ANSI AAMI ISO 13408-6-2005 A1-2013

Category: Technical


Posted on 2020-09-14, by banz.

Description

Aseptic processing of health care products - Part 6: Isolator systems

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. The document focuses on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.

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