Logo

ISO 13408-6:2021

Current Revision

Aseptic processing of health care products - Part 6: Isolator systems

$166.00

$166.00

$282.20


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


Stay effortlessly up-to-date with the latest standard revisions. When new versions are released, they're automatically charged and delivered to you, ensuring seamless compliance.

Document Preview Not Available...

This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.

This document does not specify requirements for restricted access barrier systems (RABS).

This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.

This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.

This document does not define biosafety containment requirements.


SDO ISO: International Organization for Standardization
Document Number ISO 13408
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 198
Publish Date Document Id Type View
Not Available ISO 13408-6:2021 Revision