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«Application Details Name and address of activity Iropharm Plc. Vale Road, Arklow, Co. Wicklow Class of activity: 5.6 Manufacture of pharmaceutical or ...»

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DATE: 12 June 2000

TO: Each Board Member

FROM: Annette Prendergast

RE: Summary report on review of IPC Licence Register No. 89

(Iropham) New Reg. No. 540.

Application Details

Name and address of activity Iropharm Plc. Vale Road, Arklow, Co.


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

Request from activity requesting review of IPC 10/01/2000 licence Notices under section 85 (i)(b) issued: 10/02/2000 EIS Received 24/02/2000 Information under article 16 (4) received: 24/02/2000, 14/03/2000 Article 17(2) Request issued 31/03/2000 Article 14(1) Request Issued 31/03/2000 Information Received under Article 14 18/04/2000 Information received under article 17 18/04/2000, 23/05/2000 EIS in Compliance 18/04/2000 Site visit 28 March 2000, 8 June 2000 Company Iropharm Plc. a member company of Honeywell International manufactures bulk active pharmaceutical chemicals and intermediates using organic synthesis in batch processes. A typical synthesis involves an initial condensation reaction followed by a series of crystallisation purification steps. The existing facility produces products and intermediates in three production buildings and a pilot plant. The plant produces approximately 30 different products and they are a combination of generic powdered drugs, intermediate powdered active ingredients and intermediate pure bases. The products include antidepressants, anti histamine beta-blockers and a veterinary tranquilliser.

The normal working hours is 24 hours per day, 5 days per week. There are currently 83 employees.

A new Powder Handling Facility has been constructed on-site. This will accept raw materials from other buildings on site. The facility will process the

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Reason for IPC Licence Review A new Powder Handling facility has been constructed on site and there will be two new pharmaceutical dust emission points associated with this building.

The company proposes to install a thermal oxidiser to meet emission limit values for discharge to air. Effluent discharge volume will increase from 144m3/day to 225 m3/day to allow for increased production. The company has just installed a new WWTP to meet current and future licence limits and anticipates that in general existing load limits set from 2002 will be achieved even with the increased volume proposed.

The changes proposed under the licence review are not such that they may have significant negative effects on human beings or the environment (defined as substantial change in Article 10 (b) of the IPPC Directive 1996). Article 12 (2) of the IPPC Directive 1996 requires that a permit be issued in accordance with the Directive for substantial change.

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

• Condition 1 updated.

• Condition 3.2.2 slightly modified to include for a thermal oxidiser (TO).

• Condition 5.2 is a new condition.

• Condition 5.3 is a new condition

• Condition 5.9 is new and requires the conducting of a study on nitrogen oxide emissions to air from the site

• Condition 5.10 is new and controls the waste gas exit temperature from the proposed heat recovery boiler

• Condition 5.11 requires the monitoring of dioxins in the scrubber liquor after the thermal oxidiser

• Condition 5.12 requires that the plant is shut down for bypasses in excess of one hour

• Condition 5.13 controls the shut down of the thermal oxidiser

• Condition 5.14 requires a detailed programme on fugitive emissions

• Condition 6.3 requires maintenance details to be submitted for the WWTP

• Condition 6.6 requires that effluent streams are examined for biodegradability and only biodegradable streams are permitted to discharge to the WWTP

• Condition 6.9 requires a study on the adequacy of the effluent outfall

• Condition 7.2 prohibits the use of solvents or waste solvents as a fuel for the thermal oxidiser

• 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 9.3.3 requires that a hydrogeological survey is conducted

• Condition 10 is new and requires an energy audit to be conducted by the company and recommendations implemented through the EMP.

• Condition 13.1 on emergency response has been updated.

• In relation to emissions from the proposed thermal oxidiser, the existing emission point will change location. 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.

• 2 new pharmaceutical dust emission point has been included.

