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Syndication

In Episode #24 of the Biopharma EHS podcast, Dean M. Calhoun, CIH discusses with Dr. Joe Nieusma, Senior Occupational Toxicologist for Affygility Solutions, the "Mystery of Cytotoxic Compounds." For multi-product pharmaceutical manufacturing facilities, this often a controversial topic since many people believe that cytotoxic compounds require dedicated facilities or equipment. It is also a topic of debate when setting occupational exposure limits and acceptable daily exposure values for active pharmaceutical ingredients.

Direct download: biopharma-ehs-podcast-episode-24.mp3
Category:general -- posted at: 5:27pm MDT

In this episode of the Biopharma EHS podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions interviews Kevin Rosenthal of Pharmatek Laboratories. During the interview we discuss handling potent compounds, potent compound safety, and occupational control banding.

Dean Calhoun also responds to the frequently asked question, "What type of equipment do I need to handle a highly potent compound?"

 

If you would like to learn more, visit affygility.com

Direct download: Biopharma_EHS_podcast_episode_23_final.mp3
Category:general -- posted at: 8:36pm MDT

In this episode of the Biopharma EHS Podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions, interviews Ms. Stephanie Wilkins, President of PharmaConsult US, on the subject of Risk-MaPP, ADEs and PDEs: Their importance to multi-product pharmaceutical manufacturing facilities. Risk-MaPP stands for Risk-Based Manufacture of Pharmaceutical Products. It is one of the International Society of Pharmaceutical Engineers' (ISPE) Base-line Guides. One of the essential components of Risk-MaPP is the determination of acceptable daily exposure (ADE) values. Calculation of ADEs is similar to the calculation of PDEs presented by European Medicines Agency (EMA). If you need an occupational exposure limit (OEL) or ADE for a pharmaceutical compound, please check out our entire catalog of OEL Fastrac monographs. We have many OEL monographs that come with ADEs.

Direct download: Biopharma_EHS_podcast_Episode_22.mp3
Category:general -- posted at: 10:58am MDT

BioPharma EH&S Podcast Episode No. 20

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.

 Well, it’s Sunday, July 14th, 2013 and it’s great to be here today. We have great show in store for you today and a lot of things to talk about, so let’s go ahead and get started.

 As always, I’d like to first mention what we are going to discuss in today’s podcast.  That way you can decide if it’s something that interests you, or should you just come back for our next episode.  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 19 

Then I will cover our main topic for today, which is EH&S Software – The Challenge of User Adoption

And finally, we’ll 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 number 19 we discussed the topic of “The Future of Potent Compound Safety – the next 100 years.”  In that Podcast, I presented four emerging trends that will shape the future of the pharmaceutical industry. Those trends included first, the development of medicines in space; second, the trend called “the Internet of Things;” third, the Maker Movement; and forth and finally, the Use of Big Data Tools.  If that’s something that may interest you, I would suggest that you go back and listen to Episode 19.

Alright, let’s now move on to our main topic for today which is EHS software – the challenge of user adoption. So without further delay, here we go.

 A little over a year ago, I created a post on EHS Compliance Management Software - Increasuing User Adoption and Engagement. In that post, I provide a few suggestions for encouraging user adoption of EHS software within an organization. The suggestions i provided by then included:

- Measure usage;

- Ensure data quality;

- Engage users during meetings;

- Tie individual compensation to usage; and

- Use peer pressure.

In addition to those five suggestions listed above, I would like to provide some additional suggestions. These additional suggestions include:

- Ensure executive leadership involvement;

- Identify and reward super users;

- Perform floor-walking;

- Ensure that the EHS software system is used by taking the approach, "If it isn't in the EHS software system, it didn't happen;"

- Mandate both timeliness and data quality.

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

Alright that does it for our main topic this week. One additional item that I would like to remind everyone of is oelfastrac.com, which is a convenient and affordable way to obtain high-quality occupational exposure limit monographs for common APIs. To learn more, please go to oelfastrac.com.

 O.k.  That does it for this week’s show.  Remember to submit your questions to our podcast email at info@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.

Have a great rest of the day.

Direct download: BP_EHS_20_Final.mp3
Category:general -- posted at: 2:49pm MDT

In this podcast, Dean M. Calhoun of Affygility Solutions discusses four key technologies or trends that will have a significant impact on the pharmaceutical industry for the next 100 years. These trends include: the development of medicines in space, the Internet of Things, the Maker movement, and the use of Big Data tools. He will also discuss taking leaps forward and barriers that we will encounter.

Direct download: biopharma-ehs-podcast-20.mp3
Category:general -- posted at: 10:53pm MDT

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.

Direct download: EHS_Auditing_of_High_Potency_Facilities.mov
Category:general -- posted at: 8:28pm MDT

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.

Direct download: BioPharma_EHS_Podcast_Episode_18.mp3
Category:general -- posted at: 8:23am MDT

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.  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:
  • 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

 

Direct download: Biopharma_EHS_podcast_Episode_17.mp3
Category:general -- posted at: 8:04am MDT

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.

Direct download: Biopharma_EHS_Podcast_Episode_No._16.mp3
Category:general -- posted at: 11:51am MDT

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 podcast@affygility.com 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.

 

 

 

 

 

 

 

 

 

 

Direct download: BioPharma_EHS_Podcast_Episode_15.mp3
Category:general -- posted at: 3:28pm MDT