BS EN ISO 13408-6:2021
Current
The latest, up-to-date edition.
Aseptic processing of health care products Isolator systems
Hardcopy , PDF
English
24-05-2021
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/198
|
| DocumentType |
Standard
|
| Pages |
48
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
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.
| Standards | Relationship |
| ISO 13408-6:2021 | Identical |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.