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Abstract Occupational hygiene is the highest priority in pharmaceutical industries. Potent Active Pharmaceutical Ingredients (APIs) with nanograms per cubic meter exposure limits are handled. The API manufacturing plant uses highly hazardous chemicals like methylene chloride and dimethyl formamide. This PDC will share lessons learned from 200+ pharmaceutical industries in 20+ countries in exposure assessment and containment verification. Potent compound handling, including enzymes, hazard banding and control banding, exposure controls, work practice, and respiratory protection. Addressing unique challenges in achieving a detection limit lower than the potent compound API exposure limits, particulate containment to reduce exposure below exposure limits, and effective use of respiratory protection will be discussed. Exposure profile from statistical analysis for 5000+ API exposure and surrogate monitoring results for various pharmaceutical unit operations (e.g., weighing, dispensing, charging, granulation) will be discussed. Often ignored concerns for disinfectant exposure will be discussed based on a lesson learned from disinfectant exposure assessment. A workshop will be held among the PDC participants to discuss specific exposure assessment and control challenges among participants. Upon completion of the PDC, participants will be able to learn and share: •Representative (task-based and full-shift) exposure monitoring. Identifying excursion exposures and addressing challenges in high potent compound exposure monitoring. •Significance of surface wipe sampling in pharmaceutical industries. •Likely, API exposure levels, based on pharmaceutical unit operations’ exposure profiles. •Successfully substituted potentially harmful disinfectants. •Particulate containment technologies and their effectiveness in reducing exposure below API exposure limits. Solvent exposure profile and controls. •Work practices, zoning, gowning-degowning for potent compounds •Unique challenges in respiratory protection, including variability in APF.
Mehta et al. (Sat,) studied this question.