Takeda Pharma - Environmental Protection Agency · 2018. 9. 24. · TA Luft Organics III Concept Life Sciences - Manchester Volumetric flow Fitz Scientific TA Luft Organics II-blank

Takeda PharmaGrangecastle Business Park, Nangor Road, Dublin 22.

8100/M120

Emissions to AtmosphereReport No:

Report Date:

Fitz Scientific

Unit 35, Boyne Business Park, Drogheda, Co Louth

Phone: +353 41 98 45440

21/06/2018

Industrial Emissions Licence: P0693-01

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Fitz Scientific

Grangecastle Business Park, Nangor Road, Dublin 22.

Takeda Pharma

Visit No: 2Year: 2018

Report for the Periodic Monitoring of Emissions to Air

Executive Summary

Licence / Permit Number:

Job Quote Number:

P0693-01

Y18Q19762

Operator Name:

Installation:

Phone:

Contact Name:

Takeda Pharma


014672574

Aileen Stack

Monitoring Dates:

Monitoring Organisation: Fitz Scientific

Unit 35, Boyne Business Park, Drogheda, Co. Louth, Ireland

Phone: +353 41 98 45440 / Fax: +353 41 98 46171

email: [email protected]

UKAS Registration number 2802

Report Date: 21/06/2018

Signed: ____________________________ Signed: ____________________________

-1

P0693-01Industrial Emissions Licence

Report created using QRSys version

8100/M120

18/06/2018

Jason McGuirk

MM14 1320

Level 2

Technician

TE1, TE2, TE3, TE4

Written By:

MCERTS Reg:

Competency:

Function:

Endorsements:

Aadil Khan

MM11 1120

Level 2

Field Services Manager

TE1, TE2, TE3, TE4

Approved By:

MCERTS Reg:

Competency:

Function:

Endorsements:

3.9 January 2018

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Contents

1.- Part 1

1.1.- Monitoring Objectives

1.2.- Special Monitoring Requirements

1.3.- Monitoring Results

1.4.- Operational Information

1.5.- Monitoring Deviations

1.6.- Monitoring Procedures and Deviations

2.- Part 2

Appendix 1: General Information

Appendix 2: Monitoring Information

Fitz Scientific


Takeda Pharma


P0693-01Industrial Emissions Licence8100/M120

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1.- Part 1

1.1.- Monitoring Objectives

1.2.- Special Monitoring Remarks

All the sampling points were obtainable Yes

As per request, sampling was carried out in triplicate (a, b and c).

The monitoring was carried out as requested by the management of the company above mentioned. The customer has chosen not to sample to the requirements of BS EN 15259:2007 for the substances monitored at the emission points listed below as stated in the Confirmation Form received from the customer.

Opinions and interpretations expressed in this report are outside the scope of any claimed UKAS accreditation.EPA requirements AG1 (Safety) and AG2 (Monitoring Guidance Note) were applied during the monitoring.

MP-P1-03

Parameter Result

Volumetric flow 48.1 m3/h

MP-P1-03 Run 2a Backup

Parameter Result

TA Luft Organics I <6.5 mg/m3

TA Luft Organics II <7.4 mg/m3

TA Luft Organics III <11.1 mg/m3

MP-P1-03 Run 2a Front

Parameter Result




MP-P1-03 Run 2b

Parameter Result




MP-P1-03 Run 2c

Parameter Result




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Takeda Pharma



All the sampling points were obtainable Yes

All parameters were sampled Yes

Opinions and interpretations expressed in this report are outside the scope of any claimed UKAS accreditation.EPA requirements AG1 (Safety) and AG2 (Monitoring Guidance Note) were applied during the monitoring.

Additional information

In the event of any breakthrough, a second charcoal tube was placed upstream from one of the mainadsorption tubes for each run.The results of these tubes are included in the report.

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1.3.- Monitoring Results

Emission Point

ReferenceSubstance to be Monitored ELV Result

Uncert (+/-) Units

Date of sampling

Start - End

Times Reference Method Accr.velocity

(m/s)LOD

MP-P1-03 Volumetric flow 48.1 1.4 18/06/2018 11:38-11:40

BS EN 16911-1:2013 Yes7.37n/a m3/h500 m3/h


TA Luft Organics I <6.5 n/a 18/06/2018 14:06-14:36

PD CEN/TS 13649:2014. If stack is wet, or if flue gas temp >40C during adsorption, this

method will not meet MCERTS requirements

Yes7.376.5 mg/m3n/a mg/m3


TA Luft Organics II

<7.4 n/a 18/06/2018 14:06-14:36



Yes7.377.4 mg/m350 mg/m3


TA Luft Organics III

<11.1 n/a 18/06/2018 14:06-14:36



Yes7.3711.1 mg/m3150 mg/m3







TA Luft Organics II

<7.4 n/a 18/06/2018 14:06-14:36



Yes7.377.4 mg/m350 mg/m3



<11.1 n/a 18/06/2018 14:06-14:36



Yes7.3711.1 mg/m3150 mg/m3

MP-P1-03 Run 2b





MP-P1-03 Run 2b

TA Luft Organics II

<6.8 n/a 18/06/2018 14:06-14:36



Yes7.376.8 mg/m350 mg/m3

MP-P1-03 Run 2b


<10.1 n/a 18/06/2018 14:06-14:36



Yes7.3710.1 mg/m3150 mg/m3

MP-P1-03 Run 2c





MP-P1-03 Run 2c

TA Luft Organics II

<7.3 n/a 18/06/2018 14:06-14:36



Yes7.377.3 mg/m350 mg/m3

MP-P1-03 Run 2c


<10.8 n/a 18/06/2018 14:06-14:36



Yes7.3710.8 mg/m3150 mg/m3

TA Luft Organics I-blank

<6.5 n/a 18/06/2018 PD CEN/TS 13649:2014. If stack is wet, or if flue gas temp >40C during adsorption, this


Yes7.376.5 mg/m3MP-P1-03 Run 2a Backup

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Fitz Scientific


Takeda Pharma



Analysis information

TA Luft Organics I Concept Life Sciences - Manchester

TA Luft Organics II Concept Life Sciences - Manchester

TA Luft Organics III Concept Life Sciences - Manchester

Volumetric flow Fitz Scientific

TA Luft Organics II-blank




TA Luft Organics III-blank







Yes7.376.5 mg/m3MP-P1-03 Run 2a Front












Yes7.375.9 mg/m3MP-P1-03 Run 2b












Yes7.376.3 mg/m3MP-P1-03 Run 2c









Sampling stage carried out as per MCERTS requirementsNo*:

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Takeda Pharma



Additional information

* The reported uncertainty is based on a standard uncertainty multiplied by a coverage factor k=2, providing a level of confidence of approximately 95%

** Results reported at following Reference Conditions

Reference Conditions

Abatement system and process load

Emission Point Reference Temperature (K) Pressure (KPa) Moisture (%) Oxygen (%)

Monitoring Result Reference Conditions

MP-P1-03 273 101.3 No correctionNo correction

Abatement system In Operation Fuel type and LoadLocation

Carbon Bed Yes As per BatchMP-P1-03 Extraction Process

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1.4.- Operating Information

Emission Point Reference Date Process Type

ProcessDuration Substance CEMS PR Units

MP-P1-03 18/06/2018 n/a 48.1Volumetric flowAir Extraction Batches m3/h

* CEMS: Continuous Emission Monitoring System Results

* PR: Periodic Monitoring Results

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Takeda Pharma



1.5.- Monitoring Deviations

Isokinetic conditions were outside the requirements of BS EN 13282-1 section 10.4.

Due to the high velocity in the duct a smaller nozzle size was used than required by BS EN 13282-1 section 5.2.4 (6mm) to carry out isokinetic sampling.

Emission monitoring point does not have required number of ports as per AG1 section 2.1/2.2 (per M1 Figure A2.5).

The ELV is such that the LOD for the analysis does not allow for the requirement of >10% ELV to be achieved (for ELV >5 mg/m3) (MID 13248-1 section 10.6)

The ELV is such that the LOD for the analysis does not allow for the requirement of >20% ELV to be achieved (for ELV <5 mg/m3) (MID 13248-1 section 10.6)

Negative flow was found (BS EN 13284-1 section 5.2 b).

The stack flow direction doesn’t meet the minimum requirement of 15 degrees with regard the axis of the stack. (BS EN 13284-1 section 5.2 a).

The ratio of highest to lowest local gas velocity is outside (higher than 3:1) of BS EN 13284-1 section 5.2 d) requirements.

Emission point does not meet the requirements of BS EN 15259:2007 Section 6.2.1 NOTE 4 and AG1 section 2.1/2.2 (per M1 Annex 1) - The measurement plane is not in a section of duct that is at least 5 hydraulic diameters of straight duct upstream of the sampling plane and 2 hydraulic diameters downtream (5 hydraulic diameters from the top of the stack)

Sampling port size is too small for velocity, temperature and pressure measurements to be carried out as per AG1 section 2.1/2.2 (M1 Annex 1).

Differential pressure lower than 5Pa measured with pitot tube (BS EN 13284-1 section 5.2 c).

SO2/NH3 Impinger efficiency is lower than the requirements of 95% total of concentration in the first impinger (BS EN 14791:2017 section 6.6.1)

NOx calibration drift is higher than 2% of the span value. Results are corrected to drift. (BS EN 14792:2017 Section 9.4.3)

The blank reading does not meet the required target of <10% of the daily limit value (for ELV >10 mg/m3) (BS EN 12384-1 section 10.6)

MP-P1-03Emission Point Volumetric flowParameter

NOx overall uncertainty calculated is outside requirement of <10% at the daily ELV, or the lowest limit value assigned by the local authorities, expressed on dry basis before correction to O2 reference concentration as per Section 8 BS EN 14789:2017

CO overall uncertainty calculated is outside requirement of <6% at the daily ELV expressed on dry basis before correction to O2 reference concentration as per 7.3 BS EN 15058:2017.

