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ISO 13408-6:2005 PDF
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Aseptic processing of health care products — Part 6: Isolator systems
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.
| Edition | 2005 |
|---|---|
| Standard Part No | 6 |
| Published Date | 2005 |
| Published By | International Standardization Organisation |
| Page Count | 17 |
