Industrial Emissions Ltcsense.: PO020-02 License Holder: Avara Shannon Pharmaceutical Services Ud

Facility Location: Shannon Fasillty Rev.Na: I

Llcence Holder

Stack Reference Number

Dates of the Monitoring Campaign

Job Reference Number

Report Wdtten By

Report Approved hy Stack Testing Team

Report Date

Report Type

Version

~~

Report Tltle

Avara Shannon Pharmaceutical Sewices Ltd

VE155

08/08/2018

UC1RTL108081.8 / 2018455

Dr. Brlad Sheridan

Or. Johh Casey

Or. John Casey, Or. Brim Sheridan

31/08/2am

Test Report Compliance Monltoring

1

Company address

Stack Emissions Testlng Report Commissioned by

Facllify Name

Contact Person ~ ~ ~

EPA Licence Number

Air Emissions Compllance Monitoring Ernlssions Report Air SclentificLtd., 32 DeGranvllk Court, Dubfin road.Mm, Co. Meath

Avara 5hannon Pharmaceutical Services Ltd Shannon Facility

~

Ms Lourda Moloney

P0020-I)2

Stgnatwe of Approver

1 of 23

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EPA Export 22-12-2018:04:19:07

Induslrlal Emissions Fi@nse . . P0020-@ Ucenst? Holder: Avam Shannon Pharmaceutical Services Ltd

Fact4ity Location: Shannon FacHity Rev.No: 1

Conterlk li

1 . fxecl!-t;ive summery ............................................................ 8.11 ....................................................... 4 Monitoring Objectjjves .................................................................................. ir ........................ 4

Overall Aim ofthe monitoring Campaign ........................................................................................ 4 Special 6. eguirements ........................................................................................................................ 4 Target Parameters ............................................................................................................................ 4 Emission tins& Values ......................................................................................................................... 4 Reference CondtiohS. ....................................................................................................................... 4 Qverafl Rwults ................................................................................................................................. 6 Accreditadon details ........................................................................................................................ 6 M ortitoring Dates & Times .......................................................... ..._... .................................. ..."..... .. 3 Pracess details &., ................................................................ l . r , . ........................................................... $

Sampling Deviations ................................... ................................................................................... 11 Reference Do~umeri ts .................................. ............................................................. 11 5uSta b t My of sampling location ..................................................................................................... 12

Mo-nitaring, Equ i. pment $r Ana ly€ic.al Methods ............................................................................... 9

54Wk dragr;lm ...... ....t ............................................................................................................................ $3 APPENDlC ES ............................................................................................................................................ 13

It .

Ill . [V .

Appendix I Monitoring 'Persan n el & Equipment ................................................................... 14 Stack Ern'mlarr-s MonStaring Permnnel ........... L.ri.. ........................................................................... M

4ppenBix II Stack Details XI flow characteristicg ............................................ ................ 15 Prelimhay stack survey calcuIafhm .............................................................................................. 15

Appendiw 111 Individual parameter sampling details and results ............................................ 22 Determinatton of Dlax.xlns and Furans ..................................................... ....,.. .... ........................................... 23

2 of 23

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EPA Export 22-12-2018:04:19:07

Document No.: UcIRTLlogOEl8 / 2M8455 Wsit No: 3 Year: 2018 Ofhe: Trlm

Industflal Emf$sbns Licence.: PQOZO-Q2 License Holder: Avara Shannon Pharmaceutlcal Servtces Ltd

Facility Location: Shannon Facility Rg&M; 1

Opinions and inteerpretaUms aupresws herein are autside fhe scope &Air Scientiik Lhitwd INAB wcreditafion. This test report shall not be repraduced, without the wfllften appmval of Air Scientjtlc Lhn&~d. All sampling and reporting b completed In

asdmce wkh Envbnm@W PmtectbiI Agency Air Guidance Note 2 requirements.

3 nf 23

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EPA Export 22-12-2018:04:19:07

Document No,: ucI~~~io8~0618 / 2018459 Visit No: 3 Year: 2018 Office: Tn'rn

Stack Gas Temperature

Volume (m3.h-')

Industrial Emlsslons Llcensa.: P002M2 License Holder: Avara Shannon PharmaceuUcal Servtces Ltd

Facility laeatbn: Shannon Facility Rev.No: 7

-

21.500 -

1. Executive Summary

Oxygen Reference %

Temperature K

Overall Alm of the moalhrlnQ Campaign The aim of the rnonitnring Gampaign was to demonstrate compliance with a set d emlsslon llmlt values asspecifled in the site

Ibennca.

