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, […]
USP <797> FAQs: Positive and Negative Controls Read More »
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
3 Ways to Analyze Mold Samples Read More »
According to the Centers for Disease Control (CDC), Legionnaires’ disease is on the rise in the United States. In 2000, roughly 1000 cases were reported. That number ballooned to 10,000 cases in 2018, the last year for which data is available. The CDC issued a 2021 report on waterborne diseases, but this report only looks
Should You Test for Legionella? Read More »
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 my most recent post, I covered what
What Facilities Managers Need to Know About New Jersey’s new “Legionella Law” Read More »
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
What Community Water Systems Need to Know About New Jersey’s new “Legionella Law” Read More »
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? What is
Getting Rid of Lead and Copper in Drinking Water. Introducing Legionella? Read More »
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
USP <797> Q&A: Cleanroom Requirements Read More »
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. Today, I’d like to respond to a few questions about pass-through sampling that we received during and after our webinar on Personnel Competency and Environmental Monitoring. This webinar
USP <797> Q&A: Sampling Pass-Throughs Read More »
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. If you have a question, you can count on us to follow up with
USP <797> Q&A: Do I need to have a microbiologist on staff? Read More »
Aspergillus, Bacillus, and Cladosporium – The Importance of Genus Identification The revised USP <797> standards for compounded sterile preparations (CSPs) have arrived, and they’re causing a stir in the pharmaceutical world. Adherence to the new standards will require more effort from compounding pharmacies, especially in areas such as documentation. These Standard Operating Procedures (SOPs) are
USP <797> Compliance: It’s as Easy as A,B,C…1,2,3. Or is it? Read More »