t

Ann Kehoe Office of Climate, Licensing and Resource Use South East Region Environmental Protection Agency Heiidq uarters PO Box 3000 Johnstown Castle Estate Wexford

lgth December, 2008.

Ref: PO0894

I refer to you letter dated IOth December 2008, requesting additional information relating to IPPC License application. The Company’s responses are outlined below.

EPA Request for clarification “Please indicate whether an additional class (or classes) of activity is (are) being applied for which provide(s) for the clean up of wastu solvents from external processes on the licensed site. If so, please specijjy which additional classes are being applied for ”.

Company response An additional class of activity is not being applied for. It is the company’s interpretation that the proposed activity for re-distillation of solvent can be incorporated under the existing activities which are stated in section B3 Class of activity in the license application. Sigma Aldrich Ireland Ltd (SAFC) are licensed as Class Number 5.16: “The use of a chemical or biological process for the production of basic pharmaceutical products and 11.1 The recovery or disposal of waste in a facility, within the meaning of the Act of 1996, which facility is connected or associated with another activity specified in this Schedule in respect of which a license or revised license under Part IV is in force or in respect of which a licence under the said part is or will be required.”

The existing license POO89-3 specifies in Schedule A: limitations that the following waste related processes are authorized.

(i) (ii) Waste solvent recovery (iii)

Incineration of waste as specified in Table A2 below

Waste solvent storage and blending

The Protection of the Environment Act, 2003 Schedule 4, identifies solvent reclamation and regeneration as a waste recovery activity, This is already considered in the IPPC License.

The site specifically request approval to redisti Wpurify solvents. Sigma Aldrich Ireland Ltd (SAFC) has the existing distillation infrastructure available on site which is used regularly to purify solvents for re-use in existing processes.

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EPA Request for clarification “Provide details of the specific sources of acetonitrile (or other solvents) from external activities, which are to be reprocessed at the licensed site”.

Company response The company specifically requests approval to process a reusable raw material (Acetonitrile) from Schering Plough (Avondale) Co. (660 Tonnedannum) and Astra Zeneca approx (100 Tonnes/ annum). However to allow for future business opportunities the Company seeks approval to accept all distillable organic solvents for recovery up to a maximum site allowance of 2,000 tonnes per annum.

EPA Request for clarification “Provide details of the unit processes evolving or producing the waste reusable solvent, which is to be brought on to the licensed site for clean up”.

Company response Sigma Aldrich Ireland Ltd(SAFC) has the existing distillation infrastructure available on site which is used continually to purify solvents lor re-use in existing processes. This is already approved and licensed by the Agency. Approval to purify solvent for Schering Plough is an important commercial opportunity for Sigma Aldrich Ireland Ltd. More specific details outlining the process are in the technical summary.

EPA Request for clarification “Provide quantities of solvents to be imported onto the licensed sites from external activities on an annual basis ”. Company response It is anticipated that initially up to 760 tonnes of acetonitrile from external activities will be brought onto site on an annual basis. However ihe Company requests an allowance of 2,000 tonnes per annum for all common pharmachemical distillable organic solvents.

EPA Request for clarification “Provide Arrangements to be made for the Safety, handling and storage of solvents imported onto the licensed site from external activities ”.

Company response Before any new waste stream for recovery is accepted on site, approval for the new material will be sought from the Agency. Prior to this it will be assessed from a HSE perspective in accordance with the Site Management of Change procedures and Health Safety and Environmental checklist for the introduction of new processes on site.

Material arriving on site will be accepted in accordance with Procedure SCPOOl/SCP 029 for the acceptance of raw materials on site. A more detailed description is in section 1.41 1.5 of the technical summary.

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..... . .~... .~ .. - ....

The documentation accompanying the load shall be checked i.e. Cl form, trem card, analysis details A sample shall be retained. Material accepted shall be stored in designated areas i.e. drum store platform or designated tank, until distilled/ purified. Material that has been redistilled/ purified, shall be quantified and a recycle certificate sent to the customer.

EPA Request for clarification “Provide details of new emissions to atmosphere arising from the reprocessing of solvents from external activities on the licensed site (qualitative, quantitative) and details of any new emission points and new emissions to water (or to on- site waste water treatment facilities) arising from the reprocessing of solvents from external activities on the licensed site (qualitative, quantitative and details of any new emission points”.

Company response The proposed acceptance of solvent slreams on site for recovery will not result in any new emission points, any additional monitoring or changes to emission limit values. No new plant or equipment will be required. The unit is already licenced for use.

EPA Request for clarification Please provide an updated Non Technical Summary to reflect the information provided for in reply

Company response Updated Non technical Summary is attached

Yours sincerelv

Dora Forde ’ Environmental, Health and Safety Manager

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. . ... , .... -. - - - . . - - - -

Attachment WO. A1

Non Technical Summary Updated 15 December 2008

1 . I

1.2

1.3

1.4

I .5

1.6

1.7

1.8

I .9

1.10

1.1 I

I .12

I .13

General Information. Description of Production Activity

History of Sigma Aldrich Ireland Ltd (formerly known as SAFC Pharma, Arklow)

Description of Main Buildings and Installations.

Proposed Acetonitrile Recovery process from one potential source Generic Process Overview- Acetonitrile as an example

Fig 1 Proposed Acetonitrile Recovery - Flow Chart

Plant Operating Procedures. Unit Operations linked with Recovery of Solvents from Other Sites Figure 2: Distillation Column

Procedures for Receiving, Quality Control, and Storage of Raw Materials.

Master and Batch Production Records.

Procedures for the Manufacturing, Quality Control and Storage of Intermediates and Bulk Pharmaceutical Compounds

Maintenance of Building and Equipment

Cleaning Equipment.

Environmental Control

Personnel Safety and Fire Prevention

Plant Utilities

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1.1 General Information.

Address: Sigma Aldrich Ireland Ltd (SAFC Arklow Ltd), Vale Road, Arklow, County Wicklow, Ireland.

