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.
| File Size : | 1
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| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 17 |
| Published : | 06/15/2005 |
| Same As : | ISO 13408-6:2005 |
