How to set up a biosafety level 4 laboratory: A step-by-step guide
From the Ebola and Marburg viruses to the Nipah and the Crimean-Congo Haemorrhagic Fever (CCHF) causing ones, many pathogens share a combination of factors. They’re extremely virulent, especially because of their potential for airborne spread. The lack of effective treatments and vaccines makes them notorious for their high mortality rates. They’re among the most lethal pathogens in the world, and handling them requires very stringently controlled spaces.
That’s where biosafety level 4 laboratories come into the picture. They give scientists the strict safety conditions needed to study these pathogens, develop diagnostics, therapies and vaccines, and contribute to prevention and preparedness efforts for global health.
Every biosafety level 4 laboratory plays a crucial role in the global fight against existing, emerging, and re-emerging infectious disease threats. They are a key tool in advancing science and innovation (particularly in the fields of microbiology and biomedicine), ensuring public health preparedness, and preventing global pandemics.
Given the evolving epidemiological landscape, especially with climate change and increasing urbanisation, the demand for biosafety level 4 labs (or BSL 4 labs) will only increase. So, if you’ve been planning to set one up, there’s no time like the present to reach out to biosafety level 4 lab manufacturers to get started.
Before you do, though, you should know the basics. The what, why, and how of setting up a biosafety level 4 lab so that you make an informed decision. Setting up such a stringently controlled facility isn’t, after all, as simple as it would ideally be. It requires rigorous planning while selecting its location, deciding its layout, installing equipment and utility distribution, and beyond.
This set of blog posts is your go-to guide on all the basics of BSL 4 labs. Let’s start at the very beginning.
What are biosafety levels?
Biosafety levels (BSLs, for short) are standardised classifications designed for the safe handling of infectious agents under controlled laboratory conditions.
Ranging from 1 to 4, each level requires a specific degree of contamination control and containment. These range from basic precautions in BSL 1 labs (for more or less harmless microorganisms) to extremely stringent safeguards in BSL 4 labs (for lethal pathogens).
Compliance with a BSL level and all the protocols that go along with it is essential not only from a regulatory perspective but also to ensure the safety of your personnel, the public, and the larger environment.
Let’s explore the specifics of each of the levels so that you can decide what level of biosafety you really need.
BSL-1. Biosafety level 1 is the entry-level tier to the BSL criteria. BSL 1 labs are ideal for studying microorganisms that pose little to no disease risk to the average healthy adult. If you own or operate a BSL level 1 lab, you need only worry about standard microbiological practices. Think overall cleanliness, basic hand hygiene, and simple training for facility personnel. BSL 1 laboratories are particularly well-suited to educational settings.
BSL-2. One level above BSL 1, BSL 2 facilities take containment a step further, dealing with pathogens that are capable of causing mild to moderate illness. Protocols are certainly more strict than they are in BSL level 1 labs: you need biosafety cabinets (BSCs) for some procedures, immunised staff, tighter access controls, and training for researchers and other personnel to ensure careful pathogen handling and prevent accidental exposure and/or infections.
BSL-3. BSL level 3 labs are designed to safely work with infectious microorganisms that have the potential to cause severe, possibly even fatal, disease. These microbes often also have the potential for airborne transmission, so BSL level 3 labs are designed to prevent any leaks via air flow. So containment measures in BSL 3 labs include sealed rooms maintained under negative pressure, specialised equipment, rigorous training for personnel, and strict protocols.
BSL-4. Finally comes BSL 4, the biosafety level that we’re concerned with in this blog post. The highest of all the biosafety levels, it is reserved for the most dangerous pathogens we know. It is often also used to study microbes that we don’t know much about, but could potentially be very dangerous. The microbes studied in a BSL 4 lab typically have no available vaccines or treatments. Exposure to them poses a very high risk of life-threatening illness. So the build and protocols of BSL 4 labs are designed to ensure protection from exposure; think full-body, positive pressure suits for researchers, isolated facilities with multiple barriers, and strict operational, waste disposal, and maintenance protocols to eliminate the risk of the release of these dangerous pathogens into the environment.
