Hytrel® for Medical Applications

Hytrel® SC for all medical applications

Hytrel® is a premier solution for medical applications requiring maximum flexibility, from stent deployment systems, to CPAP harness systems, medical prosthetics and much more. 

Hytrel® is incredibly resilient, providing excellent flex fatigue resistance and spring-like properties, and can be used over a wide range of temperatures while still retaining its flexibility and mechanical properties. It enables the design of a variety of parts and products that combine the best features of both high-performance rubbers and flexible plastic materials. Available in the range of 30 to 82 Shore D hardnesses, Hytrel® is also economical to process, using a variety of moulding or extruding technologies. For medical applications requiring maximum flexibility, Hytrel® is a premier solution.

The Hytrel® SC full support package

The engineering teams here at Distrupol and at key supply partner, Celanese, know the regulatory support and approvals that are imperative when working with polymers for medical applications. We understand the stringent product testing that is required before submitting to the market and the costs associated to do this.

We have a full regulatory support package in place to facilitate this process:

• GMP manufactured – ensuring sterility and repeatability of batches manufactured
• Controlled formulation with strict change control protocols
• Food contact statements (EU/FDA)
• Testing to sections of ISO 10993 5-11
• Testing against parts of USP Class VI
• Sterilisation data
• Individual grade statements

Sterilisation techniques and suitability for Hytrel® and other Celanese engineering polymers

The sterility of polymer medical devices is absolutely critical in most medical applications to prevent any risk of infection or contamination. To ensure parts are cleaned and bioburden risks are minimised, sterilisation techniques are used to kill bacteria and other microorganisms. These techniques can have a detrimental effect on polymer materials; here at Distrupol, we can recommend the appropriate polymer to suit the required cleaning technique.