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Critical Solutions for Your Critical Environment

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Design Build

Architecture and Engineering for Controlled Environments

Successful controlled environment facilities require more than technical drawings. They require a deep understanding of process, compliance, constructability, operational workflow, and long-term facility performance. CleanSpace delivers fully integrated architecture and engineering services tailored to pharmaceutical, biotechnology, advanced manufacturing, compounding, radiopharmaceutical, and regulated production environments.

Digital twins also support long term operational planning by creating a detailed virtual representation of the facility that can be used for maintenance planning, future expansion, training, system coordination, and operational optimization. By integrating intelligent modeling into the design build process, CleanSpace helps clients make faster decisions, reduce uncertainty, and improve project outcomes across complex controlled environment facilities.

Our multidisciplinary teams bring decades of experience designing complex controlled environments, allowing us to approach projects holistically from both an operational and technical perspective. We align architecture, engineering, process requirements, manufacturing operations, environmental control, and facility infrastructure into one coordinated design strategy that supports compliance, scalability, efficiency, and long term operational reliability.

CleanSpace utilizes advanced digital modeling and digital twin technologies to improve coordination, visualization, constructability, and operational planning throughout the project lifecycle. These tools allow clients to better understand workflows, equipment integration, personnel movement, utility coordination, and environmental relationships before construction begins.

CleanSpace provides both full in-house design and engineering services as well as collaborative design assist support for projects led by outside architects, engineers, or construction teams. This flexibility allows us to integrate seamlessly into a variety of project delivery models while maintaining alignment between design intent, constructability, operational objectives, and project execution.

Digital Twin and Intelligent Facility Planning

Our teams are licensed in most states to provide in-house stamped architectural and engineering drawings, streamlining coordination, improving accountability, and reducing delays associated with fragmented design responsibility. Because engineering, manufacturing, and construction are closely integrated, our teams can make informed decisions earlier in the process, improving project efficiency while reducing downstream risk, redesign, and field conflicts.

Integrated Architecture and Engineering Services

Architectural Planning and Facility Layouts

Process driven layouts supporting workflow efficiency, material flow, personnel segregation, compliance, and operational scalability.

Mechanical, Electrical, and Plumbing Engineering

Coordinated MEP systems engineered around environmental control, process demands, clean utilities, WFI, redundancy, maintainability, and energy performance.

Process and Controlled Environment Engineering

Integrated infrastructure supporting cleanrooms, cGMP manufacturing, aseptic processing, biologics production, temperature-controlled environments, and specialized regulated operations.

Design Assist and Collaborative Delivery

Technical integration and constructability support for projects involving external architects, engineers, developers, and construction teams.

Code Compliance and Regulatory Coordination

Support for regulatory alignment, permitting coordination, environmental requirements, and compliance driven facility design.

Digital Modeling and Coordination

Advanced BIM coordination, clash detection, digital twin implementation, and intelligent facility planning supporting efficient execution and long term operational value.

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.