With the development of Thermolast M the manufacturer Kraiburg TPE offers compounds that are approved for use in direct contact with blood and medications. These materials can be coloured in conformity with medical compliance requirements and open up new potential fields of applications. TPE compounds of the product portfolio can be used for medical and pharmaceutical applications such as 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 have passed standard biocompatibility certifications. These portfolio 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. In addition, a drug master file (DMF) for the materials is on file with the US Food and Drug Administration (FDA). Kraiburg TPE is therefore committed to consistent adherence to the specified formulation and manufacturing process. Any necessary changes are announced and implemented in accordance with a defined change control process. After announcement of a change, the company guarantees delivery for a period of 24 months and also has the purity of the raw materials guaranteed by its suppliers.
Compounds for medical technology or medical applications are manufactured at the firm only on special equipment reserved for these products. The company offers its customers in the medical and pharmaceutical sector an extensive service package that ensures maximum control with respect to quality, safety and reliability. The compounds can conform to cleanroom processing standards and can be sterilised using standard techniques such as gamma or beta radiation, ethylene oxide or steam.
