PolyMedex blends bioactive fillers such as tricalcium phosphate (TCP), hydroxyapatite (HA), and biphasic calciumphosphate (BCP) to make them osteoconductive, meaning that bone will grow on and bond to the polymer. Implantable polymers such as polyetheretherketone (PEEK) are used in permanent implants, often in high stress applications. Bioresorbable polymers such as polycaprolactone (PCL), polylactide (PLA) and polyglycolide (PGA) are used in implants for temporary support while the body heals and ultimately replaces the implant with natural bone. For optimum implant device performance, PolyMedex customizes bioresorbable polymers for absoption ranges from 1 to 36 months and flexural modulus (stiffness) from 30,000 psi (200 MPa) to over 1,000,000 psi (6,900 MPa).
PolyMedex processes implantable polymers in 100,000 class (ISO 8) cGMP certified clean room conditions to minimize contamination. Pharmaceutical grade twin screw extruders are used for precision metering and fine filler dispersion that is required for high surface quality and consistent implant performance. Process records of all process parameters are meticulously maintained during development and manufacturing trials. All manufacturing components are calibrated and equipment is cleaned per GMP standards.
PolyMedex Discovery Group offers its implantable polymers in multiple delivery forms for use in a variety of applications. Simple implant components can be precision cut from extruded film and fiber. Innovative implant designs are possible with implantable polymers in the form of coextruded and multi-lumen tubing. Injection molding is by far the most common process for fabricating implantable devices. PolyMedex’s custom formulations are available in a variety of pellet sizes for processing in standard or micromolding equipment.
For more information please call (860) 774-1559 x116 or visit www.polymedexgroup.com.