Metering pumps for sterile applications

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.

  • Pressure performance max. 20 bar
  • Flow rate: min. 2 l/h – 8000 l/h (linear, step, gradient)
  • Turn down ratio 1:200

Aseptic solutions for metering sensitive fluids

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:

  • Liquid end hermetically tight, 4-layer safety diaphragm with leakage detection
  • Superior priming, low shear and wear
  • CIP/SIP up to 150°C
  • Aseptic design according to EHEDG
  • Compact servomotor without fan (cleanroom)
  • 316L or higher (e.g. hastelloy) and plastic
  • Continuous operation possible
  • ATEX design possible
  • Qualified in the OEM pharmaceutical sector worldwide for decades

References of LEWA pumps for pharma applications

    Industry: Pharma API

    Application:  Oligonucleotides DNA/RNA synthesis; highly toxic and flammable fluids up to 10 bar

    LEWA Solution:  

    • Hermetically tight diaphragm metering pump in sanitary design
    • CIP/SIP possible
    • Multiplex design
    • Compact motor for clean environment
       

    Industry: Biopharma

    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: 

    • Hermetically tight diaphragm metering pump for chromatography, inline dilution processes among others
    • CIP possible
    • Corrosive resistant polypropylene or PEEK pump heads (no metal in fluid path)
    • Multiplex design

    Areas of application

    Relevant areas of applications

    • Biopharma (downstream purification) 
    • Pharma (API/vaccines/oligos)
    • Media preparation (buffer Inline-dilution) 
    • Utilities (NaOH, WFI; solvents; CIP)

    Background

    Background information for sterile applications

    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.

    Industries

    LEWA pumps and systems meet the requirements of the Pharmaceuticals industry
    Pharma and Biotech Industry

    Bombas y sistemas para las industrias farmacéutica, de ciencias biológicas y de biotecnología

    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.

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    Products

    ecoflow sanitary hygienic pump

    Bomba dosificadora de membrana LEWA ecoflow® sanitaria/higiénica

    LEWA 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.

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    LEWA ecodos sanitary/hygienic diaphragm metering pump

    Bomba dosificadora de membrana LEWA ecodos® sanitaria/higiénica

    También 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.

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    Downloads

    Diaphragm metering pumps for sterile applications (EN)

    Diaphragm metering pumps for sterile applications in the pharmaceutical industry (GMP).
    332 KB | pdf | 18.02.2022

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