O2 overall uncertainty calculated is outside requirement of <6% of the value expressed on dry basis, or 0.3% expressed as a volume concentration as per Section 8 BS EN 14789:2017

CO calibration drift is higher than 2% of the span value. Results are corrected to drift. (BS EN 15058:2017 Section 9.4.3)

O2 calibration drift is higher than 2% of the span value. Results are corrected to drift. (EN 14789:2017 Section 9.4.3)

TVOC calibration drift is higher than 2% of the span value. Results are corrected to drift. (BS EN 12619:2013 Section 6.2.3)

HCl Impinger efficiency is lower than the requirements of 95% total of concentration in the first impinger (BS EN 1911:2010 section 5.2.1.2.2)

HF Impinger efficiency is lower than the requirements of 95% total of concentration in the first impinger (BS ISO 15713:2006 section 6.4).

Homogeneity test is required for this stack as per BS EN 15259:2007 but customer did not require it in the Confirmation Form

The measurement values are invalid as the corresponding blank result is greater than the requirement identified in CEN/TS 13649:2014 section 10 (c) (must be <10% of the limit values)

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Monitoring carried out as per Standard Methods. No deviations were recorded















MP-P1-03 Run 2a BackupEmission Point TA Luft Organics IParameter











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MP-P1-03 Run 2a BackupEmission Point TA Luft Organics IIParameter











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MP-P1-03 Run 2a BackupEmission Point TA Luft Organics IIIParameter











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MP-P1-03 Run 2a FrontEmission Point TA Luft Organics IParameter











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MP-P1-03 Run 2a FrontEmission Point TA Luft Organics IIParameter











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MP-P1-03 Run 2a FrontEmission Point TA Luft Organics IIIParameter











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MP-P1-03 Run 2bEmission Point TA Luft Organics IParameter











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MP-P1-03 Run 2bEmission Point TA Luft Organics IIParameter











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MP-P1-03 Run 2bEmission Point TA Luft Organics IIIParameter











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MP-P1-03 Run 2cEmission Point TA Luft Organics IParameter











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MP-P1-03 Run 2cEmission Point TA Luft Organics IIParameter











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MP-P1-03 Run 2cEmission Point TA Luft Organics IIIParameter











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Takeda Pharma



Licence / Permit Number:

Job Quote Number:

P0693-01

Y18Q19762

Operator Name:

Installation:

Phone:

Contact Name:

Takeda Pharma


Aileen Stack

014672574

Monitoring Dates:

Monitoring Organisation: Fitz Scientific


Phone: +353 41 98 45440 / Fax: +353 41 98 46171

email: [email protected]

2.- Part 2

Supporting information

18/06/2018

Laboratory details

TA Luft Organics I

Address Contact email Phone Acc. Number

Hadfield House, Hadfield Street, Old Trafford, Manchester, M16 9FE

Duncan Campbell

[email protected]

+44 (0)161 874 2400

UKAS 1549Concept Life Sciences - Manchester

TA Luft Organics II



Duncan Campbell

[email protected]

+44 (0)161 874 2400





Duncan Campbell

[email protected]

+44 (0)161 874 2400


Volumetric flow


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Geoff Fitzpatrick

[email protected] +353 41 98 45440 - ext 2

UKAS 2802Fitz Scientific

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Appendix 1:

Sampling personnel used

Substances Monitored

Equipment Checklist References

As an accredited organisation Fitz scientific have implemented procedures to ensure that the requirements of TPS 63 (UKAS Policy on Deviating Samples) are met with regard to samples taken and tested for chemical analysis. As such all samples, when applicable, have been transported in containers, and in an environment, that meet the relevant standard requirements where applicable

Substance Fitz SOPMethod used for Monitoring

TA Luft Organics I PD CEN/TS 13649:2014. If stack is wet, or if flue gas temp >40C during adsorption, this method will not meet MCERTS requirements

232

TA Luft Organics II PD CEN/TS 13649:2014. If stack is wet, or if flue gas temp >40C during adsorption, this method will not meet MCERTS requirements

232

TA Luft Organics III PD CEN/TS 13649:2014. If stack is wet, or if flue gas temp >40C during adsorption, this method will not meet MCERTS requirements

232

Volumetric flow BS EN 16911-1:2013 122

Stack: MP-P1-03

EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

n/a

n/a

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes

Volumetric flowParameter:

Stack: MP-P1-03 Run 2a Backup

EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

EM112

6700301623

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes

TA Luft Organics IIIParameter:

18/06/2018 Technician Name Position Qualification TEs MCERTS no

Aadil Khan Team Leader Level 2 TE1, TE2, TE3, TE4

Jason McGuirk Team Leader Level 2 TE1, TE2, TE3, TE4

MM11 1120

MM14 1320

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EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

EM112

6700301623

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes

TA Luft Organics IIParameter:

EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

EM112

6700301623

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes

TA Luft Organics IParameter:

Stack: MP-P1-03 Run 2a Front

EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

EM112

6700301625

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes


EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

EM112

6700301625

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes


EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

EM112

6700301625

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes


Stack: MP-P1-03 Run 2b

EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

EM135

6700301631

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes


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Fitz Scientific


Takeda Pharma



EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

EM135

6700301631

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes


EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

EM135

6700301631

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes


Stack: MP-P1-03 Run 2c

EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

EM062

6700301624

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes


EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

EM062

6700301624

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes


EM343

n/a

n/a

Miniprobe

EM071

n/a

n/a n/a

n/a

n/a

n/a

n/a n/a

EM062

6700301624

TCR

Nozzles

Impingers

Probe

Pitot tube

Weights

Caliper Filters

Horiba

FID

FTIR

Testo Gases

Handheld pumps

Tubes


Page 27 of 43

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EPA Export 24-09-2018:03:34:33

Fitz Scientific


Takeda Pharma



Appendix 2:

Monitoring Information

1

1

7.37

100.52

20.4

0.05

52.1

48.1

48.1

273

101.3

n/a

n/a

n/a

Number of Ports

Number of Points

Average Velocity v'a (m/s)

Average Pressure (KPa)

Average Temperature (ºC)

Stack Diameter (m)

Actual Moisture Flow rate (m3/h)

Moisture Flow rate at STP (m3/h)

Dry Flow rate at STP, Ref O2 (m3/h)

T reference (Deg K)

P reference (KPa)

Isokinetic condition (%)

Oxygen measured (%)

Water vapor (%)

Wet Stack (yes/no) No

Probe Temperature (°C) n/a

Impinger efficiency (%) n/a

Size of Nozzle n/a

MP-P1-03Stack Parameter: Volumetric Flow, TA Luft Organics I, II, III

Max Flow Rate in Licence (m3/h): 500

Page 28 of 43

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Fitz Scientific


Takeda Pharma



Diagram of Sampling Location (not to scale)

X

A

MP-P1-03Circular

1

1

ports

points

Point % of Diameter Location (cm) Velocity (m/s) Temperature (ºC)

Traverse Length 0.05 m

Line

1 40.00 2 7.49 20.41

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Fitz Scientific


Takeda Pharma



Monitoring result calculations and uncertainty calculations

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EPA Export 24-09-2018:03:34:33

Fitz Scientific8100/M119Yar: 2018 Visit no: 2________________________________________________________________________________________________________________________

Takeda PharmaIndustrial Emissions Licence P0693-01

Volumetric Flowrate Correction Template BS EN 16911-1:2013Company Takeda Pharma Date of Test 18/06/2018Site gecastle Business Park, Nangor Road, Dublin 22. Reference No M119Plant Identification MP-P1-03 Run 1 Operator Id MM11 1120Test carried out by Aadil Khan TE's TE1, TE2, TE3, TE4

8100/M119

Stack information:

Stack dimensions

m Stack Area m2 No ports / No pointsSuitable ports

(Y/N)?

Comply with 5 Up / 2 Down?

(Y/N) Pressure kPa Temperature K Moisture % Oxygen %

Circular Stack 0.05 0.001963495 1 Yes YesReference Condition 101.3 273 0 20.9

Rectangular stack 0.00 0.00 0.00 1Stack Conditions 100.5 293.4 0.0 20.90

Actual Value: 0.001963495

PointVelocity m/s (v'a)

Temp degC (ta) Temp K Presssure kPa (Pa)

Flow Rate m3/sec:

Actual Flow rate m3/hr

Moisture Flow rate at STP m3/hr Moisture

Flow rate at STP, Dry m3/hr O2 %

Flow Rate at STP, Dry, Ref O2 m3/hr

1 7.37 20.4 293.4 101 0.01 52.1 48.1 0.0 48.1 20.90 48.1Volumetric flow 7.37 20.40 293.40 100.520 0.01 52.1 48.1 0.0 48.1 20.90 48.1Uncertainty 20.40 293.40 100.520 1.6 1.4 0.0 1.4 20.90 1.4

Maximum volumetric flow as per Licence 500.0 m3/h

Report Number :

Calculation spreadsheet v.54 Page 31 of 43

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EPA Export 24-09-2018:03:34:33

Fitz Scientific8100/M119Yar: 2018 Visit no: 2_________________________________________________________________________________________________________________________


v1.4 Oct-16Enter data in orange cells onlyConstantsGas constant 8.314 J/(K.mol)

