STEMart launches microbiology and sterility testing services for medical devices
STEMart introduces comprehensive microbiology and sterility testing for sterile and pyrogen-free products.
New York, United States – May 30, 2022 – STEMart, a provider of integrated medical device CRO services dedicated to the clinical development of medical devices and diagnostics, introduces comprehensive microbiology and sterility testing for sterile and pyrogen-free products. STEMart has extensive expertise in microbiology as well as sterility testing and remains dedicated to a full-service experience that helps manufacturers meet regulatory goals and minimize compliance risk.
Sterilization is the process of eliminating microorganisms. Sterility testing is defined as microbial testing applied to sterile products 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 which must be sterile. This test is generally used to reveal the presence of live bacteria, fungi and yeasts in medical devices.
The USP and EP describe two main types of media used for sterility testing of parenteral products: Fluid Thioglycolate Medium (FTM) and Soy Casein Digestion Broth (SCDB). The FTM is used for the detection of aerobic bacteria and anaerobic bacteria, while the SCDB is used for the detection of molds and yeasts.
The Uniform Standard for Medical Device Quality Management Systems (ISO 13485) “Medical devices – Quality management systems – Requirements for regulatory purposes” provides general guidance which should be considered when assessing of the medical device audit process. This describes the requirements of a quality management system targeting the design and manufacture of medical devices.
STEMart now offers comprehensive sterility testing for sterile and pyrogen-free products. With extensive expertise in microbiology and sterility testing, STEMart offers a full-service experience that helps manufacturers meet regulatory goals and minimize compliance risk.
Comprehensive Microbiology and Sterility Testing includes a series of services, including Antibiotic Potency Testing to assess the bioactivity or potency of various antibiotics for medical devices; efficacy testing of antimicrobial preservatives in medical devices to ensure that the antimicrobial action induced by a medical device is sufficient to combat the introduction; the Biological Indicator Population Verification Testing Service to help manufacturers assess the spore count on a biological indicator; and microbial identification and strain typing services, performed after microbial load, environmental monitoring, tissue testing, microbial limits and sterility or IB.
Other testing services such as tissue testing services, bioburden and sterility testing, ethylene oxide sterilant residue testing, quarterly radiation dose (QDA) audits, and rapid endotoxin tests for medical devices are also available for the medical device industry at STEMart.
If you have additional questions about microbiology and sterility testing for medical devices or would like to learn more about STEMart’s medical device development service, please visit https://www.ste-mart.com.
STEMart is an industry-leading e-commerce platform with an extensive global footprint and a broad portfolio of over 10,000 products. It aims to provide superior laboratory materials, medical instruments and consumables, excellent technologies and high-quality services to global customers in the fields of science, technology and engineering, the discovery phase through to the manufacturing process. STEMart is dedicated to making biotech research and production simpler and safer to increase access to better health for people around the world.
Company Name: STEMart
Contact person: Staci Horme
E-mail: Send an email
Country: United States