In 2015, one of our clients began the preparations for renovating their cleanroom to meet USP<797> and USP<800>. The hospital had hired a "design" team that was supposed to be one of the leaders in the USP<797> industry. I use the word, supposed to be, because the project is still faced with problems and is not producing two years later. Being on the East Coast, one would assume the design team would take into account the environmental changes our weather goes through. Unfortunately, they did not. Two years later and there are leaks in the chemo room and compounding is still on hold.
Another issue this client faced was having the hospital's in-house GC the project. Anyone that knows a hospitals inside construction management, knows how busy and inundated with all of the hospitals needs they are. It is almost impossible to throw that responsibility on their plates. What ended up happening with this project was the supervising pharmacist took the brunt of the project on. Needless to say, he was swamped and overwhelmed.
Back to the design. So, what else was an issue with the USP<797> design? Well, most know how important a material pass through to the outside pharmacy is, right? Well, this cleanroom was built without a pass through to the main pharmacy. Meaning, a lot of unwanted exposure to the USP<797> cleanroom will be an issue. Not to worry though. We will be building a material pass through that will fix this error. Just waiting on the full project to be completed. In the beginning there was a cupboard that was designed into the Cleanroom. Luckily, the supervisor put a halt on that mishap.
So, what was our role in this nightmare? Cleanetics completed the wall lamination, built the custom material pass throughs that are in the cleanrooms(one to chemo and the other to IV), installed ceilings, and furnishings. This part of the project was done with no issues and on time.
If we would have gotten our hands on the front of the project and been a part of the design and management of the Cleanroom, this USP797 hospital pharmacy would have been compounding a year ago. Fortunately, they understand this now and know who they will be turning to for the next facility upgrade.
"This project is a nightmare and one that I don't think will ever get completed. I can't believe that I am still here and working on this. What is wrong with me?!" -quote from Pharmacist.