What is USP 797?
USP <797> was developed to establish best practices for the production of compounded sterile preparations (CSPs). As part of these regulations pharmacies producing CSPs must periodically perform environmental testing to ensure compliance with USP <797>.
When must environmental and personnel sampling be performed?
Environmental and personnel sampling must be performed:
As part of the commissioning and certification of new facilities and equipment
Following any servicing of facilities and equipment
Air and Surface sampling every 6 months as part of re-certification
Surface/ Personnel sampling done at “regular intervals” internally (such as every month)
In response to identified problems with end products or staff techniques
In response to issues with CSPs, observed compounding personnel work practices, or patient-related infections
How DO I SUBMIT MY SAMPLES?
This document provides an overview of how to submit your samples to our laboratory for analysis. Please contact us with any questions.
How DO I obtain my results?
Results are obtained through Sharefile, a secure document sharing service. Please contact us if you need help creating an account or accessing your account.
What are action levels?
Action levels are limits set in place by USP as guidelines for the maximum number of viable organisms allowable in a single sample.
The number of viable organisms recovered from environmental testing must be compared to action levels to determine what corrective actions must be completed. If the number of organisms recovered exceeds the action level for the corresponding sample type, corrective action must be taken.
Current Action Levels - From USP <797>
As of November 2023, the following standards apply.
No pathogenic species
Air Sampling
ISO 8: >100 CFU
ISO 7: >10 CFU
ISO 5: >1 CFU
Surface Sampling
ISO 8: >50 CFU
ISO 7: >5 CFU
ISO 5: >3 CFU
Personnel Sampling
No growth in pre-manipulation samples
>3 CFU in post-manipulation samples