The new MEVOPUR® material is resistant to moisture related performance loss
PEBA and TPU compounds made their debut at Medtec China
Produced in ISO-13485 certified plant
Clariant plastics and coatings, the world's leading manufacturer of masterbatch and modifiers, is introducing a new polymer modifier that specifically controls the reduction or even elimination of hydrolytic degradation and inhibits the effect of hydrolytic degradation on commonly used materials for catheters.The innovative resin product, named after the MEVOPUR® brand, will be unveiled at the Medtec China exhibition in Shanghai on September 25, solstice, 27.
In polyether block-amide (PEBA) and some thermoplastic polyurethanes (TPU), adsorbed water causes polymer chains to break, weakening mechanical properties and embrittlement of these ductile and ductile materials.This effect is particularly evident in resins containing developing fillers.When exposed to x-rays, the development filler makes it easy for physicians and surgeons to see the resin.Hydrolysis risks remain even after careful pre-drying of the raw material prior to mixing and tube preparation.Changes in temperature during transportation or storage may also result in condensation of moisture from air, even in foil-lined packaging.
Steve educkworth, director of clariant's global medical and pharmaceutical business chain for plastics and coatings, explains, "the effects of hydrolysis are variable and difficult to predict.If left unchecked, quality and reliability risks can be created, which requires us to maintain a high level of vigilance in the process of quality assurance (QA).In addition, the shelf life of polymer modified material is not very predictable, may be shortened to a few months.After several years of research and testing, we are pleased to be able to limit the hydrolysis and fracture risk of these materials to help equipment manufacturers improve the reliability of the catheter."
One of the first signs of a broken link is an increase in melt flow index (MFI).Clariant researchers therefore compared a standard, unmodified tungsten filled MFI with PEBA35ShoreA compound with a new MEVOPUR sample.
The test results
After 10 weeks of storage in a humid environment, the MFI value of the unmodified compound was more than twice that of the original MFI value, and the diffusion range was wider, indicating the phenomenon of broken chain and reduced molecular weight.In contrast, MEVOPUR modifier MFI values remained in the same range as before the test began.These results showed that no significant chain breaking occurred in the polymer.
Similar results were obtained in the test of wolfram filled aliphatic thermoplastic polyurethane (TPU) Shore90A compound, again confirming that the moisture environment had little effect on MEVOPUR modified MFI.
In MEVOPUR materials, the tensile strength and elongation properties of standard test rods made of the test materials were also not affected, but these key properties of the control standard materials were significantly degraded.
Clariant attributes MEVOPUR's outstanding performance to its proprietary formula and specially developed processing technology.
As with all MEVOPUR masterbatch concentrates and finished modifiers, the new modified PEBA and TPU polymers are manufactured at specialized plants in lewiston, Maine, USA, as well as two other plants in malmo, Sweden and Singapore.All three factories have passed the iso13485-2016 certification of the new medical device quality management system.With the end of a three-year grace period, all new devices now must prove they meet the new standards for 2016.The MEVOPUR brand assures equipment manufacturers that clariant will always ensure that its processes are controlled, consistent, and in compliance with USP6 and ISO10993 pretest ingredients, as well as * finished products.
The MEVOPUR portfolio is more than 10 years old and includes PEBA, TPU, PA12 and various development fillers, as well as * recently added fluoropolymers