Implantable Polymer-Based Medical Devices Go Supercritical: From Cleaning to Sterilization.

The biomedical industry has made significant progress in recent years with the emergence of medical devices made from biocompatible polymers, improving implant performance, longevity, and patient safety. However, a major challenge for manufacturers remains the incompatibility of certain polymers with conventional processing techniques involving organic solvents or harsh operating conditions. Supercritical CO2 offers a sustainable and environmentally friendly alternative that can be applied throughout the manufacturing cycle of medical devices, including cleaning, impregnation, foaming, and sterilization. It enables the recovery of a dry, residue-free final product while preserving the integrity and functionality of the material.This article provides a comprehensive and up-to-date review of the latest developments in the use of supercritical CO2 for the different stages of manufacturing and treatment of implantable medical devices. It evaluates scCO2-based process efficiency across various applications and emphasizes processing aspects such as operating modes, key parameters, and process conditions. The review discusses the potential for scale-up and industrial implementation, providing insights into the practical challenges, advantages, limitations, and prospects of scCO2 technology in processing implantable polymer-based medical devices, with a particular focus on chemical engineering aspects.