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Updated: Jun 6, 2026

Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
Published on: March 17, 2023
A probabilistic approach to determine thermal process setting parameters: application for commercial sterility of
Jeanne-Marie Membré1, André van Zuijlen
1INRA, UMR 1014 SECALIM, Rue de la Géraudière, BP 82225, 44332 NANTES Cedex 3, France. jeanne-marie.membre@oniris-nantes.fr
Abstract:
The objective of the probabilistic data analysis presented in this paper was to enable the thermal process to be set on actual data rather than on generic or conservative rules. The application was an ambient stable soup product, heated in a continuous UHT line. The data set comes from a decade of microbiological analysis: initial spore load and survival spore concentration after moderate heat-treatment (100°C for 15 min and 110°C for 15 min) have been enumerated in forty eight ingredients. The probabilistic analysis was carried out within a risk-based context, considering a Performance Objective, PO, set after the heat-treatment process and an initial spore contamination (H₀) at the ingredient mixing step. The probabilistic analysis was based upon Bayesian inference, chosen for its flexibility when dealing with censored data (some values were reported as less than 1 log cfu/g) and also for its ability to incorporate in the data analysis prior information. Beforehand, Z values around 10°C for aerobic bacterial spores, and log count error around 1 log, were assumed. The methodology and the results are reported using two ingredients (garlic and milk powder) illustrating the 'not detected' (censored data) issue and also the inter-ingredient variability. Indeed, Z was estimated to be 13.6°C (mean) for spores selected from garlic and 5.9°C for those selected from milk powder. Based upon a hypothetical soup recipe with these two ingredients, the sterilization value was estimated to be 13 min (95th percentile). The potential use of similar methodology to design and set the sterilization value for the thermal process of future products, is discussed.
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