1990 Pa0.01 Pa

2 % of value0.2 % of range between calibrations

PITOT 0.04 % of rangeSampling probe: Miniprobe 0.68 Pa

Pitot EM071 Water vapour me 0.00 % relativePitot coefficient, K 0.823 0.61 °C CO content meas 0.00 % relativeExpanded uncertainty (95%, k=2) 0.02 1007.6 Pa CO2 content mea 0.00 % relative

0.52 % O2 content measu 0.00 % relative

Duct dimensions Circular RectangularDiameter 0.05 m a mArea 0.0 m2 b m

Area 0.00 m2Uncertainty (%) 0.52 Uncertainty (%) 0.00116889

All Pressures should be entered in Pascals, Pa

Measurement Point Atmospheric Pressure, PaStack Pressure, Pa Static Pressure, Pa meas1, Pa meas2, Pa meas3, Pa meas4, Pa meas5, Pa Delta P, Pa Stack Temperature, C

Water Vapour Content, % CO, ppm CO2, % N2, % O2, % dry molecular wt, g/mol stack molecular wt, g/mol

1 100460 100520 47.700 47.70 20.40 0.00 0.00 0 79.1 20.90 28.84 28.842 0.00 0.00 0 79.1 20.90 28.84 28.843 0.00 0.00 0 79.1 20.90 28.84 28.844 0.00 0.00 0 79.1 20.90 28.84 28.845 0.00 0.00 0 79.1 20.90 28.84 28.846 0.00 0.00 0 79.1 20.90 28.84 28.847 0.00 0.00 0 79.1 20.90 28.84 28.848 0.00 0.00 0 79.1 20.90 28.84 28.849 0.00 0.00 0 79.1 20.90 28.84 28.84

10 0.00 0.00 0 79.1 20.90 28.84 28.8411 0.00 0.00 0 79.1 20.90 28.84 28.8412 0.00 0.00 0 79.1 20.90 28.84 28.8413 0.00 0.00 0 79.1 20.90 28.84 28.8414 0.00 0.00 0 79.1 20.90 28.84 28.8415 0.00 0.00 0 79.1 20.90 28.84 28.8416 0.00 0.00 0 79.1 20.90 28.84 28.8417 0.00 0.00 0 79.1 20.90 28.84 28.8418 0.00 0.00 0 79.1 20.90 28.84 28.8419 0.00 0.00 0 79.1 20.90 28.84 28.8420 0.00 0.00 0 79.1 20.90 28.84 28.84

Mean 100460 100520 #DIV/0! 47.70 #DIV/0! #DIV/0! #DIV/0! #DIV/0! 47.70 20.40 0.00 0.0 0.0 79.1 20.9 28.84 28.84

Circular duct Rectangular ductMean velocity 7.37 m/sec Flow rate (stack conditions) 52 m3/hour 0 m3/hour

Standard uncerta 0.10 m/sec 1.4 % of value Vol. flow rate expanded uncertain 2 m3/hour #DIV/0! m3/hour

Mean density 1.188 kg/m3 Expanded uncert 0.20 m/sec 2.7 % of value Vol. flow rate expanded uncertain 3.0 % of value #DIV/0! % of value

Developed for the STA by David Butterfield & Chris Dimopoulos, NPL

Repeatability of Delta P transducerDrift of Delta P transducerLack of fit of measurement system

Uncertainty calculation for Velocity and Volume Flow Rate Measurement by Pitot tube EN ISO 16911‐1

Characteristics of pressure sensor used for Delta PEnter uncertainties as (95%,k=2) where relevant

Range of Delta P transducerResolution of Delta P transducer

Uncertainty in duct area measurement

Dry gas basis

Uncertainty in stack gas compositionUncertainty in Delta P transducer Enter uncertainties as (95%,k=2) where relevant

Uncertainty in temperature readout systemUncertainty in atmospheric pressure transducer

Enter uncertainties as (95%,k=2) where relevant

Calculation spreadsheet v.54

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EPA Export 24-09-2018:03:34:33

Fitz Scientific8100/M119Yar: 2018 Visit no: 2_______________________________________________________________________________________________________________________


Velocity associated uncertainties

Pitot Tube CoefficientExpanded uncertainty (95%, k=2) 0.02Standard uncertainty (Dimensionless) 0.01

Table 1

Delta P Standard uncertanites^2 Measurement Point SD of the mean of the DP measurements (Standard uncertainty Delta P)^2 u2(Dpi)Velocity (m/s) Standard uncertainty velocity m/s

Sigma DP See Table 1 1 1.0 2.6 7E‐04 7.4 0.22Resolution uncertainty 0.00 2Calibration uncertainty 0.11 3Lack of fit 0.21 4Drift 5.28 5

67

Molar Mass 8u(H2O) 0 9(O2)wet 20.9 10u(O2)wet 0.00 11(CO2)wet 0.0 12u(CO2)wet 0.00 13(CO)wet 0.0 14u(CO)wet 0.00 15Oxygen sensitivity 4.00E‐05 16Water sensitivity 1.00E‐04 17CO2 sensitivity 1.60E‐04 18CO sensitivity 4.00E‐08 19

