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ISO 24190:2023 Biotechnology - Analytical methods - Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses >
ISO 24190:2023 Biotechnology - Analytical methods - Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses, 2023
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General considerations
- 5 Risk management for microbiological contamination [Go to Page]
- 6 Selection of a fit-for-purpose assay [Go to Page]
- 7 Validation [Go to Page]
- 8 Use and application of rapid microbial tests [Go to Page]
- 9 Investigation of positive sterility results
- 10 Training
- 11 Documentation
- 12 Test report
- Annex A (informative) Exemplary framework for identifying microbial contamination
- Annex B (informative) Risk analysis with cellular therapeutic products related to input materials — Donor selection
- Annex C (informative) Risk analysis with cellular therapeutic products related to input materials — Cell transformation and expansion
- Annex D (informative) Risk analysis with cellular therapeutic products related to input materials — Packaging storage and administration
- Annex E (informative) Risk-based classification for monitoring practices for cellular therapeutic product manufacturing
- Annex F (informative) Validation of rapid microbial test methods
- Annex G (informative) Microorganisms for validation of rapid microbial test methods
- Annex H (informative) Methods for rapid microbial testing
- Annex I (informative) Environmental control
- Bibliography [Go to Page]