Microbiology For Medical Device

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 Test

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.

Bacteriostasis and Fungistasis Test

Sterility tests must be validated by performing a Method Suitability test (Bacteriostasis/Fungistasis or B/F). For some sterilization processes, a surrogate product or indicator may be used.

Biological Indicator Enumeration Test

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.

Endotoxin

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.

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