Rottapharm IPPC Licence Application Response to EPA Request for Further Information

Transcription

1 Rottapharm PPC Licence Application Response to EPA Request for Further nformation EPA Export :16:05:17

2 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P ROTTAPHARM LMTED PPC LCENCE APPLCATON REGSTER P RESPONSE TO REQUEST FOR ADDTONAL NFORMATON FROM ENVRONMENTAL PROTECTON AGENCY DATED 18 AUGUST 2009 ntroduction Background Responses Tables tem 1 tem 2 tem 3 tem 4 tem 5 tem 6 RF Reference Table No General Emissions to Air Solvents Emissions to Sewer Waste Miscellaneous Table of Contents Description 2b A Table E.1(iv) information for supply AHUs 2d B Table F.1(i) for emission points containing APs 2e C Table E.1(i) completed for boilers 2g(iii) D Table F.1(i) completed for the RTO 4a E Sources of process aqueous emissions 4f F F.1(i) Monitoring and controls of process effluent and domestic sewage. 5a G Table H.1 (i) Breakdown of the waste 'Chemicals'. 5c H Table H.1 (i) Wastes for deep burial, any wastes from abatement, (spent filters, pharmaceutical dust etc. Figures RF Reference Figure No Description 1b A A1. nternal Production Layout A2. Plant Room AHUs & DCUs 2a B B1. Air Emission Points B2. Emission points and the sources of the emissions for each emission point. September 2009 Page 1 of 52 EPA Export :16:05:17

3 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P B3. Emission points and the sources of the emissions for each emission point. B4, Emission points and the sources of the emissions for each emission point. B5. Emission points and the sources of the emissions for each emission point. 2g (i) C C1. Piping and nstrumentation Drawing of RTO 2g(vii) D D1: Vendor P&D of the coater D2: Lay out drawing of coater 2g(x) E E1. Piping and nstrumentation Drawing of RTO/Heat Recovery System 3c F F1. Locations and details of the coating pans and the route to the abatement system 6d G G1. Location of the nearest noise sensitive receptor Appendices RF Reference Appendix No 1a A ES Description 1f B Copy of the letter to the Planning Authority referred to in your correspondence dated 22 June 2009 (Ref A L0002). 2f C Report on air dispersion modelling 6f D Audited Accounts of Rottapharm for 2006, 2007 and E Non-Technical Summary September 2009 Page 2 of 52 EPA Export :16:05:17

4 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P ntroduction Rottapharm Ltd has applied to the Environmental Protection Agency (EPA) for an ntegrated Pollution Prevention and Control (PPC) Licence, Register P The Agency has requested additional information in its letter dated 18 August This document presents the required information. Background Rottapharm established a pharmaceutical finishing facility in Damastown, Mulhuddart, Dublin 15, construction of which was completed in Rottapharm Dublin currently produce a range of products in the form of sachets and capsules for the treatment of osteoarthritis, the bulk active pharmaceutical ingredient (AP) for these products is Crystalline Glucosamine Sulphate. This AP is manufactured at the Dublin facility. Rottapharm also produce an anti-inflammatory tablet containing the AP Bromelain, which is bought in to the facility. Rottapharm Ltd. is also responsible for batch release of two medical devices called GO- ON and GO-ON Mini. These products are manufactured by a subcontractor (Croma Pharma) based in Austria and comprise a Sodium Hyaluronate solution. n 2009 Rottapharm reland are expanding their current production capacity to produce two new capsules 150 mg and 300mg Tromalyt one new sachet product called Plantaben and one new caplet product called CGS Caplets. Rottapharm also intend to take on the business of filling and packing the following sachets at the Dublin facility: Colofibre Legalon Spagulax. These sachet products will not be manufactured at the Dublin facility. The manufacture of these new products will require an increased usage of volatile organic compounds, i.e. organic solvents, which will exceed the threshold at which an PPC licence is required: Application has therefore been made for a licence to permit the carrying on of the following two classes of activity at the facility: 5.16 The use of a chemical or biological process for the production of basic pharmaceutical products The manufacture or use of coating materials in processes with a capacity to make or use at least 10 tonnes per year of organic solvents, and powder coating manufacture with a capacity to produce at least 50 tonnes per year, not included in paragraph The facility is an existing facility but application is being made to permit the carrying on of additional activities. September 2009 Page 3 of 52 EPA Export :16:05:18

5 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P General 1a. Confirm whether an ES was required as part of the planning application for the expansion. Submit a copy of any previous ES for the development. Response: An ES was not required as part of the planning application for the expansion. A copy of the ES for the original development is attached as Appendix A. 1b. Submit drawings showing the internal layout, production areas (Area 1, Area 2, Bulk) and the emissions arising. Show the locations of equipment including the coating pans, blenders, dedusters, etc. Response: The attached Drawings Nos A1 and A2 show the requested information. The emission points are listed in the following table. Emission Point Description Source(s) of Emission A3-4 Exhaust air handler AH-201 A3-5 Exhaust air handler AH-401 A3-6 Exhaust air handler AH-601 A3-7 Dust Collector DCU-101 A3-8 Dust Collector DCU-201 A3-9 Dust Collector DCU-501 General Room Extract General Room Extract General Room Extract Out of service Coating Pan CO-201 Out of service Location of Source Manufacturing Area 1 and F1 and F2, Ground Floor Production Building Manufacturing Area 2 and Packaging Rooms, Ground Floor Production Building Bulk Manufacturing Area M18, Manufacturing Area 2 A3-11 Dust Collector DCU-301 Central Vacuum Filling Rooms F1, F2, F3, F4, M4, Manufacturing Area 1 A3-12 Dust Collector DCU-202 Coating Pan CO-202 M17, Manufacturing Area 2 1c. Provide the current and proposed production figures (tonnes/yr). Response: Current production levels are 1,458 tonnes/yr (based on 2008 output levels). Proposed production figures are projected to be 1,984 tonnes/yr in 2009 increasing to 2,591 tonnes/yr in d. Provide a timetable for construction works and production of new products. Response: September 2009 Page 4 of 52 EPA Export :16:05:18

6 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Construction work is now essentially complete. Rottapharm is in the process of dismantling coating pans and other equipment at another location outside of reland and moving these to Dublin. All the new equipment will have arrived on site by the middle of November t is expected that this equipment will be installed during the fourth quarter of 2009 and commissioned as soon as possible after installation. t is expected that all new equipment will be in operation by the end of March Rottapharm has also purchased a thermal oxidiser to abate emissions of VOCs from the coating pans. This will be installed and commissioned so as to be operational when operations under Class commence. 1e. Confirm the proposed staff numbers for the expansion. Response: There are currently 167 staff numbers working on site (179 including temporary staff). These numbers include for those working in the expanded area. There are no plans to recruit further personnel. 1f. Provide a copy of the letter to the Planning Authority referred to in your correspondence dated 22 June 2009 (Ref A L0002). Response: A copy of the letter to the planning authority is attached as Appendix B. September 2009 Page 5 of 52 EPA Export :16:05:18

