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Modular Clean Rooms: Compliance Starts At Design

Learn more about our clean room expertise.

Compliant cleanroom environments designed, engineered, manufactured, and installed entirely in-house. CleanSpace is the only vertically integrated design builder that delivers controlled environment facilities with full accountability from concept through completion, including in-house manufacturing of clean room systems in the United States ensuring cost efficiency, quality, consistency, and schedule control.

We design and build modular controlled environments for pharmaceutical, biotech, CDMO, CRO, medical device, aerospace, electronics, advanced manufacturing, semiconductor, battery manufacturing, radiopharmaceutical, and food and beverage operations. Every facility is engineered to meet the stringent cleanroom classifications required including ISO 4, ISO 5, ISO 6, ISO 7, and ISO 8, by cGMP requirements and FDA and EU regulatory standards, supporting validated performance in highly regulated industries.

Our integrated design build model unifies architecture, engineering, manufacturing, and installation under one delivery system. This approach reduces project risk, improves coordination across all phases, and ensures predictable execution, delivering high performance-controlled environments that meet strict regulatory requirements and operational demands.

Our certifications

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

Vertically Integrated Cleanroom Delivery System

CleanSpace delivers modular controlled environment solutions for any ISO 4, ISO 5, ISO 6, ISO 7, ISO 8 requirements ranging from aseptic processing suites to advanced manufacturing cleanrooms, tailored to the specific requirements of pharmaceutical, biotech, medical device, aerospace, electronics, and food and beverage industries. As a vertically integrated design build partner, we manage the entire process in-house, including design, fabrication at our U.S. manufacturing facility, and on-site installation, ensuring seamless execution from concept through completion.

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.

Design-Build Engineering

cGMP, GMP and EU, CA or FDA-aligned clean room design for pharma, biotech, and medical device facilities. Hardwall and hybrid systems tailored to your classification and process flow.

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 modular wall, ceiling, door, window, glass wall and lighting systems manufactured in-house. Shorter lead times, tighter quality control, and no reliance on overseas supply chains.

Risk Mitigation

Our integrated delivery model eliminates fragmented vendor coordination, reduces supply chain delays, and minimizes the risk of cost overruns. By controlling every phase of the project, we provide consistent quality, schedule certainty, and reliable performance for regulated controlled environments and mission-critical production spaces. We lump sum our projects to ensure zero change orders.

One of the best things about working with CleanSpace was leveraging their experience and knowledge. They were able to answer any question we had about running a cleanroom.

Clean Rooms
Paul Tramo
, 
President, Sentinel Process Systems

Modular VS Stick Build

Factor CleanSpace Modular Traditional Stick-Built
Installation speed Faster installation with reduced onsite work Slower construction timelines
Upfront cost Higher upfront cost, but lower long-term lifecycle cost Lower upfront cost, but higher long-term maintenance
Build quality Cleaner builds with lower contamination risk More trades involved, increasing risk of errors
Finish consistency Consistent, high-quality finishes Quality may vary due to onsite conditions
Cleaning resistance Withstands harsh cleaning agents Quality issues due to absorption of cleaning agents and contaminants
Durability Designed for long-term durability and lifecycle savings Contamination and durability concerns
Operational impact Less disruption during installation and maintenance More frequent repairs can disrupt operations

Materials like gypsum wallboard. which can absorb moisture, promote microbial growth, and require frequent repairs and maintenance. This disrupts operations but also adds to the long-term costs.

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.

One Source. CleanSpace exists to build environments where innovation can thrive, deliver scalable, compliant, and high-performance facilities through a single, accountable partner.

CleanSpace serves pharmaceutical, biotech, medical device, advanced manufacturing and CDMO clients across the United States, Canada and Central America with fully integrated controlled environment solutions delivered through a modern design build model. Our approach unifies design, engineering, manufacturing, and construction under one accountable team, ensuring alignment from early planning through construction and final commissioning, qualification and validation. Compliance guaranteed.

We manufacture our modular wall, ceiling, and door systems in our U.S. facility and deploy dedicated skilled trades people nationwide to execute projects with speed and consistency. This direct control over production and field execution eliminates fragmented contracting, improves coordination, and supports reliable delivery schedules for regulated environments. We eliminate risks.

