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

ABSTRACT:

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 relations

SUBMITTER: Miguel EA 

PROVIDER: S-EPMC9514632 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature