Biosafety levels (BSLs) are safety classifications for microbiology and biomedical laboratories, based on the risk of the pathogens being handled. Developed by the CDC, these levels help laboratory personnel identify and minimize biological hazards, supporting biosecurity principles and laboratory safety.¹

There are four biosafety levels, or BSLs, each with specific recommendations and requirements for laboratory practices, PPE, safety equipment, and facility construction. These levels progress in complexity based on the laboratory tasks and factors such as infectivity, disease severity, and transmission potential of the pathogen.^1,2 There is some regional variation in the nomenclature used to describe these levels, even though the facility design requirements remain consistent. In the UK, biosafety levels are referred to as ‘Containment Levels’. Let’s explore each level below:^1,2

• Biosafety level 1 (BSL-1)/containment level 1 (CL1) is suitable for handling low-risk microorganisms that pose a minimal threat to human health. Precautions at this level are low and usually involve handwashing and proper waste disposal, wearing personal protective equipment (PPE), and controlling access. Typically, this level is found in teaching and research laboratories.
• Biosafety level 2 (BSL-2)/containment level 2 (CL2) is designed for handling microorganisms presenting “moderate hazards” to humans which are unlikely to spread in the community. In addition to BSL-1 precautions, work is conducted within a physical containment device. Containment level 2 is commonly used in clinical and diagnostic laboratories.
• Biosafety level 3 (BSL-3)/containment level 3 (CL3) involves the control of infectious agents that can cause serious hazards and potentially lethal conditions via respiratory transmission. Enhanced safety measures include controlled access, specialized ventilation systems, and personnel training. Containment level 3 laboratories are found in research institutions and clinical laboratories working with pathogens like tuberculosis and certain strains of influenza.
• Biosafety level 4 (BSL-4)/containment level 4 (CL4) is the highest and most complex biohazard level, characterized by high transmission via aerosol, making the pathogens more dangerous for the laboratory workforce and the surrounding community. Only specifically trained personnel can work with these viruses as there is no treatment available, therefore, extreme isolation precautions are mandatory. Containment level 4 requires the use of specialized biosafety equipment, often including wearing a positive pressure personnel suit with a segregated breathing air supply. BSL-4 laboratories are reserved for specialized research facilities and government agencies equipped to handle the highest-risk pathogens that pose a severe threat to public health.

Compliance and certification processes for biosafety laboratories ensure institutions and individuals working with hazardous pathogens are continuing to meet the strict standards and requirements associated with the BSL classification. These strict regulations are in place to protect staff working in a potentially hazardous environment and to prevent the escape of biological agents from the laboratory to the community – where they could pose a risk to both the public and environment. Furthermore, they provide “a strict chain of custody” as to who has access to, and handles, any potentially harmful biological materials.^3,4

Respecting biosafety and biosecurity requirements is crucial for the safety of the personnel working in the laboratory as well as for the surrounding environment, making certification and validation of biosafety labs post-construction essential.³ Initial commissioning and certification coupled with annual recertification are fundamental to ensuring that biosafety laboratories meet specific safety standards and regulations.⁴ For example, biological safety cabinets operating within a biosafety laboratory must be certified annually to verify safety and performance. This certification should be complemented by a robust monitoring and preventative maintenance schedule to maintain safe performance, as sporadic audits and inspections offer limited insights. Furthermore, laboratory supervisors must monitor and enforce policies that control safety and access to the lab, only allowing trained personnel to enter. Appropriate risk communication and ongoing risk assessment can help facilitate a culture of safety for laboratory staff who handle infectious agents.⁴

Germfree is a leading manufacturer of mobile and modular biocontainment laboratories, specializing in rapidly deployable BSL-2- and BSL-3 facilities and solutions for global disease surveillance and biosecurity. These labs (and facilities) enable swift pandemic responses by offering on-site analytical and diagnostic capabilities. Germfree is also internationally recognized for the manufacturing of Class III Gloveboxes as well as for the certification and maintenance of these containment systems.

