THE MEDIPRENE CONCEPT

Mediprene Thermoplastic Elastomers (TPEs) have been developed by HEXPOL TPE to address the demands of the medical device and pharmaceutical industries. They combine the performance of rubbers with the processing properties of plastics, delivering sophisticated design opportunities through a wide and flexible range of products. 

But our Mediprene concept does not start and end with the product, it encompasses how we work. From our dedicated Mediprene team, with specialist knowledge and expertise of the medical market. Through product development, raw-material selection, regulatory compliance, to production controls, traceability, reproducibility and change management.

Our Mediprene concept offers customers highly customisable materials, originating from medical raw materials with high biocompatibility status and compounded under clean conditions. Maximising the probability that their devices will pass relevant medical tests. This is what makes us a trusted and reliable partner for the medical industry. 

Please use this guide as an introduction to the Mediprene product family. We also have a comprehensive library of product data, processing and sterilisation information available to download from our website at www.mediprene.com

To discuss your specific requirements, you can contact our medical team at mediprene@hexpolTPE.com

STRICT RAW MATERIAL POLICY

• SEBS/SBS where representative grades have passed USP Class VI 

• Medicinal white oil complying with EP & plastic that has passed USP Class VI 

• Colour masterbatch made from raw materials that have passed USP Class VI or corresponding parts of ISO 10993

PROVEN BIOCOMPATIBILITY

Representative grades from the Mediprene 500M range have passed : 

• ISO 10993-5 (cytotoxicity) 

• ISO 10993-10 (intracutaneous reactivity) 

• ISO 10993-11 (acute systemic toxicity) 

• USP Class VI

CLEAN, CONSISTENT PRODUCTION

• Documented cleaning procedures 

• Traceability (raw materials, compounding, properties) 

• Reproducibility 

• ISO 13485 accreditation

CHANGE CONTROL

• In case of change or discontinuation of a raw material/compound, we can make a volume corresponding to customer 2-year forecast available (valid for standard range & with exception of Force Majeure situations)

APPLICATIONS

Mediprene TPEs are suitable for a wide variety of uses in the medical device and pharmaceutical markets, with new applications being developed every day. 

Typical applications range from tubing to syringe plunger seals, resealable membranes to IV bags, facemasks to urinary catheter connectors, teat droppers to soft-touch grips. 

Mediprene TPEs combination of soft-touch aesthetics, functional performance and proven biocompatibility offers design freedom, processing efficiencies, product performance and compliance assurance.