Sigma Aldrich Ireland Ltd is a multi-purpose pharmaceutical company engaged in the manufacture of Bulk Active Pharmaceuticals (and Advanced Pharmaceutical Intermediates. The site is a member company of Sigma Aldrich Corporation, and is a part of the SAFC Pharma Division. Sigma Aldrich headquarters is located in St Louis, Missouri, USA.

The Arklow site was constructed in 1982 trading as Iropharm and it was family owned until 1997. AlliedSignal (Honeywell) acquired the plant in 1999, and SAFC in 2006. The current reactor volume is 106m'. The site has a total area of 64,000m2 of which 28,000m2 are developed. Special capabilities include Grignard reactions, distillation of high boiling compounds and alkylations using metal hydrides and SMB chiral chromatographic separations.

Figure 1 : General Layout of the SAFC Pharma Facility in Arklow

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. . .. ..... . ... ....... .. ....~..... ---- . -

Pfoduction Sigma Aldrich Ireland Ltd site at Arklow is capable of the following operations- Batch processes High temperature reactions up to 160°C Low temperature reactions down to -10°C Cry stallisat ions High vacuum distillations Centrifugation of solids Filtration of solids Drying of solids under vacuum Chromatographic separation of enantiomers Delumping of solids Milling of solids Packaging of solids

A flow diagram of manufacturing activities at Sigma Aldrich Ireland Ltd is shown below

SUPPORTACTIMTIES

- Qualrty Assurance lRegu latorA~ ,~ -Raw Material Purchasing -Technical Material Purchasmg - H S & E Management - 1 T Support -Plant Contmlling - H R Management

Gas - Thermal oxtaatlon

Biotreatment external treatment

Liquid - %,lid - External treatment

Raw materials arrive into warehouse where they are assigned a unique identification number (raw material i2Ml was the first on site the site is currently on raw material number RM 30400). Each container of the raw material is labelled and a “yellow” quarantine label is attached. Samples are taken to QC for testing to the specification. If the material complies with ihe specification it is released and “Green” labelled by QC. The green label is placed over the yellow quarantined label on all of the containers. The material is now approved for use in manufacturing. If the raw material is rejected all containers are “Red” Labelled and placed in the locked reject area.

When manufacturing is required to run a process, they request a batch record and labels from QA. QA assign the next batch number and write it on all pages of the batch record. The batch number is unique and takes the following form B-ABC-XXX-YYY where ABC is a letter abbreviation for the product, XXX is the year of manufacture and YYY is the chronological number of the batch. This number appears on all documentation and containers relevant to the batch. When (!A have issued the batch record, manufacturing input all of the required raw material lot number and quantity. The batch record is then issued to the warehouse where all of the required raw materials are assembled. The batch record together with the raw materials is transferred to the plant for manufacturing. Page 3 of 24

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Intermediates isolated during the course of manufacture are drummed up pending transfer to the next stage. 1n;process samples are taken by manufacturing at various stages and tested by QC.

Description of the Production Activity Sigma Aldrich Ireland Ltd manufactures bulk active pharmaceutical ingredients using batch chemical processes. A typical synthesis involves an initial chemical reaction followed by a series of crystallisation and/or distillation purification steps.

The following is a typical sequence of operations:

Material which can be either raw materials supplied by another company are mixed with a solvent in a reaction vessel and a controlled chemical reaction takes place. The method for controlling the rate of reaction may differ depending on the process. For example, the addition rate of a liquid or solid suspension may be controlled, a specific temperature may be strictly monitored, or the pH of a solution may be kept within a specified range.

After the reaction has progressed for a designated time period, inorganic salts may be removed by adding water and carrying out a phase separation. As the product is dissolved in solvent and the two phases are immiscible, the water phase is separated and removed.

The organic solvent is distilled off under vacuum leaving the crude product. The crude product is then transferred to a distillation unit and purified in a fractional distillation unit under high vacuum. This yields the purified product.

The purified product is transferred to a reaction vessel and dissolved in a suitable solvent. Then acid is added and the reaction vessel is cooled to crystallise the desired acid salt or the reaction mixture may be transferred through a carbon filter to another reaction vessel (known as a crystalliser) to be cooled and crystallised.

The slurry of crystals and liquid is transferred to a centrifuge or filter dryer to isolate the desired crystalline product. The mother liquor (waste liquid from isolation step) is pumped to a storage tank for solvent recovery or off-site disposal. If the crystalline material is an intermediate product, it may be further processed or sold as an intermediate. If the material an API it is dried, milled, sieved and packed.

When the batch is completed, QC sample all of the containers and a composite sample is tested. The containers are “Yellow” quarantine labelled and transferred to the warehouse to await release to the customer. All product containers in the plant are labelled as they are filled; equipment is labelled with batch number and name of the material in the equipment

(a) Finished Products.

Most finished products are Active Pharmaceutical Ingredients (APIs), also known as Bulk Pharmaceutical Chemicals (BPC’s). They are used to manufacture a range of formulated pharmaceutical products by SAFC customers worldwide. Each finished product is typically manufactured in 2 to 10 processing steps.

The following APl’s (BPC’s) are currently manufactured by Sigma Aldrich Ireland Ltd (formerly known as SAFC E’harma, Arklow).

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. .. . --

Note: Over the coming years new products may be added to the range and some of the existing products may cease to be manufactured depending on market requircrnents.

(6) Intermediates.

The existing facility currently manufactures a range of intermediates. These intermediates are the end result of a number of process steps and are used immediately or stored on site for use in further processes. Some of the intermediates are used on site for the production of final products and a proportion are sold as advanced intermediates to other companies for further processing.

The following intermediates for sale are currently manufactured at the site:

4-Chloro-n-methylpiperidine 8-Chlorotheoph ylline 2,6-Difluorobenzylalcohol 2- Fluoroacetophenone 2-Ethyl,-6-Methylbenzylalcohol Meth ylphenylp yridin ylcarbinol Nortriptyline Ethyl Carbamate

Note: Again this list may change depending on market requirements.

1.2 History of Sigma Aldrich Ireland Ltd

Sigma Aldrich Ireland Ltd was originally a private, family-owned independent company. It was established in 1982 on 7 acres of development land. An additional 8 acres of marsh was purchased from the Department of Forestry. The site is located just outside the Arklow town boundary. In 1983 planning permission was

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o6tained for 4 buildings: 1 production Plant (360 m2), 1 Pilot PlandWarehouse (220 m2), 1 two-storey Laboratory/office Building and 1 Boiler house.

