STEMart, a provider of integrated medical device CRO services dedicated to medical device and diagnostic clinical development, introduces comprehensive microbiology and sterility testing for sterile, non-pyrogenic products. STEMart has extensive expertise in microbiology as well as sterility testing and remains dedicated to a full-service experience that supports manufacturers in meeting regulatory goals and minimizing compliance risk.
Sterilization is the process of removing microorganisms. Sterility testing is defined as microbial testing applied to sterile products in order to demonstrate that the product is manufactured and processed according to cGMP-guided practices or to confirm whether the product is sterile or not. Sterility testing applies to substances, preparations or articles that require sterility. This test is usually used to reveal the presence of live bacteria, fungi and yeast in medical devices.
USP and EP describe two main types of media used for the sterility testing of parenteral products: fluid thioglycolate medium (FTM) and soybean casein digestion broth (SCDB). FTM is used for the detection of aerobic bacteria and anaerobic bacteria, while SCDB is used to detect mold and yeast.
The uniform standard for medical device quality management systems (ISO 13485) "Medical devices-Quality management systems-Requirements for regulatory purposes" provides general guidance that should be taken into account when evaluating audit process of a medical device. This outlines the requirements for a quality management system targeting the design and manufacture of medical devices.
STEMart now offers comprehensive sterility testing for sterile, non-pyrogenic products. With extensive expertise in microbiology and sterility testing, STEMart provides a full-service experience that supports manufacturers in meeting regulatory goals and minimizing compliance risk.
Comprehensive microbiology and sterility testing includes a series services, including the Antibiotic Potency Test to assess the bioactivity or potency of various antibiotics for medical devices; the Medical Device Antimicrobial Preservative Effectiveness testing to assure the antimicrobial action induced by a medical device is sufficient to combat introduction; the Biological Indicator Population Verification testing service to help manufacturers to assess the number of spores on a biological indicator; and the Microbial Identification & Strain Typing services, performed following bioburden, environmental monitoring, tissue testing, microbial limits, and on sterility or BI.
Other testing services such as Tissue Testing Services, Bioburden and Sterility Testing, Ethylene Oxide Sterilant Residual Tests, Radiation Quarterly Dose Audits (QDAs), and Rapid Endotoxin Testing for Medical Devices are also available for the medical devices industry at STEMart.
If you have any additional questions about microbiology and sterility testing for medical devices or if you would like to find out more about STEMart's Medical Device Development Service, please visit https://www.ste-mart.com.
STEMart is an industry-leading eCommerce platform with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide top-grade 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 increase access to better health for people worldwide.