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In-depth survey report: control technology assessment of unit operations employed in oral contraceptive tablet making operations at Ortho Pharmaceutical Corporation, Raritan, New Jersey.
Anastas MY; Caplan PE; Froehlich PA
Cincinnati, OH: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health, ECTB 105-13a, 1983 Nov; :1-47
An on site visit was made to the Ortho Pharmaceutical Corporation (OPC), Raritan, New Jersey to evaluate methods of controlling exposure to hazardous materials during the manufacturing of medications. OPC produced oral contraceptive tablets containing norethindrone (68224) (NOR), mestranol (72333), and ethynylestradiol (57636) (EE). Ventilation was an important engineering control at this site. Other engineering controls included the isolation of work procedures and automation of work practices for weighing ingredients, granulation of substances, tableting, and packaging. Area samples were taken for air monitoring of steroid concentration levels in each manufacturing area. Access to the work areas was only through the locker rooms. Samples taken in the locker rooms revealed no detectable contaminant levels. Workers performing high risk activities wore air supplied vinyl suits and disposable rubber gloves. The vinyl suits had overshoes attached. For moderate risk activities the workers wore a disposable suit, rubber gloves and shoe covers. Appropriate respirators were provided. Workers in low risk activities wore disposable rubber gloves and appropriate respirators. Sampling indicated that processing workers experienced breathing zone levels outside their vinyl suits of 16.40 and 0.36 micrograms/cubic meter of NOR and EE, respectively.
NIOSH-Author; NIOSH-Survey; Field-Study; Region-2; Pharmaceutical-industry; Laboratory-workers; Pharmaceuticals; Steroids; Hormones
68-22-4; 72-33-3; 57-63-6
Field Studies; Control Technology
NTIS Accession No.
National Institute for Occupational Safety and Health
Page last reviewed: September 2, 2020
Content source: National Institute for Occupational Safety and Health Education and Information Division