From established biotech clusters to rapidly growing life sciences regions across the Midwest, Southeast, Texas, and coastal innovation hubs, CleanSpace delivers standardized execution with localized responsiveness. Clients benefit from a single source of responsibility, consistent quality control, and a repeatable delivery model designed for cGMP compliance and predictable project outcomes.

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.

Clean Room FAQs

What is a modular clean room?

A modular clean room is a prefabricated, controlled environment built from preengineered wall, ceiling, and door panels. Unlike traditional stick-built construction, modular clean rooms install faster, can be reconfigured as processes change, and deliver consistent ISO and cGMP performance.

How long does it take to build a clean room?

CleanSpace's vertically integrated approach also provides a significant schedule advantage. With direct control of design, engineering, materials, labor, validation and sequencing, CleanSpace can accelerate project and delivery timelines and respond quickly to field conditions without delays caused by external dependencies.Our lead times are 8-10 weeks and shop drawings are 4-6 weeks.

What ISO classifications does CleanSpace design to?

We routinely design and build to ISO 4, ISO 5, ISO 6, ISO 7, and ISO 8 per ISO 14644, as well as cGMP Grades A through D and USP <797> / <800> sterile compounding environments.Any requirement or government agency we will ensure compliance.FDA, CA, EU, etc.

Why CleanSpace?

CleanSpace offers a modern design-build delivery model. Our organization is purpose-built for controlled environments, with our focus on in-house cleanroom design, engineering, preconstruction, safety, quality, procurement, construction and compliance. This specialization allows us to execute with a level of precision, speed, and technical understanding that general contractors cannot replicate.

Unlike firms that rely heavily on subcontracted labor and fragmented scopes, CleanSpace maintains in-house control over critical project elements, including design, system manufacturing, and installation. This eliminates coordination gaps, reduces risk, and ensures consistent quality and accountability throughout the project.

In addition, CleanSpace brings direct experience in regulated environments, with teams that understand cGMP / GMP requirements, contamination control, and the relationship between facility performance and operational success. This expertise allows us to anticipate challenges early, minimize change orders, and deliver environments that are ready for commissioning and operation.

The result is a more predictable project outcome, with greater control over cost, schedule, and quality. CleanSpace delivers not just construction, but confidence in execution for projects where performance and compliance are critical.

Chantilly, VA

Modular Pharmacy Cleanroom

Square Footage

4,000

Special details

CleanSpace delivered a box-style cleanroom build using modular panels and cleanroom accessories produced by CleanSpace Manufacturing. The scope also included a custom trellis system to support utilities and infrastructure above the cleanroom. Installation required careful coordination of the modular components, specialty systems, and construction sequence to meet the facility’s operational requirements.

Project Hightlights

  • CleanSpaceManufacturing supplied the modular panels and cleanroom accessories.
  • Acustom trellis system provided support for cleanroom utilities andinfrastructure.
  • CleanSpacesupplied and installed door interlocks and automatic door operators in-house,among its first projects to do so.

*Image on this page is stock dueto client confidentiality and NDA requirements

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Thousand Oaks, CA

Clinical Cell Therapy Manufacturing Facility

Square Footage

4,500

Special details

4,500-SF clinical manufacturing facility supports advanced cell therapy production. CleanSpace provided the modular cleanroom system, designed for strict biopharma standards. Key spaces include Process Suites, Change Rooms, Airlocks, and an Inspection Room—engineered for efficiency and compliance. A floor-to-ceiling glass wall system enhances visibility while maintaining a sterile environment.

Project Hightlights

  • Existingcommercial building converted into GMP manufacturing space
  • Designedfor future commercial manufacturing operations
  • Customcrash rail protection system throughout
  • Proprietarytube pass-through solution

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Boston, MA

cGMP Tissues Processing Cleanroom

Square Footage

2,500

Special details

CleanSpace designed and builtapproximately 2,500 SF of cleanroom space for a tissue processing operation inBoston. The project included Grade B, C, and D environments, with the roomfinishes and mechanical systems coordinated to support the facility’s contaminationcontrol and operating requirements.

