KRAIBURG TPE presents new pharma packaging materials solution

Primary packaging for solid and liquid drugs, as well as many other products, will benefit from the latest addition to the THERMOLAST M series from KRAIBURG TPE.

The company is also keeping abreast with the times organisationally with its service package that comes with the product to ensure customers are prepared for regulation changes.

Patients and medical professionals usually remember the outer packaging of drugs, due to the variety of the design options. It’s often easier and less costly to adjust the outer packaging than to 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. 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 in accordance with ISO 8871-1 have been successfully performed. The raw materials tested are certified under Regulation (EU) No. 10/2011 and US CFR 21 (FDA) standards, and their biocompatibility characteristics are certified in accordance with ISO 10993-4, -5, -10 and -11, as well as with ISO 8871-1 for parenterals and for devices for pharmaceutical 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).

Customers will also benefit from the unique service package for medical-grade products, which provides advantages in view of the Medical Device Regulation that will be coming into effect from early summer 2021.

Product Development Engineer Eugen Andert said: “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.”