Three events have come together in the past few years that codified a need for rapidly deployable, mobile and cost effective containment equipment.  First, there was recognition that many regions and countries in the world did not have adequate infrastructure, reliable power, or primary containment to provide a safe environment when working with emerging, re-emerging and dangerous infectious agents. In the US and elsewhere following the 2001 anthrax letters Public Health Labs and First Responders began experiencing an increase in their mission scope to collect, transport and perform analysis on unknown samples that may contain biological or chemical hazards. That mission had increased significantly due to copycat, hoax and criminal activity.  In the same timeframe, advances in biomedical research created a need to move samples, animals and materials from room to room, or into and out of imaging suites and equipment while maintaining containment.  In response to these needs portable Class III Biosafety Cabinets, flexible film isolators and compact, easily deployable hybrids were developed and refined.

Portable Class III Biological Safety Cabinet

SEA benchtop (Portable)

Small, bench top units were developed that provide safe, effective and affordable primary containment (i.e. SEA) enabling flexibility for laboratory use or field deployment. It was originally developed for diagnostic screening of unknown and highly pathogenic samples in facilities, laboratories or field settings that lack reliable secondary containment controls.  The closed system decreases the chance of aerosol escape, resultant accidental exposure and potential laboratory acquired illnesses.   

In animal research, portable battery powered Class III BSCs are increasingly being used to move animals from holding rooms to procedure rooms.  The supply is single HEPA filtered, the exhaust is double HEPA filtered as required by the CDC (Download BMBL 5th Ed. pdf).  By use of large RTPs integrated into transporter carts of Class III design, the walls of animal holding rooms, and stationary Class III systems, scientists can safely transport exposed animals from holding rooms to procedure areas equipped with devices such as magnetic resonance imaging (MRI), positron emission tomography (PET), and other non-invasive scanning devices. The systems reduce personnel and environmental exposure and reduce the time the animal must be handled and anesthetized.

 

Class III animal transfer with RTP dock

SEA with passthrough and legs built in

        

 

 

 

 

 

 

 

Transportable Class III BSC

All hazard reciept Transportable Class III Biological Safety Cabinet

Transportable Class III Biological Safety Cabinets are used in Public Health Laboratories for the receipt of unknown hazardous samples associated with chemical or biological terrorism or criminal activities.  Workers use the transport BSCs to move the unknown hazardous sample from the loading dock area or other delivery site used by the First Responder, to the containment lab without risking contamination of non-contained and public areas, as well as the containment lab itself.

Taken together, the advent of the use of transport and mobile Class III BSCs provides a significantly safer way of moving and handling infected animals or unknown samples than any past capability.

 

 

Flexible Film Isolator

Transportable flexible film isolator

The negative-pressure flexible-film isolator is a self-contained primary containment device that provides maximum protection against hazardous biological materials. Isolators can be placed on a counter top or on a mobile cart. The workspace is enclosed in a transparent polyvinylchloride (PVC) film that suspended from a plastic or steel framework. Like Class III BSC, the supply air passes through one HEPA filter and exhaust air passes through two HEPA  filters.

WHO recognizes the double HEPA exhaust obviates the need to duct exhaust air outside the building.  Flexible-film isolators are used frequently and very successfully in animal containment, field work and other instances where it is not feasible to install or maintain conventional BSC.  Hybrids (semi-flexible film isolators) exist where some of the panels are made of a rigid material such as polycarbonate, and typically the front panel is soft PVC.

 

 Deployable Isolators 

Field deployable flexible isolator

The deployable isolator unit is a self-contained negative pressure filtration system that operates on two standard D cell batteries.  Supply air is HEPA filtered. Exhaust air is double HEPA or double HEPA and carbon filtered. All filters are readily available and easily replaceable by First Responders and those involved in field collection and preliminary screening and triage. It is a rapidly deployable, light-weight, disposable system that comes in a compact transport case and sets up much like a dome tent. The isolator is made of durable 15mil polyurethane to withstand field use, repeated assembly/disassembly, and can be assembled and operational within minutes for on-demand use requirements.  Large samples and equipment are introduced through a zipper system similar to those on a BSL-4 suit.  Sampling ports are provided for use with external detectors and analytical equipment.         

The diversity in containment equipment is almost limitless and depends on user requirements and design team innovation and advances in materials. 

 

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I was at a meeting recently when someone asked, ‘What are mobile and modular BSL-3 labs and when should they be used?”  It is a good question that comes up often.   Deciding  which platform is the best choice depends on the institute mission, size requirements and in the case of mobile labs, the local road conditions.   For example, if the roads are narrow and turns are very tight, a 12.5 meter long truck lab may not be able to navigate the roads, while a Sprinter van would have no problem.

Mobile Labs: Trucks, Sprinter Vans, Trailers

Mobile labs are those labs which can be moved from place to place easily and often by their own power.  They include platforms built into 12 meter long trucks, 4 meter Sprinter vans, and trailers of various sizes (i.e. 6, 7,12 meters).

