ISO 24190:2023
Biotechnology — Analytical methods — Risk-based approach for method selection and validation for rapid microbial detection in bioprocesses
This document provides guidance, a framework and a risk-based approach for the selection and validation of methods for rapid microbial detection in cellular therapeutic product manufacturing.
This document provides a flexible risk-based framework for the detection of microbial contamination in cellular therapeutic products and cellular intermediates.
This document provides general requirements and risks associated with cellular therapeutic product manufacturing, with flexibility to address differences in specific manufacturing processes of each unique cellular therapeutic product.
This document primarily addresses sterility testing in cellular therapeutic product manufacturing. This document is applicable to other cell-derived therapeutic product manufacturing.
This document focuses on rapid microbial test methods (RMTMs) used for both in-process and final product testing.
Viral testing in cellular therapeutic product manufacturing is not included in this document.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Risk management for microbiological contamination
5.1 Risk management in manufacturing process
5.2 Risk management in microbial testing
6 Selection of a fit-for-purpose assay
6.1 General
6.2 Assay selection
6.3 Kit or system selection
6.4 Considerations for various test types
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
6.5.6 Sensitivity
7 Validation
7.1 General concepts
7.2 Selection of microorganisms for validation
7.3 Quality by design of method validation
7.4 Revalidation method
7.5 System validation
7.6 Use of reference material in validation
7.7 Acceptance criteria of targeted validation parameters
7.8 Precision
7.9 Detection limit
7.10 Accuracy
7.11 Robustness
7.12 Ruggedness
8 Use and application of rapid microbial tests
8.1 Number and type of samples
8.2 Testing environment
8.3 Sensitivity
8.4 Analytical specificity (microorganism detection)
8.5 Comparable test data
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
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Risk management for microbiological contamination
5.1 Risk management in manufacturing process
5.2 Risk management in microbial testing
6 Selection of a fit-for-purpose assay
6.1 General
6.2 Assay selection
6.3 Kit or system selection
6.4 Considerations for various test types
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
6.5.6 Sensitivity
7 Validation
7.1 General concepts
7.2 Selection of microorganisms for validation
7.3 Quality by design of method validation
7.4 Revalidation method
7.5 System validation
7.6 Use of reference material in validation
7.7 Acceptance criteria of targeted validation parameters
7.8 Precision
7.9 Detection limit
7.10 Accuracy
7.11 Robustness
7.12 Ruggedness
8 Use and application of rapid microbial tests
8.1 Number and type of samples
8.2 Testing environment
8.3 Sensitivity
8.4 Analytical specificity (microorganism detection)
8.5 Comparable test data
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