Potential problems of inadequate air removal and presence of non-condensable gasses in a steam sterilization process: A brief discussion

Das, Tapan Kumar; Laha, Sayan; Basu, Debabrata

doi:10.1017/ice.2020.88

Cited by 2 publications

(2 citation statements)

References 3 publications

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“…The presence of air and other non-condensable gases (NCGs) inside the chamber during a sterilization cycle is one of the biggest threats to the sterilization process. NCGs prevent the steam condensation on the medical device surface, inhibiting thermal coagulation of cell wall proteins of microorganisms, including spores, during the sterilization [5,[8][9][10], affecting steam quality by reducing its energy power they have a lower heat capacity compared to water. Therefore, air pockets form (bubbles of NCGs) inside the sterilizer chamber that isolate the goods to be sterilized and block further condensation of the steam before sterilization, can slow down the heating process, or the sterilization cycle may abort due to insufficient vacuum if the gases are not correctly removed [10].…”

Section: Introductionmentioning

confidence: 99%

“…NCGs prevent the steam condensation on the medical device surface, inhibiting thermal coagulation of cell wall proteins of microorganisms, including spores, during the sterilization [5,[8][9][10], affecting steam quality by reducing its energy power they have a lower heat capacity compared to water. Therefore, air pockets form (bubbles of NCGs) inside the sterilizer chamber that isolate the goods to be sterilized and block further condensation of the steam before sterilization, can slow down the heating process, or the sterilization cycle may abort due to insufficient vacuum if the gases are not correctly removed [10]. The presence of NCGs constitutes a potential factor of a process failure since they occupy space in the internal chamber of the equipment, competing with water vapor and acting as a thermal insulator when the equipment is in operation.…”

Section: Introductionmentioning

confidence: 99%

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Analysis of water quality over non-condensable gases concentration on steam used for sterilization

Miguel¹,

Laranjeira²,

Ishii

et al. 2022

PLoS ONE

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Background Non-condensable gases (NCGs) are all gases that do not undergo liquefaction during the saturated steam sterilization process. During a sterilization cycle, the NCGs presence inside the chamber is one of the biggest threats to the sterilization process compromising process validation and product quality. Methods In this work, 170 testing of NCGs concentrations performed between September 2016 and August 2021 were carried out by Orionce Serviços de Metrologia Ltda (Barueri, SP, Brazil), according to EN285:2015 procedure. For steam generation, the types of water used were softened water (SW), one-step reverse osmosis (RO), purified water (PW), and water for injection (WFI). The data obtained were analyzed using Minitab® software, version 18.1, to identify a relationship between the water quality used for steam generation and the concentration of non-condensable gases determined into equipment qualification. Findings From total tests performed, 109 tests passed, and 61 tests failed, representing 64.2% and 35.8%, respectively. A higher failure rate was observed in terms of concentration of non-condensable gases in systems that used purified water for steam generation (64.7%), followed by softened water (55.6%), one-step reverse osmosis (42.9%), and water for injection (7.6%). Conclusion System processes using WFI for steam generation showed better results for steam quality approvement, in terms of NCGs concentration, compared to softened, purified, or reverse osmosis water treatments in the concentration of non-condensable gases in steam used for sterilization processes of industrial utilities.

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