Hydrogen Peroxide (H2O2) sterilization validation
Main Article Content
The definition of validation is the process of continuously meeting the predetermined conditions that are valid and necessary for all sterilization systems. These conditions include all of the test methods and/or results determined while examining the performance criteria of sterilization devices. Evaluation of the results of the tests performed allows us to prove the effectiveness of the chosen sterilization method by examining the materials expected to be sterilized in terms of bacterial load. The unchanging common point of all sterilization methods is validation studies. The requirements of the ISO 14973 standard should include the evaluation of the sterilization method (sterilization device) performance parameters, as well as the type, content, and effectiveness of the sterilization agent during validation studies. Sterilization The main purpose of validation is to constantly prove that the targeted criteria have been achieved as a result of sterilization. The validation steps are defined as installation evaluation, operational evaluation, and performance evaluation with the most general grouping. In the Hydrogen Peroxide Sterilization method, the operational evaluation should ensure that all the tests defined in the relevant standard of the sterilization device are performed effectively. The installation evaluation should show that the sterilization device is fully assembled by the standard and that the connection to the component sources such as water, air, and steam fed to the device is guaranteed to be faultless. The operational evaluation should ensure that the sterilizer is performed by the operating parameters specified by the manufacturer. Performance evaluation should be made periodically by the users during device use, to prove effective sterilization. As a result, in the validation studies of the Hydrogen Peroxide Sterilization device, the devices to be used in the study should first be operated without load, then biological indicators should be placed in the boiler of the sterilization device by determining the points where the sterilization agent is most difficult to reach. After sterilization, it should be expected to achieve the targeted SAL value. G. stearothermophilus is preferred to provide difficult conditions in hydrogen peroxide sterilization studies.
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McEvoy, B., & Rowan, N. J. (2019). Terminal sterilization of medical devices using vaporized hydrogen peroxide: a review of current methods and emerging opportunities. Journal of applied microbiology, 127(5), 1403-1420. https://doi.org/10.1111/jam.14412
Bathina, M. N., Mickelsen, S., Brooks, C., Jaramillo, J., Hepton, T., & Kusumoto, F. M. (1998). Safety and efficacy of hydrogen peroxide plasma sterilization for repeated use of electrophysiology catheters. Journal of the American College of Cardiology, 32(5), 1384-1388. https://doi.org/10.1016/s0735-1097(98)00401-x.
Steris Corporation, (2022). Material compatibility with vaporized Hydrogen Peroxide (VHP®) sterilization: A new option for point-of-manufacture sterilization. Case Study 8
Diab-Elschahawi, M., Blacky, A., Bachhofner, N., & Koller, W. (2011). Lumen claims of the STERRAD 100NX sterilizer: testing performance limits when processing equipment containing long, narrow lumens. American journal of infection control, 39(9), 770-774. https://doi.org/10.1016/j.ajic.2011.01.010
Jacobs, P., & Kowatsch, R. (1993). Sterrad Sterilization System: a new technology for instrument sterilization. Endoscopic surgery and allied technologies, 1(1), 57-58.
Atalay, A., Altakhan, M., & Sağiroğlu, P. (2020). İki Farklı Hidrojen Peroksit Gaz Plazma Sterilizatörünün Lümenli Tıbbi Cihazlardaki Performanslarının Değerlendirilmesi. Journal of Biotechnology and Strategic Health Research, 4(3), 272-276. https://doi.org/10.34084/bshr.798413
Usta, E. Ö., & Ayaz, F. (2022). Sterilization packaging with appropriate materials and sterility assurance level. Advanced Engineering Days (AED), 4, 1-3.