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Critical Solutions for Your Critical Environment

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Design Build

Service & Facility Maintenance

Performance and compliance of your investment depends on proactive service, maintenance, operational support, and rapid response when critical systems impact production, compliance, or facility uptime. Any impact on operations affects profits.

Controlled environments require more than successful construction. Long term performance depends on proactive maintenance, operational reliability, compliance readiness, and responsive support when critical systems impact production or facility uptime. CleanSpace provides integrated service and maintenance programs designed to support cleanrooms, cGMP manufacturing facilities, temperature-controlled environments, sterile compounding operations, and other regulated spaces throughout their operational lifecycle.

As a modern design builder, CleanSpace supports clients from concept through commercialization with continued oversight of facility performance, operational readiness, and system reliability. Our teams understand the relationship between environmental control, process operations, compliance requirements, and long term maintainability, allowing us to support facilities with a higher level of coordination, accountability, and technical understanding.

Because CleanSpace designs, manufactures, and installs the environments we build, our service teams maintain direct knowledge of the systems, workflows, and infrastructure behind each facility. This integrated approach improves response time, streamlines troubleshooting, and helps clients maintain validated, high performing environments while minimizing operational disruption and long-term risk.

Preventative Maintenance Programs

Planned maintenance services supporting cleanroom systems, modular wall and ceiling assemblies, doors, environmental controls, temperature controlled environments, and critical facility infrastructure.

Operational Reliability and Uptime

Support programs focused on maintaining environmental performance, reducing downtime, improving facility reliability, and protecting ongoing manufacturing and operational activities.

Commissioning, Qualification, and Compliance Support

Ongoing support for commissioning updates, requalification activities, testing and balancing, environmental verification, temperature mapping, SOP coordination, and audit readiness preparation.

Shutdowns, Repairs, and Facility Modifications

Coordinated support for planned shutdowns, emergency response, system repairs, infrastructure upgrades, and evolving operational requirements within active regulated environments.

Workforce and Operational Readiness

Support for training reinforcement, operational coordination, compliance alignment, and facility readiness to help teams maintain efficient and compliant operations over time.

Long Term Facility Partnership

From construction turnover through ongoing operations, CleanSpace remains a long-term partner supporting the performance, reliability, compliance, and scalability of controlled environments across pharmaceutical, biotechnology, advanced manufacturing, and regulated industries.

Facility Modifications and Expansions

Support for phased expansions, reconfigurations, equipment integration, workflow modifications, and evolving manufacturing requirements without disrupting ongoing operations.

Nationwide Service Capabilities

CleanSpace supports clients across all technical industries with responsive field service and coordinated maintenance programs tailored to operational needs.

Inspired by industry approaches to integrated facility maintenance and lifecycle support, but fully rewritten and tailored to CleanSpace’s modern design build model and controlled environment expertise.

Norwood, MA

PCT Sterile Filling and Operation

Square Footage

27,000

Special details

Phase 1 & 2 Expansion of vaccine plant.

Project Hightlights

  • Modular wall and ceiling panels, cleanroom doors, high-speed roll-up doors.
  • Filling line expansion, fast-track project.
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.