We are happy to inform you that, recently, NITA-FARM has obtained a license granting us the right to create an official collection of microorganisms of the III-IV pathogenic groups.
July was marked for us by opening a new microbiological laboratory.
It is no secret that pharmaceutical production is regulated by many requirements, and to confirm the compliance with them, as well as to ensure the proper product quality, each company needs to go through a licensing procedure.
The conclusion of the Federal Supervision Agency for Customer Protection and Human Welfare confirmed that the NITA-FARM’s laboratory meets all requirements for safe working environment, which means that the products and the environment are not susceptible to microbial contamination.
In the Company’s new laboratory, it is now possible to carry out activities related to isolation and identification of conventionally pathogenic microflora.
This laboratory is unique to the industry. The NITA-FARM’s new laboratory has more than 350 square meters of clean premises, additional research facilities, and 38 workrooms. To date, the newly created microbiological laboratory is one of the few unique research sites in the Russian veterinary pharmaceutical industry. It is worth noting that, in addition to compliance with all requirements of sanitary and epidemiological regulations, the laboratory has been established in accordance with the requirements of the GMP regulations applicable to pharmaceuticals. Microbiological control of products, raw materials, and substances is carried out in clean rooms of В and С classes with an А area.
The NITA-FARM’s laboratory has an extensive instrument base. All microbiological tests are carried out in laminar boxes using disposable sterile materials. For the incubation of bacterial cultures, there are several thermostats that support different temperatures, and for filling test tubes and bottles, a filling module is used. Using its our own foreign-made water-treatment system, the laboratory obtains IInd type purified water for high-quality preparation of nutrient media and reagents.
Marina Khanadeeva, the Deputy Head of the NITA-FARM’s Microbiological Laboratory: “We opt for foreign manufacturers of laboratory equipment, including such well-known companies as IKA, Sartorius, Memmert, Sanyo, Shimadzu, and Mettler Toledo. Recently, we purchased a pass-through autoclave and a culture media preparator made by the German Systek. This equipment is programmed via touch control and operates in automatic mode. The culture media preparator allows not only to prepare large amounts of nutrient media, but also to sterilize them. Our instrument inventory includes a Carl Zeiss microscope, which is used to identify microorganisms. By the way, due to the microscope camera, it is now possible to create a database of microscopic objects”.
Our main task is ensuring the accuracy and accuracy of test results! The Company has highly qualified regular staff, having a specialized higher education and certificates from refresher courses on safe working with pathogenic microorganisms of III-IV groups.
In general, the new microbiological laboratory’s infrastructure is a guarantee of the laboratory tests quality, confirming the of the Company’s research capabilities.
Marina Khanadeeva added that “The new laboratory has definitely increased the efficiency and quality of our work; we could introduce new methods of medicine research. This is a big step forward. We are confident in the quality of our products!”.
Opening of the NITA-FARM’s Microbiological Laboratory is one of the essential steps towards ensuring a high level of production quality. Our ability to conduct the necessary tests using our own resources and practical experience allow us to get operational results which fully ensure the production and sanitary control from raw materials to finished products even in conditions of rapidly expanding production.
Currently, NITA-FARM continues the process of modernization.
This is a new stage for the Company’s history, as it means creating additional facilities to produce finished medicines for veterinary use.
As soon as in December, we will hold a grand opening ceremony of the Company’s new production sites.
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