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Organisms in petri dishes

Preparing for USP <797> Microbiology-Related Changes

For those responsible for making changes to policies and standard operating procedures (SOPs), it’s time to get started. We see changes throughout the chapter, making it critical to read and reread the chapter to pick up on some very nuanced differences between the 2008 and 2022 versions. This is especially…
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Choosing Incubators

With many organizations taking monthly surface sampling in-house, it makes sense that they plan to incubate the surface samples as well. The 2008 version of USP <797> essentially let organizations get away with having only one incubator, which was used for the incubation of gloved fingertip samples at 30 to…
Clock and calendar

Clock Is Ticking On <795>, <797> ’23 Go-Live Date

In this Pharmacy Practice News article by Gina Shaw, Kevin Hansen and Abby Roth give their insight on what sterile compounding organizations need to consider to be ready for November 1, 2023. Read Full Article
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Unrealistic Certification Expectations

Because of my contamination control background, I sit in a weird place between certification providers and sterile compounding facilities. I hear the good, the bad, and the ugly about both sides. Some things are true. Some things are exaggerated. It’s a hard place to be because I know both sides…
Understanding USP<797> Microbiology Testing Requirements – Webinar Image

Understanding USP<797> Microbiology Testing Requirements – Webinar

This webinar, originally presented through ARL Bio Pharma on December, 13, 2022, explores chapter changes to viable air and surface sampling, gloved fingertip testing, media-fill testing, sterility testing, and bacterial endotoxin testing. Click here to view the webinar recording.
Specimens in a petri dish

Determining How You Will Handle Viable Sampling and Incubation

With the release of the new version of USP <797>, you will have a lot of changes to make to your sterile compounding operation. One of the most challenging may be updating your viable sampling program and deciding how to handle increased sampling frequencies. There are a variety of factors…
USP <797> Chapter Official Date Countdown Tips Image

USP <797> Chapter Official Date Countdown Tips

USP <797> Chapter Official Date Countdown Tips This document will be updated regularly. This version has tips from 364 through 200 days to go. Click here to access a PDF of the tips.
USP <797> Chapter Release Countdown Tips Image

USP <797> Chapter Release Countdown Tips

USP <797> Chapter Release Countdown Tips If you loved these tips, they are now all in one place! Click here to access a PDF of the tips.
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