USP797 Cleanroom From non-compliance to compliance without interruption

Project Highlights

  • Lasco Services designed and created a USP797 compliant cleanroom in a tight existing space
  • Installed a seamless floor, laminated all the walls, installed ante-room separation walls and doors
  • Re-worked the HVAC supply and furnished the HEPA filtration system
  • All work was done within a tight time-frame and without hampering the pharmacy's operations

Hopkins County Memorial Hospital

Starting in January 2006, all compounding pharmacies are required by the USP Code to provide a more stringent environment for mixing medicines. Primarily, this requires creating an ISO Class 7 environment surrounding their IV Hoods. No matter how big or small, all facilities must comply, and rural hospitals actually seem to be leading the way in being the first to transform their rooms into USP 797 compliant rooms.

One such hospital is Hopkins County Memorial Hospital, about 80 miles northeast of Dallas, Texas. Serving the rural communities of northeast Texas, HCMH may have as many as 90 patients at a time. Nevertheless, their pharmacy may need to compound drugs around the clock. Like most hospitals across the country, Hopkins had to convert a non-compliant space into a compliant space without interrupting their continued operations.

USP797 Form

Lasco Services was able to install a seamless floor, laminate all the walls, install ante-room separation walls and doors, re-work the HVAC supply and furnish the HEPA filtration all within a tight time-frame and without hampering the pharmacy's operations.

Under the prior code, hoods were allowed in the ambient air; at Hopkins the hood was tucked behind a wall, near entry doors. This is direct conflict with the new code, USP 797, which says "strong air currents from opened doors, personnel traffic, or air streams from heating, ventilating, and air-conditioning systems can easily disrupt the unidirectional, columnar airflow in the open-faced workbenches."

As administrator David Yarbrough said, the cleanroom provides "an atmosphere with the least amount of chance of a problem," Crucial to that "least chance" is the constant air pressure. No door leads directly from the clean room to the ambient air rooms; instead, passage is made through the ante room, in which air pressure remains intact by use of a gravity vent. Now, the pharmacists use the ante-room, or gowning room to don their cleanroom garb.

Mixing in a clean room in full body garb has become routine for the four staff members trained in the new protocol. As Linda Nash, who has been working in the pharmacy since 1976, commented with a smile, "Used to you just have to scrub down and do it; now you just have to gown down and do it."