Zobrazeno 1 - 3
of 3
pro vyhledávání: '"Magnus Stering"'
Autor:
Magnus Stering, Sean Tomlinson, Brian Thome, Mandar Dixit, Stephanie S Ferrante, Leesa McBurnie, Dawood Dassu, Jeff Gaerke, Brian Joseph, Scott Mills, Carl Weitzmann
Publikováno v:
PDA journal of pharmaceutical science and technology. 74(5)
Eudralex volume 4, Annex 1, the European Union Good Manufacturing Practice for sterile products, requires that “The integrity of the sterilised filter should be verified before use” (1). Implicit in this requirement for a PUPSIT is the rationale
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ca97f2c13a930de75c35da89643c49bb
https://pubmed.ncbi.nlm.nih.gov/32467178
https://pubmed.ncbi.nlm.nih.gov/32467178
Publikováno v:
PDA journal of pharmaceutical science and technology. 64(1)
This paper uses the Boyle-Mariotte Law to restate a few general principles and applies them to rationalise pressure holding tests on sterile installations. The authors offer a methodology to achieve this, as well as a few mathematical models to deter
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::d72b45cdb93ed5086c7646e637c005a4
https://pubmed.ncbi.nlm.nih.gov/21502006
https://pubmed.ncbi.nlm.nih.gov/21502006
Publikováno v:
Genetic Engineering & Biotechnology News. 33:40-41
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::7fcd76f5b065789613201b6beaf7e939
https://doi.org/10.1089/gen.33.11.18
https://doi.org/10.1089/gen.33.11.18