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Mobile cGMP Cleanrooms

Flexible, Process Ready Mobile cGMP Cleanrooms

Mobile cGMP Cleanrooms

Germfree’s mobile cGMP Cleanroom Platform revolutionizes the industry by offering a cutting-edge, flexible solution for aseptic processing needs. Designed to meet rigorous standards, our mobile cleanrooms ensure efficient production, compliance, quality control and commissioning and qualification.

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Product highlights
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Sale or Lease
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Onsite in < 6 months
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Meets US and EU cGMP, ISO 14644, BMBL

Built to enable cGMP manufacturing capacity and capability

Compliant and turnkey, with QC (Quality Control) and CQV (Commissioning, Qualification, & Validation) efforts guiding each step of our cleanroom manufacturing model to deliver a process ready cleanroom suite. Design & Engineering controls are driven by application to guarantee the facility meets in-process validation checks and facility EMPQ requirements.

Serving as a platform product, Germfree provides a pre-installation consultation and a dedicated project manager providing our client one point of contact from project inception and site installation to preventative maintenance and monitoring of your facility.

  • Seamless Interior Walls & Coved Flooring
  • Process driven HVAC design
  • No Shell Building Required
  • Serviced & Maintained by Germfree
  • Movable Interior Walls
  • Independent HVAC
Door and pass-though on the same wall

Explore the features of our cGMP Cleanrooms

mobile cgmp cleanroom
Seamless Interior Walls
Coved Floor System
Germfree Stainless Steel Casework
Movable Interior Wall System
Process configured HVAC

Standard cGMP Cleanrooms Facility Layouts

Explore our standard facility layouts that cover a broad range of applications and process flows. If these do not meet your application needs, learn more about our custom solutions.

cGMP Bidirectional

cGMP Bidirectional

Designed for a variety of cGMP applications and workflows. This bidirectional flow layout provides the maximum manufacturing space for cGMP operations. This manufacturing facility has a Grade C (ISO 7) cleanroom classification with adjoining anteroom at GRADE D/C (ISO 8/7). This facility is ideal for small scale manufacturing for cell and gene therapy applications using a distributed or point-of-care manufacturing model.

Applications
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cGMP Bidirectional with Grade B Room

cGMP Bidirectional with Grade B Room

Engineered for complex manipulations seen in some Cell and Gene Therapies and Regenerative Medicine process flows. This facility uses the addition of a Grade B (ISO 5) background in the bioprocessing suite and an additional adjoining anteroom. Integrated active pass-through for material handling.

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cGMP Unidirectional

cGMP Unidirectional

Ideal facility layout when a simpler unidirectional flow is desired. Grade C (ISO 7) is background in the cGMP Mobile Cleanroom with adjoining Grade D (ISO 8) to Grade C (ISO 7) anterooms.

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Dual Facility cGMP Bidirectional w/ Large Grade B

Dual Facility cGMP Bidirectional w/ Large Grade B Bidirectional

This layout utilizes the unmatched flexibility and scalability of our Mobile cGMP Cleanroom platform. Increased Grade B (ISO 5) background bioprocessing space designed for a bidirectional flow.

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Dual Facility cGMP Unidirectional w/ Large Grade B

Dual Facility cGMP w/ Large Grade B Unidirectional

Two trailers interconnected for bioprocesses where a large grade B (iso 5) room and unidirectional flow is desired.

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Dual Facility cGMP Workflow Layout

Dual Facility cGMP w/ Large Grade B Unidirectional

Two trailers interconnected providing optimized workflows.

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Multi-Facility cGMP Workflow Layout

Dual Facility cGMP w/ Large Grade B Unidirectional

The ultimate of scalability in mobile cleanrooms. As processes scale, simply add additional trailers with cloned layouts to create the proper, compliant bioprocessing workflow.

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Talk to us about Mobile cGMP Cleanrooms today.

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Looking for something custom?

We have deployed research facilities for shipment by military aircraft, designed equipment to contain the most dangerous agents on the planet, produced facilities to manufacture lifesaving medicines and mobilized hospital compounding during times of regulatory change. Connect with Germfree experts to unlock your scientific potential.

