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ATTACHMENT No. A · IPPC Licence Application Attachment No. A A.l.1 INTRODUCTION Wyeth Medica...

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IPPC Licence Application Attachment No. A A.l.l INTRODUCTlON Page 2 A.l.2 NEW DEVELOPMENTS 2 A.l.3 FACILITY OPERATIONS 4 A.1.4 RAWMATERIALS AND PRODUCT 6 A.1.5 EMISSIONS TO ATMOSPHERE 8 A.1.6 EMISSIONS TO SEWER 14 A.1.7 EMISSIONS TO WATER 16 A.1.8 EMISSIONS TO GROUND 17 A.1.9 NOISE EMISSIONS 17 18 18 19 19 20 20 21 ATTACHMENT No. A.1 NON-TECHNICAL SUMMARY A.l.10 WASTE A.l.11 SAMPLING AND MONITORING A.1.12 ENERGY EFFICIENCY A.1.13 CONTAINMENT OF ACCIDENTAL SPILLAGES A.l.14 EMERGENCY RESPONSE A.l.15 ENVIRONMENTAL MANAGEMENT A.1.16 DECOMMISSIONING A-lof2 For inspection purposes only. Consent of copyright owner required for any other use. EPA Export 25-07-2013:15:34:52
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Page 1: ATTACHMENT No. A · IPPC Licence Application Attachment No. A A.l.1 INTRODUCTION Wyeth Medica Ireland (WMI) is a trading company of AHP Manufacturing B.V.. The company is currently

IPPC Licence Application Attachment No. A

A.l.l INTRODUCTlON

Page

2

A.l.2 NEW DEVELOPMENTS 2

A.l.3 FACILITY OPERATIONS 4

A.1.4 RAWMATERIALS AND PRODUCT 6

A.1.5 EMISSIONS TO ATMOSPHERE 8

A.1.6 EMISSIONS TO SEWER 14

A.1.7 EMISSIONS TO WATER 16

A.1.8 EMISSIONS TO GROUND 17

A.1.9 NOISE EMISSIONS 17

18

18

19

19

20

20

21

ATTACHMENT No. A.1

NON-TECHNICAL SUMMARY

A.l.10 WASTE

A.l.11 SAMPLING AND MONITORING

A.1.12 ENERGY EFFICIENCY

A.1.13 CONTAINMENT OF ACCIDENTAL SPILLAGES

A.l.14 EMERGENCY RESPONSE

A.l.15 ENVIRONMENTAL MANAGEMENT

A.1.16 DECOMMISSIONING

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Page 2: ATTACHMENT No. A · IPPC Licence Application Attachment No. A A.l.1 INTRODUCTION Wyeth Medica Ireland (WMI) is a trading company of AHP Manufacturing B.V.. The company is currently

IPPC Licence Application Attachment No. A

A.l.1 INTRODUCTION

Wyeth Medica Ireland (WMI) is a trading company of AHP Manufacturing B.V.. The company is currently involved in a number of new developments including two key production expansion facilities. These developments at the WMI, Newbridge site will require a revision of the site’s current Integrated Pollution Control (PC) licence.

WMI is a pharmaceutical production facility located at Buckley’s Cross, Old Connell, Newbridge, Co. Kildare. The site layout is shown in Drawing Al.

WMI manufactures solid dose pharmaceutical products for human consumption at the Newbridge site. Today the Newbridge plant is a centre of excellence for the provision of global health care products and also region specific health care products for Wyeth. The facility has seen significant growth since start-up with increases seen in the annual tablet volumes, the number of product variations and the head count. As an organisation, WMI is committed to increasing the quality of life of their customers as well as being a quality employer. In addition WMI is cognisant of its responsibilities to the local community and to the environment.

WMI has approximately 1,550 employees at the Newbridge site. The facility operates on a 24-hour, 4-cycle shift, 7 days per week basis. There is a security presence at the site at all times.

The total site area at WMI is 49.7 hectares, with approximately 25.5 hectares used by the company for the overall production operation and car parking requirements.

A.l.2 NEW DEVELOPMENTS The following new developments included in this revision of the Integrated Pollution Control (IPC) licence “BZA/CE- PNP, Levo/EE Continuous Use and Ancillary Projects” comprise of;

1. New production facility for Premarin New formulation Production, BZA/CE-PNP facility.

2. New production facility for Levo/EE Continuous Use Production Facility.)

3. Waste Water Pre-Treatment Plant (WWTP) and associated conveyance system (the commissioning date is the 31st December 2005).

4. Waste Management Compound. 5. TOC (Total Organic Compound) monitoring unit. 6. Research and Development Facility (this facility is only at “concept

phase” and has not been sanctioned for construction yet). 7. Building 9, Incoming Quality Control Laboratory extension 8. Site infrastructure including roadways, new site entrance, car parking,

walkways.

