http://potentcompoundsafety.com Tue, 28 Jun 2016 22:49:27 +0000 en-US hourly 1 http://wordpress.org/?v=4.2.9 http://potentcompoundsafety.com/wp-content/plugins/powerpress/rss_default.jpg http://potentcompoundsafety.com Opinion: Potent Compound Manufacturing – The Chicken or the Egg Problem http://potentcompoundsafety.com/2016/06/potent-compound-manufacturing.html http://potentcompoundsafety.com/2016/06/potent-compound-manufacturing.html#comments Tue, 28 Jun 2016 22:49:27 +0000 http://potentcompoundsafety.com/?p=2639 So your company has years of experience at being a pharmaceutical manufacturer. However, recently your business development (BD) professionals have been receiving requests that go something like this, “Can you handle potent compounds?” or “Can you handle Category 4 or 5 potent compounds?” Not wanting to say “no” and turn down potential business opportunities, the BD professionals consult with the management team. Then usually members of the management team gather around the table and discuss the market opportunities, the competition, the impact on existing operations, and what additional safety precautions or engineering controls are needed. Everyone is excited and wants to pursue this “opportunity” further. This is usually when Affygility Solutions receives a phone asking the question, “What do I need to do to handle ‘potent’ compounds?” Of course, without knowing a lot more about your goals and operations, that’s a very risky question for us to answer.

Potent Compound Manufacturing is a chicken or the egg problem

Prior to taking on projects that involve the handling of potent compounds that are Category 3 and up, it’s going to take an investment. However, often companies are willing to make the investment without having a sign contract for the project – and, no reputable client is going to sign a contract for their project without knowing that you are equipped to properly handle their potent compound. Hence, the chicken or the egg problem – which comes first? No sign contract = no investment, no investment = no sign contract.

Understand all the Business Dynamics of Handling Potent Compounds

Prior to just diving head first into the dark, murky waters of highly potent compounds (generally Category 3, 4, or 5) educate yourself in the business dynamics of potent compounds. Proper handling of potent compounds will impact almost every department in your company. Discuss amongst your team how it will impact the following:

  • How will you effectively market “potent compound manufacturing services?”
  • How will you train your business development, sales staff and operational personnel in this area of expertise? You want to make sure that you can deliver on any promises.
  • Are you willing to make the long-term capital investments in facilities, air-handling, and engineering controls to safely manufacture potent compounds? In addition, there will be ongoing operational costs in categorizing potent compounds, training employees, containment verification studies, maintenance of engineering controls, industrial hygiene monitoring, and “disposables.”
  • How will you on-board and categorize new compounds? How will you make “go” or “no-go” decisions? Just as important as it is to know what types of compounds you can handle, it’s equally as important to know what compounds or project are out of your league.
  • Once a proposal has been accepted, what type of risk-assessments will you perform for each step of the project?
  • How will you implement permissible daily exposure (PDE) or acceptable daily exposure (ADE) limits into your cleaning validation requirements? Note, depending upon the PDE/ADE value, it may require that you develop more sensitive and/or product-specific analytical methods.
  • Understand how all the above factors will impact the cost of a project. How will these costs be captured and passed onto the customer?
  • And, many others.

It takes a Commitment – both Financially and Operationally

No matter how much you debate above questions, at some point it is going to take a commitment, both financially and operationally. To do so otherwise is going to not be of value to the company or the client. Just “dabbling” in potent compound manufacturing has a low probability of providing the expected financial return.

If you would like to request an on-site gap assessment of your potent compound safety program, please contact Affygility Solutions.

 

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New Podcast is up: The Mystery of Cytotoxic Compounds http://potentcompoundsafety.com/2016/01/cytotoxic-compounds.html http://potentcompoundsafety.com/2016/01/cytotoxic-compounds.html#comments Mon, 18 Jan 2016 21:39:37 +0000 http://potentcompoundsafety.com/?p=2634 Our new podcast on “Mystery of Cytotoxic Compounds” is now posted on the affygility.com website. In this podcast, Dr. Joe Nieusma and Dean Calhoun, CIH discuss the following:

  • What is a “cytotoxic compound?”
  • How are cytotoxic compounds determined?
  • What are examples of traditional cytotoxic compounds?
  • Are the terms “cytotoxic” and “genotoxic” synonymous?
  • Do I need a dedicated manufacturing facility or equipment for cytotoxic compounds?
  • Can an occupational exposure limit (OEL) and acceptable daily exposure (ADE/PDE) value be established for a cytotoxic compound?

In addition, Dean Calhoun discusses events and happenings that are related to environmental, health, and safety in the life sciences industry. To listen to this podcast, click on the link above or below.

