ANNUAL ENVIRONMENTAL REPORT 2010 · Discharge Volumes (m3) Volume Volume 1474.15 1241.1 1268.72 1452 1321.23 1391.41 1479.2 719.5 496.9 418.6 378.6 233.7 Jan Feb Mar Apr May Jun Jul

1

ANNUAL ENVIRONMENTAL REPORT 2010

ROTTAPHARM LTD

DAMASTOWN INDUSTRIAL PARK

MULHUDDART

DUBLIN 15

IPPC LICENCE REG: P0886-01

2

TABLE OF CONTENTS 1. Introduction 4 1.1 Executive Summary 4

1.2 Purpose 4

2. Background 4 2.1 The Company 4 2.2 Economic Contribution 5 2.3 Local Environmental Conditions 5 2.4 Financial Allocation for Environment 5

3. Environmental Health & Safety Policy 6

4. Environmental Management Organization Chart 2011 7

5. Emissions to Sewer - (SE1) 8 5.1 Effluent Emissions to Sewer-Summary Data 2010 8 5.2 Mass Emission Trend Analysis 2010 8 5.3 Monthly Average pH 2010 9 5.4 Monthly pH (External Laboratory) 9 5.5 Monthly Effluent BOD Levels 2010 10 5.6 Monthly Effluent COD Levels 2010 10 5.7 Monthly Effluent Suspended Solids 2010 11 5.8 Monthly Effluent Sulphate Levels 2010 11 5.9 Monthly Effluent Oils, Fats & Greases 2010 12 5.10 Monthly Effluent MBAS 2010 12 5.11 Monthly Discharge Volumes 2010 13 5.12 Non-Conformance Summary 2010 13

6. Surface Water Emissions – (SW1/SW2) 14 6.1 Surface Water Visual Inspections 14

7. Emissions to Atmosphere: 15 7.1 Mass Emissions for VOC’s Quarterly Analysis 15

7.2 Summary of Non-Conformances 2010 15 7.4 Summary of RTO By-Pass Events 2010 16 8. Hazardous & Non-Hazardous Waste Management 17

8.1 Hazardous Waste Summary 2010 17 8.2 Hazardous Waste Data Table 2010 18 8.3 Non-hazardous Data Table 2010 19

8.4 Non-hazardous Graph 2010 19 9. Energy Consumption 20

9.1 Energy Consumption & Cost 2010 20 9.2 Energy Consumption (Full Year) 2010 20

9.3 Energy per Unit Packaged 2010 21 10. Water Consumption 22

10.1 Water Consumption by Quarter 2010 22 10.2 Waste Water Trade Effluent 20110 22 10.2 Water Consumption per Unit Packaged 2010 23

3

11. Noise 25 11.1 Noise Table Results 2010 25 11.2 Findings of Noise Survey Report 2010 25

12. Environmental Complaints 25 12.1 Rottapharm Ltd. Complaint Details 2010 25

13. Management of the Activity 26 13.1 Rottapharm Ltd. Future Plans for the Management of the Activity 26

Appendix I Noise Monitoring Report 2010 Appendix II Environmental Management Plan 2011 Appendix III Environmental Liabilities Risk Assessment 2011 Appendix IV Fugitive Emissions Risk Assessment 2011 Appendix V Solvent Management Plan 2010 Appendix VI PRTR Summary Data

4

1.0 INTRODUCTION

1.1 Executive Summary

This is the first year Rottapharm has submitted an Annual Environmental Report (AER).

The licence was required for the carrying out of the following classes of activity at the

facility:

5.16 The use of chemical or biological process for the production of basic pharmaceutical products

12.2.2 The manufacture or use of coating materials in processes with a capacity to make at least 10 tonnes per year of organic solvents, and powder coating manufacture with a capacity to produce at least 50 tonnes per year, not included in paragraph 12.2.1

In its first year of environmental objectives & targets, Rottapharm has had some notable

successes. An energy reduction committee has enabled to company to make substantial

savings in its energy bills. This committee has outlined more projects that will continue to be

progressed into 2012. Waste reduction initiatives have taken place across site, with office and

canteen segregation implemented in Quarter 3 of 2010.

The major success from an environmental view point for 2010 was the smooth transition to

the IPPC licensing programme, of which Rottapharm Ltd.

1.2 Purpose

This Annual Environmental Report (AER) is submitted in fulfilment of Schedule D of the

IPPC Licence (Licence Register Number: P0886-01) issued on the 14th of January 2010.

The format of this AER presents summary information (in line with the Guidance notes for

the Annual Environmental Report, ISBN: 1 84095 029 3), for the year 2010.

2. BACKGROUND

2.1 The Company

Rottapharm Madaus is a global pharmaceutical company which was established in Italy in

1961 by Luigi Rovati. Since then, Rottapharm has grown and the group now has six other

5

manufacturing plants in Europe. In 1999, Rottapharm established a pharmaceutical finishing

facility in Damastown Industrial Estate in Mulhuddart Co. Dublin.

Rottapharm Dublin produces a wide range of products in the form of sachets, tablets and

capsules. The facility has been constructed to manufacture solid oral dosage products and

bulk active material.

A number of different Active Pharmaceutical Ingredients are used in the formulation of

these dosage forms. In addition, the facility incorporates a dedicated manufacturing suite for

one API.

2.2 Economic Contribution

Rottapharm Madeaus Dublin currently employs 173 personnel of which 70 employees are

involved in the production area within the company.

2.3 Local Environmental Conditions

The Rottapharm facility is located in the Damastown Industrial Estate, Mulhuddart, Dublin

15. The site occupies 20 acres. The plant consists of two discrete buildings being

administration and production/warehouse both these buildings are linked together by

enclosed corridors.

