New York, USA – September 29, 2022 – STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced Biological Indicator Sterility Testing services for the industry of medical devices. This testing is performed according to the exposure of Biological Indicators (BIs) after completion of the sterilization load, and it is a qualitative test to reveal results that can appropriately indicate the growth of organisms.
Biological indicators are test systems containing live microorganisms that provide definitive resistance to a specific sterilization process. For a given sterilization process, researchers need to determine whether necessary conditions are met to destroy a certain number of microorganisms. Meanwhile, this information can be provided by BIs, which also provides a high level of sterility assurance for the sterilization process. BIs can be used to monitor the efficacy of sterilization processes and provide a direct assessment of the lethality of the process. Subsequently, researchers can use BI to track sterilizers, thus determining the effectiveness of sterilization processes.
STEMart is now providing a list of BI services. Typically, this sterility testing is performed on exposed BIs after completion of the sterilization load, which is a qualitative test to reveal results that can appropriately indicate the growth of organisms. BIs are often used for process challenge equipment designed to represent the most challenging products routinely handled. Endospores or bacterial spores are microorganisms that are used primarily for BIs because they are considered to be one of the most difficult microorganisms to kill. Additionally, bacterial spores are selected for use in a specific sterilization process based on their known resistance to the specific sterilization process.
STEMart provides biological indicator sterility testing services for both traditional BIs and stand-alone BIs, following the guidance of various standards, including USP , the ANSI/AMMI/ISO 11138 series parts 1-4, ANSI/AAMI/ISO 14161, and ANSI/AAMI/ISO 11135. Whether during validation or regular production, scientists of STEMart can help customers perform their batch release tests.
Biological indicators are made from a carrier material to which bacterial spores with a defined resistance to the sterilization process are applied. The general procedure for BI sterility testing is to place BI into soy-casein digestion broth aseptically, then incubate under certain temperature and time conditions according to the growth requirements of indicator organisms, thus determining whether spores survive during the process.
If you have additional questions about Biological Indicator Sterility Testing services for medical devices or would like to know more about STEMart’s medical device development service, please visit https://www.ste-mart.com.
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to making research and biotech production simpler and safer in order to enhance access to better health worldwide.