AAMI ST72 2019
$140.32
ANSI/AAMI ST72:2019, Bacterial endotoxins-Test methods, routine monitoring, and alternatives to batch testing
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 65 |
This standard specifies general criteria to be applied in the determination of bacterial endotoxins on or in medical devices, components, or raw materials employing bacterial endotoxins test (BET) methods using amebocyte lysate reagents from Limulus polyphemus or Tachypleus tridentatus. The document is not applicable to the evaluation of pyrogens other than bacterial endotoxins.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ST72:2019; Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 9 | Introduction |
| 11 | 1 Scope 2 Normative references 3 Definitions |
| 13 | 4 Quality 4.1 Documentation |
| 14 | 4.2 Management responsibility 4.3 Product realization 4.4 Personnel 4.5 Equipment 4.6 Reagents and materials 4.7 Measurement, analysis and improvement 5 Determination of Product required to be non-pyrogenic due to intended use |
| 15 | 6 Product with non-pyrogenic label claim |
| 16 | 7 Selection of product units 8 Selection of technique |
| 17 | 9 Method suitability 9.1 Endotoxin Limit 9.2 Maximum valid dilution (MVD) 9.3 Reagent and analyst qualification 9.3.1 Preparatory testing (confirmation of label claim/demonstration of linearity) 9.3.1.1 For the gel-clot technique |
| 18 | 9.3.1.2 For photometric quantitative techniques (chromogenic and turbidimetric) 9.3.2 Analyst qualification 9.4 Product and test method suitability 9.4.1 General 9.4.2 Gel-clot technique |
| 19 | Table 1—Preparation of solutions for method suitability test: Gel-clot technique 9.4.3 Photometric quantitative techniques (chromogenic and turbidimetric) 9.4.3 Photometric quantitative techniques (chromogenic and turbidimetric) Table 2—Preparation of solutions for method suitability test: chromogenic and turbidimetric techniques 9.5 Sample interference |
| 20 | 9.6 Demonstration of continued suitability 10 Use of technique 10.1 Critical test parameters 10.1.1 Temperature 10.1.2 Time 10.1.3 pH 10.2 Equipment and reagents |
| 21 | 10.3 Sample preparation 10.3.1 General 10.3.2 Medical devices 10.3.3 Liquids / biologics |
| 22 | 10.4 Routine testing and monitoring 10.4.1 Gel-clot limit test Table 3—Preparation of solutions for gel-clot limit test 10.4.2 Gel-clot assay Table 4—Preparation of solutions for gel-clot assay 10.4.3 Photometric quantitative chromogenic and turbidimetric techniques 10.4.4 Test frequency |
| 23 | 10.5 Interpretation of results 10.6 Change control 10.7 Out of Specification and failure investigation 11 Alternatives to batch testing 11.1 General |
| 24 | 11.2 Criteria for establishing alternatives to batch testing 11.3 Manufacturing process operation assessment 11.3.1 Quality planning of manufacturing processes 11.3.2 Process design 11.3.3 Process control |
| 25 | 11.4 Change control 11.5 Maintenance of risk assessment |
| 26 | Annex A (informative) Background on the bacterial endotoxins test |
| 29 | A.18 Endnotes |
| 31 | Annex B (informative) Guidance on test methods, routine monitoring, and alternatives to batch testing B.1 Scope B.2 Normative references B.3 Definitions B.4 Quality management system elements B.4.1 Documentation B.4.2 Management responsibility B.4.3 Product realization |
| 32 | B.4.4 Personnel B.4.5 Equipment B.4.6 Reagents and materials B.4.7 Measurement, analysis and improvement B.5 Determination of product required to be non-pyrogenic due to intended use |
| 33 | B.6 Products with non-pyrogenic label claims Table B.1—Illustration of expectation for products labelled non-pyrogenic |
| 34 | B.7 Selection of product units Table B.2—Selection of number of samples |
| 36 | Table B.3—Selection of product units for testing B.8 Selection of technique |
