The medically-compliant Thermoplastic Elastomers (TPE) of the THERMOLAST® M line from KRAIBURG TPE are to be used as a membrane for a new single-use membrane valve from the company GEMÜ. Manufactured with an optimum level of cleanliness, the valve effectively prevents cross-contamination with a heat-sealed TPE membrane. The membrane stops the channeled medium from coming into contact with staff and the environment, even after the valve unit has been removed.
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.
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.
GEMÜ (gemu-group.com) is a globally leading manufacturer of valves, measurement systems, and control systems. The globally-aligned, independent family-owned company has established itself over 50 years through innovative products and customer-specific solutions involving control of process media in important fields. GEMÜ is a global market leader in sterile applications for pharmaceuticals and biotechnology. The Group currently employs 800 people in Germany, and 1,400 globally. Products are manufactured at six production locations in Germany, Switzerland, China, Brazil, France, and the USA. Global sales are coordinated from Germany, with 24 subsidiaries. The Group is active on all continents, by means of a tight dealer network in 53 countries. GEMÜ plans to expand further into future markets with its international growth strategy. A new production and logistics center was opened in 2013 for this purpose.
About KRAIBURG TPE
KRAIBURG TPE (kraiburg-tpe.com) is one of the world's leading manufacturers of Thermoplastic Elastomers on the basis of hydrogenated styrene block copolymers (HSBC). In addition to custom-engineered solutions, the company also provides a broad range of market-specific formulations for diverse areas of application under the brand name THERMOLAST®. With the material solution HIPEX® KRAIBURG TPE is opening up the world for applications requiring high temperature and oil resistance for all thermoplastics processing companies. With new compounds COPEC® and For-Tec E it is entering new dimensions in terms of haptics, adhesion and resistance for consumer electronics products. KRAIBURG TPE has production sites in Germany, USA and Malaysia. The sales organization additionally covers France, Italy, Poland, Spain, China, India, Taiwan, Thailand, Vietnam, Brazil and Mexico. In further countries KRAIBURG TPE is represented by distributors.
Andreas Pawel - KRAIBURG TPE GmbH & Co. KG
T: +49 8638 9810-519 - E: andreas.pawel[.]kraiburg-tpe.com.