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USP 797
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USP 797 is designed for health care institutions, pharmacies and other related facilities to insure 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)
is 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.
Download USP 797 Chain of Custody
Download USP 797 Test Codes
Download USP Technical Bulletin
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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 health care institutions, pharmacies and other related facilities to insure 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 Action levels for Microbial Contamination in Air, Surface and Glove Fingertip
| ISO Class |
Air Samples (cfu*/m3) |
Glove Fingertip (cfu/plate) |
Surface Samples (cfu/contact plate**) |
| 5 |
>1 |
>3 |
>3 |
| 7 |
>10 |
Not Required |
>5 |
| 8 |
>100 |
Not Required |
>100 |
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*cfu = colony forming units **Contact plate may vary from 24 to 30cm2
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Media for USP 797 Environmental Monitoring
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Media |
Incubation |
Time of Incubation |
| Bacteria |
TSA |
30C to 35C |
48 to 72 Hours |
| Fungi |
MEA |
26C to 30C |
5 to 7 Days |
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| Test Code |
Analysis |
TAT |
| 1104 | SURFACE, BACTERIAL Counts w/ ID's | 2-3 Days | | 1106 | SURFACE, FUNGAL Counts w/ ID's | 5-6 Days | | 1107 | AIR, BACTERIAL Count w/ID's | 2-3 Days | | 1108 | AIR, FUNGAL Counts w/ ID's | 5-6 Days | | 1109 | GLOVE FINGERTIP SAMPLING (L & R), BACTERIAL Counts | 2 Days | | 1204 | SURFACE, BACTERIAL Counts Only | 2 Days | | 1206 | SURFACE, FUNGAL Counts Only | 5 Days | | 1207 | AIR, BACTERIAL Counts Only | 2 Days | | 1208 | AIR, FUNGAL Counts Only | 5 Days | | 1080 | Spore Strip Sterility Check | 2-3 Days |
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