BIOCONTAINMENT APPLICATIONS

bioGO® ISO-Lab2+™

Germfree’s ISO-Lab2+™ is a new approach to rapidly bringing high-quality and cost-effective laboratory capacity to any region of the world. These turnkey units are ready for systems start-up and include all biosafety equipment and components required for an Enhanced Biological Safety Level 2 (BSL-2+) facility. Germfree manufactures and facilitates all aspects of the project — delivered, installed and made operational in a truncated timeline—while delivering interiors that are engineered to provide an ergonomic and effective work environment.

Germfree’s ISO-Lab2+™ fills a critical void in global public health as many regions lack suitable and sustainable laboratory capacity. Building new facilities can be costly and slow. Further, many projects are not built to an acceptable level of performance or do not remain operational over the long term. A key challenge is to establish labs that are feasible for any region and will remain viable for decades. Germfree’s ISO-Lab2+™ modular BSL-2+ units are part of a comprehensive solution for building permanent infrastructure anywhere in the world.

Moving Global Laboratory Capacity Forward
Germfree’s BSL-2+ Laboratories offer a safe and secure work environment that exceeds BSL-2 biological safety guidelines. Manufacturing modular units in Germfree’s controlled environment ensures quality control and proper integration of all equipment. This pre-engineered, manufactured approach allows Germfree to quickly deliver a cost-effective facility that effectively operates in virtually all climates and regional conditions.

  • Features
  • Layout
  • Application
  • Construction
  • Germfree’s ISO-Lab2+™ is a turnkey solution that includes:
  • Two Class II, Type A Biological Safety Cabinets (4-foot / 1.2m)
  • Top-load, stand-up autoclave (greater than 50L capacity)
  • Two upright laboratory refrigerators
  • Upright laboratory freezer
  • Sink with eyewash
  • Four rolling work stations with bin carts
  • Two rolling shelving and storage racks

Advanced modular construction begins with advanced engineering and materials:
Germfree utilizes high-cube, ISO containers. These specialized units are pre-insulated and serve as a strong, thermally-efficient building block that effectively maintains internal temperatures. The insulation materials are integrated during initial manufacture to eliminate particle shedding. The walls are constructed with stainless steel interiors; aluminum extrusions and sub-plates add strength to the floors. No wood products are used. These construction methods allow for secure global deployment and ensure that heavy equipment can be installed and moved without damage to the structure.

BSL-2+ Designation — Strategically Enhancing BSL-2:
BSL-2+ laboratories (also referred to as BSL-2 Enhanced) are based on progressive improvements of a standard BSL-2 facility. These enhancements are described by biological safety experts, but have not yet been iterated in the CDC Biosafety in Microbiological and Biomedical Laboratories 5th Edition (BMBL). Specifications for BSL-2 Enhanced relate to elevated practices, procedures (SOPs), safety equipment and facility engineering. Also included are core fundamentals such as inward airflow and the integration of Class II Biological Safety Cabinets. BSL-2+ facilities also require optimized decontamination, including the installation of an autoclave and rugged, sealed, chemically-resistant interiors.

ISO-Lab2+ Onsite
Optimal Design, Functionality & Workspace
Germfree’s ISO-Lab2+™ is engineered and equipped for the most effective workflow and ergonomic design. The modular unit is divided into designated work zones. Each area of the facility is outfitted and configured for easy start-up and flexibility for any application.

Reception – Sample Receiving Room:
This room serves as the main entry to the laboratory. It is equipped with a workspace for logging in samples as well as a rolling workstation. Additionally, this area is furnished with lockers and storage for shoes and personal items.

Laboratory 1 – Sample Preparation Room:
This room functions as a work zone for opening sample packages, sample accessioning, preliminary screening and preparation of materials for the Sample Analysis Laboratory (Lab 2). The proper ingress and egress of materials between Lab 1 and Lab 2 is facilitated by an integrated static pass-through box. This area has a large sink and drying rack for cleaning glassware and instruments. Additionally, an emergency eyewash and drench hose is installed.

Laboratory 2 – Sample Analysis Room:
This area is the principle work zone of the facility as it integrates a comprehensive suite of biological safety equipment and components. The room is designed for efficient workflow and allows for future upgrades of instrumentation. The Sample Analysis Lab provides ample workspace and is engineered to meet the critical demands of any BSL-2+ application.

ISO-Lab2+ Interior Rendering
Global Demands — Comprehensive Applications:
Germfree has designed and engineered the ISO-Lab2+™ to meet the demands of a wide range of applications. These modular units are utilized for research, sample analysis and other procedures in scientific fields that include Microbiology, Pathology, Histology, Hematology and Molecular Biology. They also deliver key capabilities for initiatives related to human and zoonotic diseases conducted by Ministries of Public Health and Agriculture. Additionally, Germfree’s ISO-Lab2+™ can expedite the expansion of existing facilities and provide surge capacity.

