Biopharma EHS Podcast Episode No. 16

Category 4 potent compounds or category 5 potent compoundsCategory 4 and Category 5 potent compounds – understanding the risks and example potent compounds are discussed in this episode of the Biopharma Environmental, Health and Safety podcast.  To listen to the podcast, click on the player below or visit the Biopharma EHS Podcast on iTunes.

Note: The below text is notes from the podcast, listen to the podcast for all the details.

Thursday, May 12th, 2011.

Discuss the following topics.

Review episode number 15

Mention main topic, “Category 4 or Category 5 Potent Compounds – Understanding the Risks”

Discuss upcoming events of importance to environmental, health and safety professionals in the BioPharma Industry.

Last Episode 15 we discussed the topic of “Control Banding – How many bands is enough?”  We discussed the issue of is it appropriate to take an occupational exposure limit for an active pharmaceutical ingredient that is on a material safety data sheet, and to use that OEL to directly place into a potent compound safety control banding system that is widely used in the pharmaceutical industry.  Also, in that episode we answered several questions on when determining an occupational exposure limits, how do you consider pre-clinical data from a subcutaneous dose and use it in an occupational inhalation exposure.

Alright, so lets now move into our main topic for today, which is titled the “Category 4 or Category 5 Potent Compounds – Understanding the Risks.”

We often get asked the questions “What makes a Category 4 or Category 5 potent compound?  In addition, we often get asked, “What are some examples of Category 4 or Category 5 potent compounds?”  In this article, Dr. Joe Nieusma, Senior Toxicologist with Affygility Solutions and Dean M. Calhoun, CIH, President and CEO of Affygility Solutions discussed answers to these two questions.

What determines a Category 4 or 5 Potent Compound?

Dean Calhoun: Welcome Joe. then “What determines a Category 4 or Category 5 Potent Compound?

Joe Nieusma: Really the determination of a Category 4 or Category 5 potent compounds comes from the evaluation of a compilation of toxicological data.  The categorization of a potent compound comes together by evaluating data in seventeen or eighteen different areas, and each one of those individual toxicological data areas go into determining an occupational exposure limit (OEL) or determining a control band, or if your simply looking to just categorize the compound into one of the many control bands out there – Category 1, Category 2, Category 3, Category 4, Category 5, or even Category 6 – depending upon your company’s own potent compound containment scheme.  These acute, right now health effects come into consideration when you’re trying to decide what category to assign to a compound.  Obviously, in a Category 4 or Category 5 compound, you’re going to have a lot of serious acute effects, and those acute effects are going to be life-threatening – potentially fatal, or these effects are going to happen real quickly – maybe within a hour. These are the types of compounds that are place in a Category 4 or Category 5 potent compound safety control band.

Other things that come into play – you talk about reversibility, and if you can treat this types of acute symptoms – are they going to go away?  Or, if it takes months or years for these effects to go away, these are characteristic of a Category 4 or Category 5 potent compound.

Examples of Category 4 and Category 5 Potent Compounds

DC:  Great, that answers that question.  Now, can you provide a few examples of Category 4 and Category 5 potent compounds and what characteristics makes those types of compounds?

Note: For the remaining text of this discussion, go to the Affygility Solutions website.

Alright, that does it for our main topic, let’s now talk about some upcoming events.

Note: Listen to the podcast for all the events.

Finally in August, we have several webinars starting.  These webinars have been very popular and we have received a lot of positive feedback on them.  In addition to our very popular webinar on Advanced Topics in Potent Compound Safety, we also have a webinar on Dermal Exposure to Active Pharmaceutical Ingredients, and our every popular isoflurane safety webinar.  Again, if any of that interests you, I would suggest that you go to and look at our full schedule.

Note: End of show.


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