AAMI TIR21387 2023
$99.23
AAMI/ISO TIR21387:2023 – Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release
| Published By | Publication Date | Number of Pages |
| AAMI | 2023 |
Provides guidance on the requirements of ISO 11135 that apply when parametric release is used to release the product after exposure to the sterilization process. Provides a path for transition of existing cycles, as well as a path for the development and implementation of a parametric release specification for a new cycle. Highlights the importance and interrelationship of other process factors, i.e. load configuration and equipment performance, which influence reproducibility of an ethylene oxide (EO) sterilization process.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI/ISO TIR21387:2023; Sterilization of health care products—Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report |
| 6 | Contents |
| 7 | Committee representation |
| 10 | Background of AAMI adoption of ISO/TS 21387:2020 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 14 | 4 Quality management systems 5 Sterilization agent characterization 6 Process and equipment characterization 6.1 General 6.2 Process characterization 6.3 Equipment characterization |
| 16 | 7 Product definition 7.1 General 7.2 Product safety, quality and performance 7.3 Microbiological quality |
| 17 | 8 Process definition 9 Validation 9.1 General 9.2 Installation qualification 9.2.1 Equipment |
| 19 | 9.2.2 Installation qualification 9.3 Operational qualification 9.4 Performance qualification 9.4.1 General |
| 20 | 9.4.2 Performance qualification—Microbiological |
| 21 | 9.4.3 Performance qualification—Physical 9.5 Review and approval of validation |
| 22 | 10 Routine monitoring and control 11 Product release from sterilization |
| 23 | 12 Maintaining process effectiveness 12.1 General 12.2 Maintenance of equipment |
| 24 | 12.3 Requalification 12.4 Assessment of change 12.5 Assessment of equivalence 13 ISO 11135:2014, Annex A 14 ISO 11135:2014, Annex B |
| 26 | Annex A (informative) Establishing specifications for parametric release based on routine processing data A.1 General A.2 Procedure A.2.1 General A.2.2 Number of cycles to review A.2.3 Data to be collected A.2.3.1 Temperature A.2.3.2 Humidity A.2.3.3 EO concentration |
| 27 | A.2.4 Establishing parametric release specifications A.2.4.1 General A.2.4.2 Analysis and specification development A.2.4.3 Temperature A.2.4.4 Humidity A.2.4.5 EO concentration A.2.5 Confirmatory MPQ cycle |
| 29 | Bibliography |
