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<p>The Microbiological Risk Classification and Assessment tool (MiRCA) is a valuable instrument elaborated by the European Directorate for the Quality of Medicines &amp; HealthCare (EDQM) for evaluation of the microbiological risks associated with the procurement, processing, testing, storage and distribution of substances of human origin (SoHO). Own data of critical points in the procurement and processing of SoHO were put into the MiRCA, including the percentage of microbiological contamination before and after processing. These data were extracted from retrospective studies performed with different types of SoHO products prepared in the Tissue Bank and the Human Milk Bank of the University Hospital Hradec Králové. The result of the analysis was a final risk number calculated separately for the procurement and processing of each type of SoHO, and the overall risk value and its probability. A total of 7,881 SoHO products were analysed. For solid tissues, the lowest risk value was determined during the procurement and processing of femoral heads (total risk value 14.4 of 695 possible). Cell collection and processing revealed higher risk values (total risk values ranging from 150 to 161 of 695 possible). The greatest risk of microbial contamination was observed in breast milk processing (172.5 of 695 possible), where the percentage of post-processing microbiological findings was 11.6%. We conclude that the MiRCA is a valuable tool for conducting microbiological risk assessments for procurement, processing, testing, and distribution of SoHO.</p>

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Microbiological risk assessment during the procurement and processing of cells, tissues and breast milk using the MiRCA tool

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月19日

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  • Miroslava Jandová,
  • Šárka Rudolfová,
  • Marie Švorcová,
  • Pavel Měřička

摘要

The Microbiological Risk Classification and Assessment tool (MiRCA) is a valuable instrument elaborated by the European Directorate for the Quality of Medicines & HealthCare (EDQM) for evaluation of the microbiological risks associated with the procurement, processing, testing, storage and distribution of substances of human origin (SoHO). Own data of critical points in the procurement and processing of SoHO were put into the MiRCA, including the percentage of microbiological contamination before and after processing. These data were extracted from retrospective studies performed with different types of SoHO products prepared in the Tissue Bank and the Human Milk Bank of the University Hospital Hradec Králové. The result of the analysis was a final risk number calculated separately for the procurement and processing of each type of SoHO, and the overall risk value and its probability. A total of 7,881 SoHO products were analysed. For solid tissues, the lowest risk value was determined during the procurement and processing of femoral heads (total risk value 14.4 of 695 possible). Cell collection and processing revealed higher risk values (total risk values ranging from 150 to 161 of 695 possible). The greatest risk of microbial contamination was observed in breast milk processing (172.5 of 695 possible), where the percentage of post-processing microbiological findings was 11.6%. We conclude that the MiRCA is a valuable tool for conducting microbiological risk assessments for procurement, processing, testing, and distribution of SoHO.