Modular Clean Rooms: Compliance Starts At Design
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
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.
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.
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.
Modular VS Stick Build
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.
Clean spaces for a variety of industries
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.
Corporate Headquarters
CleanSpace Modular, LLC1035 Virginia Drive, Suite 301 | Fort Washington, PA 19034
Manufacturing and Warehouse Facility
4350 W White Road, Suite 100 Oakwood, GA 30566
Michigan Corporate Office | CleanShield
2424 Wolcott StreetFerndale, MI 48220
Houston Corporate Office
6977 Wynnwood LaneHouston, TX 77008
Dallas Corporate Office
3020 Pegasus Park DriveDallas, TX 75247
Case Studies
Major CDMO Client
Packgene Biotech – cGMP Manufacturing Facility
Gene Therapy Pilot Plant, Confidential Client
Sentinel Process Systems
Moderna
The Modern Design Build Process
Our team accelerates the design to installation process and is what enables CleanSpace to offer timeline and budget guarantees.
CleanSpace Insights
Improve the speed and efficiency, provoke dialogue for alignment and consider key decision points as you prepare for your next project.
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.