document ucirtl110121& 2018766 epa no.: visit 4 llcence ...final pitot leak check orientation of...

Document No.: UCIRTL110121& / 2018766 EPA Licence No.: POO20-02 Visit No: 4 Llcence Holder: Avara Shannon Pharmaceutical Services Ltd, VE155 Year: 2018 Facility Location: Shannon Facility Office: Trim Rev.No: 1

I Report Title I Air Emissions Compliance Monitoring Emissions Report Air Scientific Ltd., 32 DeGranville Court# Dublin road,

Trim, Co. Meath Company address

Verslon

Signature of Approver

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EPA Export 08-04-2019:03:40:44

Document No. . UCIRTLllOI2lG/ 2018766 EPA Licence No. . POU20-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Services Ltd. VEl5S Year: 2018 Facility Location: Shannon Facility Office: Trim Rev. No. 1

Cantents la ExecutiveSummary ............................................................................................................................

1 . Manitoring Objectives ......................................................................................................................

Special Requfrernents ........................................................................................................................ Target Parameters .............................................................................................................................. Emission Limit Valu.es ......................................................................................................................... Reference Conditions ........................................................................................................................ Overall Resu Its .................................................................................................................................... Accreditation details .......................................................................................................................... Monitoring Dates &Times ................................................................................................................ Monitoring, Equ.ipment & Analytical Methods ......................................................... .....,...... .......... Sampling Deviations ........................................................................................................................... Reference Documents ................................................................ .......... ................................ * ............... Suitability of sampling location ......................................................................................................... Process details ....................................................................................................................................... Stack diagram ......................................................................................................................................

2 . APPENDICES ......................................................................................................................................... Appendix I - Monitoring Personnel B Equipment ......................................................... ..............

Stack Emissions Monitoring Personnel .............................................................................................

Preliminary stack survey calculations ..............................................................................................

Overall Aim of the monitoring Campaign .......................................................................................

!I .

111 . Appendix I1 -Stack Details &flow characteristics ........................................................................

IVh A.ppendix 111 - Individual parametersampling details and results ............................................. Tota I Volatile Organ k Carbon Quality Assu rdnce .......................................................................... Total Volatile Organic Ca.rbon Results and Sampling Details ........................................................ Total Volatile Organic Carbon Trend ............................................................................................... Total Volatile Organic Carbm Measurement Uncertainty ........................................................... Oxygen Quality Assurance ................................................................................................................

Carbon Dioxide Quality Assurance ..................................................... ..... ......i..... .......................... Oxygen Trend ....................................................................................................................................

Carbon OioxideSampling Details & Results ............... ....*..-... ....................................................... Carbon DioHde Trend ........................................................................................................................ Moisture Results & Measurement Uncertainty ...........................................................................

3 3 3 3 3 4 4 5 6 7 8 9 9.1 11 12 13 14 14 14 15 15 23 23 24 28 30 31 33 34 34 36 38

Oplnions and Merprefatiom expressed herein are outside the scope oFAIr Scientific Limtted /NAB mreditafion . This t s f report shall not he repmluced. without the wrilien approval of Air Soietrtlflc Litnlted. All samplhg

and reporting Is mmpieted in accordance with Envlronmental Pmbcliofl Agency Air Guidance Note 2 requirements .

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Document No.: UCIRT11102218 / 2018766 EPA Licence No.: PUO20-02 Visit: No: 4 Licence Holder: Avata Shannon Pharmaceutical Services Ltd, VE155 Year: 2018 Facility Location: Shannon Faclllty Offie: Trim Rev.No: 2

f . Executive Summary

Uverall Aim cif the monitoring CampaiQn The aht of the monltorlng campaign was to demonstrab mmplfance with a set of emission limit values as specified in the site licence.

Special Requirements There were na special requirements.

T ' Target Parameters

Total Volatile Organic Carbon (TOC)

Stack Gas Temoerature

I Volume frn3.K1) I

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Document No.: UCIRTL1101218 12018766 Vklt No; 4 Year: 2018 Office: Trim

EPA Licence No,: PO02042 Licence Holder: Avara Shannon Pharmaceutical Services Ltd, VE155

FaciJity Location: Shannon Fadlity Rev.No: 1

Emission Limit Values I Mass Emissions Llmit VaIues

TOC

Stack Gas Temperature

Volume (ms.h-')

mg.m3 kg.h"

20

27,500

Reference Condi tians

Reference Condltlon Oxygen Reference X

Temuerature K

Value

No Cmygen Ref 273.1 5

Total Pressure kPa

Moisture %

of 32

lD1.3

Yes

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EPA Ucence MQ.: PQO2U-02 Llcence Holder: AvaraShannorl Pharmaceutical Services ttd, VES5

