Biopharma EHS

In this presentation, Dean M. Calhoun, CIH, with certification in industrial hygiene by the American Board of Industrial Hygiene (ABIH) discusses the key concepts and principles that need to be considered when auditing biotechnology and pharmaceutical facilities for potent compound safety issues. His talk was presented at the World Highly Potent Active Pharmaceutical Ingredient Summit in Philadelphia, PA in June of 2012. If you have any questions regarding potent compound safety, EHS auditing, occupational toxicology or industrial hygiene, please contact Affygility Solutions.

Nanotechnology and the Pharmaceutical Industry - an interview with Don Ewert of OSO Biopharmaceuticals.

Hello everybody and welcome back to another episode of the BioPharma EH&S Podcast, my name is Dean Calhoun of Affygility Solutions and this is the podcast dedicated to discussing critical environmental, health and safety issues facing the biopharma industry, helping you take your environmental, health and safety programs to the next level.

Overview

I’ll briefly cover what we talked about last time in episode number 17

Then I will cover our main topic for today, which is an interview with Don Ewert, Environmental, Health and Safety Manager for OSO Biopharmaceuticals. In this interview Don and I will discuss nanotechnology and some of the key environmental, health and safety issues surrounding this emerging technology

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

So, without further delay, let’s go ahead get started. Last time in Episode number 17 we discussed the topic of “Containment Validation and Surrogate Monitoring.” In that Podcast, Matt Meiners, Laboratory Services Manager for Bureau Veritas and I discussed what is surrogate monitoring, some of the key factors to consider when selecting a surrogate compound, and finally, what are some of the common mistakes that occur when performing containment validation and surrogate monitoring. It was a great interview, and I appreciate Matt taking the time out of his busy schedule to participate. If that’s something that may interest you, I would suggest that you go back and listen to Episode 17.

Alright, let’s now move on to our main topic for today which is an interview with Don Ewert, Environmental, Health and Safety Manager on nanotechnology. I should mention ahead of time, that this section of the podcast was recorded on January 19th, 2012 via Skype. There is a few instances where we have a Skype garble moment, so I do apologize in advance for that. So without further delay, here we go.

[audio portion]

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

The first set of events that I would like to mention is in early February. In February, Affygility Solutions has several webinars starting and I would suggest that look at our schedule at Affygility.com. These webinars have been extremely popular and we have received a lot of positive feedback on them. In February, we have a new webinar on Manufacturing Highly Potent Compounds – Understanding and Controlling the Risks. This is a brand new webinar and we are very excited to be premiering it. It you are an certified industrial hygienist and involved in potent compound safety, certification points are available. Additional webinars for the month of February include our every popular isoflurane safety webinar. Again, if any of that interests you, I would suggest that you go to Affygility.com and look at our full schedule.

The next event that I would like to mention is the annual Society of Toxicology conference to be held on March 11th through 15th in San Francisco. Affygility Solutions won’t be exhibiting at this conference, but our Senior Toxicologist, Joe Nieusma, may be attending. If you would like more information on this conference go to the Society of Toxicology’s website at sot.org

Then at the end of March, the Society of Chemical Hazard Communication will be having it’s Spring Meeting in Nashville, TN. We haven’t decided if we will attend this meeting or not, but in any case, these are usually very informative event and with GHS due to be finalize in early 2012 I’m sure there will be great sessions. You should go to their website for more information. The URL for their website will be in the show notes.

O.k. That does it for this week’s show. Remember to submit your questions to our podcast email at podcast at Affygility.com. You can also follow us on twitter at twitter.com/Affygility, on Facebook at facebook.com/affygilitysolutions 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.

About Affygility Solutions. Affygility Solutions provides environmental, health and safety software and services to the pharmaceutical, biotechnology, and medical device industry.

Have a great rest of the day.

Containment Validation and Surrogate Monitoring

In this episode of the Biopharma EHS podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions discusses the following topics:

• A review of Episode no. 16 of the Biopharma EHS podcast. In that episode, Dean M. Calhoun, President and CEO of Affygility Solutions, and Dr. Joe Nieusma, Sr. Occupational Toxicologist with Affygility Solutions discuss Category 4 and 5 potent compounds. Our discussions include what factors determine a Category 4 or 5 potent compound, why the occupational exposure limit (OEL) alone is not enough to determine if a specific compound falls into a category 4 or 5 control band, and specific examples of potent compounds that are classified into these control bands.
• An interview with Matt Meiners, Division Manager, Laboratory Services for the Bureau Veritas, Lake Zurich, Industrial Hygiene Laboratory. In this interview, Dean and Matt discuss containment validation and surrogate monitoring. Often call SMEPAC testing. Matt provides insight into why containment validation is necessary, the advantages and disadvantages of different surrogate compounds, the sensitivity of their industrial hygiene laboratory methods for surrogate compounds, the advantages and disadvantages of the total dust versus the Institute of Occupational Medicine (IOM) method of sampling.
• Upcoming events and happenings of interest to environmental, health and safety professionals in the biotechnology, pharmaceutical, and medical device industries. These events include:
• Affygility Solutions' webinars. These webinars include:
1. Advance Topics in Potent Compound Safety
2. Dermal Exposure and Absorption of Active Pharmaceutical Ingredients
3. Isoflurane Safety
• Society of Toxicology Annual Meeting in San Francisco, CA
• Society of Chemical Hazard Communication Spring Meeting in Nashville, TN
• The above webinars are a great way for environmental, health and safety professionals to obtain certification maintenance points.

If you have questions regarding this podcast, please email podcast @ affygility.com

In this podcast, Dean M. Calhoun, CIH and Joe Nieusma, Ph.D. of Affygility Solutions discuss Category 4 and Category 5 Potent Compounds - Understanding the Risks.

Items covered include:

• Review of the last podcast
• What factors go into determining an active pharmaceutical ingredients as a Category 4 or Category 5 potent compound
• We provide examples of Category 4 and Category 5 potent compounds
• Review upcoming events and happenings related to environmental, health and safety in the biotechnology, pharmaceutical, and medical device industry.

If you have any questions please contact Affygility Solutions at 303-884-3028 or visit the Affygility Solutions website.

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 [email protected] 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.

Our main topic for today is the Young Guns of Environmental, Health and Safety

[listen to podcast for details]

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

First I should mention, that coming up next week, we have several new webinars starting and you should look at our schedule at Affygility.com. These webinars have been very well attended 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, Global Harmonization System, Hazardous Wastes for Hospitals, Clinics, and Medical Laboratories. Again, if any of that interests you, I would suggest that you go to Affygility.com and look at our full schedule.

O.k. That does it for this week’s show. Remember to submit your questions to our voicemail feedback line at 206-337-4769 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.

Have a great rest of the day.

In this podcast, Dean Calhoun of Affygility Solutions discusses Social Media and Environmental, Health and Safety

The twitter hashtag for today’s podcast is #socialehs

First, I’ll briefly cover what we talked about last time in episode number 12

Then I will cover our main topic for today, which is the use of Social Media in Environmental, Health and Safety industry.

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

Last time in Episode 12 we discussed the topic of “Creeping Featurism of Environmental, Health and Safety software." In that episode I shared my four observations regarding the evolution of environmental, health and safety software. Those four observations were, first, everybody seems to want a comprehensive system that is off the shelf. Complete with every bell and whistle, and one that keeps track of every possible requirement, emission, or metric. The problem I have with this is, “in most companies with limited environmental, health and safety staff who is going to enter all this data?” My 2th observation was that an environmental, health and safety management system is not equal to MIS, my 3rd observation was that configuration does not equal customization, and my 4th and final observation is that comprehensive systems are pricey. In episode 12 I also shared some questions that you might want to ask yourself prior to selecting a system. So, if any of that interests you I suggest you go back and listen to episode 12 and listen to the whole thing.

Alright, now before we move into our next topic, I might indicate that it’s going to be slightly different than previous topics that I’ve discussed. For those of you that have been listening in to previous episodes, most of you know that I recently attended South by Southwest Interactive in Austin, Texas. First off South by Southwest was an amazing conference and the speakers were great, and the attendees were awesome – all 19,000 plus of them. Many of the sessions that I attended dealt with social media and that inspired me to talk about today’s main topic, which is the use of Social Media in Environmental, Health and Safety.

· So what exactly is Social Media?

· So why Social Media?

· Who is using Social Media? OSHA, NIOSH, U.S. Environmental Protection Agency all have Facebook pages and twitter feeds. The National Association for Environmental Management (NAEM), American Industrial Hygiene Association (AIHA), American Biological Safety Association (ABSA) and many other professional organizations.

· What’s the value in Social Media?

Who is doing it right?

What are the challenges of social media.

· As a final comment regarding social media, allow the users to have an opinion and to be human. Social media can get a little messy at times with mis-spelled words, the use of slang or jargon, and the occasional use of profanity. As stated before, it will have to be moderated, but again, be careful not to over moderate.

