Clariant Limits Risk of Hydrolytic Degradation of Radiopaque Polymers Used in Catheters
| Subj: Press-releses
Clariant, aáworld leader ináspecialty chemicals, is introducing new polymer compounds specially formulated toálimit oráeven eliminate hydrolytic degradation, which is known toáaffect certain materials commonly used inácatheters. Offered underátheáMEVOPUR brand name, theánew resins are being presented forátheáfirst time atátheáMD&MáWest tradeshow taking place February 5ľ7, 2019, ináAnaheim, CA. Clariant is exhibiting ináBooth 2049.
Inápolyether block amides (PEBA) andácertain thermoplastic polyurethanes (TPU), adsorbed moisture can cause aábreakdown ofátheápolymer chains andáreduce theámechanicaláproperties, rendering these ductile andátough materials brittle. This effect may be especially pronounced ináresins witháradiopaque fillers thatámake themávisible toáphysicians andásurgeons when exposed toáXárays. Even withácarefulápre-drying ofátheáingredients prior toácompounding andátube extrusion, hydrolysis remains aárisk. Moisture also can condense fromátheáatmosphere, even insideáfoil-lined packaging, due toáchanges inátemperature duringátransportation orástorage.
ôThis hydrolysis effect is variable andádifficult toápredict,ö explains Eric Rohr, Medical & PharmaceuticaláSegment Manager, North America. ôUncontrolled it creates quality andáreliability risks, increasing theáneed forávigilance ináQA procedures. Ináaddition, theáshelf-life ofátheápolymer compounds is less predictable andámay be shortened toáonly aáfew months. Afteráseveraláyears ofáresearch andátesting, we are pleased toábe able toálimit theárisk ofáhydrolysis andábreakage ináthese materials, thereby helping device manufacturers improve theáreliability ofácatheters.ö
One ofátheáfirst indications ofáchain scission is anáincreased melt-flow index (MFI). So, Clariant researchers compared theáMFIáofáaástandard, unmodified tungsten-filled PEBA 35áShore Aácompound againstáaásample ofátheánew MEVOPUR.
Similar results were noted inátesting ofátungsten-filled aliphatic thermoplastic polyurethane (TPU) Shore 90Aácompound. Again, theáMFIáofátheáMEVOPUR compound was hardly affected byátheáhumid conditions.
Tensile strength andáelongation properties inástandard test bars molded fromátheátest materials were similarly unaffected ináMEVOPUR compounds, whileátheástandard materialáshows significant degradation ináthese criticaláproperties.
Clariant credits theásuperior performance ofátheáMEVOPUR materials toátheir proprietary formulation andáspecially developed processing technology.
Like alláMEVOPUR masterbatch concentrates andáfinished compounds, theánew modified PEBA andáTPU polymers are manufactured atáaádedicated facility ináLewiston Maine, andáatátwo other sites ináMalmo, Sweden, andáSingapore. Alláthree plants have been certified compliant witháISO13485ľ2016, theálatest quality management systemáforámedicaládevices. Afteráaá3-year grace period, allánew device submissions must now prove certification toátheá2016ástandard. TheáMEVOPUR brand assures device manufacturers that, fromáUSP Class VI, ISO10993ápre-tested raw materialáingredients toáfinaláproduct, theáClariant processes are controlled, consistent andácompliant.
TheáMEVOPUR portfolio has included PEBA, TPU, PA12, andávarious radiopaque fillers forámore than 10áyears and, more recently, fluoropolymers were added.
MEVOPUR« IS AáTRADEMARK OFáCLARIANT REGISTERED INáMANY COUNTRIES.
Source: Clariant International Ltd