BS EN 14181:2004 - QAL2 CEMs Calibration Report · Novartis Ringaskiddy County Cork, Ireland, Waste Incineration 2.2.2 Type of Fuel Fuel Ratio Is a mulitple calibration function required

Process Operator & Address Main Contact at Site Type of Process

Installation Name

Permit Number

Permit Reference

Date(s) of Test(s) / Sampling:

Report Date Parameters MeasuredVersion

Report By:

MCERTS Number:

MCERTS Level:

Technical Endorsements:

Report Approved By:

MCERTS Number:

Business Title:

Technical Endorsements:

Signature: ESG Job Number

ESG Laboratory Performing this Work: Your Contact at ESG: For technical enquiries contact:

East Kilbride Laboratory David Hay Andy Tiffen

2-4 Langlands Place Senior Team Leader Tel: 0161 443 0980

Kelvin South Business Park Tel: 01355 247 514 Fax: 0161 480 4642

East Kilbride Fax: 01355 249 669 Email: [email protected]

G75 0YF Email: [email protected]

Tel: 01355 246 730

770

Section 1A

Tel: +353 21 4862374

Peripheral Measurements

Volatile Organic Compounds (VOCs)

Hydrogen Chloride

Sulphur Dioxide

Oxides of Nitrogen

Total Particulate Matter

Email: [email protected]

Carbon Monoxide

Linearity of Gaseous Analysers:

Linearity of Total Particulate Matter Analyser:

CEMs Functional Checks: 5th June 2013

N/A

5th June 2013

11th - 14th June 2013

10th - 14th June 2013

LEK09311

MM 07 885

Mcerts Level 2 - Team Leader

TE's 1, 2, 3 & 4

MM 05 640

MCERTS Level 2 - Team Leader

TE's 1, 2 & 4

BS EN 14181:2004 - QAL2 CEMs Calibration Report

Novartis

Ringaskiddy

County Cork

Noel Aherne

Ireland

Waste Incinerator

SWI

-

Comparative Measurements of Gaseous Parameters:

Andy Tiffen

12th July 2013

1

Comparative Measurements of Total Particulate Matter:

Cormac Dunne

Page 1 of 82

LEK09311

5th - 14th June 2013

Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

Title Page

Contents

Section 1 - Executive Summary

UKAS and ESG Disclaimer Statement

Calibration Summary

Deviation from the Standard Reference Methods

Deviations from BS EN 14181:2004

Inpact of Deviations on the Results

Actions Required

Section 2 - Regulatory Information

Regulated Determinands, Emission Limit Values and Required Measurement Uncertainty

Process Description

Standard Reference Method (SRM) Sampling Location

Duct Characteristics

Sampling Lines and Sample Points

Sampling Platform Information

Sampling Location / Platform Improvement Recommendations

Sampling Location Compliance with BS EN 15259:2007

Diagram / Photographs of Emission Point and Platform

Information about the CEMs

Description of the CEMs

CEMs Measurement of Stack Temperature and Pressure

CEMs & CEMs Probe Location

CEMs Self Checking / Calibration Periods

Sites Reference Materials

7

8

9

9

10

7

7

9

4

5

6

6

6

Contents

Page Number

1

2

4

9

9

7

7

7

6

7

7

7

Page 2 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

Section 3 - Information About the Monitoring Campaign

Stack Emissions Monitoring Team

Description of the Standard Reference Method (SRM)

Standard Reference Method (SRM) Monitoring Methods

Sampling Methods with Subsequent Analysis

On Site Testing

Section 4 - Data Handling

Procedure for Selecting Datapairs.

Section 4A - Data and Calculations

Section 5 - Functional Test Report Audit

Section 6 - Calibrateable Equipment Checklist

79

82

12

12

13

11

12

12

Contents (continued)

Page Number

11

13

14

Page 3 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

Opinions and interpretations expressed herein are outside the scope of UKAS accreditation.


UKAS & ESG Disclaimer Statement

This test report shall not be reproduced, except in full, without the written approval of Environmental Scientifics Group Limited.

Page 4 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

Section 1B

Y

Y

Y

N

N

N/A

150.3

5.2

10.7

2.2

-2.0

20.8

26.7

A or B

used?

N/A

B

N/A

N/A

N/A

N/A

B

B

Parameter Calibration

Reportable Conditions

VOCsPasses

Variability TestN/A 30

Where the Operator decides to use the calibration functions, then the Environment Agency of England and Wales have

asked that this test house make the Operator aware of the following statement. "Once applied, the calibration only

remains valid so long as the CEM is not adjusted, unless any adjustments are triggered and permitted through the

QAL3 procedure, in order to return the zero and span readings to the original baselines that were in place during the

QAL2 and when the calibration function was applied."

If the difference between the standardised CEM values (before applying the calibration function) and the standardised

SRM measurements do not differ by more than half of the allowable 95% confidence interval of the daily average ELV,

then it may not be necessary to apply the calibration function. This is because the differences bewteen the SRM and

CEM results can be attributed to the uncertainty of the SRM and CEM measurements. If such cases occur, then it is

advisable to contact the local site inspector for approval for this approach.

MoisturePasses


Variability Calibration Interval

of the

N/A N/A 30

Hydrogen ChloridePasses


Sulphur DioxidePasses


Carbon MonoxidePasses


Oxides of NitrogenPasses


Total Particulate Matter

OxygenPasses


Test

(AST only)

Test Acceptance %

Extended Range

Derived

of Calibration at

Sulphur Dioxide y=1.010x +0.451 50.0

Hydrogen Chloride y = 1.479x -1.553 8.5

VOCs y=1.015x -0.006

Validated Range

of Calibration at

Ref Conditions

Is Function

Derived From

Linearity?

N/A

N

Y

10.0

Parameter Outcome Outcome Legislation

Oxygen y = 0.953x +0.219 20.9

Moisture y = 0.961x +0.221 N/A

- - SWI


Function

Method

Carbon Monoxide y=1.007x -1.402 50.0

Total Particulate Matter N/A N/A

Oxides of Nitrogen y = 1.165x +1.437 286.4


QAL2 Calibration Summary

Novartis, Ringaskiddy

of the Confidence

Do the standardised

CEM and SRM values

differ by less than half

the allowable

confidence interval?

N/A

No

Yes

Yes

No

Yes

No

Yes

Page 5 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

Section 1C

None

Deviations from the Standard Reference Methods

Deviations from BS EN 14181:2004

None

Impact of Deviations on the Results

N/A

Actions Required

The CEM system has passed the requirements of the QAL2. The calibration function derived should now be

applied to all CEM data. No additional actions are required

Project Deviations

Page 6 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

Novartis

Ringaskiddy

County Cork, Ireland,

Waste Incineration

2.2.2 Type of Fuel

Fuel Ratio

Is a mulitple calibration function required

2.2.3 Abatement

Section 2.3.1 Stack and sampling ports

Duct Characteristics Sampling Lines & Sample Points

Section 2.3.2 Monitoring platform and site-provisions

Sampling Location / Platform Improvement Recommendations

Section 2.3.3 Sample - how representative is it?

Sampling Location Compliance with BS EN 15259:2007

770

2.1.1 Name of the operator

2.1.2 Name of the installation

2.1.3 Address of the installation

2.1.4 Sector for the installation

2.1.5 Permit Number

2.1.6 Date of the last QAL2/AST

Percentage of Load Varied throughout test

Nature of process Continuous

2.2.1 Process type and variations in emissions

Abatement Type OtherCatalytic Thermal Oxidisers

If emissions are at or near zero what provisions are in place to deal with

this and does the operator know and understand the implications?

Performed Linearity checks on all components

Fuel Type

Is there easy & Safe access to the CEM?

Do site have adequate reference materials?

Do site hold suitable tools

Do site stock spare parts

See page 10 for reference materials stocked at site

Yes

Yes

YesCan ref gases be injected at inlet & probe? Yes

Ratio of highest to lowest flows 0

mm

Exposed to elementsSufficient Weather Protection

Natural Gas

N/A

No

Safe & Clean Working Environment Yes

Type Permanent

Location Outside

Sampling Platform Information

m Orientation Horizontal Horizontal

4" BSP 4" BSP

Cross Sectional Area 0.06 m2 Number Points / Line 1 1

Width -

70 Filtration LocationPort Depth In-Stack In-Stack

Depth

The sampling location meets all the requirements specified in EA Guidance Note M1.

The cross sectional area of the Standard Reference Method sampling location is less than one square meter, so it

is not necessary to demonstrate that the gas distribution is homogenous.

Are emissions at or near zero

0.27 m Number Used 1 1

Shape Circular - Sample Port Size

Volatile Organic Compounds (VOCs) as C 20 10 30%

Oxygen 25 10%

Value Units TPM Gases

2.3 Monitoring provisions at the installation - perodic monitoring

Any expected variation in emissions None

Water Vapour 30 30%

2.2 Operational Information and site monitoring provisions

No

Other factors that may affect monitoring results None

Yes

Oxides of Nitrogen as NO2 400 20%

Carbon Monoxide 100 50 20%

Sulphur Dioxide 200 50 20%

Hydrogen Chloride 60 10 40%

Will emissions variations influence representative sampling

2.1.7 Regulated Determinands, Emission Limit Values and Required Measurement Uncertainty

Determinand Short Term ELV Daily ELV Virtual ELV Required

Section 2 - 2.1 Regulatory Information

(mg/m3) (mg/m

3) % Uncertainty

Total Particulate Matter 30 10 30%

Page 7 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

Diagram / Photographs of Emission Point and Platform

Page 8 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

TPM

NO

NO2

CO

SO2

HCl

VOCs

Oxygen

The CEMs analyser is located in a clean safe environment with sufficient weather protection.

There is safe access to the CEMs probe / analyser head.

The CEMs sampling location has been subjected to a BS EN 15259 homogeneity test.

Section 2.4.2 Types of monitoring for peripheral determinands

The temperature and pressure of the stack are not recorded.

See below table 4.1 for each component for details of what corrections applied to data to obtain reportable conditions

The CEMs probe / analyser head is located 1 hydraulic diameters downstream of the Standard Reference Method sampling

location.

CEMs Self Checking / Calibration Periods

Any data that is gathered across these periods will not be used as part of the datapairs used in the derivation of any calibration

function(s).

Checks are carried out manually by engineers on a weekly basis

-

-

MC030016/04

Water Vapour extractive ABB ACFNT - - FTIR MC030016/04

extractive ABB ACFNT 20.9% 20.9 Zirconia

CEMs Measurement of Stack Temperature, Pressure & Moisture

CEMs & CEMs Probe Location

MC030016/04

extractive ABB ACFNT 15 15 FTIR MC030016/04

extractive ABB ACFNT 75 75 FTIR

MC030015/02extractive ABB MultiFID 15 15 FID


extractive Sigrist Stackguard 0.05 - Photometer

MC030016/04


extractive ABB ACFNT 200 200 FTIR

Certificate

mg/m3

Number

Range

MC060081/03

2.4.1 Types of CEMs for each main determinand, oxygen and moisture

Pollutant Type of CEM Instrument Minimum Actual Measurement QAL 1

Technique /

Provider Certified mg/m3

MCERTS

CEMs System Model MCERTS Range

2.4 Continuous Emission Monitoring Systems (CEMs) at the installations

Page 9 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

VOC Air Products 306879 / 040003341365 16.0 15/02/2011

Number ppm

42415

19/01/2012 41658

SO2 Air Products 20671 / 040003866679

19/01/2012 41658

The reference materials can be injected both at the probe and at the analyser.

CO2 Air Products 20671 / 040003866679 15.0

20/04/2012 44671Oxygen Air Products 207664 / 04000409213 0.0

Sites Reference Materials

Pollutant Supplier Cylinder Conc Date of Shelf

Site has the following reference materials:

74.0 19/01/2012

CO Air Products 20671 / 040003866679 64.0

41658

NO Air Products 20671 / 040003866679 236.0 19/01/2012 41658

Manufacture Life

Page 10 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

Jun-16

N/A

MM 05 640

Mcerts Trainee

N/A

N/A

Dec-17

N/A

Dec-17

N/A

Jun-16

N/A

N/A

N/A

Certification level with expiry date

Cormac Dunne MM 07 885

L1 L2 TE1 TE2 TE3 TE4

N/A Mar-17 Sep-16 Mar-17 Dec-16 Dec-16

Name Reg Number

Andy Tiffen

Tadeusz Tazbierski

Section 3 - Information About the Monitoring Campaign

3.1 Stack Emissions Monitoring Team

Page 11 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

Section 3.2 Standard Reference Methods (SRMs)

TPM

NO

NO2

CO

SO2

HCl

VOCs

Oxygen

DX 4000 FTIR MC030014/05 0 to 200 0 to 200 1.6

System Model Technique / MCERTS Range as %

Gasmet DX 4000 FTIR MC030014/05 0 to 75 0 to 75 4.8

Gasmet DX 4000 FTIR

Gasmet

Pollutant SRM / ARM Instrument Measurement QAL 1 Minimum Operating M.U.

Description of the Standard / Alternative Reference Method (SRM / ARM)

Number mg/m3

ELV

CAE Method 5 Gravimetric - 0 to 5 - 9.9

Provider MCERTS Certified mg/m3

of

Certificate Range Daily


Servomex Zentra 4900 Paramagnetic MC030013/06 0 to 25 0 to 25 -

Water Vapour Gasmet DX 4000 FTIR MC030014/05 0 to 30 0 to 30 -


M & A Thermofid FID MC050062/00 0 to 15 0 to 15 8.7

MC030014/05 0 to 75 0 to 75 6.1

Alternative Technical AccreditedAccredited of

Standard / Alternative Reference Method (SRM / ARM) Monitoring Methods

Sampling Methods with Subsequent Analysis

Pollutant Standard / ESG UKAS MCERTS Limit Laboratory

(LOD)

Method Procedure(s) Test Test Detection

Water BS EN 14790 AE 105 Yes Yes 0.10% East Kilbride

TPM BS EN 13284-1 AE 104 Yes Yes ~0.05 mg/m3

East Kilbride

Alternative Technical AccreditedAccredited of

On Site Testing

Pollutant Standard / ESG UKAS MCERTS Limit Laboratory

NO M22 AE 063 & 016 Yes Yes ~1.00 mg/m3

East Kilbride

Method Procedure(s) Test Test Detection

CO M22 AE 007 & 016 Yes Yes ~1.00 mg/m3

East Kilbride

NO2 M22 AE 063 & 016 Yes Yes ~0.50 mg/m3

East Kilbride

HCl M22 AE 063 & 016 Yes Yes ~0.50 mg/m3

East Kilbride

SO2 M22 AE 063 & 016 Yes Yes ~1.00 mg/m3

East Kilbride

Oxygen BS EN 14789 AE 007 & 054 Yes Yes ~0.10 % East Kilbride

VOCs BS EN 12619 AE 056 Yes Yes ~0.20 mg/m3

East Kilbride

Water M22 AE 063 & 016 Yes Yes ~0.10 % East Kilbride

Page 12 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

When the SRM / ARM is performed using a manual extractive technique, the timing of such samples is stated in full.

Data is averaged in line with the site short term ELV averaging time. i.e. For sites with half hourly ELV's, half hour averages are

used. Sites with 1 hourly ELV's, 1 hour averages are used. If the site does not have a short term ELV, then a minimum of half

hour averages are used.

Section 4 - Data Handling

Procedure for Selecting Datapairs.

Where Environmental Scientifics Group Limited have used continuous analysers to perform the Standard or Alternative

Reference Methods monitoring, they initially average the data as follows:

BS EN 14181 states that if the sampling time is shorter than 1 hour, then the time interval between the start of each sample shall

be at least 1 hour.

When a Homogeneity Test to BS EN 15259:2007 has been carried out prior to the QAL 2 testing and the outcome of that testing

suggests that grid sampling is the best approach to use, then the timings of such samples are stated in full.

Once the data pairs have been assembled, any pairs that cover periods of either SRM / ARM and or CEMs zero / self checking

are discarded (as they are not deemed to be valid results). The remaining results are then subjected to an outlier test which is

described in detail in this report.

Note: Environmental Scientifics Group Limited have entered into the UKAS / Environment Agency's proficiency testing scheme

for data handling for BS EN 14181. Their submission has proven that their data handling procedure is robust enough. Therefore

this report has a start point for all calibrations when the SRM value has been converted to the same units as the CEMs reading.

Therefore the actual raw SRM may not be stated in this report.

Page 13 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

Note - CEM data requires the following corrections to be expressed at STP, Dry and 11 % O2

Temperature Correction not required

Pressure Correction not required

Moisture Correction required

Oxygen Correction required

SRM

Temp

Deg C

SRM

Press.

Mbar

- -

- -

- -

- -

- -

- -

- -

- -

142.0 1009.6

139.0 1009.6

142.0 1009.6

142.0 1009.6

143.0 1008.6

143.0 1008.6

142.0 1008.6

143.0 1008.6

--

--

--

--

--

--

--

--

14.5

15.0

15.1

14.8

14.6

14.2

15.1

15.4

15.2

15.0

15.4

15.4

15.4

15.5

15.3

13.7

13.8

14.6

13.3

143.0 1008.6

141.0 1008.6

142.0 1008.6

142.0 1008.6

143.0 1008.6

142.0 1008.6

145.0 1008.6

144.0 1008.6

143.0 1008.6

142.0 1008.6

142.0 1008.6

SRM

Water

%

--

--

--

--

--

--

--

--

13.8

20.6

20.7

10.3

22.2

21.2

21.6

20.8

21.2

22.2

21.0

20.1

20.3

20.2

20.1

22.2

20.0

19.1

19.3

SRM

Oxygen

%

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

SRM

Measured

Value

yi

mg/m3

0.0

0.0

0.0

1.2

2.0

2.2

2.3

1.6

0.7

1.3

1.5

1.4

0.1

0.2

0.4

1.3

1.0

1.7

1.4

0.2

0.2

0.1

859.5

1081.2

1067.1

968.6

957.3

714.3

981.5

1012.3

1029.1

1076.4

142.4

CEM

Press.

