On June 1, 2015, the EMA’s Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities came into effect. In this guideline there is the requirement to perform permitted daily exposure (PDE) calculations. The general process for performing these calculations is presented.
Read moreIn this article, Dean Calhoun discusses the connection between strategic potent compound safety initiatives and business performance.
Read moreWondering how to establish a comprehensive potent compound safety program? Don't know where to start? We boil it all down to the key points for you to consider in a handy, attractive, suitable-for-framing infographic.
Read moreOccupational exposure limits for active pharmaceutical ingredients (APIs) contain a number of uncertainty factors. To properly apply this OEL, you must understand these uncertainty factors and why they were used. In this telephone interview with Dr. Joe Nieusma, Sr. Toxicologist for Affygility Solutions, Joe discusses some of the reasons that there may be different occupational exposure limits for the same active pharmaceutical ingredient.
Read moreWhat are Category 4 or 5 potent compounds and what are some examples? These questions are often presented to the potent compound safety experts at Affygility Solutions. In this article, Dean M. Calhoun, CIH, President and CEO, and Dr. Jim Damewood, Senior Director of Occupational Toxicology and Industrial Hygeine with Affygility Solutions discuss answers to these questions.
Read moreAs a 14 year veteran in the environmental, health and safety field, Michael Connor has played an important role in improving the environmental, health and safety performance of Upsher-Smith Laboratories. On July 21st, 2010, Dean Calhoun, President and CEO of Affygility Solutions met with Michael and discussed a variety of issues important to environmental, health and safety professionals.
Read moreEarly in my career as an environmental, health and safety professional, there was a significant amount of time spent developing environmental, health and safety checklists for performing routine inspections. In some cases, these "checklists" grew to over forty pages in length and covered every possible health and safety aspect.
Read moreIn this article, the author will provide recommendations on how to effectively manage a bioscience EHS program as a single individual.
Read moreI am often asked "What are the most common OSHA violations that are cited in the biotechnology and pharmaceutical industry?" So with some research on the OSHA website, I created a list of the top ten OSHA violations for the pharmaceutical and biotechnology industry. From over 25 years of EH&S auditing experience, these OSHA violations are consistent with what I’ve seen during a typical compliance audit
Read moreSeven things about potent compounds that every pharmaceutical environmental, health and safety professional should know. Review your potent compound safety handling practices and determine your gaps.
Read moreDean Calhoun and Jeff Holmes discuss Genzyme Corporation’s superior environmental performance, the challenges of the LEED process, and advice for young environmental professionals.
Read moreDean Calhoun and Keith Tait discuss EH&S industry changes, opportunities, and the future challenges that lie ahead.
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