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BS EN ISO 13408-6:2021

BS EN ISO 13408-6:2021

$189.07

Aseptic processing of health care products – Isolator systems

Published By Publication Date Number of Pages
BSI 2021 48
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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.

PDF Catalog

PDF Pages PDF Title
2 National foreword
6 European foreword
8 Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
10 Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
12 Annex ZC (informative) Relationship between this European Standard and the essential requirements of Directive 98/79/EC [OJ L 331] aimed to be covered
14 Annex ZD (informative) Relationship between this European Standard and the General Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be covered
17 Annex ZE (informative) Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
21 Foreword
22 Introduction
23 1 Scope
2 Normative references
3 Terms and definitions
25 4 Quality system elements
5 Basic principle of isolator systems
5.1 General
26 5.2 Negative pressure isolators
6 Isolator system specification
6.1 General
6.2 Risk management
6.2.1 General
27 6.2.2 Negative pressure isolator systems
6.3 User requirement specification
7 Design of isolator systems
7.1 General
28 7.2 Materials of construction
7.3 Air-handling system
7.3.1 General
7.3.2 Air change rate
7.3.3 Airflow pattern
29 7.3.4 Temperature/humidity
7.3.5 Particulate air specifications
7.3.6 Recirculation of air
7.3.7 Pressure differentials
7.4 Operator interface
7.4.1 Isolator gloves/sleeves
30 7.4.2 Suits/half-suits
7.4.3 Access to the isolator/transfer systems
7.4.4 Devices acting as transfer ports
31 7.5 Ancillary isolator equipment
7.5.1 Portable and mobile equipment
7.6 Surrounding room classification
7.7 Process utilities
8 Validation
8.1 General
32 8.2 Design qualification
8.2.1 General
8.2.2 Product/process application
8.2.3 Ergonomics
8.2.4 Cleaning
33 8.2.5 Bio-decontamination
8.2.6 Selection of bio-decontamination agent
8.2.7 Development and validation of bio-decontamination processes
34 8.2.8 Bio-decontamination agent generation and testing
8.2.9 Bio-decontamination parameters
35 8.2.10 Aeration and residue limits
8.2.11 Log reduction
8.2.12 Surface bio-decontamination of items
36 8.2.13 Development and validation of sterilization processes
8.3 Installation qualification
8.3.1 General
8.3.2 Installation
37 8.4 Operational qualification
8.5 Performance qualification
8.5.1 General
38 8.5.2 Cleaning
8.5.3 Bio-decontamination
8.5.4 Process simulation tests
8.6 Review and approval of validation
8.7 Requalification
39 9 Routine monitoring and control
9.1 Procedures
9.2 System integrity
9.3 Bio-decontamination process monitoring
40 9.4 Environmental monitoring
9.5 Change control
9.6 Maintenance and calibration
10 Personnel training
42 Annex A (informative) Devices acting as transfer ports for portable and mobile equipment
45 Annex B (informative) Isolator system — Explanation of terms used and flow of air and material
46 Annex C (informative) Isolator system — Direct/indirect product contact surfaces
47 Bibliography

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BS EN ISO 13408-6:2021
$189.07