7 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Emissions to Air 2a. Provide A3 engineering drawings showing all emission points and the sources of the emissions for each emission point. Provide a description to accompany the drawings. nclude all sources of exhaust air, dust, and lab emissions. Response: Figure B1 is a revision of Figure E1 included with the licence application to include for emission points Nos A3-11 and A3-12. Figures B2, B3, B4 and B5 show emission points and sources. A description of the emission points and sources is as follows: The principal emission point is the proposed Regenerative Thermal Oxidiser (RTO). Emissions from three coating pans (CO-201 (existing), CO-203 (new) and CO-204 (new) will be ducted to the RTO where Volatile Organic Compounds (solvent vapours of acetone, ethanol and isopropanol) are oxidised to achieve an emission value of less than 20 mgc/nm³. Natural gas is to be used as an auxiliary fuel. Two boilers provide process heat and space heat to the Production Building. These are fired on natural gas and have a thermal input of 1.5 MW each, total 3MW. A third boiler provides space heating for the Administration Building. This is also fired on natural gas and has a thermal input of 422 kw. All three boilers are below the capacity threshold of 5MW (gas-fired boilers) above which their emissions would be regarded as being significant (ntegrated Pollution Prevention and Control (PPC) Licensing - Application Guidance Notes). At present two coating pans (CO-201 and CO-202) discharge to atmosphere via Dust Collection Units DCU-201 and DCU-202 respectively. (The two new coating pans CO- 203 and CO-204 are expected to be in operation in March 2010.) A further Dust Collection Unit (DCU-301) is used as a central vacuum system for the Filling Rooms and Manufacturing Area 1. This discharges to atmosphere. Other emission points are: General extract air handling units (AHUs) which incorporate High-Efficiency Particulate Air (HEPA) filters. Laboratory Fumehoods These are not process emission points. 2b. Clarify that all emission points are included in Table E. 1 (iv). Procedure ENG-UTL-001 refers to additional air handling units. Resubmit Table E.1(iv) where necessary. Response: Procedure ENG-UTL-001 refers to nine additional air handling units (AHUs). These units supply air to the buildings and do not discharge air to the atmosphere. They were not included in Table E.1(iv) because they are not emission points. These supply AHUs are AHU-101, AH-102, AH-105, AH-302, AH-103, AH-104, AHU-301, AHU-501 and AHU-801. Note that AHU-701 is not mentioned in the SOP. t is the Administration Building AHU. Please note that Dust Collectors DCU-301 and DCU-202 were inadvertently omitted from Table E.1(iv), and a revised version of this table is attached (Table A). As Dust Collector DCU-101 is currently out of commission, and DCU-301 covers all filling areas. Dust Collector DCU-202 serves the water-based coating pan. DCU-501 is also no longer used. t used to serve the Bulk Manufacturing area. September 2009 Page 6 of 52 EPA Export :16:05:18

8 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P c. Give a description of the powder containment for each product. Response: Powder containment is primarily controlled via the maintenance of room differential pressures. Section 2.3 of SOP ENG-UTL-001 (submitted with the application) addresses the production room differential pressure balancing for the plant. Central vacuum systems are utilised to remove fugitive dusts from process equipment. Other powder containment practices include LAF booths in dispensing areas. Minor spills when encountered are cleaned up using dedicated vacuum cleaners. The plant is a GMP facility and as such a strict regime is in place to maintain and monitor cleanliness. 2d. Clarify the emission points, which may contain active pharmaceutical ingredients. For these emission points provide an estimate of the emission rates (in kg/hr). Complete Table F.1(i) for these emission points. Response: The emission points that might contain active pharmaceutical ingredients (APs) are: Equipment Coating Pan CO-201 Dust Collection Unit DCU- 501 Dust Collection Unit DCU- 301 Coating Pan CO-202 Laboratory Fumehood Vents Extract AHU AH-201 Extract AHU AH-401 Extract AHU AH-601 Existing (E) or New (N) E E E E Location Discharges to Comments Room M17, Area 2 Extract from some equipment and general areas Extract from some equipment and general areas Room M18, Area 2 Atmosphere via Dust Collector DCU-201 Atmosphere Atmosphere Atmosphere via Dust Collector DCU-202 Water based coater and as such is not currently a source of VOC emissions. f converted to solvent coating, will be routed to RTO E Laboratory Atmosphere Low concentration of dust because of small quantities of powder, short duration of handling and infrequent use. E Sachet Area Bulk Synthesis Low concentration of dust because these are room extracts E Tabletting Area Bulk Synthesis Low concentration of dust because these are room extracts E Bulk Synthesis Area Bulk Synthesis Low concentration of dust because these are room extracts September 2009 Page 7 of 52 EPA Export :16:05:18

9 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Table F.1(i) has been completed for these emission points and is attached (Table B). 2e. Complete Table E.1(i) for each boiler. Clarify the purpose of the production boilers, and if they operate together or duty/standby etc. Provide an estimate of NOx emissions for each boiler. Response: See attachment Table E.1(i) (Table C). The purpose of the production boilers is to provide medium pressure hot water for the following site applications: hot water supply for radiators, hot water taps, AHU heating batteries, process heating (vessel jackets), cleaning. They operate together in line with demand. The maximum NOx emissions for each boiler are estimated to be as follows: Boiler NOx Emissions (kg/hr) at full load A3-1 Production Building 0.35 A3-2 Production Building 0.35 A3-3 Administration Building f. Submit in electronic form (e.g. excel/access), a copy of the input and output files and meteorological data for the SCREEN3 assessment. Clarify if the ground level concentrations are maximum concentrations. Clarify the height of the adjacent building (in metres) and the height of the stack above roof level. Clarify whether operation of all three boilers and TO simultaneously would have any effect on the outcome of the Screening assessment, with particular regard to emissions of NOx. Response: Following subsequent discussions with the Environmental Protection Agency, it was agreed that modelling of emissions from the Thermal Oxidiser and all three boilers would be carried out using the AERMOD model. See modelling report attached as Appendix C. The input and output files for the AERMOD assessment are attached in electronic format. The ground level concentrations are maximum 1-hour average concentrations. The height of the building adjacent to each of the stacks of the boilers serving the Production Building is 10 m. The height of each of these stacks is 3 m above roof level. The height of the building adjacent to the stack of the boiler serving the Administration Building is 8 m. The height of this stack is 3 m above roof level. 2g. Provide the following in relation to the Thermal Oxidiser (TO): i. A description of the specifications, type and details of its operation. nclude details as A3 engineering drawings in addition to Figure Fl. Response: The exhaust from the process directs through the main 1m duct to the RTO where the exhaust air fan directs the exhaust air stream into the RTO system. September 2009 Page 8 of 52 EPA Export :16:05:18

10 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Once within the RTO unit, the exhaust stream is directed alternately by timecontrolled dampers to the appropriate zones of hot ceramic heat exchanger media. The heat exchanger bed is comprised of three regenerator columns; at any given moment, the exhaust stream moves upward through one and downward through two columns. The exhaust passes vertically upwards through the media taking on heat thereby raising the temperature up to the combustion temperature that oxidises and cleans the air. n the combustion area, the natural gas-fired burner provides additional energy if required to maintain the necessary temperature level of approximately C. After passing through the combustion chamber, the air flows down through the exchanger media returning its heat back to the system. n this RTO system, part of the clean air flows through one of the two upward zones in order to purge the zone prior to entering the clean side. Due to this operation mode, one of the columns is always purged; therefore no pollutant leaks into the pure gas while switching over of the RTO inlet valves is occurring. The RTO is started and heated up at a reduced air flow rate by the natural gas burner system. For safety reasons, the RTO will be operated for start up and shut down only with fresh air. The system is especially designed for a high thermal efficiency to redure the energy consumption of the burner to a minimum. The solvent loading in the waste air gives additional energy for the oxidation process. Due to the high VOC concentration in the off-gas the excess heat of the exothermal oxidation in the RTO results in autothermal operation most of the time, without consumption of supplement gas during autothermal operation, the burner system is switched off automatically. Three LEL sensors in the exhaust ducting ensure that the maximum allowed inlet concentration will not be exceeded. Dilution air will be added automatically. Excess heat from the high solvent input is discharged out of the combustion chamber with a temperature-controlled hot-gas bypass. Figure C1 is a Piping and nstrumentation Diagram of the RTO. ii A description of the TO operating conditions (temperature, residence times etc.) and monitoring for each parameter (discrete or continuous). Response: The RTO Operating Conditions are as follows: Exhaust air flow volume from process (without dilution air) m 3 /h Exhaust air flow volume (with max. required dilution air) 17,200 m 3 /h Exhaust air temperature from process C Exhaust air inlet pressure through ducting (designed) -5 mbar Pollutant concentration from process, maximum 70 g/m 3 Pollutant concentration to RTO, maximum g/m 3 RTO combustion chamber temperature, approx. 850 C September 2009 Page 9 of 52 EPA Export :16:05:18

