CGMP-laboratories for the Production of APIs, Diagnostics and Research Chemicals for clinical phases

 

  • FDA audited clean room class C (10,000)

  • HVAC-system independent from other parts of the facility

  • Exhaust air system separated from other parts of the facility

  • Three filter stages for incoming air (Last stage: HEPA-filter)

  • Separate air locks for material, personnel and products

  • Separate areas for production, handling of powders and packaging

  • Additional Equipment: Purified water, inert gas, loop cooling system and vacuum system

  • Strict microbiological monitoring

  • Equipped with qualified safety benches for the handling of cytostatics (HERAsafe HSPC)