19/30361785 DC - BS EN ISO 13408-6. Aseptic processing of health care products. Part 6. Isolator systems

19/30361785 DC

BS EN ISO 13408-6. Aseptic processing of health care products. Part 6. Isolator systems

Status : Current, Draft for public comment   Published : April 2019

Format
PDF

Format
HARDCOPY



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 International Standard does not define biosafety containment requirements.




Standard Number19/30361785 DC
TitleBS EN ISO 13408-6. Aseptic processing of health care products. Part 6. Isolator systems
StatusCurrent, Draft for public comment
Publication Date17 April 2019
Normative References(Required to achieve compliance to this standard)ISO 13408-1:2008, ISO 14644-7:2004, ISO 10648-1:1997, ISO/IEC 90003, ISO 13408-4, ISO 13408-5
Informative References(Provided for Information)ISO 14644-1, ISO 17665-1, ISO 11139, ISO 10648-2, ISO 10648-1, ISO 14971, ISO/TS 17665-2
International RelationshipsISO/DIS 13408-6
Draft Expiry Date26 May 2019
DescriptorsSterile equipment, Quality control, Medical equipment, Production, Sterilization (hygiene), Containers, Verification, Quality management, Quality assurance systems, Clean rooms, Environment (working), Personnel
ICS11.080.01
Title in FrenchTraitement aseptique des produits de santé — Partie 6: Systèmes isolateurs
CommitteeCH/198
PublisherBSI
FormatA4
DeliveryYes
Pages46
File Size2.496 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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