Production commenced in 1984. The equipment comprised 3 reactors, I distillation unit, 1 centrifuge and 1 dryer. The first product manufactured was 8-Chlorotheophylline7 an intermediate for a motion sickness drug. Gradually further processes were developed by the in-house R&D department and additional plant was installed in the production building few years. A multipurpose warehouse was built in 1986, an administration building was added in I988 and a second production building was erected in 1990. A second warehouse (Raw Materials warehouse) was completed in 1996.

Over the years both production capacity and GMP/HSE standards have been improved. In 1990/91, a water- treatment plant was installed. A solvent recovery distillation unit followed in 1992 and a purpose-built powder handling facility was completed in 1993. In 1996 a new production facility (P3) was commissioned. lropharm Ltd was acquired by AlliedSignal, a company based in Morristown, New Jersey, in 1997. In October 1997 the company was awarded its first Integrated Pollution Control (IPC) licence. Since obtaining the licence the company has continuously developed and improved its Environmental Management System and has made significant environmental improvements on site. In December 1999, AlliedSignal merged with Honeywell and the facility renamed Honeywell Irophami plc. In June 2006, the site was acquired by Sigma Aldrich Corporation, St Louis, MO. USA. From Jan 2009, Sigma Aldrich activities in lreland are being consolidated at Arklow and SAFC Arklow Ltd will trade as Sigma Aldrich Ireland Ltd

SAFC is the custom manufacturing group within Sigma Aldrich that focuses on both biochemical production and the manufacturing of complex, multi-step organic synthesis of APl’s and key intermediates. Sigma Aldrich Ireland Ltd site is part of this group.

Currently the site comprises ofi

P Production Building 1 (Pl)

P Production Building 2 (P2)Pilot Plant

3 Production Building 3 (P3)

3 New Powder handling plant

> Raw materials warehouse

9 Administration Building

!b Security building

P Finished Goods Warehouse

P Laboratories R&D and QC and environmental

9 Maintenance workshop

> Solvent Storage Area

3 Covered storage area

3 4 Tank Farm Areas

> Main Cooling Tower

P Waste Water Treatment Plant

(a) Aqueous Waste Store

(b) Segregation Tank

(c) Final Settling Tank Page 6 of24

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(d) Emergency Tank

(e) Aeration tank

(f) Coarse and fine pH adjustment tanks

(g) Aqueous balance tank

(h) Sequencing batch reactor

(i) Waste activated sludge tank

6) Final effluent buffer tank

(k) Effluent Control Station

- Drum Storage Area

- Emergency Tank

- Electrical Switch Board

The original facility consisted of P 1 production building, the administration building and the laboratory. A number of extensions to the facility have been completed since 1982. These are listed below:

Original Manufacturing facilities 1982 Pilot Plant and workshop 1983 Tank farms security store and water intakeloutlet 1983 Industrial warehouse 1986 Office and store 1986 Extension to factory 1986 Extension to production facilities 1 98’7 New office and staff facilities 1987 Electrical substation 1989 Extension to warehouse 1989 Warehouse for raw material storage 1994 Maintenance workshop 1994 Extension of office building 1994 Construction of Powder Handling Building 1999 Wastewater Treatment Plant Commissioning 2000 Thermal Oxidiser Commissioning 2002 Single Storey Modular office Building 2008 Single Storey Warehouse Facility 2009

The site is an FDA/ IMB inspected cGMP manufacturing site with a total reactor capacity of 90,000 litres. The plant features one of the few commercial scale simulated moving bed (SMB) multi-column chromatographic separation units in the world. This is used to resolve chiral compounds from racemic mixtures into pure enantiomers.

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1.3 DESCRIPTION OF MAlN BULLDXNGS AND INSTALLATIONS.

Pmduction Building: (PI):

PI is comprised of ground and mezzanine Iloors, and is divided into three suites: It contains 2 glass-lined reactors, 2 stainless steel reactors, 2 crystallisers and associated addition and reflux vessels. There are also 9 product distillation units and the solvent recovery unit (D5). The powder handling rooms contain 2 centrihges and 1 drier. Reaction and Distillation vessels penetrate the mezzanine floor. The floor is a combination of epoxy coat and concrete and acid resistant process drainage.

The boiler room is located immediately east of the P1 Area. There are two boilers which utilise natural gas for the generation of steam, with a combined capacity of 3,000 kg/hr steam output. These boilers supply the majority of the sites process steam requirements, with a small additional supply from the thermal oxidizer boiler.

Production Building: 2 (P2):

P2 is comprises a ground floor and mezzanine floor and contains 3 glass-lined reactors, 1 stainless steel reactor, and associated addition and reflux vessels. The pilot plant suite contains a 250 litre glass-lined pilot reaction vessel and 2 glass-lined vessels with gas scrubbing capability located outside the building (A5 and A9). An isolation suite contains a centrifuge (C5). The building has a sealed concrete floor.

Production Building 3(P3):

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0 0 0 0

RO Water Plant (1st flr)

\

P3 houses the Simulated Moving Bed Chromatography (SMB) plant which is used for separation of chiral drugs. The SMB is linked to a dedicated tank farm and an evaporator and condenser for recycling of SMB solvents. The building also contains general purpose reaction capability including 2 stainless steel and three glass-lined reactors. Another suite contains one stainless steel, one glass-lined reactor and one distillation unit.

{New) Powder Handling: Area:

A dedicated powder handling building was constructed in 1999. It is located to the north-west of P3. lntennediate products from PI, P2 and P3 are pr further in this building in one or more of the following ways, drying, blending, sieving and milling. The plant contains a tumble-drier and mobile delumping equipment.

Raw Materials Warehouse:

This is located on the northern side of the facility. It is of concrete block construction with steel-clad walls and roof, and a concrete floor. Raw materials and certain intermediates (non flammable) are stored in this area. All incoming raw materials except solvents are stored in this warehouse.

Finished Goods Warehouse:.

