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«OFFICE OF LICENSING & GUIDANCE INSPECTORS REPORT ON A LICENCE APPLICATION Directors To: Kevin Motherway From: - LICENSING UNIT 05/09/2007 Date: ...»

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OFFICE OF

LICENSING &

GUIDANCE

INSPECTORS REPORT ON A LICENCE APPLICATION

Directors

To:

Kevin Motherway

From: - LICENSING UNIT

05/09/2007

Date:

Application for review of an IPPC Licence from Corden Pharma

Limited, Wallingstown, Little Island, Co.Cork. Licence Register

RE:

P0134-03

Application Details Class of activity: 5.16 The use of a chemical process for the production of basic pharmaceutical products Licence application received: 19/10/2006 Supplementary material submitted by licensee Notices under Section 90 issued: 21/5/2007 Information under Section 90 received: 19/6/2007 Submissions received: Section 99(E) 25/5/2007 Site visits: 28/7/2006, Company Corden Pharma Limited (trading as Corden Pharmachem) is a manufacturer of active pharmaceutical ingredients (APIs) and intermediates for generic and manufacturing markets. As such they manufacture a wide range of products on varying scales of production.

Corden Pharma Limited is the new owner of a long-established manufacturing installation at Wallingstown. The company was originally established in 1974 as Irish Fher Limited on the 8 ha site. In 1992 the company was acquired by private Page 1 of 13 investors and was renamed Irotec Laboratories Ltd. In 1999 the company commissioned a new API manufacturing plant known as PB2 (Production Building 2), which doubled the installation manufacturing capacity. In 1999 Cambrex acquired Irotec Laboratories Ltd. with the company changing its name to Cambrex Profarmaco Cork in October 2002 and subsequently to Cambrex Cork Ltd.

Cambrex Cork Ltd. were purchased by International Chemical Investors Group in November 2006 and changed its name to Corden Pharma Limited in January 2007, with a trading name of Corden Pharmachem currently in use.

The infrastructure has developed steadily over the years with 50% of the 8ha site now developed. The site infrastructure now comprises: Production Building 1 (PB1), Production Building 2 (PB2), an administration and laboratory building, a social building, and miscellaneous site infrastructure including a WWTP, two boilers and a thermal oxidiser. The total reactor capacity on-site is 34.6 m3 (18.9 m3 for PB1 and 15.7 m3 for PB2).

The installation is located in industrial-zoned land in the Little Island area and is near several other IPPC licensed installations. The nearest sensitive receptors to the site are the St. Lappan’s Housing Estate (c. 400m to the northwest) and the local National School (c. 250m to the north) and Cork Golf Club, which bounds the east of the installation.

The most recent planning permission for the installation dates from 14/5/2003 and relates to the retention of several prefabricated buildings used for offices, an electrical switching room, laboratory stores and a control room.

The number of staff employed at the installation is normally 105 people, with a complement of 101 people at the time of the application. The plant operates on 3cycle, 24-hour basis, Monday to Friday and is normally closed at the weekend.

Reason for Licence Review The original licence for the installation (P0134-01) was granted in 1997. A first licence review (P0134-02) was undertaken in 1999 when PB2 was commissioned.

This licence review is required to bring the site into compliance with the IPPC directive, with the class of the licence changing from Class 5.6 (EPA Act 1992) to Class 5.16 (PoE Act 2003).

Process Description

The installation has a total of 16 reactor vessels, which are highly flexible in terms of the temperature and pressure environments they can sustain, allowing the installation to manufacture a wide range of products. The manufacturing process consists of charging the reactor vessels with pharmaceutical ingredients and solvents, allowing reactions to occur, followed by centrifuging, drying and milling of the resulting product. Product is then packaged in drums and sent off-site to customers for further processing, tableting, etc. The principal chemicals used in quantity on-site are toluene, Ethyl Acetate, Acetone, THF, isoporopanol, petroleum ether and NaOH.

Air and water emissions arise primarily from the manufacturing process. Solvent emissions occur during the charging of the vessels, during reactions and emptying of the reactants. Water emissions occur from the liquid portion of the reactor Page 2 of 13 residue, centrifuging of reactants, from caustic and acidic scrubbers and general wash water used in the installation. Noise emissions are also generated by the operation of the installation.

