• Self contained modules, no complex on-site infrastructure is required
• Biocontainment at all BSL and ABSL levels
• Modules can be connected together to create a large open floor plan
• Advanced filtration, HVAC and engineering control systems; optimal integration of HVAC for a low ratio of the mechanical area
• All BSL and pharmaceutical grade interior materials; stainless steel construction of equipment, fixtures and casework
• Biopharma Lab Modules may be installed in existing buildings, warehouse/shell space or as free-standing facilities anywhere they are needed
• Factory-based global installation team and logistics experts
• On-going maintenance, training and monitoring programs available
• Comprehensive & collaborative design process; 3D Modeling
• IQ/OQ; complete validation, certification and documentation package
• Factory Acceptance Tested including pre-commissioning and pre-qualification; readiness for on-site certification and commissioning
• Single-OEM approach gets your facility operational faster

Construction & Technical Standards of Our High Containment Labs

Biocontainment Engineering:
Germfree modular laboratories are designed and manufactured in accordance with all Biosafety Level 2/3 (BSL-2 or BSL-3) guidelines as defined in the Centers for Disease Control-National Institutes of Health (CDC-NIH) publication Biosafety in Microbiology and Biomedical Laboratories (B.M.B.L.) 5th edition, and consistent with the World Health Organization publication Laboratory Biosafety Manual, 3rd Edition. We also design your pharmaceutical facility to meet any ISO cleanroom and FDA cGMP requirements.

Monolithic & Sealed Interiors:
BSL-3 labs must be extremely durable and allow for ease of cleaning and decontamination. We use highly resistant Arcoplast, which is more durable than materials used by traditional contractors. Wood products are never used in the construction of our facilities.

Arcoplast solid glass/resin core panel for wall and ceiling panels:
• Resistance to growth of mold (ASTM D3273-00)
• Resistance to fungi, bacteria and does not support microbial growth (ISO 846)
• No surface disfigurement due to fungal or algal growth (ASTM D3274-09)
• Epoxy flooring coved up the wall to provide a finished interior for wash-down, sanitizing and gas decontamination

Advanced Pressure And Leak Testing:
Effective pressure testing is critical to the integrity of any high containment facility. Germfree engineers and manufactures systems that are pressure tested to rigorous standards. Labs are Pressure Decay Tested according to filter housing ASME N5-1989 to 10″ w.g.; and duct or assemblies to 4” w.g. and rooms to 2” w.g.
• Test boundaries include: walls, floors, ceilings, APR doors and bubble tight valves.
• Ductwork Helium Leak Tested
• Components Helium Leak Tested to ensure airtight environment

Exterior Serviceability Of Lab:
Critical service points are accessible from outside the laboratory, allowing for routine maintenance without entering the containment zones. For example, sealed lights are changed from above the unit.

Integration Of Critical Facility Components:

Germfree integrates all required components into our high containment labs including:

Class III BSC’s:
Germfree is internationally recognized as a leading manufacturer of Class III Biological Safety Cabinets. Our Gloveboxes provide containment for diverse research and development applications in biocontainment laboratories. We manufacture advanced Glovebox Lines to the most demanding standards including BSL-4 labs.

Hepa Filter Banks:
Germfree’s HEPA filter banks are used to filter both inlet and exhaust air for Class III Cabinets.
• Redundant HEPA Filter and Blower System.
• HEPA filter banks available with gas decontamination ports and semi-automatic PAO scan.

APR Doors:
Integrated Air Pressure Resistant Doors compatible with BSL-3 laboratory design.
• Inflatable gasket door seal.
• Door controls; PLC

Decontamination Systems:
Gas and Effluent Decontamination Systems (EDS). We can provide chemical or heat-kill systems.

Autoclaves:
• Double-Door Pass-through Autoclaves
• Bulk /Large capacity, flush floor autoclaves; installation flush to the floor for alignment with roll-in autoclave carts.

Pass-through Systems:
Double-door HEPA-filtered Airlocks and Rapid Transfer Ports (RTPs); Through-wall Pass-through dunk tanks (also available for Class III BSC)

Downdraft Tables:
Draws contaminated air away from the work area for a range of pathology work in an open source area

Test Chambers:
Pathogen Aerosol Exposure Test Chambers

Casework And Countertops:
BSL-3 laboratory casework has stringent requirements for durability, chemical resistance and ease of cleaning and decontamination. Germfree’s manufactures and integrates a complete line of stainless steel furniture and fixtures, including movable carts and tables.