FaciHty Locatton: Shannon Facility Rev.NO: 1

~r scientnic Umiled

EWmat Analytical Lpbralory

OLher

Execuliva summary

lNAB31a

uKAsi549

Overall Results

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EPA Export 08-04-2019:03:40:44

Document No.: UCIRTL1109218 / 2018766 Visit No: 4 Year: 2028 Office: Trim

€FA Licence No.: P0020-Q2 Licence Holder: Avara Shannon Pharmaceuticat Services Ltd, VE155

Facility Location: Shannon Facility Rev.No: 1

Executive Summary

Monitoring Dates &Times

-

i

Carbon Dioxide

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EPA Export 08-04-2019:03:40:44

Document No.: UflRTLilOlZlS / 2018766 Visit No: 4 Year: 2018 Office: Trim

1 Epeuulivc Summary

EPA Licence No.: POQZO-02 Licence Holder: b r a Shannon Pharmaceutical Sewices Ltd, VE155

FaciIity Location: Shannon Facility RevaN0: 1

Monltarlnng, Equipment B Analytical Methods

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EPA Export 08-04-2019:03:40:44

Document No.: IICIRTLlIO~IlB / 2U18766 Vlsst No: 4 Year: 2018 Offlw: Trtm

EPA Licence No,: PDOZO-02 Licence Haldez: Avara Shannon Pharmaceutical 5ewlces Ltd, VE15S

Facitlty Location: Shannon Fecllity Rev.No; 1

Llst of Equlpmenf

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n

Standard ID

Standard ID

Standard la

Document No,: UCIRTLllUb218 / 2018766 EPA Licence No.: POO20-02 Visit No: 4 licence Holder: Avara Shannon Pharmaceutical Services Ltd, VE155 Year: 202-8 Facility Location: Shannon Facility Office: Trim Rev.NIx 1

EN18911:2013 -flaw rates in accordance with MID691 1-1

Sampling Deviations

I Parameter I Deviation I

Reference Documents

Risk Assessment (RA)

Site Review (SRI

Site Specific Protocol (SSP)

SOPtOl1

sop1015

SOP1015

of 32

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EPA Export 08-04-2019:03:40:44

Document No,: UCIRTLllOlZlS / 2018766 EPA Licence No.: POO20-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Services Ltd, VE155 Year: 201d Facility LocatIon: Shannon Facility Office: Trim RevAo: 1

t3eneral tnforrnation

PermaneniUemporary

InstdeE Outside

Executive Summary

Value

Perrnanenf Outside

Platform has 2 handrails (apprax. 0.5m & 1.0 m high)

Platform has vertical base boards (approx. 0.25 m high)

Platform ha3 chalns I self ctoslna w e $ at tor, of ladders

Yes Yes

Yes

Platform Details I Value Irish EPATechnical Guidance Note AG7 I BS EN T8259 Platform

Requiremsnfs

I -

-

Comment

M e are no obstructions present whkh hamper insertton of sampling equipment

Safe Acwss Avatlable

Easy Access Available

- I SuHdent Worklna area to mantautate nmbe and rneasurlno instruments I Yes I I

No Yes -

YE5

Parameter

Process status

Capacity (perhour) {if applicable)

ContInuous or Batch Process

~

Normal

NIA

Continuous

ISarnolina Location I Platform Imarovernent Recommendations I

Feedstock

Abatement System

Abatement Systems Running Status

I None 1 I BSEN 15259 Homogeneity Test Resuirements I

Solvent Air

Yes

Normal

I f: There is no requimment ta perform a 3SENl5259 Homogenity Test on this sfack I

Plume Appearance

Other Information

Process details

Yes

None

I Fuel1 Gas I

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'P

Site contact I Ms Laurda Mdoney Contractor's contact

Document No,: UCiRTLl101218; / 2018766 EPA Licence No.: POOZO-U2 Visit No: 4 Licence Holder: Avara Shannon Pharmaeutical Serviais ltd, VET55 Year: 2018 Facility beation: Shannon Facility Office: Trim Rev.Na: 1

Dr. Brian Sheridan

Llcensee I I Reu. number I ~0020-02 Contractor Alr Sctentiflc Lld.

~~

I Emissions point

Type of process

Rotogravure Prhting Cement Plant

Etech-ical generation

Steam boiler

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EPA Export 08-04-2019:03:40:44

Document No.: UCIRTLllOZ218 / 2018766 EPA Licence No.: POOZO-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Services Ltd, VE155 Year: 2018 Facility Location; Shannon Facility Office: Trim Reu.No: 1.

