Recent regulatory and market drivers, including cost pressures, are generating a material choice debate about polyvinyl chloride (PVC), thermoplastic elastomer (TPE) and rubber materials, according to Colorite, a Tekni-Plex business unit specializing in custom medical-grade compounds.
Many companies are trying to proactively address new regulatory dynamics, both in the United States and in many other global regions. Pressure is being applied by healthcare systems that are already implementing strategic initiatives for phthalate-free patient environments. TPEs are being viewed as a replacement for PVC in applications where phthalate- or plasticizer-free materials are desired. Globally, IV therapy producers are among the first in the medical device industry to transition from PVC to TPE materials.
More recently TPEs also have been used to improve ergonomics, protection and/or function. TPEs are ideal for overmolding which provides a softer touch and improved ergonomics (such as grip) for a variety of surgical tools and devices. This can improve instrument control and fatigue reduction during long procedures for medical professionals.
Colorite’s Cellene® line of TPEs are suitable for a wide variety of uses in medical devices, packaging and other regulated markets. Cellene® compounds are formulated to be silicone, latex, phthalate, halogen and PVC-free using FDA-compliant raw materials to meet USP Class VI and ISO 10993 standards.