Modular Pharmaceutical Laboratories
Self-Contained Labs and High Containment Facilities up to BSL-3
Germfree is the leading global innovator of modular laboratories. We manufacture turnkey facilities that provide new capabilities anywhere they are needed. Our modules are an ideal option for a wide range of biophamaceutical applications. We offer units for any standard operations as well as high containment.
When lab space is required, traditional building projects can be too slow and complex. Germfree’s BioPhama Lab Modules offer many advantages as they are manufactured off-site in our controlled factory environment. This mitigates the risk of on-site construction variables and delays. Our approach results in an accelerated project timeline.
Germfree Offers a Complete Range of Laboratory and cGMP Facilities
Germfree’s BioPharma Modules provide cGMP-compliant cleanroom production space as well containment options.
For cGMP production applications, please visit our BioPharma Modules section.
BioPhama Lab Modules are utilized for any applications carried out in a conventional building. They meet or exceed the functional and structural quality of brick and mortar projects. Our integrated equipment, interior finishes and casework are engineered for both cGMP-compliance and biological safety standards.
Optimal Solutions for Production Infrastructure Challenges
Germfree is recognized as the leading innovator in modular containment with laboratories operating globally. We are the only OEM that designs, manufactures and integrates all critical primary and secondary containment systems for modular labs.
We assure that all components are integrated into your initial project design. Our line of 316L stainless steel equipment includes: RABS, pharmaceutical isolators, biological safety cabinets, unidirectional (laminar flow) clean air benches, powder containment enclosures and fume hoods.
Germfree – The Engineering Control Experts
Pharmaceutical laboratories often require a complex array of specifications and functionality. Managing the intersection of BMBL (Biosafety) and FDA cGMP standards is challenging. The foundation of any biopharma laboratory is a durable, well-designed structure with properly integrated engineering controls. It is critical that HVAC, filtration and containment systems are precisely configured. Any high containment areas must be properly calibrated and part of the overall BMS. Germfree has the expertise to meet the rigorous requirements for both biological safety and cGMP. We assure a qualifiable and commissionable facility.
Our collaborative design process results in the most effective space planning and workflow for your lab. The unit is divided into designated zones for production of biologicals and containment requirements (BSL-2, BSL-2+, BSL-3, ABSL-3). Each area is equipped with all specified components and proper functionality.
BioPharma Lab Modules are Configured for the Specific Demands of Your Pharmaceutical Application
Over Five Decades of Manufacturing Innovative Biocontainment Systems
Whether you need a chemistry lab or a high containment facility, Germfree delivers advanced capabilities. Our leading-edge fabrication technology, engineering teams and subject-matter experts are located at our 140,000 square foot (13,000 square meter) US manufacturing plant. This eliminates the need for hiring numerous architects, contractors and biosafety consultants. Germfree is the single-source solution to meet your rigorous requirements and ensure the timely qualification and commissioning of your project.
Contact Germfree to discuss your specific biopharmaceutical and laboratory applications.
- 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
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.
Integrated Air Pressure Resistant Doors compatible with BSL-3 laboratory design.
• Inflatable gasket door seal.
• Door controls; PLC
Gas and Effluent Decontamination Systems (EDS). We can provide chemical or heat-kill systems.
• Double-Door Pass-through Autoclaves
• Bulk /Large capacity, flush floor autoclaves; installation flush to the floor for alignment with roll-in autoclave carts.
Double-door HEPA-filtered Airlocks and Rapid Transfer Ports (RTPs); Through-wall Pass-through dunk tanks (also available for Class III BSC)
Draws contaminated air away from the work area for a range of pathology work in an open source area
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.
Contact our Germfree’s biosafety experts about your specific ABSL or aerobiology project.
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:
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.