Executive Summary

Stack diagram

c

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EPA Export 08-04-2019:03:40:44

EPA Licence No.: POU20-02 Ooeument No.: UCIRT11101218 / 2018766 Visit Ne: 4 Licence Holder: Avara Shannon P harmaceuticel Services Ltd, VE155 Year: 2018 Facility Location: Shannon Facility Office: Trim Rev.No: 1

Team Leader Name Dr. John Casey

Qualifications

Sysfem approval I

PhU. (Eng.), MSc. wgr.), 8. Agr. Sc.

Air Scientfc Limited Approved

2. APPENDICES

i

I\. Appendix I - Monitoring Personnel & Equipment

Team Leader Name Dr. John Casey

Qualifications

Sysfem approval I

PhU. (Eng.), MSc. wgr.), 8. Agr. Sc.

Air Scientfc Limited Approved

Stack Emissions Monitoring Personnel i

Team Leader Name Dr. 3rian Sheridan QuaHkationa ~ y s t e m approval

PhD. (Eng.9, MSc. E@$.), BSc. (Hons.) FUr Scienth limited Approved

c

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Document No.: UCIRTL1101218 / 2018766 EPA Licence No.: POO20-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Services Ltd, VE155 Year: 2018 Facility Lacation: Shannon Facility Office: Trim Rev.No: 1

Sample Porl Size

Initial Pitot Leak Check

Final Pitot Leak Check

Orientation of Duct

Pitot Tube Cp

Number of Lines Avaifable

Number of Lines Used

111. Appendix It - Stack Retails & flow characteristics

rnm 160

Fa 19.2 Pa 18.4

Vertbal

0.998 2

2

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Document No.: U C l R T l l l O i Z l l / 20lB766 Vlsit No: 4 Year: 2018 Office: Trim

EPA Lleence No.: PU020-02 Licence Holder: Avara Shannon PharmacellticalSe~i~es Ltd, VEl55

F d i t y locattan! Shannon Facility Rev,No: 1

of 32

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DQCUment No.; UCIRTLIIO1218 / 2018766 VisltNo: 4

Year: 201% Office: Trim

EPA Licence No.: PW2042 Licence Holder: Avara shadnnon Pharmaceutical Services ttd, llE155

Facility Location: Shannon Fad@ Rev.No: 1

Page I 6 of 32

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EPA Llcence No.! P(1020-02 Ucmce Holder: Avara Shannon Pharmaceuttcal Services ttd, VE155

Facility Lmtlofl! Shannon Facility Rev.No: 1

Page i7 af 32

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EPA Export 08-04-2019:03:40:44

Document No.: UClRTLll~l2l@/2018766 Visit No: 4 Year: 2018 mce: Trim

€FA Licence No.: POO20-02 Ucence Holder; Avara Shannon Pharmateutical %rvicer L€U, VE155

Faclllty Location: Shannon Facilty Rav,No: 1

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EPA Ucence No.: PfIO20-02 Llcence Holder: Avara Shahnon Pharmaceutlcal ServTces Ltd, VE155

Fadllty Location: Shannon Fadllty ReV-NO: !L

Determinant Unlb

kS.rnJ k g d

Dry Uensily (STP), P STO M.m+ We1 fhfisily (STP), P SFW

Ory Denritj (Actust), P Adual

awrage wei knsily (Acluat), PActusl W Q.m3

Result

1.2w 1.274 1.202

1.I8

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EFA Llcence No.: PO02042 Licence Holdar: Auara shartnoo Pharmaceutical !kMw Lfd, VE155

Fadlity Location: Shamoh Facltlty Rev.Na: 2

f

Caleulatlon distack Gab Vblndty. Q

V e W y at Tmverse Poini, V= Kcp ' & p a t ((2' DP ) I Oemiiy)

When

Kpl= pilot lube cahbmllon cclRfliGlEnt

Campresslb~lity WneCilon faclor, a s m a d at U wnst+fllO.99B

Lowesl Gas Veincl& 6.9 NIA

Highest Oas velocity 8.77 rnh NIA

ENi6911:2013 RaUodAbow 1.27 :.1 <3:7 Yes

MmnMlocIty 7.95 mls NIA

Anble offlnwvAlh regard 10 duclads c15 degrees 15 YES EN1699112013 No local negalive ftw Ne Yes

