DIN EN ISO 13408-6
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013)
Organization: | DIN |
Publication Date: | 1 July 2013 |
Status: | active |
Page Count: | 28 |
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.