Document Detail


Environmental microbial challenges to an aseptic Blow-Fill-Seal process--a practical study.
MedLine Citation:
PMID:  7489196     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
D J Jones; P Topping; J Sharp
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Publication Detail:
Type:  Journal Article    
Journal Detail:
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:
Created Date:  1996-01-04     Completed Date:  1996-01-04     Revised Date:  2000-12-18    
Medline Journal Info:
Nlm Unique ID:  9439538     Medline TA:  PDA J Pharm Sci Technol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  226-34     Citation Subset:  IM    
Affiliation:
Waverley Pharmaceutical/Steripak Limited, Runcorn, Cheshire, England.
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MeSH Terms
Descriptor/Qualifier:
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:
0/Plastics

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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