KRAIBURG TPE GmbH & Co. KG

Friedrich-Schmidt-Str. 2

http://www.kraiburg-tpe.com

+49 8638 9810-0

Highest safety standards and a great service portfolio for our customers worldwide – this also goes unconditionally for our new product group THERMOLAST® M by KRAIBURG TPE. We herewith offer customers from the medical and pharmaceutical sectors a safe and high quality basis for their products. THERMOLAST® M Service Package of KRAIBURG TPE Our THERMOLAST® M Service Package, which is unique at the market, guarantees a maximum of quality, safety and reliability. -All medical compounds are tested according to ISO 10993-5 (Cytotoxicity) and listed as Drug Master File. Selected medical compounds are tested according to described medical basic approvals: USP Class VI (chapter 88), USP 661 (in vitro), ISO 10993-4 (Haemolysis, indirect in human blood), ISO 10993-10 (Intracutaneous Irritation) and ISO 10993-11 (Acute Systemic Toxicity). -No use of animal-based raw materials -Extractable studies for selected compounds, which have especially been developed for applications with contact to pharmaceuticals -100% safe formulation and procedure (adjustments only if the law changes) – At least 24 months lead time in case of a necessary alteration of the formulation or the procedure, combined with a delivery assurance -Optimal production standard at a company-owned medical aggregate THERMOLAST® M - Your advantages -Optimum of safety due to the THERMOLAST® M Service Package -Simple molding process and short cycle times for injection molding, co-injection molding and extrusion -Guarantee of an optimal raw material purity and of a long-term raw material availability -Excellent resealing qualities -Outstanding mechanical qualities -Translucent compounds make mistakes in the injection molding visible and reduce the risk of migration -Sterilizable with the usual methods, either EtO gas, superheated steam (134°C) or gamma ray treatment (2 x 35 kGy) -Free of latex and PVC -Translucent, transparent and precolored compounds available