ISO 13408-6:2005 PDF

Scope: 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.

ISO 13408-6:2005 Referenced Document

ISO 13408-1:1998 Aseptic processing of health care products - Part 1: General requirements
ISO 13408-4 Aseptic processing of health care products - Part 4: Clean-in-place technologies*， 2005-11-01 Update
ISO 13408-5 Aseptic processing of health care products - Part 5: Sterilization in place*， 2006-11-01 Update
ISO 14644-7:2004 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO/IEC 90003 Software engineering - Guidelines for the application of ISO 9001:2015 to computer software*， 2018-11-01 Update

2021 ISO 13408-6:2021 Aseptic processing of health care products — Part 6: Isolator systems
2013 ISO 13408-6:2006/Amd 1:2013 Aseptic processing of health care products - Part 6: Isolator systems; Amendment 1
2005 ISO 13408-6:2005 Aseptic processing of health care products - Part 6: Isolator systems