Biosafety level 4 labs: The pinnacle of contamination control
Your biosafety level 4 laboratory must represent the highest possible lab safety standards. Reserved for working with some of the most dangerous pathogens we know and don’t yet know of, BSL 4 labs are where scientists can carry out research and diagnosis under rigorous controls that minimise the risk of infection and outbreaks.
If you’re setting up a BSL 4 lab, here are some of the defining characteristics of this safety level that you should be familiar with:
For starters, a biosafety level 4 laboratory calls for complete physical isolation from the rest of your facility. This fully isolated unit will require specialised architectural design elements, including airlocks, double-door entry systems, sealed interiors and beyond.
The staff in this controlled environment must wear full-body positive-pressure suits that supply the individual with HEPA-filtered air. This personal protective equipment or gear is far superior in quality and safety compared to what is worn in lower biosafety level labs.
When it comes to the facility’s air supply, HVAC and air systems should be designed to maintain negative air pressure so that even if a door, window or any entry point is compromised, air flows into the lab rather than out of it. As for exit points for air, they ensure that outflow goes through multiple HEPA filters so that there is no danger posed to the external environment.
When it comes to operating protocols, the most important part of a biosafety level 4 lab is strict access control. Entry must be limited to only authorised personnel who have undergone extensive training in safety and emergency response. Equipment and materials entering or leaving the lab are also subject to strict protocol, requiring sterilisation or disinfection. Autoclaves or chemical treatments are used to treat waste before disposal.
These features ensure that the BSL 4 lab serves as an adequately secure environment for scientists to investigate pathogens of global health concern. But they’re only part of the picture. In part 2 of this blog post, we’ll take a step-by-step approach to how you can go about setting one up. From discussing facility design with a biosafety level 4 lab manufacturer and personnel training to equipment, lab facilities, documentation and more, we’ll discuss it all.
Whether you’re working with a highly dangerous pathogen or a related pathogen with unknown risk of transmission, it’s essential for you to invest in a biosafety level 4 laboratory. From the features we’ve discussed in part 1 of this article, you know that this is far from child’s play. But it shouldn’t be.
Considering the threats we currently face: a rapidly evolving disease landscape, threats of biowarfare, and the need for a better understanding of existing diseases, it’s crucial to invest in sufficient biosafety level 4 labs to meet global demand.
This is not child’s play, but it should be, especially in resource-scarce settings that often bear the brunt of the climate crisis, disease outbreaks, and poor investment in public health facilities. Something has to change, and prefabricated BSL 4 labs can be the answer.
Whether they’re prefabricated or not, BSL 4 labs usually come in one of two types of models: they may be either cabinet laboratories or suit laboratories. The former refers to a BSL 4 lab in which agents are manipulated in a Class III biosafety container (BSC). The latter involves personnel wearing positive-pressure supplied-air protective suits. Both these types of biosafety level 4 labs have special design and engineering features to prevent leaks from the lab into the environment.
Let’s begin by exploring facility design; your biosafety level 4 lab manufacturer will have a critical role to play in your entire process of setting up, but especially so in this step.
Facility design: Working with a biosafety level 4 lab manufacturer for facility design and engineering
When it comes to designing and building the structure of your BSL 4 lab, the layout and engineering of the space are critical to ensuring effective contamination control. BSL 4 labs are characterised by structural isolation, advanced air handling, secure entry protocols, robust decontamination, and backup safety measures.
As we’ve mentioned earlier, structural isolation refers to reinforced walls, airtight rooms, and airlocks that prevent pathogen leaks.
Advanced air handling refers to specialised ventilation systems that maintain a negative air pressure gradient, ensuring that potentially contaminated air doesn’t leave the facility. When air is removed from the space, it must go through HEPA filters that trap infectious particles and prevent environmental contamination.
Secure entry protocols include restricting access only to trained personnel. But from a facility design perspective, it also includes the presence of gowning areas, decontamination showers, and multiple door interlocks before anyone can enter the contained lab space.
