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There's a growing focus on extractables in healthcare supplies and equipment as concerns grow about endocrine disruption and other health issues, particularly for infants, which could result from chemicals leaching from plastic.There's a growing list of materials that appear to be winners and losers, and in between a group of materials that want to make sure they emerge on the right side of the ledger.

July 2, 2012

2 Min Read
Companies strive to prove purity of medical plastics

There's a growing focus on extractables in healthcare supplies and equipment as concerns grow about endocrine disruption and other health issues, particularly for infants, which could result from chemicals leaching from plastic.

There's a growing list of materials that appear to be winners and losers, and in between a group of materials that want to make sure they emerge on the right side of the ledger.

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Tubing is shipped with test results showing purity levels.

Materials with issues (perceived if not real) include polyvinyl chloride (PVC). Materials that are emerging as winners, even though more costly, include cyclic olefin copolymers that are made in high-purity reactors and then filtered to remove any potential catalyst residues.

The materials on the move are elastomers, usually based on polypropylene or some other olefin compound. Silicones are also anxious to prove their purity bona fides.

New testing protocol
One example of how companies are stepping up to the challenge is a new testing regimen announced by AdvantaPure (Southampton, PA), a division of NewAge Industries  that specializes in high purity tubing, hose, single use systems, manifolds, and other molded components for the pharmaceutical, biomedical, food, beverage, and cosmetic industries.

AdvantaPure is testing its tubing and reinforced hose manufactured from Class VI, platinum-cured silicone, its platinum-cured liquid injection molded silicone, and its AdvantaFlex biopharmaceutical-grade TPE tubing after autoclave sterilization and gamma irradiation. Testing includes some of the fluids that AdvantaPure's customers use in their manufacturing processes to better approximate actual conditions. Tests are conducted by outside laboratories and include those for endotoxins, particulate, pH, and polarity.

"We're covering a lot of bases with our tests," says John Stover, AdvantaPure's director of new business development and product technical director. "Customers who view our test portfolios are impressed with the level we've gone to, and that substantiates our credibility and reliability as a supplier. Our testing was done with forethought and a chemistry approach that relates to the end users' conditions."

AdvantaFlex is a class of thermoplastic elastomer (TPE) based on SEBS (styrene-ethylene-butylene-styrene) block copolymer block. Use of SEBS as an additive modifier in medical tubing is growing because it boosts flexibility and softness of the compound.

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