Conducting reliable physicochemical and microbiological quality control is impossible without the availability of appropriate laboratory premises, modern laboratory equipment, documentation and competent personnel.
That is why the priority tasks in the development of FF “Viola” for 2014-2016. was the reconstruction of a part of the factory building with the aim of creating a new microbiological laboratory and expanding the existing physical and chemical laboratory of the quality control department, as well as modernizing their material and technical base for the possibility of implementing modern microbiological and chromatographic methods of drug analysis in accordance with the requirements of the State Pharmacopoeia of Ukraine.
The planning, structural elements and equipment of the laboratory premises were carried out in compliance with all legal requirements for the design and construction of such laboratories, including the industry requirements of the Guidelines ST-N of the Ministry of Health of Ukraine 42-4.0:2020 “Medical products. Proper production practice”.
Ceiling structures are mounted according to the modular system. The door is equipped with a viewing window, and to open the door, push-button non-contact switches are used, installed on the wall in the direction of staff movement, ensuring the sterility of staff’s hands. The materials from which the wall panels, ceiling structures and doors of the microbiological laboratory are made are strong, do not absorb moisture, are resistant to chemical and mechanical influences, are non-toxic, and have antistatic and antibacterial surface properties.
The assembled ceiling structures, transfer gates, doors and floor covering have a homogeneous smooth and even surface, which ensures the minimization of the possibility of dirt accumulation, easy cleaning and disinfection.
To prepare the air in the clean rooms of the laboratory, a Polish-made supply-exhaust ventilation system and a USA-made compressor-condenser unit are installed.
Laboratory furniture that meets certain sanitary-hygienic and ergonomic requirements is made of high-quality materials with the use of special coatings resistant to chemical reagents and repeated sanitary treatment. One of the main conditions for complying with the pharmacopoeial requirements for the analysis of medicinal products is the availability of modern laboratory equipment that has undergone metrological certification and/or an internal qualification procedure (IQ/OQ). In addition, only high-quality certified materials (class A laboratory utensils, reagents, solvents, pharmacopoeial standard samples and strains of microorganisms that meet the requirements of the State Pharmacopoeia of Ukraine) should be used when conducting physico-chemical and microbiological analysis.
All these requirements were implemented when choosing manufacturers and suppliers of laboratory equipment and consumables for microbiological and chromatographic laboratories.
The microbiological laboratory of FF “Viola” is equipped with modern high-tech main and auxiliary equipment of leading manufacturing companies:
“Esco” (Italy)
“WTW” (Germany)
“Pol-Eco-Aparatura” (Poland)
“Hawo” (Germany)
“Systec” (Germany)
“Radwag” (Poland)
“Funke Gerber” (Germany)
“IKA” (Germany)
“Memmert” (Germany)
“Sartorius” (Germany)
“Funke Gerber” (Germany)
“Biosan” (Latvia)
In the reconstructed physical and chemical laboratory, a separate room is allocated for conducting chromatographic studies, where all the necessary engineering and technical communications for creating the necessary microclimate, providing gases and water of the required quality are laid. Modern devices of leading American companies are installed in the premises: gas chromatographs of the company “Agilent” with generators of high-purity gases and a compressor of the company “Parker Balston”, highly efficient liquid chromatographs of the company “Agilent”, as well as a system for obtaining ultrapure water for chromatography of the company “Thermo Scientific”.
Laboratory specialists of FF “Viola” have received appropriate training on the implementation of pharmacopoeial methods of drug analysis and successfully apply their professional knowledge and skills to guarantee the quality, safety and effectiveness of our drugs for the benefit of the health of the population of Ukraine.