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BSI 19/30361785 DC:2019 Edition

BSI 19/30361785 DC:2019 Edition

$13.70

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

Published By Publication Date Number of Pages
BSI 2019 46
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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 International Standard does not define biosafety containment requirements.

PDF Catalog

PDF Pages PDF Title
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Quality system elements
5 Basic principal of Isolator systems
5.1 General
11 5.2 Negative pressure isolators
6 Isolator System Specification
6.1 General
12 6.2 Risk management
6.2.1 General
6.2.2 Negative pressure isolators
6.3 User requirement specification
13 7 Design of isolator systems
7.1 General
7.2 Materials of construction
14 7.3 Air-handling system
7.3.1 General
7.3.2 Air change rate
7.3.3 Airflow pattern
7.3.4 Temperature/humidity
7.3.5 Particulate air specifications
15 7.3.6 Recirculation of air
7.3.7 Pressure differentials
7.4 Operator interface
7.4.1 Isolator gloves/sleeves
7.4.2 Suits/half-suits
7.4.3 Access to the isolator/Transfer systems
16 7.4.4 Transfer ports
7.5 Ancillary isolator equipment
7.5.1 Portable and mobile equipment
7.6 Surrounding room classification
17 7.7 Process utilities
8 Validation
8.1 General
8.2 Design qualification
8.2.1 General
8.2.2 Product/process application
18 8.2.3 Ergonomics
8.2.4 Cleaning
19 8.2.5 Bio-decontamination
8.2.6 Development and validation of bio-decontamination processes
8.2.7 Selection of bio-decontamination agent
20 8.2.8 Bio-decontamination agent generation and testing
8.2.9 Bio-decontamination parameters
8.2.10 Aeration and residue limits
21 8.2.11 Spore log reduction
8.2.12 Surface bio-decontamination of items
8.2.13 Development and validation of sterilization processes
8.3 Installation qualification
8.3.1 General
22 8.3.2 Installation
8.4 Operational qualification
23 8.5 Performance qualification
8.5.1 General
8.5.2 Cleaning
24 8.5.3 Bio-decontamination
8.5.4 Process simulation tests
8.6 ​Review and approval of validation
8.7 Requalification
25 9 Routine monitoring and control
9.1 Procedures
9.2 System integrity
9.3 Bio-decontamination process monitoring
9.4 Environmental monitoring
26 9.5 Change control
9.6 Maintenance and calibration
10 Personnel training
28 Annex A (informative) Transfer ports for portable and mobile equipment
32 Annex B (informative) Isolator system – principal figure of term and flow diagram of air and material
33 Annex C (informative) Isolator system – Critical surfaces in isolator system
34 Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
36 Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
38 Annex ZC (informative) Relationship between this European Standard and the essential requirements of Directive 98/79/EC [OJ L 331] aimed to be covered
40 Annex ZD (informative) Relationship between this European Standard and the General Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be covered
43 Annex ZE (informative) Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
46 Bibliography

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BSI 19/30361785 DC
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