Standard Swedish standard · SS-EN ISO 13408-6:2011

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

Status: Valid · Amended by: SS-EN ISO 13408-6:2011/A1:2013

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.

Subjects

Sterilization and disinfection in general (11.080.01) General (11.120.01)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-80780

Edition: 1

Approved: 7/12/2011

No of pages: 36

Replaces: SS-EN 13824:2005