ppt课件-f u n c t i o n s o f t h e p l a n t e n g i n e e r i n g d e p t- i s p e(f u n c t i o n s o f t h e p l n t e n g我n e e r n g d e p t - s p e).pptVIP
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PLANT/FACILITIES ENGINEERING IN THE PHARMACEUTICAL INDUSTRY FUNCTIONS OF THE PLANT ENGINEERING DEPT Design and construction of facilities and systems Maintenance of facilities and systems Operation of system Environmental, Health safety Regulatory compliance Energy management Technology Validation Administration, supervision, organization, planning DESIGN OF FACILITIES PROJECT PHASES Conceptual Long range plan development (1-5 years in advance) Planning Project scope development for next year (6-12 months in advance) Request for capital expenditures (RCE) Develop RCE documentation 2-4 months in advance Execution Immediately pre post funding Closeout Upon completion TYPES OF PROJECT New water for injection system Chilled water upgrade Clean rooms upgrade Installation of a second bag printer Optimize clave cycles Install thermal oxidizers Electrical bussway upgrade Upgrade hot stamp system Overhaul blow mold deflasher PROJECT INDICATORS Did you meet project scope? Did you meet project timeline? Did the project was within budget? PREVENTIVE MAINTENANCE New equipment or changes are added to PM program via VCR (validation change request) Master PM describes: Equipment identification Frequency Tasks to be performed Master PM approved by Maintenance coordinator, Engineering manager, Production manager, and Quality manager. PREVENTIVE MAINTENANCE REQUIREMENTS Tasks and frequency determined by: Manufacturer’s recommendation Historical data Department supervisor and maintenance coordinator verifies completion of PM tasks PM records maintained by the engineering department SHUTDOWN Include routine activity and projects Require project management tools Involve all department and contractors Training is critical to avoid safety issues Require maintenance resource availability SPARE PARTS Increased focus on better utilization of our stockroom dollars Plants are making progress in reducing the cost and number of spare parts in inventory Alternate suppliers are being ident
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