Controlled process reliability with GEMÜ SUMONDO®

GEMÜ, the leading manufacturer of valves, measurement and control systems for the pharmaceutical industry, has developed the world's first Single-Use diaphragm valve. GEMÜ SUMONDO® represents the long-awaited paradigm change to Single-Use design: From manual systems to automation-capable and controllable plants for safe operation and continual documentation by the plant monitoring system.

The trend towards simplified upstream and downstream plant designs and the effective prevention of cross-contamination risks means that Single-Use disposable technology is becoming an increasingly high-profile and important field – especially in pharmaceutical process engineering. Single-Use design is increasingly being used particularly in the manufacture of smaller batch sizes, which are required, for example, in research and pilot plants.

CIP/SIP processes are no longer required

The secondary processes for cleaning and sterilisation (CIP/SIP) that are well-known and required for classic stainless material plant designs are in practice no longer necessary at all with Single-Use plants and processes. The necessary purity is guaranteed through the sterilization by gamma rays of all the process components used. This not only reduces the investment costs of such a plant, but also eliminates extremely time-consuming cleaning validation for operating media that are no longer required.

GEMÜ SUMONDO® links the valve body and actuator together using patent-pending locking technology: After the application process, only the valve body is removed, the actuator itself can be reused repeatedly in the plant. The valve body is manufactured from polypropylene in a cleanroom and is gamma irradiated up to 50 kGy. It isolates the working medium hermetically from the environment and from the actuator through an ultrasonically welded TPE diaphragm. The medium remains closed off from the environment by the welded diaphragm not only during operation, but also after removing the valve body.

Reproducible and documentable procedures

The major advantage of GEMÜ SUMONDO ® in comparison with conventional pinch valves lies in the exact controllability of processes. Using a tried and tested actuator design from conventional plant engineering, the actuator can also transmit feedback to the plant monitoring system as required to ensure complete monitoring of the controlled system. This means that pharmaceutical processes can be more easily documented, reproduced and validated. The increased levels of automation also mean that the systems are less likely to have faults.

GEMÜ SUMONDO® is initially available in three valve body versions in the nominal sizes 3/8" to 1" with hose barb or clamp connection. The body is available as a straight way, T- and angle valve (right) design. The products are already in use in several testing facilities at development partners.