Using technology to meet the rules and regulations for ventilating these facilities
Most prescriptions come from a pharmaceutical manufacturing plant, but some come from small stores, called compounding pharmacies, all over the United States. Only a percent or so of prescriptions come from compounding, which involves the preparation of personalized prescriptions. To ensure the safety of the prescriptions, as well as the pharmacist and technicians, compounding must adhere to strict rules about ventilation.
NuAire (Plymouth, MN) maintains a compounding-pharmacy page, which notes that “some patients don’t simply rely on one or two individual prescribed medications, but instead, need a combination of multiple medications in order to maintain their health.” As the page adds, “Compounding pharmacies exist to combine multiple drugs into one effective medication, which is chemically mixed to the exact strength and dosage required.”
“Compounding pharmacies that perform sterile compounding are bound to the regulations set forth by the United States Pharmacopeia, USP,” says Scott Tomerlin—pharmacist, chairman of the board of the Florida Pharmacy Association, and media liaison for the American Pharmacists Association, which is headquartered in Washington, D.C. “Individuals that perform simple aseptic compounding must adhere to the rules set forth by USP 795; those that perform at a higher level practice, such as the compounding of sterile preparations and hazardous materials, adhere to the USP 797 and USP 800 guidelines, respectively.”
Some elements of these guidelines involve the handling of air. “Compounding pharmacies may use a variety of means to achieve the required level of air containment, set forth by USP,” Tomerlin explains. “Common equipment includes a cleanroom, which is pressurized to maintain air containment to the required standards of an ISO class air cleanliness of 7 or better as required by USP 797.” He also notes that “other equipment compounding pharmacies use to achieve the required level of air containment may include a compounding aseptic isolator, CAI, and compounding aseptic containment isolators, CACI, at a minimum.”
To keep compounding-pharmacy air within limits, some manufacturers make just the right products.
Picking platforms
NuAire’s compounding-pharmacy page states: “To help you with the compounding process, NuAire has created a range of pharmacy equipment that meets the U.S. Pharmacopeia’s <797> standard for compounding sterile preparations and U.S. Pharmacopeia’s <800> standard Hazardous Drugs—Handling in Healthcare Settings.”
For example, NuAire’s CAI can be used to create a positive-pressure environment for compounding nonhazardous drugs. The company’s CACI creates a negative-pressure working area that “minimizes exposure to airborne toxins and other hazardous materials.” Moreover, NuAire’s biosafety cabinets, laminar airflow workstations, and robotic enclosures can be used in compounding.
In addition to using the right equipment, a sterile compounding pharmacy needs random testing of its air quality. As Tomerlin notes, this is a “required standard operating procedure of practice.” He adds, “Practitioners who practice in the compounding of any preparation should make it a priority to review the United States Pharmacopeia guidelines frequently, to keep current with any updates to practice.”
So, in addition, to maintaining high-quality products, the air in a compounding pharmacy must also be top-notch. If it’s not, a facility cannot meet the necessary requirements for operation. If questions arise, a manager of a compounding facility should consult the United States Pharmacopeia guidelines or talk to an expert. Then, continued care should be used to keep a compounding pharmacy’s flow on point.