Skip To Content
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
Unrealistic Certification Expectations Image

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

While we waited an entire year for USP <797> to become official, Pure Microbiology offered a daily tip to help you prepare. Check out the full list of tips from 364 to 0! 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.
Stack of Petri dishes

Choosing Media

USP <797> requires the use of microbiological media for gloved fingertip sampling, viable air sampling, and surface sampling. While the chapter includes certain requirements, it falls short in providing details on media. Unless you have a microbiology background or have worked in aseptic manufacturing, finding the right media can feel…
Defining the Hand Hygiene and Garbing Competency Image

Defining the Hand Hygiene and Garbing Competency

I can’t tell you how many times I’ve read the 2021 proposed version of the chapter. But every time I read it, I pick up on another change that I somehow missed before. We all know that the frequency of the hand hygiene and garbing competency will increase. Those compounding…
View Case Studies