The site incorporates a section of the Pinkeen River on which joins the Tolka River at a later

stage. Helsinn Chemicals and Helsinn Birex sites are located southwest of the Rottapharm

plant.

2.4 Financial Allocation for Environment

The major capital items to support the IPPC programme have already been committed.

Environmental, Health and Safety is a discrete cost centre in its own right within

Rottapharm.

6

3. EHS POLICY

7

4. MANAGEMENT ORGANISATIONAL CHART 2010

Finance Manager

Technical Manager

Quality Manager

Materials Manager

Operations Manger

Managing Director – Pat Garrahy

EHS Advisor

EHS Co-coordinator

Human Resources Manager

8

5. EMISSIONS TO SEWER - (SE1) 5.1 Emissions to Sewer - Summary Data of Mass Emissions

Parameter Monitoring Frequency

Mass Emissions 2010 (KG)

Licensed Mass Emissions (KG)

Flow Continuous N/A 18,250 m3

BOD Monthly 2299.93 36,500

COD Monthly 4491.9 73,000

Suspended Solids

Monthly 416 7,300

Sulphates Monthly 1018.3 7,300

Oils/Fats/ Greases

Monthly 17.86 1,825

MBAS Monthly 4.44 1,825

5.2 Mass Emissions Trend Analysis 2010 (SE1)

Mass Emissions

0

10000

20000

30000

40000

50000

60000

70000

80000

Parameter

Kg/

yr Mass (Kg)

Limit (Kg)

Mass (Kg) 4.44 416 17.86 1018.3 4491.9 2299.93

Limit (Kg) 1825 7300 1825 7300 73000 36500

MBAS Ssolids OFG SO4 COD BOD

9

5.3 Average Monthly Effluent pH 2010

Average pH 2010

0

2

4

6

8

10

12

Month

pH R

ange pH Range

Upper Limit

Lower Limit

pH Range 6.1 7.4 7.3 7.4 7.3 7.1 7.5 9.7 7.3 7 7.4 7.4

Upper Limit 10 10 10 10 10 10 10 10 10 10 10 10

Lower Limit 6 6 6 6 6 6 6 6 6 6 6 6

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

UPPER

LOWER LIMIT

Note: Data for March and April averaged due to incomplete data collection

5.4 Monthly pH (External Laboratory)

Effluent pH (External Laboratory)

4

5

6

7

8

9

10

11

Date

pH v

alue

pH Values

Lower Limit

Upper Limit

pH Values 7.7 8.1 8.8 6.8 6.5 7.9 7.8 7.8 8.48 8.19 8.38 8.11 7.81

Lower Limit 6 6 6 6 6 6 6 6 6 6 6 6 6

Upper Limit 10 10 10 10 10 10 10 10 10 10 10 10 10

Jan FebFeb

(EPA)Mar Apr May Jun Jul Aug Sep Oct Nov Dec

UPPER LIMIT

LOWER LIMIT

10

5.5 Monthly Effluent BOD Samples 2010

Effluent BOD Levels 2010

0

500

1000

1500

2000

2500

Month

BO

D m

g/l

BOD (mg/L)

IPPC Limit

BOD (mg/L) 60.4 435 40 336 317 26.9 45.9 292 5.82 206 162 168 64.8

IPPC Limit 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000 2000

Jan FebFeb


UPPER LIMIT

5.6 Monthly Effluent COD Samples 2010

Effluent COD Levels 2010

0

500

1000

1500

2000

2500

3000

3500

4000

4500

Month

BO

D m

g/l

COD (mg/L)

IPPC Limit

COD (mg/L) 150 795 72 700 584 64 110 549 28.4 398 299 318 148

IPPC Limit 4000 4000 4000 4000 4000 4000 4000 4000 4000 4000 4000 4000 4000

Jan FebFeb


UPPER LIMIT

11

5.7 Monthly Effluent Suspended Solids Samples 2010

Effluent Suspended Solids Levels 2010

0

50

100

150

200

250

300

350

400

450

Month

SS

mg/

l

SS (mg/L)

IPPC Limit

SS (mg/L) 11 52.5 18 93 66 13 6.47 14.5 9 52 31.5 46.2 43.5

IPPC Limit 400 400 400 400 400 400 400 400 400 400 400 400 400

Jan FebFeb


UPPER LIMIT

5.8 Monthly Effluent Sulphates Samples 2010

Effluent SO4 Levels 2010

0

50

100

150

200

250

300

350

400

450

Month

SO

4 m

g/l

SO4 (mg/L)

IPPC Limit

SO4 (mg/L) 46.7 146 39.8 184 145 46.8 56.7 52.6 44.6 57.8 3.19 85.3 48.4

IPPC Limit 400 400 400 400 400 400 400 400 400 400 400 400 400

Jan FebFeb


UPPER LIMIT

12

5.9 Monthly Effluent Oils, Fats and Greases Samples 2010

Effluent OFG Levels 2010

0

20

40

60

80

100

120

Month

OF

G m

g/l

IPPC Limit

OFG (mg/L)

IPPC Limit 100 100 100 100 100 100 100 100 100 100 100 100 100

OFG (mg/L) 1 1 15 1.16 3.11 1.94 1 1 1 1.58 1.48 3.61 1

Jan FebFeb


UPPER LIMIT

5.10 Monthly Effluent MBAS Samples 2010

Effluent MBAS Levels 2010

0

20

40

60

80

100

120

Month

MB

AS

mg/

l

MBAS (mg/l)

