As we have stated in the past, not all compounding pharmacies are the same. This applies to clean rooms as well. The first thing to know is that there are different levels of clean rooms. The International Standards Organization (ISO) classifies clean rooms based on the number of contaminants per-cubic-meter. The lower the ISO rating, the cleaner the environment.
Hartley Medical’s USP compliant sterile preparation area consists of three areas: 1) a gowning room, 2) an ante room, and 3) a sterile preparation room. To meet USP 797 guidelines, a buffer room should be ISO Class 7 or better (less than 352,000 particles-per-cubic-meter), and the gowning room and ante room should be Class 8 or better (less than 3,520,000 particles-per-cubic meter). And, since workers are the largest contamination source, all rooms should be isolated through the use of sealed doors and pathways. Hartley Medical exceeds USP guidelines by utilizing an ISO Class 6 sterile prep-room, and ISO 7 for ante and gowning rooms. Access in and out of this preparation area, as well as from room-to-room inside, is through sealed, self-closing doors.
Additionally, per USP guidelines, clean rooms for non-hazardous compounded sterile preparations are to be supplied with air through ceiling HEPA filters with low wall-mounted return vents. Air is typically introduced into the cleanroom at the ceiling level after passing through a fan-powered HEPA filter that removes particles as small as 0.3 microns. This creates a pressurized room in which the air pressure is greater than that outside the room, i.e. positive pressure. The air, and any contaminants in it, is then pushed down toward the floors and out the lower vents. This produces dynamic airflow where the air and contaminants from the processes are constantly flowing out of the room. Hartley Medical’s ventilation system surpasses the standards set forth by 797. In fact, USP mandates that clean rooms should experience no less than 30 air changes per hour (ACHP). Hartley Medical experiences nearly 200 ACPH.
Hartley Medical is Setting the StandardTM nationally for quality and safety. We are dedicated to protecting our patients by practicing safe, high-quality compounding. For more information, visit Hartley Medical’s Knowledge Center by clicking here.