Finished goods and intermediates €or sale are stored in this warehouse which is located immediately adjacent to the raw materials warehouse and of similar construction. Finished goods are stored here prior to dispatch from the site. A 15m' section is segregated for document storage.

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Sinde Storey Warehouse Facility

An application was submitted to the EPA in April 2008 to expand its existing warehouse storage facilities. This building will be completed in 2009.

Laboratories:

A two-storey laboratory building provides facilities for the QC and Process Technology groups. A dedicated laboratory is situated at the WWTP plant for effluent analysis.

Effluent Treatment Plant:

The effluent treatment facilities are located in the south-eastern comer of the facility. The principle elements of the treatment plant are: - segregation tank - pH adjustment tank - aeration basin - biological treatment - settling tank

The main features of the effluent treatment plant are described in detail in section I . 1 1 Environmental Control

Pirewater Retention Tank:

This firewater lagoon is located north of the railway and is designed to retain any contaminated water in the event of an emergency. A full firewater risk assessment was completed which addresses spillages and accidental releases from site operations. The site used the EPA’s guidance note to size the current firewater retention facility A full procedure lists in detail the various scenarios for the operation of the firewater retention tank.

Tank Farm 1:

This tank farm contains I3 tanks and is divided into 8 bunded areas each of which has a capacity of in excess of 110% of the volume of the largest tank. Nine tanks are used to store solvents for recovery and recovered solvents, one tank to store waste solvent, one tank to store 36% HCI, one tank to store 30% NaOH and one tank to store Diesel fuel oil. Some of the tanks are connected to the production buildings with piping installed on a pipe rack. Each tank has a level gauge which is used for stock control.

Tank Farm 2:

This contains 7 stainless steel tanks divided into 2 bunds. Two 22m3 tanks for storage of solvent-for-recovery are located in one bund. The second bund contains three lm’ centrifuge wash tanks and two 5m3 mother liquor tanks.

Tank Farm 3:

This is located opposite the boiler house and contains 11 stainless steel tanks within one dedicated bund. It is situated on the southwestern boundary of the facility. These tanks are used to store raw materials and materials awaiting removal off-site for recovery and/or disposal. The main diesel storage tank (fuel supply for the main site boilers) is also located here.

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Tank Farm 4:

This contains 15 stainless steel tanks varying from 650 litres to 25,000 litres. Each tank is provided with pumps, flame arrestors, conservation vents, level controls and alarms and where required the tanks are heat traced and insulated.

Administration Buildine:

Offices, canteen & security are located in this building.

Drum Storage Platform:

This is located on the eastern boundary of the site and has a concrete base. It is split into three areas. The first area (closest to the warehouse) is used to store drums of new solvent material, the second is used to store intermediate products and the third is used to store aqueous and solid wastes produced on-site and awaiting disposal. The entire platform slopes in a west-to-east direction and all run-off from the platform is directed to two sumps located on the eastern (lowest) side of the drum platform. Pumps within these sumps direct liquids to the WWTP.

Covered Storage Platform:

This area is opposite the finished goods warehouse and is used as a staging area for materials assigned to production.

Drv store Storape container

A special dry storage container is located opposite the finished goods warehouse to hold Sodamide/ Lithamide which is flammable when in contact with moisture.

Maintenance Workshop:

This is located on the eastern side of the facility.

Recyclinp Area:

A recycling area is located beside the workshop. Cardboard and contaminated packaging is baled in this area before dispatching for off-site disposal. Some scrap metal is also stored in the recycling area.

Firewater Supplv Tank:

The firewater supply tank is located immediately adjacent to Tank Farm 3 in the south-west corner of the site. The sprinkler diesel pumps are located in a concrete block construction building with steel-clad roof and a concrete floor immediately east of the firewater retention tank. A transformer room is located immediately adjacent to this area and an Emergency Generator is located immediately south of the Transformer Room. The diesel tank which supplies fuel for the emergency generator is located in a bunded area immediately behind the emergency generator container.

Waste Air Treatment Plant (WATP):

The company installed a Thermal Oxidiser (TO) in 2002 to treat off-gases arising from the production processes carried out at the site. The TO is described further in Section in 1.11 ,Environmental Control section.

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Oberation of the TO and emissions frorn its stack are regulated under the site’s IPPC License (POO89-3). There are a number of plant emission points defined in the IPPC license which are not vented to the TO. These vent air from powder processing areas and the exhaust air is removed by HEPA filtration. The emission points are detailed in Section 1.1 1, Environmental Control.

1.4 Proposed Acetonitrile Recovery From one potential source- Generic Process Overview- Acetonitrile as an example

Transport documentation sent by originating firm to Site and approved prior to order acceptance

Acetonitrile received at SAFC Arklow From Customer, documented on Cl form

Details of delivery (Quantity, lots numbers etc) logged by Sigma Aldrich Ireland Ltd

Required quantity of material transferred from warehouse area to production area

Acetonitrile sampled prior to recovery to confirm composition prior to processing

Acetonitrile charged to distillation unit

Water may be charged if required depending on actual levels of impurities present in the Acetonitrile

Heating is applied to the distillation unit thus causing the Acetonitrile to distil

An initial distillation cut which will be enriched light impurities (eg toluene & water) relative to the main

quantity will be removed by distillation.

0

0

treated to remove water

IPC samples will be taken to monitor progress of the distillation

When sufficient Toluene has been removed from the acetonitrile the remaining material may then be

If applicable, IPC samples will be taken to monitor progress of the water removal

A main-fraction of purified acetonitrile will then be distilled

The initial distillation cut or “pre-run” will be retained for possible future distillation with other similar pre-

e

runs, thus resulting in enhanced re-use of the material

0

such material

The main fraction will be tested to ensure the required quality has been achieved

Further distillation may be performed if required quality has not been achieved (a repeat of the process)

When quality has been confirmed, the main fraction will be returned to customer for re-use

Recycle certificates shall be sent to customer confirming quantity redistilled

The distillation residue will be disposed of as organic solvent waste following standard site procedures for

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F$ .I Proposed Acetonitrile Recovery -- Flow Chart

ScheringPlough

Dlstil further Pre-Run if required

by same process when sufficient lots

Dryirig/water removal If required

Proceed To main-run when required purity is achieved

Distillation Complete

I--- L--

1.5 Plant Operating Procedures

Sigma Aldrich Ireland Ltd has been inspected by the US FDA and the Irish Medicines Board on a number of occasions. Typically there are 8-1 0 customer audits each year as well as regular HAS,

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‘1

I I

1

EPA and NSAl (IS014001 2004) inspections. Internal) audits are carried out at predetermined intervals ensure that the compliance status is maintained. In excess of 700 Manufacturing SOP’S are currently in place toifurther ensure compliance with all regulatory and industry standards.

