The aim of this study was to develop a Computational Fluid Dynamics (CFD) model to simulate the inactivation of bacterial spores of Geobacillus stearothermophilus inside a Peritoneal Dialysis Bag System (PDBS). The presented CFD model has three significant modifications in comparison to current state-of-the-art simulations of sterilization processes. (i) The CFD simulation can be used to consider the multiphase flow (water, steam, different dialysis solutions, non-condensable gases (NCGS)) inside the PDBS, the natural convection as well as the steam penetration. (ii) Experimentally obtained inactivation kinetics were added to the CFD code to enable simulation of the inactivation of G. stearothermophilus spores. (iii) The inactivation process of G. stearothermophilus spores was simulated in different sterilization environments which are present inside a PDBS. The CFD model was verified with measurements using Biological Indicators (BIs). Results showed that on the pre-CFD-simulated “worst case locations” CFD simulations and the BI-based verification were in well accordance. By using the presented CFD model, the simulation of a moist heat sterilization process can be performed for any given sterilization cycle. In addition, the model is a powerful tool that can be used to optimize steam sterilization processes and guarantee a high level of sterilization efficiency and product safety.
ASJC Scopus subject areas
- Radiologie, Nuklearmedizin und Bildgebung