Active Pharmaceutical Ingredients – Do you need an occupational exposure limit?

Active Pharmaceutical Ingredients (apis)At Affygility Solutions, we often get asked, “Do I need an occupational exposure limit (OEL) for my active pharmaceutical ingredient (API)?”  Well, the short answer is “it depends.”  It depends upon the stage in which your active pharmaceutical ingredients are within the overall drug development process.

Potent Compound Safety Classification of Active Pharmaceutical Ingredients

Active pharmaceutical ingredients that are early in the drug development process typically don’t need an occupational exposure limit, and the amount of pre-clinical data is such that any OEL that could be established would be so overburdened with uncertainty and modifying factors that a numerical occupational exposure limit (OEL) would not be valid.  When an active pharmaceutical ingredient is in early development, simply classifying a potent compound into one of the common potent compound 4 0r 5 band potent compound safety classification schemes is adequate.  However, be careful when deriving an OEL for a early stage active pharmaceutical ingredient – the OEL can either be too high (which can cause exposures) or too low (the likely case, which can cause implementation of costly engineering controls).

Affygility Solutions can help with establishing a classification or OEL for your potent compounds.

At Affygility Solutions, we have significant experience in classifying active pharmaceutical ingredients and potent compounds into the standard potent compound classification schemes, as well as performing containment validation studies on glove boxes and isolators. Contact us today! We can help.

In addition, if you would like to know more, please registar for one of our Advanced Topics in Potent Compound Safety webinars.


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About Dean Calhoun

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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