Modular uPVC wall and ceilingsystems provided smooth, cleanable surfaces throughout the cleanroom.CleanSpace also installed seamless epoxy flooring and a dedicated HVAC systemdesigned to maintain the temperature and humidity conditions required for tissueprocessing.

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Project Hightlights

  • Design-builddelivery of approximately 2,500 SF of tissue processing cleanroom space
  • GradeB, C, and D cleanroom environments
  • ModularuPVC wall and ceiling systems with cleanable surfaces
  • DedicatedHVAC system for temperature and humidity control
  • Seamlessepoxy flooring throughout the cleanroom

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CONFIDENTIAL

Photonics Facility

Square Footage

10,000

Special details

CleanSpace delivered a 10,000 SF turnkey cleanroom and mechanical infrastructure solution supporting the manufacture of semiconductor laser diodes, laser modules, precision optical coatings, and advanced photonics components. The facility incorporates ISO 5 through ISO 7 classified environments designed to provide the stringent temperature, humidity, and particulate control required for sensitive photonics manufacturing processes.

CleanSpace provided integrated design-build delivery encompassing design coordination, mechanical and architectural systems, installation, and commissioning. The scope included chilled water systems, custom-configured air handling units, and modular wall and ceiling systems engineered to provide reliable environmental performance and flexibility for future facility needs.

Project Hightlights

  • Chilled water system engineered for precise process temperature control
  • Custom-configured AHUs supporting humidity and particulate control
  • Modular cleanroom wall and ceiling systems
  • Integrated mechanical and architectural infrastructure
  • Environmental controls supporting sensitive photonics manufacturing
  • Modular configuration providing flexibility for future expansion and maintenance

*Image on this page is stock dueto client confidentiality and NDA requirements

Dallas, TX

Life Sciences Cleanroom Showroom

Square Footage

5,000

Special details

CleanSpace designed and delivered a 5,000 SF modular cleanroom showroom within the Pegasus Park life sciences and innovation campus in Dallas, Texas. The fully operational spec-built facility provides life sciences, biotechnology, and healthcare companies with hands-on access to modular controlled environment technologies and demonstrates how cleanroom environments can be configured for a range of manufacturing requirements.

The facility incorporates ISO 5 through ISO 8 environments, including Grade B and C spaces, with configurable modular systems designed to demonstrate flexibility and scalability. CleanSpace provided integrated design, engineering, manufacturing, and construction to bring the demonstration environment from concept through operation.

Project Hightlights

  • Fully operational spec-built demonstration facility
  • ISO 5 through ISO 8 controlled environments
  • Grade B and C cleanroom configurations
  • Configurable modular systems demonstrating adaptability and scalability
  • Hands-on environment for evaluating cleanroom technologies
  • U.S.-designed, engineered, manufactured, and assembled cleanroom systems
Pittston, PA

Veterinary Pharmaceutical Manufacturing Facility

Square Footage

16,350

Special details

This 16,350 SF compounding pharmacy was developed to support the production of specialized pet medications for a Confidential Client. The facility includes compounding suites, laboratory support spaces, office areas, a warehouse, and a dedicated mechanical equipment platform. The project required a highly coordinated approach to integrate cleanroom systems within an existing building footprint.

Project Hightlights

  • Modular cleanroom solution tailored to an existing building with structural limitations
  • ISO 8 environments designed for pharmaceutical compounding operations
  • Walkable ceiling supported by the Apex Trellis System for enhanced access and maintenance
Toronto, Ontario, Canada

Pharmaceutical Manufacturing Facility

Square Footage

30,000

Special details

This project expands an existing pharmaceutical manufacturing facility in Toronto, Ontario, to increase production capacity and introduce new sterile and nonsterile processing capabilities. The scope includes a two-story addition with sterile manufacturing suites, supporting infrastructure, and expansion of the existing Purified Water System.

The addition integrates with an active, space-constrained facility. Major HVAC, mechanical, electrical, and utility infrastructure is located on the second floor to maximize production space, with planning focused on system coordination, installation sequencing, and continuity of existing operations.