IPPC Limit

MBAS (mg/l) 0.25 0.297 0.189 0.182 0.08 0.123 0.333 0.125 5.2 0.22 0.186 0.307

IPPC Limit 100 100 100 100 100 100 100 100 100 100 100 100


UPPER LIMIT

13

5.11 Effluent Discharge Volumes 2010

Emissions to Sewer - Discharge Volumes 2010

0

200

400

600

800

1000

1200

1400

1600

Month

Dis

char

ge V

olum

es (

m3)

Volume

Volume 1474.15 1241.1 1268.72 1452 1321.23 1391.41 1479.2 719.5 496.9 418.6 378.6 233.7


D

Note: Data for March and April averaged from other months due to incomplete data collection

5.12 Non-Conformance Summary There were no non-conformances in effluent during 2010.

14

6 SURFACE WATER VISUAL INSPECTIONS 6.1 Inspection Reports SW1 (West of Attenuation pond) Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Odour √ √ √ √ √ √ √ √ √ √ √ √ Colour √ √ √ √ √ √ √ √ √ √ √ √ SW2 (North of Administration building) Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Odour √ √ √ √ √ √ √ √ √ √ √ √ Colour √ √ √ √ √ √ √ √ √ √ √ √ There were no issues with the surface water during 2010. Visual inspections were used where

the technician used a clear bottle and observed for odour and any discolouration. From

Quarter 1 2011, pH, TOC and Temperature will be taken quarterly

15

7. EMISSIONS TO ATMOSPHERE 7.1 Summary of Mass Emissions to A2-1 Quarterly Samples Parameter Stack Testing 13/07/2010 (Kg/hr) Stack Testing 28/10/2010 (Kg/hr) Total Organic Carbon (as C)

9.48-10.18 0.0015928

10.18-10.48 0.0425315

10.48-11.18 0.0545018

10.24-10.54 0.0445797

10.59-11.29 0.072265

11.32-12.02 0.0871

Nitrogen Oxides (as NO2)

9.48-10.18 0.005792

10.18-10.48 0.00703

10.48-11.18 0.007466

10.24-10.54 0.112575

10.59-11.29 0.0447

11.32-12.02 0.0179

Carbon Monoxide (CO)

9.48-10.18 0.005792

10.18-10.48 0.24505

10.48-11.18 0.194116

10.24-10.54 4.030185

10.59-11.29 0.5215

11.32-12.02 0.129775

7.2 Summary of Non Conformances Date Parameter Description Corrective Action 28th October 2010 (Quarterly Monitoring)

Carbon Monoxide (CO) mg/m3

During quarterly monitoring of the RTO, two consecutive 30 minute averages of Carbon Monoxide (CO) breached the licence limit of 100 mg/m3. From 10.24 – 10.54 the average reading taken by was 895 mg/m3. From 10.59-11.29, the average reading taken was of the magnitude of 140 mg/m3

Rottapharm ltd. Licence requires correction to dry gas and 18% Oxygen. This causes inflated readings of the parameter. The company is currently addressing this issue through its Proposed Air Abatement Test Programme. No cause was found for the exceedence after extensive investigation internally and with the equipments supplier

09/04/2010,13/07/2010, 28/10/2010 (Quarterly Monitoring)

Volume (m3/hr) Hourly rate per hour exceeded on all three monitoring occasions

Clerical error in submission for licence. RTO designed to operate at a much higher air volume rate per hour. Technical Amendment request submitted to Agency December 2010

16

7.3 Summary of RTO Bypass Events 2010

17

8. HAZARDOUS & NON-HAZARDOUS WASTE 8.1 Hazardous Waste Summary 2010

Hazardous Waste 2010 (Tonnes)

0.2320.472

5.416

1.435

0.149

3.564

0.001

2.622

0

1

2

3

4

5

6

Solid Waste Containing Dangerous Substances

Empty Organic Solvent Drums

OilsWaste Drums

Contaminated Packaging

Laboratory Chemicals

Residual Laboratory Waste (inorganic)

Residual Laboratory Waste (Organic)

Waste Type

Qua

ntity

(T

onne

s)

Hazardous Waste

18

8.2 Hazardous Waste Table 2010

19

8.3 Non-hazardous waste 2010

Totals General Waste

Mixed Dry Waste

Mixed Dry Recyclables

Metal OCC

Weight(Tn): 370.57 24.49 248.02 3.76 10.6 83.7

Recycled & Recovered

Percentage(%): 89% 82% 86% 98% 100% 100% Landfill

Percentage(%): 11% 18% 14% 2% 0% 0%

8.4 Non-hazardous waste graph 2010

24.49

248.02

3.7610.6

83.7

0

50

100

150

200

250

General Waste Mixed DryWaste

Mixed DryRecyclables

Metal OCC

Total Tonnages 2010

20

9. ENERGY CONSUMPTION 9.1 Energy Consumption and Cost Rottapharm Ltd 2010

Consumption Greenhouse Gas (GHG) Emissions

Electricity Natural Gas

Total Fuel (non-

Electricity) Electricity Natural

Gas

Total Site (non-

Electricity)

Total Energy

[kWh] [kWh] [kWh] [tCO2] [tCO2] [tCO2] [tCO2]

Jan 399,268 733,888 733,888 254.3 145.3 145.3 399.6

Feb 387,112 869,873 869,873 246.6 172.2 172.2 418.8

Mar 430,776 634,546 634,546 274.4 125.6 125.6 400.0

Apr 455,582 404,428 404,428 290.2 80.1 80.1 370.3

May 499,417 328,681 328,681 318.1 65.1 65.1 383.2

Jun 537,230 302,781 302,781 342.2 60.0 60.0 402.2

Jul 582,665 254,925 254,925 371.2 50.5 50.5 421.6

Aug 443,512 216,857 216,857 282.5 42.9 42.9 325.5

Sep 509,976 325,494 325,494 324.9 64.4 64.4 389.3

Oct 468,439 343,826 343,826 298.4 68.1 68.1 366.5

Nov 426,878 236,766 236,766 271.9 46.9 46.9 318.8

Dec 394,187 1,206,277 1,206,277 251.1 238.8 238.8 489.9

Total 5,535,042 5,858,342 5,858,342 3,525.8 1,160.0 1,160.0 4,685.8

9.2 Total Energy Consumption Rottapharm Ltd 2010

Total Energy Consumption

0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000

1,600,000

1,800,000


Mon

thly

Ele

ctric

ity C

onsu

mpt

ion

[kW

h]

Electricity Natural Gas LPG Oil

21

9.3 Energy Consumption Versus Products Packaged 2010

Energy Consumed/ Unit Packaged 2010

15.4

0

2

4

6

8

10

12

14

16

18

Total Whr/Unit 15.4

22

10. WATER CONSUMPTION 10.1 Water Consumption 2010 (Metered) 2010

Water Consumption 2010 (m3)

0

1000

2000

3000

4000

5000

6000

7000

Quarter 1 Quarter 2 Quarter 3 Quarter 4

Period (Quarter 1- Quarter 4)

Vol

ume

(m3)

Total CubicMetersPeriod

10.2 Waste Water Trade Effluent Disposal 2010

Waste Water Trade Effluent Disposal

0

1000

2000

3000

4000

5000

6000

Quarter 1 Quarter 2 Quarter 3 Quarter 4

Period (Q1 - Q4)

Cub

ic M

eter

s (m

3)

Volume (m3)

Period (Quarter 1 - Quarter 2)

Linear (Volume (m3))

23

10.3 Consumption/Unit Packaged 2010

Consumption/Unit Packaged

27

0

5

10

15

20

25

30

Millilitres/Unit 27

24

11. NOISE MONITORING As per section 6.14 of Rottapharm’s IPPC Licence” the licensee shall carry out a noise survey of the

site operations at a frequency as required by the Agency. The survey programme shall be undertaken in

accordance with the methodology specified in the “environmental noise survey guidance document” as published

by the Agency”

The thresholds as per the licence are:

• 55dB Daytime (30 minutes)

• 45 dB Night-time (30 minutes

11.1 Noise Monitoring Summary Table 2010

Table 1: Results from Day-time & Night-time Noise Monitoring in dB(A)

Monitoring Location

Monitoring Period

LAeq (30

min) L10 (30 min) L90 (30 min)

Lmax (30 min)

Day-time 66 69 62 71 N1

Night-time 60 65 59 66

Day-time 54 58 51 67 N2


Day-time 56 62 53 68 N3


At receptor N1, the daytime LAeq is 66dB which exceeds the licence limit of 55 dB. The

night-time level of 60dB exceeds the LAeq limit of 45dB. At this location, traffic noise

dominates and the facility is not audible.At receptor N2, the daytime LAeq is 54dB which

complies with the licence limit of 55 dB. The night-time levels of 46dB exceed the LAeq limit

of 45dB. At this location, traffic noise dominates and the facility is not audible. At receptor

N3, the daytime LAeq is 56dB which exceeds the licence limit of 55 dB. The night-time levels

of 50dB exceed the LAeq limit of 45dB. At this location, traffic noise dominates and the

facility is not audible.

Conclusion

The Rottapharm facility does not contribute to the noise environment at the noise

monitoring locations and is in compliance with its licence requirements.

25

12. ENVIRONMENTAL COMPLAINTS 12.1 Rottapharm Ltd. Complaint Details 2010 There were no environmental complaints in 2010

26

13. MANAGEMENT OF THE ACTIVITY

Complete

Carried Forward

Cancelled

13.1 Future Plans for Management of the Activity

ENVIRONMENTAL OBJECTIVE 1 – IMPROVED ENVIRONMENTAL MANAGEMENT

SCOPE: The scope of this objective is to improve environmental performance in the plant

by ensuring compliance and increasing awareness with the EMS. The planned steps to

achieve this target are detailed below.

Target Step Responsibility Target Status

1. Establish plan for compliance

with all conditions of the IPPC

Licence

EHS Advisor Q2 2010 Complete

2. Update existing Standard

Operating Procedures for

Currency with Regulatory Body

requirements

EHS Advisor Q4 2010

Complete

3. Develop EHS training matrix

and develop a schedule to carry

out all EHS training

EHS Advisor Q4 2010

Carried

Forward

4. Identify and prepare additional

Standard Operating procedures

required for IPPC Licence

Compliance


5. Improve communication of

EHS Metrics

EHS Advisor /

Engineering Manager

Q2 2011 Complete

Continue the

development and

improvement of the

site wide EMS.

6. Host an EHS day to improve

awareness of the EMS and IPPC

Licence requirements

EHS Advisor /

Engineering Manager

Q4 2011 Complete

27

ENVIRONMENTAL OBJECTIVE 2 – IMPROVED EFFLUENT PROCESS CONTORL

SCOPE: The scope of this objective is to improve the control of the process effluent on

site. This will ensure that the effluent system can be alarmed and critical alarms will go to

security to initiate investigation. The planned steps to achieve this target are detailed below.


1. Review current operational

parameters of the effluent

balancing system

EHS Advisor /

Building Services

Engineer

Q2 2010 Complete

2. Identify upgrades required and

obtain management approval

EHS Advisor/

Building Services

Engineer

Q3 2010

Complete

3. Implement upgrade works Maintenance Planner Q4 2010 Carried

Forward

Upgrade of the

existing effluent

treatment plant

operation

4. Carry out integrity testing on

the effluent tanks and associated

pipe work

Maintenance Planner Q4 2010 Complete

28

ENVIRONMENTAL OBJECTIVE 3 – IMPROVED ABATEMENT OF AIR EMISSIONS SCOPE: The scope of this objective is to improve the process control of the Regenerative

Thermal Oxidiser (RTO) on site, which will hence ensure compliance with the air emission

limits stipulated in the site IPPC Licence. The planned steps to achieve this target are

detailed below.


1. Develop SOP for the RTO

Process

Process Engineer Q2 2010 Complete

2. Create a log to record bypass

events


3. Create a reporting schedule

for reporting bypass events to

the EPA

EHS Advisor /

Process Engineer

Q3 2010 Complete

4. Submit RTO Test Programme

to the EPA

EHS Advisor Q3 2010 Carried

Forward

5. Investigate options for

quantifying heat recovery from

the RTO

Process Engineer Q2 2011 Cancelled

6. Investigate root cause of

bypass events


Investigate options

for minimisation of

RTO shutdown

events and for

quantifying heat

recovery

7. Review options for

minimisation of shutdown

events and put preventative

measures in place

EHS Advisor /

Process Engineer /

Technical Manager

Q3 2011 Complete

29

ENVIRONMENTAL OBJECTIVE 4 – IMPROVED CANTEEN WASTE MANAGEMENT PROJECT SCOPE: The scope of this objective is to improve the segregation of waste in the site

canteen. Currently some segregation of cardboard and general mixed canteen waste is taking

place. It is intended to establish a programme to increase and improve this segregation and

recycling. It is also intended to investigate if a compost waste stream could be created in

order to further divert waste from landfill. The planned steps to achieve this target are

detailed below.


1. Review canteen waste

production

EHS Advisor /

Warehouse Supervisor

Q3 2010 Complete

2. Introduce waste segregation

practices in the canteen

EHS Advisor /


Q3 2010 Complete


recycling of canteen waste with

the waste disposal contactor

Warehouse Supervisor Q4 2010 Complete

4. Segregate waste streams and

investigate options for

composting canteen waste

Warehouse Supervisor Q4 2010 Complete

Reduce the

percentage of

canteen waste

disposed to landfill

by 10%

5. Compile data and establish

additional targets to further

reduce waste disposed to landfill

EHS Advisor /


Q1 2011 Complete

30

ENVIRONMENTAL OBJECTIVE 5 – REDUCTION IN FUGITIVE EMISSIONS SCOPE: The scope of this objective is to reduce solvent loss through fugitive emissions and

to establish targets for 2011. The planned steps to achieve this target are detailed below.


1. Identify all potential sources

of fugitive emissions on site


2. Establish the solvent loss

from all on-site activities

through fugitive emissions


Establish a

programme for the

identification of

fugitive emissions and

investigate options

for reducing solvent

loss 3. Evaluate potential to reduce

solvent loss though fugitive

emissions and establish targets

for the next 3 years

EHS Advisor /

Technical Manager

Q1 2011 Complete

31

ENVIRONMENTAL OBJECTIVE 6 – SAVINGS IN ENERGY & MATERIAL USAGE (ENERGY)

SCOPE: The scope of this objective is to reduce energy consumption on site and to

establish targets for the plant for the next 3 years. The planned steps to achieve this target

are detailed below.


1. Establish a site wide energy

team

EHS Advisor /

Technical Manager

Q3 2010 Complete

2. Complete an Energy Audit Energy Team Q4 2010 Complete

3. Review energy consumption

of major utility systems

Energy Team Q2 2011 Complete


recording and measuring energy

usage


Identify key energy

reduction targets to

be achieved over the

next 3 years

5. Identify key targets to be

achieved over the next 3 years


32

ENVIRONMENTAL OBJECTIVE 7 – SAVINGS IN ENERGY & MATERIAL USAGE (WATER USAGE) SCOPE: The scope of this objective is to improve water conservation and establish water

use reduction targets for the site. The planned steps to achieve this target are detailed below.


1. Generate a water balance

indicating site water usage and

discharge

Maintenance Planner Q1 2011 Complete

2. Evaluate potential water re-use

projects

Maintenance Planner

/ Technical Manager

Q3 2011 Carried

Forward

Establish a water

balance for the site

3. Implement opportunities for

re-use as highlighted by the water

balance

Maintenance Planner

/ Technical Manager

Q4 2011 Carried

Forward

33

ENVIRONMENTAL OBJECTIVE 8 – IMPROVED EMERGENCY RESPONSE

SCOPE: The scope of this objective is to review and revise the current emergency response

and incident procedures on site in order to ensure the prevention and minimisation of

impacts to the environment associated with any emergency situation on site. The planned

steps to achieve this target are detailed below.


1. Update the Emergency

Response Procedure to include

relevant information relating to

environmental incidents.


2. Update the site Environmental

Health and Safety Statement

SOP to include for an accident

prevention procedure


3. Update the emergency

notification procedure and health

safety and security reporting

procedure to include for the

evaluation and reporting of

environmental incidents


Review and update

the site emergency

response procedures

4. Carry out training as necessary EHS Advisor Q2 2011 Carried

Forward

34

ENVIRONMENTAL OBJECTIVE 9 – IMPROVED RAW MATERIAL EFFICIENCY SCOPE: The scope of this objective is to reduce waste associated with the use of solvents

on site. The planned steps to achieve this target are detailed below.


1. Document a solvent

management plan


2. Undertake an assessment of

the efficiency of use of raw

materials in production

Process Engineer Q1 2011 Carried

Forward

3. Establish improvements and

potential projects to reduce

solvent consumption and

associated waste

Process Engineer /

Technical Manager

Q2 2011 Carried

Forward

Investigate options

for solvent reuse,

recovery and the

reduction of

associated waste.