Mbar

13/06/2013 11:51

13/06/2013 13:22

13/06/2013 14:37

13/06/2013 15:39

13/06/2013 16:47

14/06/2013 08:53

14/06/2013 09:53

14/06/2013 10:55

14/06/2013 12:01

11/06/2013 11:56

11/06/2013 16:04

11/06/2013 17:16

12/06/2013 10:18

12/06/2013 11:48

12/06/2013 13:03

12/06/2013 14:09

12/06/2013 15:16

12/06/2013 16:23

12/06/2013 17:25

13/06/2013 12:23

13/06/2013 13:54

13/06/2013 15:09

13/06/2013 16:11

13/06/2013 17:19

14/06/2013 09:25

14/06/2013 10:25

14/06/2013 11:27

14/06/2013 12:33

-

-

-

721.9

885.1

834.0

679.2

693.0

892.0

873.1

947.3

878.7

11/06/2013 11:14

11/06/2013 15:08

11/06/2013 16:44

12/06/2013 09:41

12/06/2013 11:16

12/06/2013 12:31

12/06/2013 13:37

12/06/2013 14:44

12/06/2013 15:51

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

CEM

Temp

Deg C

-

-

-

-

-

-

-

-

142.3

140.7

141.5

142.3

142.5

142.5

141.8

--

--

--

22.5

22.7

22.1

22.9

22.7

22.3

22.4

21.8

CEM

Measured

Value

xi

mg/m3

0.0

0.0

0.0

0.0

-0.1

-0.1

12/06/2013 16:53 -0.1

-

-

-

-

-

22.4

Linearity Data

Zero Values (<5% ELV)

Date and Time

15.0

14.1

15.1

15.4

15.3

15.2

15.2

CEM

Oxygen

%

--

--

--

15.1

15.0

15.2

15.0

14.9

15.2

15.2

15.5

15.2

15.3

CEM

Water

%

22.1

Total Particulate Matter - Raw Monitoring Data

Section 4A - Data and Calculations

Table of Results - 4.1

21.8

21.4

21.5

21.5

21.6

22.2

21.6

21.6

21.4

not used

not used

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27 15.0

15.1

Sample

1

2

3

not used

not used

not used

141.8

140.8

141.2

141.3

141.9

141.7

143.0

143.5

142.2

141.2

141.7

Page 14 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

The table shows that all the parallel test results, are below 30% of the ELV and as such the calculation of a QAL2 calibration function would be an incorrect

application of the standard. When emissions are less than 30% of the ELV it is acceptable to use linearity data to derive a calibration function, however for

particulate emissions there are no surrogates from which to derive linearity data. From the results of the parallel test it cannot be determined whether the CEM is

operating correctly or not at high particulate concentrations. It is recommended that the CEM be set at a high gain factor, and that the installations response to

particulates be tested by suitably trained personnel.

SampleDate and Time

SRM

Corrected

Value

y is

mg/m3

CEM Dry

and

corrected

for, 11%

Oxygen


Linearity Data

1

2

3

not used

not used

not used

not used

not used

14/06/2013 10:25

14/06/2013 11:27

-0.2

-0.2

-0.2

-0.3

11/06/2013 11:5611/06/2013 11:14

11/06/2013 15:08

11/06/2013 16:44

12/06/2013 09:41

12/06/2013 11:16

12/06/2013 12:31

12/06/2013 13:37

12/06/2013 14:44

12/06/2013 15:51

12/06/2013 16:53

13/06/2013 11:51

13/06/2013 13:22

13/06/2013 14:37

13/06/2013 15:39

13/06/2013 16:47

18

19

20

21

22

23

9

10

11

12

13

14

15

16

17

14/06/2013 08:53

14/06/2013 09:53

14/06/2013 10:55

-0.3

-0.3

Difference

of SRM and

CEM

corrected

values

1.2

24

25

26

1.5

1.4

0.1

0.213/06/2013 12:23

13/06/2013 13:54

13/06/2013 15:09

13/06/2013 16:11

13/06/2013 17:19

14/06/2013 09:25

14/06/2013 12:33

11/06/2013 16:04

11/06/2013 17:16

12/06/2013 10:18

12/06/2013 11:48

12/06/2013 13:03

12/06/2013 14:09

12/06/2013 15:16

12/06/2013 16:23

12/06/2013 17:25

0.4

1.3

1.0

1.7

1.4

0.2

0.2

0.0

0.0

0.0

1.2

2.0

2.2

2.3

1.6

0.7

1.3

Total Particulate Matter - Standardised Monitoring Data

Total Particulate Matter - Plot 1 - Time series of data

-0.3

-0.3

-0.2

-0.2

-0.3

-0.3

-0.3

0.0

0.0

0.0

-0.1

-0.2

-0.3

-0.3

-0.3

-0.3

14/06/2013 12:01 0.127

Yes

N/A

N/A

N/A

N/A

N/A

Yes

No

No

No

No

Yes

No

No

No

Yes

Yes

Yes

No

Yes

No

No

Yes

Yes

Yes


0.0

0.0

0.0

2.1

2.4

2.5

1.8

0.9

1.6

1.8

1.6

0.4

0.4

0.6

1.5

1.3

1.9

1.6

0.4

0.5

0.4

Difference

less than

half the

confidence

interval at

the ELV?

Yes

Yes

-0.3

-0.25

-0.2

-0.15

-0.1

-0.05

0

0.0

0.5

1.0

1.5

2.0

2.5

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

Co

ncen

trati

on

(m

g/m

3)

Data Point

Comparison of SRM and CEM Standardised Data

SRM CEM

Page 15 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to




not used -- --

9 47.1 15.3

2 1.3 -- -- 0.0 -- --

3 0.6 -- -- 0.0 -- --

not used -- --

not used -- --

not used -- --

not used -- --

22.1 61.5 14.8 22.6

Oxides of Nitrogen - Raw Monitoring Data

10 11/06/2013 15:08 11/06/2013 15:38 45.9 15.0 22.4 52.7 14.8 20.7

11 12/06/2013 11:20 12/06/2013 11:50 49.5 15.2 22.3 65.1 14.9 22.1

12 12/06/2013 15:55 12/06/2013 16:25 47.7 15.1 22.2 54.6 15.1 21.5

13 12/06/2013 18:30 12/06/2013 19:00 51.6 15.2 22.0 59.8 14.8 21.9

14 12/06/2013 19:30 12/06/2013 20:00 37.2 11.2 19.0 54.0 13.9 24.1

15 12/06/2013 20:30 12/06/2013 21:00 43.8 14.5 24.4 54.1 14.0 24.2

16 12/06/2013 21:30 12/06/2013 22:00 43.6 14.5 24.6 55.4 14.0 24.5

17 12/06/2013 22:30 12/06/2013 23:00 44.1 14.5 24.8 56.5 13.9 24.7

18 12/06/2013 23:30 13/06/2013 00:00 43.7 14.5 24.9 55.4 13.9 24.8

19 13/06/2013 00:30 13/06/2013 01:00 43.5 14.4 25.0 54.5 13.7 24.6

20 13/06/2013 01:30 13/06/2013 02:00 43.1 14.4 25.0 54.3 13.9 24.9

21 13/06/2013 02:30 13/06/2013 03:00 43.2 14.4 25.0 55.0 14.0 24.9

22 13/06/2013 03:30 13/06/2013 04:00 43.3 14.5 24.9 56.6 13.2 23.7

23 13/06/2013 04:30 13/06/2013 05:00 43.0 14.5 24.9 57.3 14.0 24.8

24 13/06/2013 05:30 13/06/2013 06:00 43.2 14.5 24.8 54.8 12.9 22.8

25 13/06/2013 06:30 13/06/2013 07:00 42.8 14.6 24.8 57.6 14.1 24.7

26 13/06/2013 10:05 13/06/2013 10:35 46.7 15.2 21.6 49.7 14.9 21.5

27 13/06/2013 19:30 13/06/2013 20:00 35.3 11.6 18.3 44.4 14.8 21.7

28 13/06/2013 20:30 13/06/2013 21:00 43.7 14.9 23.0 43.9 15.1 21.5

29 13/06/2013 21:30 13/06/2013 22:00 43.3 14.7 23.4 43.3 14.8 21.9

22.1

30 13/06/2013 22:30 13/06/2013 23:00 42.9 15.0 23.3 43.6 15.0 22.1

31 13/06/2013 23:30 14/06/2013 00:00 43.0 14.7 23.6 43.3 14.8 22.0

32 14/06/2013 00:30 14/06/2013 01:00 43.3 15.0 23.4 44.8 15.0

CEM

Oxygen

%

CEM Water

%

SRM

Measured

Value

yi

mg/m3

SRM

Oxygen

%

SRM Water

%

SampleDate and Time

1


Linearity Data

1.8 --0.0 ------

11/06/2013 13:1011/06/2013 12:40


CEM

Measured

Value

xi

mg/m3

Page 16 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

2 0.0 1.3

3 0.0 0.6

not used

0.0

SampleDate and Time

SRM

Corrected

Value

y is

mg/m3

CEM Dry

and

corrected

for, 11%

Oxygen


1

not used

not used

not used

not used

9 128.6 105.9

10 11/06/2013 15:08 11/06/2013 15:38 107.6 99.9

11/06/2013 13:1011/06/2013 12:40

Linearity Data

11 12/06/2013 11:20 12/06/2013 11:50 136.8 111.3

12 12/06/2013 15:55 12/06/2013 16:25 118.0 105.6

13 12/06/2013 18:30 12/06/2013 19:00 123.6 114.5

14 12/06/2013 19:30 12/06/2013 20:00 100.7 47.1

15 12/06/2013 20:30 12/06/2013 21:00 103.0 89.7

16 12/06/2013 21:30 12/06/2013 22:00 105.6 90.0

17 12/06/2013 22:30 12/06/2013 23:00 106.1 90.4

18 12/06/2013 23:30 13/06/2013 00:00 104.6 89.3

19 13/06/2013 00:30 13/06/2013 01:00 99.9 89.0

20 13/06/2013 01:30 13/06/2013 02:00 102.8 88.1

21 13/06/2013 02:30 13/06/2013 03:00 104.4 88.3

22 13/06/2013 03:30 13/06/2013 04:00 95.5 88.7

93.3

23 13/06/2013 04:30 13/06/2013 05:00 109.6 88.4

24 13/06/2013 05:30 13/06/2013 06:00 87.5 89.3

25 13/06/2013 06:30 13/06/2013 07:00 111.1 88.8

26 13/06/2013 10:05 13/06/2013 10:35 103.5 103.4

31 13/06/2013 23:30 14/06/2013 00:00 90.2 90.4

32 14/06/2013 00:30 14/06/2013 01:00 96.0 94.4

27 13/06/2013 19:30 13/06/2013 20:00 92.7 45.9

28 13/06/2013 20:30 13/06/2013 21:00 96.1 94.3

29 13/06/2013 21:30 13/06/2013 22:00 89.9 90.9

30 13/06/2013 22:30 13/06/2013 23:00 93.6

Oxides of Nitrogen - Standardised Monitoring Data

Oxides of Nitrogen - Plot 1 - Time series of data

1.8

Difference

of SRM and

CEM

corrected

values

22.7

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

Yes

Yes

Yes

0.6

1.3

1.8

7.7

25.5

12.4

9.1

53.6

13.3

15.6

15.7

15.3

10.9

14.6

16.1

6.8

21.2

1.8

22.3

0.2

46.7

1.8

0.9

0.2

0.2

1.6

Difference

less than

half the

confidence

interval at

the ELV?

Yes

Yes

Yes

N/A

N/A

N/A

N/A

N/A

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

Yes

Yes


0

20

40

60

80

100

120

140

160

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Co

ncen

trati

on

(m

g/m

3)

Data Point


SRM CEM

Page 17 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

No

43.3 43.3 -0.1 No

42.9 43.6 0.7 No

43.0 43.3 0.3 No43.3 44.8 1.5 No

Upper limit at 2 SD

Lower limit at 2 SD

20.04

-4.20

43.2 55.0 11.8 No

43.3 56.6 13.3 No

43.0 57.3 14.3 No

43.2 54.8 11.6 No

42.8 57.6 14.7 No

46.7 49.7 3.0 No

35.3 44.4 9.1 No

43.7 43.9 0.2

The Environment Agency have produced a Guidance Note (Monitoring Quick Guide 14, Jan 2012) which deals with outliers in

monitoring data. That Guidance suggest that the following procedure is the best means of demonstrating that your data is outlier

free.

Data Source

Surrogate Zero's

Linearity Data

Parallel test data

1.8

1.3

0

0

-1.80

-1.30

No

No0.6 0 -0.60 No

No

No

No

Outlier test data

30

3132

CEM at

measured

conditions

SRM at CEMs

Measuring

conditions

DifferenceOutlier (Yes

or No)Sample

1

23

not used

not used

not used

not usednot used

9

10

11

12

13

14

54.5 11.0 No

43.1 54.3 11.2 No

2Number of standard deviations used for outlier test

Average of the differences

Standard deviation of the differences

7.92

6.06

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

14.4

45.9 52.7 6.8

49.5 65.1 15.6

47.7 54.6 6.9

NoNo

47.1 61.5 No

No

No

No

51.6 59.8 8.2 No

37.2 54.0 16.8 No

43.8 54.1 10.3 No

43.6 55.4 11.8 No

44.1 56.5 12.3 No

43.7 55.4 11.7 No

43.5

Oxides of Nitrogen - Application of the Calibration Function & Outlier Test

1) Collect raw CEM data and raw SRM data expressed as the same units as CEMs measuring conditions

2) Calculate the difference between SRM and CEM values

3) Calculate the average and the standard deviation of the differences

4) If the difference is greater or smaller than the average by more than two times the standard deviation, then the pair is deemed

an outlier and is rejected.

-10

-5

0

5

10

15

20

25

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29

Co

ncen

trati

on

(m

g/m

3)

Data Point

Comparison of SRM and CEM Data

Outlier point Upper 2 x SD Lower 2 x SD Valid Point

Page 18 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

Daily Emission Limit Value = 400 mg/m³

C.I. of the Daily Emission Limit Value = 80 mg/m³

Oxides of Nitrogen - Calibration Function Method

Spread of SRM Values = 49.3 mg/m³

Since 136.8 > 80 (20% of ELV) and 49.3 < 60 (15% of ELV), then Method B is used to calculate the calibration function.

The Environment Agency have published a Guidance document M20 which suggest that there are three approaches (Method A,

B or C) that can be taken when using BS EN 14181:2004 to derive a calibration function for the CEMs .

Method A. This method is used when there is sufficient spread of data to apply a linear regression ( derive a calibration function)

from the data pairs with no further manipulation of the data pairs. The parameters which suggest that Method A will be

successful are; the spread of SRM data is in excess of 15% of the daily emission limit value.

Method B. This method is used when the data pairs are above the confidence interval of the daily emission limit value, but there

is insufficient spread of SRM data to use Method A. Insufficient spread is defined as less than 15% of the daily emission limit

value. In this instance the data pairs will normally form a high level cluster and the approach in this instance is to use two defined

points for the derivation of the calibration. The first point is the average figure from the valid data pairs for both the CEM (x) and

SRM (y) and a second point which is at or near zero. This zero point or offset (Z) could for instance be the value that was

measured by the CEM (x) when zero gas (y) was applied during the functional checks.

Method C. This method is used when the data pairs form a low level cluster. A low level cluster is defined as when the data is

consistently below the 95% confidence interval at the daily ELV. In such instances the measurement uncertainties associated

with such values can be too high for a meaningful calibration to be derived. Consequently the CEM may be calibrated by a use of

surrogates and a linearity exercise. Preferably that linearity should be carried out to the procedural requirements of BS EN

14181: 2004 Section A 8 and Annex B.

The Environment Agency of England and Wales's MID gives further guidance on Method C clusters and it suggests that a true

cluster will have a best line of fit that displays an R2 value of <0.9 and the difference in the average SRM value and the CEM

value will be less than the confidence interval at the daily emission limit value.

Maximum SRM Value = 136.8 mg/m³

Minimum SRM Value = 87.5 mg/m³

Page 19 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

The calibration function is calculated based on parallel test data from an SRM and the CEM.

