Potent compound safety and occupational toxicology resources list

Below is a List.ly embedded list of potent compound safety and occupational toxicology resources. Please note that this is a dynamic list and is subject to periodic additions and deletions.

Potent Compound Safety and Occupational Toxicology Resources
Potent Compound Safety and Occupational Toxicology Resources

Dean M Calhoun Potent Compound Safety and Occupational Toxicology Resources

Dean M Calhoun | 23 items | 276 views

Here's a list of potent compound safety and occupational toxicology resources.

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  1. 1. Category 4 or 5 Potent Compounds: Understanding the Risks - Affygility Solutions

    Category 4 or 5 Potent Compounds: Understanding the Risks - Affygility Solutions

    Here at Affygility Solutions, we often get asked the questions "What makes a Category 4 or Category 5 potent compound?" In addition, we often get asked, "What are some examples of Category 4 or Category 5 potent compounds?" In this article, Dr. Joe Nieusma, Senior Toxicologist with Affygility Solutions and Dean M.

  2. 2. Potent Compound Safety Training Preview

    Potent Compound Safety Training Preview

    Provides an overview of potent compound safety concepts. It is designed for laboratory, contract manufacturing organizations (CMO), and pharmaceutical manufacturing employees who may work with potent active pharmaceutical ingredients.

  3. 3. OEL Fastrac: Abiraterone

    OEL Fastrac: Abiraterone

    Need an occupational exposure limit (OEL) for Abiraterone? Available for instant download from Affygility Solutions.

  4. 4. OEL Fastrac: Tetrahydrocannabinol

    OEL Fastrac: Tetrahydrocannabinol

    Get an occupational exposure limit for delta 9-tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana. Available for instant download from OEL Fastrac.com

  5. 5. Affytrac: Qualitative Exposure Assessment Software - Affygility Solutions

    Affytrac: Qualitative Exposure Assessment Software - Affygility Solutions

    Qualitative exposure assessments are often used by industrial hygienists and other occupational health professional as a means of assisting their organization in identifying and prioritizing areas of potential occupational exposure risk. In addition, qualitative exposure assessments are used to identify industrial hygiene monitoring needs and identify areas of unacceptable risk.

  6. 6. HPAPI 2014 by Hanson Wade

    HPAPI 2014 by Hanson Wade

    Conference on the development, manufacturing & handling of highly potent drug compounds. May 28-29th, 2014 in Boston, MA.

  7. 7. ILC Dover Flexible Containment Systems

    ILC Dover Flexible Containment Systems

    Whether protecting personnel in hostile environments, containing potent powder pharmaceuticals, or developing unique inflatable devices, ILC's record of performance is enviable.

  8. 8. EHS Podcasts for the Life Science Industry - Affygility Solutions

    EHS Podcasts for the Life Science Industry - Affygility Solutions

    The voice of Biopharma EHS, expounding on a variety of topics including compliance management, potent compound safety, occupational toxicology and more.

  9. 9. Split {Butterfly} Valves, Containment Valves, Powder Transfer & Handling

    Split {Butterfly} Valves, Containment Valves, Powder Transfer & Handling

    ChargePoint are market leaders in the supply of containment valves and integrated material handling equipment for the Pharmaceutical, Chemical & Food industries.

  10. 10. Ezidock Products - Contained Technologies LLC

    Ezidock Products - Contained Technologies LLC

    Contained Technologies markets and sells contamination control & containment equipment to the Pharmaceutical, Healthcare and Clean Industries. Contained Technologies distributes Ezidock products.

  11. 11. Human Factors Lead to Occupational Exposure of HPAPIs

    Human Factors Lead to Occupational Exposure of HPAPIs

    By Dean Calhoun Each year, pharmaceutical manufacturers spend millions of dollars on engineering controls to prevent employee exposure to highly potent active pharmaceutical ingredients (HPAPIs). These engineering controls can include isolators, local exhaust ventilation, high containment split butterfly valves, downflow booths, and more.

  12. 12. Risk-MaPP and Multi-Use Facilities

    Risk-MaPP and Multi-Use Facilities

    No doubt that the Risk-MaPP approach is state-of-the-art thinking when it comes to managing the risk of cross-contamination. David Cockburn of the EMA declared as much at the launch of the new Baseline� Guide in Washington, DC this past October.

  13. 13. High Potency Rebuttal

    High Potency Rebuttal

    In High Potency Regulations in the November/December 2013 issue of Contract Pharma, Stephanie Wilkins wrote, "While other areas of pharma manufacturing are embracing science- and risk-based approaches, some in industry are back trying to define 'certain' in terms of where dedicated facilities may be required."

  14. 14. High Potency Re-Rebuttal

    High Potency Re-Rebuttal

    In the article High Potency Rebuttal (Contract Pharma, January/February 2014, bit.ly/1bPvahb), by Karen Ginsbury of PCI Pharmaceutical Consuting and Destin A. LeBlanc of Cleaning Validation Technologies, it seems apparent that there is confusion and a lack of understanding on the use of risk-based approaches to determine the need for dedicated facilities.

  15. 15. Risk assessment Presentation by Affygility Solutions

    Risk assessment Presentation by Affygility Solutions

    In this 81 slide presentation, Dean Calhoun of Affygility Solutions discusses the history of risk assessments, the regulations requiring risk assessments, an...

  16. 16. Insight - Potent compounds: 7 things every pharmaceutical environmental, health and safety professional should know -...

    Insight - Potent compounds: 7 things every pharmaceutical environmental, health and safety professional should know -...

    Potent Compounds: 7 things every EHS professional should know Review your potent compound safety handling practices and determine your gaps. Obtain occupational exposure limits for your active pharmaceutical ingredients. Unlike traditional hazardous substances, active pharmaceutical ingredients (API) are designed to have an effect on the human body.

  17. 17. OEL Fastrac Catalog - Affygility Solutions

    OEL Fastrac Catalog - Affygility Solutions

    Browse our catalog of occupational exposure limits (OELs) for active pharmaceutical ingredients (API) or drug substances. Created by potent compound safety experts with decades of experience.

  18. 18. OEL Fastrac: Morphine sulfate

    OEL Fastrac: Morphine sulfate

    Occupational exposure limit (OEL) for Morphine sulfate. Available for instant download from Affygility Solutions.

  19. 19. OEL Fastrac: Escitalopram Oxalate

    OEL Fastrac: Escitalopram Oxalate

    Occupational exposure limit (OEL) for Escitalopram Oxalate. Available for instant download from Affygility Solutions.

  20. 20. OEL Fastrac: Oxytocin

    OEL Fastrac: Oxytocin

    Occupational exposure limit (OEL) for Oxytocin. Available for instant download from Affygility Solutions.

  21. 21. OEL Fastrac: Taxol

    OEL Fastrac: Taxol

    Occupational exposure limit (OEL) for Taxol. Available for instant download from Affygility Solutions.

  22. 22. OEL Fastrac: Eszopiclone

    OEL Fastrac: Eszopiclone

    Occupational exposure limit (OEL) for Eszopiclone. Available for instant download from Affygility Solutions.

  23. 23. OEL Fastrac: Dexamethasone

    OEL Fastrac: Dexamethasone

    Occupational exposure limit (OEL) for Dexamethasone. Available for instant download from Affygility Solutions.

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Posted in compliance management software, control banding, corrective action software, occupational toxicology, OEL Fastrac, potent compound safety, resources | Comments Off

ACGIH approves new occupational exposure limit for Peracetic Acid

New ACGIH STEL for Peracetic Acid

The American Conference of Governmental Industrial Hygienists (ACGIH) Board of Directors has approved the 2014 occupational exposure limits. Included in these limits is a new short-term exposure limit (STEL) for peracetic acid (PAA, C.A.S 79-21-0). This new STEL is 0.4 ppm over a rolling 15-minute period.

Peracetic acid is a strong oxidant and is often contained in disinfectants that are used in the biotechnology, pharmaceutical, medical device and healthcare industries. In particular, in combination with hydrogen peroxide and acetic acid, peracetic acid is contained in a product called Spor-Klenz. It should be noted, that legacy material safety data sheets for this product do not list the new STEL for peracetic acid. It should be anticipated, in the near future, that the new limit will be included on revised MSDS.

What are the acute health effects of peracetic acid?

Acute exposures to peracetic acid can cause irritation of the eyes, skin irritation (including oxidation), mild irritation to the upper respiratory tract (including sore throat, nasal irritation).

Performing industrial hygiene air monitoring for peracetic acid?

The preferred method to monitor for peracetic acid is to use a combination sampler for both hydrogen peroxide and peracetic acid. This combination sampler consists of a treated filter and treated tube that is sampled a one (1) liter per minute. Sampling can then be performed for the STEL, or for the OSHA PEL for hydrogen peroxide of 1 ppm as an 8-hour time-weighted average (TWA).

With the publication of the new STEL for peracetic acid, it is important to understand what airborne concentrations are being generated. This is to ensure that either engineering or administrative controls are implemented to reduce exposures below the STEL; or if engineering or administrative controls are not feasible, that proper respiratory protection is selected and used. 3M has done a great job in preparing a technical bulletin on respiratory protection for both hydrogen peroxide and peracetic acid. Go to technical bulletin 185.

About Affygility Solutions

Affygility Solutions provides environmental, health and safety consulting services and EHS software to the pharmaceutical, biotechnology, medical device, and healthcare industries. EHS services include potent compound safety, potent compound safety webinars, potent compound safety assessments by professionals with advanced certifications, occupational toxicology, industrial hygiene monitoring. Affytrac, our EHS software contains modules for EHS task management, corrective actions, and qualitative exposure assessments. To learn more, visit our website at affygility.com

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Posted in industrial hygiene pharmaceuticals | Comments Off

Why your co-workers think “You s#ck as an EHS Manager!”

