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Medical Conforming TPE for Use in Direct Contact with Blood & Medications

Published on 2017-01-24. Author : SpecialChem

Medical Conforming TPE
Medical Conforming TPE
With the development of THERMOLAST® M the manufacturer KRAIBURG TPE offers compounds which are approved for use in direct contact with blood and medications. These materials can be colored in conformity with medical compliant requirements and open up new potential fields of applications. TPE compounds of the THERMOLAST® M portfolio can be used for medical and pharmaceutical applications as for example primary medical packagings, hospital care applications and resealing membranes.


Medical and pharmaceutical products must fulfill uncompromising requirements for safety, quality and reliability.
  • THERMOLAST® M compounds from KRAIBURG TPE have passed standard biocompatibility certifications. 
  • These materials are certified according to DIN ISO 10993-5 (cytotoxicity), -10 (intracutaneous irritation), -11 (acute system toxicity), USP Class VI (chapter 88), and DIN ISO 10993-4 (hemolysis). 
  • These certifications enable processing of the compounds for use in direct contact with medications and blood. 
  • KRAIBURG TPE will present these medical conforming materials together with the Medical Service Package at the Pharmapack in Paris in hall 4, booth A42.

THERMOLAST® M compounds can conform to cleanroom processing standards. The materials can be sterilized with gas, radiation, plasma and permit steam sterilization.

Product Reliability & Safety

For all materials from the THERMOLAST® M portfolio KRAIBURG TPE guarantees product reliability and safety within the scope of its Medical Service Package. In addition to this quality assurance, the change control process for medical and pharmaceutical technology at KRAIBURG TPE enables the company to guarantee the consistency and availability of the formulation for two years.


KRAIBURG TPE is a global manufacturer of thermoplastic elastomers. From its beginning in 2001 as subsidiary of the historical KRAIBURG Group founded in 1947, KRAIBURG TPE has become one of the pioneers in TPE compounds. With production sites in Germany, the US, and Malaysia the company offers a broad range of compounds for applications in the automotive, industrial, consumer, and for the strictly regulated medical sectors. The established THERMOLAST®, COPEC®, HIPEX®, and For Tec E® product lines are processed by injection molding or extrusion and provide numerous processing and product design advantages to manufacturers. KRAIBURG TPE features innovative capabilities as well as true global customer orientation, customized product solutions and reliable service. The company is certified to ISO 50001 at its headquarters in Germany as well as in Malaysia and holds ISO 9001 and ISO 14001 certifications at all global sites. In 2016, KRAIBURG TPE, with over 550 worldwide employees, generated sales of 167 million euros.

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