USP 797 Compliance Mistakes- And How to Avoid Them

USP 797 compliance matters to pharmacy managers, cleanroom operators, and QA staff. How can your facility make sure you are USP 797 compliant and avoid any costly and timely mistakes? Below we detail some common compliance issues that facilities could make.

1. Inconsistent Surface Sampling: Many facilities don’t sample monthly, even if it’s recommended. Establish a regular, monthly schedule with a standardized plan and assign responsilbilty to a trained person (internally) and to a certification company (Medical Technology Associates).

2. Sampling the Wrong Locations: Make sure you’re targeting the right sampling areas. Sample ISO 5 hoods and PECs, work surfaces, and any high-touch areas (door handles or pass-throughs). Map out your cleanroom and ensure all ISO-classified areas are included in your sampling program.

3. Misunderstanding Action Levels: Facilities might fail to properly count CFUs (Colony Forming Units) and interpret CFU counts. Train staff on USP 797 action levels (view current levels here) and define what a corrective action looks like for your facility, if and when CFU counts exceed the action levels.

4. Poor Documentation: Complete and consistent documentation is key for inspections. Make sure to log sampling details, chain of custody records, and any corrective actions. Stay audit-ready and organized by conducting internal reviews.

5. Ignoring Trending Data: Review your results monthly and quarterly. Identify any trends in sampling, like reoccuring organisms or elevated CFU counts. Make sure small issues don’t become major risks.

6. Improper Media Use: Using the wrong media, or even poor quality media, can compromise your results. Make sure media is not expired, stored properly, and incubated correctly to USP 797 guidelines. Need help sourcing high quality media? Check out our store.

7. Delayed Sample Shipping: Samples are time-sensitive. If shipping samples, make sure they are sent immediately after collection, with at least overnight or 2nd day return shipping speeds. Package samples appropriately to avoid any breakages.

8. Not Identifying Microbial Growth: Don’t just count CFUs- identify the organisms. Pinpoint potential contamination sources by identifying any bacteria or molds that are recovered from your samples. We identify all growth at LAB 797, no matter if your plate is above the action limit or not.

9. Lack of Staff Training: Lack of training creates risk to your sampling program. Issues could include incorrect aseptic technique and lack of understanding of compliance. Provide initial and ongoing training to staff and have a dedicated USP 797 compliance person at your facility.

10. Treating Certification as “Enough”: Passing a cleanroom certification is great- but it isn’t enough. Ensure ongoing compliance by continious monitoring and by establishing a robust environmental monitoring program at your facility.

Internal sampling can be a duanting process to tackle. LAB 797 can help! Take the hassle out of surface sampling interpretation by sending us your samples to incubate and identify bacterial and fungal growth. We offer solutions for monthly sampling and certification, so let us be your guide to USP 797 compliance, no matter what route you choose.