The market for Single-Use Systems (SUS) is rapidly increasing. More and more Bio-Pharmaceutical companies have adopted this relatively new concept. It is a method of better controlling the cleanliness of a production unit. Cleaning a conventional stainless steel vessel with all its components is a difficult task, not to mention the potential risk of cross-contamination from batch A to batch B, caused by absorption of some of the build-in components. Typically a SUS is built with new components, never exposed to any other drug before. These components are non-metallic and are usually cold sterilized by gamma irradiation. Steam sterilization is most of the time not possible because of the limited temperature resistance of some of the plastics used.
Ensuring product purity and process integrity across the pharmaceutical and biopharmaceutical industries.
European leader in FDA-compliant gaskets and validation components. Ensuring product purity and process integrity across the pharmaceutical and biopharmaceutical industries. Our screen gaskets are not used the same way as conventional filters, although they can be considered a filter. Conventional filters are built differently and have many layers to prevent particles to pass through, these can reach efficiencies of almost 100%. A particle comes in many different shapes.
For example, a hair has a diameter of Ø 0,1 mm but the length can be centimetres long. If the hair arrives perpendicular to the screen it might pass a 100 mesh screen. With a conventional filter, the second or third layer will prevent the hair to pass. Retention’s of standard screens are calculated according to international standards using perfectly round glass spheres. Our screens are only one layer and therefore they cannot be considered the same as a filter. Each screen gasket has a high-performance gasket made out of one of the validated compounds that we use for our standard Sanitary Gaskets range.
The Pharma-Clamp® is made from glass-filled nylon. This material is extremely strong and is stable during heat exposure and mechanical load. Traditional non-metallic clamps for single-use systems (SUS) are executed with a wing-nut. Operators who are putting Single-Use Systems together often complain about the number of wing nuts they have to assemble. It is time-consuming and can lead to repetitive strain injury (RSI).
Our Pharma-Clamp® is easy to use because there is only one way to close it, no adjustments are possible. Because of this over-compression and destruction of the gasket is prevented. The Pharma-Clamp® cannot be installed incorrectly, when closed it can take 10 bars of pressure without any problem.
The Pharma-Clamp® can be exposed to 50kGy Gamma radiation. It can be autoclaved and can withstand up to 150°C.
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The Pinch valve is made from the same glass-filled nylon as our Pharma-Clamp®. This material is extremely strong and is stable during heat exposure and mechanical load. The pinch valve has the same closing device as the Pharma Clamp®. Both have a locking device preventing unwanted opening during storage or transportation. A tie-wrap can easily be installed. The Pinch Valve can be exposed to 50kGy Gamma irradiation. It can be autoclaved and can withstand up to 150°C.
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This pressure gauge was developed specifically for Single-Use applications. It was designed so operators could see that the system was pressurized. The gauge indicates pressure. It is a mechanical device with low accuracy (±15%). The housing is filled with liquid silicone oil, so we recommend us a Gauge Guard Isolator gasket to prevent potential system contamination, in case of a gauge membrane rupture.
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Our technical team is ready to help you select the right solution for your application
