Compounding of radiopharmaceuticals must be performed in which class of environment?

Compounding of radiopharmaceuticals must be performed in a Class 100 environment, which is a controlled area where the maximum allowable particle count is 100 particles per cubic meter of air for particles that are 0.5 micrometers or larger. This stringent requirement is essential due to the delicate nature of the compounds being handled and the critical need to minimize contamination.

Radiopharmaceuticals are typically associated with high-risk procedures that require a sterile environment to ensure patient safety because any contamination can lead to adverse patient outcomes. Class 100 environments are typically achieved using cleanrooms equipped with specialized air filtration systems, such as High-Efficiency Particulate Air (HEPA) filters, to constantly circulate and purify the air.

The other classifications, such as Class 100,000 or Class 500, do not meet the stringent cleanliness standards required for the safe compounding of radiopharmaceuticals. Thus, performing such procedures in a Class 100 environment is critical for ensuring the utmost safety and quality of the compounded radiopharmaceuticals.