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

• DOI: 10.1371/journal.pone.0274924
• Publication Date: 2022-09-27T17:30:40Z
• Authors: Emerson Aparecido...; Paulo Roberto Lar...; Marina Ishii; Terezinha de Jesu...
• Keywords: Sterilization

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