4. Establish a timeline for

initiation of projects and

establish associated waste

minimisation metrics

Process Engineer /

Technical Manager

Q3 2011 Carried

Forward

35

ENVIRONMENTAL OBJECTIVE 10 – REMAIN CURRENCY WITH EPA REPORTING REQUIREMENTS

SCOPE: The scope of this objective is to prepare and submit all licence specific reports to

the EPA within the required reporting timeframe. The planned steps to achieve this target

are detailed below.


1. DMP

1.1 Prepare a detailed costed

Decommissioning Management

Plan

1.2 Submit to the Agency


2. Groundwater

2.1 Obtain quotations and install

groundwater wells on site

2.2 Purchase groundwater

monitoring equipment as required


3. ELRA

3.1 Commission an independent

consultant to prepare a fully

costed Environmental Liabilities

Risk Assessment to address past

and present liabilities at the site

3.2 Submit to the Agency


4. PRTR 4.1 Agree PRTR

substances and wastes to be

reported with the EPA

4.2 Compile mass balance

calculations

4.3 Complete electronic PRTR

2.4 Submit PRTR to the Agency

in the AER


Prepare and submit

licence specific

reports to the EPA

4. Noise Monitoring Report

4.1 Commission an external

consultant to complete an annual

noise monitoring report

4.2 Submit to the Agency in the

AER


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APPENDIX I NOISE ASSESSMENT 2010

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APPENDIX II ENVIRONMENTAL MANAGEMENT PLAN

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ENVIRONMENTAL OBJECTIVE 1 – IMPROVED WASTE MANAGEMENT SCOPE The scope of this objective is to improve the segregation/disposal of waste across the site.

Changing of contractors is envisaged for this proposal to be implemented

Target Step Responsibility Target

1. Implement “Slim Jims” in all office areas

EHS Advisor / Facilities

Q1 2011

2. Introduce plastic and cardboard streams across plant. Begin baling of these streams

EHS Advisor / Warehouse Manager

Q2 2011

3. Introduce compost waste stream across site

Warehouse Manager

Q2 2011

4. Investigate hazardous waste contractors

Warehouse Manager

Q1 2011

Reduce cost of waste disposal/Improve segregation

5. Investigate non-hazardous waste contractors

EHS Advisor / Warehouse Manager

Q1 2011

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ENVIRONMENTAL OBJECTIVE 2 – IMPROVED ENVIRONMENTAL MANAGEMENT PLAN

SCOPE: The scope of this objective is to improve procedures and knowledge of

Rottapharm Ltd environmental responsibilities as well as control over its aspects and

impacts


1. Draw up a management plan based on ISO 14001 (Plan, Do, Check, Act)

EHS Advisor Q4 2011

2. Update SOPs, Manuals as per point 1

EHS Advisor Q4 2011

3. Create training matrix for environmental topics on-site

EHS Advisor Q4 2011

4. Introduce register of environmental aspects

EHS Advisor Q3 2011

Improved environmental Management

5. Communication boards EHS Advisor Q4 2011

56

ENVIRONMENTAL OBJECTIVE 3 – IMPROVED ENERGY MANAGEMENT

SCOPE: The scope of this objective is to reduce energy costs across site. This is a wide

ranging objective that takes into account gas, electricity and water usage.


1. Introduce 90% recycled air and 10% fresh air to air handlers

Facilities Q2 2011

2. Investigate potential to reuse trade effluent as grey water

Facilities/EHS Advisor

Q3 2011

3. Continue energy committee

Facilities/EHS Advisor

Q4 2011

4. Using ionization by magnetic induction to reduce gas consumption on our boiler systems

Facilities Q4 2011

5. implement switch off campaign for equipment plant wide

Facilities Q1 2011

6. Reducing air change rates in areas that do not run night shift

Facilities Q4 2011

6. Change building management strategy on BMS for space heating

Facilities Q3 2011

7. Compressed air leakage investigation

Facilities Q4 2011

8. Change all lighting in plant to PIRs

Facilities Q4 2011

Reduce cost of annual energy bill by 5%

9. Reduce water consumption in CIP’s

Facilities Q4 2011

57

ENVIRONMENTAL OBJECTIVE 4 – IPPC LICENCE IMPLEMENTATION SCOPE: The scope of this objective is to continue the implementation of all aspects of the

IPPC licence across site.


1. Integrity testing of lines EHS Advisor/Facilities

Q2 2011

2. Rework of WWTP and retesting as per Agency Guidance

EHS Advisor/Facilities

Q3 2011

3. Acceptance by EPA of Proposed Air Abatement Test Programme

EHS Advisor Q2 2011

4. Technical Amendment regarding air volume in RTO

EHS Advisor Q2 2011

Implement all conditions of IPPC Licence

5. Correction for dry gas and oxygen to be omitted from licence

EHS Advisor Q2 2011

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APPENDIX III ENVIRONMENTAL LIABILITIES RISK ASSESSMENT

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APPENDIX IV FUGITIVE EMISSION RISK ASSESSMENT 2010

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TABLE OF CONTENTS

1. INTRODUCTION AND OBJECTIVES

2. SCOPE

3. DEFINITIONS

4. ENVIRONMENTAL RISK ASSESSMENT PROCEDURE

5. RESULTS

6. DISCUSSION

7. CONCLUSION

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1.0 Introduction and Objectives Condition 5.7 and 6.9 of Rottapharm's IPPC Licence (P0886-01) requires the preparation of

Fugitive Emission Programme. The specific requirements are as follows:

5.7 The licensee shall calculate annually the fugitive emissions of volatile organic compounds and the organic

solvent input, and submit a report as part of the AER. Fugitive emissions shall not exceed 5% of

organic solvent input per calendar year.