Method A Method B

where: where:

From the values above, the calibration function is:

Oxides of Nitrogen - Data used to determine the calibration function

2 0.0 1.3

3 0.0 0.6

not used

0.0 1.8

Date and Time


Sample

SRM at

CEM

conditions

yi

mg/m3

CEM

Measured

Value

xi

mg/m3

not used

not used

not used

not used

9 61.5 47.1

Xi - Xav Yi - Yav

(Xi - Xav)*

(Yi - Yav)(Xi - Xav)

2

-37.40

-37.90

-38.60

7.87


10 11/06/2013 15:08 11/06/2013 15:38 52.7 45.9

11/06/2013 13:1011/06/2013 12:40

Linearity Data

11 12/06/2013 11:20 12/06/2013 11:50 65.1 49.5

12 12/06/2013 15:55 12/06/2013 16:25 54.6 47.7

13 12/06/2013 18:30 12/06/2013 19:00 59.8 51.6

14 12/06/2013 19:30 12/06/2013 20:00 54.0 37.2

15 12/06/2013 20:30 12/06/2013 21:00 54.1 43.8

16 12/06/2013 21:30 12/06/2013 22:00 55.4 43.6

17 12/06/2013 22:30 12/06/2013 23:00 56.5 44.1

18 12/06/2013 23:30 13/06/2013 00:00 55.4 43.7

19 13/06/2013 00:30 13/06/2013 01:00 54.5 43.5

20 13/06/2013 01:30 13/06/2013 02:00 54.3 43.1

21 13/06/2013 02:30 13/06/2013 03:00 55.0 43.2

22 13/06/2013 03:30 13/06/2013 04:00 56.6 43.3

23 13/06/2013 04:30 13/06/2013 05:00 57.3 43.0

24 13/06/2013 05:30 13/06/2013 06:00 54.8 43.2

25 13/06/2013 06:30 13/06/2013 07:00 57.6 42.8

26 13/06/2013 10:05 13/06/2013 10:35 49.7 46.7

27 13/06/2013 19:30 13/06/2013 20:00 44.4 35.3

28 13/06/2013 20:30 13/06/2013 21:00 43.9 43.7

29 13/06/2013 21:30 13/06/2013 22:00 43.3 43.3

30 13/06/2013 22:30 13/06/2013 23:00 43.6 42.9

31 13/06/2013 23:30 14/06/2013 00:00 43.3 43.0

32 14/06/2013 00:30 14/06/2013 01:00 44.8 43.3

Calibrated Value Nox = 1.165 X (CEM reading) + 1.437

Oxides of Nitrogen - The Calibration Function

-12.97 13.65

1

-15.90

-14.55

10.54

19.03

38.05

30.91

6.69

10.26

8.55

12.44

-1.99

4.58

4.40

4.94

4.47

4.33

3.89

4.05

4.09

3.83

4.01

3.64

14.65

16.57

7.46

-3.90

4.55

4.12

3.70

3.83

4.07

-47.12

-47.12

-47.12

14.36

5.55

17.94

7.53

12.72

6.91

6.96

8.24

9.35

8.27

7.39

7.20

7.91

9.48

10.23

7.71

10.45

2.55

-2.70

-3.20

-3.86

-3.51

-3.81

-2.31 -9.39

-14.60

39.20

38.81

32.05

27.99

31.95

37.00

46.21

36.27

31.90

-13.72

158.19

64.39

184.04

37.14

113.03

1761.91

1785.47

1818.45

1398.41

1436.06

1489.60

61.95

44.81

105.29

73.08

154.77

3.94

21.02

19.36

24.41

20.00

18.71

15.13

16.42

16.77

14.69

16.07

13.25

55.58

15.20

20.72

16.93

Zx

yb

ˆ

Zba ˆˆ

axby ˆˆ axby ˆˆ

n

i

n

i

XXi

YYiXXi

b

1

2

1

)(

))((ˆ

XbYa ˆ

Page 20 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

The R2 value for this calibration function is 0.942

Calibrated Value Nox = 1.165 X (CEM reading) + 1.437

2 1.3 -- -- 3.0 3.0

3 0.6 -- -- 2.1 2.1

Oxides of Nitrogen - Calculation of calibrated CEM values

not used


1 1.8 -- -- 3.5 3.5

Sample

CEM

Measured

Value

xi

mg/m3

CEM

Oxygen

% (Dry)

CEM Water

%

CEM

Calibrated

Value

ŷi

mg/m3

Calibrated

CEM

Corrected

to

Reference

conditions

not used

not used

not used

not used

9 47.1 15.3 22.1 56.3 126.7

10 45.9 15.0 22.4 54.9 119.6

11 49.5 15.2 22.3 59.1 132.9

12 47.7 15.1 22.2 57.1 126.2

13 51.6 15.2 22.0 61.6 136.6

14 37.2 11.2 19.0 44.8 56.7

15 43.8 14.5 24.4 52.5 107.4

16 43.6 14.5 24.6 52.2 107.9

14.6 24.8 51.4 106.5

26 46.7 15.2 21.6 55.8 123.7

35.3 11.6 18.3 42.6 55.4

28 43.7 14.9 23.0 52.4 113.0

17 44.1 14.5 24.8 52.9 108.3

18 43.7 14.5 24.9 52.3 107.0

19 43.5 14.4 25.0 52.2 106.7

20 43.1 14.4 25.0 51.6 105.7

21 43.2 14.4 25.0 51.8 105.9

22 43.3 14.5 24.9 51.9 106.3

31 43.0 14.7 23.6 51.6 108.3

32 43.3 15.0 23.4 51.9 113.1

Oxides of Nitrogen - Plot 2 - Plot of CEM data versus SRM data

29 43.3 14.7 23.4 51.9 108.9

30 42.9 15.0 23.3 51.4 111.9

23 43.0 14.5 24.9 51.6 105.9

24 43.2 14.5 24.8 51.8 107.1

25 42.8

27

0

10

20

30

40

50

60

70

0 10 20 30 40 50 60

SR

M, m

g/m

3

CEM, mg/m3

Calibration Function for CEM - Component

SRM vs CEM data Linear (SRM vs CEM data)

Page 21 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

The variability is accepted if: Sd ≤ Qo x Kv

Where

Qo is the uncertainty laid down by the Authorities at the emission limit value as a 95% confidence interval.

Qo = Daily Emission Limit Value X Measurement Uncertainty

Where Daily Emission Limit = 400 mg/m³ Measurement Uncertainty = 20%

Kv = the test parameter (for 27 Pairs of Data is 0.9861)

Variability Pass Criteria

2 3.0 0.0 -3.0 1.1 1.2

3 2.1 0.0 -2.1 1.9 3.6

Oxides of Nitrogen - Data Used for the variability test

1 3.5 0.0 -3.5 0.5 0.3

not used

not used

not used

not used

not used

9 126.7 128.6 1.9 5.9 35.3

10 119.6 107.6 -12.0 -8.0 63.4

11 132.9 136.8 3.9 7.9 62.8

12 126.2 118.0 -8.2 -4.2 17.5

13 136.6 123.6 -13.0 -9.0 81.0

14 56.7 100.7 44.0 48.1 2308.8

15 107.4 103.0 -4.5 -0.4 0.2

16 107.9 105.6 -2.2 1.8 3.2

17 108.3 106.1 -2.2 1.8 3.4

18 107.0 104.6 -2.5 1.6 2.5

19 106.7 99.9 -6.8 -2.8 7.7

20 105.7 102.8 -2.9 1.1 1.3

21 105.9 104.4 -1.5 2.5 6.5

59.5

24 107.1 87.5 -19.5 -15.5 239.9

31 108.3 90.2 -18.1 -14.1 198.2

32 113.1 96.0 -17.2 -13.1 172.3

28 113.0 96.1 -16.9 -12.9 166.1

29 108.9 89.9 -19.0 -14.9 223.2

30 111.9 93.6 -18.3 -14.3

CEM HAS PASSED VARIABILITY TEST

204.5

25 106.5 111.1 4.6 8.6 74.8

26 123.7 103.5 -20.1 -16.1 259.0

27 55.4 92.7 37.3 41.3 1705.2

Sample

CEM Dry

and

corrected

for 11%

Oxygen

SRM

Corrected

Value*

y is

mg/m3

Difference

between

SRM and

CEM

Difference

(D - Dmean)

Square of

Difference

(D - Dmean)2


22 106.3 95.5 -10.8 -6.7 45.3

23 105.9 109.6 3.7 7.7

Oxides of Nitrogen - Variability Test

The next stage of the calibration process is to determine if the proposed calibration function passes the variability test.

Sd is the standard deviation of the differences between the SRM value at Reportable Conditions and the Calibrated CEM value at Reportable

Conditions.

1.96

15.12 < 40.25vD ks 0

Page 22 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

Plot of calibrated CEM data versus SRM data, dry and corrected to 11% oxygen

Valid Calibration Range is:

0 to 150.3 mg/m3

Oxides of Nitrogen - Plot 3 - Plot of calibrated CEM data versus SRM data

0

20

40

60

80

100

120

140

160

0 20 40 60 80 100 120 140 160

SR

M, m

g/m

3(D

ry a

nd

Co

rrecte

d f

or

Oxy

gen

)

CEM, mg/m3 (Calibration Function Applied, Dry and Corrected for Oxygen)

SRM concentrations vs Calibrated and Corrected CEM concentrations

SRM vs CEM Linear (SRM vs CEM)

Page 23 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

Oxides of Nitrogen - Valid range & range extension

0 to 286.4 mg/m3

Having passed the variability test the next stage of the process is to establish the valid range of the calibrated CEMs

values at reportable conditions. This is done by finding the maximum CEM value at reportable conditions from the

parallel testing pairs (not including linearity data) and then adding 10% to that value.

0 to 150.3 mg/m3

If after the parallel testing phase of the QAL 2 it was possible to derive a calibration function, but the function has

a limited valid range i.e. it does not extend to or beyond the emission limit value, then it may be possible to extend

the valid range of the function to which ever is the lowest of either the highest surrogate or the emission limit

value. To do this there has to be good agreement between the calibration function and the linearity data.

Good agreement is defined as when the two sets of data are overlain they lie within the allowable uncertainty at a 95%

confidence interval at the emission limit value for the parameter in question.

The allowable uncertainty at a 95% confidence interval at the emission limit value is calculated by applying the Qo

equation which is also used in the test of variability.

0.0

100.0

200.0

300.0

400.0

500.0

600.0

700.0

800.0

900.0

0 100 200 300 400 500 600 700 800 900

SR

M, m

g/m

3

Calibrated CEM, mg/m3

Range extension of calibration function based on linearity data

Min Max Linearity Data SRM v Cal'd CEM extrapolated data Linear (Linearity Data)

Page 24 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to




15.1

14.8

15.0

14.8

15.0

14.0

13.9

13.9

13.7

13.9

14.0

13.2

14.0

12.9

--

--

14.8

14.8

14.9

15.1

14.8

13.9

14.0

60.0

80.0

-7.1

-7.6

-8.2

-7.2

--

--

--

--

--

24.1

21.9

21.5

22.1

20.7

22.6

--

--

--

24.8

23.7

24.9

24.9

24.6

24.8

24.7

24.5

24.2

22.1

22.0

22.1

21.9

21.5

21.7

21.5

24.7

22.8

14.1

14.9

14.8

101.3

0.0

0.0

0.0 --

--

--

--

--

--

-7.0

-6.6

-5.1

-4.7

-4.5

-1.7

2.2

20.0

40.0

14.7

-11.2

-11.6

-8.5

-6.9

-6.7

-6.5

-14.0

24.9

24.8

24.8

21.6

18.3

23.0

23.4

23.3

23.6

--

--

--

--

--

--

--

22.1

--

22.4

22.3

22.2

22.0

19.0

24.4

24.6

24.8

24.9

25.0

25.0

25.0

24.9

--

--

--

--

--

--

--

--

15.3

15.0

15.2

15.1

15.2

11.2

14.5

14.5

14.5

14.5

14.4

14.4

14.4not used

not used

not used

not used

not used

not used

2

3

4

5

6

7

8

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

13/06/2013 10:35

not used

not used

14/06/2013 00:30

-0.5

-0.6

-0.6

-0.6

-0.6

-0.6

-0.5

11/06/2013 15:38

12/06/2013 11:50

12/06/2013 16:25

12/06/2013 19:00

12/06/2013 20:00

12/06/2013 21:00

12/06/2013 22:00

12/06/2013 23:00

13/06/2013 00:00

13/06/2013 01:00

13/06/2013 02:00

13/06/2013 03:00

13/06/2013 04:00

13/06/2013 05:00

13/06/2013 06:00

13/06/2013 07:00

0.6

100.9

80.7

61.1

43.0

22.9

1.5

13/06/2013 20:00

-0.613/06/2013 21:00

14.5

14.5

14.5

14.6

15.2

11.6

14.9

11/06/2013 13:10

15.0not used

not used

13/06/2013 20:30

13/06/2013 21:30

13/06/2013 22:30

13/06/2013 23:30

not used

-6.8

-6.7

23.4 -9.0

-10.5

-8.9

-7.5

not used

11/06/2013 12:40

11/06/2013 15:08

12/06/2013 11:20

12/06/2013 15:55

12/06/2013 18:30

12/06/2013 19:30

12/06/2013 20:30

12/06/2013 21:30

12/06/2013 22:30

12/06/2013 23:30

13/06/2013 00:30

13/06/2013 01:30

13/06/2013 02:30

13/06/2013 03:30

13/06/2013 04:30

13/06/2013 05:30

13/06/2013 06:30

13/06/2013 10:05

13/06/2013 19:30

-0.6

-0.7

-0.6

-0.6

13/06/2013 22:00

13/06/2013 23:00

14/06/2013 00:00

14/06/2013 01:00

14.7

15.0

Carbon Monoxide - Raw Monitoring Data

-0.5

-0.7

-0.1

-0.2

-0.3

-0.4

-0.6

-0.6

-0.6

-0.5

-0.6


CEM

Measured

Value

xi

mg/m3

CEM

Oxygen

%

CEM Water

%

SRM

Measured

Value

yi

mg/m3

SRM

Oxygen

%

SRM Water

%Sample Date and Time

1


Linearity Data

0.6

0.6

Page 25 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

1

2

13/06/2013 19:30

13/06/2013 20:30

-14.0

CEM Dry

and

corrected

for, 11%

Oxygen


Linearity Data

0.0

0.0

0.0

101.3

80.0

60.0

40.0

20.0

Carbon Monoxide - Standardised Monitoring Data

0.6

0.6

-15.113/06/2013 21:00

13/06/2013 21:30

13/06/2013 22:30

13/06/2013 23:30

14/06/2013 00:30

5

6

7

8

13/06/2013 07:00

13/06/2013 10:35

-0.6

-0.6

-0.8

-0.8

11/06/2013 13:1011/06/2013 12:40

11/06/2013 15:08

Carbon Monoxide - Plot 1 - Time series of data

-1.2

-1.2

-1.2

-1.2

-1.1

-1.1

-0.9

-1.4

-1.3-15.6

-19.1

-21.8

-19.3

4.7

-3.6

-9.4

-10.1

-10.5

-12.2

-22.2

-17.9

-26.9

0.6

100.9

80.7

61.1

43.0

22.9

3.5

-0.3

-1.2

-1.2

-1.1

-1.2

-1.1

-1.1

not used

not used

not used

not used

not used

not used

not used

not used

not used

13/06/2013 01:30

13/06/2013 02:30

13/06/2013 03:30

13/06/2013 04:30

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

3

4

-1.4

-1.4

-1.4

13/06/2013 22:00

13/06/2013 23:00

14/06/2013 00:00

14/06/2013 01:00

-15.113/06/2013 01:00

13/06/2013 02:00

13/06/2013 03:00

13/06/2013 04:00

13/06/2013 05:00

13/06/2013 06:00

13/06/2013 20:00

11/06/2013 15:38

12/06/2013 11:50

12/06/2013 16:25

-13.5

12/06/2013 19:00

12/06/2013 20:00

12/06/2013 21:00

12/06/2013 22:00


Sample Date and Time

SRM

Corrected

Value

y is

mg/m3

12/06/2013 11:20

12/06/2013 15:55

12/06/2013 18:30

12/06/2013 19:30

12/06/2013 20:30

12/06/2013 21:30

12/06/2013 22:30

12/06/2013 23:30

13/06/2013 00:30

-13.3

-12.7

-12.7

-13.6

12/06/2013 23:00

13/06/2013 00:00

13/06/2013 05:30

13/06/2013 06:30

13/06/2013 10:05

-14.3

-13.5

-14.4

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Difference

of SRM and

CEM

corrected

values

2.9

3.0

1.1

0.7

0.4

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

0.6

0.6

0.6

Difference

less than

half the

confidence

interval at

the ELV?

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

-30

-25

-20

-15

-10

-5

0

5

10

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Co

ncen

trati

on

(m

g/m

3)

Data Point

Comparison of SRM and CEM Standardised Data SRM CEM

Page 26 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

-6.6 No

-0.5 -8.2 -7.7 No

-0.6 -7.6 -7.0 No

not used




-5.33

3.56

Data Source

Surrogate Zero's

Linearity Data

Parallel test data

0.6

0.6

0

0

-0.60

-0.60

No

No0.6 0 -0.60 No

100.87 101.3 0.43 No

80.73 80 -0.73 No

61.13 60 -1.13 No

Sample

1

23

4

5

6

78

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used



free.

not used

not used

not used

not used

not used

Outlier test data

not used

not used

42.97 40 -2.97 No22.9 20 -2.90 No

1.5 2.2 0.7 No

-0.1 -1.7 -1.6 No

-0.2 -4.5 -4.2 No

-0.3 -4.7 -4.4 No

-0.4 -5.1 -4.7 No

-0.6 -6.6 -6.0 No

-0.6 -7.0 -6.4 No

-0.6 -6.7 -6.1 No

-0.5 -6.8 -6.2 No

-0.6 -7.2

CEM at

measured

conditions

SRM at CEMs

Measuring

conditions


or No)

Lower limit at 2 SD

1.79

-12.45

-0.5 -14.0 -13.4 No

-0.5 -6.5 -6.0 No

-0.7 -6.7 -6.0 No

-0.6 -6.9 -6.3 No

-0.6 -7.5 -6.9 No

-0.7 -8.9 -8.2 No

-0.6 -10.5 -9.8 No-0.6 -9.0

Carbon Monoxide - Application of the Calibration Function & Outlier Test






-8.4 No

Upper limit at 2 SD

-0.6 -7.1 -6.6 No

-0.6 -8.5 -7.9 No

-0.6 -11.6 -11.0 No

-0.6 -11.2 -10.6 No

-16

-14

-12

-10

-8

-6

-4

-2

0

2

4

0 1 2 3 4 5 6 7 8 9

Co

ncen

trati

on

(m

g/m

3)

Data Point


Outlier point Upper 2 x SD Lower 2 x SD Valid point

Page 27 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34


















Minimum SRM Value = -26.9 mg/m³


Since 4.7 < 10 (20% of ELV) , then Method C is used to calculate the calibration function.