No Oxygen Ref

273.15

There were no special requirements. Special Requtrements

Target Parameters

Dioxins & Furans Stack Gas Temperature

Vplume (m3.h-1)

Emisston Umit Values

I Emission Limit Values I Mass Emissions Limit Values I nS.m4 I ks. h-' I I Dioxins & Furans I rl.1 I - 1 t-

Reference Conditions

I Reference Conditions I VaIue I

I Total Pressure kPa I 101.3 I I Moisture '36 I Yes I

4 df 23

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EPA Export 22-12-2018:04:19:07

5 of23

lndustrtat Emissions License!.: PQQ20-02 LicegFG H@qA&ra . .. Shannon Pharmaceutical Services Ltd

7Facilily Location: Shannon Faclllky RW.NQ; f

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EPA Export 22-12-2018:04:19:07

ovetall Results

6o f23

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EPA Export 22-12-2018:04:19:07

Document MQ,; UCIRTL1130218/ 201BOBT Vfslt No: '1 Year 201 8 Mfice: Trlm

Industrial Emissions Lloence.: POO20-02 Ucence Holder: A v m Shannon Pharmaceutical Services Ltd

Facility hcatlon: &am Shannon Pharmaceutical Services Ltd Rev.No: I

Executive Summary

Monitoring Dates &Times

Dioxins B Furans

7 of 23

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EPA Export 22-12-2018:04:19:07

Industrial Emissions Ucance.: POQ20-02 licence Holder: Avara Shannon Phamaceuttcal SeryiCes LM

Facility Location: Avara Shannon Pharmaceutical Services Ltd Revdo: 2

Executive Summary

Pmcess status

Capacrty (perlhour) (if applicable)

Continuous or Batch Process

Feedstock

Abatement System Abatement Systems Running Status

Fuel

Plume Appearance

Other information

Process details

Normal

NIA

Continuous

Solvent Air

YW

Normal

Gas

NP

None

I Parameter I

Llcensee

Reg. number POU20-02

Site Contact M s Lourda Motoney

Role

Signature

Contractor Air Sdernfifie Ltd.

Contractor's contact Or. Brian Sheridan

Role

Si nature R -

Cement Plant Electrical 1

Load of process

8 of 23

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EPA Export 22-12-2018:04:19:07

WnitmIm Equfpment EL Ana1-t Mwfhuds

QPfW

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EPA Export 22-12-2018:04:19:07

10 item of Equipment Manufacturer

ASLTMISEQSI 0 st5 Dado ASLTM12EQ517 Testo 400 Gas Pressure Vacumn and Flow

MLTM18EQ505 ACTMI 3EQ506

Test0 ASLTM14EQ512 GemRed Electronic Level 0 t~ 180 Degrees GemRed

Therrnncoupk TC Direct

A5 LTMl4 ET;5.l6 Vernier Caliper StanlW 5wpe p1tot TCR T E C O ~ ~

10 Qf 23

Serial No.

oo~aa281305 8088

0710 -_

-

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EPA Export 22-12-2018:04:19:07

hcurnent No.: UCIRTL4130218120~ 8081 Visit Nb: 1 Year: 2018 Office: Trim

, Rtsk Assessment (RA) SOPlOll Site Review (SRI SOP1015 Site Speciflc Protocol ISSF) SOPIMS

IndusMel Em~ssioons Licence.; PO020-02 Licence Holder: Avara Shannon Pharmaceutical Services Ltd

Facility Location: Avara Shannon Pharmaceuticat Services Lld Rev.No: I

Sarnpllng Deviations

Parameter I Devlatfan Standard ID

Standard ID

EN16917 In accordance with MID 691f

Standard ID -

Standard ID -

Reference Documents

1% of 23

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EPA Export 22-12-2018:04:19:07

Document No.: UGIRTL'I 1302181 20188&f Visft No: 1 Yeat: 2018 Office: Trim

General Information

Industrtal Emissiolls Licence.: PQO20-02 Licence Holder: Avara Shannon Phamceutlcal Services Ltd

Facillty Lacattort: Avara Shannon Pharmaceutical Services Ltd Rev.No: 1

Executive Summary

Value

PermanenVTemporary

Inside/ Outside

1 Permanent

Outside

Value Irish EPA Technical Guidance Note ACSI I BS EN 75259 Platform Requirements Comment

Sufficient Worlclng area to manipulate probe and rneasurlng instruments

Platform has 2 handrails (approx. 0.5m & 1 .O rn high)

Platform has vertlcal base boar& (approx. 0.25 rn high)

YeS

Yes V P S

Sampling Locattan I Platform lmprwement Recommendations

None

P l a m has chains f self closing gates at top af ladders There are no obstructions present which hamper insertion of sampling

equipment Safe Access Available

Easy Access Available

BSEN 15259 Homogeneity Test Requirements

YeS

NO

Yes

VP.