Control Equipment Vessels are fully controlled from a Siemens Distributed Control System (DCS). This displays the current set

Calibration and Maintenance of Key Control Eauipment Written procedures are in place for inspection, calibration, maintenance and recording of all key items of equipment. These are logged on a PEMAC, a preventative maintenance control register, and CALIB, a calibration tracking system. Equipment is purchased according to design and purchase specifications and is verified upon either:-

monitored from any of the control terminals. Control features include flowmeters to track volumes of liquid

completion of the installation (eg verified by validation), significant modification (verified by HAZOP or Risk Assessment)

Operation of Safety Equipment/Instrumentation in Use: Safety equipment and instrumentation is operated in accordance with design specifications at all times while production activities are underway in the area being protected.

Departmental procedures and/or Master Batch Records shall provide instruction on the operation of safety equipment/instrumentation during start-up and operation.

Verification of Proper Operation: Proper functioning of safety equipmentiinstrumentation shall be routinely verified in accordance with written calibration (EGP-069) and preventative maintenance schedules (PEMAC). The Engineering/Maintenance department shall establish this schedule taking into consideration legislative requirements, manufacturer’s instructions and historical records of the equipment reliability.

Verification frequencies are recorded in the Calibration Master List (CML), PEMAC or individual 3rd party service contracts.

Changes in Operations: Significant changes in processes/production equipment shall be reviewed against existing safety systems to ensure adequate safety protection will be present under the new scenario. Such changes are reviewed and implemented under Change Control (PROC-ARK-OP-009274) and SEVESO requirements as appropriate (MAP 103).

Malfunctions and Unforeseen Events: If malfunctions or unforeseen events occur with safety equipment/instrumentation during production activities that could compromise safety, the activity must be shut down in such a manner as to minimise potential Safety & Environmental risks. Intermediate measures shall be evaluated (and implemented if necessary) to ensure safe operation until shutdown can be accomplished.

Repairs or corrective actions must be made and the proper operation of safety equipmenthnstrumentation demonstrated or certified prior to the resumption of operation.

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&tical Safety Systems List Critical Safety Systems are listed in the following databases:

11

I / I

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Preventative Maintenance Management Database (PEMAC): PEMAC identifies all Critical Safety Systems on the Preventative Maintenance Register. Records of completed PMs are recorded on the system.

External Service Contract List: The External Service Contracts list compiles (checks of specialised critical items by approved 31d parties. Records of completed checks are maintained in the Engineering Department.

Unit Operations Linked with Recovery of Solvents from Other Sites

a. Documentation on waste solvents from other sites must be received and approved by Sigma Aldrich Ireland Ltd prior to the delivery leaving the originating site. Sigma Aldrich Lreland Ltd receiving personnel will confirm all appropriate transport documentation and test results accompany the delivery and confirm the weights of each container and the total delivery. The containers will be retained in a designated bunded area pending processing. The C-I will be completed and copies sent to the originating site, the local authority and the haulier. A copy will be retained on file.

Reception of Waste Solvent for Recovery

Site Standard operating procedures define the manner by which a delivery of waste solvent is received, sampled and offloaded.

b. Pre-treatment Waste solvent streams to be recovered may contain small amounts of water or residual chemical impurities. Pre-treatment may be necessary depending on the nature of the stream.

C. Distillation Solvents recovered on site are purified by distillation. Separation is achieved by the redistribution of components between the liquid and vapour phases. The more volatile component concentrates in the vapour phase while the less volatile concentrates in the liquid phase. The 2 phases are separated by vapourisation and subsequent condensation of the vapourised solvent in a condenser and the required material is the collected in a distillate receiver. In some cases several fractions may be collected, depending on the materials being separated.

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Distillation Column

documents and enter the receipt onto the cornputer stock management system. The shipment is assigned quarantine status, labelled and sampled. 1

An outline of a typical distillation column that will be used for Solvent waste recovery is shown in Figure 2. Figure 2: Distillation Column

Solvent for recovery is charged to the Sump Chamber. The vessel jacket is heated by steam. Vapours enter the column and when the column is hlly heated, a proportion of the vapours enter the condenser and are cooled. The condensed vapours may then be directed to one of 3 chambers:

Q Dean and Stark Chamber: to collect and bleed off entrained water when distilling water immiscible solvents

0 Pre-run Chamber: to collect the initial, more volatile components 0 Main Chamber: to collect the less volatile components.

Non-volatile impurities remain in the sump chamber and are drummed for waste disposal at the end of the process as a hazardous material.

1.6 Procedures for Receiving, Quality Control and Storage of Raw Materials.

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. . - - . .............. -- -

Samples from a defined number of containers are sent to the QC lab for analysis. Quality Control carries out identity and purity tests according to established methods. Results are compared with the required specification, and, according to these resulls they determine the classification of the raw materials i.e. approval or rejection. If approved, the material is used in manufacturing, if rejected, the material is returned to the supplier.

Waste streams for recovery are assessed in accordance with site management of change procedures.

1.7 Master and Batch Production Instruction.

For each manufacturing operation there is a batch Record instruction Sheet. After drafting, these batch instruction sheets are approved by the Quality manager and approved by departments including, Health and Safety, Environmental, Production and Process Technology groups.

The Master Production Operating Instructions and Batch Record Sheets are drafted in accordance with current Good Manufacturing Practices (cGMP) for API’s. They describe in detail the manufacturing, purification and/or plant operations of a defined, batch of product. Space is provided to enter necessary batch information e.g. times, temperatures, lot numbers of raw materials, initials of operator and shift Supervisor.

