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eLibrary > ANSI/AAMI ST72:2019 - Bacterial endotoxins-Test methods, routine monitoring, and alternatives to batch testing >

ANSI/AAMI ST72:2019 - Bacterial endotoxins-Test methods, routine monitoring, and alternatives to batch testing, 2019

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ANSI/AAMI ST72:2019 - Bacterial endotoxins-Test methods, routine monitoring, and alternatives to batch testing, 2019

ANSI/AAMI ST72:2019; Bacterial endotoxins—Test methods, routine monitoring, and alternatives to batch testing
Title page
AAMI Standard
Copyright information
Contents
Committee representation
Introduction
1 Scope
2 Normative references
3 Definitions
4 Quality [Go to Page]
4.1 Documentation
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
6 Product with non-pyrogenic label claim
7 Selection of product units
8 Selection of technique
9 Method suitability [Go to Page]
9.1 Endotoxin Limit
9.2 Maximum valid dilution (MVD)
9.3 Reagent and analyst qualification [Go to Page]
9.3.1 Preparatory testing (confirmation of label claim/demonstration of linearity) [Go to Page]
9.3.1.1 For the gel-clot technique
9.3.1.2 For photometric quantitative techniques (chromogenic and turbidimetric)
9.3.2 Analyst qualification
9.4 Product and test method suitability [Go to Page]
9.4.1 General
9.4.2 Gel-clot technique [Go to Page]
Table 1—Preparation of solutions for method suitability test: Gel-clot technique [Go to Page]
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
9.6 Demonstration of continued suitability
10 Use of technique [Go to Page]
10.1 Critical test parameters [Go to Page]
10.1.1 Temperature
10.1.2 Time
10.1.3 pH
10.2 Equipment and reagents
10.3 Sample preparation [Go to Page]
10.3.1 General
10.3.2 Medical devices
10.3.3 Liquids / biologics
10.4 Routine testing and monitoring [Go to Page]
10.4.1 Gel-clot limit test [Go to Page]
Table 3—Preparation of solutions for gel-clot limit test
10.4.2 Gel-clot assay [Go to Page]
Table 4—Preparation of solutions for gel-clot assay
10.4.3 Photometric quantitative chromogenic and turbidimetric techniques
10.4.4 Test frequency
10.5 Interpretation of results
10.6 Change control
10.7 Out of Specification and failure investigation
11 Alternatives to batch testing [Go to Page]
11.1 General
11.2 Criteria for establishing alternatives to batch testing
11.3 Manufacturing process operation assessment [Go to Page]
11.3.1 Quality planning of manufacturing processes
11.3.2 Process design
11.3.3 Process control
11.4 Change control
11.5 Maintenance of risk assessment
Annex A (informative) Background on the bacterial endotoxins test [Go to Page]
A.18 Endnotes
Annex B (informative) Guidance on test methods, routine monitoring, and alternatives to batch testing [Go to Page]
B.1 Scope
B.2 Normative references
B.3 Definitions
B.4 Quality management system elements [Go to Page]
B.4.1 Documentation
B.4.2 Management responsibility
B.4.3 Product realization
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
B.6 Products with non-pyrogenic label claims [Go to Page]
Table B.1—Illustration of expectation for products labelled non-pyrogenic
B.7 Selection of product units [Go to Page]
Table B.2—Selection of number of samples
Table B.3—Selection of product units for testing
B.8 Selection of technique
B.9 Method suitability [Go to Page]
B.9.1 Endotoxin limit
Table B.4—Calculation of endotoxin limit of extract solution (within a sterile barrier system) [Go to Page]
B.9.2 Maximum valid dilution (MVD) [Go to Page]
Table B.5—Working Example of the Maximum Valid Dilution of Extract Solution
Table B.6—Working Example of Maximum Valid Dilution using Extraction Volume
B.9.3 Reagent and analyst qualification [Go to Page]
B.9.3.1 Preparatory testing (confirmation of label claim/demonstration of linearity) [Go to Page]
Table B.7—Calculation of geometric mean—Worked example
B.9.3.2 Analyst qualification
B.9.4 Product and test method suitability [Go to Page]
B.9.4.1 General
B.9.4.2 Gel-clot technique
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 [Go to Page]
B.10.1 Critical test parameters [Go to Page]
B.10.1.1 Temperature
B.10.1.2 Time
B.10.1.3 pH
B.10.2 Equipment and reagents [Go to Page]
B.10.2.2 Endotoxin standards and storage
B.10.3 Sample preparation [Go to Page]
B.10.3.1 General
B.10.3.2 Medical devices
B.10.3.3 Liquids / biologics
B.10.4 Routine testing and monitoring [Go to Page]
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
B.11 Alternatives to batch testing [Go to Page]
B.11.1 General
B.11.2 Criteria for establishing alternatives to batch testing [Go to Page]
Figure B.1—Key questions in evaluating the appropriateness and risk associated with alternatives to endotoxin batch testing
Figure B.2—Example of alternatives to endotoxin batch testing plan with component control/limited finished device testing
B.11.3 Manufacturing process operation assessment [Go to Page]
B.11.3.1 Quality planning of manufacturing processes
B.11.3.2 Process design
B.11.3.3 Process control [Go to Page]
B.11.3.3.3
B.11.4 Change control
B.11.5 Maintenance of risk assessment [Go to Page]
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
Annex C (informative) Guidance on out of specification (OOS) and failure investigation [Go to Page]
C.1 General considerations
C.2 Laboratory investigation [Go to Page]
C.2.1 Items to consider
C.2.2 Results of laboratory investigation
C.2.3 Additional investigational tests
C.3 Raw material and manufacturing processes [Go to Page]
Figure C.1—Bacterial endotoxin OOS decision tree
Annex D (informative) Guidance on in-process monitoring of manufacturing processes or component testing [Go to Page]
D.1 General
D.2 Selection of product units
D.3 Sample preparation
D.4 Guidance for in-process or component endotoxin specification [Go to Page]
D.4.1 General
D.5 Summary of Component/in-process endotoxin risk considerations
Annex E (informative) Guidance on conducting a risk assessment to support alternatives to batch testing [Go to Page]
E.1 General
E.2 Assessment of the severity of a pyrogenic response [Go to Page]
Table E.1—Example of severity rankings
E.3 Assessment of the probability of a pyrogenic response [Go to Page]
Table E.2—Example of probability rankings
E.4 Overall assessment of risk [Go to Page]
Table E.3—Example of overall risk rankings
E.5 Worked example: ceramic hip implant [Go to Page]
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
E.5.4 Overall assessment of risk
E.6 Worked example: cranial burr hole cover [Go to Page]
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
Bibliography [Go to Page]

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