Styrenic-based TPE compounds find their use in an immense number of medical applications such as seals, resealing membranes, drip chambers, intubation devices, tubing and wound care products. For medical grade thermoplastic elastomers, there are many specific requirements to be considered throughout the whole process; from development to production.Raw materials with high biocompatibility status have to be selected and processed under clean conditions. Thorough and well documented cleaning procedures for the compounding line have to be applied. Modern processing equipment with high dosing accuracy must be used to secure maximum batch-to-batch consistency. Traceability has to be ensured through raw material registration and sophisticated process monitoring systems.The long-term availability of the raw materials used has to be secured in a way that allows a formulation change notification to be issued in due time in case of a raw material termination.When setting up a medical grade TPE development project, specific medical requirements such as biocompatibility and regulatory requirements on the products need to be considered. Samples for medical tests have to be produced in full-scale production to secure fully representative results.
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