O.k. The does it for the discussion on “Social Media in Environmental, Health and Safety.” If you have any comments or feedback – I loved to hear it. You can call our listener voicemail feedback line at 206-337-4769 and leave an audio comment. You can also stalk us on twitter at twitter.com/Affygility, or follow us on Facebook by just searching for Affygility Solutions and giving us a “Like. You can also email us your comments at podcast at Affygility.com.

Alright, let’s now talk about some upcoming events.

First I should mention, that coming up in April, we have several new webinars starting and you should look at our schedule at Affygility.com. These webinars have been very well attended 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, Global Harmonization System, Hazardous Wastes for Hospitals, Clinics, and Medical Laboratories. Again, if any of that interests you, I would suggest that you go to Affygility.com and look at our full schedule.

Finally, as mentioned in previous podcast, I’ve been working on a podcast about the Young Guns of Environmental, Health and Safety. So far, I’ve had over 100 participants complete the survey. This week I will be working on tallying up the results and will have a free webinar presenting the results this coming Thursday, March 31st. For details on the time and how to register, please go to potent compound safety.com.

O.k. That does it for this week’s show. Remember to submit your questions to our voicemail feedback line at 206-337-4769 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.

BioPharma EH&S Podcast Episode No. 12. Saturday, March 5th, 2011 and we have so much to talk about today, so I’m going to get right into it.

First off, I’ll briefly cover what we talked about last time in episode number 11

Main topic for today :“Creeping Featurism in Environmental, Health and Safety software”, which I’m quite certain sure will stir up some controversy.

Last time in Episode 11 we discussed the topic of “The Evolution of EHS Compliance and Operational Risk Management Software.” Unfortunately I don’t have time to cover all the details today, but basically we covered the history of compliance software systems and tools, and where the future of EHS software is heading. If any of that sounds like something that might interest you, I would suggest you go back to episode number 11 and listen to the whole thing.

Let’s now get into our main topic for today which is

As many of you know, this past week I was in San Antonio, Texas at the National Association for Environmental Management’s Management Information Systems conference. At this conference, there were numerous presentations by companies that have recently gone or going through the process of implementing an environmental, health and safety management information system. In general, the presentations were good and the organizers did a great job of keeping everything on track, but as with most conferences, the best part of the conference was the excellent conversations in the hallway with your peers and colleagues, and the opportunity to meet new people. However, as I thought about the presentations more, in some respects, I would like to see a presentation style similar to the DEMO conference. Most of you listening to this podcast probably have never heard of DEMO, but DEMO is conference that is held twice per year, where technology developers are selected to showcase their latest technologies in front of venture capitalist, the technology media, and other technology interest groups. DEMO is a pay to present type of conference and their presentation requirements are fairly unique – there is no Powerpoint allowed, and you have to use a “live” system not an install that on a local machine, and you get a very short amount of time to show what your system does – I believe it’s six minutes. This style of presentation places a lot of pressure on the solution providers to make sure that their systems are clean, fast, and easy to explain. “Bloatware” will not survive this kind of presentation style. I will put a link to the DEMO conference website in the show notes.

However, backed to the conference in San Antonio, based on the presentations of the environmental, health and safety software that I saw, I have the following observations.

• First off, everybody seems to want a “comprehensive” systems that will do everything. They want it to handle everything from accident reporting to industrial hygiene, from carbon footprint reporting to sustainability reporting. But despite what the solution providers will tell you, this dream system doesn’t really exist, at least not in an off the shelf version. Solution providers tend to be reacting to perceived customer needs and keep adding module after module. While this may provide the impression of comprehensiveness, I might mention that with all this increased “comprehensiveness” comes a significant increase in “complexity” of user interfaces. Based on the seven or eight systems that I saw during my two days in San Antonio, most of the user interfaces were very, very cluttered.
• The second observation or take home point was, and as I believed as one of the speakers stated, make sure that your people understand that an environmental, health and safety management system, or EMS, is not about the software or your management information system. In other words – an EMS is not equal to MIS. The software is just a tool to support your EMS.
• The third observation was, understand that “configuration” does not equal “customization”. Much of the costs of implementing an environmental, health and safety software solution arise when the company insists that the system have certain features that are unique to their company. If you want to keep costs down and ensure rapid implementation - get a system that is easily configurable and works “off the shelf”. As soon as you start demanding customization, expect the costs to go up significantly and the time for implementation to get much longer.
• And finally, the fourth observation was that these comprehensive systems are pricey. If I recall correctly, at the closing presentation, based on a survey of its members, the typically budget for an EH&S-MIS system was somewhere between 100 thousand to 500 thousand per year.