20standard uncertainty 0.000000 kg/mol 0.00 % of value Average 0.95 2.55265455 7E‐04 7.37 0.219868402

Temperaturestandard uncertainty 0.31 K 0.10 % of value

Stack static pressurestandard uncertainty 0.0 Pa #DIV/0! % of value

Stack pressurestandard uncertainty 1007.6 Pa 1.00 % of value

Stack gas densitystandard uncertainty 0.0120 kg/m3 1.01 % of value

Standard uncertainty of velocity 0.10 m/sec 1.4 % of value

Expanded uncertainty in velocity 0.20 m/sec 2.7 % of value

Calculation spreadsheet v.54

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Volume flow rate associated uncertainties

Circular duct Rectangular ductArea uncertainty 0.01 m2 #DIV/0! m2

Flow rate standard uncertainty 1 m3/h #DIV/0! m3/h

Volume flow rate expanded uncertainty 2 m3/h #DIV/0! m3/h

Volume flow rate expanded uncertainty 3.0 % of value #DIV/0! % of value

Calculation spreadsheet v.54Page 34 of 43

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Lookup tables

Factor Loading Function

Number of measurments dn2 0.8853 0.5914 0.4865 0.436 0.3957 0.378 0.3519 0.337

10 0.32511 0.31512 0.30715 0.28820 0.26825 0.25430 0.24540 0.22750 0.22260 0.21680 0.206

100 0.199


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Swirl Test Record BS EN 16911-1:2013Company Takeda Pharma Date of Test 18/06/2018Site Grangecastle Business Park, Nangor Road, Dublin 22. Reference No M119Plant Identification MP-P1-03 Run 1 Operator Id MM11 1120Test carried out by Aadil Khan TE's TE1, TE2, TE3, TE4

Sampling Line APoint Distance to duct (m) Diff. Pressure (Pa) Temp oC Velocity (m/s) Angle of Swirl

1 0.02 47.7 20.4 7.49 <1523456789

101112

Average 47.7 20.4 7.49 #DIV/0!Min 47.7 20.4 7.49 0Max 47.7 20.4 7.49 0

Sampling Line BPoint Distance to duct (m) Diff. Pressure (Pa) Temp oC Velocity (m/s) Angle of Swirl

123456789

101112

Average #DIV/0! #DIV/0! #DIV/0! #DIV/0!Min 0 0 0 0Max 0 0 0 0


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Mass Concentation - TA Luft Organics Run 2a Front Tube PD CEN/TS 13649:2014Company Takeda Pharma 18/06/2018Site Grangecastle Business Park, Nangor Road, Dublin 22. M119Plant Identification MP-P1-03 Run 2 MM11 1120Test carried out by Aadil Khan TE1, TE2, TE3, TE4Report Number: 8100/M119

Laboratory Reference No:

Calibration Air Volume:Calibration flow rate: 210.17 ml/minINITIAL COUNT 646127Post Calibration flow rate: 204.57 ml/minFINAL COUNT 659959

Pump (EM number) EM112 @ 0.495 ml/count

Air Volume Sampled 6.84684 litresTime(min.) 30

Vol air sampled( Vga) 0.0068 m3Stack temperature 293.4 K O2 H2OStack Pressure 100.52 kPa Ref Conditions 20.9 0

Measured 20.90 0.00Vol at STP 0.0063 m3Vol at STP, H20 and O2 Ref 0.0063 m3

Blank Run Result Blank Result Run Result Blank Result RunMass Flow at STP,dry,refO2

CLASS ug ug ug/m3 ug/m3 mg/m3 mg/m3 kg/hrAcetone III 10 10 1581.8 1581.8 1.6 1.6 0.00008Benzene I 1 1 158.2 158.2 0.2 0.2 0.00001Carbon Tetrachloride I 5 5 790.9 790.9 0.8 0.8 0.00004Chloroform I 5 5 790.9 790.9 0.8 0.8 0.00004Cyclohexane II 20 20 3163.7 3163.7 3.2 3.2 0.00015Cyclohexanone II 10 10 1581.8 1581.8 1.6 1.6 0.00008Dichloromethane I 10 10 1581.8 1581.8 1.6 1.6 0.00008Ethanol III 10 10 1581.8 1581.8 1.6 1.6 0.00008Ethyl acetate III 10 10 1581.8 1581.8 1.6 1.6 0.00008Heptane III 10 10 1581.8 1581.8 1.6 1.6 0.00008Hexane III 10 10 1581.8 1581.8 1.6 1.6 0.00008m+p Xylene II 1 1 158.2 158.2 0.2 0.2 0.00001MEK Methyl Ethyl Ketone III 5 5 790.9 790.9 0.8 0.8 0.00004MIBK Methyl isobutyl ketone III 5 5 790.9 790.9 0.8 0.8 0.00004o-Xylene II 1 1 158.2 158.2 0.2 0.2 0.00001Propan-2-ol III 10 10 1581.8 1581.8 1.6 1.6 0.00008Tetrachloroethylene I 10 10 1581.8 1581.8 1.6 1.6 0.00008Tetrahydrofuran THF II 10 10 1581.8 1581.8 1.6 1.6 0.00008Toluene II 5 5 790.9 790.9 0.8 0.8 0.00004Trichloroethylene I 10 10 1581.8 1581.8 1.6 1.6 0.00008

