Biological Safety Level (BSL) is a biocontainment designation system with requirements intended to protect personnel from potentially harmful pathogenic exposure in a research or manufacturing environment.
What are the differences among the BSL designations?
The Centers for Disease Control (CDC) specifies four broad Biological Safety Levels, each of which corresponds to a level of exposure danger and a set of design features and operational protocol. Each increasing level builds on the previous level(s):
BSL-1: Required in the presence of microbes that do not consistently cause disease, such as E. coli. Work can be done on an open bench, and minimal Personnel Protective Equipment (PPE) is required. Doors separate the BSL-1 lab from the rest of the facility.
BSL-2: Required in the presence of moderately hazardous microbes, such as Staphylococcus aureus. The lab is restricted behind self-closing doors. Personnel wear minimal PPE plus face shields; many operations are performed within biological safety cabinets (BSCs – see explanation below). Negative-pressure containment is generally advised, and exhausted air may require filtration.
BSL-3: Required in the presence of potentially lethal, often “exotic” airborne microbes, such as tuberculosis. The lab is restricted behind two sets of doors. Workers may require immunizations, and PPE plus respirators are advised. All work is performed within a BSC. Filtered room air must be exhausted.
BSL-4: Required in the presence of high risk of airborne transmission; infections are frequently fatal, as from Ebola. Decontaminate all material before exiting lab; shower after exiting. Full body, positive-pressure cleanroom suit. All work performed in Class III BSC. Lab is in a separate building.
All BSL facilities require that personnel follow “standard microbial practices”: no food or drink; no cosmetics; hands and gloves are frequently washed and surfaces routinely decontaminated. Sterilization and entry/exit protocol vary by BSL level.
How do BSL designations correlate to cleanroom levels (e.g, ISO 5 or ISO 6)?
There is no necessary correlation between a BSL and an ISO cleanliness level since they correspond to two different sets of concerns: protection of personnel and the environment from biological exposure vs. protection of a sensitive sample from contaminant exposure.
Any BSL environment can require any ISO cleanliness standard, depending on the sensitivity of the process to airborne particulates (including aerosols and germs). BSL applications that involve storage or handling of packaged pathogens may tolerate a relatively “dirty” environment, such as ISO 8, whereas processing unpackaged pathogens susceptible to contamination by airborne particles might require an ISO 5 environment.
As a practical concern, the most challenging applications involve hazardous microbes (BSL-2 or higher) that are also highly sensitive to particulate contamination (requiring ISO 5 or cleaner). These situations require a high volume of micro-filtered air passing through the enclosure to guarantee cleanliness, and therefore also a high volume of exhausted air to ensure negative-pressure containment. Such systems typically incorporate high-capacity exhaust fans and ductwork, often with system redundancy, and sophisticated airflow monitoring systems.
Can Terra Provide a BSL Cleanroom?
Yes, but it depends on your specific application. Modular cleanrooms are rarely appropriate for BSL-3 and BSL-4 applications, which typically require sophisticated facility integration involving air handling systems and environmental monitoring equipment.
Terra provides BSL-2 modular cleanrooms, but how a given BSL specification affects cleanroom design and construction is not always clear. Some operations that fall under BSL-2 may require single-pass air that is filtered before being exhausted to the outside; others may allow recirculation of air and release of unfiltered exhaust air.
For this reason, Terra requests that any BSL application receive careful review by the appropriate process validation expert, who can translate the process and BSL requirement into specific environmental design specifications involving ISO cleanliness level, pressure levels, air change rates, air circulation, and exhaust air treatment, among other factors.
Once these issues are clear, Terra can propose the most economical way to address your BSL application.
Terra's modular designs allow versatile configurations using standard components, whether you need a small equipment enclosure or a multi-suite processing facility
Versatile plug-and-play Power Distribution Modules allow addition of ceiling fan/filter units and lights to meet any cleanliness requirement or to upgrade ISO levels or lighting levels after installation
Modular frame and panel designs, in several application-specific materials, adapt to any floor plan requirement
Automated fan controls simplify pressure balancing, Building Management System (BMS) integration, and certification of large, multi-suite facilities
Stand-alone A/C modules or integration with existing air handling system
Consultation services available to meet industry-specific regulations, such as USP 797/800 compounding requirements
Terra’s full engineering services adapt designs to accommodate unique equipment or facility integration challenges
Call or submit a QuickQuote Form for assistance with a modular cleanroom tailor-made to your application!
4,000 Worldwide Cleanrooms
Since 1976, Terra has designed and manufactured over 4,000 cleanrooms for companies at the leading edge of high technology
High-Throughput Cleanroom Manufacturing
Over the past 5 years, Terra has manufactured nearly 1,500 UL-approved cleanrooms at industry-leading build times. Terra’s versatile modular cleanroom frame and panel designs adapt to any floor plan requirement. The UL-rated and scalable plug-and-play power distribution system further simplifies installment of FFU's and lights to cleanrooms of any size.