So there you have my four observations 1) Everybody wants a comprehensive system that is off the shelf, 2) EMS is not equal to MIS, 3) configuration does not equal customization, and 4) comprehensive systems are pricey.

So if you’re considering selecting and implementing an EHS-MIS, I’d like to propose that you ask yourself several questions.

The first question you need to ask yourself is “Where’s the value?” When scoping out a system keep a laser like focus on the value rather than the features or comprehensiveness. Make sure that you are creating something that serves a real business outcome and not creating “bloatware.” From my perspective, companies are attempting to track too many things that really don’t advance the value of the company. And when I talk about “value” I don’t necessarily just mean economic value. In one presentation, I believe the presenter indicated that when they scoped out the user requirements they initially came up with 24 health and safety tracking requirements, and 34 sustainability requirements. Ask everyone “where are the value added measurements?” Which of these measurements are critical for reducing operational risk, improving the profitability of the company, or reducing significant amounts of pollution or wastes?

Ask yourself “What is the end user really willing to do?”When scoping out user requirements for an environmental, health and safety management information system be very careful when listening to the end user. In other words, don’t listen to what they tell you - watch what they do. Instead of asking what they want, ask what they are they willing to spend their valuable time and money on. The end user always, always wants ultimate flexibility. They want corporate colors and font, the ability to move the field input box from the left to the right, the ability to sort environmental, health and safety data by every possible way, draw every possible graph, and add custom fields at their leisure. Please understand, that while all of this is very doable, it does come at a cost. So, instead of asking about what features or requirements they want, ask them if they are willing to stay at work till 7:00 each Friday night of every week entering this data. I’m quite certain that you will get your answer very soon. Reducing complexity will improve data integrity.

Ask yourself “How can we reduce complexity?” Instead of always thinking about what features we should add, think about what we should remove instead of what we should add. Don’t get sold on all those pretty graphs that only impress yourself and your team. Instead think about flexibility. If you want those pretty graphs does the system have the flexibility to dump the data to Excel and then you can spend your personal time at night creating the graph in the official corporate colors and fonts.

What single requirement do we need to do very well?Look at what the biggest EH&S challenge facing your company is, and fix that problem in a meaningful way. Don’t worry about tracking the difference between potable and non-potable water usage when you’re having 60 occupational fatalities per year. Fix the bigger issues first.

Ask, How long is the implementation? At the conference, one company indicated that they were 2 ½ years into implementation. What? To me that equals lots of time in meetings and paying a team of consultants many, many billable hours. Consultants love this kind of stuff, because it means job security to them.

Ask, Who is on the selection and implementation team?EHS, IT, and Purchasing on the decision team - that’s a bad combination. What about operations? What about finance?

Ask, What defines success? When embarking on any software project understand that there’s risk involved – risks of cost and schedule overruns, and risk of creating a system that never get adopted by the end users. According to the Standish group, in the United States, only 16.2% of software projects are completed on time and on budget. In larger organizations, only 9% of software projects meet those goals. According to the Standish group, the average cost over run is 189% of the original cost, and the average time overrun is 222% of the original time estimate. According to their report, the 3 major factors that determined the “success” of the project was user involvement, executive management support, and clear statement of requirements.

What will our future workforce be like? Understand the future of your workforce and current trends, not the old. The future of environmental, health and safety professionals that will be entering the workforce in the next 10 years are very different than the “decision makers” of today. They are smart, comfortable with technology, used to rapid change, demand instant feedback, and are very mobile. They have practically grown up with a smartphone such as a Blackberry, iPhone or Android in their hands, and are deeply involved in Facebook, Twitter, Youtube and LinkedIn. Their needs, their demands will be very different from ours. Figuring out ways to increase user engagement with this generation of environmental, health and safety professionals will be challenging for even the best of us.

In closing this part of the podcast, I’d like to say that EH&S software, can be beneficial to any company, but be you need to be very clear about your expectations. In addition, always, always look to simplify processes, rather than making more comprehensive. Otherwise, your risk of failure rises significantly. Sometimes a simple and affordable environmental, health and safety software solution that works off the shelf is best.

O.k. The does it for the discussion on “Creeping Featurism in Environmental, Health and Safety software. If you have any comments or feedback – I loved to hear it. You can call our listener voicemail feedback line at 206-337-4769 and leave an audio comment. You can also stalk us on twitter at twitter.com/Affygility, or follow us on Facebook by just searching for Affygility Solutions and giving us a “Like. You can also email us your comments at podcast at Affygility.com.

