APIs are manufactured in Class D classified clean rooms, with the adequate environment provided for proper production process and quality control.
The air preparation system conforms to the requirements imposed on production facilities of pharmaceutical companies. The three-stage air purification system built with HEPA filters maintains in the clean room working area a specific environment with low levels of microbial contamination, which is a factor that ensures the drug quality, efficacy and safety.
Water is prepared using the two-stage reverse osmosis technique, which provides pharmacopoeial quality water. The systems for production, storage and distribution of purified water have been installed in accordance with the GMP requirements for optimal placement of equipment with regard to its regular cleaning and maintenance needs, thus ensuring the stable water quality.
The processes of air preparation and purified water production have been evidenced by validation protocols.
In addition, all production processes have been implemented in accordance with the sanitation requirements as to the manufacture of pharmaceuticals, as well as with the OHS rules and standards.
The ongoing update of the technological park with the state-of-the-art equipment and production support systems enables the implementation of production processes to synthesize various products.