One of the fastest growing generics and biosimilar pharmaceutical companies in the world, the end user of this pharmaceutical machinery is one of the fastest growing generics and biosimilar pharmaceutical companies in the world. Their facilities cover all steps of the pharmaceutical development and production process.
High Sheer Mixer Generator Performance
The specific piece of machinery used within this application is a high sheer mixer granulator. The Granulator has multi uses; the most important feature to the granulator is the endpoint control. Should the main agitator have an inverter to control the speed, the torque control can be used to sense an endpoint of the granulator, which can be validated to repeat the exact endpoint through the PLC.
The processing chamber is dome shaped to direct loose particles into the vortex flow, which is created by high-speed agitator blades. This high vortex flow ensures fast, thorough mixing of particles irrespective of varying specific gravities, wet or dry.
Combined with the vortex flow, a high-speed cutter gives fast and even granulation throughout the whole mass of the product. Both the agitator and high-speed cutter are fitted with air purged seals which are washed with an inbuilt cleaning system, without removal of any machine parts. Should environmental problems arise when drying solvent based granule, the granulator can be heated on all sides, including the cover, and dried under vacuum removing, also retaining the solvent within a recovery system.
Vacuum Application with Pharmaceutical Valve
The media passing through the Pinch Valve on this equipment is a pharmaceutical dry granule product. The granule media is 20-25°C in temperature, and is sucked through the pharmaceutical valve at a vacuum pressure of 0.25 BAR.
Installed vertically on the side of the machine, the Pinch Valve is normally open, and operates within 3 shifts per day. Per shift, the pharmaceutical valve opens/closes 25-100 times. 2.1 BAR compressed air pressure is used to fully shut off the valve.
Satisfaction with Pharmaceutical Valve
The Pinch Valve was already installed on this mixer/granulator by the original equipment manufacturer, when the medicine manufacturer acquired it. The valve is used for the vacuum transfer of the granule product, and has an FDA approved sleeve inside.
The overall satisfaction of the Pinch Valve by the medicine manufacturer is very good. Since they have been using an air operated Pinch Valve on this machine for over 30 years, they are very happy with the low maintenance, and low cost of spare parts.
The flanged pharmaceutical valve pictured is actually a very old VA type model (replaced with newer improved VMC model), but because the medicine manufacturer have no issues with the old valve they just replace the internal FDA certified sleeve yearly. With the sleeve being the only wearable part on this stainless steel pharmaceutical valve, the company are especially pleased with this as a benefit, and are also satisfied with the fact that the sleeves are readily available in stock on the shelves at AKO UK, meaning very fast and efficient delivery, should they ever need it.