BioSafe: Pre-Fabricated Cleanroom Parts
How can Terra offer industry-leading lead times and pricing? Our advanced cleanroom design doesn’t require factory pre-assembly; each components fits together perfectly, ensuring seamless on-site installation
Double-pane, frameless windows mount flush with no external hardware, for smooth easy to clean surface.
Explosion-Proof HEPA Fan and Filter Unit
Explosion-proof ULPA fan/filter unit features sealed or non-sparking components, including motor, all-potted conduit and grounded filter screens that meet NEC requirements for Class I, Division 1 hazardous locations.
Smooth Interior Walls
Smooth steel BioSafe cleanroom panels with radius corners simplify cleaning and stand up to biocides and disinfectants. Cleanrooms constructed with medical-grade and USP-compliant material.
Negative-pressure containment cleanrooms include exhaust plenums that route air to floor- or ceiling-mount fans, protecting the external environment from hazardous materials inside the cleanroom.
Available Environmental Control System
Standard cleanroom comes with analog pressure gauge and on/off controls; optional touchscreen FFU controller monitors, controls and logs internal pressure, as well as displaying temperature and RH.
Biosafe Cleanroom Hands-Free Sink
Hands-free sink and hand dryer, seen in cleanroom anteroom, boost compliance with hand-washing protocol.
BioSafe Cleanroom Sterilization
Ceiling panel covers allow wash-down and sterilization of cleanroom walls and ceilings without damage to filter medium; requires BioSafe glass or stainless steel wall panels, which stand up to biocides.
Compatible with Terra’s Pass-throughs
BioSafe cleanrooms can be specified with pre-cut openings for Terra pass-through chambers. The tempered glass version of the BioSafe cleanroom uses a special mounting kit to achieve a “floating” effect on smaller pass-throughs (shown).
BioSafe Cleanroom eliminates internal cracks
FRP or C-PVC cleanroom panels with seam seals eliminate cracks for easy disinfection. Construciton material won't produce contaminants that affect cleanliness rating.
BioSafe Cleanroom Configured for Powder Containment
Terra's Powder Containment Room features smooth interior steel BioSafe panels with radius corners for easy cleaning; optional CleanZone filtration system removes particles from work area.
Germicidal UV Lamp Sanitizes Labs, Cleanrooms
UV-C Germicidal Lamp installs on a cleanroom ceiling grid for line-of-sight room disinfection; safety occupancy sensor prevents personnel exposure.
Custom Work is Standard!
Modular designs allow versatile configurations tailored to your requirements. Terra's design and fabrication capabilities accommodate unique facility challenges.
COVID-19 Isolation Room
Terra’s modular negative pressure isolation rooms, built to your specs, support patient infection control, home isolation and package quarantine
Seismic Safe Cleanroom Design
Terra’s modular cleanrooms are designed with seismic safety in mind. Rigid steel frames and ceiling grids are designed with sufficient factors of safety to provide vertical and lateral strength recommended by professional engineers. Both hardwall and softwall designs can be installed to adhere to local seismic codes. Optional seismic and structural calculations can be drafted and stamped by a licensed PE to help meet municipal permitting requirements.
BioSafe Modular Cleanrooms
Double-Sided Tempered Glass Windows for BioSafe Steel Cleanroom
Modular BioSafe® Cleanroom Installation
Modular BioSafe® Hardwall Cleanroom
BioSafe Stainless Steel Cleanroom – Integrated Air Shower
BioSafe Stainless Steel Cleanroom Corridor with Custom Intercom
Stainless Steel BioSafe Cleanroom with Cart Pass-through
Terra Universal IQ-OQ Process
Attractive frameless windows clean easily and add visibility to BioSafe® cleanrooms. | 6603-15 displayedDouble-Sided Tempered Glass Windows for BioSafe Steel CleanroomBioSafe® modular steel cleanrooms are available with dual-sided, flush-mount tempered glass viewing windows.
Video demonstration of BioSafe® Cleanroom factory pre-installationModular BioSafe® Cleanroom InstallationTime-lapse installation of a modular BioSafe® steel cleanroom with windows, an exit swing door, entryway airshower and 50% ceiling coverage of fan/filter units.
Video overview of Terra's BioSafe® Biopharmaceutical Modular CleanroomModular BioSafe® Hardwall CleanroomVideo demonstrates why BioSafe® Modular Cleanrooms are ideal for bio/pharmaceutical applications requiring frequent cleaning and sterilization. Includes overview of accessory equipment.
This stainless steel BioSafe cleanroom features an integrated air shower and pass-through chamber to minimize the inflow | 6600-31 displayedBioSafe Stainless Steel Cleanroom – Integrated Air ShowerThis stainless steel BioSafe cleanroom features an integrated air shower and pass-through chamber to minimize the inflow of contaminants.