11 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Autothermal concentration, approx. 2.3 g/m 3 Note 1. =25% of Lower Explosive Limit of isopropyl alcohol iii. Completed Table F.1(i). Response: Table F.1(i) completed for the RTO is attached (Table D). iv. The expected oxygen content in the flue gas. Response: The RTO vendor advises that there is no reliable method for calculating the oxygen content in the RTO exhaust and that this will have to be measured once up and running. The oxygen concentration in the RTO inlet will be maintained high as the concentration of solvent in the stream is maintained below 25% of the LEL. t is expected that the minimum oxygen concentration will not be less than 18%. v. The TO thermal input capacity (MW) and the hours of operation. Response: RTO Thermal nput Capacity = Total power rating of burner system = 0.45 MW Average hours of operations: 50 minutes/hour 16 hours/day 300 days/years vi. List all processes contributing gases to the TO, how gases are directed to the TO and any process controls before reaching the TO. Response: The following process contributes gases to the RTO: Coating of Tromalyt Pellets using solvents acetone and isopropanol. Coating of Fortilase pellets using solvent ethanol Coating of Extranase pellets using solvents ethanol and acetone Process gases from the coating of Tromalyt pellets are directed from the plant ducting into the main 1m diameter supply duct for the RTO. Each coating pan has a separate inlet into the main duct controlled by means of a double damper. Once the process gases are inside the main duct the RTO exhaust air fan directs the exhaust air stream through the RTO system. The following process controls are in place to regulate the process gases before reaching the RTO: LEL control (Lower Explosive Limit) with inlet air dilution in the event of higher solvent concentration, comprising of a series of LEL sensors at various locations along the main duct and a suitable dilution air assembly. Redundant LEL safety surveillance of inlet air with suitable equipment and stack for emergency isolation of the RTO. September 2009 Page 10 of 52 EPA Export :16:05:18

12 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P vii. Response: A drawing of the Pan coating system and a description. The following drawings are attached: Vendor P&D of the coater (Figure D1) Lay out drawing of coater (Figure D2) The layout drawing shows the dimensions of the coater in its original configuration. While the principle of this may be correct there are minor differences to the current set-up. Description: Pre-formed tablets are loaded into the coating pan. Coating solution (previously made-up) is pumped from a holding vessel to the coating pan and is applied to the tablets from above by means of spray nozzles/guns. The tablets are moved and mixed by the rotating drum. The introduction of the process air evaporates the fluid and dries the film coating. viii. An outline of response procedure in the event of a bypass of the TO, an estimate of the likely duration and frequency of bypass events and how these will be monitored. Response: n the event of a bypass of the RTO, an alarm will provide visual and audible indication of the bypass to production operators. An SOP will detail the appropriate response to such occurrences. A controlled shutdown of the coating process will occur, generally following this sequence: spraying will stop, followed by a period of intermediate drying and then the process will stop. Supervisors and maintenance personnel will be informed. The frequency of bypass events will be rare and will be monitored under standard engineering maintenance procedures. ix. An outline of measures to be taken under abnormal operating conditions, including startup, shutdown, leaks, malfunctions, breakdowns etc. Response: The process will not start under abnormal operating conditions, until the RTO is ready and operational. Any conditions that would cause the RTO to operate outside of its set parameters will cause the unit to go into bypass. Alarms will sound and operators will carry out a controlled shutdown of the coating pans to preserve the product. Shutdown occurs after the coating process has ceased. Operators will be specifically trained in the operation of the RTO including all abnormal operations and all such operations will be governed by SOP. x. A description, including drawings, of any proposals for heat recovery, heat exchange and link to the boilers. Response: There exists the option of passing combustion gases from the RTO through a warm water heat recovery system before emission to atmosphere. This recovery system, comprising of a heat exchanger (water tube boiler) is designed to provide a maximum capacity of 800kW of recoverable energy with 90 C outlet temperature for the warm water loop. This recovery system will be linked to the boiler system. When operating conditions are at an optimum level, it is intended to be possible to switch off the boilers and allow the heat recovery system to meet the plant s requirements. September 2009 Page 11 of 52 EPA Export :16:05:18

13 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Drawings of the heat recovery, heat exchange and link to the boilers are attached as Figure E1. 2h. Provide details of any stand-by generator and the fuel type. Response: The site does not have a stand-by generator. 2i. s any fuel other than natural gas is proposed for the TO or boilers. Response: Natural gas is the only fuel used for the boilers and TO. Note that technically the vapour stream is a fuel for the TO as under optimum operating conditions it is possible to operate the TO without the usage of natural gas. September 2009 Page 12 of 52 EPA Export :16:05:18

14 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Solvents 3a. Provide an estimate of the potential fugitive emissions from the facility when the class activity is in operation. Explain how the installation will comply with the requirements of the Solvents Directive accordingly. Response: Emissions of Volatile Organic Compounds from Organic Solvents Regulations 2002 (S No 543 of 2002) transpose Directive 1999/13/EC (the Solvents Directive ) into rish legislation. The specific requirements for the manufacture of pharmaceutical products with solvent consumption exceeding 50 tonnes per year are set out below. Class Activity (Solvent consumption in tonnes/year) Threshold (solvent consumption threshold in tonnes/year) Emission limit values in waste gases (mg/c/nm³) Fugitive emission values (percenta ge of solvent input) Total emissio n limit values Special provisions 20 Manufacturing of pharmaceutical products (>50) 20(1) (New) 5 (2) (Existing) 15 (2) (New) 5% of solvent input (Existing) 15% of solvent input (1) f techniques are used which allow reuse of recovered solvent, the emission emit value shall be 150. (2) The fugitive emission limit value does not include solvent sold as part of products or preparation in a sealed container. As neither the existing or proposed consumption of solvents at Rottapharm exceed 50 tonnes per year, the Solvent Directive does not apply to the facility. However, even if the threshold consumption rate was such that the Directive applied to Rottapharm, the requirements of Class 20 would be met. Waste Gases The specification for the Regenerative Thermal Oxidiser is that the waste gases should not contain more than 20 mgc/nm³, and this complies with the ELV in the table above. No other waste gases containing solvents are or will be emitted from the facility. Fugitive Emissions The limit for fugitive emissions from new facilities is 5% of solvent input. The fugitive emissions of solvent have been calculated to be 3.6% of solvent input, using the methodology set out in the Directive. This complies with the requirements of the Directive. Total Emissions The total emissions of solvent have been calculated to be 3.8% of solvent input, using the methodology set out in the Directive. This complies with the requirements of the Directive. Use of Solvents with Specified Risk Phrases September 2009 Page 13 of 52 EPA Export :16:05:18