Carbon Monoxide - Application of the Calibration Function & Outlier Test






Page 28 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

The calibration function is calculated based on linearity data.

Method A Method B

where: where:


Calibrated Value CO = 1.007 X (CEM reading) -1.402

-0.6

-0.6

-0.6

-0.6

-0.6

-0.5

-0.5

-0.7

-0.6

-6.7

-6.9

-7.5

-8.9

-10.5

-9.0

Carbon Monoxide - The Calibration Function

not used

not used

-0.5

-0.6

-0.5

-7.2

-8.2

-7.6

-0.6

-8.5

-11.6

-11.2

-14.0

-6.5

13/06/2013 21:00

13/06/2013 22:00

13/06/2013 23:00

14/06/2013 00:00

14/06/2013 01:00

0.0

0.0

101.3

80.0

60.0

40.0

20.0

-6.7

-6.8

13/06/2013 00:00

13/06/2013 01:00

61.1

13/06/2013 20:00

-0.7

-0.6

-0.6

0.0 0.6

not used

not used

not used

not used

not used

11/06/2013 12:40

12/06/2013 23:30

13/06/2013 00:30

13/06/2013 01:30

13/06/2013 02:30

13/06/2013 03:30

13/06/2013 04:30

13/06/2013 05:30

13/06/2013 06:30

13/06/2013 10:05

13/06/2013 19:30

13/06/2013 20:30

13/06/2013 21:30

13/06/2013 22:30

13/06/2013 23:30

14/06/2013 00:30

not used

not used

not used

not used

not used

not used

not used

not used

not used

12/06/2013 21:30

12/06/2013 22:30

7

8

not used

not used


Linearity Data

1

2

3

4

5

6

11/06/2013 15:08

12/06/2013 11:20

12/06/2013 15:55

12/06/2013 18:30

12/06/2013 19:30

12/06/2013 20:30

-0.1

0.6

0.6

100.9

80.7

43.0

-0.2

-0.3

-0.4

-0.6

-0.6

-0.6

13/06/2013 07:00

13/06/2013 10:35

11/06/2013 13:10

-7.1

22.9

1.5

11/06/2013 15:38

12/06/2013 11:50

12/06/2013 16:25

12/06/2013 19:00

12/06/2013 20:00

12/06/2013 21:00

12/06/2013 22:00

12/06/2013 23:00

not used

13/06/2013 02:00

13/06/2013 03:00

13/06/2013 04:00

13/06/2013 05:00

13/06/2013 06:00

2.2

-1.7

-4.5

-4.7

-5.1

-6.6

-7.0

Carbon Monoxide - Data used to determine the calibration function

not used

not used

not used

not used

not used

Date and TimeSample

SRM at

CEM

conditions

yi

mg/m3

CEM

Measured

Value

xi

mg/m3

Xi - Xav Yi - Yav

(Xi - Xav)*


2

-38.20

-38.20

-38.20

62.07

41.93


-37.66

-37.66

-37.66

63.64

42.34

22.34

2.34

-17.66

22.33

4.17

-15.90 280.83

9.74

498.87

1775.35

3949.77

1438.71

1438.71

1438.71

1459.24

1459.24

1459.24

3852.27

1758.40

498.78

17.36

252.81

Zx

yb

ˆ

Zba ˆˆ

axby ˆˆ axby ˆˆ

n

i

n

i

XXi

YYiXXi

b

1

2

1

)(

))((ˆ

XbYa ˆ

Page 29 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34


Calibrated Value CO = 1.007 X (CEM reading) -1.402

Carbon Monoxide - Plot 2 - Plot of CEM data versus SRM data

14.4

14.5

15.0

24.8

21.6

18.3

23.3

23.6

23.4

-0.8

-0.8

100.2

79.9

60.1

41.9

21.7

23.0

23.4

--

--

--

--

--

--

--

22.1

22.4

22.3

22.2

22.0

19.0

24.4

-0.6not used

not used

not used

-0.6

-0.5

-0.5

-0.7

-0.6

-0.6

-0.7

-0.6

5


0.6

0.6

100.9

80.7

61.1

43.0

22.9

1.5

-0.1

-0.2

-0.3

-0.4

-0.6

-0.6

-0.6

-0.5

-0.6

-0.5

-0.6

-0.6

-0.6

14.7

11.2

14.5

14.5

14.5

14.5

14.4

14.4

-0.6not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

-0.8

-0.8

100.2

79.9

60.1

41.9

21.7

not used

not used

6

7

8

not used

not used

not used

not used

not used

1 0.6 -- -- -0.8 -0.8

2

3

4

--

--

--

--

--

--

--

15.3

15.0

15.2

15.1

15.2

24.6

24.8

24.9

25.0

25.0

25.0

24.9

24.9

24.8

14.5

14.5

14.6

15.2

11.6

14.9

14.7

15.0

Sample

CEM

Measured

Value

xi

mg/m3

CEM

Oxygen

% (Dry)

CEM Water

%

CEM

Calibrated

Value

ŷi

mg/m3

Calibrated

CEM

Corrected

to

Reference

conditions

Carbon Monoxide - Calculation of calibrated CEM values

0

20

40

60

80

100

120

0 20 40 60 80 100 120

SR

M, m

g/m

3

CEM, mg/m3



Page 30 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34


Where






Carbon Monoxide - Data Used for the variability test

SRM

Corrected

Value*

y is

mg/m3

Difference

between

SRM and

CEM

Difference

(D - Dmean)

Square of

Difference

(D - Dmean)2


1

2

3

4

5

6

7

8

not used

not used

not used

not used

not used

not used

CEM Dry

and

corrected

for 11%

Oxygen

-0.8

-0.8

100.2

79.9

60.1

41.9

21.7

3.5

2.7

not used

not used

not used

not used

-0.8 0.0 0.8 0.8 0.6

not used

not used

not used

not used

not used

not used

0.0

101.3

80.0

60.0

40.0

20.0

0.0

1.3

0.0

0.0

Sample

not used

not used

not used

not used

not used

not used

0.8

0.8

1.1

0.1

-0.1

-1.9

-1.7

0.8

0.8

1.1

0.1

-0.1

-1.9

-1.7

0.6

0.6

Carbon Monoxide - Variability Test



Conditions.

1.96

1.16 < 4.86


not used

not used

vD ks 0

Page 31 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34



0 to 5.2 mg/m3

Carbon Monoxide - Plot 3 - Plot of calibrated CEM data versus SRM data

0

20

40

60

80

100

120

-20 0 20 40 60 80 100 120

SR

M, m

g/m

3(D

ry a

nd

Co

rrecte

d f

or

Oxy

gen

)




Page 32 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:34




0 to 5.2 mg/m3

0 to 50 mg/m3

Carbon Monoxide - Valid range & range extension









On this occasion, Method C has been used meaning the calibration function has been derived from linearity data,

therefore the extended range is quoted as the ELV (If surogate values exceeded the ELV)

0.0

20.0

40.0

60.0

80.0

100.0

120.0

-20.0 0.0 20.0 40.0 60.0 80.0 100.0 120.0

SR

M, m

g/m

3




Page 33 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to




--0.0 ------

11/06/2013 13:1011/06/2013 12:40

1


Linearity Data

0.1

not used 14/06/2013 00:30 14/06/2013 01:00 -0.7 15.0 23.4 3.6 15.0 22.1

not used 13/06/2013 22:30 13/06/2013 23:00 -0.7 15.0 23.3 3.6 15.0 22.1

not used 13/06/2013 23:30 14/06/2013 00:00 -0.7 14.7 23.6 3.7 14.8 22.0

not used 13/06/2013 20:30 13/06/2013 21:00 -0.7 14.9 23.0 3.2 15.1 21.5

not used 13/06/2013 21:30 13/06/2013 22:00 -0.7 14.7 23.4 3.8 14.8 21.9

not used 13/06/2013 10:05 13/06/2013 10:35 -0.7 15.2 21.6 2.5 14.9 21.5

not used 13/06/2013 19:30 13/06/2013 20:00 -0.6 11.6 18.3 3.3 14.8 21.7

not used 13/06/2013 05:30 13/06/2013 06:00 -0.7 14.5 24.8 5.3 12.9 22.8

not used 13/06/2013 06:30 13/06/2013 07:00 -0.7 14.6 24.8 3.7 14.1 24.7

not used 13/06/2013 03:30 13/06/2013 04:00 -0.7 14.5 24.9 3.8 13.2 23.7

not used 13/06/2013 04:30 13/06/2013 05:00 -0.7 14.5 24.9 3.3 14.0 24.8

not used 13/06/2013 01:30 13/06/2013 02:00 -0.7 14.4 25.0 2.7 13.9 24.9

not used 13/06/2013 02:30 13/06/2013 03:00 -0.7 14.4 25.0 2.2 14.0 24.9

not used 12/06/2013 23:30 13/06/2013 00:00 -0.7 14.5 24.9 1.8 13.9 24.8

not used 13/06/2013 00:30 13/06/2013 01:00 -0.7 14.4 25.0 4.2 13.7 24.6

not used 12/06/2013 21:30 12/06/2013 22:00 -0.7 14.5 24.6 1.2 14.0 24.5

not used 12/06/2013 22:30 12/06/2013 23:00 -0.6 14.5 24.8 1.6 13.9 24.7

not used 12/06/2013 19:30 12/06/2013 20:00 -0.6 11.2 19.0 2.3 13.9 24.1

not used 12/06/2013 20:30 12/06/2013 21:00 -0.7 14.5 24.4 2.1 14.0 24.2

not used 12/06/2013 15:55 12/06/2013 16:25 -0.7 15.1 22.2 4.5 15.1 21.5

not used 12/06/2013 18:30 12/06/2013 19:00 -0.7 15.2 22.0 4.2 14.8 21.9

22.1 2.6 14.8 22.6

not used 11/06/2013 15:08 11/06/2013 15:38 -0.7 15.0 22.4 3.7 14.8 20.7

not used 12/06/2013 11:20 12/06/2013 11:50 -0.7 15.2 22.3 4.2 14.9 22.1

58.3 -- -- 60.0 -- --

7 38.4 -- -- 40.0 -- --

8 18.1 -- -- 20.0 -- --

not used -0.7 15.3

2 0.1 -- -- 0.0 -- --

3 0.1 -- -- 0.0 -- --

4 99.0 -- -- 100.0 -- --

5 79.3 -- -- 80.0 -- --

6

Sulphur Dioxide - Raw Monitoring Data


CEM

Measured

Value

xi

mg/m3

CEM

Oxygen

%

CEM Water

%

SRM

Measured

Value

yi

mg/m3

SRM

Oxygen

%

SRM Water


Page 34 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

not used 13/06/2013 23:30 14/06/2013 00:00 7.8 -1.5

not used 14/06/2013 00:30 14/06/2013 01:00 7.8 -1.5

not used 13/06/2013 19:30 13/06/2013 20:00 7.0 -0.8

not used 13/06/2013 20:30 13/06/2013 21:00 6.9 -1.5

not used 13/06/2013 21:30 13/06/2013 22:00 7.9 -1.5

not used 13/06/2013 22:30 13/06/2013 23:00 7.7 -1.5

not used 13/06/2013 04:30 13/06/2013 05:00 6.4 -1.4

not used 13/06/2013 05:30 13/06/2013 06:00 8.4 -1.4

not used 13/06/2013 06:30

Sulphur Dioxide - Standardised Monitoring Data

Sulphur Dioxide - Plot 1 - Time series of data

0.1

13/06/2013 07:00 7.1 -1.4

not used 13/06/2013 10:05 13/06/2013 10:35 5.3 -1.5

not used 13/06/2013 00:30 13/06/2013 01:00 7.7 -1.4

not used 13/06/2013 01:30 13/06/2013 02:00 5.1 -1.3

not used 13/06/2013 02:30 13/06/2013 03:00 4.2 -1.3

not used 13/06/2013 03:30 13/06/2013 04:00 6.4 -1.4

not used 12/06/2013 20:30 12/06/2013 21:00 4.0 -1.4

not used 12/06/2013 21:30 12/06/2013 22:00 2.2 -1.4

not used 12/06/2013 22:30 12/06/2013 23:00 3.1 -1.3

not used 12/06/2013 23:30 13/06/2013 00:00 3.4 -1.4

not used 12/06/2013 11:20 12/06/2013 11:50 8.9 -1.6

not used 12/06/2013 15:55 12/06/2013 16:25 9.7 -1.5

not used 12/06/2013 18:30 12/06/2013 19:00 8.6 -1.5

not used 12/06/2013 19:30 12/06/2013 20:00 4.3 -0.8

5 80.0 79.3

6 60.0 58.3

7 40.0 38.4

8 20.0 18.1

not used 5.4 -1.6

not used 11/06/2013 15:08 11/06/2013 15:38 7.6 -1.5

11/06/2013 13:1011/06/2013 12:40

Linearity Data

2 0.0 0.1

3 0.0 0.1

4 100.0 99.0

0.0


SRM

Corrected

Value

y is

mg/m3

CEM Dry

and

corrected

for, 11%

Oxygen


1

Difference

of SRM and

CEM

corrected

values

Difference

less than

half the

confidence

interval at

the ELV?


1.9

1.6

1.7

0.7

1.0

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

0.1

0.1

0.1 Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

-4

-2

0

2

4

6

8

10

12

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Co

ncen

trati

on

(m

g/m

3)

Data Point


SRM CEM

Page 35 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35




3.12

1.67

Data Source

Surrogate Zero's

Linearity Data

Parallel test data

0.1

0.1

0

0

-0.10

-0.10

No

No0.1 0 -0.10 No

99.03 100 0.97 No

79.33 80 0.67 No

58.3 60 1.70 No

5

6

78

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

CEM at

measured

conditions

SRM at CEMs

Measuring

conditions

-0.7 3.3 4.0 No

-0.7 5.3 6.0 No

38.43 40 1.57 No18.1 20 1.90 No

-0.7 2.6 3.3 No

-0.7 3.7 4.4 No

-0.7 4.2 4.9 No

-0.7 4.5 5.2 No

-0.7 4.2 4.8 No

-0.6 2.3 2.9 No

-0.7 2.1 2.8 No

1.6 2.3 No

-0.7 1.8 2.5 No

-0.7 4.2 4.9 No

-0.7 2.7 3.3 No

-0.7 2.2 2.9 No

-0.7 3.8 4.5

Outlier test data


or No)

No

Sample

1



free.

Sulphur Dioxide - Application of the Calibration Function & Outlier Test






Lower limit at 2 SD

6.46

-0.21

-0.7 3.7 4.4 No

-0.7 2.5 3.2 No

-0.6 3.3 4.0 No

-0.7 3.2 3.9 No

-0.7 3.8 4.5 No

-0.7 3.6 4.3 No

-0.7 3.7

23

4

4.4 No

-0.7 3.6 4.3 No

Upper limit at 2 SD

-0.7 1.2 1.8 No

-0.6

-1

0

1

2

3

4

5

6

7

0 1 2 3 4 5 6 7 8 9

Co

ncen

trati

on

(m

g/m

3)

Data Point



Page 36 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35















Since 9.7 < 10 (20% of ELV) , then Method C is used to calculate the calibration function.











