The Relation Between the Load, Duration, and Steam Penetration Capacity of a Surface Steam Sterilization Process: A Case Study.

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.LAY ABSTRACT: 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.