15 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P The solvents with specified risk phrases used at Rottapharm are listed in the following table, with usage per year, where this information is available. Risk Phrase Relevant Solvent Name(s) Solvent Consumption (t/yr) R45 (may cause cancer) Hydranal working medium k ,2-dichloroethane Arsenic () oxide Reag. Ph Eur Diarsenic trioxide No information No information No information R46 (may cause heritable genetic damage) Hydranal working medium k R49 (may cause cancer by inhalation) None No information R60 (may impair fertility) None No information R61 (may cause harm to the unborn child) R40 (limited evidence of a carcinogenic effect) and halogenated Barbital sodium Dimethylformamide, Normapur N,N - Dimethylformamide extra pure Lead () Perchlorate trihydrate No information No information No information Lead Nitrate 0.1M ,4-dioxan Acetaldehyde Aniline GR Chloroform No information No information No information No information Crystal violet Dimethyl yellow No information No information Emission Limit Values (ELVs) for Certain Discharges of Solvents with Specified Risk Phrases The Emission Limit Values (ELVs) for substances with risk phrases R45, R46, R49, R60, R61, or R40 and halogenated are as follows, where discharges are above the specified mass flows: Risk Phrase R45 (may cause cancer) Threshold mass flow of the sum of such compounds Emission limit value (mass sum of the individual compounds) R46 (may cause heritable genetic damage) 10 g/h 2 mg/nm³ R49 (may cause cancer by inhalation) September 2009 Page 14 of 52 EPA Export :16:05:18

16 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P R60 (may impair fertility) R61 (may cause harm to the unborn child) R40 (limited evidence of a carcinogenic effect) and halogenated 100 g/h 20 mg/nm³ The materials with the specified risk phrases are all laboratory chemicals, used in very small quantities. Data on usage is not available for most, but available usage figures indicate that it is not credible that the threshold mass flows are even approached. 3b. Provide a breakdown of the current and proposed solvent use (tonnes/year) for each product or process including coating, laboratory, cleaning or other purposes. Clarify if chlorinated organic solvents are in use or proposed, give the type, quantity and purpose. Response: The only production process in which solvents are used is Coating. Current (2008) and proposed solvent use in production is summarised in the following table: 2008 Product Ethanol Acetone PA Total Tromalyt Fortilase Extranase Total Proposed Product Ethanol Acetone PA Total Tromalyt Extranase Fortilase Total Laboratory use of solvent will not increase due to increased production levels. Current usage is less than 1 tonne per year. Usage of solvent for cleaning purposes is less than 250 litres per annum. Chlorinated organic solvents are not in use on site, nor are they proposed for use on site. 3c. dentify all sources of VOC emissions. Provide the locations and details of the coating pans (described as 1, 2 & 3) and the route to the abatement system. Response: September 2009 Page 15 of 52 EPA Export :16:05:18

17 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Equipment Existing (E) or New (N) Location Discharges to Comments Coating Pan CO- 201 Coating Pan CO- 202 Coating Pan CO- 203 Coating Pan CO- 204 Laboratory Fumehood Vents E E N N Room M18 Manufacturing Area 2 Room M23 Manufacturing Area 2 Room M23 Manufacturing Area 2 Via DCU-201, will discharge to RTO Via DCU-202. and thence to atmosphere Will discharge to RTO Will discharge to RTO Water based coater and as such is not currently a source of VOC emissions. f converted to solvent coating, will be routed to RTO E Laboratory Atmosphere Very minor The route to the abatement system is as shown in Figure No F1 attached (as requested in tem 2a). 3d. dentify any VOC emissions not directed to the TO. Provide details of any other VOC abatement, recovery or treatment on site, as necessary. Response: VOC emissions from laboratory fumehoods are not directed to the TO. Once commissioned all VOC emissions from coating pans CO-201, 203 and 204 will be directed to the TO. Currently VOC emissions from CO-201 are discharged directly to atmosphere. No other VOC abatement system is in use on site. 3e. Provide details on the timeframe for commencement of operations under Class , including a timeframe for commissioning of abatement. Response: Construction work is now essentially complete. Rottapharm is in the process of dismantling coating pans and other equipment at another location outside of reland and moving these to Dublin. All the new equipment will have arrived on site by the middle of November t is expected that this equipment will be installed during the fourth quarter of 2009 and commissioned as soon as possible after installation. t is expected that all new equipment will be in operation by the end of March September 2009 Page 16 of 52 EPA Export :16:05:18

18 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Rottapharm has also purchased a thermal oxidiser to abate emissions of VOCs from the coating pans. This will be installed and commissioned so as to be operational when operations under Class commence. 3f. Clarify details of solvent storage; location, volume at any one time, and type of containment, size etc. for the current and proposed situation. Clarify if bulk storage or a tank farm is proposed and give details. Response: Current Operation: Solvents are stored in two dedicated lockable bunded flammable stores adjacent to the warehouse. Acetone and PA account for the greatest volume of solvent used on site. PA is delivered to the site in 25 litre drums, on pallets of 32 drums. Acetone is delivered to site in 210 litre drums on pallets of 4 drums. The maximum storage within each of the solvent stores is 1500 litres. All solvents (lab and production use) for use on site are stored in these solvent stores. Proposed Operation: t is proposed to deliver acetone and PA to site in 1000 litre BCs, stored within a dedicated lockable bunded flammable store located in a bunded area. Connection to a distribution network is available in this store. The maximum storage of solvent will be litres (6 x 1000 litre BCs of acetone and 6 x 1000 litre BCs of PA). The store will be located adjacent to the north of the production building and the bunded area will be sized appropriately. Further bulk storage or a tank farm is not proposed. September 2009 Page 17 of 52 EPA Export :16:05:19

19 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Emissions to Sewer 4a. Provide a detailed description of all sources of process emissions (e.g. wash water), the product and stage in the process and the volumes generated. Clarify the main source for each substance emitted. nclude the existing and proposed operations. Response: Process aqueous emissions are summarised as follows: Aqueous Emissions Quantity (litres) Existing Proposed Daily emissions 2,950 4,450 Weekly emissions 10,870 15,370 Monthly emissions 1,550 5,350 Total (L/Month)* 111, ,116 *Based on 5 days per week, 4.3 weeks per month (year average) Table E attached shows all sources of process aqueous emissions for existing and proposed operations. 4b. Submit details on the aqueous wastes being filtered, referred to in the application. Response: The Non-Technical Summary (section A.11 Wastes) contained the following statement: Aqueous waste, consisting mostly of water and trace organics are filtered, balanced and monitored before discharge to the Fingal County Council sewer which discharges to the Dublin City Council Waste Water Treatment Plant at Ringsend. The word filtered is a typographical error. Aqueous waste is not filtered. Treatment comprises balancing and ph adjustment only. 4c. f revised emission limits are proposed, provide details and any correspondence with Fingal Co. Co. Complete Table E.3(i). Response: Revised limits are not proposed. The effluent discharge by Rottapharm is well within the limits set out in the trade effluent licence. t is not envisaged that even in full production that the limits would need to be revised. Table E.3(i) does not need to be adjusted. 4d. Provide details of effluent analysis associated with the proposed production. Response: ncreased solvent usage will primarily result in an increase in atmospheric emissions and not aqueous emissions. No change in effluent quality is anticipated. 4e. Explain why ph adjustment is required and the chemicals used for this. Clarify how sludge settlement is monitored and give details of sludge analysis. September 2009 Page 18 of 52 EPA Export :16:05:19

