KRAIBURG's Medically-compliant TPE Finds Application in Single-use Membrane Valve

Cross-contamination must be eliminated in valves used for sensitive pharmaceutical process technology. The safest method is to use one-way valves, which until now has meant replacing the entire valve. With its controlled single-use membrane valve GEMÜ SUMONDO®, with a special TPE membrane from KRAIBURG TPE, GEMÜ is introducing a safe and cost-effective system. With it, only the valve unit has to be replaced, because thanks to the interior membrane, it is the only part that comes into contact with the pharmaceutical media. The actuator itself remains in the system for re-use. The valve unit, which is manufactured in a cleanroom out of sterilized polypropylene, is equipped with a TPE membrane. The ultrasonically heat-sealed membrane hermetically separates the media from the environment and from the valve's actuator. Moreover, it also regulates the volume flow in the valve during operation. 

"Using THERMOLAST® M, the medically-compliant TPE from KRAIBURG TPE, represents a fundamental contribution to our new development. The elastic properties, together with the extensive chemical stability in conjunction with the Medical Service Package, are contributing to this progress," says Valentin RÜttimann, Product Engineer for single-use systems at GEMÜ, on the first collaboration between the two companies. 

A microbe-proof barrier with THERMOLAST® M

THERMOLAST® M has also generated interest thanks to its simple, time-saving, and cost-effective manufacturing process with polypropylene. This processing method enables short cycle times and makes post-processing the component unnecessary. In addition, the procedure makes it possible to create a microbe-proof barrier. THERMOLAST® M allows direct contact with a pharmaceutical medium or blood. It has comprehensive medical certifications (USP Class VI, USP 661, DIN ISO 10993-4 "Haemolysis, Indirect in Human Blood", ISO 10993-5 "Cytotoxicity", ISO 10993-10 "Intracutaneous Irritation", ISO 10993-11 "Acute Systemic Toxicity"). 

The Medical Service Package

KRAIBURG TPE ensures product reliability and safety for all of its THERMOLAST® M materials as part of its Medical Service Package. The compounds from the medically-compliant portfolio are manufactured on a separate production system. There, only materials that correspond to the requirements of the medical industry are used, and contamination with other products or parts, such as raw materials of animal origin, is eliminated. For this quality assurance in the medical and pharmaceutical technology industry, KRAIBURG TPE guarantees composition consistency and security of supply for two years. 


Source: KRAIBURG TPE 

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