Performance evaluation of chemical, biological and physical indicators in the process of sterilization under the effect of non-condensable gases

Rodrigues, Sandoval Barbosa; Souza, Rafael Queiroz de; Graziano, Kazuko Uchikawa; Erzinger, Gilmar Sidnei; Souza, Ozair

doi:10.1016/j.jhin.2020.11.005

Cited by 2 publications

(1 citation statement)

References 2 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Also, the presence of NCGs prevents the contact of the steam and the material, making difficult its condensation on the surface to be sterilized, to exchange the energy necessary to sterilization. Non-condensable gases can be originated from failures in the vacuum performed in the chamber but can also be generated during the process by possible leaks and micro-cracks in the junctions and pipes in the steam piping or inadequate generator degassing [11,24,27]. EN285 note that the method indicated in the standard norm is based on possible conditions when the methodology was established (1960).…”

Section: Discussionmentioning

confidence: 99%

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

Miguel¹,

Laranjeira²,

Ishii

et al. 2022

PLoS ONE

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 99%