10 myths regarding PDEs, ADEs, and OELs

Here at Affygility Solutions, we frequently engage in conversations with pharmaceutical professionals from all over the world regarding dedicated facilities and the underlying concepts of permissible daily exposures (PDEs), acceptable daily exposures (ADEs), and occupational exposure limits (OELs) for active pharmaceutical ingredients (1). Often, we field questions that are similar in nature and unfortunately just unsupported information, which I will call myths. These myths are as follows: Isn’t there some

In Episode 23 of the Biopharma EHS podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions discusses Handling Highly Potent Compounds and Control Banding as a CDMO with Mr. Kevin Rosenthal, Director of Manufacturing and Business Operations with Pharmatek Laboratories. To listen to this podcast, please click on the audio player below. In addition to this discussion, Dean Calhoun answer the question “What type of equipment do I

As most of you know by now, Affygility Solutions has released its next version of Affytrac. Since we completely redesigned the UI (user interface) to make it a responsive design that works on all devices (desktops, tablets, and smartphones), this was a significant update. One trick that you may not know about, is how to add a favicon to the home screen of your iPhone to make Affytrac seem more

In Episode 22 of the Biopharma EHS podcast, Dean M. Calhoun, CIH, President of Affygility Solutions, interviews Ms. Stephanie Wilkins, President of PharmaConsult US, regarding the topic of Risk-MaPP, ADEs and PDEs: Their importance to multi-product pharmaceutical manufacturing facilities. The interview is approximately 22-minutes long and is available on Affygility Solutions’ Facebook page, Soundcloud, iTunes, and now on Stitcher. You can also listen via the audio player below: If you like what

Potent Compound Safety Training Made Easy! Affygility Solutions is pleased to announce that its Introduction to Potent Compound Safety training video is now available in streaming format for only $59 on a pay-per-view basis. This price includes two views. In this 29-minute streaming video, the following topics are covered: The definition of a potent compound; Why you should care about potent compound safety; The basic principles of occupational exposure control

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

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

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

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

Affygility Solutions is pleased to announce the immediate availability of five new OEL Fastrac monographs. These occupational exposure limit (OEL) and acceptable daily exposure (ADE) value monographs are created with the same high-quality standards that you have always expected. The new OEL Fastrac monographs include: Amlodipine Erlotinib Morphine Sulfate Omeprazole Oxycodone Benefits of OEL Fastrac monographs with ADEs OEL Fastrac monographs offer the following benefits: Authoritative: Prepared by pharmaceutical industry experts with advance degrees,

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