Enhancements to Cardinal Health NPS Lab to USP-787 Standards

Abstract

As the world develops and populations expand, new diseases arise at an exponential rate. This research is based on employing new modifications to NPS (Nuclear Pharmacy Services) Laboratory at Cardinal Health, Inc. (Guaynabo, Puerto Rico) in order to provide facilities with the necessary enhancements to comply and provide quality products to clients and patients in the island. The primary purpose of this project is to increase the facilities capabilities in management of radioactive materials used for patient’s medical solutions, increasing the cleanroom compliance under federal regulations, reducing costs in the process and provide a high-quality product without compromising safety. Current federal regulations require pharmaceutical and biopharmaceutical manufacturers to follow a specific quantity of particles in their cleanroom process stated as ISO 7 or 8 cleanroom standards. The actual project development plan is to bring this facility into these standards no later than December, 1st 2019. KeyTerms⎯Nuclear pharmacy services, federal regulations, radioactive materials.