BioSafe Modular Cleanrooms

Terra manufactures five distinct cleanroom designs. Each design is ideal for different user requirements, based on ISO rating and environmental controls, for medical device, semiconductor, defense, pharmaceutical, biotechnology, and aerospace applications. As a pioneer in the critical environment industry, Terra Universal has developed and manufactured innovative solutions for over 45 years. Combining high-throughput, automated fabrication equipment with a robust, active stock of raw material, Terra is capable of producing cleanrooms of any design, size, scope and complexity at industry-leading build times. In the past 6 years, we have installed 2,132 cleanrooms, based on Terra’s scope, in active operation across the globe.

Biosafety Level Cleanrooms for Infectious Disease Research and Clinical Pathology

Biosafety levels (BSLs) are a set of safety standards and practices used to manage and control infectious agents and other biological materials in cleanroom, laboratory and clinical settings. There are four primary biosafety levels, ranging from BSL-1 to BSL-4, each of which has specific safety requirements and guidelines that must be followed to protect laboratory workers, the environment, and the general public.

1. BSL-1: The lowest biosafety level applies to work with agents that are not known to cause disease in healthy humans. Examples of agents that can be handled under BSL-1 conditions include E. coli and certain strains of Staphylococcus. Laboratories that work with BSL-1 agents must have basic safety equipment, such as gloves and eye protection, and must follow standard microbiological practices, including hand washing and surface disinfection.  All sample processing must be performed in a biosafety hood.
2. BSL-2: The second lowest biosafety level applies to work with infectious agents that pose a moderate risk to laboratory workers and the general public. Examples of BSL-2 microbes include Salmonella and the hepatitis B virus. Laboratories that work with BSL-2 agents must have additional safety equipment, such as a biosafety cabinet, and must follow enhanced safety practices, such as using sharps containers and labeling hazardous materials.  All samples processing must be performed in a biosafety hood.
3. BSL-3: Biosafety level 3 applies to work with agents that can cause serious or potentially lethal disease through respiratory transmission. Examples of BSL-3 agents include tuberculosis and the SARS-CoV-2 virus. Laboratories that work with BSL-3 agents must have specialized engineering controls, such as air handling systems, and must follow strict safety practices, such as wearing full-body suits and using airtight seals on laboratory equipment.  All sample processing must be performed in a RABS biosafety isolator.
4. BSL-4: The highest biosafety level applies to work with agents that pose a severe risk to laboratory workers and the general public, and for which there are no effective treatments or vaccines. Examples of BSL-4 agents include Ebola virus and Marburg virus. Laboratories that work with BSL-4 agents must have the most stringent safety controls, including airtight laboratory suits with positive pressure, airlocks, and highly specialized ventilation systems.  All sample processing must be performed in a RABS biosafety isolator.

BSL-rated cleanrooms are designed to protect the staff, and the outside environment, from exposure to harmful agents while protecting the microbial samples from cross-contamination.  Here is a list of  design features common to BSL-rated cleanrooms.

1. Air Filtration: BSL-rated cleanrooms are equipped with HEPA or ULPA filtration on both ingress and exhaust systems.  A centralized HVAC system with separate plenums for ingress and egress air is required to remove airborne contaminants from air entering the cleanroom while preventing the release of biohazards from air exiting the cleanroom. 
2. Access Control: Access to BSL-rated cleanrooms is restricted to authorized personnel.  Access control systems, such as biometric scanners, card readers, or iris scanners are installed on all points of entry, including doors, air locks, and pass through chambers.
3. Decontamination Showers: BSL spaces are equipped with personnel air showers designed to remove biohazards from the staff before they exit the cleanrooms.  Decontamination showers include HEPA filtration in the air exhaust system, which connects to the building HVAC system for safe removal.
4. Waste Disposal: BSL-rated areas include integral waste disposal systems, for liquid and consumables, including sharps, to ensure complete sterilization before removal from the cleanroom.  Liquid waste is commonly filtered prior to safe release while consumables are autoclaved before disposal.
5. Sealed, Closed System: BSL cleanrooms must maintaining hermetically sealed, closed systems to ensure complete isolation from adjacent areas.  While spaces within the BSL area maintain positive- or negative-pressure differentials, all air exchanges will be achieved through the HVAC system.  All walls panels, ceiling tiles, flooring, doors, pass through chambers, and windows must be fully sealed to prevent air exchanges.  All filters must be leak-rated and hermetically sealed.

Terra’s Small BSL-1 and BSL-2 Design: BioSafe Modular Steel Cleanrooms

Terra’s BioSafe modular all-steel system meets BSL-1 and BSL-2 requirements for work with infectious agents.  Each wall section is composed of two panels that snap together, with space in between for utilities, insulation and HVAC connections, similar to a conventional stick-built system.  Wall sections are interlocked end-to-end to form a continuous interior surface with very fine seams that are caulked to form a complete seal.  Wall panels are fitted with flush-mounted windows, entry and exit doors, and pass through chambers.  Air exhaust vents connect to an exterior exhaust plenum that directs air to the facility air handling system.  An all-steel ceiling grid is equipped with all-steel HEPA-filtered fan units, LED lights, and steel ceiling tiles, caulked to ensure an airtight seal.

Learn More: BioSafe Modular Steel Cleanrooms

Terra’s Large BSL-1, BSL-2, BSL-3 and BSL-4 Design: Stick-Built Cleanrooms

Terra’s fully integrated stick-built cleanrooms include wall panels, framing, filtration, and air handling, with plumbing and electrical integrations.  The design includes a UL-listed integrated control system to streamline building permitting, installation and certification.  Terra provides an individualized certificate of compliance including UL listings, ISO ratings, and, if required, seismic accreditation. Terra offers a wide variety of wall panels and finishes, including epoxy-coated gypsum, FRP and uPVC.  Seamless transitions between the ceiling, walls and flooring ensure complete isolation from adjacent spaces, support VHP (Vaporized Hydrogen Peroxide) disinfection cycles.  The system includes BSL-rated features, such as access control, decontamination showers, waste disposal, and exhaust air filtration.

Learn More: Stick Built Cleanrooms

Terra’s Manufacturing Capabilities

Terra builds and installs over 500 cleanrooms per year, on average. All cleanroom components are pre-engineered, quality control tested, and stocked for quick integration and assembly. In addition to product manufacturing, Terra offers a wide range of value-add services, including white glove delivery, cleanroom installation, structural seismic analysis, expedited production, qualification documentation and extended warranties. Order-specific certificates of compliance, listing each product’s adherence to ISO, UL, OSHA and seismic standards, are supplied with every qualifying sale. The leader in critical environment solutions, Terra also manufactures laminar flow hoods, desiccator cabinets, glove box isolators, pass through chambers, and a broad array of cleanroom-compliant furniture, storage and gowning equipment. To determine the appropriate ISO rating, room design and configuration for your project; please call 714-578-6100 to consult with a Terra cleanroom professional.