“When it came time to build our 2000-L single use mammalian cell culture biomanufacturing area, I chose AdvanceTEC. They have an unmatched level of engineering expertise as well as an exceptional reputation for delivering high quality design-build programs on-time and on-budget.”
Joe McMahon, President and CEO, KBI Biopharma, Inc.

Pharmaceutical &  Biotechnology CleanroomsPharmaceutical & Biotechnology Cleanrooms

AdvanceTEC is a leader in cleanroom design, cleanroom construction and cGMP envelope installation, serving Pharmaceutical and Biotechnology clients. Our comprehensive, in house engineering, design and construction management staff understands the various challenges and requirements for cGMP compliant cleanrooms and other validated spaces.  Our experience enables us to deploy the right resources to your project, to reduce risk, compress schedules, and ensure your project success.

  • Manufacturer independent approach allows selection of the optimal cGMP architectural solution, avoid being locked into an inflexible proprietary system 
  • Modular system integration experience and a single focal point reduces risk and accelerates project execution
  • Walkable cGMP ceilings enable concurrent construction, minimizing schedule duration as above ceiling work and flooring/wall system installation is performed at the same time
  • Flexible on scope and resource deployment, from turn-key design/build, to design assist cGMP cleanroom envelope scopes of work

serving Pharmaceutical and Biotechnology clientsWhether you require a 500 square foot BSL3 facility, a 50,000 square foot cGMP envelope, or a concept to commissioning full turn-key project, AdvanceTEC’s experience and flexibility reduces project risk and improves time to completion.

Our Approach

AdvanceTEC provides comprehensive cleanroom design and cleanroom construction capabilities to serve Pharmaceutical & Biotechnology clients. We understand the technical challenges in these industries, and deploy the specific capabilities required to ensure project success.

Requirements Gathering

Design and Engineering

Construction Management

  • Area classifications and validation requirements
  • Room to room pressure cascades
  • Personnel and product flow/segregation analysis
  • Process utility studies
  • HVAC, mechanical and exhaust systems
  • Estimating, budgeting and schedule development
  • Conceptual design, programming and layout
  • Selection of cGMP architectural finishes
  • Design for constructability
  • Budget creation and schedule optimization
  • Robust commissioning plan
  • Experienced, salaried construction management
  • Certified installation crews
  • Commissioning, certification and training
  • Process system installation
  • Safety


Experience

AdvanceTEC has a proven track record of addressing project schedule, mechanical systems and modular system integration requirements for leading edge Pharmaceutical and Biotechnology cleanrooms.

Applications

Design Approach

Facility Types

  • Walkable/workable cGMP ceiling systems
  • Panelized and rod hung T-grid ceilings
  • Plenum module and flush grid systems
  • cGMP cleanroom architectural finishes
  • Terrazzo, epoxy and other flooring options
  • Door finishes, operators and hardware
  • RO/DI water systems
  • Air locks
  • Restricted access barrier (RAB)
  • R&D applications labs
  • Modular laboratories
  • Pilot lines
  • Fill finish lines
  • Cell culture suites
  • Vaccine plants
  • Clean warehousing
  • Modular support rooms

Cleanliness Classifications

European Standard
more information

Biosafety Levels
more information

ISO Standard 14446
more information

  • Grade A
  • Grade B
  • Grade C
  • Grade D
  • BSL1
  • BSL2
  • BSL3
  • ISO 4 
  • ISO 5
  • ISO 6
  • ISO 7
  • ISO 8

Clients and Projects

AdvanceTEC is proud of the Pharmaceutical & Biotechnology clients that we have served and the projects we have delivered. Below is a partial list of our leading clients; our complete project resume is available upon request.

Altea Therapeutics
Helvoet Pharma
Northwestern University (Laurie Cancer Research Center)
Cambrex Biosciences Jacobs Engineering* Patheon Pharmaceuticals
Fleet Laboratories KBI Biopharma Pharmaceutical Product Development (PPD)
Genentech MedInstill United Therapeutics
GlaxoSmithKline Merck & Company* University Pharmaceuticals
*Multi-project client

To learn more about our complete project resume, please click here.

 

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