Modular Laboratories: Germfree offer freestanding, pre-assembled, factory fabricated modular labs built off-site for permanent installation, which can be relocated if desired. These modular facilities and solutions can accommodate specialized containment equipment, extensive storage for consumables and PPE, and highly complex HVAC and HEPA filtration systems (with HVAC capacity having been increased for BSL-3 and AG applications). Modular laboratories may also be integrated with existing facilities or processes. Furthermore, Germfree’s factory-built modular solutions afford greater flexibility and response to global disease surveillance and biosecurity.

Mobile Laboratories: Germfree’s Mobile Laboratories are vehicle based, utilizing a van, truck or trailer chassis as the platform – so do not require a shell building. Mobile labs are designed to be customized to meet a customer’s specific requirement, while adhering to biocontainment and biosafety regulations. They enable quick and reliable deployment and are instrumental in safeguarding public health, by allowing work to identify and address infectious disease outbreaks in real-time, worldwide.

Incorporating advanced technologies into BSL modular solutions is vital for enhancing safety, productivity, and data integrity. By integrating options like advanced HEPA filtration systems, automated biosafety controls, and remote monitoring capabilities, risks are mitigated and operations streamlined in high-containment environments. These advancements not only improve safety measures but also increase efficiency and accuracy in biocontainment facilities, ultimately supporting scientific research and disease surveillance efforts. Additionally, Germfree can outfit a biosafety lab with essential equipment such as Class II and III biological safety cabinets, gloveboxes, and material pass-throughs, providing comprehensive solutions for various containment needs.

With the development of biotechnology and the advancement of globalization, attention to biosafety is increasing, leading to the rapid establishment of prevention and emergency systems. Large-scale outbreaks of infectious diseases have emerged as a significant biosafety challenge. In the past 10 years, more than a dozen major international infectious disease incidents have occurred, including COVID-19, Ebola, Middle East Respiratory Syndrome (MERS), severe acute respiratory syndrome coronavirus (SARS-COV), Marburg, African swine fever, as well as multidrug-resistant bacteria.⁵ These issues underscore the need for modular solutions. Focusing on those that are easily deployable with sophisticated infrastructure and laboratory capabilities, which can help overcome some of these challenges, offering strategic advantages in responding quickly and effectively to emerging outbreaks.⁶

At Germfree, we specialize in tailored solutions for the biocontainment, pharmaceutical, and healthcare sectors, allowing our clients to concentrate on their vital work. With over sixty years of experience, Germfree customizes every aspect of the manufacturing process to meet your unique needs. With our commitment to end-to-end service, you can trust us to handle the details while you focus on your priorities.

To find out more about our BSL solutions, book a discovery call today:

• Sales: +1 (386) 265-4300
• Service & support: cs@germfree.com

References:

1. Bayot ML, King KC. Biohazard Levels. StatPearls. Available at: https://www.ncbi.nlm.nih.gov/books/NBK535351/ [Accessed March 2024].
2. Infographic: Biosafety Lab Levels. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/orr/infographics/biosafety.htm [Accessed March 2024].
3. Mourya DT, et al. Certification & validation of biosafety level-2 & biosafety level-3 laboratories in Indian settings & common issues. Indian J Med Res. 2017;146(4):459-467. doi: 10.4103/ijmr.IJMR_974_16. PMID: 29434059; PMCID: PMC5819027.
4. Biosafety in Microbiological and Biomedical Laboratories. 6^th Edition. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf [Accessed March 2024].
5. Guan R, et al. Discovering trends and hotspots of biosafety and biosecurity research via machine learning. Brief Bioinform. 2022;23(5):bbac194. doi: 10.1093/bib/bbac194. PMID: 35596953; PMCID: PMC9487701.
6. Rao V and Bordelon E. Mobile High-Containment Biological Laboratories Deployment: Opportunities and Challenges in Expeditionary Deployments to Outbreak Response. Appl Biosaf. 2019;24(1):20-29. doi: 10.1177/1535676018818563. Epub 2019 Mar 1. PMID: 36034633; PMCID: PMC9093244.