PERFORMANCE-BASED EXPOSURE CONTROL LIMITS FOR PHARMACEUTICAL ACTIVE INGREDIENTS

For many years pharmaceutical companies have established employee expo sure limits for the active ingredients used in their products. Histori cally these limits were derived using traditional risk assessment meth ods. Because the trend in the pharmaceutical industry is to identify a nd develop more selective drugs of increasing potency,and because of t he difficulty in identifying no-effect levels for certain drugs, a new performance-based approach for setting limits was developed. This met hod involves assigning materials into one of five hazard categories ac cording to their inherent toxicological and pharmacological properties . The criteria used to assign compounds into performance-based exposur e control limit (PB-ECL) categories focus on the degree to which expos ure impacts human health. These assignments dictate the level of conta inment required to assure employee safety that is achieved through the use of engineering controls and safe handling practices. Several matr ices were developed to specify general design concepts and controls fo r unit operations in laboratory and manufacturing operations. Containm ent options range from conventional handling practices for low potency (PB-ECL Category 1) materials, to technologically advanced systems th at result in essentially no open handling for potent or toxic (PB-ECL Category 3) materials, to state-of-the-a rt facilities employing close d processes and use of robotics for extremely potent (PB-ECL Category 5) materials.