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BS ISO 11737-3:2023

BS ISO 11737-3:2023

$215.11

Sterilization of health care products. Microbiological methods – Bacterial endotoxin testing

Published By Publication Date Number of Pages
BSI 2023 72
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PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
9 1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Terms and definitions
15 4 General requirements
16 5 Selection of products
5.1 General
5.2 Selection of product units
17 6 Methods for BET
6.1 General
18 6.2 Consideration of an applicable endotoxin limit
6.2.1 Endotoxin limit
6.2.2 Calculation of endotoxin limit for the extract solution
6.2.3 Maximum valid dilution (MVD)
19 6.3 Critical test parameters
6.3.1 Temperature
6.3.2 Time
6.3.3 pH
6.4 Equipment and materials
20 6.5 Reagents
7 Method suitability for BET (BET validation)
7.1 General
7.2 Product and test method suitability
7.2.1 Gel-clot technique
21 7.2.2 Kinetic and end point methods (chromogenic and turbidimetric techniques)
22 7.3 Sample preparation
7.3.1 General
7.3.2 Solid health care products
23 7.3.3 Aqueous health care products
7.3.4 Sample interference
7.4 Reagent and analyst qualification
7.4.1 Gel-clot technique reagent qualification
7.4.2 Kinetic and end point method reagent qualification
24 7.4.3 Analyst qualification
8 Routine testing, monitoring and interpretation of data
8.1 Routine testing
8.1.1 Gel-clot limit test
8.1.2 Gel-clot assay
25 8.1.3 Kinetic and end point methods (chromogenic and turbidimetric)
8.2 Monitoring (test frequency)
8.3 Interpretation of results
8.3.1 General
26 8.3.2 Gel clot methods
8.3.3 Kinetic and end point methods
8.4 Data analysis
8.5 Statistical methods
9 Maintenance of the BET method
9.1 General
9.2 Changes to either the product or manufacturing process, or both
27 9.3 Changes to the BET method
10 Alternatives to batch testing
10.1 General
10.2 Criteria for establishing alternatives to batch testing
28 10.3 Manufacturing process assessment
10.3.1 Quality planning of manufacturing processes
10.3.2 Process design
10.3.3 Process control
29 10.4 Change control
10.5 Maintenance of risk assessment
30 Annex A (informative) Guidance on bacterial endotoxin testing (following the subclauses in this document)
50 Annex B (informative) History and background on the bacterial endotoxins test (BET)
54 Annex C (informative) Guidance on out of specified limits (OSL) and failure investigation
58 Annex D (informative) Guidance on in-process monitoring of manufacturing processes or component testing
61 Annex E (informative) Guidance on conducting a risk assessment to support alternatives to batch testing
66 Annex F (informative) Typical assignment of responsibilities
68 Bibliography

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BS ISO 11737-3:2023
$215.11