Attachment No. A1

Non Technical Summary

1.1 General Information.

1.2 History of SAFC Pharma Arklow

1.3 Description of main buildings and installations.

1.4 Description of production activity.

1.5 Plant operating procedures.

1.6 Procedures for receiving quality Control and storage of raw materials.

1.7 Master and Batch Production records.

1.8 Procedures for the manufacturing, quality control and storage of intermediates and Bulk pharmaceuutical compunds

1.9 Maintenance of building and equipment

1.10 Cleaning equipment.

1.1 1 Environmental Control

1.12 Personnel safety and Fire prevention

1.13 Plant utilities

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1.1 General Information.

(a) Fin ish ed Products.

Finished Products are active pharmaceutical ingredients also known as bulk pharmaceutical chemicals (BPC's) which are used to manufacture a range of pharmaceutical products. Each finished product is typically manufactured in 2 to 10 processing steps and to clients worldwide for formulation and packaging.

The following API's(BPC's) are currently manufactured by SAFC Pharma, Arklow.

II

/An tidepres s ant i N acro IeDs v

_ _ - _ - Amitriptyline HCL i m o d a f i n i l IBromDheniramine Maleate iHistamine H I antagonist Butoconazole Nitrate I Clom imam ine HCL

" ~ " , " _ " _ l , ~ " ~ " l l - " ~ l l " " l

- " I - I ~ x -I_.- Chlorphenoxam ine HCL IAn ti choli nerg ic i S p as m o lytic

i Vas od it a tor

" - ~ ~ ~ --------- ~ -4- ---I- .- _ _ Bromide

Doxylamine Succinate - c jAntihistam inic / Hypnotic " " _

Halidor Fumarate Lofepramine HCL I Mecloxamine HCL

i Antidep ress ant i Anticholineraic / Hwnotoic /Sedative

^ x ~ " " " " , " , - - ~ x ^ x --.- ~ ~ - - _ x x _ x " - - ~ i x _ " _-

Nortriptyline HCL I Isothioendvi HCL "-

[An tide p res s ant i An ti his ta m inic

Prothipendyl HCL I Promethazine HCL I An ti p s ych o ti c Histamine H1 receDtor antaaonist /anti-emetic

xxI__IIIIIII__III ~ ~- - " - ~ -

Muscle Relaxant /Antihistam inic Muscle Relaxant /Antihistaminic -~- . " - ~- " " ~~~- Orphenadrine HCL I Orohenadrine Citrate

~ l - I _ - ~ -

-" Advanced In term ed iate I- Advanced lnterm ediate " ^

8-C h lor0 theo p h ylline 4-C hloro-n-i"ethvl~i6jridine

Note: Over the next 3 years new products will be added to the range and some of the existing products may cease to be manufactured depending on market requirements..

(b) 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.

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The following intermediates are currently manufactured by SAFC Arklow Limited for sale to other companies.

4-Chloromethylpiperidine 8-Chlorotheophylline 2,6-Difluorobenzylalcohol 2- Fluoroacetophenone 2-Ethyl,-6-Methylbenzylalcohol Meth ylphenylpyridinylcarbinol Nortriptyline Ethyl Carbamate DIPEC

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

1.2 History of SAFC Arklow Limited

SAFC Arklow limited, ( Formerly known as Honeywell Iropharm Plc), was originally a private, family owned independent company, founded in 1982 when initally 7 acres of development land and some 8 acres of marsh were acquired from the Department of Forestry just outside the town boundary of Arklow.

In 1983 Planning permission was obtained for four buildings: 1 production Plant (360 m2), 1 Pilot Plant/Warehouse (220 m2), 1 two-storey Laboratoqdoffice Building and 1 Boiler house.

Production commenced with approximately six employees in 1984. The equipment comprised of three reactors totalling 3000 gal, 1 distillation unit, 1 centrifuge and 1 dryer. The first product manufactured was 8-Chlorotheophylline, an intermediate for a motion sickness drug. Gradually further processes were developed by the in-house R & D Department and consequently the generously sized production building was equipped with additional plant over the next years.

A multipurpose warehouse was built in 1986, an administration building was added in 1988 and a second production building was erected in 1990. A second warehouse (Raw Materials warehouse) was completed in 1996.

