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

Pompe e impianti per i settori farmaceutici, delle scienze biologiche e biotecnologiche

Come leader nella produzione di pompe e impianti di pompaggio per i settori farmaceutico, delle scienze biologiche e biotecnologiche, LEWA vi supporta nello sviluppo di soluzioni complete, in grado di soddisfare esattamente le esigenze dei vostri processi. La produzione farmaceutica richiede particolari competenze per garantire il rispetto delle norme di legge. Quando si tratta di produzione, affidabilità, documentazione e convalida diventano quindi priorità assolute.

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Products

Pompa dosatrice a membrana igienico-sanitaria LEWA ecoflow

LEWA ecoflow è disponibile anche in versione igienico-sanitaria. La pompa dosatrice per applicazioni igieniche ha le stesse funzionalità complete e soddisfa tutte le specifiche per le produzioni farmaceutica e alimentare.

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Pompa dosatrice a membrana igienico-sanitaria LEWA ecodos®

Una versione igienico-sanitaria è disponibile anche per la pompa LEWA ecodos. Qui, abbiamo tutte le esigenze tipiche delle produzioni farmaceutica e alimentare.

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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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