RADIOPHARMACEUTICAL CLEANROOM DESIGN
USP standards are developed by the United States Pharmacopeia (USP) to protect patient and worker safety while developing, packaging, distributing and consuming medicines and dietary supplements. Therefore, they must be adhered to in cleanroom applications involving pharmaceutical development or manufacturing.
Some of the most common USP standards in the cleanroom industry are USP 797 and USP 800 — but in this article, we’ll be discussing one that’s relatively new to the industry: USP 825.
WHAT IS USP 825?
USP General Chapter 825 is the USP standard that provides the minimum requirements for preparing, compounding, dispensing, and repackaging both sterile and nonsterile radiopharmaceutical drugs. It describes facilities and engineering controls, personnel training and qualifications, and procedural requirements for processing radiopharmaceuticals in various clinical settings. All of these requirements work together to ensure that workers are protected while handling these hazardous drugs and that patients are protected while consuming them.
WHO NEEDS TO FOLLOW USP 825?
Simply put, if you’re working with radiopharmaceutical development or manufacturing, you need to follow USP 825. That includes a variety of healthcare personnel and environments, including:
Authorized nuclear pharmacists (ANPs)
Authorized user (AU) physicians
Individuals in training and under supervision, like students, technicians, and trainees