http://potentcompoundsafety.com Sun, 28 Jun 2015 23:58:07 +0000 en-US hourly 1 http://wordpress.org/?v=4.2.2 no http://potentcompoundsafety.com/wp-content/plugins/powerpress/rss_default.jpg http://potentcompoundsafety.com Upcoming potent compound safety presentation by Affygility Solutions http://potentcompoundsafety.com/2015/06/potent-compound-safety-presentation-affygility-solutions.html http://potentcompoundsafety.com/2015/06/potent-compound-safety-presentation-affygility-solutions.html#comments Sun, 28 Jun 2015 23:58:07 +0000 http://potentcompoundsafety.com/?p=2619 The following is a list of the upcoming potent compound safety presentations by Affygility Solutions:

  • 4th Annual HPAPI Conference, Boston, MA, Monday, July 13th, 2015: Risk Management & Industrial Hygiene: Preventing Cross Contamination & Employee Exposures In The Context Of HPAPIs
  • CPhI Worldwide, Madrid, Spain, Tuesday, October 13th, 2015: Safe Handling of Potent Compounds.
  • 2015 ISPE Annual Meeting, Philadelphia, PA. Monday, November 9th, 2015: The Future of Pharma Manufacturing – The Next 100 Years

If you’re attending any of these conferences, please feel free to come up and introduce yourself. If you would like to schedule a private meeting, please complete the “contact us” form on our main website.

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Attending AIHce 2015? Follow Affygility on Twitter or Instagram http://potentcompoundsafety.com/2015/05/aihce-2015-affygility-twitter-instagram.html http://potentcompoundsafety.com/2015/05/aihce-2015-affygility-twitter-instagram.html#comments Wed, 13 May 2015 01:07:13 +0000 http://potentcompoundsafety.com/?p=2610 Attending the American Industrial Hygiene Conference and Exposition (AIHce) 2015 in Salt Lake City, May 30th through June 4th? Follow Affygility Solutions on Twitter or Instagram for deets on #secretbeerparty2.0. Want advance notice of the location? Then follow affygility on Snapchat (works on smartphones only, no desktop version). Don’t know how to use Snapchat, then go here: Snapchat Basics. This year’s party plans to be better than ever. If you don’t follow, you won’t know. Hook up with either Peter Burke or Dean Calhoun during the conference for a wristband. Time and location to be announced later. Wristbands only.

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Get your FREE ebook: Potent Compound Safety Handbook – A Guide to Working with Potent Compounds http://potentcompoundsafety.com/2015/04/potent-compound-safety-handbook-guide-working-potent-compoundsaff.html http://potentcompoundsafety.com/2015/04/potent-compound-safety-handbook-guide-working-potent-compoundsaff.html#comments Sat, 25 Apr 2015 16:24:31 +0000 http://potentcompoundsafety.com/?p=2600 Affygility Solutions is pleased to announce the availability of its latest FREE eBook: Potent Compound Safety Handbook – A Guide to Working with Potent Compounds. In this 18-page handbook in pdf format, we will cover the following topics:

  • The definition of “What is a Potent Compound?”
  • Getting your potent compound safety program started
  • Determining occupational hazard categories
  • Ten myths regarding PDEs, ADEs, and OELs
  • The future of OELs

To download this FREE eBook in pdf format click here.

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Affygility Solutions publishes IFTTT recipe for OEL Fastrac notifications http://potentcompoundsafety.com/2015/04/affygility-solutions-publishes-ifttt-recipe-oel-fastrac-notifications.html http://potentcompoundsafety.com/2015/04/affygility-solutions-publishes-ifttt-recipe-oel-fastrac-notifications.html#comments Mon, 13 Apr 2015 00:52:52 +0000 http://potentcompoundsafety.com/?p=2596 Now stay up to date and get instantly notified by email of the latest OEL Fastrac with ADE monographs that has been posted to the oelfastrac.com site! Affygility Solutions has published an IFTTT (If-this-than-that) recipe to make it easy. Just go to the link below to get the recipe:

https://ifttt.com/recipes/275270-sends-an-oel-fastrac-update-to-your-email

]]> http://potentcompoundsafety.com/2015/04/affygility-solutions-publishes-ifttt-recipe-oel-fastrac-notifications.html/feed 0 OEL Fastrac catalog listing now available as a RSS feed http://potentcompoundsafety.com/2015/03/oel-fastrac-rss-feed.html http://potentcompoundsafety.com/2015/03/oel-fastrac-rss-feed.html#comments Mon, 30 Mar 2015 02:12:40 +0000 http://potentcompoundsafety.com/?p=2585 Affygility Solutions is pleased to announce that its OEL Fastrac catalog listing is now available as a RSS (Really Simple Syndication) feed. Listed below is an example of the feed displaying that latest six occupational exposure limit (OEL) with ADE monographs. Click on the compound name heading to go directly to the specific OEL/ADE monograph product page.

  • Ketorolac


    Ketorolac is indicated to treat short-term pain, eye pain, pain related to cataract extraction and seasonal allergic conjunctivitis.

    Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

    The OEL Fastrac monograph for Ketorolac is available for purchase for $597 USD.

  • Levofloxacin


    Levofloxacin is a fluoroquinolone antibiotic indicated for susceptible infections of various parts of the body including airways, eyes, eyelids, prostate, sinus, lungs, urinary tract, skin, and kidneys.

    Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

    The OEL Fastrac monograph for Levofloxacin is available for purchase for $597 USD.

  • Losartan


    Note, this OEL/ADE monograph applies to both losartan and losartan potassium (CAS RN 124750-99-8). Losartan is indicated for stroke prevention, kidney disorder associated with diabetes and high blood pressure.

    Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

    The OEL Fastrac monograph for Losartan is available for purchase for $597 USD.

  • Pantoprazole


    Pantoprazole is indicated for gastroesophageal reflux treatment and prevention, high stomach acid secretion, and Zollinger-Ellison Syndrome.

    Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

    The OEL Fastrac monograph for Pantoprazole is available for purchase for $597 USD.

  • Tinidazole


    Tinidazole is a nitroimidazole antitrichomonal agent effective against Trichomonas vaginalis, Entamoeba histolytica, and Giardia lamblia infections.

    Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

    The OEL Fastrac monograph for Tinidazole is available for purchase for $597 USD.

  • Ketamine


    Note, this OEL/ADE monograph covers both Ketamine and Ketamine HCl (CAS RN 1867-66-9). Ketamine is indicated for general anesthesia and procedural sedation. Ketamine hydrochloride is a rapid acting general anesthetic. Its pharmaceutical effects produce analgesia, normal airway reflexes, skeletal muscle tone, cardiovascular and respiratory stimulation, and transient respiratory depression.

    Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.

    The OEL Fastrac monograph for Ketamine is available for purchase for $597 USD.

If you wish to add the feed to a feed reader, here’s the link: http://affygility.com/oel/feed.xml

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Thoughts and musings from the 2015 NAEM EHS and Sustainability Software Conference http://potentcompoundsafety.com/2015/03/ehs-sustainability-software-conference.html http://potentcompoundsafety.com/2015/03/ehs-sustainability-software-conference.html#comments Sun, 01 Mar 2015 21:15:04 +0000 http://potentcompoundsafety.com/?p=2563 Just finished up a nice couple of days last week in Tampa, Florida at the National Association for Environmental Management (NAEM) EHS and Sustainability Software conference. The event was held at the Westin Hotel, Harbour Island which was a fantastic location, and considering the horrific weather that my colleagues have been experiencing in the northeast, I’m sure the warmer weather was a welcomed sight. This has been at least my fourth such event, and as always, the NAEM staff had a well-run event with no hiccups. The general format of the conference over the course of two-days was an opening talk/keynote each morning, then a series of “demos” throughout the day. There was a pre-conference workshop the day before the main EHS software conference, but I was unable to attend.

The demos were performed by actual customers of the systems and repeated at least once during the day. So, if you planned it right, you could catch a glimpse of the EHS software systems you wanted to see.

Overall Thoughts and Musings

Based on the sessions that I attended, here’s my thoughts and musings:

  • During the official welcome and introductions, NAEM Program Director, Mike Mahanna encourage attendees to use Twitter during the event. However, post-conference analysis of the Twitter #NAEMSoftware stream revealed 18 tweets using this hashtag, with myself (@affygility) being half of them. This clearly needs to change and every vendor should have been using Twitter to drive traffic to their booth. Take a suggestion from the tech conferences, assign #hashtags to each session and have it on the opening slide for the session. It’s a way for the presenters to collect feedback on the specific session.
  • If you’re going to call them “demos” then do real demos. Many of the sessions were the presenters talking about their company and the process that they went through to get their EHS software up and running. Then once it came down to the actual software demo, in many cases, they were screenshots embedded within PowerPoint slides. Unfortunately, when demos are run this way, it’s difficult to tell how efficiently the user-interface (UI) works and the speed of the system (a well-designed system should work in the worst of bandwidth conditions). In addition, in some cases, it’s apparent that it’s a staged presentation and they are showing the “best” looking UIs. If possible they should follow the format of the “Demo organization.” Live software with real internet connectivity and no PowerPoint, just demo. Forget the introductory slides with telling everyone how many facilities, employees, etc. that you have in your organization. You can verbally tell us that information, but we don’t need 10 minutes of it.
  • This is largely a competitive intelligence event. The majority of the attendees are EHS software providers and consultants checking out their competitors applications. No pretense on my part, that’s exactly why I attended the EHS software event. Yes, there are some actual potential customers, but they are few and far between and are typically ones that are unhappy with their current system.
  • The twisty folder interface seems to be persistent. Maybe this is a leftover from the days of Lotus Notes or the familiarity with Microsoft Outlook folders, but this UI is getting stale. In addition, with the importance of mobile usage growing and growing, this is not going to work in the long-term. Let’s get rid of that UI and think of something different.
  • There’s a real dichotomy out there in that EHS leadership keeps demanding an one-stop shop “enterprise” system where all EHS data is gathered, with totally customizable reporting, that mimics their current form system. And, by the way, it has to be intuitive, easy to use, and mobile.  Sorry people, that’s an impossible set of requirements, and you’re smoking weed if you think it’s going to happen.
  • There continues to be a discussions on mobile, but in the sessions that I attendee it’s quite clear that few vendors understand the unique UI/UX requirements of mobile. Take a look at well designed consumer apps like Foursquare, Instagram, EpicMix, and SnapChat. BTW – you can follow me on SnapChat @affygility
  • Based on the sessions I saw, and the event I attended two years ago, there is really nothing disruptive coming down the pipe. More of the same, same old stuff, with no integration with the Internet of Things technologies, no talk of gamification to drive user engagement, and still a heavy reliance on time-consuming, manual data entry. EHS software vendors need to start thinking differently about the future.

Overall thoughts – well organized event, great location, but the EHS software industry is struggling to find something new to talk about. Tweet me your thoughts @affygility or visit our site at http://affygility.com

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Follow Affygility Solutions on SnapChat. http://potentcompoundsafety.com/2015/02/follow-affygility-solutions-snapchat.html http://potentcompoundsafety.com/2015/02/follow-affygility-solutions-snapchat.html#comments Mon, 23 Feb 2015 02:50:07 +0000 http://potentcompoundsafety.com/?p=2557 Want near real-time updates on what’s going on with the field of EHS in the pharmaceutical industry? Then add us as a friend on SnapChat. Don’t have a clue about SnapChat. Well, you’re likely over 25 years old, but here’s the beginner’s guide to SnapChat by Mashable. Once you read through this guide then simply point your camera at the image below and you’ll find Affygility Solutions.

affygility snapchat

 

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Surrogate monitoring, control banding and potent compound safety http://potentcompoundsafety.com/2015/02/surrogate-monitoring-control-banding-potent-compound-safety.html http://potentcompoundsafety.com/2015/02/surrogate-monitoring-control-banding-potent-compound-safety.html#comments Mon, 09 Feb 2015 21:40:38 +0000 http://potentcompoundsafety.com/?p=2553

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D. Calhoun to present at AIHce 2015 http://potentcompoundsafety.com/2015/02/aihce-2015.html http://potentcompoundsafety.com/2015/02/aihce-2015.html#comments Mon, 09 Feb 2015 16:46:30 +0000 http://potentcompoundsafety.com/?p=2547 Affygility Solutions’ President and CEO, Dean Calhoun, will be presenting at the American Industrial Hygiene Conference and Exposition on Tuesday, June 2nd, 2015 from 2:00 – 5:00 p.m. His talk is titled, Hacking EH&S: Evolving Technologies to Present New Security Threats. If you are attending the conference and would like to arrange a meeting with Dean, please complete our contact request form and we will be in touch with you.