6.9 The licensee shall prepare a programme, to the satisfaction of the Agency, for the identification and

reduction of fugitive emissions using an appropriate combination of best available techniques. This

programme shall be included in the Environmental Management Programme

2.0 Scope

The Fugitive Emissions Programme is applicable to all activities undertaken at Rottapharm

Ltd. which have the potential to release fugitive emissions into the surrounding

environment. These activities include:

• Solvent Coating

• Solvent Handling

• Filling Diesel Tanks

• Waste Handling

3.0 Definitions

Environmental Aspect: The part of Rottapharm’s activities, products or services that can

interact with the environment.

Environmental Impact: Any change to the environment, adverse or beneficial, wholly or

partially resulting from the organisations activities, products or services.

101

Significance Rating (S): is denoted by the letter S and is a product of the Frequency of

Occurrence x Likelihood of Loss of Control x Severity of Consequences

Frequency of Occurrence (F): of the aspect is a numerical value between one (i.e. never)

and ten (i.e. regular/consistent). See Table

Where F is the Frequency of Occurrence

1 2 3 4 5 6 7 8 9 10

Never

>10

years

Rare

3 –

10

years

Infrequently Annually Monthly Fortnightly Weekly Daily Hourly Continuously

Likelihood of Loss of Control (L): is a numerical value between one and five where a

value of one indicates control loss is highly unlikely and a value of five indicates control loss

is highly likely.

1 2 3 4 5

Impossible

- can’t

happen under

any

circumstances

Unlikely –

though

conceivable

Possible Likely Certain

–

no

doubt

Severity of Consequences (C): of each environmental aspect is denoted by the letter C and

is assessed using the following decision making criteria:

i. Legislative and Regulatory compliance

ii. Potential Community/Employee sensitivity

iii. Potential Impact on air, land or water

iv. Cost/Benefit reasons, e.g. insurance liability, strategic concern

v. Potential for resource depletion

102

vi. Accident and Emergency situations

A score for Severity of Consequences (C) is calculated for each Aspect by assigning a score

under each criterion in the following manner and then adding the scores to give the final

rating.

i. Legislative and Regulatory compliance:

Not regulated / no legislative requirement = 1 point

Moderately regulated and compliant = 2 points

Strictly regulated / legislated and compliant = 3 points

Strictly regulated / legislated and occasionally non-compliant = 4 points

Strictly regulated / legislated and consistently non-compliant = 5 points

ii. Potential Community / Employee Sensitivity:

No observed reaction = 1 point

Sporadic complaints = 2 points

Widespread complaints = 3 points

Vigorous community / employee action = 4 points

Permanent injury or death caused = 5 points

iii. Potential Impact on Air, Land and Water:

No measurable impact on environmental media = 1 point

Local nuisance, e.g. odour, dust = 2 points

Short term adverse impact on environmental media e.g. fish kill = 3 points

Long term adverse impact on environmental media, = 4 points

Permanent damage to environmental media or ecosystem, e.g.

irrevocable damage to potable groundwater sources.

= 5 points

iv. Cost/Benefit Reasons:

Major financial saving to the company = 1 point

Minor financial saving to the company = 2 points

No financial cost to the company = 3 points

103

Minor financial cost to the company = 4 points

Major financial cost to the company = 5 points

v. Potential for Resource Depletion:

No depletion of natural resources = 1 point

Some depletion of renewable natural resources, e.g. paper/water

usage

= 2 points

Some depletion of non-renewable natural resources e.g. gas, oil usage = 3 points

Large scale depletion of renewable natural resources = 4 points

Large scale depletion of non-renewable natural resources, = 5 points

vi. Accident and Emergency situations:

No risk / trivial risk

(low probability and low environmental load)

= 1 - 2 points

Minor Risk

(low probability and medium environmental load

or medium probability and low environmental load)

= 3 - 4 points

Moderate risk

(High probability and low environmental load

or medium probability and medium environmental load

or low probability and high environmental load)

= 5 - 6 points

Substantial Risk

(High probability and medium environmental load

or medium probability and high environmental load)

= 7 - 8 points

Intolerable

(High probability and high environmental load)

= 9 -10 points

4.0 Environmental Risk Assessment Procedure

The Fugitive Emission Risk Assessment methodology matches Rottapharm’s Environmental

Aspects procedure. It is outlined as follows:

104

1. Select the activity

2. Identify the environmental aspect of the activity

3. Identify the environmental impact of the activity

4. Identify the environmental controls of the activity

5. Evaluate the significance of the impact (S = L X F X C)

Select the activity: Identify all activities on site which have the potential to release fugitive

emissions to the surrounding environment.

Identify environmental aspects: This assessment is regarding Fugitive Emissions to the

surrounding environment. Hence, this will be the aspect for the entire assessment

Identify environmental impact of activity: Identify as many actual and potential, positive

and negative, environmental impacts as possible associated with each aspect.

Outline Controls: Identify all control measures that are in place to decrease the impact the

fugitive emission will have on the surrounding environment.

Evaluate significance of the impact: Calculate significance by using the product of

Likelihood, Frequency and Severity. If this value is greater than 300, then the impact is

termed significant.