The company’s policy was to reinvest more or less all profits whereby not only an expansion of the production capacity is made but an emphasis is taken on upgrading of GMP standards and environmental aspects. In connection with the latter a E1 million investment was made in 1993 in order to bring the powder handling facilities to current GMP/FDA requirements, a solvent recovery distillation unit was installed in 1992, a new water treatment system was built in 1990/91 and for 1996 a custom

‘designed solvent stripper unit has been commissioned in order to reduce solvents going into the aqueous effluent.

In 1996 A new production facility P3 was commissioned.

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In July 1997 Iropharm ltd was acquired by AlliedSignal, a company based in Morristown, New Jersey.

In October 1997 the company was awarded its first Integrated Pollution Control Licence. Since obtaining the licence the company has developed and continuously improve its environmental management system. Since obtaining the licence, the company has made significant environmental improvements on site.

In December 1999, AlliedSignal merged with Honeywell and the net effect of the transaction for the facility was a change in name from AlliedSignal to Honeywell Iropharm Plc.

In June 2006, the site was acquired by Sigma Aldrich Corporation, St Louis, MO- Sigma Aldrich Corporation, is a leading Life Science and high technology company. The biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical and other high technology manufacturing. a 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 API’s and key intermediates. SAFC Arklow limited site is part of this €?OUP.

Currently the site comprises of:

9 Production Building 1 (Pl)

9 Production Building 2 (P2)/Pilot Plant

P Production Building 3 (P3)

9 New Powder handling plant

9 Raw materials warehouse

P Administration Building

P Security building

9 Finished Goods Warehouse

9 Laboratories R&D and QC and environmental

P Maintenance workshop

9 Solvent Storage Area

9 Covered storage area

9 4TankFarmAreas

P Main Cooling Tower i

9 Waste Water Treatment Plant

(a) Aqueous Waste Store

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<7.. -,:.: I L,

(b) Segregation Tank

(c) Final Settling Tank

(d) Emergency Tank

(e) Aeration tank

(0 Coarse and fine pH adjustment tanks

(8) Aqueous balance tank

(h) Sequencing batch reactor

(i) Waste activated sludge tank

(j) Pinal 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 intake/outlet 1983 Industrial warehouse 1986 Office and store 1986 Extension to factory 1986 Extension to production facilities 1987 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

The site is an FDA 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. Used to resolve chiral compounds from racemic mixtures into pure enantiomers, SMB capability is a method to obtain enantiomerically pure drugs.

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1.3 DESCRIPTION OF MAIN BUILDINGS AND INSTALLATIONS.

Production Building (Pl):

P1 is comprised of a ground floor and a mezzanine floor and is divided into three

suites:

- A room containing 2 glass lined, 2 stainless steel reaction vessels, 2

crystallisers and associated addition and reflux vessels

- A room containing 9 product distillation units and the solvent recovery unit

- The powder handling rooms containing centrifuges and dryers.

The reaction and distillation units vessels hang through the mezzanine floor and are used for a variety of processes. General manufacturing processes take place in the area for the production of intermediates. P 1 has a concrete floor (covered in tiles) and concrete floor drains.

The boiler room is located immediately east of the P 1 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 fkom the thermal oxidizer boiler.

Production Building 2 (P2):

P2 is comprises of a ground floor and a mezzanine floor and contains:

- A suite with 3 glass lined, 1 stainless steel reaction vessel 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 outside the building.

- An isolated suite containing a centrifuge.

Production Building 2 (P2) and Pilot plant are located in the centre of the site. They are used for the production of active pharmaceutical ingredients (APIs). They have a cement sheeting roof which contains bonded asbestos and a sealed concrete floor. The original concrete floor (with tiles above the concrete layer) was refurbished in July 2005 (Main P2 building only).

Production Building 3(P3):

This is located immediately to the Northeast of P1 production area. It is used for the manufacture of APIs. P3 houses the Simulated Moving Bed Chromatography (SMB)

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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.

This building is divided into a few separate processing suites. The main body of P3 contains two stainless steel and three glass lined reactors. Another suite contains one stainless steel one glass lined reactor and one distillation unit. Another suite contains the SMB unit.

The processes in P 1, P2, and P3 are for the most part multi-stage. A range of solvents are used including toluene, xylene, acetone, tetrahydrofuran, isopropanol, MEK, ethylacetate and methanol. Various other solvents may also be used from time to time.