I: There is no requirement to perform a BEN15259 Homagenity Test on this stack I E.g. SeIect Option 1: There is no requirement to perform a BSEN15259 Homogenity Test on thls stack 2: Test results ware obtained from previous Homogenelty test carried out by ASL 3: Test results were obtained from previous Homogeneity test carried out by Alternative contractor 4: Other: Enter Descdption

12 of 23

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EPA Export 22-12-2018:04:19:07

Uocument No.: UClRTLl t3027312018081 Visit No: I Year: 2018 Offlce: Trim

lndusrrtal Emissions Ltoence.: W920-02 Licence Holder: Avara Shannon PharrnaGeutical Services Ltd

Facility Locatbn: Avam Shannon Pharmaceutical Servlces Ltd Rev.No: 1

Exeeutlve Summary

Sfack dlagram

p-' R - P f

13 of23

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EPA Export 22-12-2018:04:19:07

Document No.: WCIRTll13[12I8/ 2018081 Visit No: 1 Year 2018 offics: Trtm

Industrial Emissions Licence.: PQW20-02 Licence Holder; Avara Shannon Pharmweutfcal Services Ltd

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

APPENDICES

I f . Appendix I Mon[tofing Pemmnel& Equipment

Stack €misslono Monitoring PemonneJ

14 Qf

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EPA Export 22-12-2018:04:19:07

Document MO.: UCIRTLl130218120~~81 Visit No: I Year: 2018 offlcei Trim

Sample Port Size

Initial Pitot Leak Cfieck

FInal Pitot Leak Check

Orientation of Duct

Pitot Tube Cp

Number of Lines Availabje

Number of Lines Used

Industrial Edsstons licence,: POOZO-02 Licence Holder Avara Shannon Phamaceuffcal Services LW

Fadllty Lacation: Avara Shannon Pharmaceuttcal Services Ltd Rev.No: T

mrn I60

Pa 18.15

Pa 17.03

Vertical

0.998

2

2

Ill. Appmdix [I Sfack Details & flow characteristics

Preltmhary stack survey calculations

I General Stack Details

I Stack details

~

Stack Dlameter / Depth, D

I Stack Width, W

I Average StackGas Temp., Ta

I Average Static Pressure, P static

I Averam Barometric Pressure. Pb

~

Negative flow

I Highly homogeneous flow sfreanllgas velocity

Units I Value I 081[1a/201~

09:oo

Circular

kPa 100.7

Yes

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EPA Export 22-12-2018:04:19:07

16 of 23

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EPA Export 22-12-2018:04:19:07

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EPA Export 22-12-2018:04:19:07

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EPA Export 22-12-2018:04:19:07

I I I 1 I 1 L

I I

1g of 23

I

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EPA Export 22-12-2018:04:19:07

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EPA Export 22-12-2018:04:19:07

IndusYal EmIsribns limn-.: p8020-02 Ucenoa Haldar: Avarashanmn Pharmasoutkal SemiGes Lld

I

Whate I I

zi of 23

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EPA Export 22-12-2018:04:19:07

Document No.: UClRTLlI30298E2OfBIsIJ~ V W No: 1 Year: 2018 O?%m: Trim

tndustrial Emlssions Licence.: POO20-02 License Holder: Avara Shannon Pharmaceutfcal Services Ud

Fadllty Locatton: Avara Shannon PharmaceuHcal Services Ltd Rev.No: 1

IV, Appendlr 111 Indlvtdu8l paramsfwsamplJtlg detaik end resulfs

Title: M h 0 d :

Client: L c g Sheet Complete by: Test Date: Laboratory Used: Stack Name TeSt Time Ofy Volume of Air Sampled Ernfsston Limit Value

Raferenee Conditions

Meawed Oxygen Reference Oxygen

Uncftrhlnty Data

Temperature at Pump Pressure af Pump Air Volume at Pump Humidjty at Pumps

Leak Check Results

Before Blank After Blank Befow Sample 1 changing Ports After Sample I Average Row Rate Standard Maximum Back Pressure

