Optional HEPA filtration is a best practice design concept for USP <800> Nonsterile Compounding Rooms
(Transcript from Bryan Prince on The Pharmacy Inspection podcast - Listen to AUDIO here) Hello to all of my compounding friends and colleagues and welcome to another episode of the Pharmacy Inspection Podcast. Last week when Seth pulled me out of
Is This Building Right for My Compounding Pharmacy?
[Transcript from The Pharmacy Inspection Podcast- Episode 44 - Listen to Audio here.] There are quite a few “unintended consequences” with USP 800 compliance and unfortunately most of those are hitting the pocket books of pharmacies trying to decipher and adhere
Demystifying Some Myths Around USP <800>
As a consultant in the compounding pharmacy industry I get a lot of calls and a fair amount of interactions, which often are discussing or demystifying things that people have heard. In todays age of social media, discussion forums, conferences,
Cleanroom Temperature and Humidity Problems: Who is going to own this problem?
Let me go ahead and tell you how the twice a month email or phone calls goes, it’s something like this. Hey Bryan, we were given your name by so-and-so because we are having temperature and/or humidity problems in our
Unintended Consequences of USP <800>: Additional Costs for the Professional Stamps
There are definitely some unintended consequences of USP <800> implementation for certain pharmacies that I don’t believe the expert committee anticipated. I'm not trying to lay the blame at their feet because admittedly construction can be a fickle
An Opinion on Casework and USP 800 Compliance
https://youtu.be/saFG3Gc8OH8 An Opinion on Laboratory Casework Hello to all my compounding pharmacy friends and colleagues my name is Bryan Prince and I am a compounding workflow and lab design consultant and I specialize in USP <800> compliant environments. In this brief video
Do I Need a USP 800 Nonsterile Gowning Room?
There is a question that has popped up multiple times on social media and I wanted to address it. The question is, "do I need an ante room for my USP <800> negative pressure compounding room?" The answer
How To Achieve Negative Pressure Per USP <800>
This video is a step by step instruction on how to achieve negative pressure per USP <800>. Per the chapter, the containment secondary engineering control (C-SEC) must be externally vented and maintain a certain number of air changes per
The Advantages of the Sterile Airlock in Cleanroom Design
When designing a cleanroom for both USP <797> and USP <800> sterile compounding it might make sense to include an airlock between spaces in an effort to minimize or eliminate the ingress of particulates or CFUs. This principle is
Considering Materials of Construction for USP <800> Compliance
USP chapters <797> and USP <800> use similar language with reference to surfaces inside of a cleanroom and hazardous drug compounding room, so when we consult with architects discussions around acceptable materials of construction are a strict focus. First