Project Hightlights

  • Sterile manufacturing environments: New manufacturing suites with coordinated cleanroom systems and supporting process infrastructure.
  • Two-story addition: Second-floor infrastructure preserves production space and supports equipment and utility requirements.
  • Critical utility expansion: Expansion of the existing Purified Water System and integration of new process utilities.
  • Active facility integration: Coordination of new and existing building systems within a constrained operating environment.
  • Complex installation interfaces: Alignment of cleanroom assemblies, mechanical and electrical systems, equipment support, and penetrations.
  • Future capacity planning: Infrastructure designed to accommodate evolving production needs and future growth.
Houston, TX

cGMP Biopharmaceutical Manufacturing Facility

Square Footage

22,000

Special details

CleanSpace delivered a 22,000 SF turnkey design-build cGMP biopharmaceutical manufacturing facility in Houston, Texas, supporting gene therapy production. The facility includes 10,000 SF of cleanroom space, 10,000 SF of laboratory space, and 2,000 SF of office space, with Grade A, B, and C controlled environments supporting concurrent processing of multiple gene therapies.

After transitioning the project from a design-bid-build model to an integrated design-build strategy, CleanSpace streamlined design and execution through value engineering, MEP optimization, and coordinated project delivery. The project achieved a 25% cost reduction and Certificate of Occupancy in 11 months, compared with the original 16-month schedule.

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Project Hightlights

  • Designed for concurrent processing of multiple gene therapies
  • Regulatory objectives addressing FDA, EMA, Japan, and MHRA requirements
  • Full in-house manufacturing capability including process and analytical development labs and quality control labs
  • Flexible manufacturing configuration supporting evolving production needs
  • Planned expansion capability into adjacent space
  • Execution maintained within an active, mission-critical environment
College Station, TX

Biopharmaceutical Manufacturing Campus

Square Footage

CONFIDENTIAL

Special details

CleanSpace provided design-assist and preconstruction services for a major CDMO manufacturing campus in College Station, Texas, supporting cell culture, microbial fermentation, and gene therapy production. CleanSpace worked collaboratively through the transition from design into construction, helping align controlled environment solutions with the requirements of a large-scale cGMP manufacturing program.

The approach incorporated the client’s global facility standards, with an emphasis on standardization, innovation, and modularization to support consistency across its worldwide manufacturing network.

Project Hightlights

  • Design-assist and preconstruction services
  • Large-scale cGMP biopharmaceutical manufacturing campus
  • Cell culture, microbial fermentation, and gene therapy applications
  • Design coordination through transition into construction
  • Alignment with established global facility standards
  • Focus on repeatable, standardized controlled environment solutions
  • Modularization incorporated into project planning and design
Morrisville, NC

Gene Therapy Manufacturing Facility

Square Footage

22,000

Special details

CleanSpace delivered a 22,000 SF controlled environment scope within a new 200,000 SF, two-story cGMP gene therapy manufacturing facility in Morrisville, North Carolina. The facility supports viral vector manufacturing, including processing suites for adherent and suspended AAV production, common solution preparation, plasmid manufacturing, weigh/dispense, and fill/finish operations.

CleanSpace’s scope included modular cleanroom architecture with walkable ceilings, HEPA filtration, LED lighting, and associated cleanroom systems across ISO 6, ISO 7, and ISO 8 environments, including several BSL-2 areas. Full BIM/VDC coordination and lean methodologies supported integration of the controlled environments within the larger manufacturing facility.

Project Hightlights

  • Processing suites supporting adherent and suspended AAV manufacturing
  • Plasmid manufacturing and common solution preparation areas
  • Weigh/dispense and fill/finish environments
  • Several BSL-2 areas supporting specialized operations
  • Full BIM/VDC coordination across the project scope
  • Lean methodologies incorporated into project execution
Emeryville, CA

cGMP Clinical Manufacturing Suite

Square Footage

1,000

Special details

CleanSpace developed a 1,000 SF cGMP clinical manufacturing suite within an existing facility in Emeryville, California, supporting early-stage manufacturing of novel therapeutic technologies. The facility was designed to accommodate nuclease-based processes, mRNA-LNP, AAV, and cell therapy, providing a flexible controlled environment for multiple emerging modalities.

The modular cleanroom incorporates three gene therapy suites with shared filling capabilities, along with airlocks, preparation areas, locker rooms, cold storage, and dedicated QC laboratory functions. CleanSpace’s scope included aluminum honeycomb-core wall systems, grid ceilings, plenum systems, integrated windows, doors, coving, and associated cleanroom components.

