Commonly asked question on THERMOLAST® M  - Medical TPE

Can THERMOLAST® M be sterilized? If yes, how?
THERMOLAST® M compounds can be sterilized by standard methods such as EtO gas, superheated steam, plasma, gamma irradiation and beta irradiation (electron beam). We at KRAIBURG TPE can also specialize compounds to specific methods.

How does THERMOLAST® K differ from THERMOLAST® M?
THERMOLAST® M are specially developed compounds for the medical and pharmaceutical sectors, which can be used right up to direct contact with body fluids or blood. The compounds fulfill all partial aspects of the VDI guideline 2017 "Medical Grade Plastics".

THERMOLAST® M materials also offer a globally unique medical service package: all compounds from the THERMOLAST® M series portfolio meet the strict safety standard for medical technology DIN ISO 10993- 5 "Cytotoxicity". Selected compounds also meet: 

• DIN ISO 10993-4 "Hemolysis, indirect blood contact".
• DIN ISO 10993-10 "Intracutaneous injection".
• DIN ISO 10993-11 "Acute system toxicity
• USP Class VI   

Is THERMOLAST® M also food compliant/suitable for direct food contact?
No, but we do offer TPE materials for the medical and pharmaceutical sectors in our portfolio that also meet food approvals. We will be happy to answer your questions in this regard.

What is the purpose of a Change Control Procedure?
A Change Control Procedure is required by MDR2017/745. It prevents the loss of an approval of a medical device due to raw material changes of a material. With the service package of our THERMOLAST® M portfolio compounds we guarantee a 24-month supply security. 

Does THERMOLAST® M have medical approvals?
Raw materials are not eligible for approval. Only end products can obtain medical approvals. However, we can guarantee biocompatibility, which is the basis for approvals.