Active Pharmaceutical Ingredients (API) have the prospect to bring about severe to serious health effects in personnel at very low airborne concentrations. The use of containment systems or equipment, as an integral part of an efficient method to potent compound safety, is recommended to control personnel exposure.
APIs can be classified into control bands based on their potency. Generally, APIs are categorized by occupational exposure limit (OEL) as a classification measure.
Terms:
OEB – Occupational Exposure Band ia a mechanism used to precisely assign chemicals into “categories” or “bands” based on their adverse health outcomes and potency considerations. It also aligns chemicals in groupings based on OEL in order to establish safe handling guidelines.
*Almost every facility has their own version
Hazard Banding (OEB) Criteria:
These include qualitative, semi‐quantitative, and quantitative data for each toxicological endpoint.
• Acute toxicity
• Skin corrosion/irritation
• Serious eye damage/eye irritation
• Respiratory and skin sensitization
• Germ cell mutagenicity
• Carcinogenicity
• Specific target organ toxicity, both single and repeated exposure
• Reproductive toxicity
OEL – Occupational Exposure Limit is the airborne concentration of a compound to which nearly all workers can be repeatedly be exposed to for 8 hours a day, 40 hours a week, without adverse effects.
These are values set to prevent occupational diseases, notably in personnel exposed to harmful chemicals in the workplace. OELs are often expressed in mg/m3 especially for metals, salts and other compounds that do not form vapours at room temperature and pressure. However, some OELs may be expressed in units such as fibres/cc while a few are expressed in parts per million (ppm) if the substance exists as a gas or vapour at normal room temperature and pressure.
