Industrial validation of sustainable extrusion of medical-grade PVC tubing using 25% recycled material

Abstract

Abstract This study presents a technically validated and sustainable manufacturing strategy for producing medical-grade drainage tubing using recycled polyvinyl chloride (PVC) derived from post-industrial waste. A 25% blend of regranulated PVC was compounded with 75% virgin resin and processed under standardized extrusion conditions in an ISO 13485-certified medical device facility. The approach aims to enable circular economy implementation in precision polymer processing without compromising product quality or regulatory compliance. The methodology involved mechanical compounding of the recycled blend, extrusion under controlled conditions, and validation of the tubing’s physical and functional properties using ASTM-standard testing protocols. A total of fifty tubing prototypes were manufactured and evaluated through hardness, specific gravity, tensile strength, sealing integrity, and closure force measurements. The process incorporated real-time monitoring via laser gauges and pressure/temperature sensors, ensuring repeatability and dimensional consistency. The results confirmed that tubing with 25% recycled content met all acceptance criteria for Class I non-invasive medical devices, including dimensional specifications, bond strength, and biocompatibility standards. A cradle-to-gate Life Cycle Assessment (LCA) showed environmental improvements over the conventional process, including a 22% reduction in plastic waste, 15% lower energy use, and 15% fewer CO 2 emissions. Additionally, the substitution strategy led to annual cost savings of over USD 442,000, calculated for the standard yearly production volume of peritoneal dialysis drainage tubing, by reducing virgin resin and energy consumption. This work offers a scalable and industrially validated model for sustainable manufacturing in the healthcare sector. It demonstrates that recycled materials can be reliably reintegrated into regulated production lines without altering infrastructure, enabling practical transitions toward green manufacturing.