| Environmental microbial challenges to an aseptic Blow-Fill-Seal process--a practical study. | |
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MedLine Citation:
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PMID: 7489196 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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A Blow-Fill-Seal machine, set to aseptically fill sterile liquid TSB medium into 20 ml plastic containers, was subjected to a series of environmental microbial challenges in order to evaluate the effects of the room environment, and of the actions of persons in the room, on the sterility of the product. Despite a series of relatively severe stresses to the system, none of the units filled (approximately 44,000) were found, following incubation, to display growth. |
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Authors:
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D J Jones; P Topping; J Sharp |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: PDA journal of pharmaceutical science and technology / PDA Volume: 49 ISSN: 1079-7440 ISO Abbreviation: PDA J Pharm Sci Technol Publication Date: 1995 Sep-Oct |
Date Detail:
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Created Date: 1996-01-04 Completed Date: 1996-01-04 Revised Date: 2000-12-18 |
Medline Journal Info:
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Nlm Unique ID: 9439538 Medline TA: PDA J Pharm Sci Technol Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 226-34 Citation Subset: IM |
Affiliation:
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Waverley Pharmaceutical/Steripak Limited, Runcorn, Cheshire, England. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Air Microbiology* Bacteria / growth & development Colony Count, Microbial Drug Contamination / prevention & control Drug Industry Drug Packaging* Environment, Controlled* Fungi / growth & development Plastics Sterilization / standards* Technology, Pharmaceutical* |
| Chemical | |
Reg. No./Substance:
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0/Plastics |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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