ANSI AAMI ISO 13408-6-2005 (R2013)

Category: Technical


Posted on 2020-09-14, by banz.

Description

Aseptic Processing Of Health Care Products - Part 6: Isolator Systems (Includes Amendment 1)
Specifies 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.

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