Sulphur Dioxide - Calibration Function Method

Page 37 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to


Method A Method B

where: where:


1

not used 13/06/2013 23:30 14/06/2013 00:00 3.7 -0.7

not used 14/06/2013 00:30 14/06/2013 01:00 3.6 -0.7

Calibrated Value SO2 = 1.01 X (CEM reading) + 0.451

not used 13/06/2013 19:30 13/06/2013 20:00 3.3 -0.6

not used 13/06/2013 20:30 13/06/2013 21:00 3.2 -0.7

not used 13/06/2013 21:30 13/06/2013 22:00 3.8 -0.7

not used 13/06/2013 22:30 13/06/2013 23:00 3.6 -0.7

Sulphur Dioxide - The Calibration Function

not used 13/06/2013 04:30 13/06/2013 05:00 3.3 -0.7

not used 13/06/2013 05:30 13/06/2013 06:00 5.3 -0.7

not used 13/06/2013 06:30 13/06/2013 07:00 3.7 -0.7

not used 13/06/2013 10:05 13/06/2013 10:35 2.5 -0.7

not used 13/06/2013 00:30 13/06/2013 01:00 4.2 -0.7

not used 13/06/2013 01:30 13/06/2013 02:00 2.7 -0.7

not used 13/06/2013 02:30 13/06/2013 03:00 2.2 -0.7

not used 13/06/2013 03:30 13/06/2013 04:00 3.8 -0.7

not used 12/06/2013 20:30 12/06/2013 21:00 2.1 -0.7

not used 12/06/2013 21:30 12/06/2013 22:00 1.2 -0.7

not used 12/06/2013 22:30 12/06/2013 23:00 1.6 -0.6

not used 12/06/2013 23:30 13/06/2013 00:00 1.8 -0.7

not used 12/06/2013 11:20 12/06/2013 11:50 4.2 -0.7

not used 12/06/2013 15:55 12/06/2013 16:25 4.5 -0.7

not used 12/06/2013 18:30 12/06/2013 19:00 4.2 -0.7

not used 12/06/2013 19:30 12/06/2013 20:00 2.3 -0.6

5 80.0 79.3

6 60.0 58.3

7 40.0 38.4

8 20.0 18.1

not used 2.6 -0.7

not used 11/06/2013 15:08 11/06/2013 15:38 3.7 -0.7

11/06/2013 13:1011/06/2013 12:40

Linearity Data

2 0.0 0.1

3 0.0 0.1

4 100.0 99.0

0.0 0.1

Date and Time


Sample

SRM at

CEM

conditions

yi

mg/m3

CEM

Measured

Value

xi

mg/m3

Sulphur Dioxide - Data used to determine the calibration function

325.28

4.36

486.28

1812.45

3896.61

1372.03

1372.03

1372.03

1338.65

1338.65

1338.65

3887.00

1818.67

467.10

3.05

345.50

Xi - Xav Yi - Yav

(Xi - Xav)*


2

-36.59

-36.59

-36.59

62.35

42.65

21.61

1.75

-18.59


-37.50

-37.50

-37.50

62.50

42.50

22.50

2.50

-17.50

Zx

yb

ˆ

Zba ˆˆ

axby ˆˆ axby ˆˆ

n

i

n

i

XXi

YYiXXi

b

1

2

1

)(

))((ˆ

XbYa ˆ

Page 38 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

The R2 value for this calibration function is 1

Calibrated Value SO2 = 1.01 X (CEM reading) + 0.451

CEM

Measured

Value

xi

mg/m3

Sulphur Dioxide - Calculation of calibrated CEM values

Sulphur Dioxide - Plot 2 - Plot of CEM data versus SRM data

not used -0.7 14.7 23.6

not used -0.7 15.0 23.4

23.4

not used -0.7 15.0 23.3

not used -0.7 14.6 24.8

not used -0.7 15.2 21.6

not used -0.6 11.6 18.3

not used -0.7 14.7

not used -0.7 14.5 24.9

not used -0.7 14.5 24.9

not used -0.7 14.5 24.8

not used -0.7 14.9 23.0

not used -0.7 14.4 25.0

not used -0.7 14.4 25.0

not used -0.7 14.4 25.0

not used -0.7 14.5 24.6

not used -0.6 14.5 24.8

not used -0.7 14.5 24.9

not used -0.7 15.2 22.0

not used -0.6 11.2 19.0

not used -0.7 14.5 24.4

not used -0.7 15.0 22.4

not used -0.7 15.2 22.3

not used -0.7 15.1 22.2

7 38.4 -- -- 39.3 39.3

8 18.1 -- -- 18.7 18.7

not used -0.7 15.3 22.1

4 99.0 -- -- 100.5 100.5

5 79.3 -- -- 80.6 80.6

6 58.3 -- -- 59.3 59.3

2 0.1 -- -- 0.6 0.6

3 0.1 -- -- 0.6 0.6


1 0.1 -- -- 0.6 0.6

Sample

CEM

Oxygen

% (Dry)

CEM Water

%

CEM

Calibrated

Value

ŷi

mg/m3

Calibrated

CEM

Corrected

to

Reference

conditions

0

20

40

60

80

100

120

0 20 40 60 80 100 120

SR

M, m

g/m

3

CEM, mg/m3



Page 39 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35


Where






Sulphur Dioxide - Data Used for the variability test

not used

not used

not used

not used

not used

not used

0.76 < 4.86

Sulphur Dioxide - Variability Test



Conditions.

not used

not used

not used

not used

not used

not used


not used

1.96

not used

not used

not used

not used

not used

not used

not used

not used

not used

7 39.3 40.0 0.7 0.7 0.5

8 18.7 20.0 1.3 1.3 1.6

not used

4 100.5 100.0 -0.5 -0.5 0.2

5 80.6 80.0 -0.6 -0.6 0.3

6 59.3 60.0 0.7 0.7 0.5

2 0.6 0.0 -0.6 -0.6 0.3

3 0.6 0.0 -0.6 -0.6 0.3

1 0.6 0.0 -0.6 -0.6 0.3

Sample

CEM Dry

and

corrected

for 11%

Oxygen

SRM

Corrected

Value*

y is

mg/m3

Difference

between

SRM and

CEM

Difference

(D - Dmean)

Square of

Difference

(D - Dmean)2


not used

vD ks 0

Page 40 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35



0 to 10.7 mg/m3

Sulphur Dioxide - Plot 3 - Plot of calibrated CEM data versus SRM data

0

20

40

60

80

100

120

0 20 40 60 80 100 120

SR

M, m

g/m

3(D

ry a

nd

Co

rrecte

d f

or

Oxy

gen

)




Page 41 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

0 to 50 mg/m3

0 to 10.7 mg/m3

Sulphur Dioxide - Valid range & range extension














0.0

20.0

40.0

60.0

80.0

100.0

120.0

0.0 20.0 40.0 60.0 80.0 100.0 120.0

SR

M, m

g/m

3




Page 42 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to




--

--

--

--

--

--

--

22.1

--

11/06/2013 15:38

0.0

0.9

0.8

0.9

0.8

0.7

14.5

14.5

14.5

14.4

14.4

14.4

14.7

15.0-0.1

11/06/2013 12:40

11/06/2013 15:08

12/06/2013 11:20

12/06/2013 15:55

13/06/2013 22:30

13/06/2013 23:30

11/06/2013 13:10

not used

not used

23.4

23.3

23.6

15.0

--

--

--

15.3

not used 13/06/2013 22:00

13/06/2013 23:00

14/06/2013 00:00

2.9

12/06/2013 20:00

12/06/2013 21:00

12/06/2013 22:00

13/06/2013 21:00

25.0

25.0

24.9

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

14/06/2013 01:00

13/06/2013 06:00

13/06/2013 07:00

13/06/2013 10:35

14/06/2013 00:30not used

15.0

15.2

15.1

15.2

11.2

14.5

0.0

0.0

0.0 --

--

--

--

--

--

--

--

--

--

2

3

4

5

6

7

8

12/06/2013 11:50

-0.1

-0.1

-0.1

12/06/2013 23:00

13/06/2013 00:00

13/06/2013 01:00

13/06/2013 02:00

13/06/2013 03:00

13/06/2013 04:00

13/06/2013 05:00

22.2

22.0

19.0

24.4

24.6

24.8

24.9

25.0

12/06/2013 23:30

13/06/2013 00:30

13/06/2013 01:30

13/06/2013 02:30

13/06/2013 03:30

13/06/2013 04:30

13/06/2013 05:30

13/06/2013 06:30

13/06/2013 10:05

13/06/2013 19:30

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

14.5

14.5

14.5

14.6

15.2

14.7

13/06/2013 20:30

13/06/2013 21:30

8.0

22.8

14.1

1.0

0.8

0.7

0.9

0.8

0.8

0.8

0.9

0.8

23.4

Hydrogen Chloride - Raw Monitoring Data

-0.1

0.0

-0.1

-0.2

-0.2

-0.2

-0.1

-0.1

-0.1

-0.1

-0.1


CEM

Measured

Value

xi

mg/m3

CEM

Oxygen

%

CEM Water

%

SRM

Measured

Value

yi

mg/m3

SRM

Oxygen

%

SRM Water


1


Linearity Data

0.1

0.1

0.1

16.7

13.4

9.6

6.1

13/06/2013 20:00

-0.1

12/06/2013 16:25

12/06/2013 19:00

0.7

0.9

0.9

24.9

24.8

24.8

21.6

18.3

23.0

--

--

--

--

--

16.0

20.0

12/06/2013 18:30

12/06/2013 19:30

12/06/2013 20:30

12/06/2013 21:30

12/06/2013 22:30

24.1

21.9

21.5

22.1

20.7

22.6

--

--

--

24.8

23.7

24.9

24.9

24.6

24.8

24.7

24.5

24.2

22.1

22.0

22.1

21.9

21.5

21.7

21.5

24.7

--

--

14.8

14.8

14.9

15.1

14.8

13.9

14.0

12.0 --

0.9

0.9

0.8

0.6

0.8

0.9

1.0

4.0

14.8

15.1

14.8

15.0

14.8

15.0

14.0

13.9

13.9

13.7

13.9

14.0

13.2

14.0

12.9

14.9

22.4

22.3

11.6

14.9

Page 43 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to -0.214/06/2013 01:00

0.0

0.0

0.0

20.0

16.0

12.0

8.0

4.0

2.0

1.9

1.6

1.4

1.7

1.7

not used

not used

not used

not used

not used

not used

not used

not used

not used

13/06/2013 05:30

13/06/2013 22:00

13/06/2013 23:00

14/06/2013 00:00

Hydrogen Chloride - Plot 1 - Time series of data

-0.2

-0.2

-0.2

-0.2

-0.2

-0.3

0.0

-0.2

-0.21.6

1.9

1.7

1.9

0.1

0.1

0.1

16.7

13.4

9.6

6.1

2.9

-0.1

-0.2

-0.2

-0.2

-0.2

-0.2

-0.2

13/06/2013 19:30

13/06/2013 20:30

1.5

1.413/06/2013 21:00

13/06/2013 21:30

13/06/2013 22:30

13/06/2013 23:30

14/06/2013 00:30

not used

not used

3

4

5

6

7

8

-0.4

-0.4

-0.4

-0.2

11/06/2013 13:1011/06/2013 12:40not used

13/06/2013 06:30

13/06/2013 10:05

-0.3

not used

not used

not used

not used

1.6

Difference

of SRM and

CEM

corrected

values

1.1

1.9

2.4

2.6

3.3

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A


not used

not used


SRM

Corrected

Value

y is

mg/m3

CEM Dry

and

corrected

for, 11%

Oxygen


Linearity Data

1

2

-0.2

-0.2not used

1.7

1.6

Hydrogen Chloride - Standardised Monitoring Data

1.5

1.513/06/2013 01:00

13/06/2013 02:00

13/06/2013 03:00

13/06/2013 04:00

13/06/2013 05:00

13/06/2013 06:00

13/06/2013 20:00

11/06/2013 15:38

12/06/2013 11:50

12/06/2013 16:25

12/06/2013 19:00

12/06/2013 20:00

12/06/2013 21:00

12/06/2013 22:00

12/06/2013 23:00

13/06/2013 00:00

Difference

less than

half the

confidence

interval at

the ELV?

Yes

Yes

Yes

No

No

No

Yes

Yes

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

1.5

1.6

1.3

1.6

1.5

1.8

1.9

13/06/2013 07:00

13/06/2013 10:35

11/06/2013 15:08

12/06/2013 11:20

12/06/2013 15:55

12/06/2013 18:30

12/06/2013 19:30

12/06/2013 20:30

12/06/2013 21:30

12/06/2013 22:30

12/06/2013 23:30

13/06/2013 00:30

13/06/2013 01:30

13/06/2013 02:30

13/06/2013 03:30

13/06/2013 04:30

not used

not used

not used

not used

not used

N/A

0.1

0.1

0.1

-1.0

-0.5

0.0

0.5

1.0

1.5

2.0

2.5

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Co

ncen

trati

on

(m

g/m

3)

Data Point


Page 44 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35



free.

not used

CEM at

measured

conditions

SRM at CEMs

Measuring

conditions

Difference

12 2.40 No

No

-0.1 1.0 1.1 No

Sample

1

23

4

5

6

78

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

No

-0.1 0.7 0.9 No

-0.1 0.8

0.9 1.1 No

-0.1 0.9 1.0 No

-0.1 0.8 0.9 No

-0.1 0.9 1.0 No

-0.1 0.8 0.9 No

-0.1 0.8 0.9 No

-0.1

2.40

-0.30

-0.1 0.9 1.0 No

-0.1 0.9 1.1 No

0.0 0.7 0.7 No

-0.1 0.7 0.8 No

-0.1 0.8 0.9 No

-0.1 0.9 1.0 No

-0.1 0.8 0.9 No

-0.1 0.9 1.0 No

Upper limit at 2 SD




1.05

0.67

not used

not used

Parallel test data

not used

not used

not used

not used

not used

0.8 0.9 No

Lower limit at 2 SD

Outlier (Yes

or No)Data Source

-0.1 0.9 1.0

Surrogate Zero's

Linearity Data

0.06

0.06

0

0

-0.06

-0.06

No

No0.06 0 -0.06 No

16.73 20 3.27 No

13.38333333 16 2.62 No

9.603333333

0.9

Outlier test data

6.13 8 1.87 No2.946666667 4 1.05 No

0.0 1.0 1.0 No

-0.1 0.9 1.0 No

-0.2 0.8 0.9 No

-0.2 0.6 0.8 No

-0.2 0.8 1.0 No

-0.1

Hydrogen Chloride - Application of the Calibration Function & Outlier Test






-0.5

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

0 1 2 3 4 5 6 7 8 9

Co

ncen

trati

on

(m

g/m

3)

Data Point



Page 45 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35



Hydrogen Chloride - Calibration Function Method


Since 2 < 4 (40% of ELV) , then Method C is used to calculate the calibration function.




















Maximum SRM Value = 2 mg/m³


Page 46 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to


Method A Method B

where: where:


Hydrogen Chloride - Data used to determine the calibration function

Hydrogen Chloride - The Calibration Function

Date and Time


Linearity Data

Sample

SRM at

CEM

conditions

yi

mg/m3

CEM

Measured

Value

xi

mg/m3

1

2

3

4

5

6

11/06/2013 15:08

12/06/2013 11:20

12/06/2013 15:55

12/06/2013 18:30

12/06/2013 19:30

12/06/2013 20:30

-0.1

0.0 0.1

0.0

0.0

20.0

16.0

12.0

8.0

4.0

1.0

0.9

0.8

7

8

not used

not used

not used

not used

3.48

0.01

not used

not used

not used

not used

not used

not used

not used

not used

11/06/2013 12:40

12/06/2013 23:30

13/06/2013 00:30

13/06/2013 01:30

13/06/2013 02:30

13/06/2013 03:30

13/06/2013 04:30

13/06/2013 05:30

13/06/2013 06:30

13/06/2013 10:05

13/06/2013 19:30

13/06/2013 20:30

13/06/2013 21:30

13/06/2013 22:30

13/06/2013 23:30

14/06/2013 00:30

not used

not used

not used

not used

not used

not used

not used

not used

not used

12/06/2013 21:30

12/06/2013 22:30

11/06/2013 15:38

12/06/2013 11:50

12/06/2013 16:25

12/06/2013 19:00

12/06/2013 20:00

12/06/2013 21:00

12/06/2013 22:00

12/06/2013 23:00

not used

13/06/2013 02:00

13/06/2013 03:00

13/06/2013 04:00

13/06/2013 05:00

13/06/2013 06:00

13/06/2013 20:00

not used

not used

13/06/2013 21:00

13/06/2013 22:00

13/06/2013 23:00

14/06/2013 00:00

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

0.0

-0.1

0.7

0.7

0.8

0.9

0.8

0.9

0.1

0.1

16.7

13.4

6.1

0.9

0.8

0.9

13/06/2013 00:00

13/06/2013 01:00

9.6

13/06/2013 07:00

13/06/2013 10:35

11/06/2013 13:10

0.9

2.9

0.0

-0.2

-0.2

-0.2

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

0.8

0.8

0.8

-0.1

0.7

0.8

1.0

0.9

0.9

-0.1

-0.1

0.6

0.8

0.9

-6.06

10.61

7.26

14/06/2013 01:00

Calibrated Value HCl = 1.479 X (CEM reading) -1.553

Xi - Xav Yi - Yav

(Xi - Xav)*


2

-6.06

-6.06


36.74

36.74

36.74

112.54

52.73

12.12

0.00

10.08

-7.50

-7.50

-7.50

12.50

8.50

4.50

0.50

-3.50

0.00

15.67

61.72

132.60

45.46

45.46

45.46

-3.18 11.11

Zx

yb

ˆ

Zba ˆˆ

axby ˆˆ axby ˆˆ

n

i

n

i

XXi

YYiXXi

b

1

2

1

)(

))((ˆ

XbYa ˆ

Page 47 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35


Calibrated Value HCl = 1.479 X (CEM reading) -1.553

Hydrogen Chloride - Calculation of calibrated CEM values

Hydrogen Chloride - Plot 2 - Plot of CEM data versus SRM data

CEM

Calibrated

Value

ŷi

mg/m3

Calibrated

CEM

Corrected

to

Reference

conditions

5

6

7

8

not used

not used

not used

1 0.1 -- -- -1.5 -1.5

2

3

4

--

--

--

--

--

--

--

15.3

15.0

15.2

15.1

15.2

-0.1not used

not used

not used

not used

not used

not used

22.0

19.0

24.4

24.6

24.8

24.9

25.0

25.0

25.0

24.9

24.9

24.8

14.5

14.5

14.6

15.2

11.6

14.9

--

22.1

22.4

22.3

22.2

not used

not used

Sample

CEM

Measured

Value

xi

mg/m3

CEM

Oxygen

% (Dry)

CEM Water

%

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

-0.1

-0.1

-0.1

0.0

-0.1

-0.1

-0.1

-0.1

-0.1not used


0.1

0.1

16.7

13.4

9.6

6.1

2.9

0.0

-0.1

-0.2

-0.2

-0.2

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

-0.1

14.7

11.2

14.5

14.5

14.5

14.5

14.4

14.4

15.0

--

--

--

--

--

--

23.3

23.6

23.4

-1.5

-1.5

23.2

18.2

12.6

7.5

2.8

23.0

23.4

14.4

14.5

-1.5

-1.5

23.2

18.2

12.6

7.5

2.8

24.8

21.6

18.3

not used

not used

14.7

15.0

0.0

5.0

10.0

15.0

20.0

25.0

0 2 4 6 8 10 12 14 16 18

SR

M, m

g/m

3

CEM, mg/m3



Page 48 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35


Where






Hydrogen Chloride - Data Used for the variability test

Hydrogen Chloride - Variability Test



Conditions.

