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 TIR16:2017\/(R)2020 [HISTORICAL]; Microbiological aspects of ethylene oxide sterilization \n <\/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 <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 2 Terms and definitions 3 Process and equipment characterization 3.1 Sterilization equipment 3.2 Process characterization\u2014Physical parameters 3.2.1 Introduction <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 3.2.2 EO concentration 3.2.3 Relative humidity 3.2.4 Temperature <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 3.2.5 EO exposure time 4 Process definition 4.1 Considerations for process definition 4.1.1 Ethylene oxide exposure parameters 4.1.2 Product packaging 4.1.3 Load configuration 4.1.4 Process development method <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 4.1.5 Sampling considerations for process development studies 4.1.6 Methods for microbial enumeration and fraction negative studies 4.1.6.1 Enumeration or fraction negative study approaches <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | Table 1\u2014Site selection of BI sample 4.1.6.2 Establishing relationship between developmental chamber and production <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 4.1.6.3 Parameters 4.2 Methods for process definition <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 4.2.1 Methods for estimating cycle lethality 4.2.1.1 Direct enumeration <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | Figure 1\u2014Example of a non-linear lethality curve 4.2.1.2 Fraction-negative method 4.2.2 Biological indicator\/bioburden approach <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | Table 2\uf8e7Examples of BI\/bioburden combinations for process definition <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | Figure 2\u2014Example of the relationship between biological indicator and product bioburden using the biological indicator\/bioburden method 4.2.3 Overkill methods <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 4.2.3.1 Half-cycle method Figure 3 \u2013 Example of an overkill cycle <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 4.2.4 Other approaches\u2014Absolute bioburden method of process definition 4.2.4.1 Bioburden isolates approach 4.2.4.2 Product sample approach 4.3 Sterilization process definition troubleshooting <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 4.3.1 Obtaining all positives 4.3.1.1 Methods to obtain all positives with a new process 4.3.1.2 Methods to obtain all positives in an existing cycle 4.3.2 Obtaining a linear slope in the lethality curve 4.3.3 Obtaining all negatives <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 4.4 Process challenge devices 4.4.1 Types of PCDs 4.4.1.1 Internal PCDs (IPCDs) <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 4.4.1.2 External PCDs (EPCDs) 4.4.2 Appropriateness of the PCD <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 4.4.3 Examples of PCDs 4.4.3.1 Examples of internal PCDs 4.4.3.2 Examples of external PCDs that have been used throughout the industry 4.4.3.3 PCDs for product families 5 Validation 5.1 Performance qualification 5.1.1 General considerations <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 5.2 Placement and handling of PCDs, test samples, and sensors 5.2.1 General 5.2.2 Sensor placement 5.2.3 Product and sample handling, shipping, and testing <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 5.3 Sterilization loads\u2014general considerations 5.3.1 Packaging 5.3.2 Full and partial loads <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 5.3.3 Mixed loads 5.3.4 Reuse of loads 5.4 Simulation of anticipated process conditions 5.5 Release of validation loads 5.6 Release of small batches or lots <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 6 Maintaining process effectiveness 6.1 Assessment of change 6.2 Failure investigation 6.2.1 Sterilization process or equipment issues 6.2.1.1 Potential process differences 6.2.1.2 Potential equipment differences 6.2.1.3 Potential process utility differences 6.2.2 Product issues 6.2.2.1 Product design or materials 6.2.2.2 Product bioburden <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 6.2.3 Microbiological testing issues 6.2.3.1 Test laboratory 6.2.3.2 Biological Indicators (BIs) <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI TIR16:2017\/(R)2020 [HISTORICAL] Microbiological aspects of ethylene oxide sterilization<\/b><\/p>\n |