ISO 5 BioSafe modular cleanroom include double-wall panels that create smooth, easy-clean surfaces | 6600-30 displayedISO 5 BioSafe Cleanroom; Powder-Coated SteelBioSafe modular cleanroom include double-wall panels that create smooth, easy-clean surfaces; add Fan/Filter Units to meet ISO 5 - 8 particle requirements (shown with optional stainless steel pass-throughs).
ISO-rated double-wall powder-coated BioSafe® cleanroom with multiple suitesBioSafe Powder-Coated Steel Cleanroom Multi-Room ConfigurationDouble-wall powder-coated BioSafe® cleanroom with multiple internal ISO 5 and ISO 6 processing suites.
BioSafe® cleanroom with exhaust plenum and ventilation systemBioSafe Containment CleanroomsBioSafe® cleanroom with exhaust plenum and ventilation system creates negative internal pressure for biohazard containment (shown with A/C units).
Air plenums can be added to all-steel BioSafe cleanrooms and ducted directly back into the fan/filter units (shown with integrated air conditioning unit)All-Steel BioSafe Cleanrooms Air ReturnExternal air plenums can be added to all-steel BioSafe cleanrooms and ducted directly back into the fan/filter units (shown with integrated air conditioning unit).
All-steel BioSafe cleanrooms withstand heavy use in high-volume facilities, combining durability with resistance to cleaning agentsBioSafe Stainless Steel Cleanroom Gowning AreaAll-steel BioSafe cleanrooms withstand heavy use in high-volume facilities, combining durability with resistance to cleaning agents. Stainless steel construction resists disinfectants, won't produce contaminants during sterilization.
The double-wall design of the all-steel BioSafe cleanroom allows flush-mounting of optional components (such as control panels) for easy cleaningBioSafe Stainless Steel Cleanroom Corridor with Custom IntercomThe double-wall design of the all-steel BioSafe cleanroom allows flush-mounting of optional components (such as control panels) for easy cleaning. Stainless steel wall panels resist corrosion and degradation.
BioSafe Cleanrooms are available with pass-through chambers for transferring parts and supplies, even carts and large equipmentStainless Steel BioSafe Cleanroom with Cart Pass-throughBioSafe Cleanrooms are available with pass-through chambers for transferring parts and supplies, even carts and large equipment.
This video describes the IQ/OQ process for Equipment and CleanroomsTerra Universal IQ-OQ ProcessThis video describes the IQ/OQ process for Equipment and Cleanrooms
Engineered for ease of installation and cleaning, BioSafe Cleanroom wall panels come in standard 4-foot widths and heights ranging from 7 to 12 feet. Their modular design lets you configure a custom cleanroom using pre-engineered components, many of which are inventoried at Terra’s Fullerton, California manufacturing facility.
Terra technicians assemble and test each BioSafe Cleanroom to ensure it meets performance requirements prior to packaging. Panels and other components are labeled before crating to simplify installation, which typically requires no special contracting or permitting (on-site installation and testing services are available). Whether your requirements call for a single room or a multi-suite facility, your BioSafe Cleanroom is operational in a fraction of the time and at a fraction of the cost associated with conventional cleanrooms.
Each wall section is composed of two panels that snap together, with space in between for insulation or utilities, similar to a conventional wall. Wall sections are bolted end-to-end to form a continuous interior wall surface with very fine seams that can be caulked if necessary. Wall panels can be fitted with flush-mounted BioSafe windows or any of Terra’s cleanroom door designs. Certain panels will include the required exhaust vents; customers can specify the addition of an exterior exhaust plenum that covers these vents and directs exhaust airflow to an external air handling system. Air return plenums may also be used to recirculate conditioned air to maintain suitable working temperatures and save energy.
BioSafe wall panels function equally well as exterior and interior cleanroom walls, which simplifies engineering of multi-room facilities. Corridors and anterooms can be added where necessary by regulation or to provide additional barriers against cross-contamination. These intermediate spaces help to maintain proper air pressure by providing neutral buffer spaces. They also may serve as convenient staging areas for supplies and other materials. Pass-through chambers can also be used for more staging and transfer, as well as simply limiting the number of personnel in a critical area.
The modular ceiling grid can be configured for different ISO-classifications through appropriate placement of fan/filter units. FFUs can be positioned (and repositioned) in the ceiling grid to concentrate clean air in the most critical processing areas. Rooms with less critical cleanliness requirements may operate with fewer FFUs, reducing energy and maintenance expenses. For example, a gowning room may only need one FFU to ensure a slight overpressure that limits leakage.
As FFU configurations become more complex, Terra can provide more advanced control systems, from PLC touchscreen controllers to fully automated air balancing systems. In addition, security measures can be integrated into the various access points of the cleanroom, including biometric scanning equipment and access logs.
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