The main objective of the study outlined below was to determine if continuous sampling (and multisampling point assay) offers effective monitoring for the complete production process (8 hours) by ...
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A comprehensive contamination control strategy must include a dedicated section addressing personnel-related microbiological and particulate contamination risks introduced into an aseptic process, as ...
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 ...
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