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BSI 22/30397817 DC:2022 Edition

BSI 22/30397817 DC:2022 Edition

$13.70

BS ISO 24190. Biotechnology. Analytical Methods. Risk based approach for design and validation of methods for rapid microbial detection in bioprocesses

Published By Publication Date Number of Pages
BSI 2022 50
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PDF Catalog

PDF Pages PDF Title
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
14 4 General considerations
5 Risk management for microbiological contamination
5.1 Risk management in manufacturing process
16 5.2 Risk management in microbial testing
6 Selection of a fit-for-purpose assay
6.1 General
17 6.2 Assay selection
6.3 Kit or system selection
18 6.4 Considerations for various test types
19 6.5 User requirement specifications
6.5.1 General
6.5.2 Speed
6.5.3 Sample volume
6.5.4 In-process versus final release testing
6.5.5 Specificity
20 6.5.6 Sensitivity
7 Validation
7.1 General concepts
21 7.2 Selection of microorganisms for validation
22 7.3 Quality by design of method validation
7.4 Revalidation method
23 7.5 System validation
7.6 Use of reference material in validation
7.7 Acceptance criteria of targeted validation parameters
24 7.8 Precision
7.9 Detection limit
7.10 Accuracy
25 7.11 Robustness
7.12 Ruggedness
8 Points to take into account for the use and application of rapid microbial tests
8.1 Number and type of samples
8.2 Testing environment
26 8.3 Sensitivity
8.4 Specificity (organism detection)
8.5 Comparable test data
27 9 Investigation of positive sterility results
10 Training
28 11 Documentation
12 Reporting
29 Annex€A (informative) Exemplary Framework for identifying microbial contamination
30 Annex€B (informative) Risk analysis with Cellular Therapeutic Products related to input materials – Donor selection
31 Annex€C (informative) Risk analysis with Cellular Therapeutic Products related to input materials – Cell transformation and expansion
33 Annex€D (informative) Risk analysis with Cellular Therapeutic related to input materials – Packaging storage and administration
34 Annex€E (informative) Risk-based classification for monitoring practices for Cellular Therapeutic Product manufacturing
35 Annex€F (informative) Validation of rapid microbial test methods
37 Annex€G (informative) Microorganisms for validation of rapid microbial test methods
41 Annex€H (informative) Methods for rapid microbial testing
47 Annex€I (normative) Environmental control
48 Bibliography

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BSI 22/30397817 DC
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