Highly Potent API Sampling – what to do?

Typically in the biotechnology and pharmaceutical industry, if you’re interested in air sampling for highly potent APIs (active pharmaceutical ingredients) you will need to have a product specific air sampling method developed. Development of this type of method will need to be performed by an industrial hygiene laboratory with experience in industrial hygiene air sampling methods for active pharmaceutical ingredients. In the United States, there are only a few IH labs that I personally feel confident with recommending, and you will need to have a method developed that will get down to at least 10 percent of the occupational exposure limit. This means that you will need to have a qualified occupational toxicologist develop this occupational exposure limit prior to having the air monitoring method developed. With some of the OELs for these compounds down in the ng/cubic meter of air range, you will need to have extremely sensitive methods and excellent industrial hygiene practices. If you need more information please feel free to contact Dean Calhoun at 303-884-3028.


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