Homogeneous now sIraamlnas VeloCriy Yes Yes

88.36743489

0.115

0.988

- Gas Volumetric FIDwI&~ U d b Result

Gas Vdumekic Flow Raw (Acluai) m3. h-' W70g

6ar Volumethc Flow Rata (STP, Wet) m3 h-' 9928 m3.h ' 8431

rn3.i~'

Gas Valumelric F l o d e (STP, Dry)

Gas Wurnetrlc FlOWRte REF t0 W$@n

..1;

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EPA Export 08-04-2019:03:40:44

Document Na,; UCIRTL1101218 / 2018766 Visit No: 4 Year: 2018 Offke: Trim

EPA Licence No.: PO020-U2 Licence Holder: Avara Shannon Pharmaceuttcal Services Ltd, VE155

Facility Location; Shannon Facility Rev-No: 1

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EPA Export 08-04-2019:03:40:44

Document No.: UCIRTL1.101218 / 2018766 EPA Licence No.: P0020-02 Visit No: 4 Licence Holder: 4uara Shannon Pharmaceutical Sewices Ltd, VE155 Year: 2018 Facility Location: Shannon Facility Qffice: Tr'im Rev.No: 1

Qualiiy Assurance

Con djtioning Unit Temperature

Average Temperature

Allowable Temperature

Temperature AcceptabIe

Total Volatile Organic Carbon Quality Assurance

__

Units Run 7 Run 2 Run 3

193

< OC 193

Yes

190

Zero Drift

Zero Down Sampling Line (Pre)

Zero Down Sampling Line (Post)

Zero Drift

Allowable Zero Drift

Zero Drift Acceptable

units Run 1 Run 2 Run 3 PPm 0.1

PPm 0.4

PPm 0.3 -

PPm 1.6 -

W N I Yes

P

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EPA Export 08-04-2019:03:40:44

x

Parameter Unlts Run I Run 2 Run 3

Concentration rng.m3 1.15 -

Uncertainty mg.rn3 0.59 Mass Emission kg . K' 0.01

Document No.: UCIRTL1101218 / 2018766 EPA Ljcence NO.: PflO20-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Services Ltd, VE155 Year: 2018 FacilirV Locatian: Shannon Facility Office: Trim Reu.No: 1

Mean

-

Parametor

Standard

Value

EN12619

Probe rnaterjal Filtralion TypelSize

Heated Head Filler Used

Heated Line Temperature

I Soan Gas Reference Number I ASLTM171NG514 I

ss PTFE Yes

190

Span Gas Exptry Date

Span Gas Start Pressure (bar)

Span Gas Uncertainty (016)

Gas Cyllnder Concentration (ppm)

Zero Gas Type

01/12/2021

40

82.8

e2

Zero Air

of 32

Number of Sarnpljng Llnes Used

Number of Sampling Points Used

Sample Point 1.D's

I

1 VEI 55

Reference Conditions

Temoerature {Kl 273.15

Pressure (kPa)

Gas [wet or Dry)

mfgen

701.3

Dry No Oxygen Ref

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EPA Export 08-04-2019:03:40:44

Document No.: UWRTLllOlZlE / 2018766 VisitNo: 4 Year: LolS Office! Trim

EPA Ltcence NO.: POP20-0'2 Ucence Hotder: Avara 5hannun Pharmaceutical erv vices Ltd, vEi55

FadIUy k3tfQJln: Shahnon Faclljty Rev.No: 1

hal Volatile organic CarbOh Trend ~

Run I

Time

af 31

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EPA Export 08-04-2019:03:40:44

Document No.: UCiRTLllll l213 / 2018766 EPA Licence NQ,: PO020-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Services Ltd, VE155 Year: 2018 Facility Location: Shannon F a d fty Office: Trim Rev.Na: 1

Measured Quantliiees

Certified Range of Analyser

Operational Range of Analyser Measured Readins

Total Volatile Organic Carbon Measurement Uncertainty

Units Run 'l Run 2 Run 3 ppm 0.5 to 1000

pprn 100

DDm 0.68

Measured Quantities

Nonlinearity

Temperature Dewdent Zero drift

Unlts Run 1 Run 2 Run 3 95 0.068 % 0.3

Temperature Dependent Span drift

Cross-sensitivity

Leak

Calibration Gas Uncertaintv

% 0.3;

%

% <2 % e2

Parameter

Measurement uncertainty

Requlrernent in standard is for uncertalnty to be< 10% at ELV at standard condltlons


ma.m4 0.3 -

of 32

Combined uncertainty I mgm3 I 0.59 I Expanded Uncertainty as % of Limit Value I % 2.96 1 -