TA Luft Organics I 41 41 6485.6 6485.6 6.5 6.5 0.00031TA Luft Organics II 47 47 7434.7 7434.7 7.4 7.4 0.00036TA Luft Organics III 70 70 11072.9 11072.9 11.1 11.1 0.00053

Lab Results Certificate Num Laboratory: Accreditation Analytical MethoDate of AnalysisBlank 1047/195/09 CLS - Manchester ISO 17025 GCMS 28/06/2018Run 1047/195/07 CLS - Manchester ISO 17025 GCMS 28/06/2018

ELV Blank deviation Results (mg/m3) Results breakdown ExceedanceTA Luft Organics I n/a #VALUE! <6.5 <6.5 noTA Luft Organics II 50 TRUE <7.4 <7.4 noTA Luft Organics III 150 FALSE <11.1 <11.1 no

Records of calibration sampling pump:

Date of TestReference NoOperator Id

TE's


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Mass Concentation - TA Luft Organics Run 2a Backup Tube PD CEN/TS 13649:2014Company Takeda Pharma 18/06/2018Site Grangecastle Business Park, Nangor Road, Dublin 22. M119Plant Identification MP-P1-03 Run 2 MM11 1120Test carried out by Aadil Khan TE1, TE2, TE3, TE4Report Number: 8100/M119













TE's



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Mass Concentation - TA Luft Organics Run 2b PD CEN/TS 13649:2014Company Takeda Pharma 18/06/2018Site Grangecastle Business Park, Nangor Road, Dublin 22. M119Plant Identification MP-P1-03 Run 2 MM11 1120Test carried out by Aadil Khan TE1, TE2, TE3, TE4Report Number: 8100/M119














TE's


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Mass Concentation - TA Luft Organics Run 2c PD CEN/TS 13649:2014Company Takeda Pharma 18/06/2018Site Grangecastle Business Park, Nangor Road, Dublin 22. M119Plant Identification MP-P1-03 Run 2 MM11 1120Test carried out by Aadil Khan TE1, TE2, TE3, TE4Report Number: 8100/M119














TE's


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EPA Export 24-09-2018:03:34:33

Concept Life Sciences

Certificate of Analysis

Hadfield HouseHadfield Street

CornbrookManchester

M16 9FETel : 0161 874 2400Fax : 0161 874 2404

Report Number: 746212-1

Date of Report: 26-Jun-2018

Customer: Fitz ScientificUnit 35Boyne Business ParkDroghedaCo LouthA92 D52D

Customer Contact: . Reports

Customer Job Reference:Customer Purchase Order: FS1069

Date Job Received at Concept: 21-Jun-2018Date Analysis Started: 22-Jun-2018

Date Analysis Completed: 26-Jun-2018

The results reported relate to samples received in the laboratory and may not be representative of a wholebatch.Opinions and interpretations expressed herein are outside the scope of UKAS accreditationThis report should not be reproduced except in full without the written approval of the laboratoryTests covered by this certificate were conducted in accordance with Concept Life Sciences SOPsAll results have been reviewed in accordance with Section 25 of the Concept Life Sciences, AnalyticalServices Quality Manual

This document has been printed from a digitally signed master copy

Concept Life Sciences is a trading name of

Concept Life Sciences Analytical & Development

Services Limited registered in England and

Wales (No 2514788)

1549

Report checkedand authorised by :Kathryn GleavesCustomer Service Advisor

Issued by :Kathryn GleavesCustomer Service Advisor

Page 1 of 3

746212-1Page 41 of 43

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EPA Export 24-09-2018:03:34:33

Concept Reference: 746212

Customer Reference:

Tube (Charcoal 226-09) Analysed as Tube (Charcoal 226-09)

VOC Suite

Concept Reference 746212 001 746212 002 746212 003 746212 004 746212 005

Customer Sample Reference 1047/195/01 FRONT 1047/195/01 BACK 1047/195/02 FRONT 1047/195/02 BACK 1047/195/03 FRONT

