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1 Pfizer Biotechnology Ireland Pfizer Monoclonal Antibodies Small Scale Facility IPPC Licence Application ATTACHMENT D A List of Unit Operations B List of Abatement Systems C Flow Diagrams (PFDs 1 to 10) D Site Map (Map 2) E Location Map (Map 3) F Facilities Plan (Map 6) G Material Flow Layouts (Drawings 1 and 2) H Emission Points (Drawings 3, 4 and 5) A List of Unit Operations Clinical Manufacturing Facility: o Cell Culture: Cell bank Innoculum Preparation Laboratory Cell Culture Wave Bioreactors Seed Bioreactor Media Preparation Production Bioreactors Harvest o Purification: Pre-Viral Purification: Viral Inactivation Anion Chromatography Ultrafiltration/Diafiltration Cation Chromatography Viral Removal Post-Viral Purification: Cation Chromatography Ultrafiltration Final Bulk Fill Buffer Preparation General Plant Support: o Dispensary o Central Wash o Plant Utilities o Waste Systems: Biowaste Inactivation Process Waste Sanitary Waste Solvent Process Waste - No solvent process waste collection systems are provided and there are no provisions for future solvent process waste, Solid Waste o Clean Utilities Reduced Ion Water (RIW) - RIW system Water for Injection (WFI) - WFI system, Clean Steam System Clean Condensate (will not be recovered see following D1.3, Abatement Systems) Clean Air System Clean-in-Place (CIP) Oxygen System Carbon Dioxide System Liquid Nitrogen o Clean-In-Place (CIP) J:\C2000-C2099\C2054\3) DOCUMENTS\40\REPORTS\IPPC LICENCE APPLICATION\IPPC ISSUE\PFIZER BIOTECHNOLOGY IPPC ATTACHMENT D.DOC Attachment D Page 1 Arup Consulting Engineers 24 September 2008 EPA Export :01:46:12

2 Pfizer Biotechnology Ireland Pfizer Monoclonal Antibodies Small Scale Facility IPPC Licence Application B List of Abatement Systems Sewage Treatment Plant Biowaste Inactivation System Condensate from the Cell Culture areas will be discharged to the biowaste inactivation system through closed drains. Process Waste Equalisation Tank Process Waste Neutralisation System Flow rate, ph and temperature of the pre-treated process wastewater will be measured and recorded prior to discharge. Waste Management Area for Solid Waste: Segregation and sterilization, where necessary, of solid waste, Recycling of solid waste, where possible, Disposable of solid waste to appropriate waste disposal facility, Classification of solid waste as hazardous or non hazardous, Disposal of hazardous solid waste (by suitably licensed and permitted waste contractors, to licensed or permitted waste facilities, in full compliance with the requirements of Cork County Council environment department and the EPA), Surface Water Drainage System Surface water discharges will be continuously monitored using ph, TOC and conductivity measurements and will be automatically diverted to a holding tank on site if measurements indicate that these parameters are outside set point criteria. J:\C2000-C2099\C2054\3) DOCUMENTS\40\REPORTS\IPPC LICENCE APPLICATION\IPPC ISSUE\PFIZER BIOTECHNOLOGY IPPC ATTACHMENT D.DOC Attachment D Page 2 Arup Consulting Engineers 24 September 2008 EPA Export :01:46:12