Smart Molding International 1-2021

materials 44 smart_molding international 1/2021 P atients and medical profession - als usually remember the outer packaging of drugs, due to the variety of the design options. It is of - ten easier and less costly to adjust the outer packaging than to adjust the pri - mary packaging. However, the primary packaging is critical for the patient, as it protects the drug against unwanted en - vironmental influences, alteration and contamination. The new compounds from KRAIBURG TPE have been spe - cifically developed for these uses – for solid and liquid drugs, as well as sprays. Applications that benefit from this new series of materials include seals and gaskets, valves and flexible joints. The compounds in this new seg - ment of the THERMOLAST® M series have been specially developed for ap - plications that require basic medical approval and have to meet food regu - lations. In addition, extraction tests in accordance with ISO 8871-1 have been successfully performed; all of the raw materials tested are certified under Regulation (EU) No. 10/2011 and US CFR 21 (FDA) standards. The biocompat - ibility of the materials series is certified in accordance with ISO 10993-4, -5, -10 and -11, as well as with ISO 8871-1 for parenterals and for devices for pharma - ceutical use. The materials also meet the requirements of USP661.1 (plastic materials of construction) as well as of USP661.2 (plastics packaging systems for pharmaceutical use). Overview of important additional materials properties: • The translucent TPEs can be col - ored • Excellent mechanical properties • Low compression set • Sterilizable: Autoclave 121 °C and 134 °C, β/γ radiation 2×35 kGy, EtO • Free of PVC, silicone and latex • Free of animal ingredients Another important criterion: Cus - tomers will benefit from the unique service package for medical-grade products, which provides advantages in view of the Medical Device Regu - lation that will be coming into effect from early summer 2021. • Consistent production procedure; meets all requirements for a full-fledged medical-grade plastic in accordance with the VDI 2017 technical rule • Guaranteed 24-month supply se - curity • Purity of the rawmaterials through commitment by suppliers • Separate, permanently assigned production units for THERMOLAST® M “With many years of experience and the approvals we hold, we are in a good position to compete in the pharmaceu - tical packaging market. But the human aspect also plays an import part, as customers can rely on our unique med - ical service package, with consistent materials supply as well as consistent quality and ingredients,” emphasizes Eugen Andert, Product Development Engineer at KRAIBURG TPE. The product is now available and can be ordered from partners or distribu - tors. KRAIBURG TPE www.kraiburg-tpe.com Primary packaging for solid and liquid drugs, as well as many other products, will benefit from the latest addition to the THERMOLAST® M series. But KRAIBURG TPE is also keeping abreast with the times organizationally: the service package that comes with the product ensures customers are always perfectly prepared for future rules and regulations. Safely packed and well prepared Primary packaging for solid and liquid drugs – as well as many other products – benefits from the latest addition to the THERMOLAST® M series (Image: KRAIBURG TPE)