
Aseptic Processing Of Health Care Products - Part 6: Isolator Systems
出版:British Standards Institution

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基本信息
標準編號: BS EN ISO 13408-6:2011+A1:2013
發布時間:2013/6/30 0:00:00
標準類別:Standard
出版單位:British Standards Institution
標準頁數:30
標準簡介
Gives the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products.
標準備注
Together with BS EN ISO 13408-1, 2, 3, 4 and 5, it supersedes BS EN 13824. (10/2011) 2011 Edition Re-Issued in June 2013 & incorporates AMD 1 2013. Supersedes 12/30250823 DC. (06/2013)
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