SS-EN-ISO-13408-6 › Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
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Included in this current edition are the following subparts:
2011/A1:2013 EDITION AMENDMENT - March 25, 2013
This part of ISO 13408 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. This part of ISO 13408 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.
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SS-EN ISO 13408-6:2011
July 12, 2011
EN ISO 13408-6:2011(IDT); ISO 13408-6:2005(IDT)