Improve Workflow with Cleanroom Design White Paper

White Paper

Improve Workflow with Cleanroom Design

Bryan Prince


Designing a cleanroom requires a multifaceted process that should reflect the facility's compounding model-comprising drug volumes, types (hazardous or nonhazardous, etc-while also considering the pharmacists and technicians, equipment, workflow, and processes. In addition, guidance from regulatory entities, such as state boards of pharmacy, accreditation organizations, the United States Pharmacopeia (USP), and the Federal Drug Administration (FDA) should be studied closely. This paper will focus on 503A pharmacy requirements and the USP chapters <797> and <800>. It is essential to recognize all of the above stakeholders during the cleanroom design process to improve workflow and optimize compliance.

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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.