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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 un-changed product based on customer forecast (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.

Change Management

  • 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