(437h) Safe Handling of Potent Active Pharmaceutical Ingredients (Apis) in Kilogram Quantities

The development of potent compounds with therapeutic benefit reduces the amount of material that a pharmaceutical company needs to generate for dosing. However, when microgram quantities of Active Pharmaceutical Ingredients (APIs) produce a therapeutic effect and kilograms are synthesized to meet demand, special programs need to be put into place to limit exposure to such compounds in order to keep personnel safe.

A research and development facility used to prepare APIs for use in First-In-Human clinical trials will be used as a representation of state-of-the-art technology being used to produce kilogram quantities of potent compounds up to a level of Performance-Based Occupational Exposure Limit (PBOEL) Category 3 in accordance with Johnson & Johnson Safety & Industrial Hygiene guidelines. Subjects will include facility design, engineering controls (including downward laminar flow containment booths, isolators, reactor charging, and reaction sampling), handling guidelines, contaminated surface cleaning, and the importance of training personnel in the proper use of the equipment.