How to choose the best BSL 3 labs for your facility

Biosafety isn’t bought. It is earned through good design, strict protocols, and constant vigilance.

That’s why the best BSL 3 labs aren’t just chosen from a BSL 3 lab manufacturer. Establishing and maintaining compliance with a biosafety level is an ongoing process rather than a one-and-done event.

Through this process, you want not just a good, high-quality design but also a BSL 3 lab manufacturer who works with you to deliver the best results for you and your customers. Not just till he makes a sale, but through the lifecycle of your laboratory.

So, how do you set up the best BSL 3 labs? That’s the question we’re here to answer today. We’ll kick things off with a brief overview of what biosafety means, the different biosafety levels out there, and all the design, equipment, and personnel requirements that make or break a BSL 3 lab facility.

Let’s get started.

 

What is a BSL 3 laboratory? An introduction to biosafety levels and biosafety level 3 laboratories.

We must begin with one of the most fundamental questions when it comes to BSLs: what is biosafety?

Say, you’re a scientist or technician working in a laboratory with a relatively unknown, potentially harmful microbe. You absolutely must take adequate precautions to ensure that you and others don’t get infected. To meet this standard, you would have to address some important questions: where should I work with this microbe? What safety precautions can I use? What if there is an accidental leak? What skills must I have? What protocols are non-negotiable for me to follow?

Addressing these concerns amounts to biosafety. Biosafety is the application of safety precautions that minimise the risk – to the lab personnel, the environment, and the larger community – of exposure to a potentially infectious microbe. It encompasses the design features, protocols, and training requirements that limit contamination of the laboratory space, the wider environment, and the people inhabiting that wider environment.

 

Biosafety levels.

There are four biosafety levels, with each level outlining specific controls to contain biological agents that may cause infections.

The biosafety levels have been designed keeping in mind the primary risks involved in working with different types of microorganisms: infectivity, disease severity, transmissibility, and the nature of the research work being carried out. As per the classification standards outlined by the United States Centers for Disease Control and Prevention (the US CDC), the biosafety levels also take into consideration the biological agent in question, its origin, and the route of exposure.

Ranging from biosafety level (BSL) 1 to BSL 4, with 4 being the strictest, each biosafety level builds on the controls of the level that comes before it. These containment controls cover lab practices, safety equipment, and facility construction. Besides, regardless of its assigned biosafety level, each microbiology lab follows standard microbiological practices.

A basic lab working with non-lethal agents that don’t pose a major threat to lab personnel or the environment would be designated a BSL 1 lab.

On the other end of the spectrum, a lab specialising in studying, say, Ebola, or any other potentially lethal infectious agent would be designated BSL 4. Accordingly, a BSL 4 lab would have the highest, most stringent protocols for operations and maintenance.

To determine the biohazard level and the corresponding required biosafety level, the US CDC recommends that you perform a biological risk assessment. Such an assessment would involve three distinct steps.

First, you must identify the agent’s hazardous characteristics. This includes the agent’s disease-causing ability, its severity, its transmission routes, how much of it is needed to result in an infection i.e. infectious dose, its stability, and its host range.

Next, you must determine the risks presented while working with it. This includes the risks associated with handling techniques, equipment use, aerosol routes, and exposure routes like inhalation, ingestion, skin contact, and needle sticks.

Finally, with this information, you can proceed to determine the appropriate biosafety level, keeping in mind the appropriate safety precautions, regulatory requirements, and facility safeguards. This isn’t something to worry about; it’s a determination that’s typically made by a qualified group including a principal investigator, institutional biosafety professionals, and biosafety committees.

The assigned biosafety level dictates the kinds of work practices that you are permitted to carry out in your facility. But before that, it influences the entire design, construction, and equipment requirements of your facility.

 

Biosafety level 3 laboratories.

Now, let’s look specifically at biosafety level 3 laboratories.

BSL 3 labs are used to conduct research into biological agents associated with serious or lethal human disease, generally for which there is no preventative or therapeutic treatment available yet. These microbes could be indigenous or exotic; regardless, they have the potential to cause lethal diseases, particularly through respiratory transmission, i.e. through inhalation. Mycobacterium tuberculosis, the bacteria that causes tuberculosis, is a commonly known pathogen that is generally studied in BSL 3 laboratories.

