temp., f a C

Average Static Pressure, P slatic kPa 0.1

Average Barometric Pressure, Pb hPa 1 UX7

Type of Pitot 5 Are Water Droplets Present ?

Average Pitot TubpCalibratiDn Coeff. Cp

Negative flow

Hlghly homogeneous flow streamlgas velecity

No

0.85

Ha

I Sample Port Sire 1 mm I

I Finat Pitot Leak Check 17 1.7

I OrtenLdbn of Duct I I Vertical

PKoI Tube Gp 0.998

Number of Lines Available 2 Number of Lines Used 3

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I I

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EPA Export 19-10-2018:03:54:31

tK Append& IM Individual pammetersampling defafk and restrifs

TWe: Method:

Determination of Dioxfns andkrans

Avara Shannon Pharmaceutical Services Lid Dr.John Casey 16105l2018 UKAS1549 VE165 09:38-15:38 4.4 0.1

EN 2948-1 2006

Client: Log Sheet Complete by: Test Oafe: Laboratory Used: Sack Name Test Time Dry Volume of Alr Sampled Ernissian Limit Value

Reference Condittons

20.1 20.9

Measured Oxygen Reference Oxygen

Uncertainty Data

21 88.2 5.1 0. t

Deg C kPa m3 x

Temperature at Pump Pfessure at Pump Air Volume at Pump Humidity at Pumps

teak Check Results Resuit X Leak

cc/rnin

cdmin cdmln cclmin cdmin cdrnfn

bar or kPa

G d W I h

Before Blank After Blank Before Sample 1 Changing Pwts Affer Sample 1 Average Flow Rata Standard Maximum Back Pressure

0.12 U. 18 0.93 0.14 0, f4 15 0 5

0.11 7 2 0.9 0.9 0.9 1 2 5%

Standard Criteria ZO be Met Result Standard Requirement

Angle of Flow Negatfve Flow in the Stack Pitot PmsuE DWference Ratb of Flow Measurement

4 5 agrees None >5Pa <3:1

Pitat Tube Leak Check Result

Poslliue Pressute Negatlve Pressure

Pass Pass

Number of Parts 2 2

Straight length before sarnpk pohf Strabht fengih after sample point

YW Yes

5 Hydraulic Diameters > 5 HD from fan or bend f >2 from stack exit

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Industrial Emission8 Ucence.: POWO-02 Liwnce HoHw Avara Shannon Pharmweutlcal Serufces Ltd

Facility Lwation: Avara Shannon Pharmaceutical Servkes Ud R!N,Mu: 1

Sample CalcuIations 201OIT51EU I-TEF

Concentration 201 OIISIEU

ng.Nm" @ Ref 0 2

<0,000045 4l.000023 sO.000227 -=0.000045 -=0.000045 4.000045 a.QQUO45

~0.000011 ~0.000001 <0.000455 <0.000227 <o,oooa45 <0.000045 <0.000045 4.000007 ~ I O O O O ~

<a.ooooi 1

Uncertainty Amount 20101ffUEU I-TEQ

ng,Nmd 1 .OE-05 5.1 E-06 5.1 E-05 1 .QE-O5 1 . om5 1 .OE-05 1 . UE-05 2.6E-06 2.6E-08 2.3E47 1 . W O 4 LIE-05 1.0E-05 1 .OE-O5 4 .OE-O5 1.5E-Q6 7.7E07

n0 0*00020 O.QOOI0 O . O U 7 0 ~ 0.00020 0.00020 0.0002[1 0.000211 0.00005 0.00005 0.OQOOQ 0.00200 0.001 00 o.Do020 0.00020 0.00026 0.00003 13,00002

4.0020 <O.Q020 <o. 0020 c0.0020 ~O,D020 40.0020 40.0020 43.0050 <O.DOSO 4.0045 ~0.0UZO 40. ou20 4.0020 ~ . 0 0 2 0 4.9020 CO. OD30 ~Uo.f!l50

Total A ~ Q u ~ I ~ 40.0665 o.oo5a O.OOP30

Blank Calculations 200017WEG

I-TEF

Amount 2010fl51EU Conoentratian 3OIOlTSIEU I-

TEQ nglNma

I-TEQ

0.00035 O,OMl7Cl 0.00100 0.00045 0.00025 0.00025 0.00026.

0,00009 0,00002 0.00250 0.001[30 0.00020 0.00020 0.00020 0.00D05 0.00002

o.oonas

~0~000080 <0.000023 <0.000227 ~0.0001a2 4.000057 <O. OOOU57 ~0.000057 ammazo ~0.000020 ~o.oooao3 <0.000588 <0.000227 ~0.080045 <0.000045 ~0.000045 .=OO.OOOOIQ ~0.000005

