I.S. EN ISO 13408-6:2021&LC:2021
Current
The latest, up-to-date edition.
Aseptic processing of health care products - Part 6: Isolator systems
Hardcopy , PDF
English
13-07-2021
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Basic principle of isolator systems
6 Isolator system specification
7 Design of isolator systems
8 Validation
9 Routine monitoring and control
10 Personnel training
Annex A (informative) Devices acting as transfer ports for portable and mobile equipment
Annex B (informative) Isolator system — Explanation of terms used and flow of air and
material
Annex C (informative) Isolator system — Direct/indirect product contact surfaces
Bibliography
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.
| Committee |
TC 198
|
| DocumentType |
Standard
|
| Pages |
48
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 13408-6:2021 | Identical |
| ISO 13408-6:2021 | Identical |
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