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

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 qual...

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Bibliographic Details
Published in:PloS one 2022-09, Vol.17 (9), p.e0274924-e0274924
Main Authors: Miguel, Emerson Aparecido, Laranjeira, Paulo Roberto, Ishii, Marina, Pinto, Terezinha de Jesus Andreoli
Format: Article
Language:English
Subjects:
Biology and Life Sciences
Carbon dioxide
Ecology and Environmental Sciences
Engineering and Technology
Evaluation
Failure rates
Gases
Generators
Heat
Injection
Liquefaction
Manufacturing
Medical equipment
Medicine and Health Sciences
Methods
Microorganisms
Osmosis
Pharmaceuticals
Physical Sciences
Purification
Quality standards
Research and Analysis Methods
Reverse osmosis
Steam
Steam generation
Steam-heating
Sterilization
Water
Water analysis
Water purification
Water quality
Water treatment
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Summary: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. 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.sup.® 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. 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%). 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.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0274924