| Airborne microbial challenges of Blow/Fill/Seal equipment: a case study. | |
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MedLine Citation:
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PMID: 1770413 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Controlled microbial challenges, comprising air-dispersed spores of Bacillus subtilis var niger, have been generated within a containment room (around 54 m3 in volume) housing a Blow/Fill/Seal machine. 'Stirred-settling' conditions were created throughout the room and the airborne spore challenge was monitored to ensure homogeneity within the room for extended periods of time. The Blow/Fill/Seal machine was set to fill 2 cm3 ampoules with Tryptone Soya Broth at each of three airborne challenge levels of 10(4), 10(6) and 10(7) spores m-3 (about 10(2), 10(4) and 10(5) spores ft-3 respectively). A relationship has been established between the level of airborne micro-organisms in the machine operating environment and the extent of product contamination. This relationship allows prediction of operating conditions under which a level of sterility assurance, equal to that demanded of terminal sterilization, is attained. It is stressed that the findings apply only to the particular Blow/Fill/Seal machine and to the specific conditions of machine operation. |
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Authors:
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A Bradley; S P Probert; C S Sinclair; A Tallentire |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Journal of parenteral science and technology : a publication of the Parenteral Drug Association Volume: 45 ISSN: 0279-7976 ISO Abbreviation: J Parenter Sci Technol Publication Date: 1991 Jul-Aug |
Date Detail:
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Created Date: 1992-02-24 Completed Date: 1992-02-24 Revised Date: 2000-12-18 |
Medline Journal Info:
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Nlm Unique ID: 8103145 Medline TA: J Parenter Sci Technol Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 187-92 Citation Subset: IM |
Affiliation:
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Fisons Pharmaceutical Division, Pharmaceutical Technical Development, Holmes Chapel, Cheshire, England. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Air Microbiology* Drug Contamination / prevention & control* Drug Packaging / methods* England Environment, Controlled Equipment Design Spores, Bacterial / chemistry |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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