20 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Response: ph adjustment is required to bring the process aqueous emissions to meet the ph specification of 6 10 required by Fingal Co. Co. prior to discharge into the trade sewer. Washes of equipment containing traces of Crystalline Glucosamine Sulphate (CGS) result in acidic solutions being sent to the waste water treatment plant. All process effluent is routed to a balancing tank to allow the ph to equilibrate prior to the addition of chemicals for ph adjustment. Caustic soda (30%) and Hydrochloric acid (36%) are used in ph adjustment. Sludge settlement is monitored monthly. t is done via a visual inspection. Regular operations (e.g. dosing) occur at the Waste Water Treatment Plant (WWTP) and as such any significant build-up of sludge is noticed. Over the years there has been a need to remove sludge only once per year. Due to increased volumes, it is envisaged that sludge will be removed every 6 months. Superdrain Ltd. are contracted to remove sludge from the WWTP. They transport to Dublin City Council (DCC) Ringsend Treatment Works. Each tanker is sampled by DCC upon entry to the treatment plant. All tankers from Rottapharm have been allowed discharge at Ringsend. Superdrain have not been contacted by DCC regarding any out of specification tanker loads. Sludge is not analysed by Rottapharm. The EWC Code is Sludge analysis is not available. 4f. Complete Table F.1(i). Provide a description of the monitoring and controls of process effluent. Response: Table F.1(i) is complete and attached (as Table F). Additional controls on process effluent include a level sensor on the height of the balance tank and a composite sample of the discharge is retained for analysis purposes if required. The process effluent is sampled monthly by a specialised company (Aquachem), the following parameters are tested for to ensure compliance with the trade effluent license (BOD, MBAS, oil/fats/grease/, COD, temperature, suspended solids, sulphate, ph, TOC and temperature). 4g. Provide effluent monitoring data for the previous 3 months. Response: The results of effluent monitoring for samples taken in June, July and August 2009 are shown in the following table: Parameter License Limit Units 08-Jun Jul Aug-09 Temperature 42 o C ph 6 10 ph Units BOD 2000 mg/l COD 5000 mg/l Suspended Solids 400 mg/l Oil/Grease 100 mg/l MBAS 100 mg/l Sulphates 400 mg/l September 2009 Page 19 of 52 EPA Export :16:05:19

21 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P h. Provide any relevant correspondence with Fingal Co. Co. in the previous 12 months. Response: The only correspondence on file is the notification of application for the PPC licence. This is included as Appendix B. Rottapharm is not aware of any other correspondence between the company and Fingal County Council in the last 12 months. September 2009 Page 20 of 52 EPA Export :16:05:19

22 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Waste 5a. Resubmit Table H.1 (i) providing of breakdown of the waste 'Chemicals'. Clarify the EWC code, source, quality and destination and method of recovery/ disposal for each waste stream (waste solvents, general lab waste etc,). nclude changes is any, for the proposed operations. Response: Table H.1(i) has been revised to include the requested information and is attached (Table G). 5b. Provide the EWC code for Non-regulated polysorbate Response: The EWC Code for non-regulated polysorbate is (discarded organic chemicals consisting of or containing dangerous substances). 5c. nclude in Table H.1: any wastes for deep burial, any wastes from abatement, (spent filters, pharmaceutical dust etc.). Response: Table H.1 (i) has been revised and is attached (Table H). September 2009 Page 21 of 52 EPA Export :16:05:19

23 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Other 6a. Provide the location of water purification plant and uses of purified water. Response: The purified water skid is located in the plant room, 1 st floor main production building. Purified water is used in the production of CGS (Bulk Manufacturing) where it is added to the Blender and in Manufacturing Area 2 for the preparation of coating solution. t is also used throughout the production areas for cleaning of process equipment. 6b. Clarify what is 'Eudragit spraying' referred to for Tromalyt. Response: Eudragit spraying is the spraying of a coating product called Eudragit L 12.5 onto the Tromalyt tablets. t is a pharmaceutical excipient. The only hazardous component is isopropanol. 6c. Give the specifications of the interceptors (Class and full retention/ bypass). Response: Both interceptors on site are Class Bypass Separators. 6d. Show the locations of the nearest noise sensitive receptors. Response: Figure G attached shows the nearest noise-sensitive receptor, which is a private dwelling house. 6e. Provide the annual water consumption for Response: The water consumption for the year 2008 was 9,924 m³. 6f. Provide information to show that Rottapharm Limited is likely to be in a position to meet any financial commitments or liabilities, for example a copy of the Audited Accounts for the most recent year available. Response: A copy of the Audited Accounts of Rottapharm for 2006, 2007 and 2008 are attached as Appendix D. Note: 2008 was an exceptional year for the subsidiary company Rotta Finance. The losses incurred by Rotta Finance in 2008 related to trading activities. Rottapharm Ltd made substantial profits from its core business of manufacturing in 2008 as in previous years. September 2009 Page 22 of 52 EPA Export :16:05:19

24 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Non-Technical Summary An updated non-technical summary that reflects the information provided in the above response is attached as Appendix E. September 2009 Page 23 of 52 EPA Export :16:05:19

25 Rottapharm - PPC Licence Application Response to Request for Additional nformation Register P Tables RF Reference Table No Description 2b A Table E.1(iv) information for supply AHUs 2d B Table F.1(i) for emission points containing APs 2e C Table E.1(i) completed for boilers 2g(iii) D Table F.1(i) completed for the RTO 4a E Sources of process aqueous emissions 4f F F.1(i) Monitoring and controls of process effluent and domestic sewage. 5a G Table H.1 (i) Breakdown of the waste 'Chemicals'. 5c H Table H.1 (i) Wastes for deep burial, any wastes from abatement, (spent filters, pharmaceutical dust etc. September 2009 Page 24 of 52 EPA Export :16:05:19

26 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P TABLE A TABLE E.1(iv): EMSSONS TO ATMOSPHERE - Minor atmospheric emissions Emission point Reference Numbers Description Emission details 1 Abatement system employed material mg/nm 3(2) kg/h. kg/year A3-1 Natural gas (Production) boiler 1.5 MW A3-2 Natural gas (Production) boiler 1.5 MW A3-3 Natural Gas (Administration) boiler MW A3-4 Exhaust air handler AH- 201 A3-5 Exhaust air handler AH- 401 A3-6 Exhaust air handler AH- 601 not available not available not available Crystalline Glucosamine Sulphate / Plantago not available not available not available not available not available not available not available not available not available NOT AVALABLE NOT AVALABLE NOT AVALABLE HEPA filters Acetylsalicyclic Acid HEPA filters (monitored by DP gauges - calibrated annually) Crystalline Glucosamine Sulphate A3-7 Dust collector DCU-101 Crystalline Glucosamine Sulphate / Plantago HEPA filters (monitored by DP gauges - calibrated annually) Bag and HEPA filters (DP gauges calibrated annually) A3-8 Dust collector DCU-201 Acetylsalicyclic Acid Bag and HEPA filters( DP gauges calibrated annually) A3-9 Dust collector DCU-501 Crystalline Glucosamine Bag and HEPA filters (DP gauges September 2009 Page 25 of 52 EPA Export :16:05:19

27 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P A3-10 Laboratory fume hoods and extracts Sulphate Miscellaneous laboratory reagents A3-11 Dust collector DCU-301 Crystalline Glucosamine Sulphate / Plantago not available not available not available calibrated annually) None Bag and HEPA filters (DP gauges calibrated annually) A3-12 Dust collector DCU-202 Acetylsalicyclic Acid Bag and HEPA filters( DP gauges calibrated annually) 1 The maximum emission should be stated for each material emitted, the concentration should be based on the maximum 30 minute mean. 2 Concentrations should be based on Normal conditions of temperature and pressure, (i.e. 0 o C101.3kPa). Wet/dry should be clearly stated. nclude reference oxygen conditions for combustion sources. September 2009 Page 26 of 52 EPA Export :16:05:19

28 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P TABLE B TABLE F.1(i): ABATEMENT / TREATMENT CONTROL Emission point reference number : Collectors A3-4, A3-5 & A3.6 Exhaust Air Handlers and A3-7, A3-8, A3-9, A3-11 & A3-12 Dust Control 1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up Pressure Drop across HEPA Filter Differential Pressure (DP) gauges Annually Annually None Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment calibration Pressure Drop across HEPA Filter DP Gauge checked weekly DP Gauge Annually September 2009 Page 27 of 52 EPA Export :16:05:19

