[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 to the chapter chapter requirements on hazardous drug handling. Let me see if I can back into this equation through a story about a recent consulting project.
Let me step back and give some preface first… Over the past few years, I have consulted on compounding pharmacy projects at various stages in the project timeline and one unfortunate and somewhat common theme is, the building will just not work for a compounding pharmacy if they want to adhere to USP <800> standards, such as defined on both Table-2 and Table-3 in the chapters. Usually the deal breaker with the compliance standard is where the containment secondary engineering control (C-SEC), which is the hazardous drug compounding room, must be externally vented, which means out of the building. I could go on and on about how to achieve this, but for now I will tell you watch my video on how to achieve this.
If we are talking “architect lingo” here for a moment, the first phase in a project is considered ‘Planning and Predesign’ which includes finding a piece of real estate dirt to build on, or locating an existing commercial building for remodeling. You as the business owner are most likely working with a real estate broker during this phase and exploring multiple commercial locations. The consideration for choosing a property could be any number of factors like local traffic patterns for patient convenience, proximity to medical centers for obvious synergy with providers, the price of monthly rent/lease, or the amount of tenant improvement (TI) allowance the facility owners are willing to negotiate into the lease deal. Let me throw in a very important consideration here for you to think about as a first criteria. If your new pharmacy is going to really emphasize compounding as a strategic business model and revenue driver, then know that building feasibility goes beyond the above motives and extends to structural feasibility, mechanical feasibility, and electrical feasibility because all of these three pieces must work together.
That seems like a lot of “feasibility” factors to consider in the planning phase, to which I would answer, “yes, absolutely!” Unfortunately time and time again I am engaged as a lab design consultant after the planning phase when the commercial building has been selected, the lease signed by the pharmacy owner, and now we are moving to the schematic design phase which is drawing concepts for the compounding labs, at which time the architect and/or contractor may or may not have actually been chosen. Great, I love designing compounding labs so lets go. But what I do not enjoy doing is having to tell the pharmacy owners their building is going to be a problem, which is where this story is going.
A pharmacy owner that I have had the pleasure of meeting quite a few times at conferences calls me up and excitedly announces, “I just signed a lease on a new building and I need your help designing the nonsterile compounding rooms and the cleanroom.” They then emailed me over the “as built” floorplan so I can see what we are working with and to start some brainstorming on layouts. The single story facility was previously a dentist office, with plenty of plumbing accessibility, so that was a definite plus. The first red flag was when I looked up the street address on Google street view and saw a pitched roof with maybe a 5-12 pitch, which is not steep, which means very little attic space, but the building lease is already signed so let’s see how we can make this project happen.
The real estate agent that helped the pharmacy owner had a good recommendation for a General Contractor so we worked collaboratively on the building’s intimate physical details. What was quickly revealed by the GC was old wood scissor trusses, which formed the roof. Doing all aspects of sterile and even nonsterile compounding requires moving a lot of air per USP defined standards, which requires a lot of ductwork and scissor trusses are going to create a problem to bob and weave in and out of, but we will let the mechanical engineer and HVAC contractor give us their interpretation in the coming weeks.
The next reg flag was that the building only had a single phase 200 amp panel. Containment ventilated enclosures (CVE), both sterile and nonsterile use energy efficient motors. Unguators, electronic balances, LED lights and computers are not energy hogs either, so what is the concern you might ask? Well I am glad you asked because new mechanical equipment requirements to move cold and dry air in and out of the cleanroom is not an out of the box solution that existing mechanical equipment can handle, trust me, and in this video I am going to dissect this point too (link redirects to YouTube). The new air handling equipment really needs three phase power, but you can run it off of single phase, but at least 60 amps or more in the 200 amp panel is going to the mechanical equipment, so maybe we can make this electrical panel work. Going one step further with mechanical equipment needs, and without getting too deep into the technical weeds, the facility had no access to natural gas, which will make the air handling HVAC system with modulating compressors a little more efficient, but again not a deal killer.
So you can see there are things working against us with this building, but there are workarounds and more expensive solutions that will be revealed. The final obstacles got more prevalent when the engineer stepped into the relationship and had a real opportunity to dissect the USP air handling design requirements that I defined. By this time I had finished all of the concept drawings for sterile and nonsterile compounding rooms in a floor plan for the general contractor to conceptualize walls and glass placement, compounding equipment layout with electrical duplex locations, and the big piece, mechanical air handling specifications which the mechanical engineer needed. Without belaboring the budgeting process, all of the contractors on the project team were on board with what needed to be quoted to make this building compliant to USP standards. Maybe that last sentence was too incriminating on the USP chapters. It needs to be understood that USP does not define the standards for which the building must look like, or the scissor trusses, or the electrical standards. By adhering the air handling standards, such as ISO 7 and 30 air changes per hour below 20C (68 F) and a preference for below 60% RH, these standards are what walk us down the path for the building’s structural, mechanical, and electrical parts and pieces.
When the GC collected all of the pricing from the subcontractors and consolidated it into a budget price for the pharmacy owner, the budget was double their original dollar amount expectation. Obviously the owner was not happy and was left with some tough decisions about the building.
Here’s the point of this story, the building was older and not equipped to adequately handle the needs for a compounding pharmacy, at least not without a significant capital investment to make it structurally sound for mechanical equipment. The structural piece would have been about $40,000 to support the mechanical equipment by modifying the roof structure because there was no opportunity for putting the equipment in the parking lot. The electrical piece to have three phase power brought in was about $15,000, so there was approximately $55,000 in unexpected expenses which wiped out a significant portion of the tenant improvement allowance.
There is definitely more depth to this story but just hear me on this last piece of advice, maybe worth fifty cents and a Coca Cola, if you can even buy a coke for that price these days. If you are looking to put a capital investment into your existing pharmacy building for USP <800> compliance standards, or even looking into the market for a different building, do some homework up front to make sure the building will actually serve the overal project-construction needs.
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