Pfizer Biotechnology Ireland - Environmental Protection Agency

1 Pfizer Biotechnology Ireland 2009 Annual Environmental Report Integrated Pollution Prevention Control License P0864-01 Executive Summary: The Pfizer Biotechnology Ireland facility at Shanbally Ringaskiddy commenced operations under IPPC P0864-01 on June 26th, of 2009. 2009 was a very successful year for the facility, with the granting of the IPPC license, completion of the validation programme and the awarding of a clinical manufacturing license by the IMB. Through the remainder to the year a 100% compliance level was achieved against all the permitted activities. The facility is designed to use the Monoclonal antibody (Mabs) platform for the production of Phase II and Phase III Clinical Trial medicinal products The sites Environmental management system has been based on the ISO 14001 model with a view to future certification to the standard.

2 While the facility has just commenced manufacturing its initial product a clear focus on Environmental awareness and sustainability has been marked by the awarding of: o the Sustainability award for 2009 by the ISPE International Society of Pharmaceutical Engineering o the 2009 CPD (Continuing Professional Development) Large Sized Company Category Award The facility was constructed using Pfizer s Green Building design philosophy and this was instrumental in securing the Sustainability award The award for Continuing Professional Development was presented In recognition of excellent and innovative organizational CPD practices which helped successfully deliver, a new biopharmaceutical plant for Pfizer in Ireland in less than two years.

3 The award was based on our learning and development programs, including key Environmental learning packages, with a continued commitment to Learning and Development at Shanbally. The Environmental management Programme (EMP) outlined in this report will demonstrate a focus on improved Environmental performance, specifically in the areas of water, energy and resource conservation. A phased plan has been implemented geared towards continuous improvement in all business areas not least of which is those areas of the sites which may have an Environmental impact. It is believed that substantial improvements and benefits will be derived from these efforts in 2010. Contents 1.

4 Introduction General Facility Overview Organisation Chart for Environmental management Water Emissions Monitoring Data Air Emissions Monitoring Data IPPC Licence Compliance Noise Survey Waste Arisings Resource Utilisation Environmental Incidents and Complaints Genetically Modified Micro-Organisms 2. management of the Activity Introduction Status Report on Schedule of Objectives and Targets (2009) Environmental management Plan 2009 3. Pollution Release and Transfer Register (PRTR) 4. Bund Integrity Assessment Report 5. Tank and Pipeline Testing and Inspection 6. Environmental liabilities and Residual management 7. Licence Specific Reports Attachment 1 Environmental , Health and Safety Policy Attachment 2 - Energy management audit Attachment 3 Site Noise Survey Attachment 4 Pipeline Test Report Attachment 5 - Bund Integrity Report Attachment 6 ELRA: Environmental Liabilities Risk Assessment Attachment 7 DMP: Decommissioning management Plan Attachment 8 PRTR: Pollution Release and Transfer Register 1.

5 Introduction General At the Shanbally Biotechnology facility the responsibility for Environmental Compliance and IPPC management rests with the Engineering and EHS Team, where the specific Environment Health and Safety responsibilities reside with the EHS Lead. Over the past two years the Environmental focus has moved from Construction and Commissioning activities through establishing the EHS management system , with continuous improvement of those systems. Pfizer Biotechnology s Ireland s Monoclonal Antibodies Small-scale Facility was built using industry best practices for sustainability and Pfizer s green building guidelines that included the extensive re-use of existing assets, waste minimization procedures, recycling utilization in both construction and operations, the inclusion of energy-efficient fixtures and equipment, and minimized air change rates to meet room comfort conditions and classification standards.

6 This approach resulted in the facility receiving the 2009 Sustainability Development Award from International Society of pharmaceutical Engineering. This Phase 2/3 clinical trial product facility is Pfizer s first Biotechnology brown field development and the site was chosen for a variety of reasons, including its proximity to the adjacent Pfizer Ringaskiddy site which allowed the new facility to use spare capacity of the existing wastewater treatment plant and fire main system rather than building a new treatment plant or bringing in new tanks and pumps for fire water retention. Other outstanding sustainability elements of this project included the re-use of 5,000 cube meters of crushed rubble from an old adjacent facility for the new substructure and 30,000 cubic meters of excavated material for general site fill and landscaping; the use of an eco-seal, grey, insulated roof membrane to reduce the heat island effect; and site orientation to optimize solar gain.

7 Facility Overview Introduction The Pfizer Monoclonal Antibodies (MAbs) facility was constructed at Shanbally, Ringaskiddy, County Cork, for the manufacture of Phase II & Phase III Drug Substance candidate therapies. The clinical trial and initial product launch facility is designed to manufacture, purify, formulate and bulk fill mammalian cell culture derived proteins. These will form the Active Pharmaceutical Ingredient (API) in products intended for human use. The facility includes two 2500 litre production bioreactors. In addition, the facility includes a warehouse in which the raw material and finished goods will be stored, Quality Control and Technical Services Laboratories and Administration areas.

8 The facility operates on the site formerly occupied by the ADM (Archer Daniels Midland) plant, which closed in 2006 and as part of the divestiture of this site - ADM surrendered its IPC license. During this process an audit of the site was conducted by the EPA to verify that all the required terms of the decommissioning and demolition met the agreed DMP (Decommissioning management Plan) criteria and the license surrender was accepted on that basis. The Installation and Its Activities Overview The facility comprises of a main building and a guard house. The main building has five main areas: Production area, Warehouse, Laboratory/office area, Utility area (or Central Utility Plant), Plant mechanical area.

9 The production area is predominantly on the second floor of the three storey central part of the building. The central utilities plant is be located on the ground floor of the central block. The engineering support facilities are located on the ground floor and lower mezzanine in the central block and also the plant mechanical area is located on the top floor of the central block. The warehouse is in the Western annex to the main building. The main storage areas are located in the single storey annex with ancillary facilities such as sampling, gowning and freezers on the ground floor of a two storey section, with mechanical services on the first floor. The laboratories & offices are located in the two-storey southern section of the main building.

10 The staff support facilities ( canteen, locker rooms, hygiene etc.) are located on the ground floor. Some structures from the previous facility (ADM) have been retained through the construction and commissioning phases of the project. The future retention or otherwise of these structures is likely to be decided in 2010. Production Area The production area processes include innoculum lab, cell culture, purification and process support functions. Cell culture includes seed bioreactors, production bioreactors, and recovery / harvest unit operations. Purification includes buffer hold, purification, formulation and bulk fill. The Process Support areas include the dispensary and parts wash, as well as media and buffer preparation areas.