AAMI/ISO 13408-6:2005/(R)2013 & A1:2013 PDF

AAMI/ISO 13408-6 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. The document focuses on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.

ANSI :	ANSI Approved
File Size :	1 file , 180 KB
ISBN(s) :	1570203318
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	32
Published :	09/23/2008