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NEN-ISO 13408-6

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

inactive, Most Current
Organization: NEN
Publication Date: 1 July 2005
Status: inactive
Page Count: 26
ICS Code (Sterilization and disinfection in general): 11.080.01
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.

Document History

NEN-ISO 13408-6
July 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...

References

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