The industry's first portfolio of biocompatible engineering plastic stock shapes for machining are USP Class V and VI certified and FDA and ISO 10993 compliant.
Quadrant Engineering Plastic Products has developed the portfolio of materials including a group of new, Life Science Grades (LSG) that are pre-qualified biocompatible. This saves OEMs the time and costs associated with biocompatibility testing and regulatory approvals.
The current U.S. LSG portfolio for use in medical, pharmaceutical, and biotechnology devices is based on polyetheretherketone (PEEK). It includes Ketron PEEK-Classix LSG, Ketron PEEK-CA30 LSG, Ketron PEEK-GF30 LSG, Ketron LSG PEEK, and Ketron PEEK 1000. Ketron PEEK-Classix LSG is USP Class VI certified and ISO 10993 compliant for both resin and shape and can be implanted for up to 30 days. The Ketron CA30, GF30 LSG grades are also USP Class VI certified and ISO 10993 compliant (for shape) and can be implanted for up to 24 hr. The FDA compliant Ketron 1000 is not implantable.
In Europe the LSG range expands to include other high performance polymers such as Techtron HPV LSG (polyphenylene sulfide), Radel 1000 LSG (polyphenylsulfone), Utem 1000 LSG (polyethylenimine), Polysulfone LSG, polycarbonate LSG, and Acetron LSG 7 colors.
Quadrant provides OEMs with the assurance of full traceability (every product is labeled with a unique batch number referring to resin and manufacture) and tech support from concept through machining.
Quadrant Engineering Plastic Products