5Psq-107 Microbiological Stability Risk Assessment of Sterile Hospital Preparations

<h3>Background and Importance</h3> The implementation of microbiological stability studies for hospital sterile preparations is challenging due to the heterogeneity of these products and the technical limitations of hospital pharmacy facilities. Furthermore, the concept of a batch is specific in this context, as preparations are often produced in small quantities under individualised conditions. <h3>Aim and Objectives</h3> This study aims to assess the risks associated with the microbiological stability of sterile hospital preparations, by identifying and analysing the key factors that influence their stability. <h3>Material and Methods</h3> A targeted Failure Mode and Effects Analysis (FMEA) was developed to identify organisational, human, material, and environmental factors, and to prioritise those most critical to the microbiological stability of sterile hospital preparations. <h3>Results</h3> The analysis identified exposure temperature, container integrity, quality of sterile devices, and staff training as the main risk factors with criticality scores ranging from 80 to 120. The aseptic filling process validation and the composition of the mixtures were also crucial to maintaining microbiological stability. Corrective measures included tighter raw material control, enhanced preventive maintenance, and operator microbiological validation through media-fill tests. <h3>Conclusion and Relevance</h3> By focusing on influencing factors rather than the process, this analysis identified key critical control points. The next step is to design a pragmatic decision-making algorithm to estimate the microbiological stability of sterile hospital preparations. <h3>Conflict of Interest</h3> No conflict of interest