Name: AAMI TIR16 2023 PDF - PDF Standards Store
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Addresses various microbiological aspects of the development and validation of an ethylene oxide sterilization process. Does not address the various factors that can have an effect on the bioburden of the product and on the sterilization process. Provides additional guidance to ANSI/AAMI/ISO 11135:2014 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations.

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PDF Pages	PDF Title
1	AAMI TIR16:2023; Microbiological aspects of ethylene oxide sterilization
3	Title page
4	AAMI Technical Information Report Copyright information
5	Contents Page
7	Committee representation
12	Foreword
13	Introduction
15	1 Scope 2 Normative references 3 Terms and definitions
16	4 Process and equipment characterization 4.1 Sterilization equipment 4.2 Process characterization—Physical parameters 4.2.1 Introduction 4.2.2 EO concentration
17	4.2.3 Humidity 4.2.4 Temperature 4.2.5 EO dwell time
18	5 Process definition 5.1 Considerations for process definition 5.1.1 EO dwell time 5.1.2 Product packaging 5.1.3 Load configuration 5.1.4 Process definition method
19	Table 1 Comparison of methods for process definition and validation 5.1.5 Process challenge devices Table 2 Site selection of PCD
20	5.1.6 Developmental/Research chambers 5.1.6.1
21	5.2 Definition of process lethality 5.2.1 Spore log reduction
22	5.2.2 Equivalent exposure time
23	Figure 1 Exposure phase / EO process phases diagram
24	5.2.3 Defining lethal rate for industrial application 5.2.3.1 Fraction-negative method
26	Table 3 Summary of the procedures for calculating D values 5.2.3.2 Survivor Curve Method
28	Figure 2 Example of a non-linear lethality curve 5.3 Troubleshooting 5.3.1 Obtaining all positives 5.3.1.1 Methods to obtain all positives with a new process 5.3.1.2 Methods to obtain all positives in an existing cycle
29	5.3.2 Obtaining a linear slope in the lethality curve Table 4 Potential causes of nonlinear lethality curve 5.3.3 Obtaining all negatives
30	5.4 Process challenge devices 5.4.1 Types of PCDs 5.4.1.1 Internal PCDs 5.4.1.2 External PCDs 5.4.2 Appropriateness of the PCD
31	5.4.3 PCDs for product families
32	6 Validation 6.1 Microbiological performance qualification 6.2 Placement and handling of PCDs, test samples, and sensors 6.2.1 Sensor placement 6.2.2 Product and sample handling, shipping, and testing
33	6.3 Sterilization loads 6.3.1 Packaging 6.3.2 Full and partial loads
34	6.3.3 Mixed loads 6.3.4 Reuse of loads 6.4 Simulation of anticipated process conditions 6.5 Release of validation loads 6.6 Qualification of process lethality 6.6.1 Biological indicator/bioburden approach
35	Figure 3 Example of the relationship between biological indicator and product bioburden using the biological indicator/bioburden method
36	6.6.1.1 Requalification 6.6.2 Overkill approach Figure 4 Example of an overkill cycle
37	6.6.2.1 Half-cycle method 6.6.2.1.1 Requalification 6.6.2.2 Cycle calculation method 6.6.2.2.1 Procedures for qualification of lethal rate 6.6.2.2.2 Stumbo-Murphy-Cochran Procedure (SMCP) for qualification
38	6.6.2.2.3 Requalification 6.6.3 Bioburden Approach 6.6.3.1 Determine average bioburden 6.6.3.2 Microbicidal effectiveness
39	6.6.3.3 Determination of the inactivation kinetics 6.6.3.4 Product selection 6.6.3.5 Fraction-negative bioburden procedure
40	6.6.3.6 Maintaining process effectiveness 6.7 Release of small batches or lots 7 Maintaining process effectiveness 7.1 Assessment of change 7.2 Failure investigation
41	7.2.1 Sterilization process or equipment considerations 7.2.1.1 Process 7.2.1.2 Equipment 7.2.1.3 Utilities 7.2.2 Product considerations 7.2.2.1 Design or materials 7.2.2.2 Bioburden
42	7.2.3 Microbiological testing considerations 7.2.3.1 Test laboratory 7.2.3.2 Biological Indicators (BIs) 7.2.4 Remediation
43	Annex A (informative) BI/Bioburden examples
44	Table 5 Trial cycle #1 with a 15-minute exposure phase time
45	Annex B (information) Overkill cycle calculation examples
49	Bibliography
50	For further reading

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AAMI	2023


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Standard Title	AAMI TIR16:2023 Microbiological aspects of ethylene oxide sterilization
Published Code	AAMI
Publication Date	2023

AAMI TIR16 2023

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