Plastic Machining Stock Meets USP Standards
Reading, PA - Quadrant Engineering Plastic Products (Quadrant EPP) has introduced the first high performance plastic machining stock that carries certifications for conformance to ISO 10993-1 and USP Class VI standards. The initial product offering designated Ketron PEEK LSG (life science grade) is certified for applications requiring bodily contact for a maximum of 24 hours.
The new Ketron PEEK LSG shapes are made from Victrex PEEK resins in natural (light tan) and black, and ultra-high strength grades that are reinforced with 30% levels of carbon or glass fiber, especially suited to fixturing applications. While PEEK resins themselves do not carry certification for USP Class VI, the rod and plate products from Quadrant fill that need.
According to Marc Knebel, Market Development Manager at Quadrant, "In the past, engineers had to rely on either certification of the plastic resin used to make machining stock if available on the resin, or their own certification work after parts were made. However, the melt extrusion process in which plastic resins are converted to rods and plates for machining can also affect plastic material properties and quality." Not all plastic resins, as is the case with PEEK, carry USP class VI certifications, according to Knebel. "The pre-certification of Quadrant's machining stock provides an added level of confidence toward final part compliance with certifications," he added.
In addition to standard Ketron LSG PEEK grades certified for 24 hour exposure, the company also offers machining stock made from Victrex PEEK-Classix which is approved for bodily contact up to 30 days.
All Ketron PEEK LSG products with their high temperature and chemical resistance withstand all forms of sterilization including autoclaving. Quadrant also offers comprehensive data on x-ray, radiation and chemical resistance of the materials. Other application environments beyond medical device components such as handles and fixtures where their properties bring similar benefits include pharmaceutical production and medical laboratories. The PEEK-based materials are available in a wide range of rod and plate sizes for machining.
Quadrant also offers FDA compliant rod and sheet materials for applications that do not require direct body contact. They include a new chemically resistant, wear-resistant material called Techtron HPV PPS., as well as Acetron GP acetal copolymer, Radel PPSU, Ultem 1000 PEI, Quadrant PSU (polysulfone) and PC (polycarbonate).
Ketron PEEK LSG grades are part of a series of products under development at Quadrant EPP for use in life science environments. "Quadrant EPP has a history of providing unique products for critical applications, based on our industry-specific product development, quality assurance and test methods. The new products for the life science industry are an excellent complement to our existing materials portfolio" according to the Quadrant spokesman.
SOURCE: Quadrant Engineering Plastic