1.8 Procedures for Manufacturing, QC, and Storage of lntermediates and BPC’s.

The schedule for chemical production is generally determined by customers orders. The operations dept issue the production Batch Sheet. This contains the raw materials requisition data and is sent first of all to the warehouse personnel. Upon receipt of the batch sheet warehouse personnel prepare raw material goods, record them in daily stock sheet and deliver them to the manufacturing areas. The information is entered into the computerised stock management system.

At the production building, the operator checks the delivered raw materialdintermediates to verify conformance with the master formula and batch records. During the manufacturing process the operator fills in the required data on the batch records. On completion of manufacturing activities, the operator takes samples of intermediates requiring analysis and delivers them to the laboratory for testing. The Production Supervisor/Team Leader checks and signs the batch production record and assigns quarantine status to the product.

QC performs testing according to established methods and specifications for each product. QC personnel compare the results with the specifications and determine the disposition of the product. After QC approval the status of the product is changed.

Batches of raw materials, intermediates and API’s which do not comply with specifications may be reprocessed following prescribed methods and GMP principles.

1.9 Maintenance of Building and Equiprneint

The maintenance department is responsible for maintenance and upkeep of buildings and equipment. Preventative maintenance and regular equipment checks are carried out. Preventative maintenance includes lubrication, supply and fitting of replacement parts and general upkeep of process equipment.

An equipment calibration and preventative maintenance schedule is in place at the site to ensure that equipment is calibrated and maintained regularly and in a controlled manner.

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1 1.11 Environmental Control.

1.10 Cleaning Equipment.

All process equipment is cleaned at the end of the operations as described in comprehensive cleaning

The site’s Environmental Policy is based on SAFC Environmental, Health & Safety Policy and implemented throughout the whole site. All documentation which supports the environmental management system is controlled.

All environmental procedures are approved by EHS management. The procedure becomes valid when all relevant people are trained in the new or revised procedure. The site currently operates an environmental management programme, which is a specific requirement of the sites Integrated Pollution Prevention and Control (IPPC) Licence. There is one dedicated Environmental, Health and Safety Manager employed at the site, in addition to a Health and Safety Officer.

The site has been accredited to the IS0 14001:2004 since January 2008. Environmental awareness training is given to each employee on site. On-site induction training is given to new employees. The training officer is responsible for the implementation of the site’s training programme.

Treatment of Waste Gases.

All volatile organic carbon emissions (VOC’s) are required to meet the German TA Luft limits and limits as set out in the Integrated Pollution Control Licence.

Scrubbers in which the circulating liquid is used to absorb vapours and dusts in an exhaust air stream may be used to remove VOC’s. The emissions from all main process vents are combined into one main header system which then pass through a dual scrubber system.

The dual scrubber system comprises of 2 packed bed scrubbers, which are identical in construction and each containing a 2,0001 sump on which a 6 m high packed tower is fitted. The packed section of the tower is 700 mm in diameter. Each tower is fitted with two circulation pumps rated at 8 m’/ hr and arranged to operate as duty/ standby. pH probes are connected to each scrubber. The two scrubbers operate in series. The first scrubber unit contains an acidic solution consisting of water and 30% sulphuric acid operating typically within the range of less than 7. The second scrubber contains a light viscous oil and operates typically within a pH range of 6-8. The second scrubber is connected to a 13m high tower through a fan system consisting of two fans arranged operating in Duty/Standby mode. The fans are suitably sized to meet flow and pressure specifications. The entire system is contained within a bunded area and all electrical equipment is suitably rated for use in Hazardous areas.

The Company installed a Thermal Oxidiser (TO) in 2002 to treat off gases arising from the pharmaceutical actives production processes carried out at the site. Operation of the TO and emissions from the TO stack are regulated under the site’s IPPC Licence Reg No POO89-3, issued in December 2006.

There are a number of emission points defined in the IPPC licence which are not treated in the TO. These are related to emissions potentially containing pharmaceutical dust and are treated via HEPA filtration. There are a number of licensed emission points at the site, including: Emission Point Source Licensed Emissions.

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AY -7 (formerly known as No. 194) Thennal oxidiser S02 , N02, CO, particulates, HCI, VOCs, dioxins A1 -2 (formerly known as Vent 5) Powder handling Pharmaceutical dust A.2-5 (formerly known as AI) Powder handling Pharmaceutical dust A1 -6 (formerly known as A2) Powder handling Pharmaceutical dust AI -3 (formerly known as 192) Powder handling Pharmaceutical dust A1 -4 (formerly known as193) Powder handling Pharmaceutical dust No. I Boiler No specific limits No. 2 Boiler No specific limits

The boilers do not have specific emission limits as they have always complied with T.A.Luft limits however annual monitoring is completed to assess the boiler efficiency.

The plant vent header system collects ofT-gases and vapours from reactors and other vessels in the site production buildings and draws the waste gas to the thermal oxidiser (TO) area.

The Thermal oxidiser, supplied by Kraftanlagen Energie und Umwelttechnik GmbH (KEU) receives waste gases from the vent header system and raises the gases (within the combustion chamber) to a temperature in excess of 850°C for a period in excess of two seconds. In order to maintain the temperature within the combustion chamber natural gas is employed as the primary support fuel, though a diesel backup system is also available if required. A quench, scrubber and reheat unit are also located after the combustion chamber to further condition the gas prior to emission to atmosphere.

The oxidiser does experience occasional bypass/shutdown events, which are reported to the EPA. In these instances untreated flue gas may be released to atmosphere via an emergency bypass release stack (the released gases would include process related emissions collected in the plant vent header system). The site maintains detailed records of the quantities of gaseous volatile organic compounds released during these events and reports the data to the EPA. Site management are working on an ongoing basis to minimise the number and duration of bypass/shutdown events. In 2004 the oxidiser availability was approximately 98.78 %. In 2005, an annual uptime of 98.7%. The performance of the thermal oxidizer in 2006 was at 99.14%. This is a 40% improvement on 2005 figures. In 2007, the performance was 98.94% and the performance for 2008 is currently being assessed.

