Parenterals Production Facility Building

Room No. Area Activity Floor Wall Ceiling  

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PARENTERALS PRODUCTION FACILITY BUILDING C Solution Preparation... 

Process Description for Parenterals Production Facility Building C 111... 

Utility systems such as water for injection (WFl). clean steam, clean-in-placc (CIP) solutions and sterile process air must be similarly proven. Also the building system itself has to be validated. Many bioprocess operations which contain potentially hazardous materials are operated in closely-controlled negative pressure enclosures with filtration of exhaust ventilating air. Sterile and particularly parenteral products arc processed in clean rooms which are maintained at positive pressure with filtered incoming air. Validation of building control systems and of personnel changing facilities and systems of work are necessary to meet CMP requirements. Manuals for formal test procedures are required to validate these activities. 

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