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Development of a package-sterilization process for aseptic filling machines: A numerical approach and validation for surface treatment with hydrogen peroxide

  • Within the present work a sterilization process by a heated gas mixture that contains hydrogen peroxide (H₂O₂) is validated by experiments and numerical modeling techniques. The operational parameters that affect the sterilization efficacy are described alongside the two modes of sterilization: gaseous and condensed H₂O₂. Measurements with a previously developed H₂O₂ gas sensor are carried out to validate the applied H₂O₂ gas concentration during sterilization. We performed microbiological tests at different H₂O₂ gas concentrations by applying an end-point method to carrier strips, which contain different inoculation loads of Geobacillus stearothermophilus spores. The analysis of the sterilization process of a pharmaceutical glass vial is performed by numerical modeling. The numerical model combines heat- and advection-diffusion mass transfer with vapor–pressure equations to predict the location of condensate formation and the concentration of H₂O₂ at the packaging surfaces by changing the gas temperature. For a sterilization process of 0.7 s, a H₂O₂ gas concentration above 4% v/v is required to reach a log-count reduction above six. The numerical results showed the location of H₂O₂ condensate formation, which decreases with increasing sterilant-gas temperature. The model can be transferred to different gas nozzle- and packaging geometries to assure the absence of H₂O₂ residues.

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Author:Zaid B. Jildeh, Patrick Kirchner, Jan OberländerORCiD, Farnoosh Vahidpour, Patrick H. Wagner, Michael Josef SchöningORCiD
Parent Title (English):Sensor and Actuators A: Physical
Place of publication:Amsterdam
Document Type:Article
Year of Completion:2020
Date of the Publication (Server):2020/03/09
Institutes:FH Aachen / Fachbereich Medizintechnik und Technomathematik
FH Aachen / INB - Institut für Nano- und Biotechnologien
collections:Verlag / Elsevier