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

• Modified limits have been included for the WWTP


The principal changes from the original IPC application with regard to air are: The installation of 2 additional pharmaceutical dust emission points 192 and

193. These dust emission points are at the new plant BATNEEC limit value for pharmaceutical dust.

• The installation of a distillate fired thermal oxidiser with heat recovery boiler and post combustion scrubber for SO2 and HCl to treat combined emissions from the site.

Air abatement system

Currently all significant emissions from production buildings 1, 2 and 3, the solvent stripper and the pilot plant are combined into a polypropylene vent header which leads to a two stage caustic/water scrubbing system, this discharges through a single discharge point Vent 72. The existing scrubber system is not achieving the BATNEEC emission limit values, applied in the existing licence from June 1999. The company proposes to install a thermal oxidiser to treat scrubbed emissions from the scrubber and ensure compliance with new plant BATNEEC emission limit values. This proposal has been included in the PD. In relation to planning permission the company states that there has been some correspondence with the Planning Authority but planning permission will not be applied for until detailed design engineering is complete. At a meeting with the company on the 8/06/2000 they stated that they hoped to have detailed design complete by mid July. (Condition 1.3 of the PD states that the licence is for the purpose of IPC licensing only) They anticipate that the TO should be operational by end of March 2001. The existing emission point will be decommissioned and emissions will discharge via the thermal oxidiser to vent 194.

The proposed design of the thermal oxidiser system is as follows: The thermal oxidiser system contains a reaction chamber designed to provide a residence time of at least 2 seconds at a temperature of 1,100 0C under oxidising conditions. Flue gas leaving the reaction chamber enters a steam raising boiler where the flue gas is cooled to 300 0C. The boiler is of single pass fire tube design and will produce a maximum of 1700 kg/hr of steam at 21 bar.

Flue gas leaving the boiler enters a hastalloy quench where fresh and recirculated water is sprayed into the flue gas to cool the gas to the adiabatic saturation temperature. The cooled gas then enters a packed tower scrubber where HCl and SO2 are removed from the gas prior to discharge to atmosphere. Emission limit values for the thermal oxidiser although not a hazardous waste incinerator have been set in accordance with the Agency’s BATNEEC note on hazardous waste incineration. The PD requires continuous monitoring of TOC, HCl, SO2, NO2, CO and oxygen from the thermal oxidiser. If the thermal oxidiser shuts down due to problems, pre scrubbed emissions will by pass the thermal oxidiser and discharge through vent 194 (this incident requires notification of the Agency in the PD).

The decision to select the thermal oxidiser was made by the company in order to meet BATNEEC emission limit values. The company states the following reasons for selecting s thermal oxidiser over other abatement techniques: The production schedule at Iropharm is client driven and hence technical production facilities must maintain a high degree of flexibility. The most flexible of the available abatement technologies is thermal oxidation. Based on the design mass flow-data for both VOC’s and inorganics in the vent header system, thermal oxidation results in the least significant residual streams. Thermal oxidation will result in the lowest residual emissions of VOC’s to atmosphere, usually less than 5mg/Nm3 TOC. Thermal oxidation will produce usable energy to supplement/replace steam generated on-site by oil-fired boilers. It will also provide the option at a later date, for the economic reuse of clean solvent streams generated onsite to recover the high inherent energy potential (this issue is discussed in more detail in the waste section).

Chlorinated VOC loading to the thermal oxidiser The design specification of the thermal oxidiser (TO) is based on a total VOC loading maximum of 40.1 kg/hr and an average of 7.6 kg/hr. The total chlorinated VOC loading is a maximum of 0.16 kg/hr (as DCM) and an average of 0.03 kg/hr. In addition, inorganic chlorine compounds-HCl- may also be present in the vent gas up to 2 kg/hr.

The combustion chamber of the proposed TO, to be supplied by KEU, is designed to achieve complete combustion, i.e. high temperature ( 1,100 0C), excess air and a residence time of 2 seconds. The chamber and arrangements of gas ports and burner nozzle also promotes very high turbulence and consequently good mixing. The flue gas leaving the reaction chamber is cooled to less than 300 0C in one single-pass fire-tube boiler. The system is designed to treat vapour phase VOC’s and uses light fuel oil as support fuel. Based on the inputs specified in the design brief, the maximum level of free HCl/Cl in the flue gas travelling through the boiler is expected to be less than 800 mg/Nm3.

