CEN - EN ISO 13408-6
Aseptic processing of health care products - Part 6: Isolator systems
inactive
| Organization: | CEN |
| Publication Date: | 1 June 2011 |
| Status: | inactive |
| Page Count: | 30 |
| 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,
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
May 1, 2021
Aseptic processing of health care products - Part 6: Isolator systems
This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related...
June 1, 2011
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...
EN ISO 13408-6
June 1, 2011
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...