In the manufacture of pharmaceutical products adherence to legal and regulatory requirements is essential for consistently high end product quality.
LEWA offers diaphrahm metering pumps that meet the high demands of pharmaceutical production without limitations: LEWA ecodos and LEWA ecoflow in hygienic design are the perfect choice for various sterile applications in the GMP environment.
LEWA hygienic metering pumps are hermetically sealed, leak-free, and have no connection to the product chamber. This ensures contamination-free metering and conveying.
Advantages of hygienic metering pumps:
Application: Oligonucleotides DNA/RNA synthesis; highly toxic and flammable fluids up to 10 bar
LEWA Solution:
Application: Conveying aqueous buffers, WFI and monoclonal antibodies at various flow rates (linear, step or gradient) at a pressure of up to 6 bar max.
LEWA solution:
GMP stands for "Good Manufacturing Practice" for Medicines. For example, the GMP rules lay down requirements for hygiene, premises, equipment, documentation and controls.
The production of sterile products, such as pharmaceuticals, therefore has special requirements in order to minimize the risk of contamination with microorganisms, particles and pyrogens. Quality assurance is of particular importance in this context. Production must be carried out strictly according to defined and validated methods and procedures.
The metering pumps used are an important component of the production facilities. Therefore, they must also meet the GMP requirements. Important properties include CIP/SIP cleanability or hermetic tightness.
Como fabricante líder de bombas y sistemas para las industrias farmacéutica, de ciencias biológicas y de biotecnología, LEWA le da soporte durante el desarrollo de soluciones completas que satisfacen con precisión los requerimientos de su proceso. En la fabricación de productos farmacéuticos se requieren conocimientos especiales para garantizar que se cumplan los requisitos legales. Nuestra principal prioridad es la fiabilidad en lo relativo a la producción, documentación y validación.
More DetailsLEWA ecoflow también está disponible en el modelo sanitario/higiénico. La bomba dosificadora para aplicaciones higiénicas posee las mismas propiedades generales y cumple todas las especificaciones para la producción farmacéutica y de alimentos.
More DetailsTambién se ofrece una versión sanitaria/higiénica para la LEWA ecodos. En este caso, cumplimos todos los requisitos para el funcionamiento en la producción farmacéutica y de alimentos.
More DetailsDiaphragm metering pumps for sterile applications in the pharmaceutical industry (GMP).
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18.02.2022
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