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Microscopic Organisms

Proactive Garbing and Behavior Considerations for Those Servicing USP 797 Customers

Nearly every certification company I have worked with has at some point had viable results come back from the lab that are off the charts. It may be something like 120 CFU/m3 of Staphylococcus, Micrococcus, and Corynebacterium species on a sample; and the counts are similar for all buffer and…
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It’s Here! The Revision to CAG-009

Over the last two years, I have had the privilege of working with an outstanding group of CETA members who worked diligently to revise CETA Application Guide (CAG)-009. Expertise came from sterile compounding pharmacists, certification professionals, and microbiologists. It was with their dedication and the supportive guidance of the CAG…
Petri dishes filled with specimens

Microbiological Growth Media Demystified

There are so many microbiological media options available, so how do you know which media is right for your application? Or which manufacturer is reputable? Research is essential and sterile compounding organizations should consider auditing their media vendors. This article explores the sterile compounding industries media need, ensuring compliant media…
A lab professional cleans and disinfects surfaces

Effective Cleaning and Disinfection

The concepts of cleaning and disinfection seem simple; however, they can be very confusing, especially when it comes to choosing agents. This 3-part series of articles addresses many of the cleaning and disinfection myths and inconsistencies associated with USP <797>, which typically lead to noncompliant practices. General concepts of cleaning,…
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Environmental Monitoring in the Clean Room

Are you a designated person responsible for your environmental monitoring (EM) program? It’s not enough for you to just be a pharmacist or pharmacy technician. You now, to a certain extent, need to fill the role of microbiologist. Understanding the purpose and limitations of viable EM is essential to a…
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The United States Pharmacopeia: Beyond <797>

The United States Pharmacopeia (USP) Chapter <797> is one that has become very familiar to the certifier. This chapter is revisited often, and many compounding customers rely on their certification company for help in understanding this chapter. Because of this, the certifier must not only be familiar with the content of <797>…
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