SCR has been conducting tests and providing advice for the Medical Device industry since 2007. We provide precise and timely service for our customers to meet their respective production needs.
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Sterility of Medical Device
The Sterility of Medical Device test evaluates samples for sterility by placing them in growth media, incubating them for a minimum of 14 days, and then checking for evidence of microbial contamination. Samples may be tested using either direct transfer or membrane filtration, and using a soybean casein digest broth (soy) or fluid thioglycollate (thio) media.
Bioburden tests determine the total number of viable microorganisms in or on a medical device, container or component. It is performed on any product that requires control and/or monitoring of bioburden counts, usually as part of a sterilization program. This test acts as an early warning system for possible production problems that could lead to inadequate sterilization.
Biological Indicators (BIs) are widely used to monitor the efficacy of sterilization processes. BIs provide a high level of sterility assurance and are ideal monitors of the sterilization process. The BI Enumeration Test is performed on exposed BIs after completion of a sterilization load through either a validation or routine lot release monitoring.
Lipopolysaccharides, also known as lipoglycans and endotoxins, are large molecules consisting of a lipid and a polysaccharide composed of O-antigen, outer core and inner core joined by a covalent bond; they are found in the outer membrane of Gram-negative bacteria.