MkB Test a.s. prepares culture media in a sterile "clean room" environment.
Clean rooms first appeared in the United States in 1960 in the electronics industry that required high-quality control of the surrounding area in the production process to reduce the number of non-compliant products and increase productivity. Clean rooms were then adapted to the pharmaceutical and agricultural industries as well as to hospitals and laboratories. ISO 146441 (standardized and operating rules) determines and specifies the classification of clean rooms according to the degree of mechanical and biological contamination.
In the filling and packaging processes for finished media, clean rooms are the decisive factor supporting their high standard and quality.
Because even excellent automated substrate and media preparation systems will not ensure the required substrate and media sterility and their standard without clean rooms. It is a closed and contained system of separate rooms with a transient blocking mechanism with overpressure and a known dose of air that is limited and controlled. The air into the rooms passes through HEPA filters. The computer continuously records and controls the air volume, flow velocity, purity, temperature and humidity to create a standard work environment. In boxes, the maximum sterility (Purity Class A according to SL 1 EU Guide GMP, 100 according to STN 125 310) is ensured by ceiling modules with laminar flow of filtered (EU 12) air.