Germantown, Wis.-based Sunlite Plastics Inc. is the first company in the world to earn an extrusion accreditation for tubing and profiles from MedAccred, a supply chain oversight program managed by the medical device industry to prevent product defects.
Founded in 1946, Sunlite is a subsidiary of Diversatek Inc., specializing in PVC extrusion. It has two facilities in Wisconsin and Virginia for in-house compounding of PVC, non-DEHP PVC and proprietary formulations of the material used in custom medical tubing.
Sunlite's compounding and blending processes are automated. Pelletized materials are then vacuum-fed to extruders in positive-pressurized controlled rooms where employees wear gowns and cover their hands and heads. They manufacture products for a wide variety of medical markets, such as cardiology, dialysis, enteral feeding, minimally invasive procedures and urology, among others.
Sunlite passed audit criteria developed by leaders in the medical device industry to improve product quality and patient safety. A nonprofit group called the Performance Review Institute (PRI) administers MedAccred. The auditors determine whether customer requirements are satisfied, stringent industry specifications are met, and best practices for manufacturing are followed.
After the audit, technical experts from other medical device companies review the findings and any corrective actions taken before voting to grant the MedAccred accreditation.
Diversatek Chairman and CEO Brant Stanford said Sunlite was recognized for manufacturing expertise and quality assurance.
"We have always operated as a partner to our clients, not a vendor," Stanford said in a news release. "Process is central to this commitment and we pride ourselves on regular evaluation and refinement to ensure consistent product quality and efficacy. Our MedAccred 'first global' distinction is a testament to our team's hard work and to seven decades of experience in high-volume manufacturing."
Joe Pinto, PRI's executive vice president and chief operating officer, said plastics extrusion accreditation joins a list of process oversight for cable and harness, heat treating, plastics injection molding, printed circuit board assembly, and sterilization and welding. The newest audit covers extruded sheet, film, blown film, over-jacketing, co-extrusion and ram extrusion in addition to tubing and profiles.
"Credit must be given to the pioneers, like Sunlite Plastics, who step up to this rigorous evaluation of their systems, processes and industry best practices to achieve their MedAccred accreditation from industry," Pinto said in a news release.
Sunlite, which also extrudes other materials, said it processes enough tubing annually to circle the globe.