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IPPC Licence Application Attachment No. A

9. Utilities support equipment including new boilers, pipe rack, cooling water towers and generators.

10. New Combined Heat and Power (CHP) Plant.

Amendments to IPC Licence Register No. 673 (made in accordance with Condition 1.2) since the issue of this licence in April 2004, as approved by the Agency, are included in the scope of this IPC Licence Review. Such licence changes include: 1. Installation of an existing standby generator (Approved by the EPA as

per correspondence to the EPA dated the 6th of May 2005 reference M673/apll4bk). Installation of effluent cooling skids on Girton Washer (Approved by the EPA as per correspondence to the EPA dated the 6th of May 2005 reference M673/ap114bk). Effluent buffer tank (Approved by the EPA as per correspondence to the EPA dated the 6th of May 2005 reference M673/ap114bk). Dedicated air exhausts for (a) a fan enclosure within the plant room (Old Reference Number: M3-43, New Reference Number: A3-38) and (b) an ICP laboratory instrument in the HT Laboratory in Building 3 (Old Reference Number: M3-44. New Reference Number: A3-17). (Approved by the EPA as per correspondence to the EPA dated the 6th of May 2005 reference M673/ap114bk). Revised Emission Limit Values (ELVs) for Al-1OA to be included The Agency in letter dated 6 May 2005 (Reference M673/ap14bk) has approved the revision of the emission limit value for NOx and CO for Al-10 to 600mg/ms and 2000mg/ms respectively. Combined operation of A2-16 and A2-41 Alterations to the list of chemicals used on site (Table G) (Approved by the EPA as per correspondence to the EPA dated the 6th of May 2005 reference M673/ap114bk). Trial for the recycling and treatment of chlorinated solvent streams from the Proscon and Kuhni units by incineration at the Shanks Chemical Services Ltd., facilities in Granton, Scotland and in Fawley, UK respectively using the Onyx Group. (Approved by the EPA as per correspondence to the EPA dated the 6th of May 2005 reference M673/ap114bk).

2.

3.

0 4.

5.

6. 7.

The new BZA/CE-PNP facility is a high containment tablet manufacturing facility designed to manufacture a new formulation of an existing hormone treatment product.

The proposed BZA/CE-PNP development consists of a three-storey extension to the existing Building 3 manufacturing facility, including office accomrrtodation, ancillary site building, structures and site services. Planning permission has been granted for this extension. The buildings within this development comprise a total footprint area of 6,466m2. The infrastructural

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IPPC Licence Application Attachment No. A

requirements of this development will also necessitate the construction of a central utilities building (CUB) with an approximate floor area of l,llOmz, in addition to a cold store, diesel fuel tank, cooling towers, ESB substation extension, chilling pump and generator, and two temporary (only for the duration of the construction phase of the proposed development) contractor compounds. The larger compound (which will be the main contractors compound) will have an area of approximately 18,98Om* and the smaller compound (which will be the lay-down area for the BZA/CE-PNP construction site) will have an area of approximately 3,875m2.

A section of the existing Building 4 warehouse will be converted to accommodate the manufacture of new oral contraceptive products Levo/EE Continuous Use. The process will be operated on a single floor with the process equipment stacked as required. The facility will be used as a single product line, but is being designed for multi-purpose.

The BZA/CE-PNP and Levo-EE Continuous Use processes are similar to existing site operations, which are well proven and utilise Best Available Techniques (BAT), and will be operated using best available practices. In particular, the technologies and systems to be employed to minimise and control environmental emissions are considered to comply with the standards of BAT.

The proposed manufacture of the new products will involve mixing, blending, coating and drying of pharmaceutical active ingredients using a water-based process. No organic solvents will be used in either the manufacture of Premarin or Levo/EE Continuous Use products.

It is proposed that a new building (location to be defined) will house the new research and development laboratory (R&D). Pilot scale evaluation of processes are proposed to take’ place in the R&D Facility, which would be similar to operations that currently take place in the Technical Services area. (Note this project is currently at “concept stage” and has not been sanctioned for construction yet.)

A.l.3 FACIiYTY OPERATIONS Operations are based on formulation activities, consisting of blending of raw materials, granulation, drying and coating processes, with subsequent filling and packaging operations and product distribution from the site. There are associated warehouse facilities on-site to provide storage facilities for raw materials and final product.

Production takes place in buildings 3, 3A, 3B, 3C, and 4C with ancillary activities taking place in the packaging building (2, 2A), solvent recovery plant (Proscon and Kuhni) and laboratories. Other facilities include warehousing for raw materials, intermediates and finished goods, external

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Page 5: ATTACHMENT No. A · IPPC Licence Application Attachment No. A A.l.1 INTRODUCTION Wyeth Medica Ireland (WMI) is a trading company of AHP Manufacturing B.V.. The company is currently

IITC Licence Application

materials storage, services including steam, compressed air, nitrogen, cooling water and process water, Combined Heat and Power (CHP) plant, an engineering office building, an engineering workshop, an administration building and canteen.

Site operations are divided into the various buildings on-site (Drawing Al), which may be further detailed as follows:

Building I -Administration

The administration services required to support the WMI pharmaceutical facility are based in Building 1. Such services include the accormting, purchasing and data processing activities associated with a manufacturing facility. The canteen is also located in Building 1.

Building 2A - Packaging

Packaging operations for all pharmaceutical products manufactured at the WMI facility (and potentially for other plants within the Wyeth organisation) are contained in this building. The packaging process involves the filling of tablets into blister packs, and then further packaging into various primary and secondary containers. A maintenance department for the packaging operation is also based in this building. In addition, this building also contains the Quality Assurance (QA) Inspection Department.

Building 3 - Tablet Manufacture and Quality Control Situated in close proximity to the warehouse and packaging buildings, the main tabletting operations on-site are conducted in this building, and may be further subdivided into the following manufacturing areas:

+ Oral Contraceptives (OC) + Hormone Therapy (HT - previously referred to as HRT) + Tranquillisers (TRANQS) + Efexor (previously referred to as Lederle)

For quality control purposes and for protection of cross contamination of product, the manufacturing areas are operated and maintained as separate sections with individual processing operations associated with each area. The quality control laboratories associated with each of these manufacturing areas are located in Building 3.

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IPPC Licence Application Attachment No. A

Building 4 - Warehouse

This building was originally the main warehouse on-site but previous developments involved the conversion of sections of the building to a lay down area for incoming materials movement, QA inspections for finished product, pallet wash room, HT sort/print area, OC sorting, solvent storage area, hazardous and non-hazardous waste compactor rooms and engineering stores.

The southeast section of Building 4 will be converted as part of the current site developments to house the production facility for Levo/EE Continuous Use.

Building 5 - UtilitieslMaintenance

The Utilities building is situated adjacent to the east car park, and contains the utilities and services required for the present WMI facility. This includes the boiler house, CHP unit, cooling towers and associated services.

Building 9 - ASRS Warehouse

This building was constructed in 1999 to provide sufficient storage of all raw materials, finished goods, packaging materials and supplies for site production. Organic solvents are not stored in this building. The warehouse utilises an automatic storage and retrieval system for materials. There is a dedicated tanked basement under the building, designed to contain all firewater generated in the event of a fire in the warehouse. The volume of this basement is 3,433m3. A dedicated access corridor links this building with the process areas, to facilitate materials movement between buildings.

A.1.4 RAW MATEXZALS AND PRODUCT

The raw materials utilised at the WMI facility for production operations may be categorised as iollows.

- Physiologically active substances (Active Pharmaceutical Ingredients - APIs)

- Physiologically inactive substances (Excipients) - Solvents

APIs form the physiologically active material in a tablet, which provide the therapeutic effect in the tablet.

Excipients are typically biologically inactive substances, which are utilised in tablet production for any of the following reasons:

’ Automated Storage and Retrieval System

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IPPC Licence Application Attachment No. A

l G>

(ii)

(iii)

(iv>

(VI

l

Coating May be incorporated into tablet manufacture to apply a different colour to tablets, to make tablets easier to swallow, improve appearance or taste or for other reasons. Binder: May be utilised as substances to bind the other ingredients together prior to pressing. Disintegrators: May be incorporated into tablet manufacture to facilitate rapid adsorption of the active ingredient after the tablet is ingested into the system. This is achieved by the disintegrator causing the tablet to swell resulting in the break up of the tablet ‘form and the release of the active ingredients. Diluents: May be utilised to varying degrees depending on tablet specification. Diluents provide the inert material, which is mixed with the active material to form the tablet. Lubricants: The addition of this substance is to improve movement of the tablet mix in the processing stage, thus minimising blockages in process pipelines.

Other materials such as glidants, flavourings, sweeteners and dyes are also used in tablet manufacture.

The use of organic solvents is incorporated into some tablet manufacture (Efexor - Dichloromethane, Methanol; HT - IMS) to facilitate coating operations. In addition, solvent is utilised in cleaning programmes for specific equipment systems.

The main products currently manufactured and proposed for manufacture (in bold typeface) at the facility include the following:

1. Hormone Therapy - Premarin, Premarin MPA, Premarin New Formulation, Prempack

C, Premelle and Premique

2. Oral Contraceptives - Harmonet, Trinordiol, Nordette, Ovranette, Minesse, Minulet,

Levo/EE Continuous Use

3. Cardiovascular - Monocor, Isoten

4. Gastrointestinal - Zoton

5. Central Nervous System - Efexor, Efexor XR, Sonata, Tavor

6. Antibiotics

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IPPC Licence Application Attachment No. A

- MinocinMR

A.15 EMISSIONS TO ATMOSPHERE

A.1.5.1 Point Source Emissions

A summary list of main emission points to atmosphere is provided in Table A.l.l, this includes the list of existing and proposed (in bold typeface) main emission points.

