Potent Compound Safety and Occupational Toxicology Resources
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.
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.
Get an occupational exposure limit for delta 9-tetrahydrocannabinol (THC), the psychoactive ingredient in marijuana. Available for instant download from OEL Fastrac.com
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.
Conference on the development, manufacturing & handling of highly potent drug compounds. May 28-29th, 2014 in Boston, MA.
Whether protecting personnel in hostile environments, containing potent powder pharmaceuticals, or developing unique inflatable devices, ILC's record of performance is enviable.
ChargePoint are market leaders in the supply of containment valves and integrated material handling equipment for the Pharmaceutical, Chemical & Food industries.
Contained Technologies markets and sells contamination control & containment equipment to the Pharmaceutical, Healthcare and Clean Industries. Contained Technologies distributes Ezidock products.
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.
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.
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."
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.
In this 81 slide presentation, Dean Calhoun of Affygility Solutions discusses the history of risk assessments, the regulations requiring risk assessments, an...
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.