BioPharma EH&S Podcast Episode No. 15. – discusses listener questions on peptides/proteins and absorption, molecular size and skin absorption, and moving potent compounds from a 4 control band system to a 5-band system, and other control banding discussions.
Thursday, April 21, 2011. the twitter hashtag for today’s podcast is #biopharma15. I will put a link to how to use hashtags in the shownotes:
First, I’ll briefly cover what we talked about last time in episode 14
Answer some of listener questions, which will lead us into our main topic for today, which is Control Banding – how many bands is enough?
Discuss upcoming events and happenings.
In Episode 14 we discussed the topic of “Young Guns of Environmental, Health and Safety.” Which was mainly about the younger generation of environmental, health and safety professionals that are entering the workforce. It that episode we discussed some of their priorities, communication styles, and technology interests. The audio and video portion of this presentation is available online (click on above link).
Questions on peptides and protein therapeutics.
Questions on skin absorption and molecular size, and the maximum amount of skin absorption.
We have another question regarding control banding.
In some cases, we have MSDS’s that list an acceptable occupational exposure limit (or similar terminology). Is it reasonable for us to translate those numbers directly into the control band categories? For example, if I have an MSDS that lists a TWA exposure limit of 5 ug/m3. On a four band system I have that category 3 means OELs ranging from 30 ng/m3 to 10 ug/m3. So is that a reasonable justification for us to communicate that the compound is Category 3 (per the information in this MSDS)? Without repeating the risk assessment of all the factors that go into it (and having someone sufficiently trained on how to put them together.)
Control Banding – How many bands is enough?
Thank you Corinne for the question. A couple of comments here. The first comment is that you should remember that placement of a compound into a control band category or control banding system should be based on a whole picture approach, not just the occupational exposure limit (OEL). The OEL is only one factor that you need to consider – potential for skin absorption, irritation, sensitization and other effects need to be consider. Placement of a compound into a hazard category and determination of the OEL is based on the toxicology of the compound.
The second comment is the number of control bands that you have in your control banding system really depends upon the number of engineering control options available to your company. The number of control bands should be company specific, and that the width of each of the bands should be based on a solid understanding of your industrial hygiene and containment validation.
The final point is risk equals hazard times probability. As we mentioned, the hazard of the compound depends upon its toxicology, the probability of exposure depends on many factors such as physical form, such as a dry powder, wet cake, or liquid, and the quantity handled, the frequency handled, the duration handled and many other factors. So you need to consider both the hazard of the compound and the probability of exposure when assigning a risk.
So to answer the question, “Control Banding – How many bands is enough?” It really depends upon the number of control options available to your company, and the breath of potent compounds that you may handle. When establishing a potent compound safety program, design your control banding system well. Don’t just automatically adopt someone elses.
Comment from Nicole.
Hello Dean –
I was at a company that used a 5 band system. At my current company, it
is a four band system . Since most of our compounds are in early stage development, every compound is in the same default band.
The presentation was very good. Obviously, both of you have a lot of experience. It was very good to hear the case studies.
First off, thank you Nicky so much for the kind comments Joe and I really appreciate them.
That does it for our questions, if any of you have any other questions please email them to me at firstname.lastname@example.org
That does it for our main topic on control banding, let’s now talk about some upcoming events.
Also, as a final note, here at Affygility Solutions we have been working very hard on our compliance management and corrective action system – Affytrac. Just recently we have been testing it on tablet computers and other mobile devices. It works great on the Android Motorola Xoom tablet, as well as the iPhone.
Remember to submit your questions by email to email@example.com and follow us on twitter at twitter.com/Affygility, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions.
Thanks for listening in about Control Banding today.