device manufacturers have traditionally used thermoset silicone rubber to mold
pump valve inserts. However, these inserts are often hampered by inefficient
designs and a manufacturing process that is time-consuming and costly, as it
involves several labor-intensive assembly steps.
address these issues, PolyOne developed the GLS thermoplastic elastomer (TPE)
created in a two-shot molding process to eliminate assembly operations.
custom-formulated grades PolyOne creates are based on Dynalloy OBC and Versaflex
TPEs to facilitate two-shot molding. PolyOne conducts compatibility testing to
confirm that the new grades will bond chemically with the rigid engineering thermoplastic
substrate required in these applications.
custom grades are formulated with multi-functional capabilities, so that they
can replace several different hardness grades of silicone rubber. The TPE
materials also provide better tension set, improved compression and enhanced
permeability compared to silicone rubber. In addition, the new TPE grades boast
lower extractables because, unlike thermoset silicones, they require no cross-linking.
These materials also offer quick set-up on standard two-shot molding equipment along
with faster cycle times for higher productivity.
a multi-component process cuts the need for assembly operations, offering as
much as $50,000 in savings to medical device OEMs annually. This savings is
achieved because several assembly steps are removed because the TPE custom
formulations deliver multi-functional capabilities.
the lower specific gravity of the TPEs cuts overall part weight by 15 to 20
percent and reduces associated freight costs for further savings.
addition, these custom materials result in major scrap rate reductions, providing
savings of up to $40,000 annually. The regrind also offers recycling benefits
that are not available with thermoset silicone rubber.
total, the use of custom TPE pump valve inserts can create more than $100,000
in operational savings by reducing manufacturers' costs for assembly, freight
Joe Kutka, is technology launch manager, PolyOne GLS Thermoplastic
The FDA has just released draft guidelines for using 3D printing in the design, development, and manufacture of regulated medical products. Although the recommendations are non-binding, they do set some much-needed parameters.
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