The table below shows scoring matrix for what is considered Significant

0-100

0-100

0-100

0-100

0-100

0-100

100-250 100-250

100-250

100-250 100-250 ≥250

100-250

100-250 ≥250 ≥250

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Not Significant

Not Significant but should be addressed in environmental objectives and targets

Significant, potential for environmental harm, action required

106

107

108

5.0 Discussion

Due to the fact that Rottapharm uses more than 10 tonne per annum of organic solvent in

its coating process and the high frequency that this occurs at, the process has been deemed

significant by the environmental risk assessment. The Waste Water Treatment Plant

(WWTP) also has potential for fugitive emissions due to the frequency of use and the fact

that integrity tests has shown that repair is required imminently. It should be noted that this

does not constitute a fugitive emission at present but rather the potential and hence the high

score

Throughout 2010, there were issues with bypass events in the RTO which led to fugitive

emissions. This too has been addressed and results in 2011 should show better operation

with non-routine bypass events. Both these significant emission sources will be focused on

during 2011 and reported in the AER of that year.

6.0 Conclusion

The fugitive emissions identified do not cause a significant risk to the environment. Any

fugitive emission scoring >300 will be corrected during 2011.

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APPENDIX V SOLVENT MANAGEMENT PLAN 2010

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1.0 Introduction:

This document reports on the use and emission of Volatile Organic Compounds (VOCs) at

Rottapharm Ltd. Future VOC reduction options are also evaluated. This document can be

viewed as a Solvent Management Plan (Annual), as required under condition 6.19 of IPPC

licence P0886-01, the EU Solvents Emissions Directive EU 1999/13/EC (1) and Emissions

of Volatile Organic Compounds from Organic Solvents Regulations 2002 (9).

Sources of VOC use were identified based on the study of the organic solvents used in the

Tromalyt coating process. Due to the fact that Rottapharm is a batch manufacturing facility,

exact quantities of solvents used are available from the batch manufacturing records as well

as receipts of solvents purchased.

Table 1: Solvent Management Plan Conditions of Licence

An SMP for 2010 has been prepared based on a mass balance approach and taking into

Account the guidelines outlined in Annex III of the Solvents Directive (as referenced

above). A mass balance on solvent input and output has been performed on each of the

solvents used on site at Rottapharm for 2010.

The following equation will be used to calculate the fugitive emission as per guidance.

F = I1 – O1 – O5 – O6 – O7 – O8

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Where:

I1 = The organic solvent input into the system (receipted – used)

O1= Emissions in waste gases (Rottapharm has an RTO for the abatement of solvents

O5 = Organic solvents lost due to physical or chemical reactions

O6 = Organic solvents contained in collected wastes

O7 = Organic solvents or organic solvents in preparation which are intended to be sold as

a commercially viable product

O8 = Organic solvents contained in preparations recovered for reuse but not as an input

to the process

2.0 Calculations:

The quantity of each solvent purchased and then used is recorded via an electronic stock

control system. Batch records are also available for the processes that use the solvent and

hence exact volumes used can be calculated via batch records and MAX systems.

Rottapharm Ltd employs a thermal oxidiser on its premises for the destruction of solvents.

At present, destruction efficiency does not exist for the installation. However, as per

manufacturer guidance, it is estimated to be approximately 95% of total throughput.

Due to this, it will be necessary to convert the organic solvents molecular constituents in

terms of TOC as C as per Table 1 below.

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Table 2: Organic Solvent input expressed in TOC as C (I1)

Solvent Total Usage 2010 (Kg)

Chemical Formula TOC as C (Kg)

IPA 11755.2 C3H8O 7053.1

Acetone 14898.8 CH3COCH3 10,119.9

Ethanol 1952.8 C2H6O 1018.8

Methanol 260.4 CH3OH 97.65

Acetonitrile 390.6 CH3CN 228.6

Acetic Acid 145.8 C2H4O2 58.3

Hydranol 151 CH4O 56.6

Dimethylformamide 1.04 C3H7NO 0.5

Acetylacetone 5.3 C5H8O2 3.1

Totals 29560.94 18636.55

Table 3: Results of Solvent Inputs calculations for site (I1)

Solvent input into the process (Kg) 29560

Solvent input into the process (as Total C) 18636.55

Table 4: Solvent emitted to air (O1)

Average Concentration of solvent (mg TOC as C/Nm3) 14.6

Maximum flow through Thermal Oxidiser (Nm3/hr) 8000

Number of hours in operation per year 509

Quantity of solvent emitted (Kg TOC as C/year) 594.5

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Table 5: Quantity of solvent destroyed in Thermal Oxidiser (O5)


Destruction rate in the Thermal Oxidiser (%) 0.95

Calculated input in the Thermal Oxidiser 11890

Calculate solvent emitted during bypass events (Kg TOC as C/year)

350.49

Quantity of solvent destroyed in the Thermal Oxidiser (Kg TOC as C/year)

10945

Table 6: Quantity of solvent used in other coating processes (O5)

Quantity of solvent used in Fortilase Process (Kg TOC as C/year)

245.5

Quantity of solvent used in Extranase Process (Kg TOC as C/year)

2531.7

Adsorption rate of solvent liqueur to tablets 0.95

Quantity of solvent used in process (Kg TOC as C/year) 2638.3

Table 7: Quantity of solvents in waste (O4)

Organic solvent collected as waste (Kg) 2.622

Organic solvent collected as waste (Kg TOC as C/Year) 1651.9

Organic solvent disposed of as mixed laboratory waste (Kg TOC as C/Year)

2245.3


3.0 Conclusion:

F = I1 – I1 – O1 – O5 – O6

18635.55 – 594.5 - 10945 – 2638.3 – 3897.2 = 560.6 Kg = 3% Solvent Unaccounted

F is less than 5 % of organic solvent input for 2010.

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APPENDIX VI PRTR 2010

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Documents

ANNUAL ENVIRONMENTAL REPORT 2010 · Discharge Volumes (m3) Volume Volume 1474.15 1241.1 1268.72 1452 1321.23 1391.41 1479.2 719.5 496.9 418.6 378.6 233.7 Jan Feb Mar Apr May Jun Jul