In an increasingly commoditized world of architectural/engineering firms that design and build pharmaceutical manufacturing facilities, how can facility managers be sure that they are getting an A&E firm that will produce a design that will work for them now and in the future? It comes down to experience versus expertise.
Perusing the world wide web using search terms such as pharmaceutical or biotech facility design results in more results (2 million plus) than the busy pharmaceutical plant manager has time to examine and analyze. Chances are that the renovation or greenfield project is just one of a myriad of tasks on the plate of the plant professional tasked with making it happen. Finding the best partner to engage in designing and constructing your project can seem a little overwhelming at first. All, or at least most, of the A&E firms claiming to offer this type of specialized design have project examples on their website, resumes of competent design professionals, and business development managers who will tell you that they are the best at what they do. But how do you really decide?
You could ask another facility manager you know who they used on their last project and whether they did a good job. This kind of anecdotal evidence is useful, but it should be coupled with other criteria. After all, the project is more consequential to you and your company than anyone else, so what worked for a different project, in a different facility and possibly in another part of the country, may not be an ideal fit for your project.
You could also interview the big names in the Life Sciences design industry because that is what everyone does, so what is the worst that could happen? This too is short sighted for a few reasons. Big firms also have big overhead, so to pay for that, they hire young engineers and architects with lower salaries and large multipliers to contribute to the bottom line. So, while the big guys may come in and flaunt their vast expertise and knowledge, your project may not end up with those “A players” because they must compete on price.
Merriam-Webster defines expertise as “having the skill of an expert”. That can be interpreted in many ways, so for the purposes of this article, let’s define expertise as “having the skill of someone with the education and experience in performing a specific task”. In this case, design of a pharmaceutical/biotech facility. We can assume that most A&E firms that advertise that they design such facilities have this expertise. Expertise is certainly important, but like anecdotal references you might get from a friend, they are only a piece of the puzzle.
Industry experience is different from industry expertise. Industry experience cannot be gained by designing and building facilities alone. It must include working in, maintaining, and operating these facilities as well because many design issues are not discovered on paper, or during construction. They can only be discovered by those living and working in the facility after it is completed, and the designers have moved on to their next project. Pharma/biotech projects add additional complexity due to regulatory concerns. How many facility managers have looked at the drawings they were delivered at the end of a project (that were perfectly fine for construction), only to discover that they are less than ideal for troubleshooting, maintenance, or for showing to an auditor? When coupled with expertise and firm references, industry experience might just be the most important factor to consider when selecting and A&E firm for your project.
Consider the following points that may or may not be contemplated as part of the design if not done from an experienced perspective.
High purity water systems are found in most, if not all pharma/biotech manufacturing facilities.Someone with expertise, knows how to design your system for proper flow rate, production/storage capacity, materials of construction and sanitization.Some examples of what someone who does not have the experience operating or maintaining such a system may not think of are:
Where do sample valves need to be placed for initial and ongoing validation?
Are the shut-off valves accessible to maintenance personnel without the hassle of going to find a ladder?
Is the space around the generation skid enough to allow removing RO membranes without going into contortions?
Can the components of the entire system be easily accessed and are their hoist points to connect to when they inevitably need to be replaced?
HVAC systems are arguably one of the most important and thus most studied systems in the regulated plant.There are myriad experts out there that will tell you how to design a system to meet the regulations and some smaller number of experts who will tell you how to make them more energy efficient, but those with experience on the owner’s side, will also know:
Leave enough room next to the coils so that those coils can be easily removed for future maintenance or replacement.
Make sure there is an easy way to test any HEPA or ULPA filters in the system, including a port for injecting the Emory oil as well as easy access for filter face scanning.
Include appropriate protection above and around any outdoor unit so that maintenance personnel don’t freeze when replacing pre-filters in January.
Architectural considerations are also important when designing your plant.Not just consideration for standard finishes for cleaning, or aesthetics, but also for functionality and durability.The experienced professional will know:
Avoid the use of ceiling tile clips unless absolutely necessary (i.e. if you have to deal with an existing lay in ceiling and company procedure requires it to be clipped).In a few years, after the ceiling space has been accessed a few times, many of the clips will be missing or just laying on top of the tiles.They are not practical to a maintenance technician.
Manual sliding doors are a great way to save money over automated doors, but to the operator that must open and close the doors before and after maneuvering a large tank through them, will probably not appreciate them nearly as much as the guy who “value engineered” the automation out.
Bumper rails are prolific in plants where large heavy loads are moved around corridors and rooms often.Make sure they are durable enough to last, easy to clean, and don’t get in the way of operating the equipment.
These are just a few examples as this list could be expanded many times over. This illustrates the importance of having the right people on your design team. A successful project requires experience as well as expertise. Interview your A&E firm to determine who will be on your project and what their role will be. Do they have expertise, experience, or both? Will the personnel with industry experienced be present during the construction phase to see problems before they are covered up with drywall?
Insist that your design team be experienced in operating and maintaining facilities, not just designing them. This experience comes from working on the owner’s side or from working as an owner’s representative. If they have personnel who have worked in numerous places as owners, that is even better, since there is not just one right way of doing things. If their experienced personnel have worked in operations as well as engineering or facilities, so much the better. Also insist and check references that the firm has expertise designing numerous facilities in different parts of the industry whether that be Biotech, Solid Oral Dosage, Aseptic Fill/Finish, laboratories or something else. This diversity of experience will benefit your project regardless of what type of facility you are remodeling or building. You will be glad you did.