Dimethyl fumarate OEL Fastrac monograph now available

Dimethyl Fumarate (DMF) requires advance handling precautions in an occupational exposure setting.

Dimethyl fumarate OELIMPORTANT: Dimethyl fumarate (DMF) is a severe dermal sensitizer and advance handling precautions need to be taken before handling this compound in an occupational exposure setting. In addition, dimethyl fumarate is known to sublimate (going from the solid to gaseous phase without turning into a liquid). This has implications for containment, respiratory protection and industrial hygiene monitoring. The majority of material safety data sheets (MSDS) or safety data sheets (SDS) are inadequate in warning of the hazards of dimethyl fumarate. This occupational exposure limit monograph contains the most current health and safety information regarding dimethyl fumarate.

In addition, this OEL Fastrac monograph also contains the acceptable daily exposure (ADE) value.

Click on the following link for more information on the OEL Fastrac monograph for Dimethyl Fumarate with instant download.

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Posted in OEL Fastrac, potent compound safety | Leave a comment

Dean Calhoun to present at the Pharmatek booth during AAPS 2014

Affygility Solutions’ President and CEO, Dean Calhoun, CIH will be presenting “The Future of Pharmaceutical Manufacturing – the Next 100 Years,” during the American Association of Pharmaceutical Scientists (AAPS) annual convention. Mr. Calhoun’s presentation will be on November 4th, 2014 at 2:00 p.m. at the Pharmatek booth (booth no. 3319). For more information on all the other exciting activities that Pharmatek is providing, go to Pharmatek’s AAPS webpage.

Mr. Calhoun will be available for one-on-one meetings immediately following his presentation. If you would like to discuss potent compound safety, exposure control banding, or qualitative risk assessment of pharmaceutical manufacturing operations please send a meeting request via the contact us form on the Affygility Solutions’ website.

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Posted in conferences, pharmaceutical contract manufacturers, potent compound safety | Leave a comment

Whiteboard Friday: What determines the Category 1-4 of a potent active pharmaceutical ingredient?

In this episode of Whiteboard Friday, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions, answers the listener question, “What determines the Category 1-4 [of a potent active pharmaceutical ingredient], the biological activity or the OEL?

Understanding Occupational Health Categorizations (OHC) vs. Control Bands

Before viewing the video below, it’s important to understand that the occupational health categorization (OHC) of a specific active pharmaceutical ingredient is determine by reviewing the entire toxicological profile of the API and then calculating the occupational exposure limit (OEL). Once the OEL is determine, the occupational toxicologist will then use the OEL and other information to assign an OHC to the compound. Therefore, the OEL and OHC is based solely on the toxicology of the compound.

The industrial hygienist will then look at the OEL and the OHC assignment and place it into a given control band. A control band is a function of the control capabilities of the combination of engineering, administrative and personal protective equipment. The number of control bands will differ amongst organizations, depending upon the number of options that they have available at their facility.

While we would like to think that there is a 1:1 relationship between the OHC vs. the Control Band, it may not always be the case. For example, you may have a compound with a fairly large numerical OEL, but have a concern over skin irritation. In that case, you might assign it to a higher control band to further prevent skin exposure.

If you have additional questions, tweet them to @affygility with the hashtag #potentsafety, or submit them via the “Contact Us” form on the Affygility Solutions’ website.

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EHS Software: The challenge of comprehensive vs. bloatware

EHS Software Risk

Here at Affygility Solutions we often hear the statement, “We want it simple to use.” But, almost in the same breath, they will indicate “We want it comprehensive and want it to do this, this, and this” and “Oh, by the way does it work on iPhones, Android devices, and iPads?” As you can see, these statements presents a huge dichotomy and challenge for designers and developers that are tasked with developing environmental, health, and safety software. People want it “simple to use, but comprehensive.”

EHS software terms

Several years ago while attending a conference on EHS software, this situation presented itself ever so clearly. A company was giving a demo on their new EHS software package that they have spent numerous years developing and implementing. While showing one of the forms on the screen, the presenter indicated that, “Well, there’s a lot of fields on this form and you won’t use half of them.” After this statement, I’m thinking to myself why do you even have them? He then proceeded to perform an action and the whole EHS software system froze up. Much to his embarrassment, he stated, “Oh, that’s never happened before.”

The Birth of EHS Bloatware

For those of you not familiar with the term “bloatware” it is a piece of software or a website that attempts to do too much and become utterly useless for its end users. There is just too many moving parts. Here at Affygility Solutions, we see this all the time in large, expensive enterprise-based EHS software management systems. These are typically the systems that are designed by corporate committees that want everything throw into the system, and the consulting practices that typically develop these systems are more than happy to comply because the “customer is alway right” and it just means more billable hours for them. As an example, I saw one company that had a system that was tracking 26 health and safety metrics and 32 environmental and sustainability metrics. Are you kidding me? How in the world is their one part-time EHS staff member at a facility ever going to have the time to collect and enter all that data on a monthly basis? In addition, the company had to bring all their EHS staff members from around the world in for 1 week of training in how to use the system. My theory, if it takes a week of training to learn how to use it, it’s way too complicated. We need to think about online banking. Did anyone ever trained you on how to use your online banking site? Probably not. Designers and developers need to make it that simple to use!!! If your user interface looks anything like the Access database below, you got usability issues:

complicated access form

Several important points need to be made here:

  • We can’t let technology get in the way of us doing meaningful EHS work;
  • We always ask “What features can we add?” rather than “What features should be take away?” We need to become feature assassins; and
  • You shouldn’t expect an EHS professional to be a programmer, just like you wouldn’t expect a programmer to be an occupational toxicologist.

Welcoming Responsive-design EHS Software

Here is the next several weeks, Affygility Solutions will be releasing its next version of Affytrac with a responsive-design interface. Responsive web design is a web design approach aimed at crafting sites so they provide a great user experience across a wide-range of devices – desktops computers, tablets, and smartphones. Responsive design allows easy reading and navigation regardless of the screen size. Responsive design principles are in alignment with the “think mobile first” movement, where all websites and applications should be optimized to work on a mobile device first. It will allow you to perform EHS task management, corrective actions, and quantitative exposure assessments all from the convenience of your smartphone. It will be awesome!

If you would like to know more or schedule a free-demo, please contact us at Affygility Solutions.

If you enjoyed this article, please give it a “Like” or share it. I would also enjoy hearing your comments.

 

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Posted in compliance management software, compliance management systems, corrective action software, ehs software, infographics, occupational toxicology, OEL Fastrac | Comments Off