Risk-based Exposure Evaluation Process: Protecting Worker Exposure to Active Pharmaceutical Ingredients

The purpose of this project is to support Alcon’s Risk-based Exposure Evaluation Process (REEP). The objective of REEP is to transfer Novartis’s decision-making process from a hazard-based approach to a risk-based, data driven approach in order to protect their pharmaceutical workers’ exposure to active pharmaceutical ingredients (APIs) during the manufacturing process. Personal breathing zone air sampling was conducted for the high risk APIs to determine personal exposure during different unit operations. Sampling results were compared to Novartis Internal Occupational Exposure Limits (NIOEL). Bayesian statistical analysis was performed to determine if a change in control is necessary and to interpret findings. While REEP is a continuous process, these preliminary results revealed the first set of risk-based API exposure data for Alcon’s six pharmaceutical sites. Based on the results, improvements to multiple levels of control such as engineering, administrative, and respiratory protection equipment (RPE) are currently in the process of implementation.