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Microbiological risk assessment during the procurement and processing of cells, tissues and breast milk using the
Miroslava Jandová1,2, Šárka Rudolfová3, Marie Švorcová3
1Tissue Bank, University Hospital Hradec Králové, Hradec Králové, 500 05, Czech Republic. miroslava.jandova@fnhk.cz.
Abstract:
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.
Insights
The Microbiological Risk Classification and Assessment tool (MiRCA) effectively evaluates microbial risks in substances of human origin (SoHO). Analysis of 7,881 products shows breast milk processing poses the highest contamination risk.
Area of Science:
- Microbiology
- Public Health
- Biotechnology
Background:
- Microbiological contamination poses risks in handling substances of human origin (SoHO).
- Accurate risk assessment is crucial for ensuring the safety of SoHO products.
- The European Directorate for the Quality of Medicines & HealthCare (EDQM) developed the MiRCA tool.
Purpose of the Study:
- To evaluate the microbiological risks associated with the procurement, processing, testing, storage, and distribution of SoHO using the MiRCA tool.
- To apply the MiRCA tool with real-world data from a university hospital's tissue and milk banks.
- To identify specific SoHO types with higher microbiological risks.
Main Methods:
- Utilized the Microbiological Risk Classification and Assessment (MiRCA) tool.
- Incorporated retrospective data from 7,881 substances of human origin (SoHO) products.
- Analyzed microbiological contamination data before and after processing for various SoHO types.
Main Results:
- Femoral heads showed the lowest risk (14.4/695) during procurement and processing.
- Cell collection and processing presented higher risks (150-161/695).
- Breast milk processing exhibited the highest risk (172.5/695), with 11.6% post-processing contamination.
Conclusions:
- The MiRCA tool is valuable for assessing microbiological risks in SoHO.
- Specific SoHO types, like breast milk, require stringent processing controls.
- Risk assessment is essential for safe procurement, processing, testing, and distribution of SoHO.
