Keeping Pace^® with Analytical Services

If You Didn’t Document It, Did It Really Happen? 

USP <797> is often talked about as though compliance is a “pass/fail” test. Either CFU counts are exceeded or they are not. However, the USP <797> mentions data trending several times throughout the standard. In this post, we will look at what data trending is, how it’s used to promote patient safety, and how and when it’s required. 

At its essence, USP <797> is a quality control (QC) standard used to protect patients from contamination that can occur when pharmacies produce compounded sterile preparations (CSPs).Media-fill, gloved fingertip, surface sampling, and other tests are used to confirm personnel competency and ensure bioburden control of compounding areas and personnel. For these results to be valid, the medium used in these tests must be uncontaminated and capable of supporting growth. This can be confirmed using positive and negative controls. 

In our USP <797> Q&A Series, we’ve mentioned cleanrooms a few times but haven’t gone too deeply into the topic. As in other areas, the revised USP <797> standard includes a few changes. Some tighten up the requirements, while others leave things open to interpretation. Here are answers to some of the more frequent questions we get on USP <797> cleanroom standards. 

In this series of Q&A posts, we’re answering questions from customers about USP <797> compliance. Some of these are common questions. Others, not so much. All are important.  

If you have questions about how to comply with the latest revisions to USP <797>, you’re not alone. Even though the standard has been in effect since November of 2023, we’re still getting a lot of foundational questions about specific requirements.  

Aspergillus, Bacillus, and Cladosporium – The Importance of Genus Identification 

On September 18, Dr. Michael Berg, Technical Director Pace® Building Sciences, and Rhonda Lintner, Pace® Account Executive, presented a webinar on the USP <797> Personnel Competency requirements.  

In 2023, the USP <797> standard for compounded sterile preparations was significantly revised to improve patient safety. Not only are there more protocols to follow, but pharmacies may need to demonstrate their adherence to USP <797> to various Authorities Having Jurisdiction (AHJ). Proving adherence includes documenting standard operating procedures (SOPs), but it also includes providing ample evidence that these SOPs are followed and effective.

Lately, the Pace^® microbiology team has been fielding a lot of questions on how to interpret and implement different aspects of the revised USP <797> standard. Here are some of the most frequently asked questions regarding the use of sampling media kits.