Sterilizing filtration of liquids. Technical report no. 26 (revised 2008)
Antonsen, H.R.Kviat.; Awafo, V.; Bender, J.L.; Carter, J.R.; Conway, R.S.; Egli, S.; Feeser, T.M.; Jornitz, M.W.; Kearns, M.; Levy, R.V.; Madsen, R.E.; Martin, J.M.; McBurnie, L.D.; Meissner, L.S.; Meltzer, T.H.; Pawar, V.; Phelan, M.; Stinavage, P.S.; Sweeney, N.; Vega, H.; Witchey-Lakshmanan, L.C.; Antonsen, H.R.Kviat.; Awafo, V.; Bender, J.L.; Carter, J.R.; Conway, R.S.; Egli, S.; Feeser, T.M.; Jornitz, M.W.; Kearns, M.; Levy, R.V.; Madsen, R.E.; Martin, J.M.; McBurnie, L.D.; Meissner, L.S.;
PDA journal of pharmaceutical science and technology 62(5 Suppl TR26): 2-60
2008
ISSN/ISBN: 1079-7440 PMID: 19642423 Document Number: 15019
Sterilizing filtration is the process of removing microorganisms* from a fluid stream without adversely affecting product quality (1-4) This technical report is intended to provide a systematic approach to selecting and validating the most appropriate filter for liquid-sterilizing filtration applications. PDA'.s original Technical Report No. 26, Sterilizing Filtration of Liquids, published in 1998, described the use and validation of sterilizing filtration to a generation of pharmaceutical scientists and engineers. This revision of the original report was developed in response to enhancements in filtration technologies and recent additional regulatory requirements within the pharmaceutical industry. References to regulatory documents, standards and scientific publications are provided where more detail and supportive data may be found. When membrane filters entered the market in the 1960s, 0.45μ,m-rated membranes were considered "sterilizing-grade" filters and were used successfully in the sterilizing filtration of parenterals. These filters were qualified using Serratia marcescens as a standard bacterium for qualifying membranes used for water quality testing. In a paper published in 1960, however, Dr. Frances Bowman of the U.S. Food and Drug Administration observed a 0.451.1m "sterile-filtered" culture medium to be contaminated with an organism subsequently shown to repeatedly penetrate 0.45 μm-rated membranes in small numbers at challenge levels above 104-106 per cm2. (5) This led to the development of ASTM F 838, a standard test method for evaluating sterilizing-grade membrane filters. (6) Challenge organisms are discussed further.
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