In 2013 a microbiology department for control of microbiological purity and bacterial endotoxins became a part of the laboratory of quality control department.
The technical competence and objectivity of the researches that are being held by laboratory of the quality control department were certified by the Certificate of Attestation of the State Medicine Service of Ukraine for the right to perform quality and safety control of medicines.
The laboratory the quality control department performs raw materials quality control, intermediate, technical and finished products control, equipment cleaning and facilities control, monitoring of the manufacturing conditions. It also conducts an ongoing analysis of air, purified water, outwash of the technological equipment, clothing and hands of the staff.
The total number of aerobic microorganisms (ТАМС), the total number of yeasts and molds (TYMC) as well as certain kinds of microorganisms are identified according to the requirements of the State Pharmacopoeia of Ukraine.
The laboratory the quality control department is equipped with modern instruments. Our main analytical tools include:
– laminar flow cabinets
– membrane filtration utilities
– equipment for determination of bacterial endotoxins.
All methods used in the laboratory were validated, the equipment was qualified.
High level of education and training of the specialists working in the laboratories of the company, allows them to participate in the development of methods of analysis of new products and conducting their validation.