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
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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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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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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Diaphragm metering pumps for sterile applications (EN)
Diaphragm metering pumps for sterile applications in the pharmaceutical industry (GMP).
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18.02.2022