Powder handling area:

The powder handling building was constructed in 1999 and is located to the north west of P3. Intermediate products from P 1, P2 and P3 are processed further in this building in one or more of the following ways, drying, blending, sieving and milling. This plant contains a tumble drier and 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 for sale are stored in this warehouse.

This is located immediately adjacent to the raw materials warehouse, and is of similar construction. This houses finished goods prior to dispatch from the site. A small section 1 5m3 of this warehouse is divided off and used as a document store

Laboratories:

A two-storey laboratory building provides facilities for Quality Control, In Process Control and Process Technology. Another laboratory is situated at the Wastewater treatment plant for effluent analysis.

Effluent Treatment Plant:

These are located in the south eastern corner of the facility.

The principle elements of the effluent treatment plant are:

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- 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 5.1 1

Firewater retention tank:

This is a firewater lagoon and is located the north side 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 fiom 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 13 tanks and is divided into 8 bunded areas each of which has a capacity of in excess of 1 10% 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% HC1, 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 3 * lm3 centrifuge wash tanks and 2*5m3 mother liquor tanks.

Tank Farm 3:

This is located opposite the boiler house. This contains 11 stainless steel tanks all contained within the one dedicated bund. These are located on the southwestern boundary of the facility in a concrete bunded area. {These storage tanks are for the storage of raw materials and materials awaiting removal off site for recovery and/or disposal. They also house the main diesel storage tank (fuel supply for the main site boilers)}.

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.

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Administration Building:

Offices, canteen & security are located in this building. I ,

Drum Storage Platform:

This is located on the eastern boundary of the site and has a concrete base. This is spilt 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. Condition 9.4.2 of the IPC licence (see Appendix B) requires that the integrity of bunding is tested at least once every three Years,

Covered storage platform:

This area is opposite the finished goods warehouse and is used to store dedicated intermediate and product awaiting to be used by production .

Sodamide Storage container

This is located opposite the finished goods warehouse

The Maintenance workshop:

This is located on the eastern side of the facility.

A recycling area is located beside the workshop area. Cardboard is baled in this area, in addition to baling of other materials sent off-site for disposal such as fibre board drums and contaminated drum liners. Some scrap metal is also stored in the recycling area.

Firewater supply 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. The transformer room is located immediately adjacent to this area. The Emergency Generator container (self contained unit) 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.

J Waste Air Treatment Plant:

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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 SectionS. 1 1. The operation of the Thermal Oxidiser and emissions from the Thermal Oxidiser stack are regulated under the site’s IPC License No 540/P0089-2, issued in November 2000. There are a number of emission points defined in the IPC license which are not treated in the thermal oxidiser. These are related to emissions potentially containing pharmaceutical dust and are treated via HEPA filtration. The emission points are detailed in Section 5.1 1.

1.4 Description of the production activity

SAFC Arklow ltd manufactures bulk active pharmaceutical ingredients using batch chemical processes. A typical synthesis involves an initial chemical reaction followed by a series of crystallisation 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 of controlling the rate of reaction may differ. It may be the addition of a liquid or suspension of solid in a liquid at a controlled rate, maintenance of a specific temperature or reflux, or maintenance of specific PH.

After the reaction has continued for a required length of time, inorganic salts may be removed by adding water to dissolve the inorganic salts. 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, generally called a crystalliser to be cooled and crystallised.

The slurry of crystals and liquid is transferred to a centrifuge to isolate the desired crystalline product.

The mother liquor (waste liquid from centrifuge) is pumped to a storage tank for solvent recovery or off site disposal.

If the crystalline material is an intermediate product, it is further processed or sold. If the material is a final product it is dried, milled, sieved and packed.

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1

The reaction vessels, in production buildings P1, P2, P3 and powder handling are general purpose.

, 1 : ’ 7 $ 4

1.5 Plant Operating Procedures:

SAFC Arklow ltd has been inspected by the US F.D.A. (Food and Drug Administration) and internal Good Manufacturing Practices (GMP) audits are carried out at predetermined intervals ensure that the status is retained. The site has been inspected on several occasions by the FDA. The site is also IMB (Irish Medicines Board) approved. External audits are also carried out from time to time by customers. In excess of 700 Manufacturing SOP’S are currently in place to further ensure compliance with c’GMP Regulations.