Test Sample AR AR AR AR AR

Date Sampled 18-JUN-2018 18-JUN-2018 18-JUN-2018 18-JUN-2018 18-JUN-2018

Determinand Method LOD Units Symbol

Propan-2-ol GC/MS 10 µg U <10 <10 <10 <10 <10

Acetone GC/MS 10 µg U <10 <10 <10 <10 <10

Benzene GC/MS 1 µg U <1 <1 <1 <1 <1

Carbon tetrachloride GC/MS 5 µg U <5 <5 <5 <5 <5

Chloroform GC/MS 5 µg U <5 <5 <5 <5 <5

Cyclohexane GC/MS 20 µg U <20 <20 <20 <20 <20

Cyclohexanone GC/MS 10 µg U <10 <10 <10 <10 <10

Dichloromethane GC/MS 10 µg U <10 <10 <10 <10 <10

Ethanol GC/MS 10 µg U <10 <10 <10 <10 <10

Ethyl acetate GC/MS 10 µg U <10 <10 <10 <10 <10

Heptane GC/MS 10 µg U <10 <10 <10 <10 <10

Hexane GC/MS 10 µg U <10 <10 <10 <10 <10

Meta/Para-Xylene GC/MS 1 µg U <1 <1 <1 <1 <1

Ortho-Xylene GC/MS 1 µg U <1 <1 <1 <1 <1

Methyl ethyl ketone GC/MS 5 µg U <5 <5 <5 <5 <5

Methyl iso butyl ketone GC/MS 5 µg U <5 <5 <5 <5 <5

Tetrachloroethylene GC/MS 10 µg U <10 <10 <10 <10 <10

Tetrahydrofuran GC/MS 10 µg U <10 <10 <10 <10 <10

Toluene GC/MS 5 µg U <5 <5 <5 <5 <5

Trichloroethylene GC/MS 10 µg U <10 <10 <10 <10 <10


Customer Reference:


VOC Suite


Customer Sample Reference 1047/195/03 BACK 1047/195/04 FRONT 1047/195/04 BACK 1047/195/05 FRONT 1047/195/05 BACK





Acetone GC/MS 10 µg U <10 <10 <10 <10 <10







Ethanol GC/MS 10 µg U <10 <10 <10 <10 <10


Heptane GC/MS 10 µg U <10 <10 <10 <10 <10

Hexane GC/MS 10 µg U <10 <10 <10 <10 <10










Produced by Concept Life Sciences, Hadfield House, Hadfield Street, Cornbrook, Manchester, M16 9FE Page 2 of 3

746212-1Page 42 of 43

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Index to symbols used in 746212-1


Customer Reference:


VOC Suite


Customer Sample Reference 1047/195/06 FRONT 1047/195/06 BACK 1047/195/07 FRONT 1047/195/07 BACK 1047/195/08 FRONT





Acetone GC/MS 10 µg U <10 <10 <10 <10 <10







Ethanol GC/MS 10 µg U <10 <10 <10 <10 <10


Heptane GC/MS 10 µg U <10 <10 <10 <10 <10

Hexane GC/MS 10 µg U <10 <10 <10 <10 <10










Customer Reference:


VOC Suite

Concept Reference 746212 016 746212 017 746212 018

Customer Sample Reference 1047/195/08 BACK 1047/195/09 FRONT 1047/195/09 BACK

Test Sample AR AR AR

Date Sampled 18-JUN-2018 18-JUN-2018 18-JUN-2018


Propan-2-ol GC/MS 10 µg U <10 <10 <10

Acetone GC/MS 10 µg U <10 <10 <10

Benzene GC/MS 1 µg U <1 <1 <1

Carbon tetrachloride GC/MS 5 µg U <5 <5 <5

Chloroform GC/MS 5 µg U <5 <5 <5

Cyclohexane GC/MS 20 µg U <20 <20 <20

Cyclohexanone GC/MS 10 µg U <10 <10 <10

Dichloromethane GC/MS 10 µg U <10 <10 <10

Ethanol GC/MS 10 µg U <10 <10 <10

Ethyl acetate GC/MS 10 µg U <10 <10 <10

Heptane GC/MS 10 µg U <10 <10 <10

Hexane GC/MS 10 µg U <10 <10 <10

Meta/Para-Xylene GC/MS 1 µg U <1 <1 <1

Ortho-Xylene GC/MS 1 µg U <1 <1 <1

Methyl ethyl ketone GC/MS 5 µg U <5 <5 <5

Methyl iso butyl ketone GC/MS 5 µg U <5 <5 <5

Tetrachloroethylene GC/MS 10 µg U <10 <10 <10

Tetrahydrofuran GC/MS 10 µg U <10 <10 <10

Toluene GC/MS 5 µg U <5 <5 <5

Trichloroethylene GC/MS 10 µg U <10 <10 <10

Value Description

AR As Received

U Analysis is UKAS accredited


Produced by Concept Life Sciences, Hadfield House, Hadfield Street, Cornbrook, Manchester, M16 9FE Page 3 of 3

746212-1Page 43 of 43

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Documents

Takeda Pharma - Environmental Protection Agency · 2018. 9. 24. · TA Luft Organics III Concept Life Sciences - Manchester Volumetric flow Fitz Scientific TA Luft Organics II-blank