New Custom PEEK Compounds Ideal for Orthopedic Applications

Foster Delivery Science now offers custom radiopaque PEEK (polyetheretherketone) compounds for use in long-term orthopedic implants. The company’s twin-screw extruder in its Class 7 current good manufacturing practices (cGMP) clean room has the capability of producing batches of the compound as small as 5 lbs.

PEEK, being biocompatible, chemical and heat resistant, and organic, is in high demand for medical applications. It has become an industry standard for intervertebral body fusion devices, and is finding new applications in spinal surgeries, trauma repair, and joint replacement. Due to the rise in applications, there has also been a rise in demand for customizable compounds of PEEK, including being filled with additives that provide visibility under X-ray (radiopacity).

Because of its extreme resistance to heat, custom compounding PEEK requires specialized extrusion equipment capable of temperatures exceeding 700°F (371°C). The clean room at Foster has manufacturing capabilities of up to 900°F (482°C). PEEK compounds used in orthopedic applications must be processed in a controlled, cGMP clean room environment. The company’s 27 mm 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.”

Foster Delivery Science is a business unit of Foster Corp, based in Putnam, Conn. The business unit specializes in contract development and manufacturing of implant and drug delivery polymers.