Table A.l.l Summary of Main Emission Points to Atmosphere

Ejq&&q$

A2-1 General dust collection - Efexor/ Tranqs (TB 1) A2-2 General dust collection -Tranqs/Efexor (TB 4)

A2-3 Coating Pan (Accelacota) - Tranqs/Efexor (TB 5) A2-4 Fluid Bed Dryer (Glatt) - Tranqs (TB 6)

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IPPC Licence Application Attachment No. A

A2-29

A2-30

A2-31

A2-32

A2-33

A2-34

A2-35

A2-36

A2-37

A2-38

A2-39

A2-40

A2-41

A2-42

A2-43

A2-44

A2-45

Pelligrini Pans 9-12 OC (TB 32) Seal Coat Exhaust (Pelligrini) - HT (TB 33) MPA Coating Pans-HT (PA-14914) (TB 34) MPA Coating Pans-HT (PA-15014) (TB 35)

HCV - Tranqs (TB 36) Aeromatic MP4 FBD-Efexor (TB 37)

Dust Extract for Coating Pans 5-8 - OC (TB 38) Glatt Procoater Pan 1 MPA-HT (TB 43) Glatt Procoater Pan MPA-HT (TB 44)

Glatt 120 fluid bed dryer- Efexor (TB 45) House Vacuum Unit (TB46)

Dust Collection Unit - Efexor (TB 47) Proscon Secondary Abatement System (TB 48)

General Dust Collection - RMDU (AS 1) HCV Exhaust (AS 2)

General Dust Collection (A)-Packaging Lines (l-9) (PB 1) General Dust Collection (B) -Packaging Lines (10-17) (PB

2) A2-46

A2-47

General Dust Collection -2A Packaging Lines (PB 3) NUMBER NOT USED

II A2-48 NUMBER NOT USED I A2-49

A2-50

A2-51

A2-52

R & D Lab Emission Point

Tablet Coater 1 BZAKE-PNP

Tablet Coater 2 BZA/CE-PNP

Tablet Coater 3 BZAKE-PNP A2-53

A2-54

A2-55

A2-56

A2-57

Tablet Coater 4 BZA/CE-PNP

Tablet Coater 5 BZAKE-PNP

Tablet Coater 6 BZAKE-PNP

Tablet Coater 7 BZAKE-PNP

Tablet Coater 8 BZAKE-PNP

A2-58

A2-59

A2-60

Tablet Coater 9 BZA/CE-PNP

Tablet Coater 10 BZAKE-PNP

Tablet Coater 11 BZAKE-PNP

A2-61

A2-62 Tablet Coater 12 BZAKE-PNP

Tablet Coater 13 BZAKE-PNP

A2-63 Tablet Coater 14 BZAKE-PNP

Tablet Coater 15 BZAKE-PNI?

A2-65

A2-66

Tablet Coater 16 BZAKE-PNP

Active Loading Dispensing Isolator (Levo/EE

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IPPC Licence Application Attachment No. A

\\

A2-67 Roller Compactor Isolator/RC (Levo/EE Continuous

Use 2)

I Press 1 Isolator (Levo/EE Continuous Use 3)

Press 1 Manual Sampling Isolator (Levo/EE Continuous Use 4)

Press 2 Isolator (Levo/EE Continuous Use 5)

Press 2 Manual Sampling Isolator (Levo/EE Continuous Use 6)

Press 3 Isolator (Levo/EE Continuous Use 7)

Press 3 Manual Sampling Isolator (Levo/EE Continuous Use 8)

A2-69

A2-70

A2-71

A2-72

A2-73

A2-74

A2-75

A2-76

Coating Room Manual Sampling Isolator (Levo/EE Continuous Use 9)

Glatt Coater Exhaust (Levo/EE Continuous Use 12) I

1 Central Dust Collector (Levo/EE Continuous Use 13)

A2-77

A2-78

A2-79

A2-80

A2-81

A2-82

A2-83

A2-84

A2-85

A2-86

BZAKE-PNP FBD/Granulator 1

BZAKE-PNP FBD/Granulator 2

BZAICE-PNP Dust Extract 1

BZAKE-PNP Dust Extract 2

BZAKE-PNP Vacuum Extract 1

BZAKE-PNP Vacuum Extract 2

Seal coat exhaust (Pelligrini) - HT (MPA) (TB 39)

Seal coat exhaust (Pelligrini) - HT (MPA) (TB 40)

Sugar coating Pan 1 (Accelacota) - HT (TB 41) I

Sugar coating Pan 2 (Accelacota) - HT (TB 42) A2-87

A2-88 BZAKE-PNP FBD Tablet Press 1 Dust Collector BZAKE-PNP FBD Tablet Press 2 Dust Collector

A249 A2-90

A2-91

A2-92

\ BZ AK&YNY FBD T aMet Press 3 Dust C&ector BZAKE-PNP FBD Tablet Press 4 Dust Collector

Charging Isolator (Levo/EE Continuous Use)

Laminar Downflow Booth Vacuum Lifter

(Levo/EE Continuous Use)

A2-93

A2-94

Roller Compactor Exhaust

(Levo/EE Continuous Use)

Coater - Dessicant Wheel/Dehumidifier

(Levo/EE Continuous Use)

