van Doornmalen Josephus P C M, van Wezel Ralph A C, Kopinga Klaas
Department of Applied Physics, Eindhoven University of Technology, P.O. Box 513, 5600 MB, Eindhoven, The Netherlands;
Steelco Benelux B.V., de Limiet 2, 4131 NR Vianen, The Netherlands; and.
PDA J Pharm Sci Technol. 2019 May-Jun;73(3):276-284. doi: 10.5731/pdajpst.2017.008490. Epub 2018 Nov 27.
In practice it is claimed that load characteristics influence a surface steam sterilization process. To the best of our knowledge, no information on this topic has been found in the literature. The purpose of this study was to find if a load influences the duration and related characteristics of a surface steam sterilization process. In a case study, every load monitoring using an objective, quantifying steam penetration test was performed during 30 days. This resulted in 98 production processes with load monitoring. The acquired data were analyzed. A relation between the weight of a load and the duration of a surface steam sterilization process has been found. In this case study, it is demonstrated that the process time increases with the weight of the sterilizer load. Additionally, it is concluded that when the duration of a process is longer, diffusion will have a greater effect and steam penetration increases. Steam sterilization is applied in most health-care facilities that reprocess medical devices, in pharmaceutical industries, and in labs where specific instrumentation and equipment have to be sterile. Steam sterilization is still not fully understood, as demonstrated in the literature. Our manuscript contributes to understanding the surface steam sterilization process. The information shared in our manuscript demonstrates by a case study that relations exist between the weight of the load which is steam sterilized, the duration of a process, and the steam penetration in a process. A quantitative relation can be used to predict the duration of a process and the steam penetration. It is likely that for other steam sterilizers these relations can be found as well. This is of interest for institutes researching decontamination and sterilization, health-care facilities, developers and manufacturers of medical devices, and committees addressing standards for steam sterilization.
在实际操作中，有人声称负载特性会影响表面蒸汽灭菌过程。据我们所知，文献中尚未找到关于此主题的任何信息。本研究的目的是确定负载是否会影响表面蒸汽灭菌过程的持续时间及相关特性。在一个案例研究中，在30天内对每次负载进行了客观的、量化蒸汽穿透测试的监测。这产生了98个有负载监测的生产过程。对获取的数据进行了分析。发现了负载重量与表面蒸汽灭菌过程持续时间之间的关系。在这个案例研究中，证明了处理时间会随着灭菌器负载重量的增加而增加。此外，得出的结论是，当过程持续时间较长时，扩散的影响会更大，蒸汽穿透会增加。蒸汽灭菌应用于大多数对医疗器械进行再处理的医疗机构、制药行业以及必须使特定仪器和设备无菌的实验室。正如文献中所表明的，蒸汽灭菌仍未被完全理解。我们的手稿有助于理解表面蒸汽灭菌过程。我们手稿中分享的信息通过一个案例研究表明，在蒸汽灭菌的负载重量、过程持续时间和过程中的蒸汽穿透之间存在关系。定量关系可用于预测过程持续时间和蒸汽穿透。很可能对于其他蒸汽灭菌器也能找到这些关系。这对于研究去污和灭菌的机构、医疗机构、医疗器械的开发者和制造商以及制定蒸汽灭菌标准的委员会来说是有意义的。