Emissions Air The main emission to Air There are 6 main emission points to air (4 emission points specified in the application with a further 2 “minor” emission points that are more appropriately classed as main emission points. The emission points are associated with HVAC/air handling units used to manage air in the production buildings and a thermal oxidiser used to abate VOCs arising. All air emission from the reactor vessels on-site are directed to acidic/caustic scrubbers and then to a catalytic regenerative thermal oxidiser. It should be noted that the licensee has renumbered their emission points in accordance with the guidance note with a table and revised drawings included in the application.





The six main emission points to Air are:

A2/1 Thermal Oxidiser(TO). (Formerly A1/2) This abatement measure is designed to destroy water immiscible solvents (e.g.

toluene, ethyl acetate), which have not been captured by the scrubber system.

The TO is of catalytic type and destroys VOCs at temperatures below 4500C. The load on the TO is quite low (average load 4.6 g/hr) with a maximum hourly flow rate of 5,000 m3/hr. There have been numerous bypasses direct to atmosphere, via bypass vent A4/32 (122 between July –December 2006) due to Lower Explosive Limit (LEL) being exceeded, but predominantly due to low bed temperature (41%) and valve/mechanical failures (21%). The licensee is continuing to investigate the issue in conjunction with the manufacturer and have liaised throughout the process with OEE. A retrofit to resolve the issue was carried out during the company’s annual shut-down in July 2007 and initial indications are that no low temperature bypasses have occurred since. The OEE are concerned with the issue and are seeking to have it resolved as soon as possible. Licence P0134-02 specified that a continuous TOC meter be used to monitor emissions from the TO, in conjunction with monthly sampling of VOCs.

The licensee has reported metered TOC values as THC values with a maximum loading of 0.09 kg/hr at a maximum emission level of 63 mg/m3. The licensee has stated that the manufacturers specifications for the THC meter state that the THC level is equivalent to TOC and this has been confirmed after consultation with air experts in the Agency. This matter has been noted with the OEE inspector.

When the TO is functioning correctly emissions are well below the ELVs set out in P0134-02 (derived from the 1996 Batneec note) and air dispersion modelling submitted as part of the application has demonstrated the very low impact the TO is estimated to have on the local air quality even when on bypass. No ELV was set for TOC in the previous licence and in line with other installations with TOs being reviewed, it is appropriate that such a limit be set. Given the low loading on the TO, it should comfortably meet the TOC limit as specified in the May 2007 Draft BAT note for the activity and this has been applied in the RD for when the TO is functioning properly, with the current emission limit value to be applied when the TO is on bypass. This will mean that the licensee will continue to meet the current applicable standard, while being required to meet the standard for TOC that a new installation would be expected to meet, when the TO is operating correctly. The licensee will be required to notify the Agency of any bypass

–  –  –

A2/2 Air Handling Unit (formerly A1/3) Deduster in PB1 Dryer Loading Area HEPA handling 6,200 m3/hr A2/3 Air Handling Unit (formerly A1/4) Deduster in PB1 Dryer Loading Area HEPA filter handling 6,200 m3/hr A2/4 Air Handling Unit (formerly A1/5) Deduster in PB1 Dryer Loading Area handling 20,520 m3/hr The Nature and volume of emissions from the above air-handling units for the PB1 Dryer loading/unloading area are unchanged and the levels set in the RD are already consistent with the May 2007 Draft BAT note.

Air Handling Unit A2/5 (Applied for as A3/10 formerly A2/10) handling 7,500 m3/h from PB1.

This room air emission from PB1 was classed as a minor emission in P0134-02 (with no ELV, specified control parameters or monitoring set) and has a scrubber employed as abatement. However the licensee has supplied monthly monitoring data from 2004-2006 for TA Luft Class I, II and III organics that show emission levels significantly above 20% of the emission limit specified in 1996 Batneec Note. The RD renames this point as A2/5 (to reflect that it is a main (A2/X) and not a minor (A3/X) emission point and requires continued monitoring, with the relevant BAT emission limit imposed. It should be noted that air dispersion modelling has shown that the current emission levels are not having a significant impact on air quality.

HVAC Unit A2/6 (Applied for A3/17 was A2/17) HVAC Unit HEPA filtered Air Exhaust handling 50,000 m3/h from PB2.

