Dissolution Platform for Testing Medical Devices
DISSOLUTION PLATFORM FOR TESTING MEDICAL DEVICES
FDA approval of a new drug delivery system – drug-eluting implantable prosthetics – required new technology for testing quality and efficacy. A company building a compendial small volume dissolution platform for its customers needed precision liquid sample handling for HPLC. In contrast to existing systems that depended on large fluid samples for testing oral medications, they needed to achieve higher accuracy with large numbers of smaller, concentrated samples to meet throughput requirements.
Norgren integrated Kloehn’s expertise in precision liquid handling to the customer’s existing technology and engineering skill set to develop a platform that set the industry standard in the new market for testing drug-eluting medical prosthetics.