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)
|Publication Date:||1 July 2013|
|ICS Code (Sterilization and disinfection in general):||11.080.01|
This part of ISO 13408 specifies the requirements for isolator
systems used for aseptic processing and offers guidance on
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.