Air handling sets the layout of a pharmaceutical suite before the walls do. Room classifications, pressure cascades and air-change rates decide how big the mechanical room is, where the ceiling plenum goes and which rooms can share a corridor. A floor plan drawn first and ventilated second tends to be redrawn when the HVAC engineer sees it. We read the process flow and the air strategy together, so the walls we build are the ones the air system needs.
We build production, packaging, laboratory-support and warehouse space for pharmaceutical, biotech and medical-product manufacturers. The scope runs from a cleanroom suite inside an existing building to a ground-up manufacturing plant with its own utilities. The construction is demanding because the documents matter as much as the building: material certifications, weld records, test and balance reports and the turnover package are the evidence that the facility was built to the design the validation team will qualify.
We do not sit in the owner's quality group; the owner and their validation consultants own qualification. What we provide is a build that is documented, traceable and ready to be qualified, with change control that stops design drift between issued-for-construction drawings and what is in the ceiling.
Where life sciences construction concentrates
Colorado's Front Range has an established life sciences footprint along the Boulder, Louisville and Longmont corridor. Redtail Ridge in Louisville is a 389-acre, 2.6 million-square-foot life sciences campus along U.S. 36, with $88 million in general obligation bonds for infrastructure reported on March 10, 2025. In Longmont, AstraZeneca announced on October 10, 2016 that it paid $64.5 million for 159 acres of vacant land just west of Amgen's campus to support its Boulder operations. These are the kind of sites where manufacturing and process development buildings get built.
Buyers considering sites in Louisville or Longmont should expect competing contractors, trade labor demand and a long utilities lead time. We start site assessment with the same questions: process water, power, wastewater discharge limits and truck access for bulk chemicals and gases.
Process-first construction
We organize work around process flow. Personnel, materials, waste and product each get a defined path, and the construction sequence respects those paths so a finished clean zone is not used as a construction corridor. We build from the farthest clean room toward the entrance, close in each zone and seal it, and maintain air-handling operation so the finished rooms stay clean while later work proceeds.
Submittals follow the process too. We review each product and material against the specification for cleanability, off-gassing and particulate shedding: wall panels, ceilings, flooring, sealants and doors. A door that sheds particles or a sealant that cannot be cleaned will fail the first environmental monitoring. Our submittal log tracks each item to the owner's approval and matches the installed product to the approved one at inspection.
Codes, hazardous materials and occupancy
Pharmaceutical buildings often include hazardous materials in solvents, gases and bulk chemicals, and the building code treats them through control areas, fire barriers and occupancy classifications. Louisville is listed as having adopted the 2024 IBC, 2024 IRC and 2024 IFC, effective December 6, 2025, while other Boulder County jurisdictions run different editions. We confirm the edition and hazardous-materials limits with the building and fire departments before the design is frozen.
Energy code compliance affects cleanroom HVAC, which is energy intensive. Colorado HB22-1362 requires any jurisdiction updating its building code on or after July 1, 2023 to adopt an energy code at least as stringent as the 2021 IECC. Designers need to account for that in air-change rates and heat recovery. We coordinate energy documentation with the permit set so mechanical design and code compliance move together.
Spaces, utilities and finishes
The scope includes cleanroom wall and ceiling systems, epoxy or resinous flooring with coved bases, pass-through chambers, gowning rooms and airlocks. Mechanical scope includes air handlers with HEPA filtration, pressure monitoring, exhaust for fume hoods and isolators, and building automation. Process utilities include purified water loops, clean steam, compressed air, nitrogen and vacuum, usually in stainless steel or specialized piping with documented welding.
Support spaces matter as much as the production floor. Warehousing needs temperature-controlled zones for raw materials and finished product, and we coordinate cold rooms with our cold storage construction experience. Many pharmaceutical owners start in leased space; a conversion of an existing building follows the path in industrial renovations and modernization, with demolition, structural upgrades and new utilities.
Schedule and qualification handoff
Schedules are driven by equipment lead times and qualification windows. Air handlers, process equipment and clean utilities take months to deliver, and the validation team needs time to qualify each system after construction is finished. We build the schedule backward from the production start date, with milestones for turnover of each system to commissioning and qualification, and a hold on punch list items that could interfere with testing.
Turnover is by system, not by building. We hand over the air system with balance reports, the water loop with passivation and weld records, and each room with its finish schedule. The detailed method is described in our commissioning and turnover work. Owners in pharmaceutical and life sciences receive documents indexed to their qualification protocols.
Safety, cleanliness and contamination control
Construction in or near an operating pharmaceutical facility requires contamination control. We implement dust barriers, negative-pressure containment, entry protocols and daily cleaning, and we restrict materials that could introduce contaminants. Workers are trained on the site's gowning and material-handling rules before entering clean areas.
Worker safety is tied to hazards in the process: solvents, potent compounds and compressed gases. We review the owner's safety plan, coordinate lockout and permit systems, and stage hot work so it is out of clean zones. Documentation of training and permits is kept in the project file for audit.
Bring the process flow and the target start date
Share the process flow, the room classifications and the target production start. We will return a construction plan that shows the air strategy, the utility loops and the turnover by system.
Common Questions
Do you handle validation or qualification?
No. The owner and their validation consultants own qualification. We provide a build that is documented and traceable, with material certifications, test reports and as-built records ready for the qualification team. We also coordinate access and system readiness for their testing.
How do you keep a finished cleanroom clean while construction continues nearby?
We seal the finished zone, keep air handling running with proper filtration, restrict access and clean on a schedule. Construction traffic never runs through finished zones, and materials are brought in through defined paths. The rule is that the clean zone is closed once it is finished.
What flooring is used in production rooms?
Resinous or epoxy systems with coved bases are common because they are seamless and cleanable. The choice depends on chemical exposure, traffic and cleaning agents. We test substrate moisture and prepare the slab per the manufacturer's requirements so the floor does not fail.
How long does a cleanroom suite take?
A suite inside an existing building can take several months, while a new plant takes much longer. Equipment lead times and qualification windows control the schedule more than construction. We build the schedule backward from the production start date.
Can you work in an operating pharmaceutical plant?
Yes, with containment and strict protocols. We phase work by zone, protect operating areas with pressure-controlled barriers and coordinate shutdowns with production schedules. All work follows the plant's change control process.