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MS ISO 13408-6:2011
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005, IDT)
This Malaysian Standard 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.
This standard is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.
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07/06/2019
26
NSC 18 - Medical Devices and Facilities for Healthcare
11.080.01
45.00