Emissions from these reference points are subject to control and abatemen t

technology and comply with existing emission limit values as defined in the current WMI IPC licence Reg. No. 673

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IPPC Licence Application Attachment No. A

l With regard to the “BZA/CE-PNP, Levo/EE Continuous Use and Ancillary Projects”, the main process emissions will arise from Levo/EE Continuous Use (Building 4) and the BZA/CE-PNP (Building 3C). The main emissions consist of discharge of air from:

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Tablet Coaters Granulators Fluid Bed Dryers Vacuum Dryers Active Loading Dispensing Isolator Roller Compactor Isolator Press Isolators Manual Sampling Isolators Glatt Coaters Exhaust Dust Collectors

In addition to the main emission points, small discharges take place from minor emission points and could take place from potential emission points.

A.1.5.2 Boiler Emissions A summary list of boiler emission points to atmosphere is provided in Table A.1.2, this includes the list of existing and proposed (in bold typeface) boiler emission points.

Table A.1.2 Summary of Boiler Emission Points to Atmosphere

Al-2 I B08101 MTHW Boiler

Al-3 I BOB102 MTHW Boiler

Al-4 I B08103 MTHW Boiler

Al-5 I B08104 Steam Boilers

Al-6

Al-7

Al-8

Al-9

Al-lO A

BOB106 Steam Boiler

B08034 MTHIW Boiler

B08107 Steam Boiler

BOB108 MTHW Boiler

Existing CHP

Al-10 B Proposed CHP

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IPPC Licence Application Attachment No. A

Al-12

Al-13

BOSllO Proposed Steam Boiler

B08111 Proposed Steam Boiler

Under normal conditions the boilers will operate on natural gas. Fuel oil (low sulphur content) is used for a maximum period of two months per annum as a standby fuel in event of loss of supply of natural gas. However, the actual usage is likely to be significantly less than this.

The three boilers proposed to be installed, as part of the BZA/CE-PNP production facility will also operate on natural gas. However, should any of these additional boilers be required to operate on fuel oil, boiler equipment will be fitted with low NO, (oxides of nitrogen) burners to reduce the formation of NOX during the combustion process. Control of the combustion process will also assist in minimising the formation of CO (carbon monoxide) and unburnt hydrocarbons.

A.M.3 Control G, Abatement Technology

As site operations comprise mainly of tablet manufacture, process emissions are generally particulate in nature. Control and abatement technology employed on-site for particulate emissions include built-in extraction systems for process equipment and house cleaning vacuum systems for areas associated with tablet manufacture and packaging. Dust collection systems include a combination of cartridge and high efficiency particulate air (HEPA) filters, which are subject to monitoring and inspections. The HEPA filters provide 99.97% efficiency at 0.3 micron size for dust collection.

Solvent emissions also arise on-site, primarily due to solvent use in tablet manufacture. In particular, dichloromethane and methanol are used as carrier agents in the coating process of some products (Efexor). An on-site solvent recovery system (SRS) removes solvent from the air stream through a cooling and condensation process. The recovery system has a recovery efficiency of 98.5%. The gas stream is then vented to a dedicated solvent abatement system (SAS), where any remaining solvent is removed by absorption, discharging to atmosphere with VOC levels less than O.O05kg/hour.

In July 2004 WMI received permission from the EPA to simultaneously operate the Proscon (A2-41) and the Kuhni (A2-16) solvent recovery systems.

A.1 Li.4 Fugitive Emissions

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IPPC Licence Application Attachment No. A

l The facility has been designed to minimise potential sources of fugitive emissions arising from process areas and buildings. Fugitive emission sources are limited to minor leakages from connections, isolation and control valves, relief valves, equipment seals and analysers. Dust emissions are vented to specific extract systems and house cleaning vacuum systems. Fugitive solvent emissions are minimal due to the closed loop systems of the Glatt coating process and dedicated solvent recovery and abatement system on-site.

Good housekeeping practices, including preventative ma-intenance and routine monitoring of equipment on-site minimise the potential for any equipment leaks.

l

Conservation vents are fitted on all tanks in the bulk storage tank farm to minimise any fugitive emissions during storage of materials. Standard operating procedures are implemented to minimise any fugitive emissions during road tanker loading/unloading.

Premarin, which is currently produced at the WMI site uses organic solvent- based technology (IMS), will now be manufactured using water as the alternative to organic solvent (Premarin New Formulation). This will help minimise potential sources of fugitive organic solvent emissions arising from process areas.

A.l.5.5 Assessment of Impact of Atmospheric Emissions

Air dispersion mode&g was carried out on the major process emission sources of APIs (HT and OC active) as well as Volatile Organic Compounds (VOCs). Levels of VOCs are predicted to be within the Environmental Assessment Limits published by the English Environmental Agency.

