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«Application Details Name and address of activity Irotec Laboratories Ltd., Wallingstown, Little Island Co. Cork. Class of activity: 5.6 Manufacture ...»

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DATE: 11 January 1999

TO: Each Board Member

FROM: Annette Prendergast

RE: Summary report on review of IPC Licence Register No. 134

(Irotec) New Reg. No. 461.

Application Details

Name and address of activity Irotec Laboratories Ltd., Wallingstown,

Little Island Co. Cork.

Class of activity: 5.6 Manufacture of pharmaceutical products and their intermediates.

Request from activity requesting review of IPC 26 June 1998 licence Notices under section 85 (i)(b) issued: 17 July 1998 EIS Received 23 July 1998 Information under article 16 (4) received: 23 July 1998 Article 17(2) Request issued 19 August 1998 Article 14(1) Request Issued 19 August 1998 Information Received under Article 14 12 October 1998 Information received under article 17 13 October 1998 EIS in Compliance 12 October 1998 Article 17(3) Clarification request issued 05 November 1998 Information Received 23 November 1998 Section 97 notice issued: 05 August 1998 Information under section 97 received: 09 September 1998, 12 September 1998, 04 November 1998 Site visit 06 January 1999 Company Irotec Laboratories Ltd. is a manufacturer of fine chemical, pharmaceutical substances and their intermediates for generic and contract manufacturing markets. It is also a Research and Development facility, developing a number of in-house products. Presently there is a product range of 29 products. The product list includes a wide range of active materials which are used in the formulation of final dose forms at secondary pharmaceutical facilities off-site.

The therapeutic use of Irotec’s products include: anti-rheumatic, anti inflammatory, anti coagulant, anti-depressant. The total reactor capacity in the production plant is 18.83 m3.

l : \l i c e n si n g u n i t \l i c e nc e d e t e r m i n a t i o n \i p p c \l i c e n c e d e c i si o n s\p 0 4 6 1 \4 6 1 r ep t. d oc The normal working hours are 24 hours per day, 5 days per week. The shut down period is two weeks in summer and one week at Christmas. There are 77 employees.

The new production building will be involved in the manufacture of an identical range of products to those which are currently being manufactured at the existing facility. A total of six reactors with a total capacity of 15.7 m3, two centrifuges, two dryers and a milling unit will be provided in the new production building. A range of additional facilities will be provided to support production building two which include; a new utilities plant, a new drum store, fire water retention pond, an additional scrubber plant for air emissions, a thermal oxidiser to treat combined emissions from both production plants and upgraded waste water treatment plant facilities.

Reason For IPC Licence Review It is proposed to construct a new production building to increase production capacity. In support of this expansion of production capacity, it is proposed to replace the existing gas fired boiler with a boiler, that has double the capacity of the existing boiler. There will be a new pharmaceutical dust emission point associated with the new milling unit. A new scrubber plant will be installed to treat air emissions from the new production plant and a new thermal oxidiser will be installed to treat combined emissions from both production plants.

Emissions from the thermal oxidiser will discharge to the existing main air emission point A1/2. Effluent discharge volume will increase from 120 m3/day to 255 m3/day. Maximum loading for BOD, COD, ammonia and suspended solids discharge will double in line with increased production capacity.

Summary of Main Changes from existing Licence to proposed review Licence.

• Condition 1 updated.

• Condition 3.2.2 slightly modified.

• Condition 3.3.2 (iii) slightly modified.

• Condition 5.5 is a new condition.

• In emissions to sewer Sanitary Authority conditions have been included.

Condition 6.9 and 6.14 are new conditions.

• Condition 9.2 on firewater retention has been updated as a proposal to construct a firewater retention pond has been agreed with the Agency.

• Condition 9.3.4 is updated on groundwater quality.

• The updated bund condition 9.4 has been included.

• Condition 10.2 on fugitive emissions modified.

• Condition 12.1 on emergency response has been updated.

• The Residuals Management condition has been included because the company have included an outline plan in the review application.

Groundwater underneath the site has been contaminated but indications to date suggest off-site sources. Following the isolation and elimination of the off-site sources of ground water contamination the company are then required to determine if there are any on-site sources of groundwater contamination. If on-site sources are identified a groundwater remediation plan will be required.

• Sanitary Authority charges have been included.

• In relation to emissions from the proposed thermal oxidiser, the emission point has not changed. However as a result of the Thermal Oxidiser it is necessary to set limits for dioxins, nitrogen oxides, sulphur dioxide and carbon monoxide. Additional monitoring requirements for CO, NOx dioxins, and SO2 are included. The company propose in the review application to install a continuous TOC monitor on the thermal oxidiser and this has been included in the licence.

• 1 new pharmaceutical dust emission point has been included.

• The abatement treatment section for the Thermal oxidiser has been included.

• In relation to emissions to sewer a limit for sulphate at the request of the Sanitary Authority has been included. The volume limit has been increased to take into account increased production. A limit value for phosphorus has been included. The loading limit for BOD, COD, suspended solids and ammonia has been increased. The time limits for achieving reduced ammonia and FOG, limits has been increased to allow for additional assessment of the impact of PB2 on the current WWTP. An additional 15 months to achieve reduced ammonia limits has been included in the PD.

• The waste analysis requirements have been expanded to ensure complete records for all hazardous wastes are maintained by the company.


The principal changes from the original IPC application with regard to air are: The upgrade in size of the existing natural gas boiler.

• The installation of 1 additional pharmaceutical dust emission point A 2/17.

This dust emission point is at the new plant BATNEEC limit value for pharmaceutical dust.

• The installation of an acid and basic scrubber system for production building two and a gas fired thermal oxidiser to treat combined emissions from production buildings one and two, and associated emission limits.

Air abatement system Currently all significant emissions from production building 1(PB1) are collected into a vent header and sent to either the acid or caustic scrubbers for treatment. There is a third vent header system with scrubbers which is used infrequently to treat pilot plant emissions and assist in characterisation of emissions from new processes. The existing scrubber systems are ineffective in removing water-immiscible solvents (e.g. toluene, ethyl acetate) and hydrocarbon gases (methane isobutylene). It is proposed to install a regenerative catalytic thermal oxidiser to treat scrubbed emissions from the acid and basic vent header systems from PB1 and to ensure compliance with new plant BATNEEC emission limit values. Emissions will discharge to the existing emission point A 1/2. The third vent header system will bypass the thermal oxidiser and discharge to A1/2 also. This scrubbing system was installed for potential future use where small quantities of other emission types (e.g. hydrocarbon gases which need to be isolated from the acidic and basic vapour emissions) may be scrubbed in a specialist scrubber system.

There will be continuous monitoring of TOC from Vent A 1/2 to ensure compliance with licence limits. The PD requires the licensee to notify the Agency of any by pass of the thermal oxidiser. The process emissions from production building 2 (PB2) will initially be scrubbed in two aqueous absorption column systems, operated in parallel with the existing scrubbing systems from PB1. The emissions from both scrubbing systems, including, chlorinated emissions will then be discharged to the regenerative catalytic thermal oxidiser. Emissions from the thermal oxidiser will then be discharged through the existing main emission point A 1/2. New plant BATNEEC limits will be achieved. There is an emergency vent located before the Thermal Oxidiser (A 3/32). This will be activated if there is a high LEL concentration of solvents in the vent header system. If the thermal oxidiser shuts down due to problems, pre scrubbed emissions will by pass the thermal oxidiser and discharge through vent A 1/2.

The decision to select the regenerative catalytic thermal oxidiser (RCTO) was made by the company in order to meet BATNEEC emission limit values.