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New EU GMPs go into effect March 1st – Are you ready? http://potentcompoundsafety.com/2015/02/guideline-setting-health-exposure-limits-pharmaceuticals.html http://potentcompoundsafety.com/2015/02/guideline-setting-health-exposure-limits-pharmaceuticals.html#comments Mon, 09 Feb 2015 05:22:14 +0000 http://potentcompoundsafety.com/?p=2535 The European Medicines Agency’s new GMP requirements go into effect March 1st, 2015

The EMA’s new good manufacturing practice (GMP) requirements set forth in Chapters 3 and 5 in the EU GMP Guideline will go into effect March 1st, 2015. Pharmaceutical manufacturers of human medicinal products will be allowed 6-months to come into compliance with the requirements for new products being introduced into their facilities, and 1-year for existing products. Pharmaceutical manufacturers of veterinary products will have different timelines.

So, what are the changes? In Chapter 3, the most noteworthy change is to Section 3.6 which requires the prevention of cross-contamination by appropriate design and operation of manufacturing facilities. In addition, Section 3.6 states that dedicated facilities or equipment “when a medicinal product presents a risk because:

i.  the risk cannot be adequately controlled by operational and/or technical measures,

ii. scientific data from the toxicological evaluation does not support a controllable risk (e.g. allergenic potential from highly sensitising materials such as beta lactams) or

iii. relevant residue limits, derived from the toxicological evaluation, cannot be satisfactorily determined by a validated analytical method.”

While it’s easy to overthink the above requirements and begin believing that all high potency products will require dedicated facilities or equipment, that’s not the intent of the new requirements. The intent of the new requirements is to ensure that the potential for cross-contamination in a multi-product facility is managed in a manner appropriate to the “risk.” And, as most pharmaceutical professional know RISK = HAZARD X PROBABILITY. Furthermore, in order to appropriately determine the hazard, each medicinal product will require a toxicological evaluation that is based on scientific data. The purpose of this toxicological evaluation is to determine the health-based permissible daily exposure (PDE) limit for each pharmaceutical product.

Chapter 5, Sections 17 to 21 then continues to provide further guidance on prevention of cross-contamination and the toxicological assessment.

In order to support the above changes to the GMPs, in November of 2014, the EMA published a Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. This guideline sets forth the approach for determining the Permitted Daily Exposure (PDE). Important statements in this guideline include:

  • The derivation of the PDE or Threshold of Toxicological Concern (TTC) should be the result of a structured scientific evaluation of all available pharmacological and toxicological data including both non-clinical and clinical data; and
  • The toxicological evaluation strategy and results needs to be thoroughly documented and needs to be an “expert” review (author’s note: it cannot be a poorly documented “cookie cutter” approach performed by amateurs).

While it is tempting to immediately focus your attention on the PDE equation in Section 4, it is important to thoroughly read and understand the entire guideline. For example, it should be noted that the use of the No-Observed-Adverse-Effect-Level (NOAEL) shown in the PDE equation may not always be the appropriate choice for the point-of-departure in the derivation of the PDE. NOAELs are typically derived based on animal data, short-duration studies, and are sometimes difficult to find a reliable value from a trustworthy source. The selection of other PODs may be more appropriate and this is where having a toxicology expert perform the evaluation can make a real difference.

Fortunately, for many generic pharmaceutical manufacturers, the toxicology experts at Affygility Solutions have prepared OEL Fastrac with ADE monographs for many common active pharmaceutical ingredients.  These monographs have been used by pharmaceutical companies throughout the world. To view our catalog of OEL/ADE monographs for purchase, please visit oelfastrac.com. In addition to our OEL Fastrac monographs, the toxicology experts at Affygility Solutions can also determine OELs and PDEs for proprietary compounds. Please contact us for additional information.

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