Standard Criteria to be Met

Angle of Flew Negative Flow in the Stack Pitot Pressure Dirence Ratia of Flow Measurement

Pitd Tube Leak Check

Positlve Pressure Negative Pressure

Number of Ports

stmight length before sample point

Dederminatior, af Dfmins and Fumns

Avara Shannon Pharmaceutical Serulces Ltd DtJahn Casey 08R)BEOq 8 UKAsl549 VE155 09:T8-m18 4.73 0-I

EN 1948-1 2006

20.1 20.9

22.32 89.94 5.71 0.1

Result

0.71 0.13 a1s 0.12 0.12 15 0.3 -

Result

-45 None 56Pa Yes

Result

Pass Pass

2

Yt3s Straight length after sample point i(es-

Deg kPa ms %

c

cdmin cdrnin cdmln w h i n cdmin cdmin cchnin

bar or K P ~

% Leak

Standard Requlrement

C l 5 Degrees None 55Pa *3:1

2

z 5 Hydraullc Diameters 5 HD from fan or bend I >2 from stack exit

22 of 23

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EPA Export 22-12-2018:04:19:07

Uocurnent NOA: UCIRTLI 130218/2018081 Visit No: I Year: 201 8 Office: Trlm

Industrtal Emissions LIGE~CEL: PW20-02 Limnce Holder: Avara Shannon Pharmaceutical Sewlces Ltd

Faciltty Location: Avara Shannon Pharmaceutical Services !Ad Rev.No: 1

Sampie Calculations Amount

ng 20101751EU

I-TEQ Uncertainty

ng,Nm'' 9.5E-Oia 4.8E-06 4.8E-05 9.5E-U6 9.5E-06 O.OE+OU 9.5E-96 1.2E-OS 1,2E-06 9.5E4E $.E-05 4.%E-Od 9.5E-06 9.5606 ME-06 2.dE-06 41e-w

n$ 0.00020 O.ODO10 0.00100 Q.00020 0.00020 0.(30000

0.00003 0.00003

(1.00200 0.00100 0.00020 0.00020 (1.00020 0.00085 0.00001

0.00020

o.oooao

0.1 0.05 0.5 0.i 0.1 0.1 a. 1 0.01 0.01 0.001

1

0-1 0. 'I 0.1 0.01 0.001

23,Tt8-TCDF 1,2,3,7,8-PeCDF 2,3,4,7,8-P&DF ll2,3,4,7,8-HXCDF 1,2,3,6,7,8-H&DF 2,3,4,6;,7,8-H&DF 1,2,3,7,8,9+HxCDF I ,2,3,4,6,7.8-HpCOF 1,2,3,4,7,8,%HpCDF OCDF 2,3,7,8-TC DO 1,2,3,7,8-PeCDD 1,2,3,4,7,8-HXCOD 7,2,3,6,7,8-HxCDD 2,2,3,7,8,9-hCDD ?,2,3,4,6,7,8-HpCDD DCDD

Total Amount 0.0056 .;0.00119 (1.00027

Blank Calculations 20ODi76/EC

I-TEF

Amount Concentration 201017~EU I-

TEQ nglNmJ

nu I -TEQ w

0.1 0.08 0.5 0.1 0.7 0.f 0.1 0.01 0.01 0.001 7 0.5 0.1 0.1 0. I 0.01 0.001

2.3,7,8-JCDF 1,2,3J,&PeCDF 2,3,4,7,&PeCDF

1,2,3,6,7,8HxCDF J ,2,3,4,7,8-HXCDF

2,3,4,6,7,1-H%CDF 1,2,3,7,8,Q-HxCDF 1,2,3,4,6,7,8-HpCW Il2,3,4,7,8,Q-HpCDF OCDF 2,3,tt8-TCDD 1,2,3,7,8-PeCOD 1,2,3,4,7,8-H~C€lD 1,2,3,6,7,8-H~CDD 1,2,3,7,8,4HXCDD lt2,3,4,6,7,8-HpC00 OCDD

0.00035 0.00010 0.00100 O.DOQ20 0.00025 0.00025 O.OOO25 0.00005 0.0000z ~..00001 0.00200 0.00100 0.00020 0.00020 0,00020 0.00007 0.00001

dO.0036 40.0020 co.oo2u <0.0020 -=D.0036 C0.0025 uo.0025 .=0"0045 ~0.0DZO 40.0050 <0,0020 *Q,O020 r0*0020 c0.0020 ~0.0020 a0,0085 ~ a o l o o

Total Blank <n.ou1ao

Fleld Blank Status Method Rlaok Status

1.30 Pass

4 0 % of ELV Pass I Fail

Yes1 No Blank < 10% of the Emission LlrnitValtms res

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EPA Export 22-12-2018:04:19:07

CONCEPT L I F E SCIENCES v a i i v c w i a w i n e 6

Concept Life Sciences

Certificate of Analysis

Repctrf Number: 760025-1

Date of Report: 30-Aug-2018

Customer: Air Scientific Unit 32 Degranville Court Dubtin Road Trim Co. Meath I reland.

