GEMÜ Valves in Liquid Pharmaceutical Plants
Application
The plant is used for manufacturing liquid pharmaceutical products and consists of raw material supply, preparation and mixing of liquids and cleaning. Three tanks are available for the preparation of liquids (2 x 1000 l and 1 x 2000 l). The tanks are pressure and vacuum resistant from -1 bar to +3 bar. Each tank is equipped with a separate heating/cooling system. The prepared products are mixed in 3 different mixing tanks with contents of 2000 l each or in movable containers. The plant is designed according to Good Manufacturing Practice (GMP) and qualified.
Plant design
The tanks, all other parts of the plant and the pipelines are made from stainless steel 1.4404 316 L. All medium wetted surfaces are Ra 0.8 µm. The plant is intrinsically safe. The switch gear cubibles for the control system of the plant are located in a non hazardous area. For the operation of the automated plant there is a touch panel in the hazardous area and a PC in the control centre. The PC visualizes all the operating sequences via WINCC. PM-Batch and PM-Quality are used to make recipes, manufacture preparations, generate preparation and cleaning protocols. The raw materials are DI water, ethanol and isopropanol which are directly batched from the raw material storage tanks, solid and other liquid components are batched by means of vacuum suction from drums.
Solution
The DI water, ethanol and isopropanol supply is controlled by GEMÜ 688 diaphragm valves with pneumatic two-stage actuators. The end positions are monitored by means of GEMÜ 1231 electrical position indicators with proximity switches according to NAMUR. The GEMÜ 688 two-stage batch valve in conjunction with a totalizer enables exact batching of the raw materials and shortest possible batch times. GEMÜ 612/673 manual diaphragm valves and GEMÜ 687 pneumatic valves are also used in this application.
GEMÜ 673 and 687 valve bodies can be lined with high-quality polypropylene (PP), fluoroplastics (PFA), as well as soft and hard rubber lining making the valves highly versatile and robust when used in Lined Pipe Systems, when containing and transporting active pharmaceutical ingredients (API’s) in their raw chemical state.
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