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Clean spaces

Modular Clean Rooms

Learn more about our clean room expertise.

Clean Rooms

Safe and clean environments for all industries

Safe, compliant clean room environments, designed, built, and installed in-house. CleanSpace delivers modular clean rooms for pharmaceutical, biotech, medical device, aerospace, electronics, and food & beverage operations. Every project is engineered to ISO 14644 (ISO 5, ISO 7, ISO 8), cGMP, and FDA standards, 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 Clean Room Design, Manufacturing & Installation

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.

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

ISO 14644, cGMP, and FDA-aligned clean room design for pharma, biotech, and medical device facilities. Hardwall, softwall, 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, and door systems manufactured in-house. Shorter lead times, tighter quality control, and no reliance on overseas supply chains.

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.

Rapid On-Site Installation

Our CleanFit® process compresses the schedule from design through validation. Turnkey installation by CleanSpace crews means one accountable partner from concept to cGMP-ready handoff.

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

A Nationwide Partner for Pharmaceutical and Biotech Clean Rooms

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.Pharma, biotech, medical device, and CDMO clients across the United States rely on CleanSpace to deliver cGMP-compliant, ISO-classified clean rooms on a predictable timeline and budget. From coastal biotech hubs to the rapidly expanding biomanufacturing corridors in the Midwest, Southeast, and Texas, CleanSpace brings the same turnkey process, US-made modular systems, and in-house installation crews to every project.

Because we manufacture our modular wall, ceiling, and door systems in the US and self-perform installation, clients anywhere in the country get faster project delivery, consistent quality control, 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
cGMP clean room design-build
ISO 5, ISO 7, and ISO 8 modular suites
Gene therapy and cell therapy pilot plants
Sterile fill-finish and aseptic suites
CDMO facility build-outs and expansions

Hardwall, Softwall, and Hybrid Modular Clean Rooms

Not every process needs the same envelope. CleanSpace builds three modular clean room system types, and we 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.

Hardwall Clean Rooms

Rigid, flush, cleanable wall panels for cGMP pharma, biotech, and medical device environments where durability and validation matter most.

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.

Softwall Clean Rooms

Fast-deploy, flexible enclosures ideal for R&D, pilot lines, and temporary ISO 7 or ISO 8 spaces that may need to move or scale.
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.

Hybrid and Expandable Systems

Hardwall cores with softwall expansions, designed to grow with your process and protect capital spend over time

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.

Clean Room FAQs

What is a modular clean room?

A modular clean room is a prefabricated, controlled environment built from engineered 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 CleanFit® process typically delivers a modular clean room in a fraction of the time of conventional construction. Most ISO 7 and ISO 8 pharma suites move from design to validated handoff in weeks, not the 12 to 18 months common to stick-built facilities.

What ISO classifications does CleanSpace design to?

We routinely design and build to 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.

Are CleanSpace clean rooms cGMP and FDA compliant?

Yes. Every pharmaceutical, biotech, and medical device clean room we deliver is engineered to meet cGMP, FDA, and applicable EU Annex 1 requirements, with documentation to support validation.

Where does CleanSpace work?

CleanSpace serves clients nationwide. Our US-based manufacturing and self-performed installation crews support projects across every major life sciences and advanced manufacturing region in the country.

How much does a modular clean room cost?

Cost depends on classification (ISO 5 versus ISO 8), square footage, utilities, and equipment integration. CleanFit® provides a fixed-price, guaranteed-timeline quote after a scoping session.

Hardwall versus softwall clean room, which do I need?

Hardwall is the default for validated cGMP and long-term pharma or biotech use. Softwall fits R&D, pilot, and flexible applications. We will recommend the right system during design.