CLEANROOM PRODUCTION

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Controlled Environment

 

 

In our cleanroom production, we rely on perfect interaction between technology and people.


Our GMP-certified facility in Hannover, Germany, includes cleanrooms classified as Class C and D (ISO7/8), which mitigates the risk of contamination during the compounding and filling of liquid and solid components.

Cleanroom Production

Facts and Figures

  • 800 m² cleanroom area, divided into liquid and solid areas
  • Clean corridor concept
  • Production facility free of animal components (AOF)
  • Personnel airlocks
  • Weighing of raw materials in cleanroom class C & D
  • Compounding and filling in cleanroom class C & D
  • Three filling rooms for liquid media cleanroom class C & D
  • Two filling rooms for solid media cleanroom class C & D
  • Automatic transport conveyor system with integrated weighing technology
  • SIP/CIP system for sanitisation and cleaning with validated cleaning processes
  • In-house quality control, including microbiology
  • Washroom to clean production equipment
  • In-process use of nitrogen and ultra-pure steam

Production set-up

  • Multipurpose equipment with validated cleaning procedures
  • Stainless-steel vessel with integrated double agitator
  • 2,000 and 5,000-litre stainless-steel vessels with magnetically coupled agitators, heatable, temperature-regulated, inline pH control
  • 2,000 and 5,000-litre plastic vessels (PVDF)
  • Vessels on integrated scales for direct weighing of raw materials
  • 200 l mobile vessel for pilot or small batches
  • 1,000 l mobile single-use mixer for small-scale batch production
  • Weighing containers of 100–1,000 l volume

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