Transcription of PhEn-602 Pharmaceutical Facility Design
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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 requirements Maintenance access requirementsMaintenance access requirementsJ. ManfrediPhEn-602 Spring '093 Architecture & Layout ConsiderationsArchitecture & Layout ConsiderationsThe layout of the sterile manufacturing Facility The layout of the sterile manufacturing Facility must be developed around the needs of the must be developed around the needs of the Facility .
• § 211.42 Design and construction features. • (a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. • (b) Any such building shall have adequate space for the orderly
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