Whiteboard Friday: What determines the Category 1-4 of a potent active pharmaceutical ingredient?

In this episode of Whiteboard Friday, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions, answers the listener question, “What determines the Category 1-4 [of a potent active pharmaceutical ingredient], the biological activity or the OEL?

Understanding Occupational Health Categorizations (OHC) vs. Control Bands

Before viewing the video below, it’s important to understand that the occupational health categorization (OHC) of a specific active pharmaceutical ingredient is determine by reviewing the entire toxicological profile of the API and then calculating the occupational exposure limit (OEL). Once the OEL is determine, the occupational toxicologist will then use the OEL and other information to assign an OHC to the compound. Therefore, the OEL and OHC is based solely on the toxicology of the compound.

The industrial hygienist will then look at the OEL and the OHC assignment and place it into a given control band. A control band is a function of the control capabilities of the combination of engineering, administrative and personal protective equipment. The number of control bands will differ amongst organizations, depending upon the number of options that they have available at their facility.

While we would like to think that there is a 1:1 relationship between the OHC vs. the Control Band, it may not always be the case. For example, you may have a compound with a fairly large numerical OEL, but have a concern over skin irritation. In that case, you might assign it to a higher control band to further prevent skin exposure.

If you have additional questions, tweet them to @affygility with the hashtag #potentsafety, or submit them via the “Contact Us” form on the Affygility Solutions’ website.


About Dean Calhoun

view all posts

Dean is the President and CEO of Affygility Solutions. Affygility Solutions provides environmental, health and safety software, potent compound safety, industrial hygiene, containment validation services to the pharmaceutical, biotechnology, and medical device industry. "Dean's Google+ Profile"

Affygility Solutions - provider of potent compound safety, webinars, and compliance management software