title: ÐÐ°Ð»Ð¸Ð´Ð°ÑÐ¸Ñ Ð¼ÐµÑÐ¾Ð´Ð¸ÐºÐ¸ Ð²Ð½ÑÑÑÐ¸Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²ÐµÐ½Ð½Ð¾Ð³Ð¾ Ð¸ Ð²ÑÐ¿ÑÑÐºÐ°ÑÑÐµÐ³Ð¾ ÐºÐ¾Ð½ÑÑÐ¾Ð»Ñ ÑÑÐµÑÐ¸Ð»ÑÐ½Ð¾ÑÑÐ¸ Ð°ÑÑÐ¾Ð»Ð¾Ð³Ð¸ÑÐ½Ð¾Ð³Ð¾ Ð±Ð¸Ð¾Ð¼ÐµÐ´Ð¸ÑÐ¸Ð½ÑÐºÐ¾Ð³Ð¾ ÐºÐ»ÐµÑÐ¾ÑÐ½Ð¾Ð³Ð¾ Ð¿ÑÐ¾Ð´ÑÐºÑÐ° (ÐÐÐÐ)
title: Ð²ÑÐ¿ÑÑÐºÐ½Ð°Ñ ÐºÐ²Ð°Ð»Ð¸ÑÐ¸ÐºÐ°ÑÐ¸Ð¾Ð½Ð½Ð°Ñ ÑÐ°Ð±Ð¾ÑÐ° Ð¼Ð°Ð³Ð¸ÑÑÑÐ°
titleType: Subtitle
title: Validation of the method for in-process and release sterility control of autologous biomedical cell product (BMCP)
Creators: name: ÐÑÐ¸Ð³Ð¾ÑÑÐµÐ²Ð°, ÐÐ»ÑÐ½Ð°
Publisher: name: Ð¡Ð°Ð½ÐºÑ-ÐÐµÑÐµÑÐ±ÑÑÐ³ÑÐºÐ¸Ð¹ Ð¿Ð¾Ð»Ð¸ÑÐµÑÐ½Ð¸ÑÐµÑÐºÐ¸Ð¹ ÑÐ½Ð¸Ð²ÐµÑÑÐ¸ÑÐµÑ ÐÐµÑÑÐ° ÐÐµÐ»Ð¸ÐºÐ¾Ð³Ð¾
Year: 2023
Subjects: automated microbial detection systems bact/alert
ÑÑÐµÑÐ¸Ð»ÑÐ½Ð¾ÑÑÑ
Ð¼ÐµÑÐ¾Ð´ Ð¿ÑÑÐ¼Ð¾Ð³Ð¾ Ð¿Ð¾ÑÐµÐ²Ð°
Ð°Ð»ÑÑÐµÑÐ½Ð°ÑÐ¸Ð²Ð½Ð°Ñ Ð¼Ð¸ÐºÑÐ¾Ð±Ð¸Ð¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ°Ñ Ð¼ÐµÑÐ¾Ð´Ð¸ÐºÐ°
Ð±Ð¸Ð¾Ð¼ÐµÐ´Ð¸ÑÐ¸Ð½ÑÐºÐ¸Ð¹ ÐºÐ»ÐµÑÐ¾ÑÐ½ÑÐ¹ Ð¿ÑÐ¾Ð´ÑÐºÑ
sterility
direct inoculation
alternative microbiological methodics
biomedical cell product

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description: A study was conducted to validate the AMM for sterility control of an autologous BMCP. Tasks that were solved during the research: 1.To review the research literature describing microbiological methods for controlling the sterility of BMCP (ConsultantPlus, eLIBRARY.RU). 2. To develop a scheme for the introduction of AMM for determining the sterility of biomedical cell products. 3. To assess the applicability of the validated methodology for the analysis of the sterility of BMCP based on the selected parameters. 4. To study the effect of BMCP samples on the possibility of detecting microorganisms in sterile samples. 5. To analyze the suitability of AMM for determining sterility in routine control of BMCP samples. The suitability of the alternative method was assessed according to such acceptance criteria as: the lower limit of detection of model test strains, correctness, stability, specificity. A comparison was made with the pharmacopoeia sterility control technique (State Pharmacopoeia of the Russian Federation, GPM 1.2.4.0003.15.). The paper presents experimental substantiations of the ability of the validated technique to provide accurate and reproducible results that demonstrate the advantages and possibility of its application in routine quality control of autologous BMCP.