Foster Delivery Science, a business unit of Foster Corporation that specializes in contract development and manufacturing of implant and drug delivery polymers, now offers custom radiopaque PEEK compounds for use in long term orthopedic implants. A twin screw extruder within the company’s Class 7 cGMP clean room is designed to produce development PEEK compound batches as small at 5 lbs (2.27 kg) through production quantities.
PEEK has become an industry standard for intervertebral body fusion devices, and is finding new applications in spinal surgeries, trauma repair, and joint replacement. The proliferation of applications has created demand for customized compounds with specific properties, including PEEK filled with additives that provide visibility under x-ray (radiopacity) to implanted components.
Custom compounding PEEK polymer requires specialized extrusion equipment capable of temperatures exceeding 700°F (371°C). PEEK compounds used in orthopedic applications must be processed in a controlled, cGMP clean room environment. Foster Delivery Science added high temperature custom compounding capabilities, up to 900°F (482°C), for processing PEEK within its 900 square foot (84 square meters) clean room. The company’s 27mm (1.06 in) extruder is capable of small scale formulation development trials, through process development and full manufacturing of implantable materials.
“Materials for permanent implants require compounding in a highly controlled environment,” said Tony Listro, Managing Director for Foster’s Delivery Science business. “Many traditional polymer compounders may have experience with PEEK, but do not have a cGMP clean room. Our ability to provide custom, clean room compounding of PEEK is unique.”