Specifications for cGMP Cleanrooms

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Mechanical
  • Stand-alone, fully integrated HVAC, built to maintain critical environmental conditions required for cGMP manufacturing.
  • HVAC sized to optimize Air Changes per Hour (ACH) rates
  • Low wall returns create a particle reducing air turnover
  • Temperature, Humidity, & Differential Pressure Controls
  • Robust HVAC allows switching between positive & negative pressure for BSL-2 containment.
  • Designed for reliability in varying climates & regions
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Electrical
  • 208/120V 3-phase, 225amp service
  • Optional: Generator or Battery Back-Up Power
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Plumbing
  • Ready to accept site infrastructure for both fresh and grey water.
  • Onboard hand wash sink with hot water
  • Optional: Purified water
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Door Controls
  • Wave to open door controls with configurable interlocks and timing
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Building Management System
  • Reliable controls central HMI, remote access (requires client IT interface), includes calibrated sensors for parameter control & monitoring, audible & visible alarm in each space
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Environmental Monitoring System
  • Monitors critical environmental conditions, trends and stores environmental data. FDA cGMP Part 11 compliant.
  • In lab user interface
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Architectural
  • Stainless Steel, Powder coated or FRP Doors.
  • Drop or Monolithic Arcoplast ceiling with Coved flooring.
  • Facility is designed for cleanability and chemical compatibility
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Gas Piping
  • Gas manifolds to accept a variety of gases. (co2,o2,n2, & compressed air for example)
  • Oxygen cleaned piping to minimize potential contaminants, 316L Stainless Steel, ASME-BPE Compliant
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Integrated Equipment
  • Active, HEPA-purging 100% stainless steel material pass through for an optimized material flow.
  • 100% stainless steel casework, designed for mobile applications with optimal cleanability & durability.
  • Class 2 BSC or Laminar Flow Workstation
  • Optional: Gowning benches, shelving & storage
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Security, Access, Fire & Data
  • CCTV with 1TB storage system
  • 4 internal cameras
  • 4 external cameras
  • Fire & burglar alarm
  • Unique code personnel access control
  • Intercom system for in-lab communication
  • Optional: Key Card Access

Equipment Add-Ons For cGMP Cleanrooms

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Smarthood™
Smarthood™EQT-Pass-Through

Smarthood™

Smarthood™ is our innovative solution that integrates essential peripherals like touchscreen PCs, cameras, scales, and printers directly into a clean, clutter-free hood, enhancing aseptic technique and streamlining your workflow.
100% Stainless Steel Casework
Stainless steel casework in a lab
100% Stainless Steel CaseworkEQT - 100% Stainless Steel Casework

100% Stainless Steel Casework

Germfree's stainless steel casework is a premium choice for laboratory and cleanroom facilities that demand high standards of cleanliness and durability.
Stainless Steel Laboratory Furniture
Stainless steel casework in a lab
Stainless Steel Laboratory FurnitureEQT - 100% Stainless Steel Casework

Stainless Steel Laboratory Furniture

Germfree's stainless steel casework is a premium choice for laboratory and cleanroom facilities that demand high standards of cleanliness and durability.
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Factory Acceptance, Onsite Testing & CQV

Mobile cGMP cleanrooms are factory acceptance tested before shipment and site acceptance tested onsite to support CQV efforts towards commissioning of the facility.

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Project Management

We manage all complexities associated with your project: site infrastructure audits, documentation submittals for certification, installation, equipment manufacturing & procurement, and more.

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Support & Maintenance

Germfree’s service team supports facilities 24/7, providing preventative monitoring, diagnostics and maintenance worldwide.

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Flexible Ownership Options

This mobile cleanroom can be deployed from Germfree instantly via our lease fleet and made operational in a matter of hours.

Contact us: Let's unlock your scientific potential together

Complete our contact form and a member of our commercial team will reach out to you within 24 hours.

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Service & support: cs@germfree.com

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