Skip to content

Cleanroom Construction: Constructability Considerations Among Cleanroom Options

November 14, 2023
Jose Jimenez

As the biotech and pharma industry continues to evolve at such a rapid pace, speed to market remains a critical factor that impacts many project decisions. According to CBRE’s 2023 U.S. Life Sciences outlook, “The industry is currently undertaking an all-time high number of clinical trials with over 31,000 active studies in the U.S. and nearly 11,500 in Phases 2 and 3 as of the end of February 2023.” This level of activity directly impacts demand for manufacturing space.

When your new or renovated facility improvement program involves aseptic spaces, you have an opportunity to improve speed to market by considering prefabricated modular cleanroom systems in lieu of the conventional stick-build approach. For years, conventional building materials – such as gypsum wallboard (GWB) partitions and ceilings – have been used to construct cleanrooms’ interior architectural envelope. A GWB-based cleanroom system requires the proper construction details, architectural finishes, and trims to ensure an easily cleanable, non-porous, and sealed envelope to avoid cross-contamination and avoid conditions that may encourage microbial growth. Alternatively, today’s laboratories often use prefabricated modular cleanroom systems, including both panelized and podular/portable (POD). Both of these alternatives are manufactured in a factory off-site rather than in the field, allowing for quality, safety, and schedule reliability improvements. Selecting between these three types of systems – stick-build vs. panelized vs. POD – requires careful evaluation with your construction team from the early stages of concept and schematic design.

In the table below, we’ve collected some of the key constructability considerations for each of these alternatives based on our extensive experience in construction of aseptic spaces. Our evaluation will walk you through the various aspects of constructability such as design flexibility, schedule, coordination with base building existing conditions and new MEP/FP systems, construction means and methods, trade labor skills and construction quality, and budget.

Stick-Build CleanroomPrefabricated Panelized CleanroomPrefabricated Podular Cleanroom
Flexibility in Design
Can adapt to any floor plan, providing 100% flexibility to implement the desired layout.

Design changes are easy to incorporate as long as they occur in advance of construction documents.

Engagement of this trade contractor can wait until after design documents are issued for bid.
Can adapt to any layout, providing a high level of flexibility.

Changes in design are not as easy to incorporate and must be made in advance of fabrication drawings.

Integration of this trade contractor into the design and construction management team occurs during or soon after schematic design (design-assist).
Limited customization (or layout flexibility). These units are practical for single-use or small-scale processes.

Standardization, modularization, and scale up by multiplication is best use.

Similar to an equipment purchase, this is a turnkey solution; integration into the design must occur early in concept design (design-assist).
Schedule
Bulk materials are relatively readily available or have reasonable lead times.

Relative to prefabricated systems, field erection is significantly slower and requires higher levels of manpower.
Lead times are longer, typically no less than eight weeks for first delivery after approval of fabrication drawings.

Field erection goes 20% to 40% faster and requires much lower levels of manpower.
Lead times are longer than the panelized system, but installation is greatly accelerated.
Coordination
Coordination with other building systems is flexible. The most significant coordination is the closure of in-wall utility drops and ceiling closure.

Once in-wall or above-ceiling systems are covered, major rework is necessary to make changes.    
Coordination with other building systems requires a higher level of attention, particularly between above-ceiling MEP/FP systems and hanging rods for the clean room ceilings. This further accentuates when seismic restraints are required.

Depending on the base building’s structure loading capacity or clearance from ceiling elevation to bottom of structure above, an intermediate steel structure may be required.
Coordination with other building systems comes down to MEP/FP connections. A key consideration is the coordination of the slab-on-grade or slab-on-deck and the unit’s finished floor elevations. This is important if ramps must be avoided for ease of material flows.
Means and Methods
This conventional construction process requires stricter engineering controls during construction to achieve a clean build protocol, particularly dust control.

Airborne particulate potential inherent in GWB installation is not ideal on a schedule that overlaps construction with progressive occupancy.
The erection of the panelized system follows a top-down installation approach (ceilings first, before partitions).

Given that this is a prefabricated and pre-finished system, the dust control challenge of the stick-build is not an issue.

Construction waste is also minimized.
The podular unit is placed inside a building and is free-standing.

Installation is basically a rigging operation followed by MEP/FP connections to base building MEP/FP systems.

Scale up occurs by multiplying the number of units.
Construction Quality
Achieving the desired level of quality is more difficult and varies depending on the experience and skillset of the local trades.

Pre-installation field mockups are an effective tool to test, inspect, and agree on the standard of quality that is needed.
This is a higher quality system given that the system is pre-finished at factory.

Pre-installation field mockups are also an effective tool to test, inspect, and agree on the standard of quality.
As a complete unit of operations, quality is essentially achieved in an off-site factory-controlled manufacturing environment and verified through factory acceptance testing and commissioning prior to shipment.

Once the POD is set on site and interconnected to the MEP/FP systems, a final commissioning and validation process ensures compliance.
Budget
Material and installation costs may appear less costly; however, depending on scale, the total cost between stick-build and prefabricated panelized system may be similar if not same when schedule and bid packaging and integrated systems considerations are properly evaluated.Material and installation costs may appear higher. However, depending on scale, the total cost between the stick-build and prefabricated panelized system may be similar if not same when schedule improvement, bid packaging and integrated systems, and life cycle cost considerations are properly evaluated.While standard “catalog” podular units may appear cost effective and faster to deliver and install, customization is limited.

A proper cost evaluation for this type of application is better assessed in terms of total life cycle cost. Similar to equipment purchases, there is a large upfront cost associated with these units.


About Authors
Jose Jimenez is vice president and life sciences center of excellence leader.  In this role, Jose supports Gilbane’s life sciences clients and project teams with speed to patient goals, and a focus on safely delivering quality facilities. His 24 years in the construction industry include directing major capital programs involving new building construction, building additions, and renovations of active cGMP manufacturing and research facilities ranging between $5 million and over $500 million per project. A trusted leader in the life sciences market, Jose has spoken on topics such as “Building Cleanrooms at Warp Speed” for the American Pharmaceutical Review and “Rapid Cleanroom Builds for COVID-19 Facilities: Lessons Learned” for Pharma’s Almanac. Jose is a member of both the International Society of Pharmaceutical Engineering (ISPE) and the Construction Management Association of America (CMAA). 
Read more posts by Jose Jimenez