USP 797 governs and regulates not only the clean room itself, but everything that happens in that cleanroom from cleaning methods to monitoring of sterility. First issued in 2004 and revised in 2008, USP 797 sets standards “for the design of and the procedures used in sterile compounding areas”, according to usp797.org. Though usp797 is generally universal in its regulations, state and organizations also have written standards and should be consulted also.
A major component affected by these regulatory standards is the cleanliness of a usp797 clean room. Only staff trained in high-level disinfection should be allowed to clean the area and dressed in appropriate personal protective equipment. This equipment should be donned before entering the sterile clean room. Staff must only enter at times scheduled for cleaning per written procedures. Compounding areas should be cleaned with 70 percent isopropyl alcohol only after pharmacy staff has removed any open product.
In regards to the cleaning schedule for a usp797 cleanroom, time must be set aside for both pharmacy and cleaning staff to clean throughout the workday. Staff must clean daily at the beginning of a workshift and pharmacy staff clean every 30 minutes of continuous compounding; wiping down and cleaning countertops, storage anteroom sinks, vents and shelving. Monthly cleaning of walls, ceiling and storage shelving is expected. And “terminal cleaning” is expected at the same level of a surgical suite, also monthly.
Though these are regulations that your staff needs to make sure to comply with on a daily and monthly basis, we at TCA make sure that your modular clean room is built to the exacting specifications of both you and USP797. Contact us at 970-203-0516 for further information regarding how a TCA clean room is superior.