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November 28, 2007

"Clean room" provides sterile space for preparing IV solutions
 
An area in Haywood Regional Medical Center’s pharmacy known as a “clean room” is actually cleaner than clean.

Stricter regulations concerning intravenous solutions now require pharmacies to prepare them within a more sterile environment, said George Methvin, pharmacy director at HRMC.

In January 2006, workers started preparing a space formerly used as a linen room for the new clean room. The move-in date was Sept. 17, 2007.

Prior to entering the clean room, technicians place the IV preparation materials in a compartment that can be accessed from inside the clean room. After the pharmacy technician washes his or her hands, they enter the “ante room” and don shoe covers, hair covers, a gown, facemask and gloves. In that area, the air is so pure that even micron-sized particles are screened out by high efficiency particulate air (HEPA) filters. The ante room is critical to meeting guidelines because it forms a protective perimeter outside the clean room, Methvin said.

Once the pharmacy technician is properly clothed, they enter the clean room, where they prepare the IV solutions for hospital patients. The air entering in this room is also filtered by HEPA filters that will not allow bacteria to enter the room.

The IV solutions are then prepared within laminar flow hoods, where the air is cleaned by a second set of HEPA filters.

“We batch our work so we can prepare eight to ten IVs at a time, so the technician doesn’t have to repeat the gowning process so often,” he said.

Haywood Regional Medical Center’s pharmacy clean room exceeds the “SP 797” regulation issued by U.S. Pharmacopoeia that governs any pharmacy that prepares compounded sterile preparations. The regulation is designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals.

Haywood Regional Medical Center’s pharmacy will be able to meet or exceed those standards for the next 10 to 20 years, Methvin said.

HRMC Pharmacist Cynthia Shelton attended a meeting of the American Society of Hospital Pharmacists two years ago and received special training about the USP 797 standards and the clean room process. Shelton then presented a series of 797 training classes to the pharmacy staff.

There is another similar clean room in the Home Care Services’ building, which is used primarily for ambulatory infusion services, said James Moore, ambulatory infusion/hospice pharmacist. That room has been in use for about seven years, he said.

“I don’t think many hospitals in Western North Carolina have two clean rooms,” Methvin said.

Meredith Baker prepares an IV solution in the “clean room” at Haywood Regional Medical Center’s pharmacy.