Biopharma EHS Podcast Episode No. 15

Biopharma EHS

BioPharma EHS Podcast Episode No. 15 - Thursday, April 21, 2011. We have a lot of great things to talk about. But before I tell you what were going to discuss I should mention that the twitter hashtag for today’s podcast is #biopharma15. For those of you that don’t know how to use Twitter and believe it’s useless, you should really try it out. OSHA, the EPA, NIOSH and many other agencies and organizations are using twitter. I will put a link to how to use hashtags in the shownotes:

http://mashable.com/2009/05/17/twitter-hashtags/

O.k., so what are we going to discuss in today’s podcast. In today’s podcast, we’re going to talk about the following topics.

First, I’ll briefly cover what we talked about last time in episode number 14

Then, we will answer some of listener questions that where sent in, which will lead us into our main topic for today, which is Control Banding – how many bands is enough?

And finally, I’ll then discuss upcoming events and happenings of importance to environmental, health and safety professionals in the BioPharma Industry.

So, let’s go ahead get started. Last time 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 and I will put a link to the presentation in the shownotes.

Questions on peptides and protein therapeutics.

Questions on skin absorption and molecular skin, 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.)

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 should be based on a whole picture approach, not just the 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 really depends upon the number of 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 containment validation. I’ve seen companies that were using powders weighing hoods, but because of poor work practices were not getting anywhere near the level of containment they should be achieving.

The final point is risk equals hazard times probability. As we just 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. For example, you can have a hazard category 4 or 5 compound in a sealed double container and the probability of exposure is almost zero, so the risk of handling the sealed drum is almost zero.

O.k. are next comment is 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.

Thank you,

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 podcast at Affygility.com

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

The first event that I would like to mention is the annual American Industrial Hygiene Conference and Exposition is coming up on May 14-19th in Portland, OR. I won’t be attending the conference this year since my daughter is graduating from high school during that time.

Then in June, on the 12th through 15th, we have the American Society of Safety Engineers Annual Conference in Chicago, IL.

O.k. That does it for this week’s show. Remember to submit your questions by emailing [e-mail] and stalk 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.

That does it for this week’s show. We look forward to having you listen in next time.