Compliance with USP 797 and USP 800 are critical for maintaining a sterile cleanroom for CSPs. Proper environmental conditions, as outlined by USP 797 and USP 800, help to ensure the effectiveness and quality of medications.
In most hospital pharmacy cleanrooms, standard operating procedure includes sampling of air quality for viable particles (i.e. particles that include or are composed of microorganisms). These tasks are traditionally executed with an air sampler containing agar strips or simply by placing agar contact plates on surfaces throughout the facility. These samples are then left to incubate and are then analyzed to determine the environment’s air quality.
Hospital pharmacies are unique because of the critical role they play in maintaining patient health and safety. Pharmacies that perform compounded sterile preparations (CSPs), in particular, must meet specific clean room standards to ensure sterile conditions are maintained. While there are many established environmental requirements in these spaces, some pharmacy managers are choosing to go the extra mile in exchange for added peace of mind.