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PhEn-602 Pharmaceutical Facility Design

J. ManfrediPhEn-602 Spring '091 PhEnPhEn--602602 Pharmaceutical Facility DesignPharmaceutical Facility DesignNotes # 8 Notes # 8J. ManfrediJ. ManfrediJ. ManfrediPhEn-602 Spring '092 Architecture & Layout ConsiderationsArchitecture & Layout ConsiderationsImportant to understand the manufacturing processes Important to understand the manufacturing processes and conduct the Facility conduct the Facility Facility layoutlayoutmust be an integrated Design that must be an integrated Design that satisfies the following:satisfies the following: Process requirementsProcess requirements Personnel flowsPersonnel flows Material flows (product, component and raw material Material flows (product, component and raw material movements) movements) Equipment layout requirementsEquipment layout requirements Operational access requirementsOperational access

Architecture & Layout Considerations Gray zones: Service space or maintenance space typically adjacent to the production room • Contains the majority of piping, valves, electrical conduit and other utilities that support the manufacturing area. • Maintenance personnel have separate access to these areas, allowing less stringent gowning

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