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Pharmacy Cleanroom Guidance from Abby Roth Image

Pharmacy Cleanroom Guidance from Abby Roth

This compilation contains five sterile compounding cleanroom articles, all published in Pharmacy Purchasing & Products. Topics include viable sampling excursion remediation, microbiological media, and effective cleaning principles. Click on the image to access the document.
Top 5 Things to Look for When Choosing a Lab for the Processing of USP <797> Viable Samples Image

Top 5 Things to Look for When Choosing a Lab for the Processing of USP <797> Viable Samples

The requirement for more frequent viable sampling is hopefully coming soon with the release of a new chapter. To prepare for this change, some sterile compounding facilities are planning to collect viable air and surface samples themselves and outsource the incubation and analysis to a contract lab. But what makes…
Viable Sampling Challenges and Limitations Image

Viable Sampling Challenges and Limitations

As you are well familiar with, USP General Chapter <797> currently requires viable air sampling every 6 months and surface sampling “periodically.” By default, many are collecting viable surface samples every 6 months as well. It just makes sense, right? Plus, nobody knows what periodically means anyway. But as we…
Agents for Cleaning and Disinfecting Sterile Compounding Areas Image

Agents for Cleaning and Disinfecting Sterile Compounding Areas

Cleaning agents are confusing! Some are just cleaning agents, while others are disinfectants and some are both. Some are bactericidal, some sporicidal. How are you supposed to know what to use? This article takes a deep dive into cleaning agents, defining terms, listing what you should look for in a…
A Look at “Highly Pathogenic Organisms” Image

A Look at “Highly Pathogenic Organisms”

Nothing makes my skin crawl more than hearing the term “highly pathogenic organisms.” And it’s not because I’m a germaphobe. I think it’s because the term is so misunderstood. For those of you familiar with the current version of USP <797> (and hopefully that is all of you reading this),…
Remediating Environmental Monitoring Excursions Image

Remediating Environmental Monitoring Excursions

The release of the proposed revisions to USP General Chapter <797> in September 2021 was long awaited and came with unexpected, significant changes to Section 6, “Microbiological Air and Surface Monitoring” (see TABLE 1). Under these revisions, those who plan to perform Category 1 and 2 compounding are required to…
Choosing a Viable Air Sampler For USP <797> Applications Image

Choosing a Viable Air Sampler For USP <797> Applications

As many sterile compounding pharmacies are looking to move to collecting their own viable air and surface samples, they will be in the market for a viable air sampler. The search for an air sampler can be overwhelming and you’ve probably asked yourself a few questions. “How do I know…
Stack of Petri dishes

How Good is Your USP <797> Viable Sampling Plan?

Your viable sampling plan can make or break your environmental monitoring (EM) program. Too few sample locations won’t give you the information you need and too many sample locations may risk the act of sampling being a cause of contamination. Hopefully, you have taken on the responsibility of choosing your…
Clock and calendar

Controlled Environment Professionals Serving USP <797> Customers Need to Understand Beyond Use Dating

Controlled environment professionals are responsible for collecting most of the viable air and surface samples in 503A sterile compounding organizations. This means that in the event of a microbial excursion, the sterile compounding organization is most likely going to contact the servicing company for guidance on next steps. This typically…
Professionals in a clean room working together at a computer

Microbiology in the Clean Room

Every sterile compounding clean room will experience a microbial excursion at one point or another. It might be an exceeded action level or an organism of concern. Being prepared is half the battle. What does being prepared really mean? Your organization should have robust standard operating procedures (SOPs) in place…
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