25 Mar Understanding Occupational Exposure ( OEL & OEB )

At extremely low airborne concentrations, Active Pharmaceutical Ingredients (API) have the potential to cause severe to significant health impacts in personnel. Containment devices or equipment should be used to control personnel exposure as part of a comprehensive approach to potent chemical safety.

Control bands can be assigned to APIs based on their potency. APIs are often classified using the occupational exposure limit (OEL) as a classification criterion.

The Occupational Exposure Band (OEB) is a system for categorising chemicals into “categories” or “bands” based on their adverse health effects and potency. In order to develop safe handling recommendations, it also groups compounds into groups based on OEL.

Criteria for Hazard Banding (OEB):

For each toxicological endpoint, there are qualitative, semiquantitative, and quantitative data.

Toxicity in the short term
Irritation/corrosion of the skin
Irritation/damage to the eyes
Sensitization of the respiratory and cutaneous systems
Mutagenicity of germ cells
Carcinogenicity
Single and repetitive exposure to specific target organ toxicity
Toxicology in the reproductive system

The Occupational Exposure Limit (OEL) is the maximum concentration of a substance in the air that virtually all workers may be exposed to for 8 hours per day, 40 hours per week without experiencing detrimental effects.

These are thresholds designed to avoid occupational illnesses, particularly in workers exposed to hazardous substances. Metals, salts, and other chemicals that do not produce vapours at normal temperature and pressure are frequently given OELs in mg/m3. If the material exists as a gas or vapour at normal room temperature and pressure, certain OELs are reported in units such as fibres/cc, whereas others are represented in parts per million (ppm).

The following criteria must be used to evaluate each application:

Dustiness of the product – the smaller the particle size, the more likely the powder may become airborne.
Unless the quantity/process make full isolation impractical, consider full containment (isolator) if the substance is cytotoxic/genotoxic and the need is in the 1-5 microgram range. Operators should employ supplementary protective equipment (complete air fed suit) if full isolation is not possible, and downflow booth room entry must be via an airlock.
The process – if the procedure, such as milling, transfers considerable energy to the powder.
The length of time it takes to complete the procedure – the longer the process takes.

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