Product sterility test This test aims at verifying sterility of medical devices after sterilization. The service includes validation on product charges, preparation of a validation protocol and report, and routine testing. Bioburden testing Medistri offers the complete determination of the present contamination on your product. For it, we can make counting of total or partial viable germs (aerobic, anaerobic bacteria, mushrooms, yeasts). We can also go further to know and identify germs: -   Gram coloration -   Partial or complete Identification till genome analysis The knowledge of your contamination and its control are key-factors for the quality of your product.

Biological indicators analyses

Population control on biological indicators (BI)
This analysis verifies the number of bacterial spores indicated by the supplier. This procedure is required to assure the conformity of your microbiological validation.

Sterility test on biological indicators (BI)
With this service, the quality of sterilization is assessed via BI testing, which include spore strips, spore discs or spore suspensions.

Viable enumeration of germs on biological indicators. During the sterilization validation, this analysis allows to make a counting and an complete analysis of lethality. 

Detection of Endotoxin

Endotoxin is known to play an important role in pathological manifestations, e.g. sepsis, and organ dysfunction. We offer the LAL (Limulus Amebocyte Lysate) test, which allows a quantitative detection of Endotoxin on medical devices.