29 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P List the operating parameters of the treatment / abatement system which control its function. 2 List the equipment necessary for the proper function of the abatement / treatment system. 3 List the monitoring of the control parameter to be carried out. September 2009 Page 28 of 52 EPA Export :16:05:19

30 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P TABLE F.1(i): ABATEMENT / TREATMENT CONTROL Emission point reference number : A3-1, A3-2 and A3-3 Natural Gas Boilers Control 1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up O 2 /CO/CO 2 concentration in flue gas Flue Gas Analyser Annual service by boiler service company Annually Boiler controlled to lock out on equipment failure Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment calibration O 2 /CO/CO 2 concentration in flue gas Annually Flue Gas Analyser Prior to use 1 List the operating parameters of the treatment / abatement system which control its function. September 2009 Page 29 of 52 EPA Export :16:05:19

31 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P List the equipment necessary for the proper function of the abatement / treatment system. 3 List the monitoring of the control parameter to be carried out. September 2009 Page 30 of 52 EPA Export :16:05:20

32 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P TABLE F.1(i): ABATEMENT / TREATMENT CONTROL Emission point reference number : A3-10 Laboratory Fumehoods Control 1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up Face velocity Extract Fan Annually None None Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment calibration Face velocity Annually Anemometer Prior to use 1 List the operating parameters of the treatment / abatement system which control its function. 2 List the equipment necessary for the proper function of the abatement / treatment system. September 2009 Page 31 of 52 EPA Export :16:05:20

33 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P List the monitoring of the control parameter to be carried out. September 2009 Page 32 of 52 EPA Export :16:05:20

34 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P TABLE C Table E.1 (i) BOLER EMSSONS TO ATMOSPHERE Emission Point: (1 Page for each emission point) Emission Point Ref. N o : A3-1 (This is a Minor Emission Point) Location: Plant Room Boiler Room, 1st Floor Production Building Grid Ref. (12 digit, 6E,6N): , Vent Details Diameter: 0.38m Height above Ground(m):13m Date of commencement of emission: May 1999 Characteristics of Emission: Boiler rating Steam Output: Thermal nput: 0kg/hr 1.5 MW Boiler fuel Type: Maximum rate at which fuel is burned % sulphur content: Natural gas 102kg/hr negligible NOx 120 mg/nm 3 September 2009 Page 33 of 52 EPA Export :16:05:20

35 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P o C. O 2 (Liquid or Gas), O 2 (Solid Fuel) Maximum volume* of emission 2,938 m 3 /hr 0 o C, O 2 (liquid or gas), O 2 (solid fuel) Temperature 250 o C(max) 230 o C(min) 240 o C (avg) * Volume flow limits for emissions to atmosphere shall be based on Normal conditions of temperature and pressure, (i.e. 0 o C,101.3kPa), dry gas; 3% oxygen for liquid and gas fuels; 6% oxygen for solid fuels. (i) Period or periods during which emissions are made, or are to be made, including daily or seasonal variations (start-up/shutdown to be included): Periods of Emission (avg) min/hr 24 hr/day 365 day/yr September 2009 Page 34 of 52 EPA Export :16:05:20

36 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P Table E.1 (i) BOLER EMSSONS TO ATMOSPHERE Emission Point: (1 Page for each emission point) Emission Point Ref. N o : A3-2 (This is a Minor Emission Point) Location: Plant Room Boiler Room, 1st Floor Production Building Grid Ref. (12 digit, 6E,6N): , Vent Details Diameter: 0.38m Height above Ground(m):13m Date of commencement of emission: May 1999 Characteristics of Emission: Boiler rating Steam Output: Thermal nput: 0kg/hr 1.5 MW Boiler fuel Type: Maximum rate at which fuel is burned % sulphur content: Natural gas 102kg/hr negligible NOx 120 mg/nm 3 0 o C. O 2 (Liquid or Gas), O 2 (Solid Fuel) September 2009 Page 35 of 52 EPA Export :16:05:20

37 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P Maximum volume* of emission 2,938 m 3 /hr 0 o C, O 2 (liquid or gas), O 2 (solid fuel) Temperature 250 o C(max) 230 o C(min) 240 o C (avg) * Volume flow limits for emissions to atmosphere shall be based on Normal conditions of temperature and pressure, (i.e. 0 o C,101.3kPa), dry gas; 3% oxygen for liquid and gas fuels; 6% oxygen for solid fuels. (i) Period or periods during which emissions are made, or are to be made, including daily or seasonal variations (start-up/shutdown to be included): Periods of Emission (avg) min/hr 24 hr/day 365 day/yr September 2009 Page 36 of 52 EPA Export :16:05:20

38 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P Table E.1 (i) BOLER EMSSONS TO ATMOSPHERE Emission Point: (1 Page for each emission point) Emission Point Ref. N o : A3-3 (This is a Minor Emission Point) Location: Plant Room Boiler Room, 1st Floor Administration Building Grid Ref. (12 digit, 6E,6N): , Vent Details Diameter: 0.38m Height above Ground(m):11m Date of commencement of emission: May 1999 Characteristics of Emission: Boiler rating Steam Output: Thermal nput: 0kg/hr MW Boiler fuel Type: Maximum rate at which fuel is burned % sulphur content: Natural gas 29kg/hr negligible NOx 120 mg/nm 3 0 o C. O 2 (Liquid or Gas), O 2 (Solid Fuel) September 2009 Page 37 of 52 EPA Export :16:05:20

39 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P Maximum volume* of emission 1,037 m 3 /hr 0 o C, O 2 (liquid or gas), O 2 (solid fuel) Temperature 250 o C(max) 230 o C(min) 240 o C (avg) * Volume flow limits for emissions to atmosphere shall be based on Normal conditions of temperature and pressure, (i.e. 0 o C,101.3kPa), dry gas; 3% oxygen for liquid and gas fuels; 6% oxygen for solid fuels. (i) Period or periods during which emissions are made, or are to be made, including daily or seasonal variations (start-up/shutdown to be included): Periods of Emission (avg) min/hr 24 hr/day 365 day/yr September 2009 Page 38 of 52 EPA Export :16:05:20

40 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P TABLE D TABLE F.1(i): ABATEMENT / TREATMENT CONTROL Emission point reference number : A2-1 (RTO) Control 1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up Pressure at inlet to RTO Unit Concentration of Flammable Gases at RTO inlet Combustion Temperature Exhaust fan controlled by pressure at inlet Valve on dilution air inlet (bypass) controlled by LEL Meters on air supply Thermo couples in combustion chamber 2-yearly inspection N/A N/A Regular inspection of function 2-3yearly inspection and replacement Deposits on ceramic bed Filters on inlet 2-yearly inspection and dp measurement Temperature of RTO exhaust air Exhaust gas composition Defined by equipment design (~60K above inlet air temperature, max.300 C), measured by thermocouple Defined by equipment and process design Annual calibration N/A N/A Redundant LEL meters for safety 3 redundant thermocouples N/A 2-yearly inspection N/A N/A N/A N/A Regular external measurement of Exhaust gas composition September 2009 Page 39 of 52 EPA Export :16:05:20

41 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment calibration Pressure at inlet to RTO Unit Concentration of Flammable Gases at RTO inlet Combustion Temperature Deposits on ceramic bed Temperature of RTO exhaust air Exhaust gas composition Continuous monitoring and control of pressure Continuous monitoring and control of concentration Continuous monitoring and control of temperature Continuous monitoring of pressure drop across ceramic bed Continuous monitoring of temperature Regular external measurement of Exhaust gas composition Pressure indicator and data logger N/A 3 LEL meters and data logger Annual calibration 3 redundant thermocouples N/A Pressure indicator Temperature measurement device and data logger External contractor equipment 1 List the operating parameters of the treatment / abatement system which control its function. 2 List the equipment necessary for the proper function of the abatement / treatment system. 3 List the monitoring of the control parameter to be carried out. N/A N/A As per contractor calibration schedule/ prior to measurement September 2009 Page 40 of 52 EPA Export :16:05:20