Condition 4.1.1 of the IPC licence requires that all bypasses are reported to the EPA, though site management report that no action has been taken to date by the EPA in relation to the reported bypasses. This was subsequently changed in the current license ( Condition 1 1.1 .(i) to report any bypasses greater than 15 minutes duration.

Condition 5.10 of the site IPC license, where a bypass event in excess of 1-hour occurs, production processes generating VOC emissions are shut down unless safety considerations require a process to continue or unless no significant environmental Impact is anticipated (based on measurement of the concentration and quantity of released VOC’s). The company tracks all events and Investigates all causes of bypasses. Meetings are held with key departments on a regular basis to prevent recurring issues and improve overall performance of the system.

In 2005, company completed a study to investigate the feasibility of fuel substitution. The involves using clean waste solvent instead of fossil fuel ( i.e. gas/ diesel ) as a fuel in the thermal oxidiser to maintain the temperature at which it operates( 850 C).

The TO was originally proposed to the EPA as an end of pipe treatment system for vapour phase organics using commercially available fossil fuels ( Fuel oil or natural gas) to provide heat input for VOC oxidation( Air abatement equipment).

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The possibility of using clean solvents as a support fuel was mentioned in the license revision application (2000) to the EPA and subsequently in the inspector’s memo to the Board of the EPA recommending the granting of a license. At the time, Honeywell Iropharm did not formally request the use of solvents in the last review and condition 7.2 in the current license specifically states “Neither waste solvents streams or solvents shall be used as an alternative fuel in the thermal oxidiser”.

In the application dated June 2006 the site included this option. The current application is to amend the NOx Emission limit value that was applied in the license dated December 2006, as the requirements imposed on the company are not being applied to other similar installations.

Advantages The use of solvent generated on site, as a he1 for the thermal oxidiser would result in the following environmental and financial advantages including:

* consumption (gas) on site is 1330900m3. (Approximately 50% of this is used to operate the TO).

Use of solvent as a fuel would reduct: gas consumption by approximately 50%; the annual &el

0 The solvent streams on the site are clean in that they do not contain any significant amount of chlorine, sulphur or nitrogen and therefore will not result in any additional burden on the flue gas treatment system. The substitution of gas/ diesel with solvent as a fuel to maintain the temperature is a “Fuel recovery operation”, the solvents typically generated on site would be seen as a cleaner fuel to that of diesel or natural gas. This would result in lower emissions from the site( a reduction of 1441 kg of CO2 emitted to atmosphere)

An estimated 600 tonnes of high grade solvent could be used on site, depending on the calorific value which would reduce the number of waste shipments offsite by a potential 75%.Lowering associated transport &el consumption and exhaust emissions from this operation( waste transport).

Financial savings in fuel consumption cost reduced waste disposal costs (up to 200,000).

Treatrnen t of fupitive emissions

Fugitive emissions may occur through a number of non point sources. The most recent fugitive emissions study reviewed in March 2006 showed that the total fugitive losses were calculated to be 0.76% of the total solvent input which is significantly lower than the solvent regulations limit of 15% Fugitive emissions are reviewed on an annual basis as part of the environmental management programme.

Treatment of waste Solids.

General non-hazardous waste is disposed of in accordance with current licence conditions and applicable regulations. The waste is segregated and recycled /reused for an alternative purpose where practicable. Non hazardous waste which cannot be reused or recycled is sent to landfill.

Toxic and dangerous waste including packaging which has come in contact with process materials and filters are collected and transported off-site for incineration by licensed specialised companies. All waste is handled in accordance with the appropriate Regulations and also in accordance with conditions with current IPPC Licence.

Waste arising from Solvent recovery activities include:

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Oi05Ol 070503 070504 Non Halogenated organic solvents 070508

Aqueous washing liquors and other liquors Organic halogenated solvents, washing liquids and mother liquors

Other still bottoms and reaction residues

Recovered solvent may be stored in a dedic,ated tank pending re-use on site or customer call-off. Supply Chain and EHS' department personnel will generate the appropriate documentation. The volume of solvent despatched to customers will be tracked on a waste management log.

These wastes are already generated on site and are transported to an approved Hazardous waste facility in accordance with license requirements.

Treatment of effluent.

The on-site W WTP treats aqueous process waste produced during the production Process. Effluent from the canteen area, toilets, hand wash basins, etc. are not treated in the on-site WWTP.

There are four categories of effluent emanating from the facility: 0 surface water run-off; 0 domestic effluent; 0 weak process effluent; e strong process effluent.

Surface water run-off from roads, roofs, car park and other low risk areas drain via a Separate surface water collection system to a surface water sump located adjacent to the Waste Activated Sludge Tank at the WWTP. The surface water is continuously monitored at this point for pH and TOC. From here the surface water is pumped either directIy to the River (as long as pH and TOC are within normal parameters), or pumped to the firewater retention tank where it can be released back into the WWTP for treatment.

Domestic effluent is piped to a septic tank which is located in the northwest corner of the site and the overflow or bypass discharged into a soak pit and hence to a stream leading to the Avoca River. This septic tank is desuldged a number of tiems during the year. In 2008 , a study on the operation of this system was completed and sent to the Agency in December 2008. Recommendations for improvement will be included in the sites Environmental Management programme for 2009 The run-off from the drum platform area, bunded areas and other higher risk area of the site are discharged to

the weak process effluent drains.

Weak process effluent arises from: a laboratory sinks and condensers. 0

0 cleaning of process vessels. a

floor washings in the production buildings (through floor drains).

cooling tower water dump from process vessels.

Weak process effluent drains are fed directly into the WWTP as opposed to strong process effluent which may adversely impact the operation of the WWTP if fed into the WWTP in large volumes.These are discharged to the waste treatment plant where they are treated before being discharged to the Avoca River.

Strong process effluents arise from IiquidAiquid separation processes in the production buildings. This effluent is discharged to the Emergency Tank (balancing tank for the WWTP). Release from the emergency tank into the main WWTP process is controlled by the WWTP operator and is dependant on the loading and effluent

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cliaracteristics etc. Wastewater which is unsuitable for on-site treatment in the WWTP are stored in various tanks on site (normally Tank 10 or Tank 55’) and is sent off-site for either recovery or disposal by incineration.

