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Critical Solutions for Your Critical Environment

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Design Build

Estimating and Preconstruction

Successful controlled environment projects begin with accurate estimating, transparent planning, and early alignment between operational goals, compliance requirements, constructability, budget, and execution strategy. CleanSpace leads preconstruction through an open book approach that gives clients clear visibility into project scope, system selections, procurement strategy, schedule drivers, and real time cost alignment from the earliest stages of development.

As a modern design builder, our estimating process is directly connected to engineering, manufacturing, field operations, and real world installation experience. Because the same teams responsible for design, manufacturing, and construction are involved during preconstruction, projects are planned around actual operational requirements, constructability conditions, installation sequencing, and controlled environment performance expectations rather than conceptual assumptions disconnected from execution realities.

This integrated process significantly reduces scope gaps, coordination conflicts, redesign, procurement delays, and downstream cost escalation. By identifying risk early and aligning decisions collaboratively throughout design and preconstruction, CleanSpace is able to deliver highly predictable project outcomes with a focus on eliminating unnecessary change orders and protecting both schedule and budget certainty.

Our teams work closely with clients, operators, architects, engineers, and stakeholders to evaluate infrastructure constraints, workflow demands, environmental classifications, phasing requirements, utility coordination, and operational objectives before construction begins. This early collaboration allows projects to move into execution with greater confidence, stronger coordination, and clearer alignment around conditions of satisfaction for all stakeholders involved.

In addition to budgeting and scheduling, the preconstruction process includes value engineering, logistics planning, constructability review, procurement coordination, system integration analysis, and operational planning strategies designed to reduce both capital expenditures and long term operational costs while maintaining compliance, performance, and scalability objectives.

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.