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B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

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ISO 13408:2021

ISO 13408:2021 Aseptic processing of health care products – Part 6: Isolator systems

CDN $259.00

SKU: 921fed02a763 Categories: ,

Description

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.

Edition

2

Published Date

2021-04-13

Status

PUBLISHED

Pages

25

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

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.

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