| 37 | B.9 Method suitability B.9.1 Endotoxin limit |
| 38 | Table B.4—Calculation of endotoxin limit of extract solution (within a sterile barrier system) B.9.2 Maximum valid dilution (MVD) |
| 39 | Table B.5—Working Example of the Maximum Valid Dilution of Extract Solution |
| 40 | Table B.6—Working Example of Maximum Valid Dilution using Extraction Volume |
| 41 | B.9.3 Reagent and analyst qualification B.9.3.1 Preparatory testing (confirmation of label claim/demonstration of linearity) Table B.7—Calculation of geometric mean—Worked example B.9.3.2 Analyst qualification B.9.4 Product and test method suitability B.9.4.1 General B.9.4.2 Gel-clot technique |
| 42 | B.9.4.3 Photometric quantitative techniques (chromogenic and turbidimetric) B.9.5 Sample interference B.9.6 Demonstration of continued suitability B.10 Use of technique B.10.1 Critical test parameters B.10.1.1 Temperature B.10.1.2 Time B.10.1.3 pH |
| 43 | B.10.2 Equipment and reagents B.10.2.2 Endotoxin standards and storage B.10.3 Sample preparation B.10.3.1 General B.10.3.2 Medical devices |
| 44 | B.10.3.3 Liquids / biologics B.10.4 Routine testing and monitoring B.10.4.1 Gel-clot limit test B.10.4.2 Gel-clot assay B.10.4.3 Photometric quantative chromogenic and turbidimetric techniques B.10.4.4 Test frequency B.10.5 Interpretation of results B.10.6 Change control B.10.7 Out of Specification and failure investigation |
| 45 | B.11 Alternatives to batch testing B.11.1 General B.11.2 Criteria for establishing alternatives to batch testing |
| 46 | Figure B.1—Key questions in evaluating the appropriateness and risk associated with alternatives to endotoxin batch testing |
| 47 | Figure B.2—Example of alternatives to endotoxin batch testing plan with component control/limited finished device testing |
| 48 | B.11.3 Manufacturing process operation assessment B.11.3.1 Quality planning of manufacturing processes B.11.3.2 Process design |
| 49 | B.11.3.3 Process control B.11.3.3.3 B.11.4 Change control B.11.5 Maintenance of risk assessment |
| 50 | Figure B.3—Example of a risk assessment flow diagram that could be used to evaluate endotoxin contamination risks from incoming components and to determine any ongoing monitoring requirements |
| 51 | Annex C (informative) Guidance on out of specification (OOS) and failure investigation C.1 General considerations C.2 Laboratory investigation C.2.1 Items to consider C.2.2 Results of laboratory investigation |
| 52 | C.2.3 Additional investigational tests C.3 Raw material and manufacturing processes |
| 53 | Figure C.1—Bacterial endotoxin OOS decision tree |
| 54 | Annex D (informative) Guidance on in-process monitoring of manufacturing processes or component testing D.1 General D.2 Selection of product units |
| 55 | D.3 Sample preparation D.4 Guidance for in-process or component endotoxin specification D.4.1 General D.5 Summary of Component/in-process endotoxin risk considerations |
| 56 | Annex E (informative) Guidance on conducting a risk assessment to support alternatives to batch testing E.1 General E.2 Assessment of the severity of a pyrogenic response |
| 57 | Table E.1—Example of severity rankings E.3 Assessment of the probability of a pyrogenic response |
| 59 | Table E.2—Example of probability rankings E.4 Overall assessment of risk |
| 60 | Table E.3—Example of overall risk rankings E.5 Worked example: ceramic hip implant E.5.1 Product description E.5.2 Assessment of the severity of a pyrogenic response E.5.3 Assessment of the probability of a pyrogenic response |
| 61 | E.5.4 Overall assessment of risk E.6 Worked example: cranial burr hole cover E.6.1 Product description E.6.2 Assessment of the severity of a pyrogenic response E.6.3 Assessment of the probability of a pyrogenic response E.6.4 Overall assessment of risk |
| 63 | Bibliography |
