Facility and Engineering Control Design Under USP 800 White Paper

White Paper

Facility and Engineering Control Design Under USP 800

In light of the recently published versions of USP chapters <795>, <797>, and <800>, with the intention of creating cohesive alignment between nonsterile and sterile compounding, it is essential to consider engineering controls for Hazardous Drug (HD) handling within these two categories of compounding. Issues such as compounding volume, production downtime during renovations, air filtration, make up air units, and exhaust methods all factor into the design considerations for creating a compliant HD compounding operation.

Bryan Prince, Lab-Red Pharmacy Consultants

About the Author

Bryan Prince

Bryan Prince, MBA is the owner and lead consultant at Lab·Red Pharmacy Consultants. His early career in containment technology allowed him access to pharmaceutical labs around the U.S. where he gleaned extensive knowledge of chemical handling technique and safety strategies. In 2012 he started visiting compounding pharmacies to observe workflow habits and share his knowledge, which led to writing articles for the International Journal of Pharmaceutical Compounding (IJPC). Bryan has been invited to speak at conferences on “Quality, Safety, and Workflow in the Compounding Pharmacy” for the American College of Apothecaries and PCCA. Most recently he has spoken on "Facility and Engineering Controls Using USP 800 Guidelines" for the ACA and IACP. He is also a contributor to the ACHC’s USP 800 education conferences and webinars.