42 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P Table E Sources of Process Aqueous Emissions Area Source Product Stage in Process Bulk Manufacturing Dispensing System (B4) Glucosamine Hydrochloride / Sodium Sulphate Approx Volume Generated - (Litres) Existing Proposed Equipment Clean Weekly Bulk Manufacturing Bicone Blender (B5) Crystalline Glucosamine Sulphate Equipment Clean Weekly Bulk Manufacturing Condenser Glucosamine Hydrochloride / Sodium Sulphate Bulk Manufacturing Blender Filter Cartridge (B5) CGS Drying Daily Crystalline Glucosamine Sulphate Equipment Clean Daily Bulk Manufacturing Mill (B5) Crystalline Glucosamine Sulphate Equipment Clean Monthly Manufacturing Area 1 Manufacturing Area 1 Manufacturing Area 1 Manufacturing Area 1 Manufacturing Area 1 Manufacturing Area 1 LAF Booth Dispensing Room M6 Discharge Station BB- 105 and LAF Booth (M8) Discharge Stations BB- 101 & BB-103 (M9) Bromelaine / Crystalline Glucosamine Sulphate Crystalline Glucosamine Sulphate / Plantaben Crystalline Glucosamine Sulphate / Plantaben Parts Wash M10 Crystalline Glucosamine Sulphate / Sorbitol / Plantaben BC Wash Room M10 Crystalline Glucosamine Sulphate / Sorbitol / Plantaben Equipment Clean Weekly Equipment Clean Monthly Equipment Clean Monthly Equipment Clean Monthly Equipment Clean Daily Capsule Filler G140 (M5) Crystalline Glucosamine Sulphate Equipment Clean Monthly Frequency of Operation September 2009 Page 41 of 52 EPA Export :16:05:20

43 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P Sources of Process Aqueous Emissions Area Source Product Stage in Process Manufacturing Area 1 Manufacturing Area 1 Manufacturing Area 1 Manufacturing Area 2 Manufacturing Area 2 Manufacturing Area 2 Manufacturing Area 2 Manufacturing Area 2 Manufacturing Area 2 Manufacturing Area 2 Manufacturing Area 2 Approx Volume Generated - (Litres) Existing Proposed Capsule Filler G60 (M4) Crystalline Glucosamine Sulphate Equipment Clean Monthly Tablet Press (M3) Crystalline Glucosamine Sulphate Equipment Clean Monthly Suberblender (M31) Crystalline Glucosamine Sulphate / Plantaben Equipment Clean Weekly Dispensing Room M21 Acetylsalicylic Acid / Tromalyt Equipment Clean Weekly Dispensing Room M24 Ethyl Cellulose / Sugar Pellets / Triacetin / Kollidon VA-64 Equipment Clean Monthly Sieving (M25) Acetylsalicylic Acid / Tromalyt Equipment Clean Monthly Parts Wash M26 Tromalyt / Fortilase / Extranase / Ananase BC Wash Room M26 Tromalyt / Fortilase / Extranase / Ananase BL-201 Tromalyt / Fortilase / Extranase / Ananase Equipment Clean Monthly Equipment Clean Daily Equipment Clean Weekly CO-201 (M18) Acetylsalicylic Acid Equipment Clean Daily CO-202 (M17) Sucrose Equipment Clean Daily Frequency of Operation September 2009 Page 42 of 52 EPA Export :16:05:20

44 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P Sources of Process Aqueous Emissions Area Source Product Stage in Process Manufacturing Area 2 Coating Solution Prep (M16) Approx Volume Generated - (Litres) Existing Proposed Sucrose Equipment Clean Daily Frequency of Operation September 2009 Page 43 of 52 EPA Export :16:05:20

45 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P TABLE F TABLE F.1(i): ABATEMENT / TREATMENT CONTROL Emission point reference number : SE1 Control 1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up ph Effluent treatment plant Preventive maintenance every 12 weeks ph probes calibration every 12 weeks Spares held on site Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment calibration ph Continuous ph probe ph probes calibration every 12 weeks September 2009 Page 44 of 52 EPA Export :16:05:20

46 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P List the operating parameters of the treatment / abatement system which control its function. 2 List the equipment necessary for the proper function of the abatement / treatment system. 3 List the monitoring of the control parameter to be carried out. September 2009 Page 45 of 52 EPA Export :16:05:20

47 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P TABLE F.1(i): ABATEMENT / TREATMENT CONTROL Emission point reference number : SE2 (sewage) This table is not applicable to emission point to sewer SE2 as no treatment of foul effluent from the site takes place. Control 1 parameter Equipment 2 Equipment maintenance Equipment calibration Equipment back-up None None None None None Note: Foul effluent is discharged to sewer without treatment, as is the norm at most industrial premises. Control 1 parameter Monitoring to be carried out 3 Monitoring equipment Monitoring equipment calibration September 2009 Page 46 of 52 EPA Export :16:05:20

48 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P List the operating parameters of the treatment / abatement system which control its function. 2 List the equipment necessary for the proper function of the abatement / treatment system. 3 List the monitoring of the control parameter to be carried out. September 2009 Page 47 of 52 EPA Export :16:05:20

49 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P TABLE G TABLE H.1(i): WASTE - Hazardous Waste Recovery/Disposal Waste material EWC Code Main source 1 Quantity On-site Recovery/Disposal Off-site Recovery, reuse or recycling Off-site Disposal Tonnes / month* m 3 / month (Method & Location ) (Method, Location & Undertaker) Thioglycollic Acid QC Lab Eco-safe Systems (R3 Recycling/reclamati on of organic substances which are not used as solventa R4 recycling/reclamati on of metals and metal compounds) Lead Perchlorate / Methanol QC Lab 0.24 Eco-safe Systems (R3 Recycling/reclamati on of organic substances which are not used as solventa R4 recycling/reclamati on of metals and metal compounds) (Method, Location & Undertaker) Ecosafe Systems (D10 ncineration on land) Eco-safe Systems (D10 ncineration on land) September 2009 Page 48 of 52 EPA Export :16:05:20

50 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P Waste material EWC Code Main source 1 Quantity On-site Recovery/Disposal Off-site Recovery, reuse or recycling Off-site Disposal Tonnes / month* m 3 / month (Method & Location ) (Method, Location & Undertaker) UN 1993 Acetone QC Lab Eco-safe Systems (R3 Recycling/reclamati on of organic substances which are not used as solventa R4 recycling/reclamati on of metals and metal compounds) Non-regulated polysorbate Production Eco-safe Systems (R3 Recycling/reclamati on of organic substances which are not used as solventa R4 recycling/reclamati on of metals and metal compounds) (Method, Location & Undertaker) Eco-safe Systems (D10 ncineration on land) Ecosafe Systems (D10 ncineration on land) * total over a year divided by 12 September 2009 Page 49 of 52 EPA Export :16:05:20

51 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Register P TABLE H TABLE H.1(i): WASTE - Hazardous Waste Recovery/Disposal Waste material EWC Code Main source 1 Quantity On-site Recovery/Disposal Off-site Recovery, reuse or recycling Off-site Disposal Bulky waste including Rejected Product, Wastes from Abatement - pharmaceutical dust, Filter elements and Contaminated Packaging Manufacturing Process, Dust Collectors, Air Handling Equipment and Raw Material delivery Tonnes / month* m 3 / month (Method & Location ) (Method, Location & Undertaker) (Method, Location & Undertaker) 26 Not Available Not applicable Not applicable Deep Burial, Knockharley, Co Meath, Greenstar * total over a year divided by 12 September 2009 Page 50 of 52 EPA Export :16:05:20

