What is USP 800 Design Consulting?
We specialize in compounding lab designs that strive to lean your pharmacy’s workflow processes, to mitigate risk, and for USP compliance.
Introduction to Compounding Workflow USP 800 Facility Design and Air Handling Consulting Services
Video transcript – edited with additional information
Hello, it all about compounding friends and colleagues my name is Bryan Prince. I am a compounding workflow and lab design consultant and I specialize in USP <800> compliance. Over the past eight years
I have had the pleasure of meeting a lot of pharmacists and technicians. I have spoken at conferences and done webinars on various compounding pharmacy related topics. I also have the distinct honor of speaking with the ACHC / PCAB at their USP 800 education workshops. Some of you watching this video recognize my voice and southern accent from the pharmacy inspection podcast. Regardless of how we met thank you for taking time to watch this video.
The purpose of this short video is to introduce you to our consulting services that you can find compounding workflow dot com. The heaviest lift of USP 800 compliance is really in the planning, budgeting, and the construction phase. Now there is no doubt your pharmacy must write a set of SOPs specific to hazardous drugs and you’ve got to develop a hazardous drug communication program. You have got to come up with new training modules and of course with that is employee assessments and that’s very time-consuming. But by and large the heaviest financial lift and time lift is going to be inside of this planning and construction and engineering design phase.
Bryan Prince’s history in construction, pharmaceutical containment, and consulting
In my previous life I spent 10 years in the construction industry. My grandfather built houses, my father is an electrician and so I understand a lot about the process of design and construction because I have been around construction the better part of my life. One of our main goals as consultants is to make sure
that your general contractor, and/or your architect, and/or engineer, and/or HVAC contractor, and/or plumber, and/or the electrician, or any other folks that come in and on the pharmacy project team are all speaking the same language and moving in the same direction to truly understand what is a USP 800 compliant facility (sorry for the run on sentence!). That truly is the basis for our pre-construction design and budgeting consulting services. We can also follow the project team through the construction phase, but by the time we get to the permit set of drawings, everyone should be solid on the goal of USP compliant design.
We design the compounding labs for the project team
I am going to walk you through a couple of 2D and 3D drawing examples from a previous compounding pharmacy project just so you can get an understanding of the deliverables we offer to the project team.
I want to introduce you to the two main design components that we work through with the general contractors the architects the engineers and all those folks that are going to be introduced into this project. Our consulting design services have two design criteria. Number one is the floor plan which is a two-dimensional compounding lab floor plan. In this graphic you see the architect is usually working on this area on the right that has the retail front end, breakrooms, offices and other general areas. The architect has given us this blank canvas on the left-hand side of the building to design the compounding labs. This particular pharmacy project scenario on the computer screen is a new construction project being built from the ground up, but this could easily be a replacement retrofit remodel type situation and so we were given this vanilla envelope to work with from compounding.
The Pharmacy’s business model drives the design criteria
This pharmacy you are seeing here does all aspects of compounding which is USP <795> non-sterile non-hazardous as well as USP <800> nonsterile hazardous. Up above the nonsterile area we see all aspects of sterile compounding which is USP <797> sterile (non-hazardous) and USP <800> sterile hazardous. Also, in this pharmacy design scenario you can see they were doing a pre-sterilization weighing area because they are doing what we now know as high-risk compounding. The important take away here on this design, which is critical to the success of the pharmacy’s business model is that we work through this design criteria based first and foremost on the business model. Our number one question we ask during consulting is, “tell us about your business model first.” Great that you’ve got a sixteen foot by twenty-foot room, or whatever your room dimension size is, but really, we want to understand your pharmacy’s business model first and then we’ll back into the lab design equation.
After we do business model exploration, equipment placement, we settle on a good working model for the floor plan for the pharmacy with hopefully some opportunity for future compounding volume growth and just a great place to be with the design. Then we move into really the hard part which is the supply exhaust explanation design because all the compounding rooms that we are now dealing with have different air change requirements, temperature humidity requirements, positive pressure or negative pressure. USP has given us defined parameters for all the different rooms and so of course then we design to those parameters. This engineering specific design is the road map with all the airflows and pressure maps. How we are going to move the air in and out of the building, what air can be recirculated and what air cannot is completely defined for the engineering team in this very important design. This supply and exhaust explanation drawing becomes a big piece of the pie.
Designing labs in three dimensional models with equipment to better understand workflow
I want to briefly give you another design piece that we sometimes do for projects, just to help mechanical contractors and/or engineers better understand what the air handling process. There are different ways to move air out of the building with USP 800. We are basically externally venting the air which means we are taking all that air out of the building and we must replace that externally vented air. More times than not that process of air-in and air-out takes a dedicated makeup air unit. This example in the three-dimensional model just happens to be a roof-mounted unit. I have labeled in an appropriate color. The red ductwork are those ducts that need to be exhausted. The blue or purple is going to be supply air from the air handling unit. As we move to the next pharmacy model you see a ground mounted make up air unit example. The third model here is an a-frame roof. We are kind of doing somewhat of
the same thing with getting air in and air out of the building, but we call scenario a split unit where the main air handler unit is inside the building. It is pulling its fresh air through a roof mounted intake and your condensers outside.
Looking at these three different pharmacies models the biggest takeaway here is that depending on the type of building will drive the best way to move the air requirements. Based on your building is how we plan for the air handling and so these two-dimensional and three-dimensional drawings and models are put together for the general contractors, the architects, the HVAC people so it just really helps everybody in the process understand where we need to go with USP 800 compliance.
I appreciate you stopping by the Compounding Workflow website and watching this video. If we can help your pharmacy project please give us a call or email firstname.lastname@example.org