US plastics compounder Teknor Apex (Pawtucket, Rhode Island; www.teknorapex.com) has launched a range of medical-grade PVC compounds that are formulated without orthophthalate plasticisers such as bis (2-ethylhexyl) phthalate (DEHP).

The “Apex” and “Flexalloy” elastomer compounds are available in 10 series, each with Shore A hardness from 50-90 and 40-80, respectively. Teknor Apex offers the standard grades in a high-clarity blue tint and can also formulate options to meet a variety of colour, opacity and self-frosting needs. All of the compounds can be sterilised using gamma and electron-beam radiation or ethylene oxide methods.

The compounds use tris (2-ethylhexyl) trimellitate (TOTM), acetyl tributyl citrate (ATBC) and dioctyl terephthalate (DOTP) as alternatives to orthophthalate plasticisers. TOTM, which Teknor Apex said is a high-performing alternative to other non-DEHP plasticisers, shows the least extractability from the PVC matrix and greatest resistance to crazing or stress cracking when in contact with PC or ABS.

Derived from citric acid, ATBC exhibits processing behaviour almost identical to that of DEHP. The TOTM/DOTP and ATBC/DOTP blends are based on Teknor Apex’s proprietary technologies and are said to yield plasticisers that are more cost-effective than 100% TOTM or 100% ATBC formulations, provide as good or better processing and maintain or improve compatibility with PC and ABS.

All the grades are free from bisphenol A (BPA), latex and animal-derived materials. The compounds also comply with several global regulations, including REACH-SVHC (substances of very high concern), Medical Devices Regulation (MDR) and Restriction of Hazardous Substances (RoHS) in Europe, ISO 10993-5 (the standard for evaluating the biocompatibility of medical devices) and California Proposition 65 in the US.