chapter  3
10 Pages

Industrial Hygiene Aspects of Pharmaceutical Manufacturing

WithDonna S. Heidel

Industrial hygiene sampling is a process that quantifies the breathing zone concentration of a drug-active ingredient during a work activity. Before the industrial hygienist can begin to assess employee exposure, a laboratory experienced in the analysis of industrial hygiene samples of drug actives must develop an analytical method. The pharmaceutical industry has a long tradition of establishing internal occupational exposure limits for pharmaceutical compounds. Pharmaceutical compounds can be absorbed systemically through contact with contaminated needles, broken glass, or lacerations from contaminated equipment. Pharmaceutical compounds may function as primary irritants, can cause allergies, or can be absorbed systemically across the skin. Using a performance-based approach for managing employee exposures corrects the shortcomings of the traditional industrial hygiene process. The traditional industrial hygiene method of sampling employees’ breathing air is less viable for highly potent compounds due to constraints from the detection limits of standard High Pressure Liquid Chromatography analytical methods.