Biosafety level 3 labs are designed to protect people and the environment using both administrative and engineering controls. For instance, access to these labs is strictly controlled. Any waste generated from a BSL 3 lab is sterilized before it is disposed of. Personnel working in the controlled space undergo rigorous training to guarantee that they’re knowledgeable and capable in all the procedures involved in safely handling the biological agent and managing the space.

Moreover, lab personnel are kept under medical surveillance for infection from the microbes they work with. They are required to wear appropriate PPE and sometimes even respirators. Biosafety cabinets (more on this later) are a mainstay of BSL 3 laboratories. As are hands-free sinks, controlled directional airflow, and dual door systems.

As you choose the best BSL 3 lab manufacturers and the best lab equipment for your purposes, there is a lot more you need to understand. From the risks involved in operating a BSL 3 lab and the specifics of addressing them to personnel training requirements, equipment requirements, and regulatory compliance. So that’s exactly what we’ll discuss in part two of this blog post. Stay tuned.

Building on everything you’ve learned in part one of this blog post, we’re now going to explore some of the specifics of what goes into making biosafety level 3 labs. Not just the design and engineering of the space, but also the training, SOPs, and paperwork that are non-negotiable in BSL 3 labs.

 

What must BSL 3 laboratories protect against?

When working in a biosafety level 3 lab, researchers and other personnel in the space face the risks of autoinoculation, aerosol exposure, and ingestion of the dangerous biological agents that they handle. If the biological agents in question escape the contained laboratory space, they also pose health risks to the communities living around the facility through contamination of the air, soil, and/or water.

To protect against these possibilities, BSL 3 laboratories use containment devices like biosafety cabinets. They rely on well-designed and thoroughly vetted procedures and practices during every step of installation, operations, and dismantling. The design and construction of the BSL 3 lab structure itself must meet strict guidelines to ensure that any accidental release within the facility does not impact the environment or communities around.

This is how biosafety level 3 labs ensure that they can carry out important research and scientific work without endangering the planet or the public:

The specifics of BSL 3 laboratories.

Types of agents studied. The agents studied in BSL 3 labs are referred to as biohazard level 3 agents. These agents are typically exotic or indigenous biological agents that can cause potentially fatal disease through inhalation. Some of the most common examples of microbes handled in BSL 3 labs include Covid-19, anthrax, hantavirus, Rift Valley fever, West Nile virus, Mycobacterium tuberculosis, and yellow fever.

Commonly used equipment. BSL 3 laboratories must use specialised equipment that is suited specifically to the types of hazards encountered in this setting. As you set up or choose the best BSL 3 lab for your needs, make sure that it is equipped with biosafety cabinets and incinerators. You also need a pass-through autoclave with a bioseal in the laboratory. Ensure that all critical operations are carried out in a space with a sustained directional airflow system. This draws clean air from non-laboratory areas into the lab and other potentially contaminated areas. In this way, potentially contaminated air from the BSL 3 lab doesn’t flow outwards towards areas where it could cause harm to personnel or the public.

The non-negotiables of establishing and operating BSL 3 laboratories.

Safety comes first. The owners and operators of the best BSL 3 labs understand this. That’s why when it comes to setting up or selecting a BSL 3 lab for any purposes, there are some non-negotiables, some ground rules that absolutely must be in place before you can begin operations.

Safety protocols. Level 3 biohazards are extremely dangerous to work with because the consequences of any spill or leak can impact the lives and health of not only lab personnel but also the general public. That’s why the operation of BSL 3 laboratories is strictly controlled, with registration and verification of BSL 3 labs with appropriate government agencies being necessary.

