The customer is a company in the biomedical sector whose core business consists in the design, manufacture and sale of medical devices and components.
Request
The customer contacted TPV Compound, highlighting several critical issues:
– New machinery purchased for moulding with hot runner technology could not be used due to incompatibility with the processing of the PVC compound they habitually purchased, with consequent delays in production and in the investment payback.
– Working hours and materials were wasted in the attempt to adapt the PVC compound in stock to the new machines by modifying the working setup (temperature and pressure), but the efforts were initially in vain as the material continued to burn.
– The cycle times, and hence the production costs, were increased as a result of efforts to use the PVC compound in stock, so the potential advantages of the new machines were lost.
– The new material had to be adapted to new European medical regulations, because while the new machines were being installed, amendments were announced which regarded plastic raw materials intended for the manufacture of medical devices in accordance with Regulation 745/2017/EU.
Proposed solution
TPV Compound was contacted because of our reputation in the market as a leading manufacturer of medical-grade PVC compounds. We were already working on adapting our products to comply with the new European legislation in the medical sector by replacing substances that had always been used in this business – but were recently reclassified as SVHC according to the REACH Regulation – with others not classified as hazardous, in order to fully guarantee the biological inertia of the articles made with these compounds. The final compound was then tailored to the new requirements of the customer’s hot runner machine by adapting its rheological and thermal characteristics.
Future benefits and developments
Thanks to the solution proposed, the customer’s investment in new machines was not wasted. With hot runner moulding, the sprue to be discarded was reduced by 30%; this was a historical problem, because the sprue could not be recycled in the mix for the production of medical devices. The new material enabled the customer to reduce cycle times, optimizing production by 20%, and to continue supplying – without interruption – medical devices with the new formulation complying with the requirements of Regulation 745/2017/EU.