KRAIBURG TPE Introduces New Material Solution for Pharmaceutical Packaging

Patients and medical professionals often remember the outer packaging of medicines due to the variety of design options available. Adjusting the outer packaging is usually easier and less costly than adjusting the primary packaging. However, primary packaging is critical for patients because it protects the medicine against unwanted environmental effects, changes and contamination.

KRAIBURG TPE's new compounds have been developed specifically for these applications for solid and liquid medicines as well as sprays. Applications utilizing this new material series include gaskets and seals, valves and flexible connectors. The compounds in this new segment of the THERMOLAST® M series have been developed specifically for applications requiring fundamental medical approval and that must meet food regulations. Extraction tests have also been successfully performed in accordance with ISO 8871-1; all raw materials tested are certified under Regulation (EU) No. 10/2011 and US CFR 21 (FDA) standards. [caption id="attachment_110065" align="aligncenter"] Primary packaging for solid and liquid medicines - and many other products - is benefiting from this latest addition to the THERMOLAST® M series. (Image: © 2020 KRAIBURG TPE)[/caption] The biocompatibility of the material series has been approved in accordance with ISO 10993-4, -5, -10 and -11 as well as ISO 8871-1 for devices for parenteral and pharmaceutical use. The materials also meet the requirements of USP 661.1 (plastic construction materials) and USP 661.2 (plastic packaging systems for pharmaceutical use).

Overview of important additional material properties:

• Semi-transparent TPEs are colorable
• Excellent mechanical properties
• Low compression set
• Sterilizable: Autoclave 121°C and 134°C, β/γ radiation 2 × 35 kGy, EtO
• PVC, silicone and latex-free
• Free of animal content

Another important criterion: Customers will benefit from a unique service package for medical-grade products that offers advantages under the Medical Device Regulation, which will come into force from the beginning of summer 2021.

• Consistent manufacturing process; meets all requirements for fully certified medical-grade plastic in accordance with VDI 2017 technical rules
• Supply security guaranteed for 24 months
• Purity of raw materials ensured through supplier commitment
• Separate, permanently assigned production units for THERMOLAST® M

Eugen Andert, Product Development Engineer at KRAIBURG TPE, states: "With our years of experience and the approvals we hold, we are in a good position to compete in the pharmaceutical packaging market. However, the human element also plays an important role, because customers can rely on our unique medical service package with consistent material supply as well as consistent quality and composition.