Advancing the Sustainable Use of Ethylene Oxide through Process Validation
| Autor: | Nicole McLees, Ken Gordon, Gerry Kearns, Brian McEvoy, Paulo Laranjeira, Stacy Bohl Wiehle |
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| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Ethylene Oxide Medical device Computer Networks and Communications Computer science business.industry Scale (chemistry) Biomedical Engineering Sterilization Process validation Patient care 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Compatibility (mechanics) Humans Industry Process optimization Sterility assurance level Process engineering business 030217 neurology & neurosurgery Analysis |
| Zdroj: | Biomed Instrum Technol |
| ISSN: | 0899-8205 |
| Popis: | Based on excellent material compatibility and ability for scale, ethylene oxide (EO) sterilization constitutes approximately 50% of single-use medical device sterilization globally. Epidemiological considerations have elevated focus toward optimization of EO processes, whereby only necessary amounts of sterilant are used in routine processing. EO sterilization of medical devices is validated in accordance with AAMI/ANSI/ISO 11135:2014 via a manner in which a sterility assurance level (SAL) of 10(−6) is typically achieved, with multiple layers of conservativeness delivered, using “overkill” approaches to validation. Various optimization strategies are being used throughout the medical device industry to deliver the required SAL while utilizing only necessary amounts of sterilant. This article presents relevant experiences and describes challenges and considerations encountered in delivering EO process optimization. Thus far, the results observed by the authors are encouraging in demonstrating how EO processing can be optimized in the delivery of critical single-use medical devices for patient care. |
| Databáze: | OpenAIRE |
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