1.6 Procedures for receiving, Quality Control and storage of raw materials.

When shipments of raw materials arrive, warehouse personnel verify identity and quantity against appropriate documents and enter the receipt onto the computer stock management system. The shipment is assigned quarantine status, labelled and sampled.

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 results 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.

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 foreman.

1.8 intermediates and BPC’s.

Procedures for Manufacturing, Quality Control, and storage of

The program for chemical production is generally determined by customers orders. The Operations and Supply chain manager issues the Production InstructiodBatch Sheet. This contains the raw materials requisition data and is sent first of all to the warehouse personnel.

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Upon receipt of the batch sheet warehouse personnel prepare raw material goods, record in daily stock sheet and delivers 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 materials/ Intermediates 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.

Quality Control performs testing according to written established methods described in the specification reports of the product. Quality Control personnel compare the results with the specifications and determine the disposition of the product. After approval fkom Quality Control personnel, 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 equipment

The maintenance department is responsible for maintenance and upkeep of the 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.

1.10 Cleaning Equipment.

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

1.11 Environmental control.

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 a suitably qualified person. 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

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Specific requirement of the sites Integrated Pollution Control (IPC) Licence and was first submitted to the EPA in March 1998. There is one dedicated Environmental Manager employed at the site, in addition to a Health and Safety Manager.

The site is in the process of implementing the IS0 14001 Environmental Management standard at the site. Environmental awareness training is given to each employee on site. On site induction training is given to new employees. There is also a dedicated training officer who 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 Lufi 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 m3/ 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 the range of 6-8. The second scrubber is connected to a 13 M high tower through a fan system consisting of two fans arranged to operate as Duty and Standby. The fans are suitable 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 IPC Licence No 540, issued in November 2000.

There are a number of emission points defined in the IPC licence which are not treated in the thermal oxidiser. 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.

No. 194 Thermal oxidiser S02, N02, CO, particulates, HC1, VOCs, dioxins Vent 5 Powder handling Pharmaceutical dust A1 Powder handling Pharmaceutical dust A2 Powder handling Pharmaceutical dust

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192 Powder handling Pharmaceutical dust 193 Powder handling Pharmaceutical dust No. 1 Boiler No specific limits No. 2 Boiler No specific limits

The boilers do not have specific emission limits however annual monitoring is required to assess the boiler efficiency.

The plant vent header system collects off-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 bypasdshutdown 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 is at 99.92%. This is a 40% improvement on 2005 figures.

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. S

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).

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 this application, the site now wishes to include this option as part of this application

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

0 Use of solvent as a fuel would reduce gas consumption by approximately 50%; the annual fuel consumption (gas) on site is 1330900m3. (Approximately 50% of this is used to operate the TO).

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)

\

0 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 fuel consumption and exhaust emissions from this operation( waste transport).

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

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 S.I. No. 33 of 1992 and also in accordance with conditions with current IPC Licence.

Treatment of effluent.

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The on-site WWTP 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; 0 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 directly 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. 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: 0 laboratory sinks and condensers. 0

0 cleaning of process vessels. 0

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 liquidliquid 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 characteristics etc. Wastewater which is unsuitable for on-site treatment in the WWTP are stored in various tanks on site (normally Tank 10 or Tank 59) 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.

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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 buffer tank. The inlet buffer tank provides buffer and storage capacity used during the aeration/settling/decanting/desludging part of the SBR reaction cycle.

- The process wastewater from the inlet buffer tank is pumped into the Sequencing 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 the WAS 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.

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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 shuts down for the Christmas/New Year holiday period, typically from the December to the first working day after 1 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.

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 solidifjmg.

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 P1, 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 I b s h , and 11,000 I b s h , 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 OOm3h 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 Methanolwater: 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.

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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 vdntilation 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 at approximately 5,746,000 kilowatt-hours. A standby diesel generator is also available at the site. The diesel tank for this generator is stored in a bunded area adjacent to the generator in the southern corner of the site.

'@ The majority of process water used on-site is from 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 fuel in the thermal oxidiser, while oil or gas maybe used in the boilers. Gas is supplied by Energia. Total reported gas usage in 2004 amounted to 1,047,863 m3, approximately half of which was required for operation of the thermal oxidiser.

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EPA Export 25-07-2013:20:19:39