Full Description

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.

Product Details

Published: 06/15/2005 Number of Pages: 17 File Size: 1 file , 220 KB Same As: DIN EN ISO 13408-6, BS EN ISO 13408-6:2011, BS EN ISO 13408-6:2011+A1:2013