Contact

Special service and technology

  • Purification of unknown impurities by preparative HPLC
  • Manufacturing of emulsions and suspensions by High Pressure Homogenization
  • Stability testing and in-use stability (CPMP/ICH and on-going under GMP)
  • Climatic storage of API, clinical supplies and medicinal products in our climatic chambers:
    • 25°C, 60 % RH (climatic zone II / long term)
    • 30°C, 65 % RH (climatic zone IVa / alternative long term and intermediate)
    • 30°C, 75 % RH (climatic zone IVb)
    • 40°C, 75 % RH (accelerated)
  • Refrigerated storage
    • 2°C to 8°C
  • Freezer storage
    • -20°C (WHO / ICH-long-term) or ≤ -15°C (Ph. Eur. „deep-freeze“)
    • considering ICH conditions and on-going conditions (in accordance with GMP requirements)
  • Blister packaging for ICH stability storage and testing / Screening of packaging material (foils)
    • semi-automatic blistering (Blister-Omar)