Patients and medical professionals usually remember the outer packaging of drugs due to the variety of design options. It’s often more comfortable and less costly to adjust the outer packaging than adjust the primary packaging. However, the primary packaging is critical for the patient, as it protects the drug against unwanted environmental influences, alteration, and contamination. The new compounds from Kraiburg TPE have been specifically 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 segment of the Thermolast M series have been specially developed for applications that require basic medical approval and have to meet food regulations. In addition, extraction tests by 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 biocompatibility of the materials series is certified by ISO 10993-4, -5, -10, and -11, as well as with ISO 8871-1 for parenteral and for pharmaceutical use devices. The materials also meet the requirements of USP661.1 (plastic materials of construction) and USP661.2 (plastics packaging systems for pharmaceutical use).
According to the company, an overview of important additional materials properties include
- The translucent TPEs can be colored
- 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, the company said customers would benefit from the unique service package for medical-grade products, which provides advantages given the Medical Device Regulation that will be coming into effect from early summer 2021.
- Consistent production procedure; meets all requirements for a full-fledged medical-grade plastic following the VDI 2017 technical rule
- Guaranteed 24-month supply security
- The purity of the raw materials through a 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 pharmaceutical packaging market. But the human aspect also plays an import part, as customers can rely on our unique medical 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 your familiar contact partner or distributor.
Kraiburg TPE is a global manufacturer of thermoplastic elastomers. From its beginning in 2001 as a subsidiary of the historical Kraiburg Group founded in 1947, Kraiburg TPE has pioneered in TPE compounds, today being the competence leader in this industry. With production sites in Germany, the US, and Malaysia, the company offers a broad range of compounds for the automotive, industrial, consumer, and strictly regulated medical sectors. The established Thermolast, Copec, Hipex, and Tec E product lines are processed by injection molding or extrusion and provide numerous processing and product design advantages to manufacturers. The company is certified to ISO 50001 at its headquarters in Germany and holds ISO 9001 and ISO 14001 certifications at all global sites.