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Clean spaces

Modular Cold Rooms and Stability Chambers

Learn more about our cold room expertise.

Cold Rooms

Low and ultra-low temperature environments for all industries

Low and ultra-low temperature environments for every regulated industry. CleanSpace designs, manufactures, and installs modular cold rooms, walk-in cold storage, and stability chambers for pharma, biotech, healthcare, and food and beverage operations. Every project is engineered to GMP, HACCP, and ISO standards, aligned with U.S., EU, and local regulatory requirements, and delivered turnkey through our CleanFit® design-build process with a guaranteed timeline and budget.

Our certifications

Good Manufacturing Practice
Isnetworld Member Contractor
ISO
UL

Turnkey Cold Room Design, Manufacturing, and Installation

From 2 to 8 °C vaccine and biologic storage to minus 20 °C, minus 40 °C, and ultra-low minus 80 °C environments, CleanSpace is a single-source modular cold room manufacturer and builder. We design, fabricate in our US facility, and install on your site, removing vendor hand-offs, supply-chain delays, and cost overruns.

CleanSpace - Industry Pharamaceutical Biotech

Precision Temperature and Humidity Control

Redundant cooling systems, validated controls, and continuous monitoring engineered to hold setpoint under real-world load.

State-of-the-art cleanroom environment designed to support gene therapy processes. high-efficiency fume hood equipped with flammable and acid storage cabinets, indicating careful consideration of chemical handling and safety. The clean, seamless flooring and integrated coved base support contamination control, while ample counter space and stainless steel-framed workstations provide functional, easy-to-clean surfaces. Deep sink with gooseneck faucet enhances utility for washing and rinsing procedures. The brightly lit space, with minimal visual clutter and smooth wall finishes, reflects strict adherence to GMP and ISO cleanroom standards, essential for sterile manufacturing in advanced biotherapeutic applications.

US-Manufactured Modular Systems

100% US-made insulated panels, doors, and finishes manufactured in-house. Shorter lead times, tighter quality control, and no reliance on overseas supply chains.

CleanSpace Biotech

Rapid On-Site Installation

Our CleanFit® process compresses the schedule from design through IQ/OQ validation. Turnkey installation by CleanSpace crews means one accountable partner from concept to qualified handoff.

We have a very demanding project in support of the Project Warp Speed program. We selected CleanSpace because we know they will develop a program to get our project done very rapidly.

Cold Rooms
Robert Griffith
Endo Pharmaceuticals

A Nationwide Partner for Cold Rooms and Cold Chain Design

From ISO 5 aseptic suites to ISO 8 controlled manufacturing environments, CleanSpace is a single-source modular clean room manufacturer and builder. We design, fabricate in our US facility, and install on your site, eliminating vendor hand-offs, supply-chain delays, and cost overruns. From 2 to 8 °C vaccine and biologic storage to minus 20 °C, minus 40 °C, and ultra-low minus 80 °C environments, CleanSpace is a single-source modular cold room manufacturer and builder. We design, fabricate in our US facility, and install on your site, removing vendor hand-offs, supply-chain delays, and cost overruns. Pharma, biotech, healthcare, and food and beverage clients across the United States rely on CleanSpace to deliver GMP and HACCP compliant cold rooms on a predictable timeline and budget. From coastal biotech hubs to Midwest and Southeast distribution centers, CleanSpace brings the same turnkey process, US-made modular systems, and in-house installation crews to every project.

Because we manufacture our modular panel, door, and ceiling systems in the US and self-perform installation, clients anywhere in the country get faster project delivery, consistent quality, and a single point of accountability from kickoff through validation.

Where We Work

Projects delivered coast to coast, including the Northeast biotech corridor, Mid-Atlantic, Southeast, Midwest manufacturing hubs, Texas biomanufacturing centers, the Mountain West, and the West Coast life sciences cluster.

Request a Clean Room Quote
GMP and HACCP cold room design-build
Walk-in 2 to 8 °C pharma and vaccine storage
Minus 20, minus 40, and ultra-low minus 80 °C rooms
ICH-compliant stability chambers
Hospital and laboratory cold rooms
Hygienic cold rooms for food and beverage

Cold Room Types We Build

Not every cold application needs the same envelope. CleanSpace builds four modular cold room configurations and will recommend the right fit during design:

High-performance cleanroom tailored for gene therapy manufacturing. Coved epoxy flooring and seamless wall panels, supporting strict contamination control and cleanability. Integrated utility panels with stainless steel process gas outlets and pressure gauges ensure safe and reliable delivery of critical utilities. Double-pane cleanroom windows allow visibility between spaces while maintaining pressure integrity. The stainless steel pass-through, liquid line passthroughs, and flush-mounted air grilles underscore a focus on maintaining ISO-classified cleanliness and unidirectional airflow. Cleanroom is purpose-built for advanced cell and gene therapy workflows, prioritizing sterility, process control, and operational efficiency.

Walk-In Cold Rooms

Standard and custom walk-ins for vaccines, biologics, reagents, and clinical samples, with redundant refrigeration and continuous monitoring.

