Freeze-Thaw Testing of Drug-Eluting Devices
Freeze-Thaw Testing of Drug-Eluting Devices Freeze-Thaw Testing of Drug-Eluting Devices: Ensuring Stability and Release Consistency Drug-eluting devices—such as coronary stents, orthopedic implants, and intrauterine systems—are classified as combination products and must meet the stability requirements of both pharmaceuticals and medical devices. These products contain APIs embedded in or coated onto polymeric or metallic surfaces, making…