This room air emission from PB2 was classed as a minor emission in P0134-02 (with an ELV, specified control parameters and monitoring set) and employs a HEPA filter as abatement. In error the hourly and daily flow rates specified in P0134-02 were 200 m3/hr and 1,600 m3/day (8-hour day) respectively when the actual; values are 50,000 m3/hr and 1,200,000 m3/day (24-hour day). This total air volume is in line with the volume of air being moved by the Air handling units in PB1. These flow rates are corrected in the RD.

The licensee has supplied monthly monitoring data from 2004-2006 for TA Luft Class I, II and III organics that show emission levels significantly above 20% of the emission limit values specified in 1996 Batneec Note and therefore should be classed as a main emission point. The RD renames this point as A2/6. and requires continued monitoring, with the relevant BAT emission limit imposed. It should be noted that air dispersion modelling has shown that the current emission levels are not having a significant impact on air quality.

Page 4 of 13 Boiler emissions There are two 2.5 MW Natural Gas boilers on-site with stacks A1/1 (formerly (A1/1) and A1/2 (formerly A1/6). One boiler is operated on duty and the other on cold standby. The licensee wishes to have the provision to use Gas Oil as a back up fuel, should it be required, with a condition allowing this specified in the RD.

Given their size and current use of natural gas fuel, the boilers are classed as minor emission, with the RD requiring annual monitoring of NOx, and combustion efficiency, with monitoring for SOx and particulates required only when fuel other than Natural Gas is being burned.

Minor emissions description There are 33 minor emission points consisting of the two boilers (A1/1 and A1/2), laboratory fume cupboards, room air emissions and minor vents, and an emergency generator. There are eight new minor emission points applied for in the application, with these all consisting of laboratory fume cupboards.

Fugitive emissions arising.

There are 30 fugitive emission points in the application with twenty-three of these (including ten new points) being potential emission points (bursting discs on vessels). There are also breathing vents and pressure relief valves itemised among the fugitive emission points. There have been complaints relating to odour from the WWTP in 2006, but none related to the main plant.

Page 5 of 13Impact of Air Emissions on Receiving Environment.

HCl Due to a 2.5 fold increase in the level of hydrogen chloride (HCl) being detected from the TO analyser between May and June of 2006, the licensee commissioned an air dispersion model (ISCST3). Subsequent inorganic sampling showed the actual level of HCl to be lower than that detected in the TO analyser. The predicted modelled ground level concentrations at the closest receptors were two orders of magnitude below United Kingdom Environment Agency (EA) hourly and 24-hour concentration limits specified for IPPC facilities and the 1/40th HSA 8-hour OEL derived value of 175 µg/m3. The HCl step has since been eliminated from a number of reactions and a HCl scrubber has been installed, ensuring that HCL will not reach the TO. Given the nature of the production on-site and the scrubbers in use the risk of dioxin formation is minimal as demonstrated by bi-annual monitoring. The operation parameters of the TO and the low risk of dioxin formation were outlined in the IR for P0134-02 when the TO was being installed and the TO is operated as specified by the manufacturer to prevent the formation of dioxin or damaging the TO. Given the low volume of Chlorinated substances used and the effectiveness of the scrubbers as outlined by the licensee the RD specifies that Waste gas streams going to the Thermal Oxidiser shall contain less that 1% halogenated organic substances expressed as Chlorine. The continued monitoring of the TO will ensure compliant operation.

VOCs from TO/Room Air/Combustion gases A second ISCST3 air dispersion model was commissioned by the licensee to model emission of VOCs from the TO (A1/2), room air emission from A2/5 and the HVAC process area exhaust (A2/6) and combustion gases from the two boilers A1/1 and A1/2.

The model for VOCs assumed a worst-case scenario of a maximum volume of VOCs emanating from the TO (A1/1) on bypass, and room air exhausts A1/5 and A1/6. In all, twelve solvents were modelled, with all parameters below the relevant EA short term 1-hour concentration limit by one to two orders of magnitude. The exception was toluene which at a predicted concentration of 3,037 μg/m3 was 38% of the EAL short term 1-hour concentration of 8,000 μg/m3.

All substances were also well below 1/40th HSA 8-hour OEL derived values.

Predicted concentrations at the nearest receptors (the local national school, St.

Lapians estate and Cork Golf Club) were predicted to be one to three orders of magnitude below the EAL short term 1-hour concentration for the relevant parameters.



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