Total Blank <O.OBTS O.OOP0 <:9.00169

Field Blank Status Method Blank Status

1.59 Pass

<lo% of ELV Pass I Fail

Yes I No 3lank < 10% of the Emkslon Umit Vatues Yes

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EPA Export 19-10-2018:03:54:31

Document No.: tlClRTL4 1302181 201 8081 usit No: I Year: 2018 Qfkf?: Tzhn

Industrial Emissfdm Licence.: POO20-02 Lkence Holder: Avara Shannon PharmaceuticaI Services Ltd

Facility LacaUon: AVam Shannon PhaFmacellticaf SeMkes Lid Rev.No: 1

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EPA Export 19-10-2018:03:54:31

CONCEPT L I F E SCIENCES b C l l V E 1 1 1 6 S C l P l l E t

Concept Life Sciences Certificate of Analysis

Report Number: 738796-1

Date of Report: 06-Jun-2018

Customer: Air Scienfific Unit 32 Degranville Court Dublin Road Trim Ca. Meath Ireland.

Customer Contact: Project Management

Customer Job Reference: UCIRTLI 160618 Date Job Received at Concept: 22-May-2018

Date Analysis Started: 25-May-2018 Date AnalysEs Completed: 06-Jun-2018

The results reported relate to samples received h the laboratory and may not be representative of a whde batch. Opinions and interpretations expressed herein are outside the scope of UKAS accreditation This report should not be reproduced except in full wtthaut the written approval of the laboratory Tests cavered by this certificate were conducted in awordance with Concept Life Sciences SOPS All results have been reviewed in acwrdanm with Section 25 ofthe Coneept Life Sciences, Analytical Services Quality Manual

1549

Report checked and authorised by : Mary Hughes Customer Service Manager

Issued by : Mary Hughes Customer Sewice Manager

Thts document has been ptirrted from it digitally signed master copy

Pagel of6

738796-1

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EPA Export 19-10-2018:03:54:31

Summary Of Results

Composite (FIR, Trap, Wash)

Sampling Recoveries

PrQdUcf!d by Concept Life Sciences, Hadfldd House, Hadfleld Street, CDmbrQOk, Manchester, MI6 9FE

Thls document has been printed from a digHally signed master copy Page 2 of 6

738796-7

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Composite (Filt, Trap, Wash)

ample : Combined 755 Dio 4 165 DioW + 155 T W

Our Sample Reference : 738796 004 Data Sampled : 16-MAY-2QlB

Dioxins and Furans (BS EN 1948:06)

Technique : GClMS (Hi?)

Determinand

I TOWS :I 0.0 I 0.0060

Produced by Concepk Life Sclencm, Hadfield Mouse, Hadfield Street, Cornbmok, Manchester, M16 BFE

This document has been printed from a digitatly signed master ~ @ p y Page 3 of 6 738796-1

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Composite (Filt, Trap, Wash)

Totals :I 0.0

Customer Sample Reference : Combined 155 DioW B + 155 Trap B + 155 Dio Blank

Date Sampled : 16-MAY-2018 Our Sample Reference : 738796 008

0.00’10

BS EN 1948 specifies a list of information that should be available within reports. This is extensive, so in the interest of reports being concise the information is omitted. The EA are content with this being the case. Note that all the information Is recorded and can be made available on request.

Dioxin and Furan - Blanks (BS EN 1948:06)

Technique : GClMS (HR)

Delermlnand Lower Bound

Produced by Concept Llfe Sciences, Hadfield House, Hadfield Street, Cornbrook, Manchester, MI6 9FE

This document has been printed from a digitally signed master copy

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Composite (Filt, Trap, Wash)

Customer Sample Reference : Combined METHOD BLANK Our Sample Reference : 738796 012

BS EN 1948 specifies a list of information that should be available within reports. This is extensive, so in the interest of reports being concise the information is omitted. The EA are content with this being the case. Note that all the information is recorded and can be made available on request.

Dioxin and Furan - Method Blank (ES EN 1948:06)

Technique : GC/MS (HR)

Determinand Lower Bound

Totals !I 0.a I 0.0068

Produced by Concept Life Sciences, Hadfield House, HadReld Street, Cornbrook, Manchester, MI6 9FE

This document has been printed from a digitally signed master copy

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EPA Export 19-10-2018:03:54:31

Index tu symbols wed in 738796-1

Anasisis UKAS t iwdi ted

Produced by Concept Life Sciences, Hadfield House. Hadfield Street, Cornbrook, Manchester, MI6 9FE

This document has been prlnted from a digitally signed masfer copy Page 6 of 6

7387981

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