Solvent recovery was not chosen because the wide range of solvent mixtures, small quantities and purification difficulties mean that recovery is not economically attractive and not feasible. Liquid/solid waste incinerator was considered but the systems are much more expensive and complex than systems designed for vapours only and also the small quantities of liquid waste generated at Irotec would not justify liquid incineration with heat recovery. A regenerative heat exchanger allows heat efficiency of 90%. A recuperative shell-and-tube exchanger would have about 70% efficiency under optimal conditions. Therefore a RCTO is preferred at Irotec as the waste gas loading is relatively low and may fluctuate. At low waste gas concentrations the RCTO can operate without a burner (autotherm). The plant will operate autotherm at waste gas concentrations between 0.7 and 1 g/m3 depending on the nature of the VOC. Average loads at Irotec range from 1-2 g/m3. An RCTO destroys VOC’s at temperatures below 450oC compared to non catalytic units which operate at temperatures of about 1000oC. This reduction in temperature offers the following advantages; production of nitrogen oxides and carbon monoxide is negligible, VOC removal efficiency greater than 99%, fuel consumption is lower, start up time is shorter, flow rate through the unit can be varied, no waster water is produced and reliability is improved.

The supplier of the thermal oxidiser KEU has provided a written guarantee that the dioxin level of the emissions from the RCTO will not exceed a dioxin limit of 0.1 ng/m3. A dioxin limit of 0.1 ng/m3 has been included in the PD. The total maximum licensed emission for dioxins from the plant is less than 5mg/ annum. This is much lower that any of the licensed hazardous waste incinerators. KEU has performed tests on dioxin formation in their catalytic thermal oxidisers. Tests confirm the capability of the catalytic thermal oxidiser to operate well below dioxin emission limit values. KEU also has years of experience with catalytic oxidation involving various chlorinated solvents from chemical plants, operating well below the dioxin emission limit value. The thermal oxidiser is equipped with a chromium-based catalyst. KEU give a process guarantee that the thermal oxidiser emissions will not exceed the dioxin limit of 0.1 ng/Nm3 if the total inlet concentration of chlorinated hydrocarbons and HCl is less than 60 mg/Nm3 over a 30 minute average. This has been included as condition 5.5 of the PD. The PD also requires continuous monitoring of HCl and quarterly monitoring for dioxins. (The chromiumbased catalyst is able to handle chlorinated organics or HCl concentrations up to about 10g/Nm3 without generating dioxin concentrations exceeding 0.1 ng/Nm3 ). The material of construction of the thermal oxidiser is carbon steel, which limits the chlorinated/HCl inlet concentration to 60 mg/Nm3.

Impact of air emissions Normal operations The US EPA Industrial Source Complex Short model was used to predict maximum 1 hour ground level concentrations of individual pollutants outside the boundary from the thermal oxidiser and boiler. The maximum predicted hourly or daily ground level concentrations of the individual compounds based on maximum emission rates for existing and proposed new sources were less that the relevant Air Quality Standard (for SO2 and NO2) or guideline such as the WHO and the OEL/40 for individual solvents. It is therefore predicted that the maximum emission rates for individual compounds for the main existing and proposed new sources will not have any adverse effects on the environment.

By-pass of thermal oxidisers Modelling conducted on pre-scrubbed emissions from PB1, which would be similar to emissions discharged from an emergency vent, predicted no significant impact.


The company sought revision of the following emission limit value from the original IPC application with regard to emissions to sewer : An increase in effluent discharge volume from 120 m3 / day to 255m3/day to cater for a doubling of production capacity and the installation of a sludge dewatering press.

• An increase in BOD load from 100kg/day to 200 kg/day due to a doubling of production capacity at the plant. Irotec state that they propose to reduce BOD concentration from 1670 mg/l to 1000mg/l by the end of 1999, by optimising WWTP performance. The company is currently achieving a BOD reduction of 78% and this is expected to be improved to 91% reduction by implementing planned modifications to the WWTP.

• An increase in COD load from 500 kg/day to 1000 kg/day to cater for a doubling of production capacity at the plant. Irotec state that they propose to reduce COD concentration from 8500 mg/l to 5000 mg/l by the end of 1999, by optimising WWTP performance.

• An increase in suspended solids concentration from 100 mg/l to 200 mg/l and an increase in loading from 12kg/day to 30 kg/day. Recent results indicate that suspended solids levels in final effluent are generally below 100 mg/l however there are periodic exceedances. A limit value of 200 mg/l is achievable.

• An increase in the timeframe to achieve reduced ammonia concentrations.

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