Some waste solvents and mother liquors are recovered Solvents which cannot be recovered on-site are collected and transported off site for recovery or incineration by specialist companies.

A brief summary of the WWTP process/components is as follows:

Process effluent gravitates to the Inlet Treatment section of the WWTP which comprises of pH correction in 2 No. pH correction chambers and then removal of Influent solids in the segregation tank. The segregation tank is periodically emptied and the settled solids are removed via a suction tanker. The integrity of the tank is visually checked during these periods.

- The process wastewater in the segregation tank is pumped to the inlet buffertank. The inlet buffer tank provides buffer and storage capacity used during the aeration/settling/decan tingldesludging part of the SBR reaction cycle.

- The process wastewater from the inlet buffer tank is pumped into thesequencing Batch Reactor (SBR). The process wastewater is then treated biologically to reduce the BOD/COD content of the wastewater.

- The waste activated sludge (WAS) removed from the SBR is pumped to theWAS buffer tank. Flocculation and dewatering of the WAS is carried out using a DEWA Flocculator and Belt Filter Press to approximately 15%) dry matter.

- The treated final effluent which decants from the SBR is collected and stored in the Final Buffer Tank. The purpose of this tank is to provide buffer storage of final effluent. The tank is designed to accept up to two days inflow. Final effluent is pumped from this tank via a final effluent monitoring station to an outfall located in the River Avoca.

A drum crusher and drum washer is also located in the WWTP area. Aqueous material from the drum crusher and drum wash flow across the concrete base in this area into the process drains serving this area.

1.12 Personal Safety and Fire Prevention.

Fire safety is a major consideration in the design and construction of all buildings and facilities. Safety is of prime importance in all operating procedures.

Every staff member working in the production areas or laboratories wears protective gloves, helmets, shoes and safety glasses as required. Also air conditioned hoods are provided for working with certain materials.

There is a site wide fire alarm system in all buildings. In the processing area explosion-proof electrical equipment is used. Powder and carbon dioxide fire extinguishers, hydrants and fire hoses, fire blankets, eye washes and emergency showers are available.

Fire drills are practised twice yearly and involve all operating personnel. .Drills are also conducted with the outside emergency services on site.

1.13 Normal Hours of Operation.

The site currently operates continuously, in three shifts, from 07.00 on Monday to 23.00 pm on Friday. During periods of high demand for product the plant operate from 07.00 on Monday to 15.00 on Saturday. The plant

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s h t s down for the Christmas/New Year holiday period, typically from the December to the first working day aher I st January, and for the first week in August.

The current hours of operation are under review with a plan to eventually work 24 hours a day 7 days a week, to provide extra flexibility and output.

i

The effluent treatment plant and cooling tower for reactors continue to operate at weekends and during the 2 shutdown periods when the production plant is stopped. Occasionally a reaction vessel may be set in a fail- safe only mode to prevent the contents solidifying.

Weekends and in particular the summer shutdown are used to carry out maintenance and replace items of equipment. Just before summer shutdown, all process equipment is emptied and cleaned before it is handed over to the maintenance team.

1.14 Plant Utilities.

Production buildings PI, P2, P3 are supplied with cold water, electricity, heating, ventilation, and steam, cooling water, chilled water, deionised water, compressed air, nitrogen and vacuum.

The available energies are:

Steam: 2 Heinkel water tube boilers rated at '7,700 Ibshr, and 1 1,000 lbs/hr, of steam, are normally on line to the plant at a pressure of 20-25 bar. A Babcock Roley boiler is available as standby. The boilers are fuelled by natural gas, with gas oil (diesel) as a back up. Two different steam pressures are supplied to the plant. The first is a high pressure (20 bars) and the second is a pressure (25 bars). Low pressure steam is used for glass- lined reactors and the dryers. High pressure steam is used for the distillation units.

Cooling Tower Water: There are 4 mechanically air induced draft type cooling towers on site. The smaller one re-circulates water at 40m3/hour and is used for cooling condensers only. The large tower re-circulates water at 1 OOm'/hr and is used for cooling of process vessels.

P3 Cooled Water Chilling Plant: which is capable of cooling water to + 5°C is used for cooling process vessels and to regulate highly exothermic reactions.

P1/P2 MethanoVWater: mixture capable of cooling to -30°C is used for cooling contents of the reactor below 0°C and to regulate highly exothermic reactions. Hence, reaction vessels are provided with direct heating and cooling which enable a temperature from - 30°C - 180°C to be provided.

- P3 Glycol system Which operates at -1 5 C for the operation of the filter dryer PHU chiller water system required for the SMB and HVAC. -

In the powder handling rooms, conditions are regulated by air supply and extraction. In all process areas a local exhaust ventilation system is provided at equipment.

/

Compressed air is available for general use at reaction vessels and hose stations. Conditioned air for use in compressed air hoods is available at different Places. For safe handling of highly volatile and flammable solvents, a nitrogen gas supply is installed and connected to all reaction vessels, centrifuges and dryers.

The site is connected to a mains electricity supply. Annual electricity consumption is

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- . . . . . . . . . . . . -. . . -. . . . . . . . . . . . . - -

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The majority of process water used on-site is fi-om the municipal supply with additional water from a well located in the WWTP area. Well water, when used, is treated by filtration, chlorination and UV sterilisation prior to use in the process. This water is used in reaction vessels and centrifuges either as a raw material or as a cleaning agent. Water usage at the site during 2004 is reported at 38,415 m3. Heating at the site is via 5 boilers (one located in the laboratory building, one in the Administration building, one in the workshop area and two in the boiler room) which can operate on either oil or gas. Total oil purchases in 2004 amounted to 34,691 litres. Typically only gas is currently used as a support he1 in the thermal oxidiser, while oil or gas maybe used in the

The site recognises resource consumption reduction as a significant goal for the site. An energy audit was completed in early 2008, and an energy team established. This cross functional team, focus on a wide range of opportunities for resource consumption reduction, which are prioritised. Success on completing these items are reported in the site's Environmental Management Programme

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