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White Paper

Improve Workflow with Cleanroom Design

Bryan Prince
Improve Workflow with Cleanroom Design White Paper
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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, MBA is a USP <800> and compounding workflow consultant, laboratory design consultant, technical writer, and graphic designer. He focuses on engineering controls, hazardous drug handling, and cleanroom design strategies that support safe and compliant compounding environments. Bryan holds certifications in cleanroom behavior, hazardous drug handling, and USP <800> workflow practices.