Customer Contact: Project Mctagament

.. Customer Jab Reference; UCIRTLI 080B18 ' 6&e Job Received at Concept: 7 5-Aug-2018

Date Analysis Started: 16-Aug-2018 Date Analysis Cempleted: 30-Aug-2018

The results reported relate to samples received in the.l@qyi$atory and may natb? ppre~efl@v$ qf g wholg batch. Opinions and interpretations expressed herein are ouikide the scope of UKAS accreditGthn This report should not be reproduced except in full without the written approval of fhe laboratory Tests cavared by this certificate were conducted in accordance with Concept Life Sciences SOPS All results have been reviewed in accordance with Section 25 of the Concept Life Sciences, Analytical Sewices Quality Manual

1549

Report checked and authorised by ; Emma Spear Customer Service Advisor

. .

Issued by : Emma Spear Customer Sexvice Advisor

Page 1 of 6

780025-4

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EPA Export 22-12-2018:04:19:07

Summary Of Results

Sarnpl ing Recoveries

Produced by Concept Life Sclence&, Hadfield House, Hadfield Street, combrook, Manchester, MIGQFE

fhfs document has been printed from a digitally signed master ropy

Page 2 of 6 760025-1

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EPA Export 22-12-2018:04:19:07

Composite (Filf, Trap, Wash)

customer sample R ~ ~ ~ ~ ~ ~ ~ ; Combined '155 Dto + 155 DioW + 156 Trap

Our Sample Reference ! 760025 004 Date Sampled : 08-AUG-2018

BS EN 1948 spectfies a tist of information that should be available Mthm reports. This is extenstwe, so in tha Interest of reports bdng concise the Information 1s omitted. The EA are content wlth lhis being the w e . Note that all the information Is reoorcled and can be made available on request,

Dioxins and Furans (BS EN 7948336)

Technique : GClMS {HR)

Determlnand

Totals :] 0.0 1 o.006a

Pruduced by Contrepf &! Sctwces, Hadffeld House, Hadfield Street. Combrook. Manchester, MI6 9FE

This document has been prlnted from a digitally signed master copy

Page 3 of 6 760025-1

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EPA Export 22-12-2018:04:19:07

Composite (Filt, Trap, Wash)

Sample Referen,.. : Combined 155 DioW B -t $55 Trap B + 155 Dio Blank

Date Sampled ; 08-AUG-2018 Our Sample Reference ; 760025 008

BS EN 1948 specks a list of information that should be available within reports. This is extensive, so in the interest of reports being concise the information is omltted. 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 : GCIMS (HR)

Produced by Concept Life Sciences, Hadfield House, Hadfield Street, Cornbrook, Manchester, Mi6 9FE

This document has been printed from a digitally signed master copy

Page 4 of 6

760025-1

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EPA Export 22-12-2018:04:19:07

Composite (Filt, Trap, Wash)

Customer Sample Reference : Combined METHOD BLANK our Sample Reference: BOO25 Dl2

EB EN 1948 spacities a list of informath that should be auailabie within reports. Thts la wtxtanslve, so in the Interest of mpork being concise the information is omitted. The EA are content with thts behg the case. Note lh;it dl the informelan is recorded and can be made available on request.

Dioxin and Furan - Method Blank (BS €N 1948;QB)

Techmque : GCEMS (HR)

Produced by Concept Ufe Sciences, Hadfleld Ho~~se, Hadfield Sheet, Combrook, Manchester, MI6 WE Thb document has been printed from a dgltarly signed master CRPY

Page 5 of 6

760025-7

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EPA Export 22-12-2018:04:19:07

Index to s~rnbols used in 760025-3 Valua osscripuon

produced by Coneapt Life Soienees, Hadfield Mouse, Hadfieid Street, Combrook, Manchester, M16 9FE

Thisdocument has been printed from a digitally signed master wpy

Page 6 of 6 7’60025-1

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s only

.

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EPA Export 22-12-2018:04:19:07

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EPA Export 22-12-2018:04:19:07