The product is injection molded from radiation-stable medical grade polycarbonate, specifically for biotech industry applications. The resin meets USP Class VI Biological Reactivity, Physiochemical Hemolysis and In Vitro Cytotoxicity assays. Free of animal derived components (ADCF).
Manufacturing is in a BSENISO14644 compliant facility, ISO class 8 clean room monitored for particulate and bioburden to this standard. Processing is controlled within the quality management systems of ISO13485:2003 and ISO 9000:2000.