TPE membrane from Kraiburg enables safe, cost-effective medical manufacturing


One-way valves typically are used in pharmaceutical manufacturing processes to prevent cross contamination. However, when the valve needs to be replaced, the entire unit, including the actuator, must be scrapped. Gemü (Ingelfingen-Criesbach, Germany), a global supplier of valves and control and measurement systems, has developed a single-use valve that incorporates a thermoplastic elastomer (TPE) membrane from Kraiburg TPE (Waldkraiburg, Germany) that enables replacement of only the valve. Kraiburg TPE is one of the world's leading manufacturers of TPE based on hydrogenated styrene block copolymers.

Gemu membraneThe Sumondo single-use membrane valve is a safe and cost-effective system, according to Gemu, because the interior membrane is the only part of the device that comes into contact with the pharmaceutical media. The valve unit is manufactured from sterilized polypropylene in a cleanroom; the ultrasonically heat-sealed TPE membrane hermetically separates the media from the environment and from the valve actuator. Moreover, it also regulates volume flow in the valve during operation.

"Thermolast M, the medically compliant TPE from Kraiburg TPE, [is] a fundamental contribution to our new development," says Valentin Rüttimann, Product Engineer for single-use systems at Gemü. "The elastic properties, together with the extensive chemical stability in conjunction with [Kraiburg's] Medical Service Package, are contributing to this progress." This is the first collaboration between the two companies.

Compounds in the Medical Service Package are manufactured on a segregated production system. This eliminates medical-grade compounds from coming into contact with other products or parts, such as raw materials of animal origin. Kraiburg TPE guarantees composition consistency and security of supply for two years.

Thermolast M has also generated interest thanks to its simple, time-saving, and cost-effective polypropylene manufacturing process, says Kraiburg. This processing method enables short cycle times and renders post-processing unnecessary. In addition, the procedure makes it possible to create a microbe-proof barrier. The material allows direct contact with a pharmaceutical medium or blood and carries extensive medical certifications.

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