Analysis of water quality over non-condensable gases concentration on steam used for sterilization.
<h4>Background</h4>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 proc...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2022-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0274924 |
| _version_ | 1797997224267874304 |
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| author | Emerson Aparecido Miguel Paulo Roberto Laranjeira Marina Ishii Terezinha de Jesus Andreoli Pinto |
| author_facet | Emerson Aparecido Miguel Paulo Roberto Laranjeira Marina Ishii Terezinha de Jesus Andreoli Pinto |
| author_sort | Emerson Aparecido Miguel |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methods</h4>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.<h4>Findings</h4>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%).<h4>Conclusion</h4>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. |
| first_indexed | 2024-04-11T10:29:41Z |
| format | Article |
| id | doaj.art-ca48522b92c544aaba961082930e8b36 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-04-11T10:29:41Z |
| publishDate | 2022-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-ca48522b92c544aaba961082930e8b362022-12-22T04:29:28ZengPublic Library of Science (PLoS)PLoS ONE1932-62032022-01-01179e027492410.1371/journal.pone.0274924Analysis of water quality over non-condensable gases concentration on steam used for sterilization.Emerson Aparecido MiguelPaulo Roberto LaranjeiraMarina IshiiTerezinha de Jesus Andreoli Pinto<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Findings</h4>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%).<h4>Conclusion</h4>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.https://doi.org/10.1371/journal.pone.0274924 |
| spellingShingle | Emerson Aparecido Miguel Paulo Roberto Laranjeira Marina Ishii Terezinha de Jesus Andreoli Pinto Analysis of water quality over non-condensable gases concentration on steam used for sterilization. PLoS ONE |
| title | Analysis of water quality over non-condensable gases concentration on steam used for sterilization. |
| title_full | Analysis of water quality over non-condensable gases concentration on steam used for sterilization. |
| title_fullStr | Analysis of water quality over non-condensable gases concentration on steam used for sterilization. |
| title_full_unstemmed | Analysis of water quality over non-condensable gases concentration on steam used for sterilization. |
| title_short | Analysis of water quality over non-condensable gases concentration on steam used for sterilization. |
| title_sort | analysis of water quality over non condensable gases concentration on steam used for sterilization |
| url | https://doi.org/10.1371/journal.pone.0274924 |
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