Here are some of the safety protocols that ensure the safety of people and the environment:

• Laboratory personnel are kept under medical surveillance and may be immunised against the microorganisms that they work with.
• The use of personal protective equipment (PPE) like gloves, goggles, gowns, and sometimes even respirators, is non-negotiable.
• The gowns that form part of the PPE must be solid-front wraparound gowns, scrub suits, or coveralls.
• Hands-free sinks and eye wash stations should be accessible to personnel at all exit points.
• The BSL 3 lab must have self-closing locking doors with access that is apart from general building corridors. Moreover, access to the lab must be controlled at all times to ensure that untrained or extraneous persons do not enter the contained space.

 Requirements for personnel training. The best BSL 3 labs aren’t just about cutting-edge engineering and sophisticated machinery. Since safety is as much about process as it is about design, there is an intrinsic risk involved in operating a BSL 3 lab. So, having highly knowledgeable personnel is a non-negotiable.

Before they can work in a BSL 3 lab, every researcher and operator’s knowledge and ability must be evaluated to ensure they have the necessary proficiency. In addition to having a basic skill set, researchers must also embody of culture of questioning and expressing their concerns so that no gaps or errors are overlooked. An internal expert serving as a mentor is also an important part of the staff of a BSL 3 laboratory.

Depending on the experts and committees overseeing any BSL 3 lab, personnel may have different training and operational requirements. Many labs will lay out guidelines covering the skills and knowledge that BSL 3 lab personnel must have. These include general lab safety procedures, set up, use and clean up of biosafety cabinets, protocols for bringing materials into and out of biosafety cabinets, safely growing and manipulating microbial cultures, common procedures like plating, incubating and centrifugation, autoclave use, safe waste disposal, and emergency procedures.

As the owner or operator of a BSL 3 laboratory, you must thoroughly document training sessions. These trainings must cover theoretical and practical tests, the results of which must be evaluated by relevant experts.

Compliance with BSL 3 laboratory guidelines and regulations.

Given the high risks involved in operating a BSL 3 lab, it’s a given that the space is heavily regulated. Besides meeting standard industry practices, you have to ensure compliance with the regulations laid out by relevant government agencies. These will vary by country and region, so it’s important that you research the ones that apply to you.

In the United States, for instance, the Department of Health and Human Services, the Centers for Disease Control and Prevention, and the Department of Agriculture mandate certain verification processes that must be completed before you begin operations as well as some that must be completed at regular intervals.

Among other requirements, the verification process requires that in entities that possess certain agents of toxins, “biosafety and containment procedures must be sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards).”

Prior to operation, the BSL 3 facility design, operational parameters, and procedures must be verified and documented. Going forward, the facility must also be tested annually or after significant modification. Most importantly, the BSL 3 lab must be designed such that airflow will not be reversed under failure conditions. This process involves both facility verification and HVAC verification.

Meanwhile, in India, the Department of Biotechnology, the Department of Health Research, and the Indian Council of Medical Research (ICMR) have established the “National Guidelines for the Establishment and Certification of Biosafety Level-3 (BSL-3) Containment Facility (2024)”. These guidelines address the threats presented by emerging and re-emerging infections, new or exotic viruses, and genetically engineered (GE) organisms. They cover the ISO standards that must be met, prerequisites for construction, pre-design considerations, HVAC, lab equipment, commissioning, validation, certification, and annual re-validation for BSL 3 labs in India.

How to choose the best BSL 3 labs for your facility.

Choosing the best, safest, and most reliable lab for your facility begins with choosing the right BSL 3 lab manufacturer. You want expertise, experience, adaptability, promptness, and quality from your lab manufacturing partner.

Equipped with all the knowledge you have gained in these blog posts, you are ready to evaluate BSL 3 lab manufacturers to decide if they’re the right partner for you. But beyond the technicalities, you want to ask: do they service the region in which I’m located? How long will construction take? Are their construction methods accepted? Are they familiar with local regulations in my location?

At PodTech™, we love a dialogue. We’re here to work with you. To understand your context, your requirements, and deliver the solutions you need in a timeline that no traditional lab manufacturer can promise. At PodTech™, we promise agility, expertise, and global experience that can help you deliver unparalleled results. We promise prefabricated infrastructure that will transform how the biopharma world works.

In your search for the best BSL 3 labs, reach out to us for a consultation on how we can solve for you.