medical Device components

Pain points

Plastic and polymer components used in medical devices — catheter hubs, IV connectors, needle-free access ports, surgical instrument handles, infusion pump housings — are handled repeatedly between cleaning cycles, making them potential vectors for healthcare-associated infections (HAIs).

For manufacturers, the challenge is not efficacy alone — it is compliance. Any antimicrobial additive incorporated into a medical device component must pass biocompatibility assessment under ISO 10993-1 and satisfy the general safety and performance requirements of EU MDR Annex I. Silver-based additives, the most common industry choice, introduce systemic toxicity considerations that complicate this process: ionic silver release must be characterised, quantified, and justified in the technical file — adding cost and time to the CE marking process.

What we offer

zetapura’s non-metallic, non-leaching additive is designed for this regulatory context. The active agent remains bound within the polymer matrix and does not release into surrounding tissue or fluids, eliminating the systemic exposure pathway that drives ISO 10993-1 concerns. This reduces the biocompatibility documentation burden and avoids heavy metal classifications under REACH.

The additive integrates at the compounding stage into polymers commonly used in device components — PP, PE, TPU — without altering mechanical or processing properties. The result is continuous, surface-level antimicrobial protection for the expected service life of the product, without adding regulatory complexity.