Originally Published EMDM October 2001
TECHNOLOGY NEWS
MATERIALSCompounds Offer Alternatives to PVC and Latex
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| New thermoplastic elastomer compounds provide medical OEMs with alternatives to PVC and latex in the manufacture of tubing. |
Three new thermoplastic elastomer compounds enable manufacturers of medical tubing to replace latex or avoid the use of PVC plasticizers.
Introduced by Teknor Apex (Pawtucket, RI, USA) at the Medical Design & Manufacturing East show in New York City, the compounds are additions to the company's Monprene line of styrenic block copolymer thermoplastic elastomers.
Grades MP 1580L1 and MP 1871-R, with Shore A hardness ratings of 37 and 35, respectively, are formulated to replace latex, which has been observed to cause allergenic reactions in some healthcare workers and patients. The 1580L1 grade meets USP Class VI standards, while the 1871-R grade meets ISO 10993 requirements.
According to Brian Mulvany, market manager for medical and regulated products at Teknor Apex, grade MP 1848, with a Shore A hardness of 75, is designed to replace flexible PVC in tubing and moulded components. The compound provides comparable clarity and kink resistance, he says, and, as a thermoplastic elastomer, it is inherently elastic and does not contain plasticizer.
"The clarity of the 1580L1 and 1871-R grades is in contrast to the inherently milky-white or yellowish translucency of latex," says Mulvany. "And as thermoplastics, our compounds are easily processed at high rates of extrusion, whereas latex is based on thermoset rubber and requires curing or vulcanization." Monprene products contain ingredients approved under US FDA 21 CFR.
The thermoplastic elastomer division of Teknor Apex manufactures custom and standard compounds. The division's parent company is a privately held firm whose other plastics businesses include a division dedicated to flexible PVC compounds, a chemical division that creates plasticizers, and a specialty compounding division.
Benjamin Lichtman
Copyright ©2001 European Medical Device Manufacturer