Project Hightlights

  • Three gene therapy suites with two shared filling units
  • Manufacturing support areas including airlocks, prep space, locker rooms, and cold storage
  • Dedicated QC areas supporting bioassay, PCR, vector, and microbiology
  • Modular aluminum honeycomb-core wall system
  • Integrated ceiling, plenum, door, window, coving, and trim systems
  • Multiple therapeutic modalities accommodated within a compact clinical manufacturing footprint
Pennington, NJ

Cell & Gene Therapy Manufacturing Facility

Square Footage

13,000

Special details

CleanSpace delivered a 10,000 SF cleanroom box within a 13,000 SF renovation in Pennington, New Jersey, converting existing space to support cell and gene therapy manufacturing. The project required the new controlled environment to fit within the building’s existing structure while accommodating the equipment, utilities, and movement of people and materials needed for manufacturing operations.

Most of the cleanroom was constructed with 9-foot ceilings, while one area reaches 12 feet to meet specific operational needs. CleanSpace also provided a custom crash rail protection system and a tube pass-through, integrating these features into the cleanroom layout. Careful coordination of the cleanroom components, building conditions, and installation sequence helped bring the new space together within the facility’s available footprint.

The completed cleanroom gives the client a controlled manufacturing environment designed for its current operations and planned future commercial production.

Project Hightlights

  • 10,000 SF cleanroom box within a 13,000 SF renovation
  • Conversion of existing space for GMP manufacturing
  • 9-foot ceilings with a 12-foot-high area for operational needs
  • Custom crash rail protection and tube pass-through
  • Cleanroom installation coordinated with existing building conditions
Hopewell, NJ

Biomanufacturing Facility

Square Footage

5,000

Special details

CleanSpace supported the delivery of a new biomanufacturing facility in Hopewell, New Jersey, providing cleanroom environments for the client’s first U.S. manufacturing site. The project brought controlled environment requirements together with the facility’s production equipment and building systems to support biologics manufacturing.

Project Hightlights

  • Cleanroom environments designed for advanced biologics production
  • Coordination with manufacturing equipment and supporting building systems
  • Facility designed to accommodate both fed-batch production and a modular continuous manufacturing platform

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Charlotte, NC

ISO 7 Industrial Cleanroom

Square Footage

5,700

Special details

CleanSpace delivered a 5,700 SF ISO 7 cleanroom in Charlotte, NC. The turnkey scope included cleanroom construction and coordination of the mechanical, electrical, and plumbing (MEP) systems from design through installation. The team integrated prefabricated components with work performed on site, managing installation sequencing and system interfaces to meet the project’s schedule, quality, and performance requirements. Systems were tested and commissioned to support operational readiness and client handoff.

Project Hightlights

  • Delivered a 5,700 SF ISO 7 cleanroom through a turnkey scope.
  • Coordinated MEP systems from design through installation.
  • Integrated prefabricated components with on-site construction and MEP work.
  • Tested and commissioned systems to support operational readiness.

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Norwood, MA

PCT Filling Operation

Square Footage

17,000

Special details

CleanSpace provided the architectural envelope for the cleanroom spaces supporting Moderna’s Personal Cancer Therapy sterile filling operation.​

The scope of work included CleanSpace’s modular ½” uPVC wall systems and non-walkable ceilings, CleanSpace PVC doors, fire-rated doors, automatic door operators, interlocks, and wall protection throughout the facility.

Project Hightlights

  • Architectural cleanroom envelope supporting sterile filling operations for Personal Cancer Therapy.
  • Modular ½” uPVC wall systems and non-walkable ceilings designed for controlled manufacturing environments.
  • Integrated door and safety systems including PVC and fire-rated doors, automatic operators, interlocks, and wall protection
Hatboro, PA

Process Systems

Square Footage

2,000

Special details

Medical tubing cleanroom suite.

Project Hightlights

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

Gene Therapy Pilot Plant

Square Footage

Not specified

Special details

New cGMP flexible clinical process suite for early clinical manufacturing.

Project Hightlights

  • 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

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 Hightlights

  • 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 Hightlights

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