Disease Surveillance:
It is critical to have effective diagnostic and monitoring resources distributed globally to react to outbreaks of disease. This infrastructure is needed to protect public health as well as a nation’s livestock and agricultural sectors. Germfree’s ISO-Lab2+™ is ideal for regional monitoring to initiate further testing of the local population based on epidemiological investigation. Rapid sample diagnosis expedites strategies for containment and programs for treatment. Our units can play a key role as the first line of defense, acting as sentinel laboratories. In some cases, they are used for quick presumptive analysis of higher risk agents that are sent on for confirmation in another facility.

Augmenting Clinical Laboratory Capacity:
Germfree’s ISO-Lab2+™ is also an ideal turnkey solution for adding clinical operations to hospitals and public health facilities including pathology and medical diagnostics or food safety monitoring. While standard BSL-2 is sufficient for most routine practices in a clinical lab, BSL-2+ significantly expands capabilities to handle a potentially higher risk scenario.

The Rationale for BSL-2+ Containerized Modular:
Presently, there is a call for new laboratory capacity to fill current and emerging deficiencies, while there has been a proliferation of sub-par BSL facilities has deteriorated capabilities in many nations. Many governmental, research and public health institutions have aspired to construct BSL-3 labs, but the initial installation, effective ongoing operation or maintenance of BSL-3 is often not practical. This presents major challenges to the global public health community where historically cheaper basic BSL-2 facilities are not effectively equipped to safely handle emerging public health applications. With escalation to BSL-3 not viable, there has been a lack of laboratory capacity that bridges the gap between BSL-2 and BSL-3.
Germfree rigorously adheres to construction practices that maintain a sealed and seamless interior. Unlike typical modular construction, our techniques avoid penetrations to the unit. For example, all wires and cables run in surface mounted chases and raceways. Additionally, all laboratory equipment, HVAC systems and components are optimally integrated to enhance the overall performance and integrity of the structure. Germfree’s advanced manufacturing methods are a key distinction of the ISO-Lab2+™.

The interior of the facility is constructed exclusively with laboratory grade materials. These superior products are non-absorptive, chemically resistant and suitable for frequent cleaning, sanitizing and gas decontamination. Germfree uses Arcoplast® wall and ceiling panels that are installed with sealed and coved corners. We use Armstrong Medintech® vinyl monolithic flooring which is sealed and coved up the wall for spill-containment. The ISO-Lab2+™ incorporates a rugged, durable interior which allows for ease of maintenance and withstanding ongoing wear.

Traditional methods of building construction often result in projects that fail to meet project timelines, budget constraints as well as specified functionality. Modular laboratories provide an alternative approach to quickly and effectively adding capacity. However modular design and engineering standards vary dramatically. Units have typically been fabricated with improper materials that are not durable, biosafety-compatible or sustainable for long term installations. Conversely, Germfree’s modular units offer significant engineering advantages. They are manufactured in our controlled factory environment, ensuring adherence to rigorous quality standards, and minimizing construction variables due to weather, site irregularities or lack of quality construction materials. To ease of maintenance and support sustainability, Germfree utilizes highly durable, pre-insulated ISO containers, fitting them with exclusively with sealed and coved laboratory grade materials for ease of decontamination.

What to avoid when selecting a modular laboratory:
The construction of modular biological safety facilities should not include any wood products. It is also important to avoid labs that utilize drywall, epoxy paints, tile, grout as well as any spray-on insulation materials. These materials have an adverse impact on the facility and may cause issues such as ineffective decontamination, shedding of particulates and degradation of interior surfaces. Further, many commonly available modular units are constructed with sub-optimal engineering practices. For example, these fabricators do not utilize a seamless integrated design resulting in significant perforations that compromise the structure.

BIOCONTAINMENT APPLICATIONS

Germfree introduces the ISO-Lab2+™ a new approach to rapidly bringing high-quality and cost-effective laboratory capacity to any region of the world

Past Germfree Projects

Germfree consistently delivers exceptional cGMP compliant products around the globe. Browse the grid below to see a selection of relevant past projects:

Microbiome Research Modular Cleanroom
This BSL 2+ cGMP Modular Biocontainment Cleanroom Facility is made up of five (5) prefabricated modules (2,000 ft2 / 184 m2 gross area) and is housed within a renovated warehouse structure. The cleanroom is designed to comply with FDA and EU cGMP standards and utilizes a unidirectional process flow.
Alachua, FL
Mobile Viral Vector Production Facility
This Mobile BSL-3 Viral Vector Production Facility is based on quantity 2 semi-trailer chassis (840 ft2 / 79 m2 gross area) and functions as a mobile cGMP cleanroom to facilitate Viral Vector Manufacturing (VVM).
Maryland, USA
Gowning cGMP Training Trailer Facility
This Mobile cGMP Cleanroom is self-contained on semi- trailer chassis (420 ft2 / 39 m2 gross area). This facility is divided into multiple cleanrooms designed to support Gowning Training and Aseptic Qualification.
Rensselaer, NY, USA

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Easier to Operate – Lower Cost to Maintain – Local Compatibility
Germfree’s Modular Container Labs provide energy efficient HVAC and provide easy intermodal global shipping options. The BSL-2 Container Labs were developed to meet the requirements of regions with limited utilities and infrastructure. Because we understand the logistics for each country, we specialize in regionally specific compatibility of our equipment. Fit for a multitude of applications, all systems are designed for ease of local serviceability.