Keeping Pace^® with Analytical Services

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. 

Mold spores are ubiquitous in the indoor and outdoor environment. Damp and moldy conditions indoors have been associated with adverse health effects such as the development and exacerbation of asthma, bronchitis, allergic rhinitis and other respiratory tract symptoms. Please note that if you or your client are concerned about specific health effects, you should consult a medical professional. In this post, we will be discussing the laboratory methods used for identifying molds and how they can inform the remediation process. 

In 2024, the New Jersey state legislature passed S2188/A1970, a law requiring Public Community Water Systems, owners or operators of certain types of buildings, and others to take action to protect public health by preventing and controlling Legionella in their water systems. This bill is now enshrined in New Jersey state law.  

After several months of initial monitoring for PFAS under the National Primary Drinking Water Regulations (NPDWR), water systems across the country continue to ask questions about how to interpret these rules, especially the Hazard Index calculation. Late last month, I did a national webinar in which I drilled down into some of the more confusing aspects of the PFAS MCLs and the initial monitoring period. This webinar is now available on-demand:

In 2024, the New Jersey state legislature passed S2188/A1970, a law requiring Public Community Water Systems, owners or operators of certain types of buildings, and others to take action to protect public health by preventing and controlling Legionella in their water systems. This bill is now enshrined in New Jersey state law. In this post, we drill down on how this bill impacts the state’s Public Community Water Systems. In a follow-up post, we will look more closely at the law’s impact on facilities. 

Now that the U.S. EPA’s Lead and Copper Rule has been finalized, planning is underway in communities across the country to replace the estimated 9 million service lines made of lead or galvanized steel. This should reduce the amount of lead in the nation’s public water systems, but can it introduce another potential hazard – Legionella? 

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