Comprehensive Risk Assessment of Potent API Exposure in Solid Dosage Form Production Using FMEA Methodology

In pharmaceutical manufacturing, occupational exposure to potent active pharmaceutical ingredients (APIs) presents a critical health risk, particularly in facilities processing highly potent compounds classified under Occupational Exposure Band (OEB) 4-5. These compounds often have extremely low Occupational Exposure Limits (OELs), requiring robust containment and control measures across various production stages. This risk assessment focuses on the OEL risks associated with granulation, blending, compression, coating, blister packaging, and dispensing processes in the context of solid oral dosage form manufacturing. Using Failure Modes and Effects Analysis (FMEA), this assessment systematically evaluates the severity, likelihood, and detectability of exposure risks. This method provides a quantitative basis for ranking risks based on the Risk Priority Number (RPN), helping to prioritize engineering and procedural control measures to mitigate exposure and protect operators.