Analytical Services

VUAB Pharma Inc. It offers free capacities of chemical and microbiological laboratories certified GMP.

Chemical Laboratory

Chemical analyzes according to EP and USP:

  • gas chromatography
  • liquid chromatography (HPLC)
  • spectrophotometry (UV-VIS, IR)
  • determination of particle size below the limit of visibility
  • chemical analysis of water according to Czech Pharmacopea
  • additional tests (titration, melting point, optical rotation, the determination of water according to Karl Fischer)
  • spare capacity in 4 boxes for stability studies (25 ° C ± 2 ° C, RH 60% ± 5%, temperature 30 ° C ± 2 ° C, RH 75% ± 5%, temperature 40 ° C ± 2 ° C, RH 75% ± 5%; temperature 5 ° C ± 3 ° C)

Microbiological laboratory

Microbiological tests according to the EP:

  • sterility tests
  • membrane filtration method
  • Method of membrane filtration in a closed system (Steritest Merck-Millipore)
  • method of direct inoculation into the living soil
  • microbial contamination of non-sterile products, air, gas and water
  • microbiological testing of antibiotics
  • test for endotoxin (LAL test) – Method KQCL
  • test of the effectiveness of sterilization – evaluation of biological indicators
  • other services (microbiological monitoring of manufacturing space, microbiological monitoring of clean rooms)

Validation

VUAB Pharma Inc. It offers validation activities (validation of clean rooms) as “The Rules Governing Medicinal Products in the European Union. Volume IV Medicinal Products for Human and Veterinary Use: Good Manufacturing Practices, Annex 15: Qualification and Validation”.