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A comprehensive array of new medical-grade PVC compounds formulated without DEHP or other orthophthalate plasticizers are pre-compliant with global regulations and readily available to device manufacturers as standard products, it was announced recently by Teknor Apex Company, which will introduce the products at MD&M West.
The new Apex® PVC and Flexalloy® PVC elastomer compounds are available in ten series, each with Shore A hardness from 50 to 90 for Apex grades and 40 to 80 for Flexalloy grades (see table). Teknor Apex offers the standard grades in a high-clarity medical blue tint, and can custom formulate options to meet a variety of color, opacity, and self-frosting needs as specified by the device manufacturer. All of the compounds can be ETO-, gamma-, and E-beam-sterilized and exhibit good color hold.
Extrusion grades of the new compounds are suitable for use in respiratory, blood transport and delivery, catheter, enteral feeding, and many other types of tubing applications, as well as for cable jacketing on powered medical devices.
The new compounds offer these alternatives to DEHP and other orthophthalate plasticizers:
● TOTM. This trimellitate is a high performing alternative to other non-DEHP plasticizers, exhibiting the least extractability from the PVC matrix and greatest resistance to crazing or stress cracking when in contact with polycarbonate or ABS. TOTM delivers excellent toxicology results as well.
● ATBC. Acetyl Tributyl Citrate, derived from citric acid rather than petroleum sources, exhibits processing behavior almost identical to that of DEHP and has excellent toxicology.
● TOTM / DOTP and ATBC / DOTP. These plasticizers are based on proprietary blending technologies developed by Teknor Apex. Di-octyl terephthalate (DOTP or DEHT), a non-orthophthalate plasticizer, is a cost effective alternative to DEHP. Blending it with TOTM or ATBC yields plasticizers that are also more cost-effective than 100% TOTM or 100% ATBC formulations; provides as good or better processing; preserves or enhances the excellent toxicology performance of TOTM or ATBC; and maintains or improves compatibility with PC and ABS. All this adds up to reliable long-term performance while meeting the toxicology and biocompatibility requirements critical for product acceptance in worldwide markets.
"Teknor Apex has developed this comprehensive portfolio of 'off-the-shelf' medical PVC compounds in order to help customers reduce their time-to-market while having multiple options for replacing conventional phthalate plasticizers," said Derek Laffey, Medical Industry Manager for the Vinyl Division of Teknor Apex. "We supply these new products with a full complement of physical property, biocompatibility, and regulatory test data, and we support rapid prototyping by offering quick turnaround times for samples. In addition, identical grades of each compound are available worldwide."
The new-generation compounds comply with EU REACH-SVHC; EU-MDR; EU ROHS 1, 2 and 3; ISO 10993-5; and California Proposition 65. All grades are ADM-, BPA-, and latex-free. All ingredients are FDA 21 CFR listed except for TOTM, which has a proven history of safe use in medical device applications. In addition, USP Class VI test data is available for each family.
About the company
Teknor Apex Company, a privately held firm founded in 1924, is one of the world's leading custom compounders of plastics. Teknor Apex produces flexible and rigid vinyl, thermoplastic elastomers, nylons, color masterbatches, specialty chemicals, and hoses. The company is headquartered in Pawtucket, RI, U.S.A. and operates thirteen manufacturing facilities worldwide in the United States, Belgium, Germany, China, and Singapore.
