The fluid bed drying (FBD) process, commonly used in pharmaceutical manufacturing for drying and granulation, involves suspending particles in a fluidized bed where air or gas is used to ensure uniform drying. However, there is an important consideration: during this process, air containing NOx (nitrogen oxides) can come into contact with the drug product, particularly when high temperatures are used. Under these conditions, NOx can be converted into nitrous acid, which may react with amines present in the formulation, potentially leading to N-nitrosamine formation. This highlights the critical need for monitoring and controlling NOx levels during the drying process to mitigate the risk of contamination. Optimizing process parameters such as temperature and airflow, and implementing effective gas filtration systems, are key strategies to ensure product safety. Are you managing these risks effectively in your manufacturing processes? #nitrosamines #pharmaceuticals #riskassesment #qualitycontrol #drugmanufacturing #FBD #formulation #FDA #EMA #drugsafety #processoptimization
Güler Yağmur Akyüz, Ph.D.’s Post
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