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Flexible, Process Ready Mobile cGMP Cleanrooms
Mobile cGMP Cleanrooms
Aseptic processing that goes wherever the work does. Germfree’s Mobile cGMP Cleanroom platform is built to meet rigorous standards for production efficiency, compliance, quality control, and commissioning and qualification, deployable anywhere the project calls for it.
Product highlights
Sale or Lease
Onsite in < 6 months
Meets US and EU cGMP, ISO 14644, BMBL
Applications
Built to Enable cGMP Manufacturing Capacity and Capability
QC and CQV guide every step of our cleanroom manufacturing model, so what arrives is a compliant, process-ready suite. Design and engineering controls are driven by application, built to clear in-process validation checks and facility EMPQ requirements.
Every project starts with a pre-installation consultation and a dedicated project manager, your single point of contact from inception and site installation through preventative maintenance and monitoring.
- Seamless Interior Walls & Coved Flooring
- Process driven HVAC design
- No Shell Building Required
- Serviced & Maintained by Germfree
- Movable Interior Walls
- Independent HVAC
Explore the features of our cGMP Cleanrooms
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.
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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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When your mission calls for something custom, we deliver.
Some environments can’t take a catalog answer: the one-of-a-kind containment lab, the facility that has to survive shipment by military aircraft, the compounding pharmacy that has to stand up overnight. Tell us the constraints, we’ll build around them.
Specifications for cGMP Cleanrooms
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
Electrical
- 208/120V 3-phase, 225amp service
- Optional: Generator or Battery Back-Up Power
Plumbing
- Ready to accept site infrastructure for both fresh and grey water.
- Onboard hand wash sink with hot water
- Optional: Purified water
Door Controls
- Wave to open door controls with configurable interlocks and timing
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
Environmental Monitoring System
- Monitors critical environmental conditions, trends and stores environmental data. FDA cGMP Part 11 compliant.
- In lab user interface
Architectural
- Stainless Steel, Powder coated or FRP Doors.
- Drop or Monolithic Arcoplast ceiling with Coved flooring.
- Facility is designed for cleanability and chemical compatibility
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
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
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
Smarthood™
Stainless Steel Laboratory Furniture
Vertical Laminar Flow Hood
Horizontal Laminar Flow Hood
The Germfree difference
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.
Project Management
We manage all complexities associated with your project: site infrastructure audits, documentation submittals for certification, installation, equipment manufacturing & procurement, and more.
Support & Maintenance
Germfree’s service team supports facilities 24/7, providing preventative monitoring, diagnostics and maintenance worldwide.
Flexible Ownership Options
This mobile cleanroom is available from Germfree’s lease fleet and can be made operational in a matter of hours.
Related insights
Beyond the Blueprint: Practical Infrastructure for Cell Therapy Manufacturing
Advancing Patient Access Through Decentralized Manufacturing
Related resources
Germfree Biopharma Products Brochure
Germfree Mobile cGMP Cleanroom Product Brochure
Contact us: Let's deliver on your mission together
Complete our contact form and a member of our commercial team will reach out to you within 24 hours.
Sales: + 1 (386) 265-4300
Service & support: cs@germfree.com
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