CleanSpace - Industry Pharamaceutical Biotech

Freezer and Ultra-Low Rooms

Minus 20, minus 40, and minus 80 °C environments engineered for biologics, API storage, and advanced therapies.

Cleanroom technician in full gowning performing routine wall cleaning, a critical component of contamination control in regulated environments. The cleanroom’s construction plays a key role in enabling effective sanitation—smooth, non-porous wall panels, flush-mounted features, and coved corners eliminate crevices where particles or microbes could accumulate.The flush doors and integrated viewing panels further enhance cleanability by minimizing surface transitions and allowing disinfectants to reach all contact points. Cleanroom architecture is deliberately engineered to support frequent, thorough cleaning procedures essential to maintaining ISO or GMP classification standards in pharmaceutical, biotech, and gene therapy facilities.

Stability Chambers

ICH Q1A compliant chambers for pharmaceutical stability testing, validated to exact temperature and humidity setpoints with IQ/OQ documentation.

Machine Laminating Pressing

Hygienic Cold Rooms for Food and Beverage

HACCP-aligned cold storage and processing rooms with cleanable finishes, coved details, and wash-down ready construction.

The CleanFit Process

CleanFit accelerates the design to installation process and is what enables CleanSpace to offer timeline and budget guarantees.

Norwood, MA

Moderna

Square Footage

27,000

Special details

Phase 1 & 2 Expansion of vaccine plant.

Project Highlights

  • Modular wall and ceiling panels, cleanroom doors, high-speed roll-up doors.
  • Filling line expansion, fast-track project.
Hatboro, PA

Sentinel Process Systems

Square Footage

2,000

Special details

Medical tubing cleanroom suite.

Project Highlights

  • ISO 7 Single-Use Product Assembly Room.
  • Gowning rooms, doors, interlocks.
  • Innovative Control Systems.
Confidential Client, Emeryville, CA

Gene Therapy Pilot Plant, Confidential Client

Square Footage

Not specified

Special details

New cGMP flexible clinical process suite for early clinical manufacturing.

Project Highlights

  • Supports nuclease(s), mRNA-LNP, AAV, and Cell Therapy.
  • Three core gene therapy suites + two shared drug product filling operations.
  • Quality Control laboratories for bioassay, PCR, vector, and Microbiology.
Houston, TX

Packgene Biotech – cGMP Manufacturing Facility

Square Footage

23,000

Special details

CleanSpace successfully delivered a 22,000 SF state-of-the-art facility, featuring 2,000 SF of office space, 10,000 SF of lab space, and 10,000 SF of cleanroom space. The project was originally managed by a large construction management (CM) firm before CleanSpace took over, implementing a more efficient design-build approach.

Project Highlights

  • Transitioned from a design-bid-build model to a design-build strategy, aligning user quality requirements with budget constraints.
  • Achieved 25% cost reduction through value engineering, eliminating MEP system redundancies.
  • Delivered Certificate of Occupancy (CO) in just 11 months, outperforming the original CM firm's 16-month schedule.
  • The project included all design aspects, ensuring a seamless turnkey solution fully owned by CleanSpace.
College Station, TX; Bellingham, UK

Major CDMO Client

Square Footage

25,000

Special details

A global CDMO in pharmaceutical manufacturing providing process development and cGMP production in cell culture, microbial fermentation, and gene therapies.

Project Highlights

Texas site will become the largest single-use CDMO campus in North America.

Cold Room FAQs

What is a modular cold room?

A modular cold room is a prefabricated, insulated, temperature-controlled environment built from engineered panel systems. Unlike stick-built cold storage, modular cold rooms install faster, can be reconfigured as processes change, and deliver consistent GMP and HACCP performance.

What temperature ranges does CleanSpace design to?

We routinely design and build controlled room temperature (15 to 25 °C), refrigerated (2 to 8 °C), frozen (minus 20 and minus 40 °C), and ultra-low (minus 80 °C) environments, along with ICH-compliant stability chambers.

Are CleanSpace cold rooms GMP and HACCP compliant?

Yes. Every cold room is engineered to meet GMP, HACCP, FDA, and applicable EU requirements, with documentation to support IQ, OQ, and PQ validation.

Do you build stability chambers?

Yes. CleanSpace designs and installs ICH Q1A compliant stability chambers at standard setpoints (25 °C / 60% RH, 30 °C / 65% RH, 40 °C / 75% RH) and custom profiles for pharmaceutical stability testing.

Do you serve clients nationwide?

Yes. CleanSpace serves clients across the United States with US-based manufacturing and self-performed installation crews supporting every major life sciences, healthcare, and food and beverage region.

How long does it take to build a modular cold room?

CleanFit® typically delivers a modular cold room or stability chamber in a fraction of the time of conventional construction, moving from design to validated handoff in weeks rather than many months.

How much does a cold room cost?

Cost depends on temperature range, square footage, redundancy, monitoring, and equipment integration. CleanFit® provides a fixed-price, guaranteed-timeline quote after a scoping session.