Expanded uncertainty expressed with a level of confidence of 95% Expanded uncertainty expressed with a level of confidence of 95%

% of value

mg.rn"

57-72

0.59

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EPA Export 08-04-2019:03:40:44

Document No,: UCIRTLllOlZI,8 / 2018766 EPA Licence No.: POO2Q-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Sewices ltd, VE155 b a r : 2018 Facility location: Shannon Facility Office: Trim Rev.No: 1

rem mift Zero Down Sampling Litre (Pre)

Zero Down Samulina Line fPastl

Oxygen Quality Assurance

U n b Run I Run 2 Run 3

ppm 0, l -

VQtTl 0.3

AllowableZero Drift

Zero Drift Acceptable

I Zera D M I m m I 0.2 I - I I twm 0.4

Yea IYW " -

Span Drift

Span Down SampIing Line (me) Span Down Sampling Line (Post]

Span Drifl

Allowable Span Drift


ppm 20.9

PPm 20.8

QPm 0.7

DDrn D.4

Span DrTft Acceptable 1 rcrw Yes

Run Ambient Temperature Range I OC I 5 I I I

L@ak Check

Sum Gas Conc.

of 32


m m 20.9

Recorded Conc, down Llne Leak check acceptabIe (c 2%)

PPm 20.9

(YIW YeS +

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Document NO.: U C I R T L ~ ~ O ~ ~ I ~ f ~18766 VsitNo; 4 Year: 2018 Office: Mrn

EPA Licence No.: FO02PQZ Licence Holder: Avara Shannon PharrnaEeutical SeWkes ttd, VEL55

Facllity Location: Shannon facllitv Rev.Na: 1

Run 3

20.6

w.4

20.3

E 20.2 20.1

20

? L B

Ttme

P a p 25 of 32

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EPA Export 08-04-2019:03:40:44

Raeument No,: UGIRTLll01218 / 2018766 EPA Licence No.: P0020-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical Services Ltd, VE155 Year: 2018 Facility Location: Shannon Facility Office: Trim Rav.No: 1

Quality Assurance

Condltfoning Unit Temperature

Average Temperature AI Iowable Temperature

Temperature Acceptable

Pump flow rate

Carbon Dioxide Quality Assurance


OC 2

< OC 2 - 4

Yes Ilmtn 0.4

Sampllng Details

Stack ID VEI 55

'I

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EPA Export 08-04-2019:03:40:45

Document No.: UC1RTL1101218 / 2018766 EPA Licence No.: POO2O-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutlcal Services Ltd, WE155 Year: 2018 Facility Location: Shannon Facility Office: 'Trim Rev.No: 1

Parameter Units Run I Run 2

Concentration % 0.98

Uncertainty % 0.23

Run 3 M@an

-

General Sampling Information

Standard

Technlcal Procedure

I Parameter I Value I 15012039 SOP 2045

Filtration TypdSize

Heated Head Filter Used

Heated Line Temoerature

I Probe material I SS I Ceramic

Yes

190

Span Gas Reference Number

Span Gas Expiry Date

Saan Gas Start Pressure (bar)

ASLTM181NG524

23-Feb

50

Gas Cylinder Concentration (pprn) Span Gas Uncertainty (%)

Zero Gas Type

'E

15.2

<2 Nitrogen

Number of Sampling Lines Used

Number of Sampling Points Used

Sample Polnt I.D's

I Reference Condltlons I I

1

1 VE'155 .

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Dowment No.: UClRTLlI012lSX/ 2018766 VlsitNo; 4 Year: 2018 Office: Trim

EPA Licence NO.: PW~O-a2 Ucence Holder: Avara Zhantjan Pharmaceutical Services L€d, UE155

Fa_cl[lty &+on: Shannon Facility Rev.No: i

Carbon Dloxlde Trend

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EPA Export 08-04-2019:03:40:45

Document MO.: UCIRTLllOlZlO / 2018766 EPA Licence No.: PO02042 Visit No: 4 licence Holder; Avara Shannon Pharmaceutical Services Ltd, V U 5 5 Year: 2013 Facility Location: Shannon Facility Office: Trim RwNQ! 1

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EPA Export 08-04-2019:03:40:45

Document No,: UQRTL1101218 / 2018766 EPA Licence No.: POO20-02 Visit No: 4 Licence Holder: Avara Shannon Pharmaceutical services Ltd, VET55 Year: 2018 Facility Location: Shannon Facility Offiee: Trim Rev.No: 1

Moisture Results & Sampling Details

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EPA Export 08-04-2019:03:40:45