Rapid Sample Triage and Screening

They are rapidly deployable and often used in incident investigation (i.e. suspicious materials), military and civil preparedness applications (NBC sampling and analysis at high level events), surge capacity at different locations, and in support of testing during natural disease outbreaks.  They are designed to provide on-the-spot rapid sample triage and screening, and presumptive diagnostic capability to assist in prioritizing samples being sent to national reference labs.  
Mobile labs were initially developed in 1986. It wasn’t until the late 1990’s with the advent of decreased size and ease of portability of analytical equipment and prepackaged reagents, and the availability of igh speed communications technology that these labs became increasingly popular.

Hazmat trailer lab interior

They are rapidly available from time of order to time of delivery, and can be cost effective.  Mobile labs are not however meant to be a substitute for fixed labs, rather they augment the mission and provide a capability not possible with a fixed asset.  The advantages and disadvantages various platforms such as trucks, vans, trailers and containers on flatbeds will be discussed in a later blog.

Truck lab with slide out

Modular labs are constructed using containers that are retrofit and finished at the factory then shipped to a location where they are permanently installed.  The containers are fabricated to be strong and durable enough to withstand handling and stacking during shipping while acting as a protective enclosure to the valuable cargo they contain.  Containers come in a variety of sizes and while one container can be turned into a lab, it is not uncommon in the US and overseas to use multiple containers to build a versatile suite of labs with support and change areas, animal housing and a separate mechanical space.  Connecting 3 containers provides a space that is approximately 7.3 meters wide and 12.2 meters long. 

 

Truck lab interior

Once they are installed onsite they become fixed labs and do not move.  These labs are used for teaching, research, public health and as diagnostic reference labs.  

Modular containment labs have become increasing popular over the past 10-15 years.  They do not require the same process for construction approval as ‘stick-built’ labs and are an increasingly attractive solution to providing additional facility space and new technology capability to existing buildings.

  

 

 

 

Truck lab interior 2

Modular labs are designed and assembled by organizations with expertise in biocontainment, making them a sensible solution to providing turn-key containment capability in countries where resident expertise is not yet available or is nascent and would benefit from partnering with experienced entities. 

  

  

  

 

   

 

Modular Laboratories: Rapidly Available | Easily Shipped

They also are rapidly available from time of order to time of delivery (compared to ‘stick built labs’, the container itself is of low relative cost and can house a lab that is custom designed with ample space, and is easily shipped nationally and internationally.

Modular Container - just delivered

Modular container lab interior rm 1

Modular lab interior- rm 2

Sprinter van lab

Sprinter lab interior

   

Changes in Class III Biological Safety Cabinets:

Primary Containment and User Comfort

In the 1950’s when Class III BSC became widely used in the nuclear and defense departments the primary focus for design was on absolute containment, with little attention given to ergonomic/user comfort.  Class II BSC became popular in the 1970’s and provided the user with an alternate means of primary containment.  While Class II BSC do not provide the same level of user and environmental protection, based on a risk assessment they do have a rightful and very useful place in the biocontainment laboratory.  In recent years with increasing work conducted at BSL-4 and the advent of samples containing mixed hazards or biological powders, there has been a significant resurgence in the use of Class III BSC in research, public health labs and with emergency responders.  It was time for the Class III BSC to be improved upon and redesigned for diverse missions.

What has changed for Class III Biosafety Cabinets?

Lessons learned from Class II BSC & Biocontainment Lab Design

Lessons have been learned and applied regarding enhancements to ergonomics.  Some have been taken from the design of Class II BSC such as use of:

• 10 degree tilt view panel to allow the user to lean into the screen for comfort and to reduce glare
• adjustable deck height to provide more/user required leg room and accommodate work in a seated position
• control panels that are positioned so they can be observed easily by the operator

Other innovations were developed to increase user range of motion and decrease fatigue, to include:

• extra large, oval shaped gloveports to allow for natural arm positioning and extended reach
• a wide rimmed gloveport to enable the user to rest their arms
• the use of motion studies to determine the best locations for gloveports and to better size the work area (after all, what is the benefit of having a 33 inch (0.9 meter) deep BSC if you can not reach the back wall for manipulations or cleaning).

Other improvements were made when considering how containment labs are designed.  Class II Biological Safety Cabinets really have not changed much in 30 years and still have right angles where the walls, deck, back panel and ceiling meet.  This can pose a challenge when wiping down surfaces during decontamination.  Per the CDC/NIH BMBL, WHO and Canadian Biosafety Guidelines, modern labs are constructed with coved or radiused joints to facilitate cleaning and prevent material from being trapped in 90 degree joints.  Rounded joints were easily incorporated into new Class III BSC designs.  Again, as in lab design, pass through boxes have been developed for BSC with interlocks and alarms to facilitate material transfer and prevent a accidental breach of containment. 

Interestingly the flow of design information is now going from Class III BSC to applications in the laboratory…namely the use of Rapid Transfer Port embeds into laboratory walls.  These mate with mobile Class III Biological Safety Cabinets to facilitate the transfer of animals from the BSC to the holding room.

Prospective improvements have few limits as most Class III BSC are custom designed…the next advances will likely combine user requirements and ingenuity and manufacturer problem solving and design expertise.

References

Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition  (Download PDF)

 Public Health Agency of Canada’s Laboratory Biosafety Guidelines (Download PDF)

World Health Organization Biosafety Manual (Download PDF)

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