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.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | AAMI TIR16:2023; Microbiological aspects of ethylene oxide sterilization <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Technical Information Report Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents Page <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 4 Process and equipment characterization 4.1 Sterilization equipment 4.2 Process characterization\u2014Physical parameters 4.2.1 Introduction 4.2.2 EO concentration <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 4.2.3 Humidity 4.2.4 Temperature 4.2.5 EO dwell time <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | Table 1 Comparison of methods for process definition and validation 5.1.5 Process challenge devices Table 2 Site selection of PCD <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 5.1.6 Developmental\/Research chambers 5.1.6.1 <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 5.2 Definition of process lethality 5.2.1 Spore log reduction <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 5.2.2 Equivalent exposure time <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Figure 1 Exposure phase \/ EO process phases diagram <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 5.2.3 Defining lethal rate for industrial application 5.2.3.1 Fraction-negative method <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Table 3 Summary of the procedures for calculating D values 5.2.3.2 Survivor Curve Method <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 5.4.3 PCDs for product families <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 6.3 Sterilization loads 6.3.1 Packaging 6.3.2 Full and partial loads <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | Figure 3 Example of the relationship between biological indicator and product bioburden using the biological indicator\/bioburden method <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | 6.6.1.1 Requalification 6.6.2 Overkill approach Figure 4 Example of an overkill cycle <\/td>\n<\/tr>\n | ||||||
| 37<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 6.6.2.2.3 Requalification 6.6.3 Bioburden Approach 6.6.3.1 Determine average bioburden 6.6.3.2 Microbicidal effectiveness <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 6.6.3.3 Determination of the inactivation kinetics 6.6.3.4 Product selection 6.6.3.5 Fraction-negative bioburden procedure <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | 7.2.3 Microbiological testing considerations 7.2.3.1 Test laboratory 7.2.3.2 Biological Indicators (BIs) 7.2.4 Remediation <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Annex A (informative) BI\/Bioburden examples <\/td>\n<\/tr>\n | ||||||
| 44<\/td>\n | Table 5 Trial cycle #1 with a 15-minute exposure phase time <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | Annex B (information) Overkill cycle calculation examples <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Bibliography <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | For further reading <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI TIR16:2023 Microbiological aspects of ethylene oxide sterilization<\/b><\/p>\n |