Analytical services

VUAB Pharma a.s. offers available capacities in chemical and microbiological laboratories with GMP certification.

Chemical Laboratories

Chemical analyses according to EP and USP:

• gas chromatography

• liquid chromatography (HPLC)

• spectrophotometry (UV-VIS, IR)

• determination of particle size below the visibility threshold

• chemical water analysis according to ČL

• other tests (titration, melting point, optical rotation, water determination according to Karl Fischer, pH, loss on drying, sulfate ash content, standard test tube reactions)

• free capacity in 4 boxes for stability studies (temperature 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)

• photostability studies according to ICH Q1B

Microbiological Laboratories

Microbiological tests according to EP:

• sterility tests

• membrane filtration method

• membrane filtration method in a closed system (Steritest, Merck-Millipore)

• direct inoculation method into live culture media

• microbial contamination of non-sterile products, air, gases, and water

• microbiological testing of antibiotic efficacy

• endotoxin content test (LAL test) – KQCL method

• sterilization efficacy test – evaluation of biological indicators

• other services: (microbiological monitoring of production areas, microbiological monitoring of cleanrooms)

Validation

VUAB Pharma a.s. offers validation activities (cleanroom validation) according to "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".