Medisol is a leading provider of sterility assurance test services for medical device, pharmaceutical and tissue manufacturers for both sterile and nonsterile products. Most tests follow United States or European Pharmacopeia (USP or EP) and similar international standards. terilized medical device standards are also found in ISO, AAMI and ASTM guidance documents.
For convenience in finding routine quality control test services, the links below may contain test services not traditionally associated with formal sterility assurance programs but are aligned routine test services for many medical device and pharmaceutical products.
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.
For clarification, product bioburden is intended for medical devices, containers and components. However, we also offer standard plate counts and microbial enumeration studies for powders, solutions and similar products where reconstitution and filtering may be required. Tissue products may also be assessed for bioburden.