Where I last left off was there were various Boards of Pharmacy not allowing us to renew our license until we were up to speed with our <797> compliance. The timing couldn’t have been better (or worse, depending on how you look at it). There was this new standard that was due to come online in the near future called USP Chapter <800>; heard of it?
So we had to make a decision; build out to the new standard, including negative pressure secondary engineering controls or wait it out and put off until a later date. At the time, no one I knew was building out to this standard yet and there weren’t many resources to turn to. However, myself and my partners are just not known for shying away in the face of uncertainty. After all, we’re all entrepreneurs.
We started out by looking around for cleanroom designers. While I’m not going to name names there were only a few that we could find and I guess trust (i.e. had seen them advertised). We got a couple of quotes from those vendors and went back and forth. We ended up having a modular cleanroom built.
So here’s what we had drawn up for us. This was not a small undertaking or investment for us. We were building out the entire pharmacy including the cleanroom; it was going to be costly. Nonetheless we proceeded and by October 2015 we had an operational cleanroom and facility. Remember, we had a Board of Pharmacy visit in March of that year so it was a quick 7 months of preparation.
Our first certification of the cleanroom was interesting. It didn’t go as expected to say the least. We’d been through many, MANY certifications with our previous cleanroom and never had an issue. But this was different. Rather than having a positively pressured room, two of our rooms were under negative pressure (i.e. sucking air in).
We had multiple CFUs growing in the air in our anteroom, hazardous buffer room and non-sterile hazardous area. Our positively pressured buffer room had nothing in it. Hmm. What’s going on here? Where are all of these microorganisms coming from?
I made some calls to the cleanroom builder/designer and I have to say honestly, they didn’t offer too many insights on how to fix the issue. They said that this wasn’t their first negatively pressured cleanroom they built and it should be working. Okay, but it’s not. So now what?
Our cleanroom certifier didn’t have much to say either. I started doing more and more google searches on a daily basis to figure out the issue. I learned that you can do a triple clean (3 cleans with a disinfectant followed by a sporicide) and this eradicates any and all bacteria in the cleanroom (but really, just the SURFACES of the cleanroom). So that’s what we did. We cleaned it like it had never been cleaned before and called in our certifiers again to test the room.
Only marginal change. Nothing profoundly different. Our cleanroom was still not qualifying based on the viables alone. Our certifiers at this point clued us into it possibly being a balance issue. So we called in an air balancing company to do the work. The air balancer seemed very knowledgeable and helpful but had an extremely difficult time trying to balance the room. A job that usually only takes him an our or two filled his entire day.
One main issue with balancing the room was all of the dampers/louvres in the doors and wall panels throughout each room. It just throws off the entire equation. But at the end of the day, he did his best and we called it balanced. It took some major adjustments to the exhaust and air flow coming into the room but he got it done.
We cleaned the room again and called in the certification company. No dice. Again, we still had failing results with only MINOR improvement. Even so, we were still on a mission because it was November and our busy season was just around the corner. We had to be up and running by February at the latest or we wouldn’t be able to make any compounds to sell.
We reached out to a different cleanroom certification company in town and had them take a LOT of air measurements. This company was owned and operated by a mechanical engineer and seemed to have a lot more insight into, as he called it, “the ins and the outs.” What he meant was is that what comes in must go out. They showed us that our exhaust was running much higher than it really needed to be and we needed to adjust the whole airflow of the room down to help the issue.
After making some adjustments, cleaning and re-testing with the new certification company we noticed a lot better results. Not passing, but a significant reduction. We knew we were on to something…but what else could be done?
To be continued…
If this sounds all too familiar check out my certification results to see if they compare to what you’re seeing! Download them here: