| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 1 Scope 1.1 Inclusions 1.2 Exclusions 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4 General requirements <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5 Selection of products 5.1 General 5.2 Selection of product units <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 6 Methods for BET 6.1 General <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 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) <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 6.3 Critical test parameters 6.3.1 Temperature 6.3.2 Time 6.3.3 pH 6.4 Equipment and materials <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 7.2.2 Kinetic and end point methods (chromogenic and turbidimetric techniques) <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 7.3 Sample preparation 7.3.1 General 7.3.2 Solid health care products <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 9.3 Changes to the BET method 10 Alternatives to batch testing 10.1 General 10.2 Criteria for establishing alternatives to batch testing <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 10.3 Manufacturing process assessment 10.3.1 Quality planning of manufacturing processes 10.3.2 Process design 10.3.3 Process control <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 10.4 Change control 10.5 Maintenance of risk assessment <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | Annex A (informative) Guidance on bacterial endotoxin testing (following the subclauses in this document) <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Annex B (informative) History and background on the bacterial endotoxins test (BET) <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | Annex C (informative) Guidance on out of specified limits (OSL) and failure investigation <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | Annex D (informative) Guidance on in-process monitoring of manufacturing processes or component testing <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | Annex E (informative) Guidance on conducting a risk assessment to support alternatives to batch testing <\/td>\n<\/tr>\n | ||||||
| 66<\/td>\n | Annex F (informative) Typical assignment of responsibilities <\/td>\n<\/tr>\n | ||||||
| 68<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Sterilization of health care products. Microbiological methods – Bacterial endotoxin testing<\/b><\/p>\n |