Mediprene TPE

The Mediprene Concept

Mediprene Thermoplastic Elastomers (TPEs) were developed to address the demands of the medical device industry. But the Mediprene concept does not start and end with the product, it also encompasses how we work.

From our Mediprene team, with specialist knowledge of the medical market. Through product development, raw-material selection, regulatory compliance, to production controls, traceability and change management. This 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.

The Mediprene Concept is Built on the Following Pillars

Strict Raw Material Policy

Proven biocompatibility

Clean, Consistent Production

Change
Control

Strict Raw Material Policy

The basis for a successful outcome in medical tests is raw material selection, only allowing raw materials that, from a medical point of view, are highly qualified. The raw materials are then compounded together under clean conditions, with high consistency. To produce our Mediprene TPE materials we use:

SEBS/SBS rubber where representative grades have passed USP Class VI
Medicinal white oil complying with European European Pharmacopoeia & Plastic that has passed USP Class VI
Colour masterbatch made from raw materials that have passed USP Class VI or the corresponding parts of ISO 10993

Proven Biocompatibility

To further assure the customer, representative grades from the Mediprene standard series (500200M and 520580M, respectively) have been tested by NAMSA in the USA for cytotoxicity according to USP <87>/ISO 10993-5 and for biocompatibility according to ISO 10993-4 (Hemolysis), ISO 10993-10 (Intracutaneous Reactivity and Sensitization), ISO 10993-11 (Acute Systemic Toxicity) and USP Class VI. All materials that were tested successfully passed (copies of the certificates are available on request).

The other compounds in the Mediprene standard series with hardness values between 20 ShA (500200M) and 58 ShD (520580M) consist of the same raw materials and would therfore probably pass if tested. Note that there is an overlap between some tests in USP Class VI and tests described in parts of ISO 10993, meaning that the material is highly likely to pass parts of ISO 10993 when having passed USP Class VI. However, be aware that it is always the responsibility of the supplier of the finished product to perform relevant tests to ensure that the complete device fulfils the compliance criteria that have been set up for the product.

Further details regarding regulatory information including Cytotoxicity test – USP <87> and ISO 10993-5, Biocompatibility tests according to USP Class VI, Systemic injection test, Intracutaneous test, Implantation test and European Pharmacopoeia (EP) are available in the Mediprene 500M Product Guide.

Clean, Consistent Production

We were the 1st TPE compounder in Europe to gain the ISO 13485 accreditation. We have strict controls around cleanliness, traceability & reproducibility. We operate modern, high-precision production equipment with gravimetric feeders and advanced monitoring systems.

Documented cleaning procedures. Following the material from mixer & feeding area to the box with finished goods
Traceability of raw materials, compounding processes and properties
Reproducibility
ISO 13485 accreditation

Change Control

Product reliability and formulation stability are critical requirements for the medical device manufacturer, that is why we have introduced a long-term supply guarantee for a number of our Mediprene TPE compounds for the medical market.

Through the good co-operation and close dialogue we have with our raw material suppliers we have achieved agreements that will ensure a two year availability of unchanged product based on customer forecast (valid for standard range & excluding force majeure situations). Additionally, should a feedstock material be discontinued, we will also be able to cover the forecasted two year compound volume of our customers, allowing for qualification of a new material.

We worked with our suppliers to define what a change is and agreed with them that notification only in cases of changes to raw material specification is not sufficient. Any change of the chemical composition of the raw materials also needs to be announced by the supplier.

Always use the same raw material in the same quantities
Always produce the material under the same conditions on the same lines
Close cooperation with suppliers to solve product change notification and supply during the time required for the qualification of a replacement compound

Mediprene TPE Sterilisation Tests

Representative Mediprene grades have been sterilised via:

Ethylene oxide (EtO)
Gamma Irradiation
Steam / Autoclave

Test Specimens for tensile tests were punched out of injection-moulded plaques. All mechanical test values refer to tensile testing of the material parallel with the flow direction. Changes reported have been calculated by comparing values for sterilised specimens with the corresponding values for the unsterilised reference. A guide detailing the test results is available to download here.

Investigation shows that EtO is the most gentle sterilisation method for Mediprene TPEs.