Superseded
Standard
Historical
NBN EN ISO 13408-6:2011
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
Preview
Summary
ISO 13408-6:2005 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.
ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
ISO 13408-6:2005 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.
ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
ISO 13408-6:2005 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.
Technical characteristics
| Publisher | Bureau de Normalisation Belge (NBN) |
| Publication Date | 07/29/2011 |
| Cancellation Date | 12/31/2011 |
| Page Count | 32 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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Previous versions
25/05/2021
Active
Most Recent
21/06/2013
Superseded
Historical
29/07/2011
Superseded
Historical