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Services


External consulting
Consultations on GMP-conformance
GMP quality control
  • Sterility testing
  • Flow cytometry
  • PCR




Sterility testing
Sterility testing of clinically evaluated medicinal products
  • Direct inoculation method, in accordace with Czech Pharmacopoeia (articles 2.6.1 and 2.6.27)
  • Sterility testing using alternative method on BacT/ALERT machine
  • Validation of sterility testing for a particular medicinal product



Cleanrooms monitoring
  • Particle monitoring using APC M3 machine
  • Microbial monitoring
    • Air contamination monitoring
      • Active monitoring using Aeroscope MAS 100 device
      • Passive monitoring – fallout method
    • Surface contamination monitoring
      • Printing method
      • Swabing method