Building Management System And Monitoring:
The Building Management System (BMS) is a web-enabled BTL listed BACnet control system. This facilitates trending and data logging for remote management and alarm/notification. Monitoring systems include: room pressure monitors, lighting IR detectors, closed circuit TV monitors and low temperature freezer alarms.

Pharmaceutical ABSL & Aerobiology Applications

Animal Biological Safety Level 3 (ABSL-3) facilities for pharmaceutical applications have unique design and engineering requirements. They must meet all the stringent specifications for Biological Safety Level 3, as well as additional requirements for properly housing and handling animals. ABSL-3 labs require advanced primary and secondary containment systems for handling any potential hazards to personnel or the environment. The facility must be constructed so that it is highly durable to withstand the frequent moving of heavy racks and cages. ABSL-3 laboratories must be easily cleaned and meet all parameters for animal well-being.

Germfree has delivered complete modular BSL-3 and ABSL-3 laboratories worldwide. Our BioPhama Lab Modules let you expand your existing operations or augment new ABSL-3 capabilities. This may include aerobiological R&D; testing, development and production of new vaccines and biotherapeutics.

Our laboratories meet or exceed all applicable guidelines for CDC-NIH BMBL 5th Edition and WHO; all facility standards compatible with AAALAC accreditation and all specified requirements for SA registration.

ABSL Zones:
The facility is divided into designated work zones and animal housing areas. Each zone provides the specified components, proper functionality, temperature control and level of bio-containment that is required for your procedures and animal species.

AAALAC International Accreditation:
Germfree’s ABSL-3 labs are designed to meet the requirements for AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) as they pertain to physical facilities, environment, housing, and ventilation/air quality. These structural aspects of the lab are critical to the AAALAC International regulations stating “physical facilities and the methods of care and use for animals should permit their maintenance in a state of well-being and comfort”.

Class III Biological Safety Cabinets for ABSL and Aerobiology Applications:
Germfree is internationally recognized as a leading manufacturer of Class III Biological Safety Cabinets. Our Gloveboxes provide containment for diverse biopharmaceutical research applications in ABSL-3 laboratories. Our Class III BSCs are engineered to the most stringent standards for work that involves dangerous pathogens. We also specialize in custom integration components into our Class III Cabinets including aerosol generators. Our systems include Custom Class III Biosafety Cabinets for aerosol exposure as well as Class III Animal Transfer Carts.

Integrated and ISO BioPharmaceutical Modular Labs

Germfree Integrated Modular is a highly innovative approach that provides new capabilities that meet the demands for your pharmaceutical processes, containment requirements as well as architectural standards. All technical (bio-containment) areas are fabricated at Germfree and then shipped to your site. Our engineering team concurrently works with your facility managers to coordinate a final exterior building that allows uniformity with your existing architecture. Additionally, the laboratory space is designed to easily integrate with non-technical areas, such as administrative and office areas.

Germfree Integrated Modular offers many benefits over traditional construction:

• Variety of exterior options ranging from simple exterior finishes to complete multi-functional facilities
• Designed to fully match the architectural style of your other buildings
• Manufacturing of modules is concurrent with coordinated site preparation
• Availability of containerized platforms that can be relocated for research or pharma process changes
• All lab space and integrated biosafety components are fabricated in our controlled manufacturing environment
• Dual-structures add additional layer of biosecurity
• ISO International Shipping Containers can be utilized for global delivery and installation to any area
• Mitigates disruptions typical of standard construction
• Accelerated completion and commissioning timeline
• Optimal placement of HVAC systems maximizes lab/production space

ISO International BioPharmaceutical Modular Labs

For certain regions, Germfree builds modular laboratories into specialty International ISO shipping containers. This provides the most practical solution for easy global deployment and installation of a pharmaceutical facility. We design our modular units to sustain the rigors of international transportation. They are comprehensively engineered for structural integrity, seismic and wind activity and floor loading. Germfree is uniquely qualified to deliver BSL-3 and ABSL-3 laboratories wherever they are needed.

• BioPharma Lab Modules are Configured for the Specific Demands of Your Pharmaceutical Application
• Research and production of vaccines and biologicals; high containment processes that are isolated from the cleanroom
• R&D labs for new drugs and emerging therapeutics in the pipeline
• Aerobiology research; containment up to ABSL-3 and the integration of all biological safety equipment
• Modules for product testing, QA/QC, molecular/PCR and chemistry laboratories
• Applications that require a multi-purpose, dedicated facility that has zones for cGMP-compliant cleanrooms as well as biocontainment areas