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BS ISO 18362:2016+A1:2022:2023 Edition

BS ISO 18362:2016+A1:2022:2023 Edition

$167.15

Manufacture of cell-based health care products. Control of microbial risks during processing

Published By Publication Date Number of Pages
BSI 2023 42
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PDF Catalog

PDF Pages PDF Title
2 National foreword
5 Foreword
6 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
13 4 General
5 Process definition
5.1 General
14 5.2 Risk management
5.2.1 General considerations
15 5.2.2 Cell-based starting material risk assessment
5.2.3 CBHP process risk assessment
16 6 Manufacturing environment
6.1 General
6.2 Alternative processes
17 6.3 Manufacturing environment design
6.3.1 Containment area
6.3.2 Construction containment features
6.4 Layout
6.5 Material and personnel flow
6.5.1 General
18 6.5.2 Equipment
6.5.3 Handling of waste material
6.6 HVAC system
6.7 Utility services and ancillary equipment
6.8 Environmental and personnel monitoring programmes
7 Equipment
7.1 General
19 7.2 Additional requirements
8 Personnel
8.1 General
8.2 Personnel procedures
8.3 Gowning procedures
8.4 General employee health
20 9 Manufacture of product
9.1 General
9.2 Control of starting material
9.2.1 Cell-based starting material
9.2.2 Other starting materials
21 9.3 Manufacturing procedures
9.4 In-process controls and process monitoring
9.5 Virus elimination and inactivation
10 Process simulation and process confirmation
10.1 General
22 10.2 Process simulation
10.3 Process confirmation studies
10.4 Media selection and growth support
23 11 Finished product release: test for sterility
11.1 General
11.2 Additional requirements
24 12 Finished product release: testing for biological contamination that cannot be detected by the test for sterility
12.1 General
12.2 Extrinsic biological contamination
12.3 Intrinsic biological contamination
25 Annex A (informative) Examples of microbial risks for CBHP
26 Annex B (normative) Decision trees for application of risk assessment for cell-based starting materials
28 Annex C (informative) Containment facilities
35 Annex D (normative) CBHP starting material
37 Annex E (normative) Containment requirements for procured, non-sterile starting materials before entering the manufacturing area
38 Annex F (informative) Typical elements of a process definition
39 Bibliography

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BS ISO 18362:2016+A1:2022
$167.15