Decontamination systems in BSL 4 labs must ensure that equipment, all surfaces, and even waste undergo sterilisation to prevent the spread of contaminants.
Finally, backup safety features include emergency ventilation shut-offs, power redundancies, and integrated alarm systems that add an extra layer of safety and protection in case of any potential breach.
BSL 4 lab equipment: Primary barriers and personal protective equipment (PPE) in cabinet-type BSL 4 labs
All procedures in a BSL 4 laboratory which involve the manipulation of infectious materials must be carried out within Class III BSCs. These BSCs themselves should be in containment, away from the surrounding laboratory.
When working with your biosafety level 4 lab manufacturer, make sure that the Class III BSC(s) you get contain a double-door, pass-through autoclave to decontaminate materials passing out of them. The doors of the autoclave must be interlocked so that only one door can be opened at a time. Moreover, the doors should be automatically operated to minimise human errors during decontamination cycles.
Your BSC should also have a pass-through dunk tank, fumigation chamber, or other equivalent method of decontamination for equipment and materials that cannot be decontaminated in the autoclave for whatever reason.
HEPA filters are also key to the successful use of biosafety containers. You ideally need one HEP filter on the supply air intake side, and at least two in series on the unit’s exhaust outlet. Air should be supplied to the container in a manner that prevents positive pressurisation. Gas-tight dampers on the supply and exhaust ducts must be in place for gas or vapour decontamination of the cabinet. And there should be ports for the injection of test medium on all HEPA filter housings.
As with the interiors of all controlled environments, all surfaces in your BSL 4 lab should have smooth finishes. This not only minimises the collection of dust and other contaminants, but it also reduces the chance that your staff’s gloves or PPE may tear and expose them to dangerous pathogens.
Secondary barriers in your BSL 4 lab
Considering the dangerous pathogens you’ll be working with in your BSL 4 lab, compliance with this biosafety level requires not just primary but also secondary barriers.
As you set up your biosafety level 4 laboratory, ensure that it is located in a separate building or clearly isolated and demarcated zone. The exit from this space should be only through a sequential passage that includes a changing area, a shower area, and an outer change room.
You must also ensure the installation of secondary safeguards like an automatically activated emergency power source for lighting, alarms, exhaust, BSCs, and entry and exit controls. You must have a hands-free sink, an eyewash station, and sufficient illumination which doesn’t impede vision with reflections or glare.
A sealed internal shell, minimal furniture, and break-resistant windows are simple but essential parts of contamination control.
Documentation and communications systems in BSL 4 labs
You must document the design parameters and operational procedures of your BSL 4 lab.. The facility must be tested to verify that it meets design and operational parameters before you begin operations. The documentation process also involves annual re-testing or testing after major modifications.
As for communication systems, your BSL 4 lab should be appropriately connected to the outside world via video, voice, computer, fax, or any other appropriate systems. These are essential for emergency communication, including emergency access or exit.
Personnel training: The key to operational safety in BSL 4 labs
While facility design, equipment and appropriate documentation are key to ensuring safety in a contained environment, personnel training makes all the difference between safety and risk during operations.
If you’re setting up a biosafety level 4 lab, you must ensure that your personnel are appropriately trained in multiple areas: the fundamentals of containment, aseptic techniques, lab workflows, operating the particular equipment that you have, the nature of the microorganisms being studied, and beyond.
Personnel training isn’t a one-time affair; it is an ongoing activity in which you must impart practical skills relevant to your facility, ensuring continuing education and assessments to keep up with evolving research and industry practices.
PodTech™: Your partner in setting up a biosafety level 4 laboratory
Setting up a BSL 4 laboratory is no piece of cake. It involves multiple experts, rigorous planning, and complex regulatory procedures. The complexities of traditional construction add to your inconveniences.
That’s where we, as providers of prefab modular biosafety labs, come in. We have the expertise and manufacturing infrastructure to create the BSL 4 lab you need, wherever in the world you need it.
Get in touch with us today to discuss how we can help you in your journey of setting up a BSL 4 lab.