FAQs
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.
What is USP 797 compliance?
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.
When must environmental and personnel sampling be performed?
This document provides an overview of how to perform surface sampling.
Please submit this form with all samples sent to the lab for evaluation. Include a printed copy of this form with your samples when they ship, or you can email this form to us at orders@lab797.com prior to shipping. This form will be used when setting up your account to receive your results (Client Reporting Information) and Client Billing Information. Please fill out the form in its entirety. If you have any questions regarding filling out the form, please contact us.
This document provides an overview of how to submit your samples to our laboratory for analysis. Proper packaging is crucial to make sure your samples arrive to us in satisfactory condition. It is recommended that samples are sent in no slower than 2nd Day Shipping to our facility. We accept samples sent in from UPS, Fedex, or USPS. Samples are accepted Monday-Saturday during our business hours.
How do I submit my samples?
What are the current action levels from USP 797 standards?
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.
As of November 2023, the following standards apply.
Air Sampling Surface Sampling
ISO 8: >100 CFU ISO 8: >50 CFU
ISO 7: >10 CFU ISO 7: >5 CFU
ISO 5: >1 CFU ISO 5: >3 CFU
Personnel Sampling
No growth in pre-manipulation samples
>3 CFU in post-manipulation samples
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How do I obtain my results?
How can I get pricing?
Water testing options vary depending on your industry and the type of water you are testing. Inquire with us today and we can help discuss a custom option for your facility that meets your goals and expectations. Follow this link to inquire.