The OEB (occupational exposure band) is a range of an airborne concentrations of an active pharmaceutical ingredient (API) that it is believed that an estimated OEL will be within the specified bandwidth of a company’s banding system. The occupational exposure band is often referred to as the occupational hazard classification (OHC). Airborne concentrations are typically expressed in micrograms/cubic meter and will require industrial hygiene monitoring to determine the airborne concentration in the specific workplace. Industrial hygiene monitoring in the pharmaceutical industry will require professionals with knowledge of pharmaceutical industry and the unique aspects that are involved in performing industrial hygiene monitoring within the pharmaceutical industry. Depending upon a specific company’s OEB system, there can be either 3, 4, 5, or even 6 bands. An occupational exposure band classification is typically based upon the performance-based occupational exposure limit (PB-OEL), which is determined by an expert toxicologist reviewing the pre-clinical and early stage clinical data set, and then estimating the occupational exposure limit. An OEB is based solely on the toxicology of the specific compound. The OEB should not be confused with occupational control banding, which defines the engineering, administrative and personal protective equipment needed to ensure safe handling. A risk assessment is the link between an OEB and a control band.
OEB categories are often referred to as OEB 1 (low hazard); OEB 2 (moderate hazard); OEB 3 (high hazard); OEB 4 (very high hazard); and OEB 5 (extremely high hazard);
Here at Affygility Solutions, our toxicology and industrial hygiene experts can assist you in assigning OEBs for all your active pharmaceutical ingredients. We have performed work for clients in over 48 different countries. Please contact us today for more information.