Fully Integrated Cleanroom Services

Maintain the highest level of cleanliness and ease of use in cleanrooms designed and built by a single expert vendor. CleanSpace accelerates project execution seamlessly with in-house design, manufacturing, and construction.

Your Complex Projects, Made As Easy As Possible.

Speed to market Is at the forefront of all cleanroom projects.

Integrated project delivery allows CleanSpace to own the entire modular cleanroom process from design to turnover, relieving the pressure of working with multiple vendors. Leave your cleanroom project to experts who set expectations up front, communicate throughout the project, and ensure the highest quality of not just your cleanroom, but your facility build as a whole.

Clients Trust Our Leading Cleanroom Manufacturing Company

CleanSpace met with us, listened and understood our challenge to grow our business very rapidly across multiple locations in the US. They responded quickly and developed a complete program to get us to a successful completion. We have worked with other firms before, yet CleanSpace has gone above and beyond to help us succeed.
Confidential Client

Cleanroom Design and Construction Services

Fast and cost-effective cleanroom design and construction solutions adhere to ISO and GMP standards for pharmaceutical, biotechnology, and laboratory cleanrooms. For life sciences and medical device industries, the importance of aseptic cleanrooms cannot be overstated. This meticulous control goes beyond adhering to standards; it enhances the efficacy of processes that lead to the development of critical medical therapies and products.

Modular construction provides numerous benefits to cleanroom owners. Begin by defining the physical design of the cleanroom, extent of its footprint, and the people and process flow required. Identify critical terminations, tie-ins, and coordination points, establish target values and schedules, and develop User Requirement Specifications (URS).

Next, clearly review the budget, schedule, and scope for all project stakeholders to guarantee alignment with your objectives and to ensure predictability and successful implementation. Preconstruction team members are critical coordinators.

Next, we manufacture cleanroom components in our in-house factory, which allows us to control the timing, budget, and quality. Modular construction allows us to be extremely flexible. Zone-based manufacturing supports just-in-time shipping with best speed to market. Our panels are backed by ISO 9001 certified quality assurance.

This service encompasses the overall coordination and installation of projects on-site, ensuring timely and efficient execution according to the developed design.

The QA process confirms the cleanroom class, along with certifying that the cleanroom operates according to the original design and operation quality.  With the cleanroom in operation, we will perform testing and balancing, temperature control, particulate counts, air changes, pressurization and more.

Let Us Protect Your Complex Processes with Start-to-Finish Cleanroom Manufacturing

Having systems in place to control your critical environment’s cleanliness, temperature, and humidity protects your process, and allows you to focus on moving your mission forward.

Single-Source of Responsibility

A single-point of contact fosters a culture of openness, trust, and responsibility, leading to dynamic adjustments, higher quality outcomes, and enhanced client satisfaction.

Active Executive Team Engagement

Our top executive talent is not only in charge of your modular cleanroom project, but actively involved in the process. Every client receives individualized attention.

Industry Experience and Reputation

With 20 years of deep technical knowledge of complex clean space manufacturing operations, our team masterfully designs high-functioning cleanrooms.

Featured Projects: Pharma, Bio, Lab, Semiconductor Cleanrooms

New Bioprocessing Facility
Design assist and construction of a new manufacturing bioprocessing facility for a leading CMO. With a tight schedule, modular components were on the project site within 4 weeks of the start of the project.
Microbial Fermentation & Protein Purification Pilot Plant
Construction of a new cGMP flexible clinical process suite to support early clinical manufacturing of novel process technologies. This 1,000 SF suite will be developed within Metagenomi’s existing building in Emeryville, CA.
Beigene
Beigene, a global biotechnology company focused on the development of cancer treatment drugs, brought CleanSpace on board to construct 4,200 SF of clean space for sterility testing, sampling, and weigh/dispense rooms.
cGMP Manufacturing Facility
The 23,000 SF facility will focus on gene therapy CDMO process development and have Good Manufacturing Practice (GMP) manufacturing capabilities. The areas in this facility will include Process and Analytical Development Labs, GMP Manufacturing Clean Rooms and Supporting Areas, QC Labs, Warehouse, Office Space, New Storage Mezzanine above Warehouse and a New Office Mezzanine.
Gene Therapy Manufacturing Facility
The Gene Therapy Manufacturing (GTM) facility is a new, 200,000SF two-story facility for viral vector cGMP manufacturing. Phase 1 of the project includes three processing suites for adherent or suspended AAV manufacturing served by a common solution preparation area. The overall project will be BSL2-capable and has a goal of LEED Platinum.
Global Standardization Projects
A global CDMO in pharmaceutical manufacturing providing process development and cGMP production in cell culture, microbial fermentation and gene therapies. Texas site will become the largest single-use CDMO campus in North America.
New Manufacturing Facility
Design/build/commissioning of a new manufacturing facility of single-use products to be used in gene therapy and bioprocess manufacturing facilities. Project included the master planning of the 210,000 sf facility, and the design of the fit-out of this facility in three phases. The development phases are developed concurrent with ongoing manufacturing operations.
Confidential Client US Government Mid-West
Fast-track design and installation of entire freezer and building for COVID-19 vaccine storage for Novavax. Project was completed as part of Operation Warp Speed.
PCT Filling Operation
CleanSpace is providing the architectural envelope for the cleanroom spaces associated with Moderna’s Personal Cancer Therapy sterile filling operation.

Critical Solutions for Your Critical Environment