Based on the VOC’s to be treated and the relatively clean support fuel coupled to the low HCl/Cl content of the untreated flue gas, KEU (the suppliers of the TO) have guaranteed a final PCDD/PCDF level in the flue gas of less than 0.1 ng/Nm3. This limit has been applied in the PD. Condition 5.10 of the PD requires that the temperature of the flue gas leaving the waste heat recovery boiler shall not be less than 450 0C until such time as the licensee can demonstrate compliance with licence limits at lower temperatures. This can be assessed through out the test programme. Quarterly monitoring for dioxins is required (this can be reduced pending satisfactory operation of abatement equipment). The company is required to conduct a test programme for the abatement equipment. Condition 5.11 requires the licensee to conduct dioxin monitoring on the scrubber liquor. Condition 5.12 requires the plant to be shut down for any bypass of the thermal oxidiser in excess of one hour’s duration.

Condition 5.13 requires that the thermal oxidiser be shut down if control or monitoring equipment malfunctions or if the TO fails to reach its operating parameters. A footnote in schedule 1(i) allows the minimum operation temperature of the TO to be reduced where it is demonstrated that emission limit values (including dioxin) will not be exceeded.

Impact of air emissions Powder Plant Impact Dust emissions from the new powder handling plant were modeled and the maximum predicted ground level concentration was 10.6 ug/m3. This was compared against acute toxicity (inhalation data) available for some compounds present in the powder handling plant. Inhalation data ranged from 0.53 g/m3 to 200 g/m3, which is orders of magnitude greater than the predicted ground level concentrations.

Dioxin emissions The total maximum licensed emission for dioxins from the plant is 3mg/ annum.

Modelling submitted by the company predicts a maximum 1 hour average concentration for dioxin of 60 fg/m3 and a maximum annual average of 1 fg/m3.

In the UK annual mean values range from 80- 390 fg TEQ/m3 in coastal rural areas.1 Normal operations The US EPA Industrial Source Complex Short model (ISCST3, version 95250) was used to predict maximum 1 hour ground level concentrations of individual pollutants outside the boundary from the thermal oxidiser. The maximum predicted hourly or annual average ground level concentrations of the individual compounds based on maximum emissions were less that the relevant Air Quality Standard (for SO2 and particulate) or guideline such as the WHO and the OEL/40 for individual solvents and combined solvents and HCl. In relation to NO2 the maximum annual average values predicted are well below the EC limit values. The EC limit for NO2 is 200 µg/m3 (1-hour average) not to be exceeded more than 18 times a year. The margin of tolerance is 50% (i.e.

300 ug/m3) on commencement of the directive falling linearly to 0% by 2010.

Modeling conducted by the company assuming all NOx emitted is NO2 and not taking background into consideration predicts that at a worst case 200 µg/m3 would be exceeded nine times a year. In reality up to 95% of NOx exits as NO and in TA Luft it is estimated that there is an approximate conversion of 60% NO to NO2. Taking this into account reduces the predicted maximum by approximately 38% and all the maximum one hour values are reduced below 200 µg/m3. However if the nearest available background concentrations (99%tile ambient monitoring data from IFI background 70 µg/m3) are added to this the maximum 1 hour average predicted is 221 µg/m3. The EC limit value of 220 µg/m3 applies from 2008. Condition 5.9 of the PD requires the following: the licensee shall conduct a dispersion modeling study (using up-todate data) for Oxides of Nitrogen (NOx and NO2) emissions from the site.

Results shall be compared to relevant ambient air quality standards specified in EU Council Directive 1999/30/EC. A report on this study and modifications, if any, required to ensure continued compliance with relevant ambient air quality standards shall be submitted to the Agency within two years of the date of grant of this licence. Any modifications required shall be implemented within a time frame to be agreed with the Agency.

As a comparison Iropharm are licensed in this PD to discharge a maximum of

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