AAMI 13408-6
Aseptic processing of health care products - Part 6: Isolator systems
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| Organization: | AAMI |
| Publication Date: | 1 January 2005 |
| Status: | active |
| Page Count: | 44 |
scope:
This part of ISO 13408 specifies the requirements for isolator
systems used for aseptic processing and offers guidance on
qualification, bio-decontamination,
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.
Document History
January 1, 2013
Aseptic processing of health care products - Part 6: Isolator systems Amendment 1
A description is not available for this item.
January 1, 2005
Aseptic processing of health care products - Part 6: Isolator systems
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...
January 1, 2005
Aseptic processing of health care products — Part 6: Isolator systems
A description is not available for this item.
AAMI 13408-6
January 1, 2005
Aseptic processing of health care products - Part 6: Isolator systems
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...