1.96

1.84 < 1.94


not used

not used

not used

not used

not used

not used

not used

not used

2.1

10.2

5.0

0.4

0.2

1.4

0.5

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

0.0

0.0

20.0

16.0

12.0

8.0

4.0

-2.2

-0.66

7

8

not used

not used

1.5

1.5

-3.2

-1.5 0.0 1.5 1.5 2.1

-1.5

-1.5

1.2

0.5

1.2

-0.6

23.2

18.2

12.6

7.5

2.8

2.11.5

1.5

-3.2

-2.2

Sample

CEM Dry

and

corrected

for 11%

Oxygen

SRM

Corrected

Value*

y is

mg/m3

Difference

between

SRM and

CEM

Difference

(D - Dmean)

not used

not used

Square of

Difference

(D - Dmean)2


1

2

3

4

5

vD ks 0

Page 49 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35



0 to 2.2 mg/m3

Hydrogen Chloride - Plot 3 - Plot of calibrated CEM data versus SRM data

0.0

5.0

10.0

15.0

20.0

25.0

-5 0 5 10 15 20 25

SR

M, m

g/m

3(D

ry a

nd

Co

rrecte

d f

or

Oxy

gen

)




Page 50 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35




0 to 2.2 mg/m3

0 to 8.5 mg/m3

Hydrogen Chloride - Valid range & range extension











0.0

5.0

10.0

15.0

20.0

25.0

-5.0 0.0 5.0 10.0 15.0 20.0 25.0

SR

M, m

g/m

3




Page 51 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to




8 4.0 -- -- 4.0 -- --

not used 0.1 15.3

2 0.0 -- -- 0.0 -- --

3 0.0 -- -- 0.0 -- --

not used -- --

5 15.9 -- -- 16.0 -- --

6 11.8 -- -- 12.0 -- --

7 7.8 -- -- 8.0 -- --

22.1 -1.1 14.8 22.6

--

VOC - Raw Monitoring Data

not used 11/06/2013 15:08 11/06/2013 15:38 0.1 15.0 22.4 -1.2 14.8 20.7

not used 12/06/2013 11:20 12/06/2013 11:50 0.1 15.2 22.3 -1.4 14.9 22.1

11/06/2013 12:40

not used 12/06/2013 15:55 12/06/2013 16:25 0.1 15.1 22.2 -1.4 15.1 21.5

not used 12/06/2013 18:30 12/06/2013 19:00 0.1 15.2 22.0 -1.5 14.8 21.9

not used 12/06/2013 19:30 12/06/2013 20:00 0.2 11.2 19.0 -1.6 13.9 24.1

not used 12/06/2013 20:30 12/06/2013 21:00 0.1 14.5 24.4 -1.6 14.0 24.2

not used 12/06/2013 21:30 12/06/2013 22:00 0.1 14.5 24.6 -1.6 14.0 24.5

not used 12/06/2013 22:30 12/06/2013 23:00 0.1 14.5 24.8 -1.6 13.9 24.7

not used 12/06/2013 23:30 13/06/2013 00:00 0.1 14.5 24.9 -1.6 13.9 24.8

not used 13/06/2013 00:30 13/06/2013 01:00 0.1 14.4 25.0 -1.6 13.7 24.6

not used 13/06/2013 01:30 13/06/2013 02:00 0.1 14.4 25.0 -1.6 13.9 24.9

not used 13/06/2013 02:30 13/06/2013 03:00 0.1 14.4 25.0 -1.5 14.0 24.9

not used 13/06/2013 03:30 13/06/2013 04:00 0.1 14.5 24.9 -1.5 13.2 23.7

not used 13/06/2013 04:30 13/06/2013 05:00 0.1 14.5 24.9 -1.5 14.0 24.8

not used 13/06/2013 05:30 13/06/2013 06:00 0.1 14.5 24.8 -1.5 12.9 22.8

not used 13/06/2013 06:30 13/06/2013 07:00 0.1 14.6 24.8 -1.4 14.1 24.7

not used 13/06/2013 10:05 13/06/2013 10:35 0.1 15.2 21.6 -1.4 14.9 21.5

not used 13/06/2013 19:30 13/06/2013 20:00 0.2 11.6 18.3 -1.4 14.8 21.7

not used 13/06/2013 20:30 13/06/2013 21:00 0.1 14.9 23.0 -1.4 15.1 21.5

not used 13/06/2013 21:30 13/06/2013 22:00 0.1 14.7 23.4 -0.9 14.8 21.9

not used 13/06/2013 22:30 13/06/2013 23:00 0.1 15.0 23.3 -1.3 15.0 22.1

not used 13/06/2013 23:30 14/06/2013 00:00 0.1 14.7 23.6 -1.3 14.8 22.0

not used 14/06/2013 00:30 14/06/2013 01:00 0.1 15.0 23.4 -1.2 15.0 22.1


CEM

Measured

Value

xi

mg/m3

CEM

Oxygen

%

CEM Water

%

SRM

Measured

Value

yi

mg/m3

SRM

Oxygen

%

SRM Water


1


Linearity Data

0.0 0.0 ------

11/06/2013 13:10

Page 52 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

2 0.0 0.0

3 0.0 0.0

not used

0.0


SRM

Corrected

Value

y is

mg/m3

CEM Dry

and

corrected

for, 11%

Oxygen


1 0.0

VOC - Standardised Monitoring Data

Difference

of SRM

and CEM

corrected

values

Difference

less than

half the

confidence

interval at

the ELV?

5 16.0 15.9

6 12.0 11.8

7 8.0 7.8

8 4.0 4.0

not used -2.3 0.3

not used 11/06/2013 15:08 11/06/2013 15:38 -2.4 0.3

11/06/2013 13:1011/06/2013 12:40

Linearity Data

not used 12/06/2013 11:20 12/06/2013 11:50 -2.9 0.3

not used 12/06/2013 15:55 12/06/2013 16:25 -3.1 0.3

not used 12/06/2013 18:30 12/06/2013 19:00 -3.0 0.3

not used 12/06/2013 19:30 12/06/2013 20:00 -3.0 0.3

not used 12/06/2013 20:30 12/06/2013 21:00 -3.0 0.2

not used 12/06/2013 21:30 12/06/2013 22:00 -3.1 0.2

not used 12/06/2013 22:30 12/06/2013 23:00 -3.0 0.2

not used 12/06/2013 23:30 13/06/2013 00:00 -3.0 0.3

not used 13/06/2013 00:30 13/06/2013 01:00 -2.9 0.2

not used 13/06/2013 01:30 13/06/2013 02:00 -2.9 0.3

not used 13/06/2013 02:30 13/06/2013 03:00 -2.9 0.3

not used 13/06/2013 03:30 13/06/2013 04:00 -2.6 0.2

0.2

not used 13/06/2013 04:30 13/06/2013 05:00 -2.9 0.2

not used 13/06/2013 05:30 13/06/2013 06:00 -2.3 0.2

not used 13/06/2013 06:30 13/06/2013 07:00 -2.8 0.2

not used 13/06/2013 10:05 13/06/2013 10:35 -3.0 0.2

not used 13/06/2013 23:30 14/06/2013 00:00 -2.7 0.2

not used 14/06/2013 00:30 14/06/2013 01:00 -2.5 0.2

not used 13/06/2013 19:30 13/06/2013 20:00 -3.0 0.2

not used 13/06/2013 20:30 13/06/2013 21:00 -3.1 0.2

not used 13/06/2013 21:30 13/06/2013 22:00 -1.8 0.2

not used 13/06/2013 22:30 13/06/2013 23:00 -2.7

VOC - Plot 1 - Time series of data

N/A

N/A

N/A

N/A

N/A

N/A


Yes

Yes

Yes

N/A

Yes

Yes

Yes

Yes

N/A

N/A

N/A

N/A

0.0

0.2

0.2

0.2

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

0.0

0.0

0.0

-3.5

-3.0

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

0.5

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Co

ncen

trati

on

(m

g/m

3)

Data Point


SRM CEM

Page 53 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35



free.

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

No

0.1 -1.6 -1.7 No

0.1 -1.5 -1.7 No

0.1 -1.5 -1.6

not used

CEM at

measured

conditions

SRM at CEMs

Measuring

conditions


or No)




-1.17

0.71

Data Source

Surrogate Zero's

Linearity Data

Parallel test data

0.02

0.02

0

0

-0.02

-0.02

No

No0.02 0 -0.02 No

No

15.85 16 0.15 No

11.77 12 0.23 No

-1.5 No

0.1 -1.4 -1.6 No

0.1 -1.5 -1.6 No

0.2 -1.6 -1.8 No

0.1 -1.6 -1.7 No

Sample

1

23

78

not used

not used

not used

not used

not used

not used

not used

Lower limit at 2 SD

0.24

-2.58

0.1 -1.4 -1.5 No

0.1 -1.4 -1.5 No

0.2 -1.4 -1.6 No

0.1 -1.4 -1.5 No

0.1 -0.9 -1.0 No

0.1 -1.3 -1.4 No

0.1 -1.3 -1.4 No

0.1 -1.2 -1.3 No

Upper limit at 2 SD

0.1 -1.6 -1.7 No

0.1 -1.6 -1.7 No

0.1 -1.6 -1.7 No

0.1 -1.6 -1.7

Outlier test data

not used

not used

VOC - Application of the Calibration Function & Outlier Test






No

0.1 -1.5 -1.6 No

0.1 -1.5 -1.6 No

7.80 8 0.20 No3.97 4 0.03 No

0.1 -1.1 -1.2 No

0.1 -1.2 -1.3 No

0.1 -1.4

not used

5

6

-3.0

-2.5

-2.0

-1.5

-1.0

-0.5

0.0

0.5

0 1 2 3 4 5 6 7 8

Co

ncen

trati

on

(m

g/m

3)

Data Point



Page 54 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35



VOC - Application of the Calibration Function & Outlier Test


Minimum SRM Value = -3.1 mg/m³

Since -1.8 < 3 (30% of ELV) , then Method C is used to calculate the calibration function.




















Maximum SRM Value = -1.8 mg/m³

Page 55 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to


Method A Method B

where: where:


VOC - Data used to determine the calibration function

VOC - The Calibration Function

0.0 0.0

Date and Time


Sample

SRM at

CEM

conditions

yi

mg/m3

CEM

Measured

Value

xi

mg/m3

5 16.0 15.9

6 12.0 11.8

7 8.0 7.8

8 4.0 4.0

not used -1.1 0.1

Xi - Xav Yi - Yav

(Xi - Xav)*


2

-5.62

-5.62

-5.62

10.21

6.14

2.17

-1.67

12/06/2013 11:20 12/06/2013 11:50 -1.4 0.1

not used 12/06/2013 15:55 12/06/2013 16:25 -1.4 0.1

not used 12/06/2013 18:30 12/06/2013 19:00 -1.5 0.1

not used 12/06/2013 19:30 12/06/2013 20:00 -1.6 0.2

not used 12/06/2013 20:30 12/06/2013 21:00 -1.6 0.1

2 0.0 0.0

3 0.0 0.0

not used

not used 12/06/2013 21:30 12/06/2013 22:00 -1.6 0.1

not used 12/06/2013 22:30 12/06/2013 23:00 -1.6 0.1

not used 12/06/2013 23:30 13/06/2013 00:00 -1.6 0.1

not used 13/06/2013 00:30 13/06/2013 01:00 -1.6 0.1

not used 13/06/2013 01:30 13/06/2013 02:00 -1.6 0.1

not used 13/06/2013 02:30 13/06/2013 03:00 -1.5 0.1

not used 13/06/2013 03:30 13/06/2013 04:00 -1.5 0.1

not used 13/06/2013 04:30 13/06/2013 05:00 -1.5 0.1

not used 13/06/2013 05:30 13/06/2013 06:00 -1.5 0.1

not used 13/06/2013 06:30 13/06/2013 07:00 -1.4 0.1

not used 13/06/2013 10:05 13/06/2013 10:35 -1.4 0.1

not used 13/06/2013 19:30 13/06/2013 20:00 -1.4 0.2

not used 13/06/2013 20:30 13/06/2013 21:00 -1.4 0.1

not used 13/06/2013 21:30 13/06/2013 22:00 -0.9 0.1

not used 13/06/2013 22:30 13/06/2013 23:00 -1.3 0.1

not used 13/06/2013 23:30 14/06/2013 00:00 -1.3 0.1

not used 14/06/2013 00:30 14/06/2013 01:00 -1.2 0.1

Calibrated Value TVOC = 1.015 X (CEM reading) -0.006

1

not used 11/06/2013 15:08 11/06/2013 15:38 -1.2 0.1

11/06/2013 13:1011/06/2013 12:40

Linearity Data

not used

-5.71

-5.71

-5.71

10.29

6.29

2.29

-1.71 2.86

4.95

38.57

105.05

32.10

32.10

32.10

31.55

31.55

31.55

104.31

37.66

4.69

2.78


Zx

yb

ˆ

Zba ˆˆ

axby ˆˆ axby ˆˆ

n

i

n

i

XXi

YYiXXi

b

1

2

1

)(

))((ˆ

XbYa ˆ

Page 56 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

The R2 value for this calibration function is 1

Calibrated Value TVOC = 1.015 X (CEM reading) -0.006

VOC - Calculation of calibrated CEM values

VOC - Plot 2 - Plot of CEM data versus SRM data

2 0.0 -- -- 0.0 0.0

3 0.0 -- -- 0.0 0.0

not used

CEM

Oxygen

% (Dry)

CEM Water

%

CEM

Calibrated

Value

ŷi

mg/m3

Calibrated

CEM

Corrected

to

Reference

conditions

5 15.9 -- -- 16.1 16.1

6 11.8 -- -- 11.9 11.9

7 7.8 -- -- 7.9 7.9

8 4.0 -- -- 4.0 4.0

not used 0.1 15.3 22.1

not used 0.1 15.0 22.4

not used 0.1 15.2 22.3

not used 0.1 15.1 22.2

not used 0.1 15.2 22.0

not used 0.2 11.2 19.0

not used 0.1 14.5 24.4

not used 0.1 14.5 24.6

not used 0.1 14.5 24.8

not used 0.1 14.5 24.9

not used 0.1 14.4 25.0

not used 0.1 14.4 25.0

not used 0.1 14.4 25.0

not used 0.1 14.5 24.9

not used 0.1 14.5 24.9

not used 0.1 14.5 24.8

not used 0.1 14.6 24.8

not used 0.1 15.2 21.6

not used 0.2 11.6 18.3

not used 0.1 14.9 23.0

not used 0.1 14.7 23.4

not used 0.1 15.0 23.3

not used 0.1 14.7 23.6

not used 0.1 15.0 23.4


1 0.0 -- -- 0.0 0.0

Sample

CEM

Measured

Value

xi

mg/m3

0

2

4

6

8

10

12

14

16

18

0 2 4 6 8 10 12 14 16 18

SR

M, m

g/m

3

CEM, mg/m3



Page 57 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35


Where






VOC - Data Used for the variability test

2 0.0 0.0 0.0 0.0 0.0

3 0.0 0.0 0.0 0.0 0.0

Sample

CEM Dry

and

corrected

for 11%

Oxygen

SRM

Corrected

Value*

y is

mg/m3

Difference

between

SRM and

CEM

Difference

(D - Dmean)

Square of

Difference

(D - Dmean)2


1 0.0 0.0 0.0 0.0 0.0

not used

not used

not used

not used

5 16.1 16.0 -0.1 -0.1 0.0

6 11.9 12.0 0.1 0.1 0.0

7 7.9 8.0 0.1 0.1 0.0

8 4.0 4.0 0.0 0.0 0.0

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used

not used


VOC - Variability Test

not used



Conditions.

