In medical devices industries, a change management plan is crucial for maintaining regulatory compliance and ensuring product quality. The materials have to meet design needs such as mechanical, thermal, chemical, as well as biocompatibility requirements. It is also important to have safety of long-term supply with constant quality.
Plasticizers play a key role in sensitive applications such as medical tubing and other device components by imparting flexibility, durability, and elasticity required to resist kinking and failure in future modes. Plasticizers are selected for their ability to meet critical application requirements while maintaining biocompatibility and enhancing clarity.
As part of their commitment to innovation, continuous improvement of safety, performance, and cost-efficiency, companies within the medical PVC value chain have progressively made available a wide range of alternatives to DEHP plasticizer for medical applications, which are approved by the European Pharmacopeia.
By Joseph Wilson, Business Development Manager, PEAK Performance Compounding, LLC, USA Radiopaque fillers are mineral or metal powders incorporated into polymers to enhance their visibility under X-ray and fluoroscopy. The use of radiopaque fillers enables healthcare professionals to monitor the placement, movement, or functionality of a medical device inside the body to deliver lifesaving therapies. This is critical for minimally invasive medical procedures.