52 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Figures RF Reference Figure No Description 1b A Drawings showing the internal layout, production areas (Area 1, Area 2, Bulk) and the emissions arising. Show the locations of equipment including the coating pans, blenders, dedusters, etc 2a B A3 engineering drawings showing all emission points and the sources of the emissions for each emission point. 2g (i) C A3 engineering drawings of RTO (in addition to Figure Fl) 2g(vii) D D1: Vendor P&D of the coater D2: Lay out drawing of coater 2g(x) E P&D of RTO/Heat Recovery System 3c F Locations and details of the coating pans and the route to the abatement system 6d G Location of the nearest noise sensitive receptor September 2009 EPA Export :16:05:21

53 Rottapharm - PPC Licence Application - Response to Request for Additional nformation Appendices RF Reference Appendix No 1a A ES Description 1f B Copy of the letter to the Planning Authority referred to in your correspondence dated 22 June 2009 (Ref A L0002). 2f C Report on air dispersion modelling 6f D Audited Accounts of Rottapharm for 2006, 2007 and E Non-Technical Summary September 2009 EPA Export :16:05:21

54 nternal Production Layout Rottapharm PPC Licence Application RF D September 2009 Figure A1 EPA Export :16:05:21

55 Plant Room AHUs & DCUs Rottapharm PPC Licence Application RF D September 2009 Figure A2 EPA Export :16:05:21

56 0 metres 40 Scale 1:1,000 Ordance Survey reland Licence Number EN Government of reland N A2-1 A3-4 A3-5 A3-6 A4-1 A3-7 A3-8 A3-9 A3-11 A N A3-1 A N A3-10 A N E E E E E E Air Emissions to Points atmosphere Rottapharm PPC Licence Application RF D D September 2009 Figure Figure E.1 B1 Rev A EPA Export :16:05:21

57 Emission points and the sources of the emissions for each emission point Rottapharm PPC Licence Application RF D September 2009 Figure B2 EPA Export :16:05:21

58 Emission points and the sources of the emissions for each emission point Rottapharm PPC Licence Application RF D September 2009 Figure B3 EPA Export :16:05:21

59 Emission points and the sources of the emissions for each emission point Rottapharm PPC Licence Application RF D September 2009 Figure B4 EPA Export :16:05:21

60 Emission points and the sources of the emissions for each emission point Rottapharm PPC Licence Application RF D September 2009 Figure B5 EPA Export :16:05:21

61 Nr. / No WG153 VP111 VV141 Ausrüstung / Brennkammer Kamin KA190 Brenner Prozess.vent. Verbrenn. ventilator Equipment Comb. chamber Stack Burner Process air fan Combustion air fan Warmwasser Warmwasser Druckluft Erdgas Abluft Abluft Abluft Abluft Reingas Reingas Spülluft Verbrennungsluft Frischluft Frischluft Erdgas Prozessluft Verbrennungsluft Medium Warm water Warm water Compressed air Natural gas Exhaust air Exhaust air Exhaust air Exhaust air Clean gas Clean gas Purge air Combustion air Fresh air Fresh air Natural gas Process air Combustion air Durchflussmenge nominal HOLD HOLD HOLD HOLD HOLD Flow rate max HOLD HOLD HOLD HOLD HOLD [ Nm³/h ] min. Rottapharm Rottapharm HOLD HOLD HOLD HOLD HOLD Temperatur nominal HOLD HOLD HOLD HOLD HOLD Temperature max HOLD HOLD HOLD HOLD HOLD [ C ] min HOLD HOLD HOLD HOLD HOLD Druck nominal Rottapharm Rottapharm HOLD HOLD HOLD Pressure max. Rottapharm Rottapharm Rottapharm Rottapharm Rottapharm Rottapharm HOLD HOLD HOLD [ mbar ] min. Rottapharm Rottapharm Rottapharm Rottapharm Rottapharm HOLD HOLD HOLD Konzentration nominal HOLD HOLD HOLD HOLD Concentration max HOLD HOLD HOLD HOLD HOLD HOLD [ mg/nm³ ] min HOLD HOLD HOLD HOLD HOLD HOLD Leistung Power kw Hersteller Manufacturer Piping and nstrumentation Drawing of RTO Rottapharm PPC Licence Application RF D September 2009 Figure C1 EPA Export :16:05:21

62 SDE VEW FRONT VEW REAR VEW TOP VEW PRELMNARY NCOMATC COATNG SYSTEM 350 CLASSC /ELTE SK.NCS.241 Vendor P&D of the coater Rottapharm PPC Licence Application RF D September 2009 Figure D1 EPA Export :16:05:21

63 Lay out drawing of coater Rottapharm PPC Licence Application RF D September 2009 Figure D2 EPA Export :16:05:21

64 Nr. / No WG153 VP111 VV141 Ausrüstung / Brennkammer Kamin KA190 Brenner Prozess.vent. Verbrenn. ventilator Equipment Comb. chamber Stack Burner Process air fan Combustion air fan Warmwasser Warmwasser Druckluft Erdgas Abluft Abluft Abluft Abluft Reingas Reingas Spülluft Verbrennungsluft Frischluft Frischluft Erdgas Prozessluft Verbrennungsluft Medium Warm water Warm water Compressed air Natural gas Exhaust air Exhaust air Exhaust air Exhaust air Clean gas Clean gas Purge air Combustion air Fresh air Fresh air Natural gas Process air Combustion air Durchflussmenge nominal HOLD HOLD HOLD HOLD HOLD Flow rate max HOLD HOLD HOLD HOLD HOLD [ Nm³/h ] min. Rottapharm Rottapharm HOLD HOLD HOLD HOLD HOLD Temperatur nominal HOLD HOLD HOLD HOLD HOLD Temperature max HOLD HOLD HOLD HOLD HOLD [ C ] min HOLD HOLD HOLD HOLD HOLD Druck nominal Rottapharm Rottapharm HOLD HOLD HOLD Pressure max. Rottapharm Rottapharm Rottapharm Rottapharm Rottapharm Rottapharm HOLD HOLD HOLD [ mbar ] min. Rottapharm Rottapharm Rottapharm Rottapharm Rottapharm HOLD HOLD HOLD Konzentration nominal HOLD HOLD HOLD HOLD Concentration max HOLD HOLD HOLD HOLD HOLD HOLD [ mg/nm³ ] min HOLD HOLD HOLD HOLD HOLD HOLD Leistung Power kw Hersteller Manufacturer Piping and nstrumentation Drawing of RTO/Heat Recovery System Rottapharm PPC Licence Application RF D September 2009 Figure E1 EPA Export :16:05:21

65 SDE VEW FRONT VEW REAR VEW TOP VEW PRELMNARY NCOMATC COATNG SYSTEM 350 CLASSC /ELTE SK.NCS.241 Locations and details of the coating pans and the route to the abatement system Rottapharm PPC Licence Application RF D September 2009 Figure F1 EPA Export :16:05:21

66 0 metres 400 Scale 1:1,000 Dam asto. wn A ve. wn Roa Tol k d ns en asto ar Co Dam to f c Fo op r i yr ns ig pe ht ct ow ion ne pu r r rp eq os ui es re o d nl fo y. ra ny ot he ru r se Da ma s tow e en Riv Pinke nd riv e Ordance Survey reland Licence Number EN Government of reland ive N3 r Tolka Valley River Clon ee B ypas s Nearest Noise Sensitive Receptors Location of the nearest noise sensitive receptor Rottapharm PPC Licence Application RF D September 2009 Figure G1 EPA Export :16:05:21