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Aseptic sampling : ウィキペディア英語版 | Aseptic sampling
Aseptic sampling is the process of aseptically withdrawing materials used in biopharmaceutical processes for analysis so as not contaminate or alter the sample or the source of the sample.〔ASTM E1287-89(1999) "Standard Practice for Aseptic Sampling of Biological Materials," ASTM International, West Conshohocken, PA, 1999, DOI: 10.1520/E1287-89R99, www.astm.org〕 Aseptic samples are drawn throughout the entire biopharmaceutical process (cell culture/fermentation, buffer & media prep, purification, final fill and finish〔Stockdale, D. Overview of Aseptic Fill/Finish Manufacturing. Am. Pharm. Rev. 2004.〕). Analysis of the sample includes sterility, cell count/cell viability, metabolites, gases, osmolality and more. ==Aseptic sampling techniques==
Biopharmaceutical drug manufacturers widely use aseptic sampling devices () to enhance aseptic technique. The latest innovations of sampling devices harmonize with emerging trends in disposability,() enhance operating efficiencies and improve operator safety.
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