SS-EN-ISO-13408-6 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

SS-EN-ISO-13408-6 - 2021 EDITION - CURRENT
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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.

To find similar documents by classification:

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

11.120.01 (Pharmaceutics in general)

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Designation Name

SS-EN ISO 13408-6:2021

Revision Level

2021 EDITION

Status

Current

Publication Date

May 24, 2021

Language(s)

English

Page Count

52

International Equivalent

EN ISO 13408-6:2021(IDT); ISO 13408-6:2021(IDT)