Microbiology of Medical Device
SCR provides product sterility analysis for medical devices at a competitive price. Our tests follows USP and ISO standards to meet producer's requirements.
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. It is also used to calculate the necessary dose for effective radiation sterilization and to monitor product routinely as part of quarterly dose audits.
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. Most commonly the use of a biological indicator (BI) or spore strip saves both test time and product cost. BI sterility tests at SCR are performed similar to product sterility but require a shorter incubation time and low volumes of media, allowing for a more cost effective sterility test to verify sterilization load processing.