Alright, let’s now talk about some upcoming events.The first event is the Society of Toxicology meeting on March 6th through 10th in Washington, DC. Dr. Joe Nieusma, Senior Toxicologist with Affygility Solutions will be attending this event, so if you would like to meet with Joe let me know.

Next, on March 11th through 15th, I will be attending South by Southwest Interactive in Austin, Texas. I’ve been looking at the schedule of sessions and events that will be happening at South by Southwest and it is amazing. This event has nothing to do with environmental, health and safety, but more to do with interactive technologies.

Then I should also mention, that coming up in April, we have several new webinars starting and you should look at our schedule at Affygility.com. These webinars have been very well attended 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, Global Harmonization System, Hazardous Wastes for Hospitals, Clinics, and Medical Laboratories. Again, if any of that interests you, I would suggest that you go to Affygility.com and look at our full schedule.

BioPharma EH&S Podcast Episode #11

• Discuss: The Evolution of Environmental, Health and Safety Compliance and Operational Risk Management Software
• Upcoming Events and Happenings of Importance to Environmental, Health and Safety professionals in the BioPharma industry.

Hello everybody and welcome back to the Biopharma EH&S Podcast, Episode #11, it's Saturday, February 26th, 2011. And this is the podcast helping you take your environmental, health and safety program to the next level.

This next week, on Tuesday, I will be heading to San Antonio, Texas for the National Association for Environmental Management (NAEM) Management Information Systems conference which will be happening on Wednesday and Thursday, and then on Thursday of the following week I will be heading to Austin, Texas for South by Southwest.

So the first thing that we always go over is to review what we talked about in the last episode, then we will cover our main topic for today, which is "The Evolution of Environmental, Health and Safety Compliance and Operational Risk Management Software". Then after that we will discuss important events and happenings of importance to EH&S professionals in the biotechnology, pharmaceutical, and medical device industry.

As a podcaster, having listener questions and feedback is extremely important and it would me a lot to me. So, please call our listener voicemail feedback line at 206-337-4769 with your questions regardingenvironmental health and safety software, potent compound safety, industrial hygiene, and anything else related to EH&S in the Biopharma Industry.

In Episode #10 we discussed "Industrial Hygiene in the Pharmaceutical Industry." In that discussion we talked about the strategies for managing a potent compound safety program in the pharmaceutical industry is actually similar to managing a traditional industrial hygiene program, however, the big difference is that many of the compounds have occupational exposure limits that are significantly lower than those of traditional industrial chemicals, and that you will have to place an emphasis on engineering controls in order to achieve acceptable airborne concentrations.

So, let's go ahead and move into our main topic for today, which is:

So what exactly is EH&S Compliance and Operational Risk Management Software? Well that can mean many things to many different people and companies. For some companies that are somewhat in the reactive mode - it may mean just tracking occupational injuries, accidents, and claims. For others, for those companies that are slightly more proactice - it may mean audit finding tracking, corrective action tracking, and leading indicator tracking. And for the more advance companies it can mean tracking sustainability efforts, and greenhouse gas reduction efforts. It also can mean authoring and managing material safety data sheets, air emissions reporting, hazardous wastes management generation tracking, industrial hygiene data management, and many, many other environmental, health and safety program elements.

So, let's step back for a moment and talk a little about the history of environmental, health and safety compliance software, and operational risk management software. Back in the mid-1980's when I started in the environmental, health and safety field I was working for Waste Management of North America as an Environmental Coordinator. Back in those days I remember that the majority of EH&S tasks were done by paper, and completion of paper-based forms. I also recall that EHS professionals were largely the people with the big binders on their bookshelves containing all the company EH&S rules and programs. At that time, at least at the entry level, personal computers in the workplace were rare. Then as we approached the 1990's a few computers starting appearing around the office, but were pretty much exclusively limited to divisional presidents, directors, and an administrative assistant or two. I still recall, looking out my office door, and seeing our library of federal and local regulations that covered the entire wall in one of our common areas. Then in the late 1980's, our first safety management software system appear. It was a DOS based system used for reporting occupational injuries, accidents, and other claims. It was basically, a workers' compensation and liability claims management system. So, it was really an operational risk management software tool. Still at that point, data entry into the system was primarily done by the admins, and the EH&S management would receive a printed report once per month. As more and more people in the office begin to have dedicated computers, everyone started to get creative in using them to manage various issues, including environmental, health and safety. I believe the first EH&S software tool that I every developed was a Lotus 1-2-3 spreadsheet used to track employee training.

