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BS EN ISO 13408-6:2021 – TC

BS EN ISO 13408-6:2021 – TC

$246.62

Tracked Changes. Aseptic processing of health care products – Isolator systems

Published By Publication Date Number of Pages
BSI 2021 112
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PDF Catalog

PDF Pages PDF Title
1 30446295
65 A-30361786
66 National foreword
70 European foreword
72 Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
74 Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
76 Annex ZC (informative) Relationship between this European Standard and the essential requirements of Directive 98/79/EC [OJ L 331] aimed to be covered
78 Annex ZD (informative) Relationship between this European Standard and the General Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be covered
81 Annex ZE (informative) Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
85 Foreword
86 Introduction
87 1 Scope
2 Normative references
3 Terms and definitions
89 4 Quality system elements
5 Basic principle of isolator systems
5.1 General
90 5.2 Negative pressure isolators
6 Isolator system specification
6.1 General
6.2 Risk management
6.2.1 General
91 6.2.2 Negative pressure isolator systems
6.3 User requirement specification
7 Design of isolator systems
7.1 General
92 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
93 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
94 7.4.2 Suits/half-suits
7.4.3 Access to the isolator/transfer systems
7.4.4 Devices acting as transfer ports
95 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
96 8.2 Design qualification
8.2.1 General
8.2.2 Product/process application
8.2.3 Ergonomics
8.2.4 Cleaning
97 8.2.5 Bio-decontamination
8.2.6 Selection of bio-decontamination agent
8.2.7 Development and validation of bio-decontamination processes
98 8.2.8 Bio-decontamination agent generation and testing
8.2.9 Bio-decontamination parameters
99 8.2.10 Aeration and residue limits
8.2.11 Log reduction
8.2.12 Surface bio-decontamination of items
100 8.2.13 Development and validation of sterilization processes
8.3 Installation qualification
8.3.1 General
8.3.2 Installation
101 8.4 Operational qualification
8.5 Performance qualification
8.5.1 General
102 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
103 9 Routine monitoring and control
9.1 Procedures
9.2 System integrity
9.3 Bio-decontamination process monitoring
104 9.4 Environmental monitoring
9.5 Change control
9.6 Maintenance and calibration
10 Personnel training
106 Annex A (informative) Devices acting as transfer ports for portable and mobile equipment
109 Annex B (informative) Isolator system — Explanation of terms used and flow of air and material
110 Annex C (informative) Isolator system — Direct/indirect product contact surfaces
111 Bibliography

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BS EN ISO 13408-6:2021 - TC
$246.62