The creeping feeling of impending delays in a cleanroom facility project is all too familiar. The nice Gantt chart your team has been reviewing for weeks with architects, consultants and partners just got thrown out the window. Setbacks are happening one after the other and installation costs are soaring. What went wrong? Where have we lost control?
Fortunately, if you are still in the planning phase of a new cleanroom or the expansion of an existing facility, it's not too late. Here are just of few tips from the industries bests, to avoid traps that may derail your expansion dreams before they even get a chance to materialise.
Truly define your requirements
First, when planning a cleanroom project, it's paramount to clearly define your requirements for the room itself. To do so, you need to have a good idea of what will be happening in that controlled environment. Unless you have a clear vision of the end result and how you will use it, it will be challenging for the design team to propose the best possible solution. It might seem obvious, but you must remember that the goal is to provide a custom-designed cleanroom that will check all your boxes and not just meet the base requirements or what someone else might need.
Your cleanroom partner is there to accompany you during that process to ensure the optimal solution. Here are a few questions that you should be prepared to answer.
What are your operational requirements?
- Will you need custom removable panels for easy access of equipment? If that brand new bioreactor coming from Europe has a lead time longer than the whole project, we can make sure your cleanroom is ready for use even before it arrives.
- Where will you position your equipment and how can we maximise your precious floor space? You don't want columns? Then we will use an engineered steel structure to remove any obstacles from your optimal layout.
- Will you need custom preparations in your walls for easy access to gases, process liquids or special equipment. Just give us your technical specifications and we will design the right preparations.
Are there special compliance regulations for your process, product, application, or location? GMP for current good manufacturing practices?
- USP for pharmacies or drug manufacturing
- Emergency egress routes, sprinkler locations/fire protection systems
- ADA for accessibility and usability by individuals with disabilities
What do you need to make your cleanroom unique and a perfect fit for your needs?
- Do you have a machine that needs an opening in the ceiling?
- Maybe a dual height ceiling to support tall equipment without the huge cost of making the full facility tall?
- A ventilated cart-size pass through the improve your process?
Prioritising long lead time items
To ensure that no delays are incurred, it will come as no surprise that the HVAC design must be prioritised since these are usually the items with the longest lead time. With this in mind, some cleanroom manufacturers like Mecart have their own in-house teams that can design and select the necessary equipment and limit the time lost by outsourcing these calculations.
This step goes hand in hand with the design of the cleanroom since room volumes, equipment heat generation, personnel comfort, and other key factors need to be included in our design for the perfect solutions to happen. The walls and ceilings are the "body" of the cleanroom, and the HVAC system is the "heart" that ensures that the certifications needed for your cleanroom can be achieved.
By this point everyone is tired of hearing it, but the current state of the supply chain has been more than unpredictable for almost two years
The concurrent engineering that takes place between the shell and HVAC system ensures that all variables are accounted for and that no detail is left unchecked.
All you need to do is have the right personnel available to attend the meetings and be active participants. Having key departments involved in these discussions keeps the number of revisions of the approval drawings to a minimum and shortens the length of the design phase and secures the manufacturing of your modular cleanroom. Every department might have different demands and their involvement will limit any unnecessary back and forth.
The third thing to consider, and by this point everyone is tired of hearing it, is the current state of the supply chain which has been more than unpredictable for almost two years now. The HVAC system has already been mentioned, but many more items you might want to incorporate in your design, such as medical gas valves, speakers, WiFi, screens, etc., can now have a much longer delivery time.
Therefore, starting these discussions early in the project can ensure you capture any potential obstacles for your operations. These might also need to be as flush as possible or properly covered and protected. Our prefabricated modular panel approach highlights all these points that some other companies might simply "deal with later" which can create those dreaded installation delays.
The host building
The next things that we consider during our engineering phase are all of the building related questions. We coordinate with the customer to target any possible gaps in their planning and coordination with other trades that could prevent a hassle-free installation process. Some of the recurring points of irritation we have observed over the years are the following:
- Is your electrical supply system big enough to accommodate a cleanroom which is far more demanding than office space?
- Do you have the necessary building permits for the work that will take place in your building? If applicable regulations have not been considered, you could potentially face months of delays.
- Are you handling dangerous products and therefore need to exhaust the air from your cleanroom? Do you need an environmental study to look at the impact of your operations? This could affect the HVAC equipment selection.
- Is the building in which the cleanroom will be installed brand new? If so, have you considered keeping some buffer between its completion and the cleanroom installation? Trying to do too many things at once might slow everyone down and create delays rather than speed things up.
Finally, the last key elements we consider in the engineering phase are the logistics of delivery and the start of installation.
There are certainly things that can only be coordinated once everyone has their boots on the ground, but our traveling team can always arrange for a site visit to ensure that any potential issues are resolved ahead of time, and the start of installation happens without a hitch. These considerations go from access to a loading dock to where the material will be stored once on site.