There are currently no guidelines for ambient levels of APIs so in order to establish the hotential impact of APIs on the receiving environment the concept of Maximum At Risk Individual (MARI) assessment was used. The theoretical dose of the solvent to the MARI was calculated for the HT and OC APIs. These were then compared to the therapeutic dose of each API. It was found that HT and OC APIs would pose no significant impact to individuals in the vicinity of the WMI facility.

Air dispersion modelling has also been conducted for the existing and proposed boiler emission sources on-site, operating on both diesel oil and natural gas. Worst-case conditions were used for each scenario to predict the maximum ground level concentrations (GLCs) of pollutants (NOX, CO, SO2 and I’Mlo) likely to occur as a result of atmospheric emissions from the facility.

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Predicted concentrations of NOz, SO2, PM10 and CO are all within the appropriate AQS (air quality standards) and WHO (World Health Organisation guidelines) air quality guideline values. As the maximum predicted GLCs of pollutants occurring as a result of the emissions from the boilers based on worst case scenario condition assumptions are below the relevant air quality limits and guideline values, emissions from the facility will not have any significant adverse impact on human health and the environment and the existing ambient air quality.

WMI has been granted a Greenhouse Gas Emissions Permit by the EPA (permit number GHG057-02). This permit authorises WMI to undertake named activities resulting in emissions of carbon dioxide.

A.Z.6 EMISSIONS TO SEWER

A.l.6.1 Process Emissions There are two sewer emission points at the WMI site. The process waste

emission point (SE-2) joins the foul sewer within the site to become emission point SE-l, at the site boundary, which is summarised in Table A.1.3. The “BZA/CE- PNP, Levo EE Continuous use and Ancillary Projects” will connect to the existing process drainage system and therefore not result in an additional emission point to sewer.

SE-l Existing 15Omm diameter rising main Foul & discharging to existing 300mm Wastewater diameter municipal sewer outside site boundarv. at Bucklev’s Cross Roads

Process

Process wastewater arises from the production areas (Process wastewaters generated at the facility are those originating from daily wash-down activities, namely wet washing of blending bins/pans, washing of utensils/small items, washing oi pallets) on-site and hmboiler blow down. This is ccmbined with the domestic stream, comprising wastewater from the canteen and toilets. As part of the WWTP and associated conveyance system development, the foul system on-site will no longer convey domestic wastewater from the three residential properties located adjacent to the site.

l

0

WMI are constructing a state of the art WWTP to meet and exceed the requirements imposed by Condition 6.2 of the existing IPC Licence Registration No. 673. The WWTP will be capable of routinely handling 55Oma of waste water per day with turn down and turn up capacities of 300m3 to 777m3 per day respectively.

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The resultant treated wastewater stream will be pumped to the tie-in with the Kildare County Council municipal sewer. Effluent discharged through this route will be monitored in accordance with the revised IPPC licence. As part of WMI water consumption reduction initiatives, the treated effluent may alternatively be routed to the site utilities area, for re-use in the facility cooling water system.

A.1.6.2 Assessment of Impact of Emissions to SewedWaters

At all stages of the development of the WMI site, assessments were carried out on the effluents (independent toxicity, respirometry and biodegradation trials) to ensure that the effluents were:

l Biodegradable l NonToxic l Non inhibitory

to the downstream municipal wastewater treatment (MWWTP) biological processes (Osberstown WWTP). This was verified on several occasions in accordance with the WMI IPC licence provisions and whenever process changes were anticipated.

As part of this process, and also in accordance with current and future needs and Condition 6.2 of the current IPC Licence Registration No. 673, a treatment plant to biologically pre-treat the effluent prior to subsequent residual API destruction by ozone is being constructed at the WMI site.

An additional benefit of this process is that the organic content of the effluent is substantially reduced prior to discharge to the municipal treatment plant. This reduces the load to the plant. As the WMI treatment system will use bacteria, which will not have sufficient ‘food’ from the process effluent, the plant will treat some or all of its own domestic wastewater. This is doubly beneficial as it produces a better bacterial population and further reduces the load to the MWWTP.

WMI is however retaining the current IPC load allowance for potential future product development at the Newbridge site.

The proposed on-site treatment system is state of the art and exceeds BAT requirements for organics removal. The plant design is very flexible to be efficient at all stages of development at the WMI site.

Because of on site water conservation measures WMI has obtained approval from Kildare County Council that the emissions to sewer be expressed as mass or total load emissions rather than as concentrations. This is environmentally beneficial as it enables water conservation to be implemented without the artificial and unnecessary constraint of meeting a

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concentration limit. The downstream treatment is only dependent on the mass of the materials in the effluent and separately on the volume.

The only parameter to increase substantially in this licence request is the salt load. This is necessary due to water softening requirements on site and is a con-m-ton circumstance for industrial sites.

The increased salt level will not have an impact on the on-site or off-site WWTPs or on the receiving water (the worst case rise in the receiving water would be less than 2% of the permitted load).

Overall the pre-treated effluent leaving the WMI site will be similar to, or better than, the high quality final effluent discharged from Osberstown treatment plant to the River Liffey.

The requested increase in effluent volume from approximately 450 m3/day to 777m3/day at full production will represent an insignificant 1% increase in the dry weather flow to the expanded Osberstown plant.

Overall it has been acknowledged by the Sanitary Authority that the on site treatment and requested changes to the WMI IPC licence will have no detrimental impact on the receiving MWWTP or the River Liffey, and in fact will be largely beneficial.

The on site WMI WWTP will be operational by the start of January 2006.

The entire package of WMI treatment and controls meets all current and future anticipated EU and National regulations and guidelines.

Since the introduction of the expanded biological treatment at Osberstown with final polishing and nutrient removal, there has been a marked improvement in the chemical and biotic quality of the River Liffey.

A.1.7 Emissions to Water

The foul/process wastewater system and surface water system are segregated to minimise the unnecessary treatment of uncontaminated water.

The surface water system conveys storm water run-off from the site, discharging directly to the River Liffey. The surface water discharge point (SW-l) incorporates penstock valves, which can be activated to cease discharging as required. Oil interceptors are incorporated into the surface water system as a precautionary measure, an oil spy monitor reports back to the Building Management System (BMS).

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The “BZA/CE-PNP, Levo Continuous Use and Ancillary Projects” development will be connected to the existing system and will not result in an additional emission point for storm waters.

The quantities of surface water arising on-site depend on rainfall. The additional storm waters arising from the “BZA/CE-PNP, Levo/EE Continuous Use and Ancillary Projects” expansion will be minimal therefore, the impact of storm water run-off arising from “BZA/CE-PNP, Levo/EE Continuous Use and Ancillary Projects” may be considered negligible.

Surface water run-off will be attenuated using an attenuation tank to ensure there will be no nett increase in the peak surface water run off rate from the WMI site.

Ail.8 EMISSIONS TO GROUND

There are no emissions to ground from the WMI site. However, the company is monitoring site groundwater quality on a biannual basis in accordance with the requirements of its current PC Licence Register No. 673.

A.1.9 NOISE EMISSIONS

Annual noise surveys conducted at the WMI site have demonstrated compliance with IPC licence specified emission limit values for noise for daytime and nighttime measurements.

The minimisation of noise emissions has been an integral part of the design of “BZA/CE-PNP, Levo/EE Continuous Use and Ancillary Projects”. Noise level criteria have been specified for particular items of equipment to ensure that operation of the facility has minimal impact on any noise sensitive receptors.

Various noise control measures have been incorporated into the design of “BZA/CE-PNP, Levo/EE Continuous Use and Ancillary Projects”including the selection of equipment with low inherent noise emission levels and the provision of acoustic insulation of equipment.

In addition, some specific items of noise generating equipment, namely the emergency diesel generator, will only be used in emergency situations.

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Noise attenuation measures will be used where possible. These will minimise any noise emissions arising on site. These measures include:

l Selection of plant with low inherent potential for generation of noise and/ or vibration;

l Erection of barriers as necessary around items such as generators or high duty compressors;

l Location of any noisy plant as far away from sensitive properties as permitted by site constraints; and

l The use of vibration isolated support structures where necessary.

A.1.10 WASTE

Wastes arising at the WMI facility from process, laboratory, packaging, and other typical sources are both hazardous and non-hazardous, and are classified accordingly. Rigorous waste management programmes are controlled by standard operating procedures, which are established on-site for waste segregation, handling, labeling, documenting, storage and treatment/disposal of waste off-site.

A new waste management facility will be constructed as part of the “BZA/CE-PNP, Levo/EE Continuous Use and Ancillary Projects” development. In the new waste management facility there will be dedicated hazardous and non-hazardous waste storage areas, which will be separated by a wall. This waste management facility will be suitably contained in accordance with IPC licence requirements and best practice.

Wastes generated by the “BZA/CE-PNP, Levo/EE Continuous Use and Ancillary Projects” development are similar in character to wastes currently generated by existing operations, but much smaller in quantity. Permission is also being sought to increase the quantities of existing waste generated to reflect current output levels and production processes. When the new WWTP is commissioned, some wastes currently sent for treatment off site will be \r.reated on site. This wiU. result in a reduction in the total quantity of waste sent for off-site treatment.

Waste management programmes are on-going at the facility, incorporating the waste management principles of prevention, minimisation, re-use, recycling, recovery and disposal. These will continue for the “BZA/CE-PNP, Levo/EE Continuous Use and Ancillary Projects” developments.

A.1.11 SAMPLING AND MONITORING

Monitoring of emissions to the environment is conducted to ensure all control/ treatment systems continue to operate to specification and in compliance with emission limit values and the requirements of the PC licence. Provisions for monitoring, sampling and analyses of environmental

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emissions have been incorporated into the design of “BZA/CE-PNP, Levo/EE Continuous Use and Ancillary Projects”.

A.1.12 ENERGY EFFICIENCY

Energy conservation plays an integral part in plant operations at the Newbridge site. WMI has adopted to a Corporate Strategic Energy Utility Plan, which assesses all aspects of energy usage at the facility for current and future requirements. Enviros Consulting Ltd., on behalf of Sustainable Energy Ireland carried out an energy audit at WMI between December 2002 and February 2003. The energy audit forms part of the Negotiated Energy Agreements Pilot Programme. The aim of the study was to:

l Identify individual cost effective energy savings projects and to quantify the scope for energy conservation at the site.

l Investigate the calculation of an energy performance indicator.

Over the coming years, it is anticipated that items identified in this report will translate into energy efficiency projects and will form the basis of a number of key environmental objectives. This will result in a significant energy saving over a 5-year period.

WMI is also an active participant in the Annual Self-Audit and Statement of Energy Accounts Scheme, which is operated by Sustainable Energy Ireland. Scheme members are committed to establishing annual targets for energy savings within their companies, with subsequent publication of their achievements. Previous energy saving programmes on-site include the installation of the CHIT’ unit, conversion of boiler fuel from oil to natural gas and installation of variable speed drives on air handling units.

For the BZA/CE-PNP process, operation of the mechanical utilities will be automated and controlled by a central building management system (BMS) allowing for accurate control and monitoring of the systems to improve energy efficiency.

A.l.13 CONTAZNMENT OF ACCIDENTAL SPHL4.GES AND EMISSIONS

WMI has comprehensive spill response procedures in place to address the emergency action and remedial measures required in the event of a spillage on-site.

The surface water system collects surface water runoff from the site and discharges to the municipal surface water sewer. Isolation valves (penstock valves) are closed near the discharge point to the municipal surface water sewer in the event of a spillage, thus containing the material.

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The storage and containment of all materials at the WMI facility will continue to conform to existing IPC licence requirements and best practice. Rainwater collected in bunded areas will continue to be inspected and if uncontaminated will be released to the municipal foul sewer under controlled conditions. If the bund water is contaminated, then it will be appropriately stored on-site, prior to disposal off-site by an appropriately licensed waste management contractor.

WMI has established emergency response procedures to minimise the impact of accidental emissions on the environment.

A risk assessment of firewater run-off has been carried out. It was found that maximum required retention capacity of 6,284ms has been calculated for potentially contaminated firewater and coincident rainwater. However, this volume is based on the unlikely coincidence of two very unlikely events

l The 20-year return 24-hour rainfall event i.e. 68mm of rainwater and

l Suppression of an on-site fire requiring all the firewater stored on site, plus all the water brought on-site by Kildare Fire Brigade

Firewater retention facilities are provided for those parts of the site that hold the largest quantities of materials that could damage the aquatic environment and hence pose the greatest risk. However, the runoff retention capacity is insufficient to ensure compliance with the EPA guidelines. The shortfall is approximately 1,300m3 and WMI are assessing options for providing this additional capacity.

A.Z.14 EMERGENCY RESPONSE

WMI ensures that appropriately high standards of safety and environmental protection measures are implemented and appropriate equipment used to preventmdminimise accidental/uncontrolledemissionstothe environment. In addition, WMI has established emergency response procedures for all potential emergencies.

Taking into consideration the “BZA/CE-PNP, Levo/EE Continuous Use and Ancillary Projects” development and existing operations on-site, the facility is not classified as a major hazard site under the Seveso II Directive.

A.1.15 Environmental Management

WMI is committed to implementing and employing high standards of safety. Environmental awareness is a priority of the company.

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The Environmental Health & Safety (EHS) Associate Director and EHS Department ensures the day-to-day operations of the facility are conducted with minimal risk of harm to humans and the environment. Since 1997, the site has operated under the IPC Licensing system, the EHS department ensures a high level of compliance with the conditions of the operating IPC Licence is maintained.

The Environmental Management System (EMS) has been audited and independently certified since 1998, as complying with the requirements of IS0 14001.

Internal audits are conducted by WMI staff throughout the year, with each area of the operation undergoing a detailed environmental, health and safety audit by the EHS Department on an annual basis. The Environmental Health and Safety Management Committee annually review the EMS, to ensure its continuing suitability, adequacy and effectiveness. The management review addresses the possible need for changes to Environmental, Health and Safety Policy, environmental objectives and other elements of the environmental management system, in the light of environmental management system audit results, changing circumstances and the commitment to continual improvement.

WMI is registered under the European Eco-Management Audit Scheme (EMAS) since 2004. EMAS goes beyond the overall requirements of IS0 14001 and provides a publicly available statement of WMI’s environmental performance.

WMI has recently been certified by SGS International Certification Services Ltd. as complying with the requirements of OHSAS 18001. OHSAS 18001 is an international specification which defines a set of requirements for a comprehensive Occupational Health and Safety Management System specification, designed to enable organisations to manage both their operational risks and improve their performance.

A.P.16 Decommissioning

WMI has prepared a Residuals Management Plan (RMP) for the Newbridge site, providing details and costs for the decommissioning of the site in the event of full or permanent partial closure. This RMP is reviewed and updated on an annual basis.

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