Výsledky vyhledávání - "T H, Meltzer"

The Importance of Accurate Microorganism Identification in Microbial Challenge Tests of Membrane Filters. Part II. The Comparison of Hydrogenophaga pseudoflava ATTC 33668 and Curvibacter sp. ATCC 700892 by Microbial Challenge Tests with Membrane Filters

Autor: T H Meltzer, I Kaesler-Neumann, G Haake, M W Jornitz, H Hennig

Publikováno v: PDA Journal of Pharmaceutical Science and Technology. 66:346-353

The ASTM 838-05 standard describes a bacteria challenge test procedure based on Brevundimonas diminuta (ATCC 19146) to verify a 0.2 μm rated sterilizing-grade filter. For process validation procedures a correct identification of the challenge organi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2332be6f97d3ffd4069a9b6dd4287cae
https://doi.org/10.5731/pdajpst.2012.00876

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The importance of accurate microorganism identification in microbial challenge tests of membrane filters--part I

Autor: I, Kaesler, G, Haake, H, Hennig, A, Rosenhagen, T H, Meltzer, M W, Jornitz

Publikováno v: PDA journal of pharmaceutical science and technology. 65(2)

Microbial challenge testing is a common procedure to determine the retention efficiency, performance, and validity of a sterilizing-grade filter. The ASTM 838-05 standard describes a bacteria challenge test procedure based on Brevundimonas diminuta (

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::2b01d88402fb617f87157a606e88eb21
https://pubmed.ncbi.nlm.nih.gov/21502070

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Validation of sterilizing grade filtration

Autor: M W, Jornitz, T H, Meltzer

Publikováno v: Developments in biologicals. 113

Validation consideration of sterilizing grade filters, namely 0.2 micron, changed when FDA voiced concerns about the validity of Bacterial Challenge tests performed in the past. Such validation exercises are nowadays considered to be filter qualifica

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::cc1f45821263c147ca6d30650c1f0f14
https://pubmed.ncbi.nlm.nih.gov/14620854

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