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bioGO® Modular cGMP Cleanrooms

bioGO® Modular cGMP Cleanrooms

BioPharma Modules - Flexible cGMP Facilities

Germfree designs and manufactures complete modular facilities to provide fast and flexible cGMP-compliant production space optimal for various ATMP’s incorporating cleanroom process areas as well as any needed containment for potent APIs.  By enabling unmatched speed to market, GF’s modular cleanrooms allow quicker delivery of therapies to patients to maximize revenue realization and ROI.  Off-site built with single source design through CQV, minimizes risk to project timelines and the administrative burden of managing and coordinating multiple trades and vendors.

Configured for Your Current Process – Flexible for Future Applications

bioGO® BioPharma Modules meet the rigorous aseptic processing and containment demands for a wide range of biopharmaceutical applications, which include:

 

  • Vaccine production
  • Biotechnology R&D
  • Gene therapy
  • Monoclonal antibodies (mAbs)
  • Cytotherapy Applications that require biocontainment 

Why Germfree

Germfree Process

The Modular Difference

Decades of Experience
Having manufactured air filtration and containment systems for nearly six decades, Germfree is uniquely positioned to deliver in the cGMP space. Germfree’s BioPharma Modules offer a highly flexible approach to adding cGMP-compliant infrastructure. New types of drugs and biomanufacturing techniques require more agile production platforms. Germfree provides a range of solutions for both preclinical-stage startups and pharmaceutical manufacturers.

Contact our engineering experts to discuss your specific biopharmaceutical application.

Offsite-Built, Process-Ready
Germfree’s self-contained BioPharma Modules do not require any complex on-site infrastructure and feature:

  • Fast-track design process
  • Optimal integration of HVAC for a low ratio of mechanical space
  • 316L stainless steel integrated biosafety and laboratory equipment
  • Modules/zones for designated ISO cleanroom classifications
  • Biocontainment up to BSL-3
  • All cGMP-compliant materials and interior finishes for durability and ease of decontamination
  • Units are pressure decay tested to insure integrity
  • Arcoplast walls and ceilings; Cleanroom-certified seamless vinyl flooring; radius coved corners
  • Pharmaceutical grade fixtures and casework including movable carts and tables
  • Ability to disconnect MEP for relocation
  • Modules can be reconfigured and repurposed
  • Units meet or exceed the functional and structural quality of a site-built facility

Comprehensive Solution
Germfree offers solutions that are scalable as drug development or production is ramped up. These units are effective as a separate dedicated lab such as: quality control (QA/QC), chemistry and molecular-PCR laboratories. Further differentiation:

  • Modules for R&D batches; small-batch manufacturing including Phase I & II clinical trials
  • Available as a single cleanroom or designed for separate production and containment zones
  • Modules may be connected together to create a large, open floor plan
  • Integrated into upstream or downstream processes
  • Moderate footprint is compatible with some continuous manufacturing operations
  • IQ/OQ; complete validation and documentation package
  • Factory Acceptance Testing; Factory pre-qualification and readiness for on-site validation, certification or commissioning
  • Easily installed in warehouse/shell buildings, existing space or free-standing by a factory-based global installation team and logistics experts

Germfree is a single source OEM for both the module and core equipment

Germfree Deploys Advanced cGMP-Compliant Capabilities to any Region
There is an increasing demand for biomanufacturing facilities located in the markets being served. Close-proximity of production or clinical trials has many advantages. BioPharma Modules are a practical approach to meeting the challenges of producing sensitive therapeutics and maintaining the cold chain. We have experience with modular installations in remote locations worldwide. Our units are engineered for effective operations, compatible with local resources.

Current and emerging biotherapeutics require innovative production strategies. Legacy buildings and production platforms often are not easily adapted to these applications. There is also a need for flexible space that can be repurposed for new biologics and APIs. Traditional construction is too rigid or slow for solving many of these challenges. A modular approach, when properly implemented, is ideal for meeting these demands.

Manufacturing Excellence
Germfree’s bioGO® BioPharma Modules are manufactured and pre-qualified in a controlled factory environment. Germfree's cutting-edge fabrication technology, engineering teams and subject-matter experts are located at a 173,000 square foot (16,000 square meter) US manufacturing plant. Having a single source solution simplifies the complexity of factors inherent to brick and mortar buildings, mitigating the risk of on-site construction variables and delays. This approach results in an accelerated project timeline.

bioGO®Adaptive Modules – Flexible for Early Stages of Drug Development
Germfree’s BioPharma Modules provide an optimal platform when dedicated space is needed for preclinical drug development or small-batch production for clinical trials. Germfree facilities are reconfigurable and can be repurposed to accommodate the next project in the pipeline.

ASK GERMFREE









    Creating Environments that Serve Life Science Innovation and Advance Global Health

    Germfree’s bioGO® BioPharma Modules are manufactured and pre-qualified in our controlled factory environment. Our leading-edge fabrication technology, engineering teams and subject-matter experts are located at our 173,000 square foot (16,000 square meter) US manufacturing plant.

    Explore what makes Germfree's cGMP Cleanroom products a true differentiator in design, construction, and time to market.

    Get a Consultation with a Sales Engineer

    + 1 (386) 265-4300