Traditional cleanroom infrastructures like epoxy coated gypsum walls (stick-built) have been utilized for many decades with varying satisfaction by the end users. Although the cost of the stick-built solution may look attractive, it’s an option with several potential downsides including a lengthy construction period, varying qualities and weaknesses of the materials, potential mold contaminations and inflexibilities to the design. Now, the industry is reviewing alternative solutions.
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These solutions can be found in recent cleanroom material and design innovations, like modular UPVC wall panels or fully functional prefabricated and prequalified cleanroom units. These alternative cleanroom materials and infrastructures have created more robust and faster build solutions for the end user. These solutions meet the needs of the industry instead of being a compromise.
The needs of the industry
Recent initiatives, such as the Biophorum Modular & Mobile Technology Roadmap, have shown distinct industry needs, which are required to supply the facilities of the future. Furthermore, industry engineering and architecture experts voice the same at multiple conferences and in recent publications. These needs are:
- Reliability of the delivery time and cost budget for a new infrastructure and capacity build-out
- Staff hours and other hidden costs need to shift off-site
- Facilities and cleanroom infrastructures need to be rapidly deployable with delivery times half of what is experienced right now
- Scaling of the facility should not disrupt existing processes, which also means capital investment decisions can be made gradually
- Cleanroom infrastructures need to be repurposable, instead of being sunk assets
- Cloning of facilities and infrastructures helps design timeline abbreviation, personnel training and regulatory familiarity
- Mobility of the infrastructures helps to move capacities where required or allow temporary manufacturing in a location to be moved at a later stage to the final location
A recent Aspen Alert survey showed a major discrepancy between the promised timeline of delivery and cost proposal. According to results, when it comes to onsite construction projects running as planned in terms of budget and schedule, 68 percent usually do not or never do. No respondents reported that projects “always” run as planned. This shows that any capacity build-out for now is a gamble with reliability and a potential career risk for any project manager leading such project. Reliability of capacity build-out is essential to avoid any drug shortages or stock out.
Meeting the needs
New modular, but especially off-site prefabricated (podular) cleanroom designs meet the described needs, as the design and build are predictable and known. Off-site production of the cleanroom allows capacity or build flexing, production crews all utilize SOPs so there is no variability, and speed to build is motivated by a fixed price and not an hourly rate. But most importantly, the units get prequalified to eliminate any surprises when installed.
As mentioned, the traditional stick-built infrastructures may seem more feasible when somebody throws a cost per square foot price into the midst. However, other Aspen surveys have shown that the initial cost per square foot promise is typically not held. Examples have illustrated that some of the quoted prices do not even include everything required to run the cleanroom and costs are typically added after the purchase order is signed. Hidden costs like temporary parking, insurance and safety are not addressed, and change orders are manifold within the project. All this adds to the initial cost promise and misses the mark to a large degree, not allowing cost reliability and, respectively, planning.
Prefabricated cleanroom structures are designed with the customer and then priced. This price is typically fixed and does not move, as all components are accounted for. Just like buying a car, one buys for a price and drives the fully functional unit out of the lot. One does not buy a car in bits and pieces. With prefabricated cleanrooms, what the customer gets is a fully functional cleanroom unit with a firm delivery and price tag.