PharmacyInspection.com for Compounding Pharmacies and Hospitals.
Strengthening the practice of Compounding Pharmacy.
Please select a page for the Contact Slideout in Theme Options > Header Options

Cleanroom on the GO – A mobile solution?

Cleanroom on the GO – A mobile solution?
January 28, 2018 Seth DePasquale

Cleanroom on the go - a Mobile solution? - UPDATED 10AM 1/29/18

I recently came across an interesting cleanroom concept that I originally thought was a good idea; upon further contemplation I realized it was a GREAT idea: A mobile cleanroom. A picture is worth a thousand words and a video is made up of thousands of pictures…

If you watched the entire video you saw some features that you might not see in most cleanrooms. There’s a touch screen that monitors temperature, humidity and pressure differentials. You’re also able to set alarms and change settings to adjust each of those.

After inquiring more about these with the President of the company (Cleanroom Design, LLC), Brian Clark, also made me aware they’re able to add real-time particle counting as well. These features give my current room a run for its money and the downside of mine is it’s stationary.

Applications

At the beginning I eluded to this being not just a good idea but a GREAT idea; here’s where this company’s mobile cleanroom obviously shines: mobility.

Had I seen this in 2015 when we needed to rebuild our entire pharmacy with about 5 months of downtime; we could’ve had this on site within days and incurred minimal cost for the lease and had nearly zero downtime. Although we may have just kept the mobile cleanroom as our permanent solution after working in it.

It’s also not a compromise in space or functionality as these are about the size of my current cleanroom (28’x13′) and can be outfitted with both positive and negative pressures allowing for compliance with USP <797> and <800>.

Mr. Clark also mentioned that these come fully equipped with all of the necessary fixtures AND Primary Engineering Controls for your particular situation.

Aside from using this as a gap measure for limiting downtime for a fixed cleanroom I had some other thoughts for applications. Much like mobile MRIs that give hospitals, clinics or ambulatory care centers capabilities they may not be able to afford on their own; having a mobile cleanroom would allow multiple locations to utilize a compliant cleanroom that could be shuttled from site to site based on demand or needs.

Immediate Compliance

One of the most alluring aspects of the mobile cleanroom is that you can have compliance with USP <800> within days, not months (at least from an engineering controls standpoint). Again, this would’ve saved so much time and pain with our own project.

Final thoughts

I think with the delay in USP <800> many people have put their projects on the back burner and will procrastinate their builds however, I caution that move considering all of the issues we encountered. Even if the project went flawlessly we would’ve had at least 4 months of downtime. With these rooms they employ an airlock system at the point of entry which mitigates the most problematic issue we encountered with our negative pressure areas.

If anything, use the delay wisely to plan, plan, plan. Looking back, we didn’t have time on our side given it was a compliance issue with regards to 5 states licenses. Had we planned a little more I think we wouldn’t have had the large headache we did; or at least I contend I would’ve done more homework.

Using a solution like this allows you to have a room installed, working and certified before they ever leave the job site. Cleanroom Design in particular knows their rooms work because they verify they’re compliant before they arrive and before they leave. Unfortunately, I can’t say the same thing occurred with our project.

 UPDATE 1/19/18 – 1000

I’ve received MANY comments and questions about the mobile cleanroom already and I just wanted to provide a couple other points of clarification. Cleanroom Design actually has multiple sizes of this mobile unit. Their smaller unit is capable of being EITHER compliant with USP <797> or <800> but not both at the same time given space constraints. However, they also build a larger unit that is 48′ x 14′ and THIS is capable of being compliant with BOTH.

I’ve also been able to secure some drawings from them to better illustrate the larger unit since achieving compliance with 800 and 797 simultaneously with a mobile unit has garnered the most feedback and questions. Also, with <800> compliance the question has been asked, “is there an unpacking room?” The answer is yes. In both the larger and the smaller dedicated <800> unit you’re compliant with meeting that aspect of the standard.

Drawings of Mobile Cleanroom (click here)

Sign up for updates from PharmacyInspection.com:

 

About the author:

Seth DePasquale is a pharmacist and co-owner of BET Pharm, LLC in Lexington, KY; a compounding pharmacy specializing in long-acting injectable hormone formulations for equine reproduction. Seth is a 2002 graduate of Albany College of Pharmacy in Albany, NY and is a Registered Pharmacist in New York, Kentucky, Michigan, Oklahoma, Texas, West Virginia, Virginia, Alabama, Tennessee, Mississippi, Arkansas, Nebraska, Louisiana and Oregon.

Comments (0)

This site uses Akismet to reduce spam. Learn how your comment data is processed.

%d bloggers like this: