USP 797 LABORATORY SERVICES
Pace Analytical® Aerobiology offers USP 797 services designed for healthcare institutions, pharmacies and other related facilities to ensure the sterilization of drugs that are used in compounding sterile preparations. The environmental monitoring and the microbial evaluation of the staff’s sterile techniques in compounding sterile preparations (CSPs) are critical to patient care. This applies to facilities in which CSPs are prepared, stored, and transported. It affects those involved in sterile compounding; physicians, pharmacists, pharmacy technicians, and nurses.
All Pace Aerobiology locations offering USP 797 lab services are skilled in enumeration and identification of bacteria and fungi in air samples, surface samples, glove samples and can assist in developing a microbial
monitoring program for compliance with USP 797.
United States Pharmacopeia (USP), Chapter 797 “Pharmaceutical Compounding, Sterile Preparations” specifies the monitoring of microbiological concentrations on surfaces and air for sterile pharmaceutical compounding.
USP 797 specifies a written plan and schedule for microbiological monitoring procedures in pharmaceutical cleanrooms. Monitoring locations are selected to test the areas most prone to contamination during compounding. Typically, this would include area sampling in the proximity of Class II biocabinets or barrier isolators (ISO Class 5 containment). The plan needs to specify sampling for the controlled environments of the pharmacy, including the interior of biocabinets and barrier isolators, compounding rooms (ISO Class 7 buffer areas), and anterooms (ISO Class 8 support areas) located outside the buffer area. Each sampling site (air, contact plate, swab, or glove fingertip plate) needs to have predetermined alert and action levels as part of the written plan. Any sample result exceeding the action level requires immediate corrective action which may include full-scale cleaning, ventilation, or High-Efficiency Particulate Air (HEPA) filter assessment and suspension of drug compounding until retesting verifies compliance.
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