Believe it or not, but here at Affygility Solutions, a leading provider in potent compound safety services, we often get asked "What is OEL testing?” Well, it depends upon what exactly a person is asking. However, OEL testing can be defined as the physical collection of airborne (or surface level) occupational hygiene samples and comparing those results to an established occupational exposure limit (OEL) for an active pharmaceutical ingredient. These are typically performed using industrial hygiene sampling pumps or swipe samples. OEL testing cannot be performed remotely or by mathematical calculation, but needs to be performed onsite by a certified industrial hygienist. For remote regions of the world, this often makes the cost for performing OEL testing cost prohibitive. However, Affygility Solutions has the experience to help.

From the standpoint of Affygility Solutions, OEL testing means that a pharmaceutical company wants to obtain industrial hygiene (or occupational hygiene) air monitoring results to determine if their results are at or below the targeted occupational exposure limit (OEL) for an active pharmaceutical ingredient or a surrogate compound. These surrogate compounds typically include lactose, naproxen sodium, or mannitol. However, any pharmaceutical compound can be used as a surrogate for another compound. OEL testing is typically used to determine if containment systems (isolators, flexible containment) are adequate and/or if the level of respiratory protection is adequate such that assigned protection factors are not exceeded. OEL testing typically requires either personal occupational exposure level monitoring or area exposure monitoring using industrial hygiene methods that are conducted by certified industrial hygienists (CIH). While these methods seem fairly simple, sampling and quality control mistakes are often made. Experience matters!

It should be noted that just because a single “OEL testing” result is below or above the established occupational exposure limit (OEL) does not mean that a company is non-compliance with the occupational exposure limit. A significant amount of statistics and risk assessment methodologies need to be applied before an absolute determination that compliance or noncompliance can be determined.

The potent compound safety experts here at Affygility Solutions can assist. We have performed OEL testing in many countries throughout the world. If you need additional information please contact us.

Published July 15, 2021

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