Then in 1990, the next environmental, health and safety management software tool that I recall using was a system called CMS, which stood for Compliance Management System, and as the name refers to, it was primarily a PC-based system to manage EH&S compliance tasks and requirements. It was ugly, but it actually worked quite well. The one challenge however, was in those days, implementation was a pain. A team of people would come out for a week or more, review every permit, every requirement and input them by hand into the environmental, health and safety software system.

Then around 1993, I recall my first experience with the world wide web - I clearly remember that I was in the office of the IT manager who's office was next to mine, and using Mosaic we pulled up the Center for Disease Controls' website.

After that event, I remember that information technology just exploded, and in March of 1993, I attended the Global Environmental Management Initiative meeting in Pentagon City. During that meeting, there was a presentation about integrating right-to-know information at Dupont. It was basically centered around managing material safety data sheets. During that same time frame, I recall seeing a presentation by Bill Sugar on Anheuser-Busch's Environmental Management System, which was originally written in Lotus Notes. It had it's shortcomings, but with the leadership of Bill Sugar and his team of environmental, health and safety professionals they took EH&S management to a whole new level. We then began to see environmental, health and safety software move from compliance-focused, and regulatory reporting focused to more of a total quality management approach. With the emergence of ISO14001 and OHSAS 18001 managing data began more important. In addition, with increase demand for corporate transparency, the need for rapid access to environmental, health and safety data became even more important.

So, that's some of the early history of environmental, health and safety software. And were do we stand today? Well, that vast majority of environmental, health and safety management systems are web-based. Everyone has an email, everyone has access to a computer. Our cell phone's have more computing power than my first computer. Most major corporations collect and report all kinds of environmental, health and safety data. The majority of this data is readily available to anyone with a computer.

So what challenges do we face today? First off, reducing complexity. As a provider of environmental health and safety software, we have to realize that not every company is going to have a full-time administrator to run these complicated systems. More features, doesn't necessarily mean better. If you think about it, the one reason text messaging and twitter is so popular is that if you can't say it in 140 characters then you're saying too much. Second, there's too many companies offering EHS software solutions out there, there has to be, and will be some industry consolidation.

So, what's in store for the future of environmental, health and safety software? Well,EH&S mobile apps, like Affytrac mobile will become more important. I also have addditional thoughts, but prefer to keep those to myself for now.

Alright, so that does it for our discussion on "The Evolution of Environmental, Health and Safety Compliance and Operational Risk Management Software"

So here's events and happening for environmental, health and safety professionals.

Next week, as previously mentioned, in San Antonio, Texas - the National Association for Environmental Management will be having its Management Information System conference. I'll be there and would love to meet you. Please call me at 303-884-3028 or email me at [email protected]

Next on March 6-10, it's the Society of Toxicology's annual conference in Washington, DC. I won't be there, but Joe Nieusma, Senior Occupational Toxicologist with Affygility Solutions will. If you would like to talk to Joe, please give me a call and I can arrange it.

Then in April, Affygility Solutions has a whole bunch of environmental, health and safety webinars starting. These include, our every popular Advanced Topics in Potent Compound Safety, our Dermal Exposure and Absorption of Active Pharmaceutical Ingredients, Isoflurane Safety, and much more. Go to Affygility.com and check out our schedule.

BioPharma EH&S Podcast Episode No. 10

Note: This is the abbreviated script of the podcast, for the more detailed version go to http://potentcompoundsafety.com/?p=642

Cover what we talked about last time in episode number 9

Then I will cover our main topic for today, which is “Industrial hygiene in the pharmaceutical industry.”

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

Discussed the topic of “Are you an environmental, health and safety road warrior?” Get into our main topic for today which is “Industrial hygiene in the pharmaceutical industry.”

What I’m going to talk about here is based off of a journal article written by myself, Dr. Joe Nieusma, Senior Occupational Toxicologist with Affygility Solutions, and Angela Coler of Affygility Solutions. This article is titled “Strategies for preventing occupational exposure to potent compounds” and was published in a 2010 edition of Toxicology Mechanisms and Methods. In that article, Joe, Angela, and I discuss that since the 1970’s, occupational toxicologists, industrial hygienists and other occupational health professionals in the pharmaceutical industry have recognized that occupational exposure to active pharmaceutical ingredients can cause unintended health effects in workers handling these substances. In our Advanced Topics in Potent Compound Safety webinar, Dr. Nieusma, always discusses that chemical compounds that are routinely handled in the pharmaceutical industry are unique from other chemicals in that these compounds are designed to have an effect on the human body. In an occupational setting, if an employee provides a pathway of exposure to a potent compound, there is a high probability that the compound is going to elicit the designed response. Industrial hygienists and other occupational health professionals in the industry have responded to this hazard recognition by employing strategies for the risk evaluation and control of potent active pharmaceutical ingredients, otherwise known by the term “potent compounds.”

The strategies for preventing occupational exposure to potent compounds are very similar to any other industrial hygiene process, and consist of anticipating and evaluating the hazards of potent compounds; determining which of those process activities pose the highest risks; evaluating those risks, and finally, controlling potential exposures primarily through engineering devices. These strategies should be applied at all stages of pharmaceutical product development including discovery, pre-formulation, initial test batches, pilot plant, scale-up, and production. These strategies can be applied to initial discovery of a potent compound by an innovator company or to the development of a product coming off patent by a generic pharmaceutical company.

Don't go into the definition of a potent compound, refer to article

So, let’s now talk about our first strategy component, the first component is Evaluating the Hazards of Existing and New Compounds

Prior to the introduction of any new APIs into the workplace, a thorough scientific literature search on the specific or similar compounds should be conducted. If your company is just getting started in developing a potent compound safety program, a thorough literature search should be performed on pharmaceutical products already in the company’s portfolio – either in development or already on the market. The industrial hygiene professional needs to gain an understanding of the potential hazards of all of the company’s products. While retrieving literature and understanding the hazards may seem like a fairly simple task, for new compounds early in the development process it is often challenging to find information that is relevant to an occupational exposure scenario. However, the primary focus should be to identify sufficient information to allow preliminary classification of the potent compound into a control banding strategy. Much has been written about control banding in the pharmaceutical industry, so I won’t go into those details today, but would suggest you either attend one of our webinars on this topic or do some research on this subject. I will however mention that one of the most common modification to the classification scheme is typically in the number of classification bands individual companies utilize for their products. The number of bands that a company chooses to employ depends on the range of pharmaceutical products in the company’s portfolio and the number of control options that the company has implemented. As an example, Affygility Solutions use a 5 band scheme.

When you or your occupational toxicologist are searching for potential literature sources of information, these can originate from both inside a company and from published scientific literature. Primary articles, can come from high quality databases from the National Library of Medicine can provide published resources on numerous chemical substances. However, for discovery compounds, the internal toxicology studies will provide the most useful information. If the chemical entity has been on the market for a significant period of time, the literature can possibly provide all the necessary data to complete a potent compound safety classification. Once the data has been assembled, professional judgment must be exercised to evaluate the data and determine the critical toxicological endpoints.

Conduct Risk Assessments on All Potential Exposure Scenarios

After you have an understanding of the potential hazards of the compound has and a preliminary occupational exposure limit has been calculated, the occupational toxicologist or industrial hygienist should perform a detailed risk assessment. Risk assessments are often an overlooked, but extremely important, component of a potent compound safety program. These risk assessments will contain a number of risk factors that will define the probability of exposure. These risk factors include how the active pharmaceutical ingredient is handled, the physical form, the quantity, the frequency and duration of exposure, and several other factors. Ideally, a well developed potent compound safety program will have completed detailed risk assessments on every step of the process. Also, in addition to manufacturing processes, risk assessments should also be conducted for non-routine activities, such as emergency repair activities, spill situations, or equipment failure. In order to appropriately conduct a risk assessment, a number of departments will need to be involved. These departments can include: industrial hygiene, occupational toxicology, occupational health, and operations.

Strategy Component 3: Evaluate Potential Exposures

After you have completed risk assessments, a risk-based monitoring strategy will need to be developed. Exposure assessment strategies such as those used for other industrial hygiene purposes are fine. But, briefly, exposure assessments are utilized to identify the need for engineering controls or in the case where engineering controls alone are not adequate to control occupational exposure, if personal protective equipment is required as an additional means of protection. Data from an exposure assessment will determine the level of containment achieved and if other means of controlling exposure are required.

When conducting air monitoring for potent compounds, it is frequently the case that air sampling and analytical methods will not be available and will need to be developed by specialty industrial hygiene analytical laboratories. We go into a lot more detail on this subject in our webinars, so I won’t discuss it here. However, during the interval of method development for a potent compound, the integrity of the containment strategy can be tested. It is a very common practice in the pharmaceutical industry to use either lactose or naproxen sodium to perform surrogate monitoring on the equipment prior to inclusion of the more potent compounds. This practice is typically called performing containment validation studies. Affygility Solutions has significant experience in performing these types of studies, so if you need more information please don't hesitate to contact us. The data from these evaluations can then be used to determine how the containment strategy will perform when the potent compound is actually introduced.

After you receive the exposure assessment results, the industrial hygienist will need to carefully evaluate the data and compare to the field notes to determine the activities and operations that contribute to increased exposures. Exposure assessments are a critical tool for performance verification of engineering controls. Operator effects are numerous. Even the most sophisticated engineering controls can be ineffective due to poor operator technique or failure to follow established procedures. It’s been my experience that a single instance of inappropriately using a compressed air hose to remove spilled dry API from the top of a container can result in an 8-hour time weighted average exposure that is 400% higher than other who did not use a compressed air hose. Training is critical to decrease or eliminate variability in operator technique. Consistent techniques, attention to detail, and proper use of the available engineering controls is critical in preventing occupational exposure to potent compounds

Implement Risk Management and Control Measures

The primary focus of a comprehensive potent compound program is to prevent occupational exposures through effective process containment. When handling highly potent compounds, containment must be provided during all steps in the process. Typical containment devices include the use of downflow booths during weighing or dispensing activities, the use of high containment or split butterfly valves during product transfer between containers, local exhaust ventilation near dust generating activates, closed systems, vacuum transfers, and the use of isolators to enclose the process. Engineering controls need to be a workable design, ergonomically correct, and user friendly or they will quickly be relegated to the backroom by operators. The operator interface is one main aspect that is controllable. Minimize operator interaction in a process, and the exposure potential will also be minimized.

In addition to engineering controls, other risk management strategies may need to be utilized. These can include administrative controls such as compound-specific hazard communication training and product-specific medical surveillance. However, these aspects cannot be considered as a substitute for the previously mentioned engineering controls. Other examples of administrative controls include time limits for operator exposures, gender restrictions, biomonitoring protocols, and process changes to eliminate operator variability. The use of personal protective equipment should only be used as a tertiary means of exposure control.

Strategies for preventing occupational exposures to potent compounds require that all elements be considered. Failure to control exposures to potent compounds can result in costly program missteps, delayed production schedules, or potentially hazardous exposures to workers. A comprehensive potent compound program will have contributions from occupational toxicology, industrial hygiene, safety, engineering, and operations. The bottom line is employee safety and increased productivity.

O.k. The does it for the discussion on “Industrial hygiene in the pharmaceutical industry. If you have any comments or feedback – I loved to hear it. You can call our listener voicemail feedback line at 206-984-3214 and leave an audio comment. You can also stalk us on twitter at twitter.com/Affygility, or follow us on Facebook by just searching for Affygility Solutions and giving us a “Like. You can also email us your comments at podcast at Affygility.com.

Alright, let’s now talk about some great upcoming events.

The first event is the National Association for Environmental Management MIS Conference to be held on March 2nd and 3rd in San Antonio, Texas. I will be attending this event and showing off our new mobile EHS app, so if you would like to meet up with me, please feel free to call the listener voicemail feedback line and let me know that you’re going to be there.

The second event is the Society of Toxicology meeting on March 6th through 10th in Washington, DC. Dr. Joe Nieusma, Senior Toxicologist with Affygility Solutions will be attending this event, so if you would like to meet with Joe and discuss potent compound safety, so let me know.

Next, on March 11th through 15th, I will be attending South by Southwest Interactive in Austin, Texas. I’ve been looking at the schedule of sessions and events that will be happening at South by Southwest and it is amazing. This event is going to be “off the chain”. If you don’t know what that means “Google it” and find out.

I should also mention, that in April, we have several new webinars starting and you should look at our schedule at Affygility.com. These webinars have been very well attended 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, Global Harmonization System, Hazardous Wastes for Hospitals, Clinics, and Medical Laboratories. Again, if any of that interests you, I would suggest that you go to Affygility.com and look at our full schedule.

Finally, I’m starting to prepare for a podcast on the Young Guns of Environmental, Health and Safety, and I need several volunteer guests. If you’re between the age of 25 to 34, and work in the environmental, health and safety field please send me an email if you’re interested in participating. My email address is [email protected]

O.k. That does it for this week’s show. Remember to submit your questions to our voicemail feedback line at 206-984-3214 and stalk us on twitter at twitter.com/Affygility, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally onLinkedIn by searching for Affygility Solutions.