TPE y tế Medalist® trong suốt và trong suốt do Teknor Apex sản xuất có thể được sử dụng như một giải pháp thay thế hiệu quả để bổ sung cho tình trạng thiếu silicone hiện nay.
Ptucket, Rhode Island, USA, December 17, 2018: Three new medical-grade thermoplastic elastomers (TPE) used in biopharmaceutical tubing have shown better performance than industry standard TPE, making them widely used An effective substitute for medical silicone tubing.
Teknor Apex will launch new Medalist ® TPE products at MD & MWest (Booth No. 2015), and will introduce these products for peristaltic pump tubing and biopharmaceutical tubing applications in the “Tech Theater” during the exhibition. The demonstration is scheduled to be held at 1:30 pm local time on Wednesday, February 6, 2019.
Three new TPE products recommended by Teknor Apex can be used as peristaltic pump tubing in the biopharmaceutical industry and demanding pharmaceutical tubing under extremely low temperature environments. These materials for peristaltic pump tubing provide the elasticity needed to keep pace with the rapid movement of the pump, while their durability allows them to maintain shape and integrity over time. Compared with the standard TPE substitute products of silica gel, Medalist® TPE has a lower amount of particle exfoliation (particle exfoliation refers to the fact that the pump tube is repeatedly squeezed and released during the operation of the pump, which causes particles to be generated and fall off from the surface of the pump tube).
Medalist MD-12352 is a 52 Shore A translucent TPE specially designed for peristaltic pump tubing.
Medalist MD-50357 is a transparent, slightly harder TPE (58 Shore A) for peristaltic pump tubing, which can be aseptically welded and heat sealed.
Medalist MD-10353 is a transparent TPE used for biopharmaceutical tubes in extremely low temperature applications. The TPE embrittlement temperature is lower than -60°C, and it can still maintain the flexibility and elasticity of the pipe at low temperatures, which can effectively meet the demanding requirements for low-temperature drug delivery in the biopharmaceutical production process.
The permeability of these three Medalist TPE products is significantly lower than that of silica gel. It can be sterilized by electron beam, gamma radiation and ethylene oxide (EtO).
“When the supply of silicone is in short supply, Teknor Apex can provide a guaranteed global supply chain for all Medalist TPEs, produced in ISO-13485 certified factories in the United States and Singapore,” said Rossvan Royen, *Marketing Manager in charge of regulatory and medical products industries. “As an alternative to silica gel, our three new Medalist products can provide better performance than the industry standard TPE currently in use.”
These new Medalist compounds are manufactured from ingredients listed by the FDA (U.S. Food and Drug Administration) and have at least passed the ISO 10993-5 biocompatibility standard certification, and meet the requirements of REACHSVHC. They are free of DEHP (dioctyl phthalate) and other phthalates, BPA (bisphenol A) and latex. The standard grade does not contain ADM (animal derived material).
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