Tue, 18 November 2014
In this episode of the Biopharma EHS podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions interviews Kevin Rosenthal of Pharmatek Laboratories. During the interview we discuss handling potent compounds, potent compound safety, and occupational control banding.
Dean Calhoun also responds to the frequently asked question, "What type of equipment do I need to handle a highly potent compound?"
If you would like to learn more, visit affygility.com
Fri, 24 October 2014
Risk-MaPP, ADEs, and PDEs: Their importance to multi-product pharmaceutical manufacturing facilities
In this episode of the Biopharma EHS Podcast, Dean M. Calhoun, CIH, President and CEO of Affygility Solutions, interviews Ms. Stephanie Wilkins, President of PharmaConsult US, on the subject of Risk-MaPP, ADEs and PDEs: Their importance to multi-product pharmaceutical manufacturing facilities. Risk-MaPP stands for Risk-Based Manufacture of Pharmaceutical Products. It is one of the International Society of Pharmaceutical Engineers' (ISPE) Base-line Guides. One of the essential components of Risk-MaPP is the determination of acceptable daily exposure (ADE) values. Calculation of ADEs is similar to the calculation of PDEs presented by European Medicines Agency (EMA). If you need an occupational exposure limit (OEL) or ADE for a pharmaceutical compound, please check out our entire catalog of OEL Fastrac monographs. We have many OEL monographs that come with ADEs.