1.96

0.06 < 1.45

not used

not used

not used

not used

not used

not used

not used

not used

vD ks 0

Page 58 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35



0 to -2 mg/m3

VOC - Plot 3 - Plot of calibrated CEM data versus SRM data

0

2

4

6

8

10

12

14

16

18

0 2 4 6 8 10 12 14 16 18

SR

M, m

g/m

3(D

ry a

nd

Co

rrecte

d f

or

Oxy

gen

)




Page 59 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

VOC - Valid range & range extension

0 to 10 mg/m3




0 to -2 mg/m3











0.0

5.0

10.0

15.0

20.0

25.0

0.0 5.0 10.0 15.0 20.0 25.0

SR

M, m

g/m

3




Page 60 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to



0.0--

11/06/2013 13:10

O2 - Raw Monitoring Data

--


CEM

Measured

Value

xi

%

CEM Water

%

SRM

Measured

Value

yi

%

SRM Water


1


Linearity Data

0.2

22.132 14/06/2013 00:30 14/06/2013 01:00 15.0 23.4 15.0

31 13/06/2013 23:30 14/06/2013 00:00 14.7 23.6 14.8 22.0

29 13/06/2013 21:30 13/06/2013 22:00 14.7 23.4 14.8 21.9

30 13/06/2013 22:30 13/06/2013 23:00 15.0 23.3 15.0 22.1

outlier 13/06/2013 19:30 13/06/2013 20:00 11.6 18.3 14.8 21.7

13/06/2013 20:30 13/06/2013 21:00 14.9 23.0 15.1 21.5

25 13/06/2013 06:30 13/06/2013 07:00 14.6 24.8 14.1 24.7

26 13/06/2013 10:05 13/06/2013 10:35 15.2 21.6 14.9 21.5

28

20 13/06/2013 01:30 13/06/2013 02:00 14.4 25.0 13.9 24.9

17 12/06/2013 22:30 12/06/2013 23:00 14.5 24.8 13.9 24.7

18 12/06/2013 23:30 13/06/2013 00:00 14.5 24.9 13.9 24.8

23 13/06/2013 04:30 13/06/2013 05:00 14.5 24.9 14.0 24.8

24 13/06/2013 05:30 13/06/2013 06:00 14.5 24.8 12.9 22.8

21 13/06/2013 02:30 13/06/2013 03:00 14.4 25.0 14.0 24.9

22 13/06/2013 03:30 13/06/2013 04:00 14.5 24.9 13.2 23.7

16 12/06/2013 21:30 12/06/2013 22:00 14.5 24.6 14.0 24.5

13 12/06/2013 18:30 12/06/2013 19:00 15.2 22.0 14.8 21.9

outlier 12/06/2013 19:30 12/06/2013 20:00 11.2 19.0 13.9 24.1

19 13/06/2013 00:30 13/06/2013 01:00 14.4 25.0 13.7 24.6

12/06/2013 16:25 15.1 22.2 15.1 21.5

not used --

not used --

not used --

15 12/06/2013 20:30 12/06/2013 21:00 14.5 24.4 14.0 24.2

2 0.2 -- 0.0 --

3 0.2 -- 0.0 --

not used --

not used --

9 15.3 22.1 14.8 22.6

10 11/06/2013 15:08 11/06/2013 15:38 15.0 22.4 14.8 20.7

11 12/06/2013 11:20 12/06/2013 11:50 15.2 22.3 14.9 22.1

11/06/2013 12:40

12 12/06/2013 15:55

Page 61 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

outlier 13/06/2013 19:30 13/06/2013 20:00 14.8 11.6

28 13/06/2013 20:30 13/06/2013 21:00 15.1 14.9

29 13/06/2013 21:30 13/06/2013 22:00 14.8 14.7

30 13/06/2013 22:30

O2 - Standardised Monitoring Data

O2 - Plot 1 - Time series of data

31 13/06/2013 23:30 14/06/2013 00:00 14.8 14.7

32 14/06/2013 00:30 14/06/2013 01:00 15.0 15.0

13/06/2013 23:00 15.0

21 13/06/2013 02:30 13/06/2013 03:00 14.0 14.4

22 13/06/2013 03:30 13/06/2013 04:00 13.2 14.5

15.0

23 13/06/2013 04:30 13/06/2013 05:00 14.0 14.5

24 13/06/2013 05:30 13/06/2013 06:00 12.9 14.5

25 13/06/2013 06:30 13/06/2013 07:00 14.1 14.6

26 13/06/2013 10:05 13/06/2013 10:35 14.9 15.2

17 12/06/2013 22:30 12/06/2013 23:00 13.9 14.5

18 12/06/2013 23:30 13/06/2013 00:00 13.9 14.5

19 13/06/2013 00:30 13/06/2013 01:00 13.7 14.4

20 13/06/2013 01:30 13/06/2013 02:00 13.9 14.4

13 12/06/2013 18:30 12/06/2013 19:00 14.8 15.2

outlier 12/06/2013 19:30 12/06/2013 20:00 13.9 11.2

15 12/06/2013 20:30 12/06/2013 21:00 14.0 14.5

16 12/06/2013 21:30 12/06/2013 22:00 14.0 14.5

11 12/06/2013 11:20 12/06/2013 11:50 14.9 15.2

12 12/06/2013 15:55 12/06/2013 16:25 15.1 15.1


1 0.2

not used

not used

not used

not used

2 0.0 0.2

3 0.0 0.2

not used

0.0


SRM

Corrected

Value

y is

%

CEM Dry

9 14.8 19.6

10 11/06/2013 15:08 11/06/2013 15:38 14.8 15.0

11/06/2013 13:1011/06/2013 12:40

Linearity Data

Yes


Difference

of SRM and

CEM

corrected

values

4.8

Yes

Yes

Yes

Yes

Yes

No

Yes

Yes

N/A

Yes

Yes

Yes

Yes

Yes

0.2

0.2

0.2

0.2

0.4

0.1

0.4

0.5

0.5

0.6

0.5

0.7

0.5

0.5

1.2

0.5

1.7

0.5

0.3

0.2

0.1

0.0

0.1

0.0

Difference

less than

half the

confidence

interval at

the ELV?

Yes

Yes

Yes

N/A

N/A

N/A

N/A

N/A

No

Yes

Yes

Yes

N/A

Yes

Yes

Yes

Yes

0

5

10

15

20

25

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Co

ncen

trati

on

(%

)

Data Point


Page 62 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35



free.

21

22

23

24

25

26

outlier

28

29

Outlier test data

30

3132

CEM at

measured

conditions

SRM at CEMs

Measuring

conditions


or No)




-0.15

0.98

Data Source

Surrogate Zero's

Linearity Data

Parallel test data

0.23

0.23

0

0

-0.23

-0.23

No

No0.23 0 -0.23 No

No

No

No

15.1 15.1 -0.1 No

15.2 14.8 -0.4 No

11.2

14.0 -0.5 No

Sample

1

23

not used

not used

not used

not usednot used

9

10

11

12

13

outlier

15

16

Lower limit at 2 SD

1.81

-2.10

14.6 14.1 -0.5 No

15.2 14.9 -0.3 No

11.6 14.8 3.3 Yes

14.9 15.1 0.2 No

14.7 14.8 0.1 No

15.0 15.0 0.0 No

14.7 14.8 0.1 No15.0 15.0 0.0 No

Upper limit at 2 SD

14.5 14.0 -0.5

17

18

19

20

No

14.5 13.9 -0.5 No

14.4 13.7 -0.7 No

14.4 13.9 -0.5 No

14.4 14.0 -0.5 No

14.5 13.2 -1.2

13.9 2.7 Yes

14.5

O2 - Application of the Calibration Function & Outlier Test






No

14.5 14.0 -0.5 No

14.5 12.9 -1.7 No

NoNo

15.3 14.8 -0.5 No

15.0 14.8 -0.2 No

15.2 14.9 -0.4 No

No

14.5 13.9 -0.6

-3.0

-2.0

-1.0

0.0

1.0

2.0

3.0

4.0

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29

Co

ncen

trati

on

(%

)

Data Point



Page 63 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

Daily Emission Limit Value = 25 %

C.I. of the Daily Emission Limit Value = 2.5 %

Minimum SRM Value = 12.9 %




















Maximum SRM Value = 15.1 %

Spread of SRM Values = 2.3 %

Since 15.1 > 2.5 (10% of ELV) and 2.3 < 3.75 (15% of ELV), then Method B is used to calculate the calibration function.

O2 - Application of the Calibration Function & Outlier Test

Page 64 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to


Method A Method B

where: where:


1

31 13/06/2013 23:30 14/06/2013 00:00 14.8 14.7

32 14/06/2013 00:30 14/06/2013 01:00 15.0 15.0

Calibrated Value Oxygen = 0.953 X (CEM reading) + 0.219

outlier 13/06/2013 19:30 13/06/2013 20:00 14.8 11.6

28 13/06/2013 20:30 13/06/2013 21:00 15.1 14.9

29 13/06/2013 21:30 13/06/2013 22:00 14.8 14.7

30 13/06/2013 22:30 13/06/2013 23:00 15.0 15.0

23 13/06/2013 04:30 13/06/2013 05:00 14.0 14.5

24 13/06/2013 05:30 13/06/2013 06:00 12.9 14.5

25 13/06/2013 06:30 13/06/2013 07:00 14.1 14.6

26 13/06/2013 10:05 13/06/2013 10:35 14.9 15.2

19 13/06/2013 00:30 13/06/2013 01:00 13.7 14.4

20 13/06/2013 01:30 13/06/2013 02:00 13.9 14.4

21 13/06/2013 02:30 13/06/2013 03:00 14.0 14.4

22 13/06/2013 03:30 13/06/2013 04:00 13.2 14.5

15 12/06/2013 20:30 12/06/2013 21:00 14.0 14.5

16 12/06/2013 21:30 12/06/2013 22:00 14.0 14.5

17 12/06/2013 22:30 12/06/2013 23:00 13.9 14.5

18 12/06/2013 23:30 13/06/2013 00:00 13.9 14.5

11 12/06/2013 11:20 12/06/2013 11:50 14.9 15.2

12 12/06/2013 15:55 12/06/2013 16:25 15.1 15.1

13 12/06/2013 18:30 12/06/2013 19:00 14.8 15.2

outlier 12/06/2013 19:30 12/06/2013 20:00 13.9 11.2

not used

not used

not used

not used

9 14.8 15.3

10 11/06/2013 15:08 11/06/2013 15:38 14.8 15.0

11/06/2013 13:1011/06/2013 12:40

Linearity Data

2 0.0 0.2

3 0.0 0.2

not used

0.0 0.2

Date and Time


Sample

SRM at

CEM

conditions

yi

%

CEM

Measured

Value

xi

%

O2 - Data used to determine the calibration function

O2 - The Calibration Function

Xi - Xav Yi - Yav

(Xi - Xav)*


2

-12.79

-12.79

-12.79

2.24

2.02

2.22

2.13

2.16

1.45

1.44

1.43

1.43

4.62

5.20

4.96

4.40

4.86

161.38

161.38

161.38

163.52

163.52

163.52

5.02

4.10

4.92

4.54

4.65

2.21

2.34

2.11

1.31

1.11

1.31

2.06

2.05

2.05

1.33

0.59

1.39

0.25

1.47

2.23

2.51

2.18

2.36

2.18

2.35 4.61

3.74

4.61

3.75

4.82

4.87

2.26

0.38

2.04

0.86

1.89

1.87

1.59

1.88

1.86

2.15

2.121.49

1.53

2.01

2.09

2.14

2.29

2.36

4.76

3.68

2.96

3.81


1.42

1.45

1.46

1.51

1.53

2.94

3.85

2.18

1.92

1.72

1.95

1.71

1.96

-12.62

-12.62

-12.62

2.17

2.17

2.23

2.44

2.14

1.42

1.41

1.28

Zx

yb

ˆ

Zba ˆˆ

axby ˆˆ axby ˆˆ

n

i

n

i

XXi

YYiXXi

b

1

2

1

)(

))((ˆ

XbYa ˆ

Page 65 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35


Calibrated Value Oxygen = 0.953 X (CEM reading) + 0.219


1 0.2 -- 0.4 0.4

Sample

CEM

Measured

Value

xi

%

CEM Water

%

CEM

Calibrated

Value

ŷi

%

Calibrated

CEM

Corrected

to

Reference

conditions

31 14.7 23.6 14.3 14.3

32 15.0 23.4 14.5 14.5

28 14.9 23.0 14.4 14.4

29 14.7 23.4 14.3 14.3

30 15.0 23.3 14.5 14.5

25 14.6 24.8 14.1 14.1

26 15.2 21.6 14.7 14.7

outlier 11.6 18.3

22 14.5 24.9 14.0 14.0

23 14.5 24.9 14.0 14.0

24 14.5 24.8 14.1 14.1

19 14.4 25.0 14.0 14.0

20 14.4 25.0 14.0 14.0

21 14.4 25.0 14.0 14.0

16 14.5 24.6 14.1 14.1

17 14.5 24.8 14.0 14.0

18 14.5 24.9 14.0 14.0

13 15.2 22.0 14.7 14.7

outlier 11.2 19.0

15 14.5 24.4 14.0 14.0

10 15.0 22.4 14.5 14.5

11 15.2 22.3 14.7 14.7

12 15.1 22.2 14.7 14.7

not used

not used

9 15.3 22.1 14.8 18.9

not used

not used

not used

2 0.2 -- 0.4 0.4

3 0.2 -- 0.4 0.4

O2 - Calculation of calibrated CEM values

O2 - Plot 2 - Plot of CEM data versus SRM data

0

2

4

6

8

10

12

14

16

0 2 4 6 8 10 12 14 16 18

SR

M, %

CEM, %



Page 66 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35


Where



Where Surrogate Emission Limit = 25 % Measurement Uncertainty = 10%



Sample CEM Dry

SRM

Corrected

Value

y is

%

Difference

between

SRM and

CEM

Difference

(D - Dmean)

Square of

Difference

(D - Dmean)2


1 0.4 0.0 -0.4 -0.3 0.1

O2 - Variability Test



Conditions.

1.96

0.93 < 1.26

0.3 0.1

outlier


30 14.5 15.0 0.5 0.7 0.4

25 14.1 14.1 0.0 0.2 0.0

26 14.7 14.9 0.2

24 14.1 12.9 -1.2 -1.0 1.0

16 14.1 14.0 0.0 0.1 0.0

17 14.0 13.9 -0.1 0.1 0.0

18 14.0 13.9 -0.1 0.1 0.0

13 14.7 14.8 0.1 0.3 0.1

outlier

0.9 0.7

29 14.3 14.8 0.5 0.7

19 14.0 13.7 -0.3 -0.1 0.0

20 14.0 13.9 -0.1 0.1 0.0

21 14.0 14.0 0.0 0.1 0.0

22 14.0 13.2 -0.8 -0.6 0.4

23 14.0 14.0 0.0 0.2 0.0

0.5

0.2 0.015 14.0 14.0 0.0

10 14.5 14.8 0.2 0.4 0.2

11 14.7 14.9 0.1 0.3 0.1

12 14.7 15.1 0.4 0.6 0.3

not used

not used

9 18.9 14.8 -4.1 -4.0 15.8

not used

not used

not used

2 0.4 0.0 -0.4 -0.3 0.1

3 0.4 0.0 -0.4 -0.3 0.1

O2 - Data Used for the variability test

31 14.3 14.8 0.6 0.7 0.5

32 14.5 15.0 0.5 0.6 0.4

28 14.4 15.1 0.7

vD ks 0

Page 67 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

Plot of calibrated CEM data versus SRM data, dry


0 to 20.8 %

O2 - Plot 3 - Plot of calibrated CEM data versus SRM data

0

2

4

6

8

10

12

14

16

18

20

0 2 4 6 8 10 12 14 16 18 20

SR

M, %

(D

ry)

CEM, % (Calibration Function Applied, Dry)



Page 68 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35




0 to 20.8 %

O2 - Valid range & range extension

0 to 20.9 %









0.0

10.0

20.0

30.0

40.0

50.0

60.0

0.0 10.0 20.0 30.0 40.0 50.0 60.0

SR

M, %

Calibrated CEM, %



Page 69 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to


CEM

Measured

Value

xi

%

SRM

Measured

Value

yi

%


1


Linearity Data

0.2

H2O - Raw Monitoring Data

0.0

11/06/2013 13:10

22.1

30 13/06/2013 22:30 13/06/2013 23:00 23.3 22.1

31 13/06/2013 23:30 14/06/2013 00:00 23.6 22.0

outlier 13/06/2013 19:30 13/06/2013 20:00 18.3 21.7

28 13/06/2013 20:30 13/06/2013 21:00 23.0 21.5

32 14/06/2013 00:30 14/06/2013 01:00 23.4

23 13/06/2013 04:30 13/06/2013 05:00 24.9 24.8

29 13/06/2013 21:30 13/06/2013 22:00 23.4 21.9

24 13/06/2013 05:30 13/06/2013 06:00 24.8 22.8

25 13/06/2013 06:30 13/06/2013 07:00 24.8 24.7

26 13/06/2013 10:05 13/06/2013 10:35 21.6 21.5

19 13/06/2013 00:30 13/06/2013 01:00 25.0 24.6

20 13/06/2013 01:30 13/06/2013 02:00 25.0 24.9

21 13/06/2013 02:30 13/06/2013 03:00 25.0 24.9

22 13/06/2013 03:30 13/06/2013 04:00 24.9 23.7

15 12/06/2013 20:30 12/06/2013 21:00 24.4 24.2

16 12/06/2013 21:30 12/06/2013 22:00 24.6 24.5

17 12/06/2013 22:30 12/06/2013 23:00 24.8 24.7

18 12/06/2013 23:30 13/06/2013 00:00 24.9 24.8

12/06/2013 11:20 12/06/2013 11:50 22.3 22.1

11/06/2013 12:40

12 12/06/2013 15:55 12/06/2013 16:25 22.2 21.5

13 12/06/2013 18:30 12/06/2013 19:00 22.0 21.9

outlier 12/06/2013 19:30 12/06/2013 20:00 19.0 24.1

not used -- --

9 22.1 22.6

10 11/06/2013 15:08 11/06/2013 15:38 22.4 20.7

11

not used --

0.2 0.0

3 0.2 0.0

not used -- --

not used -- --

not used -- --

--

2

Page 70 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

24.9 25.0

21 13/06/2013 02:30 13/06/2013 03:00 24.9 25.0

22 13/06/2013 03:30 13/06/2013 04:00 23.7 24.9

23.3

23 13/06/2013 04:30 13/06/2013 05:00 24.8 24.9

24 13/06/2013 05:30 13/06/2013 06:00 22.8 24.8

25 13/06/2013 06:30 13/06/2013 07:00 24.7 24.8

26 13/06/2013 10:05 13/06/2013 10:35 21.5 21.6

14/06/2013 01:00 22.1 23.4

31 13/06/2013 23:30 14/06/2013 00:00 22.0

12 12/06/2013 15:55 12/06/2013 16:25 21.5 22.2

1.5

1.3

H2O - Plot 1 - Time series of data

0.0


SRM

Corrected

Value

y is

%

CEM

Corrected


1 0.2

not used --

not used --

not used --

not used --

H2O - Standardised Monitoring Data

Yes

Yes

Yes

Yes

Yes

N/A

Yes


0.2

0.2

1.8

0.2

0.7

0.1

0.2

9 22.6 22.1

10

23.6

32 14/06/2013 00:30

23.4

30 13/06/2013 22:30 13/06/2013 23:00

0.4

0.1

0.1

1.2

0.1

2.0

0.1

0.1

1.5

1.5

1.2

22.0

outlier 12/06/2013 19:30 12/06/2013 20:00 24.1 19.0

15 12/06/2013 20:30 12/06/2013 21:00 24.2 24.4

16 12/06/2013 21:30 12/06/2013 22:00 24.5 24.6

17 12/06/2013 22:30 12/06/2013 23:00 24.7 24.8

18 12/06/2013 23:30 13/06/2013 00:00 24.8 24.9

19

13/06/2013 21:00 21.5

22.1

13 12/06/2013 18:30 12/06/2013 19:00 21.9

13/06/2013 22:00 21.9

2 0.0 0.2

3 0.0 0.2

not used --

N/A

N/A

N/A

11/06/2013 15:08 11/06/2013 15:38 20.7 22.4

11/06/2013 13:1011/06/2013 12:40

Linearity Data

11 12/06/2013 11:20 12/06/2013 11:50 22.1 22.3

Difference

less than

half the

confidence

interval at

the ELV?

