Metering pumps for sterile applications in the GMP environment

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

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

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).
215 KB | pdf | 27.10.2020

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Metering pumps for sterile applications

Aseptic solutions for metering sensitive fluids