Extrusion International 1-2018

13 Extrusion International 1/2018 KRAIBURG TPE www.kraiburg-tpe.com TPEs forMedical andPharmaceuticalMarkets 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 colored in conformity with medical compliance requirements andopenupnewpotential fields of applications. TPE compounds of the THERMOLAST ® M portfolio can be used for medical and pharmaceutical applications such as primary medical packagings, hospital care applications and resealingmembranes. Medical and pharmaceutical products must fulfill uncom- promising requirements for safety, quality and reliability. THERMOLAST ® Mcompounds fromKRAIBURGTPEhavepassed standard biocompatibility certifications. These portfolio materi- als 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 certifi- cations 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 manu- facturing process. Any necessary changes are announced and implemented in accordance with a defined change control pro- cess. After announcement of a change, KRAIBURG TPE guaran- tees delivery for a period of 24months and also has the purity of the rawmaterials guaranteed by its suppliers. Compounds for medical technology or medical applications are manufactured at KRAIBURG TPE 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. THERMOLAST ® M compounds can con- form to cleanroom processing standards and can be sterilized using standard techniques such as gamma or beta radiation, ethylene oxide or steam. TPE compounds of the THERMOLAST ® M portfolio can be used for medical and pharmaceutical applications such as primary medical packagings, hospital care applications and resealing membranes (Photo: © 2018 Aptar Pharma)