Yes

Yes

Yes

N/A

N/A

Yes

Yes

Yes

Yes

Yes

Yes

N/A

Yes

Yes

Yes

Yes

Yes

Difference

of SRM and

CEM

corrected

values

0.5

Yes

Yes

0.2

13/06/2013 00:30 13/06/2013 01:00 24.6 25.0

20 13/06/2013 01:30 13/06/2013 02:00

Yes

Yes

Yes

0.1

0.1

0.1

outlier 13/06/2013 19:30 13/06/2013 20:00 21.7 18.3

28 13/06/2013 20:30 23.0

29 13/06/2013 21:30

0

5

10

15

20

25

30

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Co

ncen

trati

on

(%

)

Data Point


Page 71 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

15

16

17

18

19

20

21

22

23

24

25

26

outlier

28

29

--



free.

22.1 -0.2 No

No

22.0 21.9 -0.1 No

19.0 24.1 5.1 Yes

24.4 24.2 -0.2 No




-0.23

1.46

12

13

outlier

Data Source

Surrogate Zero's

Linearity Data

Parallel test data

0.23

0.23

0

0

-0.23

-0.23

No

No0.23 0 -0.23 No

-- -- 0.00 No

-- -- 0.00 No

-- -- 0.00 No

1

23

not used

not used

not used

not usednot used

9

10

11

22.2 21.5 -0.7

Lower limit at 2 SD

2.69

-3.16

24.8 24.7 -0.1 No

21.6 21.5 -0.1 No

18.3 21.7 3.4 Yes

23.0 21.5 -1.5 No

23.4 21.9 -1.5 No

23.3 22.1 -1.2 No

23.6 22.0 -1.5 No

23.4 22.1 -1.3 No

Upper limit at 2 SD

24.6 24.5 -0.1 No

24.8 24.7 -0.1 No

24.9 24.8 -0.1 No

25.0 24.6 -0.4 No

25.0 24.9 -0.1 No

25.0 24.9 -0.1 No

24.9 23.7 -1.2

22.4 20.7 -1.8 No

22.3

Outlier test data

30

31

32

CEM at

measured

conditions

SRM at CEMs

Measuring

conditions


or No)

No

24.9 24.8 -0.1 No

24.8 22.8 -2.0 No

-- 0.00 No-- -- 0.00 No

22.1 22.6 0.5 No

H2O - Application of the Calibration Function & Outlier Test






Sample

-4

-3

-2

-1

0

1

2

3

4

5

6

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34

Co

ncen

trati

on

(%

)

Data Point



Page 72 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

Daily Emission Limit Value = 30 %

C.I. of the Daily Emission Limit Value = 9 %




















Maximum SRM Value = 24.9 %

Spread of SRM Values = 4.3 %

Since 24.9 > 9 (30% of ELV) and 4.3 < 4.5 (15% of ELV), then Method B is used to calculate the calibration function.

Minimum SRM Value = 20.7 %

H2O - Application of the Calibration Function & Outlier Test

Page 73 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to

to


Method A Method B

where: where:


1

29 13/06/2013 21:30 13/06/2013 22:00 21.9 23.4

30 13/06/2013 22:30 13/06/2013 23:00 22.1 23.3

26 13/06/2013 10:05 13/06/2013 10:35 21.5 21.6

H2O - The Calibration Function

31 13/06/2013 23:30 14/06/2013 00:00 22.0 23.6

32 14/06/2013 00:30 14/06/2013 01:00 22.1 23.4

Calibrated Value Moisture = 0.961 X (CEM reading) + 0.221

24 13/06/2013 05:30 13/06/2013 06:00 22.8 24.8

24.6 25.0

20 13/06/2013 01:30 13/06/2013 02:00 24.9 25.0

21 13/06/2013 02:30 13/06/2013 03:00 24.9 25.0

22 13/06/2013 03:30 13/06/2013 04:00 23.7

25 13/06/2013 06:30 13/06/2013 07:00 24.7 24.8

outlier 13/06/2013 19:30 13/06/2013 20:00 21.7 18.3

4.00

28 13/06/2013 20:30 13/06/2013 21:00 21.5 23.0

2 0.0 0.2

3 0.0 0.2

not used -- --

0.0 0.2

Date and Time


Sample

SRM at

CEM

conditions

yi

%

CEM

Measured

Value

xi

%

not used -- --

not used -- --

not used

1.281.13

11 12/06/2013 11:20 12/06/2013 11:50 22.1 22.3

12 12/06/2013 15:55 12/06/2013 16:25 21.5

9 22.6 22.1

10 11/06/2013 15:08 11/06/2013 15:38 20.7 22.4

11/06/2013 13:1011/06/2013 12:40

Linearity Data

H2O - Data used to determine the calibration function

22.2

420.75

420.75

420.75

Xi - Xav Yi - Yav

(Xi - Xav)*


2

-20.69

-20.69

-20.69

3.99

3.91

3.86

7.10

5.91

0.72

2.08

2.49

2.36

2.66

2.43

-20.33

-20.33

-20.33

2.23

0.32

1.79

1.19

1.54

3.84

4.16

4.34

4.46

4.29

4.59

4.55

3.36

4.44

2.45

4.32

1.17

1.21

1.59

1.72

1.71

1.73 4.22

4.56

4.06

3.95

2.51

0.84

16.67

9.59

17.74

13.46

18.59

1.48

1.39

1.25

1.11

18 12/06/2013 23:30 13/06/2013 00:00 24.8 24.9

19 13/06/2013 00:30 13/06/2013 01:00

-- --

not used -- --

13 12/06/2013 18:30 12/06/2013 19:00 21.9 22.0

outlier 12/06/2013 19:30 12/06/2013 20:00 24.1 19.0

15 12/06/2013 20:30 12/06/2013 21:00 24.2 24.4

16 12/06/2013 21:30 12/06/2013 22:00 24.5 24.6

17 12/06/2013 22:30 12/06/2013 23:00 24.7 24.8

24.9

23 13/06/2013 04:30 13/06/2013 05:00 24.8 24.9

2.19

1.93

1.56

1.22

12.18

13.17

15.14

16.72

16.01

15.96

15.29

14.87

0.51

4.33

6.20

5.58


15.86

16.50

16.58

3.49

3.63

3.89

3.98

18.70

17.44

17.77

16.88

15.10

13.39

1.71

1.48

2.49

0.47

2.52

428.15

428.15

428.15

4.06

4.07

4.09

Zx

yb

ˆ

Zba ˆˆ

axby ˆˆ axby ˆˆ

n

i

n

i

XXi

YYiXXi

b

1

2

1

)(

))((ˆ

XbYa ˆ

Page 74 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35


Calibrated Value Moisture = 0.961 X (CEM reading) + 0.221


1 0.2 0.4 0.4

Sample

CEM

Measured

Value

xi

%

CEM

Calibrated

Value

ŷi

%

Calibrated

CEM

Corrected

to

Reference

conditions

28 23.0 22.3 22.3

29 23.4 22.7 22.7

30 23.3 22.6 22.6

31 23.6 22.9 22.9

32 23.4 22.7 22.7

22 24.9 24.2 24.2

23 24.9 24.2 24.2

24 24.8 24.1 24.1

25 24.8 24.0 24.0

26 21.6 21.0 21.0

outlier 18.3

16 24.6 23.8 23.8

17 24.8 24.1 24.1

18 24.9 24.2 24.2

19 25.0 24.2 24.2

20 25.0 24.2 24.2

21 25.0 24.3 24.3

10 22.4 21.8 21.8

11 22.3 21.7 21.7

12 22.2 21.5 21.5

13 22.0 21.4 21.4

outlier 19.0

15 24.4 23.7 23.7

not used --

not used --

not used --

not used --

not used --

9 22.1 21.4 21.4

2 0.2 0.4 0.4

H2O - Calculation of calibrated CEM values

3 0.2 0.4 0.4

H2O - Plot 2 - Plot of CEM data versus SRM data

0

5

10

15

20

25

30

0 5 10 15 20 25 30

SR

M, %

CEM, %



Page 75 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35


Where



Where Surrogate Emission Limit = 30 % Measurement Uncertainty = 30%



Sample CEM

SRM

Corrected

Value

y is

%

Difference

between

SRM and

CEM

Difference

(D - Dmean)

Square of

Difference

(D - Dmean)2


0.4

24.9 0.7

31

0.5 0.2

13


0.3

25 24.0 24.7 0.6 0.6 0.4

26 21.0 21.5 0.5

24 24.1 22.8

0.5 0.2

not used

not used

9

24.1 24.7 0.6 0.6 0.4

18 24.2

22.9 22.0 -0.8 -0.8 0.7

32 22.7 22.1 -0.6 -0.6 0.4

28 22.3 21.5 -0.8 -0.8 0.6

29 22.7 21.9 -0.8 -0.8

19 24.2 24.6

H2O - Variability Test



Conditions.

1.96

0.69 < 4.53

21.4 21.9

15 23.7 24.2 0.5

-1.3 -1.3 1.7

23 24.2 24.8 0.6 0.6 0.4

0.7

30 22.6 22.1 -0.6 -0.6

16 23.8 24.5 0.7 0.7 0.4

17

0.4 0.2

20 24.2 0.7 0.5

21 24.3 24.9 0.6 0.6 0.4

22 24.2 23.7 -0.5 -0.5 0.2

outlier

0.6 0.6 0.4

0.5 0.5 0.2

outlier

24.8

10 21.8 20.7 -1.1 -1.1 1.2

11 21.7 22.1 0.5 0.5 0.2

12 21.5 21.5 0.0 0.0

not used

not used

not used

21.4 22.6 1.1 1.1 1.3

0.0

2 0.4 0.0 -0.4 -0.4 0.2

3 0.4 0.0 -0.4 -0.4 0.2

1 0.4 0.0 -0.4 -0.4 0.2

H2O - Data Used for the variability test

vD ks 0

Page 76 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

Plot of calibrated CEM data versus SRM data


0 to 26.7 %

H2O - Plot 3 - Plot of calibrated CEM data versus SRM data

0

5

10

15

20

25

30

0 5 10 15 20 25 30

SR

M, %

CEM, % (Calibration Function Applied)



Page 77 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

It is not possible to extend the range further




0 to 26.7 %

H2O - Valid range & range extension









Page 78 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

Note - CEMS Functional testing and associated reporting do not form part of ESG's Mcerts accreditation.

Gas conditioning systems Yes

Pumps Yes

Contamination control (internal check of optical surfaces) Yes

2. Sampling Systems

A visual inspection of the sampling system shall be performed, noting the condition of the following components, when fitted:

Sampling probe Yes

After re-assembly at the measurement location at least the

following shall be checked

Yes

Alignment of the measuring system Yes

Obstructions in the optical path Yes

A visual inspection, with reference to the CEMs manuals, shall be carried out on the following when applicable:

Internal check of the CEM Yes

Cleanliness of the optical components Yes

EA Proforma Functional Checks

Requirement Yes / No / N/A Notes

1. Alignment and Cleanliness

Flushing air supply Yes

4. Zero and Span check

Reference zero and span materials shall be used to verify the

corresponding readings of the CEM.

Yes

In case of non-extractive CEM, zero and span checks shall be

performed using a reference-path free of flue gas before and

after readjustment and after re-assembly of the CEM at the

measurement location.

N/A

The sampling system shall be in good condition and free of

any visible faults, which may decrease the quality of data

Yes

3. Leak testing

Leak testing shall be performed according to the CEMs

manuals. The test shall cover the entire sampling system.

Yes

Power supplies Yes

Filters Yes

All connections Yes

Sample lines Yes

Section - Functional Test Report

Page 79 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

Section 5 - Functional Checks


Requirement Yes / No / N/A Notes

5. Linearity

Reference material with zero concentration; Yes

After each change in concentration, the first instrument reading shall be taken after a time period equal to at least three times the

response time of the CEM. At each reference material concentration, at least three readings shall be made, six readings shall be

taken at zero. The time period between the start of each of the three readings shall be separated by at least four times the

response time.

Note

Where no other method is possible, the linearity can also be performed with the aid of reference materials such as grating filters

or gas filters.

Reference material concentration approximately 60 % of 2 x

the ELV;

Yes


the ELV;

Yes


the ELV;

Yes


the ELV;

Yes

The reference material concentrations shall be selected such

that the measured values are at approximately 20 %, 40 %,

60 % and 80 % of the range of two times the emission limit

value. It is necessary to know the values of the ratios of their

concentrations precisely enough so that an incorrect failure of

the linearity test does not occur. The dry test reference

material shall be applied to the inlet of the CEM.

Yes

The individual CEMs are tested using the following concentrations applied in a randomised sequence:

Reference material with zero concentration; Yes

The reference material with zero concentration, as well as the

reference materials with four different concentrations, shall

have a verifiable quantity and quality.

Yes

In case of gaseous reference materials, these four reference

materials can be obtained from different gas cylinders or can

be prepared by means of a calibrated dilution system from

one single gas concentration.

Yes

During the calibration/linearity tests the applied

concentrations should be logged onto the DCS to prove the

complete system i.e. concentration applied to the instrument

is represented by the instrument output and identical to the

value logged on the DCS. DCS logged values should be

included in the instrument service report.

Yes

The linearity of the CEM's response shall be checked using

five different reference materials, including a zero

concentration.

Yes

8. Response Time

The response time of the CEM shall be checked. This can be

performed, if appropriate, by feeding of the reference material

at the end of the sampling probe. The response time shall not

exceed the measured value that has been identified during

QAL1.

Yes

7. Zero and Span drift (Audit)

The zero point and span drift shall be obtained from and

evaluated on the basis of the records of QAL3.

Yes

The linearity shall be calculated and tested using the procedure as given in EN 14181 annex B. If the CEM does not pass this

test, then the problem shall be identified and rectified.

6. Interferences

A test shall be undertaken if the process gases to be

monitored contain components that are known interferences,

as identified during QAL1.

N/A

Page 80 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

Instrument Serial No Yes

Instrument configuration including computer file and name if

available

Yes

Instrument type Yes

Instrument model Yes

Document reference for work instruction for the type of work

being undertaken

Yes

Instrument manufacturer Yes

9. Service Report

As a minimum requirement the service report should include the following:

Section 5 - Functional Checks


Logged data for period of calibration and linearity Yes

Name and signature of service engineer Yes

Gases used – certificate numbers, expiry dates, binary / mix Yes

Calibration and linearity data as required by EN14181 Yes

Date and time work was undertaken Yes

Equipment used – type, serial no’s, calibration dates Yes

Compliance with MCERTS (including certificate no.) Yes

Location Yes

Measuring condition Yes

Certification details Yes

Operating principle Yes

Operating range Yes

Page 81 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

Control Box DGM Horiba PG-250 Analyser Laboratory Balance

Box Thermocouples JCT JCC P-1 Cooler Tape Measure

Meter In Thermocouple MAK 10 Cooler Stopwatch

Meter Out Thermocouple FT-IR Protractor

Control Box Timer FT-IR Oven Box Barometer

Umbilical Bernath 3006 FID Digital Micromanometer

Oven Box Signal 3030 FID Digital Temperature Meter

Probe Servomex Stack Thermocouple

Probe Thermocouple JCT Heated Head Filter Mass Flow Controller

Probe Thermo FID Mass Flow Control Box

Probe Thermocouple Stackmaster 1m Heated Line (1)

Probe 1m Heated Line (2)

Probe Thermocouple 1m Heated Line (3)

S-Pitot 5m Heated Line (1)

L-Pitot 5m Heated Line (2)

Site Balance 10m Heated Line (1)

Last Impinger Arm 10m Heated Line (2)

Dioxins Cond. TC 15m Heated Line (1)

Callipers 15m Heated Line (2)

Small DGM 20m Heated Line (1)

Heater Controller 20m Heated Line (2)

Ecophysics Analyser

- -

13.21 -

- 8.11

- -

- - -

6.46 -

1.35 -

14.CD -

- -

13.13 - 12.2

11.24 - 10.24

10.24 - -

- 8.15 -

- - -

- FTIR Heater Box for - -

Section 6 - Calibrateable Equipment Checklist

Extractive Sampling Instrumental Analyser/s Miscellaneous

Equipment Equipment I.D. Equipment Equipment I.D. Equipment Equipment I.D.

9.17 12.5 -

9.11 - 20.4

9.17 - 17.21

9.17 05854 23.13

17.6 - 16.2

- - 15.7

END OF REPORT

Page 82 of 82

LEK09311


Permit No. 770

Novartis

Ringaskiddy

-

For

insp

ectio

n pur

pose

s only

.

Conse

nt of

copy

right

owne

r req

uired

for a

ny ot

her u

se.

EPA Export 04-01-2017:02:05:35

Documents

BS EN 14181:2004 - QAL2 CEMs Calibration Report · Novartis Ringaskiddy County Cork, Ireland, Waste Incineration 2.2.2 Type of Fuel Fuel Ratio Is a mulitple calibration function required