USP 797 Laboratory Services

USP 797 is 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 staff’s sterile techniques in compounding sterile preparations (CSPs) are critical to patient care. All locations of Aerobiology 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 is 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 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.


Compliance

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.


Environmental Monitoring

Recommended limits for microorganisms during operation*:

GradeAir sample (CFU/m3)90 mm diameter settle plates (CFU/4hours)55 mm diameter contact plates (CFU/plate)Glove print (5 fingers) (CFU/glove)
A<1<1<1<1
B10555
C1005025-
D20010050-

Test CodeTest Code DescriptionSamples Accepted:Sample ProtocolSampling Report
1104Surface, USP 797 Bacterial Counts with Genus ID, TAT 2-3 DayMonday-FridayClick HereClick Here
1106Surface/Wipe, USP 797 Fungal Counts with Genus ID, TAT 6 DaysMonday-FridayClick HereClick Here
1107Air, USP 797 Bacterial Counts with Genus ID, TAT 2-3 DayMonday-FridayClick HereClick Here
1108Air, USP 797 Fungal Counts with Genus ID, TAT 5-7 DayMonday-FridayClick HereClick Here
1109Surface/Wipe, Culture, USP 797 Glove Fingertip Bacterial Counts Only, TAT 3 DaysMonday-FridayClick HereClick Here
1204Surface/Wipe, USP 797 Culture Bacterial Counts Only, TAT 3 DaysMonday-FridayClick Here
1206Surface/Wipe, USP 797 Culture Fungal Counts Only, TAT 5-7 DaysMonday-FridayClick Here
1207Air, USP 797 Culture Bacterial Counts Only, TAT 3 DayMonday-FridayClick Here
1208Air, USP 797 Culture Fungal Counts Only, TAT 5-7 DayMonday-FridayClick Here
HVH1USP 797 Media Fill Kit ONLY, High Risk HVH1, TAT 7-12 DayMonday-FridayClick Here
HVL1USP 797 Media Fill Kit ONLY, Low Risk HVL1, TAT 7-12 DayMonday-Friday
HVM1USP 797 Media Fill Kit ONLY, Medium Risk Comprehensive HVM1, TAT 7-12 DayMonday-Friday
HVM2USP 797 Media Fill Kit ONLY, Medium Risk Basic HVM2, TAT 7-12 DayMonday-Friday
AERO031Compliance USP <797> Sampling Kits, BasicMonday-Friday
AERO032Compliance USP <797> Sampling Kits, MediumMonday-Friday
AERO033Compliance USP <797> Sampling Kits, ComplexMonday-Friday

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