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Modular Cleanrooms
Standalone, turnkey, process ready cGMP modular cleanrooms
Germfree cGMP modular cleanrooms are a platform solution that unlock standalone manufacturing capacity for a variety of applications. Serving processes from cell therapy to sterile fill-finish manufacturing cGMP modular facilities offer unmatched finishes, layout flexibility, controls, timeline assurance, and cost benefits for the biopharmaceutical industry. This is why Germfree has been chosen by 12 of the top 20 biopharmaceutical companies as their modular cleanroom providers.
Modular cleanrooms highlights
Biopharma
International building codes, IBC, NFPA, ISO. BSL-2 BMBL, FDA, EMA, cGMP compliant.
Turnkey modular cleanrooms to enable cGMP production
Germfree cGMP modular cleanroom facilities are a genuine turnkey platform solution that enable both cGMP and cGMP/BSL-2 production. All systems necessary to operate the facility are fully integrated. Germfree facilities are free standing, do not require a shell building and provide a high quality interior working environment. Germfree Modular facilities are designed with room and facility features such as Grade D (ISO 8), Grade C (ISO 7), Grade B (ISO 5), Material Air Locks (MALs), Personnel Airlocks (PALs), Anterooms, and Degowning rooms in a layout most efficient for your process flow.
- No shell building required
- Independent HVAC design
- Maintained & serviced by Germfree
- Process segregation capabilities
- Adaptable into an existing facility
- Relocatable
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Standard Modular cGMP Cleanrooms 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.
Single Module for Large Process Equipment
Single Module for Large Process Equipment
The flow of this facility contains a CNC Entry Room, Grade D Anteroom, Grade C Processing Suite, Grade D Anteroom, and a CNC Exit Room.
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Single Module Large Grade B Suite with Unidirectional Flow
Single Module Large Grade B Unidirectional
The flow of this facility contains a CNC entry room, grade D Anteroom, grade C anteroom, large grade B processing suite, grade C anteroom, grade D anteroom and a CNC exit room.
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Single Module Large Grade B Suite with Bidirectional Flow
Single Module Large Grade B Suite with Bidirectional Flow
This facility flow includes a CNC entryroom, grade D anteroom, large grade C processing suite, grade B anteroom, and a grade B processing suite allowing for a bidirectional flow throughout.
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2 Module Facility with Exit Corridor
2 Module Facility with Exit Corridor
This facility flow is a CNC entryroom, ISO 8/grade D material packing and storage suite, large grade D anteroom connected to a grade D supply corridor with a large grade D suite.
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2 Module Facility with "Ballroom" Layout
2 Module Facility with "Ballroom" Layout
This facility flow is a CNC entryroom, grade D anteroom, grade C large processing suite suitable for large bioreactors and process equipment with a grade D anteroom and CNC exit.
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5 Module CGT Facility with Unidirectional Flow
5 Module CGT Facility with Unidirectional Flow
This 5 module facility has the following flow: CNC entryroom, grade D locker room, grade C gowning and material storage connected to a grade C supply corridor. Large grade C processing suite ballroom, grade D anteroom and a CNC exit corridor.
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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.
Modular Cleanrooms Specifications
Room Classification Types
- CNC Entry Room, Grade B (ISO 5)
- Grade C (ISO 7), Grade D (ISO 8)
Mechanical
- Stand alone, Freestanding modular facility no shell building required
- Fully integrated HVAC maintains critical environment conditions, provides segregation between bioprocessing and admin spaces
- HVAC is sized to provide optimal ACH rates in each room, entry, exit, personnel airlocks, and processing spaces. – Bio-decontamination compatible Personnel Airlock(s), low wall returns, and ductwork
- Temperature, Humidity, & Differential Pressure Controls
Electrical
- Internal site power connection
- Seamless backup UPS power for critical cleanroom and building management system equipment
- NFPA 70 NEC 2017 Compliant
Plumbing
- Ready to accept site infrastructure for both fresh and grey water
Door Controls
- Wave to open door controls with configurable interlocks and timing
Building Management System
- A central BMS controls HVAC through our calibrated sensors including temperature, humidity, differential pressure, valve positioning, and exhaust controls
- The BMS monitors and distributes all facility data using BACnet communication protocols
Environmental Monitoring System
- 21 CFR Part 11 compliant EMS system serves as permanent record keeping and storage with compliant visual and audible alarms, report generation, message lists, and access levels
- The EMS reports data from calibrated sensors on refrigerators, freezers, incubators, Grade D/C classified spaces and more
Architectural
- Durable against harsh cleaning agents such as sporicidal agents and VHP
- Every build decision prioritizes a sealed, smooth, cleanable and compliant interior envelope
Gas Piping
- Gas manifolds 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
- Germfree Biosafety Cabinets (BSC’s)
- Integrated Active-HEPA Material Pass Through(s)
Security, Access, Fire & Data
- Sprinkler, Material, & Fire panels built to local code
- Emergency eye wash and power backup for other life safety systems
- Code Access with optional Key card access into facility
Site Requirements
- Concrete pad or pillars
- Fresh and Grey Water connections
- Electrical utility connections
- Staff access and site security
Types of Modular Cleanrooms Equipment Add-Ons
Filter
The Germfree difference
Factory Acceptance, Onsite Testing & Quality Control
Modular 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: URS Development, Operational Flow Design, Basis of Design, Site Infrastructure Audits, Engineering, Commissioning, Qualification, Installation, Equipment Sourcing and more.
Support & Maintenance
Germfree’s service team supports facilities 24/7, providing preventative monitoring, diagnostics and maintenance worldwide.
Flexible, Adaptable, Cost saving construction methods
Our Modules do not require a shell building, they can be relocated by our service team, and our robust single HVAC system allows the option to switch between positive or negative pressure in some instances.
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.
Sales: + 1 (386) 265-4300
Service & support: cs@germfree.com
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