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Clean spaces

Cold Rooms Built for Critical Storage and Protection

Learn more about our cold room expertise.

Cold Rooms and Warehousing

CleanSpace designs and builds temperature-controlled environments where environmental consistency and product protection are critical. Our modern design build approach integrates planning, engineering, manufacturing, construction, commissioning, and operational readiness into one coordinated delivery model, reducing project risk while accelerating deployment for cold storage infrastructure.

From refrigerated storage and controlled environments to biologic material preservation and ultra-low temperature applications, our teams engineer cold rooms around process requirements, operational workflows, temperature recovery performance, and long-term reliability. We understand the critical relationship between refrigeration systems, insulation assemblies, airflow, vapor barriers, humidity control, door openings, and environmental monitoring, ensuring facilities maintain stable operating conditions under real world production demands.

CleanSpace delivers scalable temperature-controlled clean room environments supporting a wide range of operating conditions, including refrigerated warehouses and storage, freezer applications, and ultra-low temperature spaces reaching as low as -80 degrees Celsius. Our teams also provide temperature mapping, commissioning, airflow analysis, calibration coordination, and qualification readiness to help clients achieve compliant and operationally reliable environments.

Our certifications

Good Manufacturing Practice
Isnetworld Member Contractor
ISO
UL
FM approved
ASTM International

Turnkey Cold Room Design, Manufacturing, and Installation

From 2 to 8 °C vaccine and biologic storage to -20 °C, -40 °C, and ultra-low -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.

Design And Engineering

CleanSpace designs and engineers temperature controlled environments built for seamless integration, reliable performance, and long-term environmental stability.

Precision Temperature and Humidity Control

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

Design Build

Across all engagements, CleanSpace has distinguished themselves as a highly reliable,knowledgeable, and adaptable partner. Their professionalism, technical competence, andcommitment to delivering compliant, high‑quality environments make them an asset to anyorganization operating within regulated pharmaceutical or sterile manufacturing settings.

Cold Rooms
Engineering Maintenance
Sr. Manager

Cold Room Applications

Every cold environment is engineered to the exact setpoint, tolerance, and regulatory standard your process requires. CleanSpace regularly designs and builds:

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.

Controlled Temperature Storage

Temperature controlled environments supporting pharmaceutical materials, biologics, injectables, finished goods, and regulated storage operations.

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.

Biologics and Vaccine Environments

Cold storage infrastructure designed for biologics preservation, vaccine storage, temperature sensitive therapeutics, and cGMP regulated support spaces.

CleanSpace - Industry Pharamaceutical Biotech

Ultra Low Temperature Applications

High performance freezer environments supporting biologic materials, drug substance storage, and specialized low temperature process requirements.

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.

Environmental Monitoring and Temperature Mapping

Integrated monitoring strategies supporting calibrated sensor placement, temperature uniformity analysis, recovery verification, and qualification driven performance documentation.

CleanSpace cleanroom

Process Driven Infrastructure

Cold room systems engineered around airflow performance, humidity control, vapor barriers, airlocks, insulated assemblies, equipment loads, and operational workflows to ensure long term reliability and product protection.

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.

Integrated Delivery and Operational Readiness

End to end project execution including preconstruction planning, engineering coordination, modular system manufacturing, installation, commissioning, startup support, and qualification readiness for regulated operations.

Integrated Cold Storage for cGMP Operations

Temperature controlled environments are often a critical component within larger cGMP manufacturing and regulated production facilities. CleanSpace understands how cold rooms, refrigerated process spaces, biologics storage, warehouses, and ultra-low temperature environments must integrate seamlessly with cleanrooms, aseptic processing suites, manufacturing workflows, material flow strategies, and validated GMP operations.

Our teams bring expertise in both controlled environment construction and temperature controlled infrastructure, allowing us to design and deliver cohesive facilities that align refrigeration systems, environmental controls, cleanroom performance, utility coordination, and operational requirements under one integrated design build approach. This coordination reduces risk, improves system reliability, and ensures critical environments operate together as part of a unified manufacturing ecosystem.

In addition to design and construction, CleanSpace supports long term operational performance through commissioning coordination, temperature mapping, environmental verification, ongoing service support, and maintenance programs. From initial planning through sustained operations, we help clients maintain reliable, compliant, and high performing environments built around the demands of modern cGMP manufacturing.

Where We Work

CleanSpace delivers projects throughout the United States, Canada, and select markets in Central and South America. Our reach spans major life sciences, pharmaceutical, healthcare and advanced manufacturing regions, supporting clients wherever controlled environment facilities are needed. In the United States, we serve key industry hubs coast to coast.

The Modern Design Build Process

Our team 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.