 

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http://potentcompoundsafety.com/2016/01/cytotoxic-compounds.html/feed 0 Our new podcast on “Mystery of Cytotoxic Compounds” is now posted on the affygility.com website. In this podcast, Dr. Joe Nieusma and Dean Calhoun, CIH discuss the following: What is a “cytotoxic compound?” How are cytotoxic compounds determined? Our new podcast on “Mystery of Cytotoxic Compounds” is now posted on the affygility.com website. In this podcast, Dr. Joe Nieusma and Dean Calhoun, CIH discuss the following: What is a “cytotoxic compound?” How are cytotoxic compounds determined? What are examples of traditional cytotoxic compounds? Are the terms “cytotoxic” and “genotoxic” synonymous? Do I need […] 27:58
Affygility Solutions on SnapChat http://potentcompoundsafety.com/2016/01/affygility-solutions-snapchat.html http://potentcompoundsafety.com/2016/01/affygility-solutions-snapchat.html#comments Wed, 13 Jan 2016 17:16:02 +0000 http://potentcompoundsafety.com/?p=2631 Getting ready to starting posting some serious sound-bites of EHS knowledge on SnapChat. Will be cover the basics of environmental, health and safety in the life science industry, as well as fun stuff regarding the world-wide travels of an EHS professional. Add Affygility through the username affygility or take a picture of the Snap code below:

affygility-snapchat-code

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Affygility Solutions encrypts its entire website for all visitors http://potentcompoundsafety.com/2015/07/affygility-solutions-encrypts-website-visitors.html http://potentcompoundsafety.com/2015/07/affygility-solutions-encrypts-website-visitors.html#comments Mon, 13 Jul 2015 02:56:07 +0000 http://potentcompoundsafety.com/?p=2623 Beginning today, Affygility Solutions will encrypt its entire website, making it extremely difficult for hackers, governmental agencies, and others to track the reading habits of people visiting the site. The added security will apply to all pages on the affygility.com domain.

“Here at Affygility Solutions, security and privacy for our site visitors has always been a top priority” says Dean M. Calhoun, CIH, President and CEO of Affygility Solutions “and while, our e-commerce portions of the site have always been encrypted, we recognize that many of our visitors are frequent business travelers and are accessing our site through airport and public WiFi hotspots. We want our visitors to know that their visits to our site, no matter where they connect, are protected.”

While encryption has long been the standard for finance and e-commerce sites, Affygility Solutions, as an industry leader, is the first environmental, health, and safety consulting firm to roll-out encryption for all its site visitors.

Most browsers will note the added security with a display icon depicting a small lock, in the web address bar. The secure affygility.com site will also begin with “https” instead of the former “http.” The type of encryption used by Affygility Solutions is known as SSL (secure sockets layer) which establishes a private connection between the website and the user, making spying or hijacking extremely difficult.

This encryption technology also has the potential to make online monitoring more difficult for governments with high levels of censorship and surveillance. When visitors go to a site using SSL, someone monitoring their traffic will only see the domain that they are visiting – not the specific page. Since Affygility Solutions has potent compound safety clients in over 30 different countries, this is of growing importance in protecting the privacy of our clients’ information.

For further information, please contact Affygility Solutions.

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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.

  • Mizolastine


    Mizolastine is indicated for the treatment of running nose and itchy eyes, caused by seasonal and chronic allergy, and itchy skin rash. Mizolastine is a histamine H1 receptor antagonist.

    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 Mizolastine is available for purchase for $597 USD.

  • Ketoconazole


    Ketoconazole is a synthetic broad-spectrum antifungal agent which should be used for systemic purposes only when other effective antifungal therapies are not available or tolerated. It is active against clinical infections with Blastomyces dermatitidis, Coccidioides immitis, Histoplasma capsulatum, Paracoccidioides brasiliensis.

    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 Ketoconazole is available for purchase for $597 USD.

  • Ivermectin


    Ivermectin is indicated for the topical treatment of head lice and adult acne and for the oral treatment of parasitic infections - strongyloidiasis and onchocerciasis. It also has wide use in veterinary medicine for the treatment of various parasitic 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 Ivermectin is available for purchase for $597 USD.

  • Iloprost


    Iloprost is a synthetic analog of prostacyclin indicated for the treatment of high blood pressure in the arteries of the lungs to improve a composite endpoint consisting of exercise tolerance, New York Heart Association functional symptoms, and lack of deterioration.

    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 Iloprost is available for purchase for $597 USD.

  • Canagliflozin


    Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

    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 Canagliflozin is available for purchase for $597 USD.

  • Rimantadine


    Please note, this OEL/ADE monograph also applies to rimantadine hydrochloride (CAS RN 1501-84-4). Rimantadine is an antiviral medication use primarily for treatment of influenza A.

    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 Rimantadine 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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