In-depth survey report: control technology assessment of unit operations employed in oral contraceptive tablet making operations at Mead Johnson and Company, Evansville, Indiana.
Control technologies employed at Mead Johnson and Company (SIC-2834) oral contraceptive tablet manufacturing facility in Evansville, Indiana, were evaluated on February 7 to 11, 1983. Processing and tableting of oral contraceptives were performed in the steroid area, while packaging was performed elsewhere. Three workers were involved in the production of contraceptive granulation. Ingredients for several batches, including ethinyl-estradiol (57636) (EE) and norethindrone (68224) (NOR) were prepared simultaneously. Concentrations of EE and NOR in the breathing zone of workers outside the personal protective equipment were measured. The hazard control techniques of interest were engineering controls including isolation, ventilation, and automation; work practices; exposure monitoring; and personal protective equipment. The geometric means for EE exposure in the dry milling, wet milling, and cleanup operations were 1.36, 0.67, and 0.26 micrograms per cubic meter, respectively. Comparable values for NOR were 22.71, 13.60, and 2.0 micrograms per cubic meter, respectively. Actual worker exposures were about 0.01 to 0.001 percent of these values since respiratory protective equipment was worn. The author concludes that workplace concentrations of NOR and EE are reduced by a system of controls consisting of engineering safeguards, personal protective equipment, worker training, and environmental and medical monitoring.