I’ve been in this field for over 28 years, and have been fortunate enough to have spent a lot of time traveling throughout the globe working with a wide variety of environmental, health and safety managers (EHS). Most are really good at what they do, but some need a drastic upgrade in a few areas. Here’s my top ten list:

  1. You are horrible at email. This comes first because I encounter this all too frequently. You don’t respond to people, or worse yet you never open their email and leave it sitting in your Inbox for weeks. Yes, I understand that you get a lot of email, but I know many individuals that that get way more email that you can imagine (800 emails/day) and know how to effectively manage it. Take a look at your email Inbox, if you have to scroll down to see the end of the messages, you need to improve your email ninja skills. With email there’s only a couple things you can do: 1) Delete: If you know it’s not relevant, delete without opening. If it’s a FYI, read then delete or archive; 2) Delegate: If you have staff and it’s best suited for them, forward to them to handle, but don’t wait till that last minute to let them know. If you need to follow-up to make sure it’s done, set up a “Waiting on others” folder; 3) Respond: Most email responses can be handled in one sentence, such as “got it” or “will respond tomorrow.” Those that require more thought might need to go to a “defer” folder, which is covered next; 4) Defer: This should be a folder that is for those responses that require greater thought, research, or detail than you can do in a minute or less; or 5) Do. Take care of the email request right then. After it’s done, file in the archive folder. It takes a while to get used to it, but once you starting using the “Inbox Zero” or other similar email management strategy, you will never go back.
  2. Lack of vision. You are just trying to get by with the day-to-day tasks and don’t provide direction to where you want the EHS program to go. The management of most day-to-day tasks can be handled by EHS software. Set some goals and let your people run with it. People want to work with leaders. They don’t want to feel like the janitorial staff and make a daily routine of cleaning up the mess someone else created.
  3. You have meetings that aren’t necessary or too long. This wastes people’s precious time. Enough said.
  4. You are a conference groupie. We all need to expand our knowledge and know about the latest regulations and requirements, but when you are never in the office and always out giving presentations to volunteer groups, your coworkers will begin to resent you. You will become disconnected from them.
  5. You always refer to the ways you did it at your former company. We can all appreciate experiences from different companies and perspectives. However, when all people hear is, “Back when I worked at [x], we did it this way.” Well guess what, you don’t work at [x] anymore, and if it was so great back there, why aren’t you still working for them? People want to know about the future and how it’s going to be better for them, not how it was so much better at your former company.
  6. Constantly negative. EHS is a tough field because we are always dealing with the potential for injuries, accidents, and regulatory violations. Unfortunately, these are all negative topics, which others hope that never happen. So, if you’re going to be an outstanding EHS manager, try to think about the things that can be framed in a positive light. Celebrate the positive things with the rest of your team. Give credit to others for achievements.
  7. You are boring. Your social and presentation skills are lacking and you don’t show any passion for what you do. The presentations that you do provide are essentially the same ones you gave ten years ago. Don’t be afraid to have a personality. While you don’t have to be best friends with all your co-workers, act like you care about them as a person. If you need to brush up on your skills on how to become more interesting, go here to listen to this talk by Jessica Hagy.
  8. You never leave your office, except for meetings. Great EHS managers get out and see the real world. They see the way that the company really operates. They make it a point to dedicate hours a month out visiting facilities, manufacturing and laboratory employees. People know who the is EHS manager and they are a resource.
  9. You refuse to get your hands dirty. You don’t help out when things get bogged down, or you make your staff work long hours and weekends while you go play golf.
  10. You are just trying to hang in there till retirement. Lately I’ve been seeing this way too often. EHS managers that are late in their career are afraid to rock the boat or do anything that might be risky. So instead they go to the other extreme and don’t set goals that are challenging for members of your team.

So what are the signs that your co-workers will give you when they think you suck as an EHS manager. According to Forbes magazine, the 3 signs that your employees think you stink as a manager are:

  1. They act like you’re not there. When you walk by, they don’t even acknowledge your presence. They just keep on working.
  2. They don’t keep you in the loop.
  3. Your team doesn’t play by the rules.

If you recognize a couple of those item in the list in yourself, then an upgrade in leadership skill might be needed. It takes work and there’s no free ticket. Love to hear comments and feedback.

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Potent Compound Safety 2014 Webinar Schedule is Posted

Affygility Solutions is pleased to announce that its Advanced Topics in Potent Compound Safety webinar series is now posted on its website. In this highly visual, 5-module series, the industry experts from Affygility Solutions will cover the following topics:

  • Module 1 will cover an introduction to potent compound safety and will review case studies where occupational exposures to active pharmaceutical ingredients have caused adverse effects in pharmaceutical and laboratory workers.
  • Module 2 will cover an introduction to occupational toxicology.
  • Module 3 will cover industrial hygiene, as it relates to potent compound safety.
  • Module 4 will cover advanced toxicology including numerous examples on how occupational exposure limits for APIs are determined.
  • Module 5 will cover control banding and engineering controls.

Avoid costly and time consuming travel by attending from the convenience of your own office. Group discounts are available. To view the schedule and register for the series, go to the Affygility Solutions’ website.

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