ISO 13408-6:2005
International Standard
Historical
·
Approved on
20 June 2005
Aseptic processing of health care products — Part 6: Isolator systems
ISO 13408-6:2005 Files
English
17 Pages
Historical
45.83 BHD
ISO 13408-6:2005 Scope
ISO 13408-6:2005 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.
ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
ISO 13408-6:2005 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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