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Pharmaceutical Manufacturing and Packing Sourcer
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There are certain factors a pharmaceutical manufacturer should consider when adding an isolated filling unit to an existing or new manufacturing facility. Adapted from a case study of an installation of an isolator filling line into an existing pharmaceutical manufacturing facility, this article explores the importance of a full analysis of existing facilities and processes, and the effect new equipment may have on capital expense and schedule delays.
Among the factors for consideration are the resources required to prepare and introduce stoppers into the isolator fill/finish operation. Stopper preparation requires significant capital expense and could cause schedule delays. However, by working closely with the stopper manufacturer, the pharmaceutical company can expedite project completion times and enhance its process.
Sterilised stoppers, usually intended for use in isolated filling units, are designated as ready-to-use (RU) versus ready-to-sterilise (RS). RU stoppers must be final rinsed in USP 'water for injection' (WFI) and must be terminally sterilised; they may also be siliconised at the pharmaceutical manufacturer's request. The stoppers must be delivered in a packaging system that allows direct introduction into the isolator - a sterile filling unit. Most importantly, the stopper manufacturer must control and validate the sterilisation process, bacterial endotoxins, particle load and silicone levels to comply with current US, Japanese and European regulatory requirements.
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By Robert S Nase, Westar® Programme Director for West Pharmaceutical Services and Douglas Stockdale, President of Stockdale Associates, Inc
Robert S Nase is Westar® Programme Director for West Pharmaceutical Services. He has held various positions in the quality assurance department at West at manufacturing and corporate levels. Prior to joining West Pharmaceutical Services, he was employed by the Johnson & Johnson family of companies for 11 years in the cardiovascular division, holding positions in quality assurance, microbiology and sterilisation technology. Robert holds a BSc in Biology and Chemistry from Catawba College and is a member of the International Society of Pharmaceutical Engineers (ISPE) and Association for the Advancement of Medical Instrumentation (AAMI). He has also served on the Health Industry Manufacturers Association Biological Support Committee for Microbiological Methods for Package Integrity.
Douglas Stockdale is the President of Stockdale Associates Inc, which provides extensive aseptic fill/finish and sterile packaging consulting services for the life sciences industry. Prior to founding the company, he had 20 years of operational experience with Baxter Healthcare. Douglas is an internationally known consultant, speaker and writer on the issues of aseptic fill/finish and sterile packaging. He is a member of PDA, AAPS, IOPP and ISPE and a member of the Board of Directors for the Greater Los Angeles chapter of ISPE. Douglas has an MBA from the University of La Verne and a BSc in Engineering from Michigan State University.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
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News and Press Releases |
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“PACK DIFFERENT” with EMBALLAGE 2008
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