Year: 2025
Type: article
Abstract: Testing of biological products for sterility, harmlessness and determination of the concentration of hydrogen ions is mandatory in the pharmaceutical industry and is regulated by pharmacopoeias. Pharmaceuticals intended for intravenous, subcutaneous and intramuscular administration, as well as some other solutions, are available marked "sterile", therefore they must be checked at production. The ingress of microflora into sterile preparations can cause an inflammatory process or a septic condition, therefore the manufacturer is fully responsible for the sterility and harmlessness of solutions and carries out constant monitoring in production conditions. This article presents the results of tests conducted to verify sterility, harmlessness and determination of the concentration of hydrogen ions of series of the biological product "Liquid live vaccine against anthrax from the strain " 55-VNIIVVIM " for cattle and small ruminant." The vaccine was monitored in strict accordance with the approved regulatory documentation. When checking the vaccine, the following data were obtained: no growth of extraneous bacterial and fungal microflora was observed on nutrient media such as meat-peptone broth, meat-peptone agar, Saburo and KittaTarozzi media. Based on the analysis of the results obtained, it was established that the live anthrax vaccine from strain “55-VNIIVVIM” is sterile. At subcutaneous application of the vaccine, the tested preparation within 10 days after administration had no toxic effect on the body of rabbits, did not cause visible local and general manifestations, which proves the harmlessness of the preparation. The vaccine series showed non-significant pH differences of 0.1-0.3.
Source: Biosafety and Biotechnology
Language: English
Subfield: Molecular Biology
Domain: Life Sciences
Open Access status: hybrid
OpenAlex ID: W4409196741