Bioprocess Containers: Levels of Biological Confinement

All biological research and production must be conducted at an appropriate level of containment to ensure worker safety and prevent environmental release. There are four levels of biological containment commonly used ranging from Biosafety Level 1 (BSL-1) representing the lowest level of risk up to Biosafety Level 4 (BSL-4) which handles the most dangerous pathogens requiring the highest level of protection. Laboratories working with infectious microorganisms select the appropriate biosafety level based on the risk group classification of the agents they are working with.

BSL-1 is recommended for working with well characterized agents that are unlikely to cause disease in healthy humans. Facilities require basic safety equipment like gloves, lab coats, and access to hand washing facilities. BSL-2 is for work with agents that pose moderate risk to humans like those that may cause human disease by ingestion or skin/mucous membrane exposure. It requires BSL-1 practices plus controlled access, biosafety manual, decontamination of all waste, and potential use of biological safety cabinets depending on the procedure being performed.

BSL-3 is recommended for indigenous or exotic agents with potential for aerosol transmission that may cause serious or potentially lethal disease through inhalation exposure. It has all the requirements of BSL-1 and 2 plus special containment equipment like biological safety cabinets and closed medical waste handling systems. BSL-4 is the highest level of containment for dangerous exotic agents that pose a high individual risk of life-threatening disease through the aerosol route and for which no vaccine or therapy is available. It includes all standard and special practices, safety equipment, and laboratory design found in BSL-3 with additional design and construction features to prevent pathogen release.

Bioprocess Containers: Types of Primary Containment for Biosafety

To prevent exposure of laboratory personnel or escape of Bioprocess Containers into the environment during procedures that may produce aerosols or droplets, primary containment equipment is employed inside the laboratory. The two main types are biological safety cabinets and laminar flow clean benches.

Biological safety cabinets (BSCs) provide product and personnel protection through the use of inward airflow and high-efficiency particulate air (HEPA) filtration of exhaust air. Class I BSCs provide personnel and environmental protection only since they do not protect the product or experiment. Class II BSCs have HEPA-filtered laminar airflow and are divided into Type A and B models depending on whether they recirculate 70% of air inside the cabinet or exhaust 100% of air to the outside. Class III BSCs provide the highest level of containment for handling the most infectious agents as they are gas tight and operated at a negative pressure, allowing manipulation of agents through attached gloves or class III gloves boxes.

Laminar flow clean benches use HEPA-filtered vertical or horizontal unidirectional airflow to provide a particle-free work area and are primarily used to protect products from particulate contamination. They do not provide personnel protection like BSCs unless supplemented by additional primary containment devices and procedures. BSCs and clean benches should be properly certified annually to verify operational parameters and effectiveness of containment systems.

Other types of primary containment devices include centrifuge safety buckets, sealed rotors, and containment centrifuge enclosures that fully contain any aerosols produced during high-speed centrifugation of infectious materials. Glove boxes allow microbiological manipulations to take place inside an enclosed workspace with attached gloves providing access and can be incorporated into BSL-3 or 4 laboratories.

Bioprocess Containers: Secondary Containment Systems

To protect the external environment from exposure to biological agents, secondary containment systems prevent their release outside of the primary containment equipment in the event of failure or accidental spill. Secondary barriers include the laboratory design features and facility engineering controls employed in biosafety levels 2-4 that isolate and contain the agent.

In BSL-2 labs, secondary barriers consist of physical separation of the laboratory work area from public access areas. Laboratories have self-closing doors to contain agents, hand washing sinks for hand hygiene, and signs controlling access. Surfaces are impervious and easy to clean in case of spills. BSL-3 laboratories have all BSL-2 features with additional engineering controls for supply and exhaust air, decontamination of effluents, and controlled air pressure differentials isolating the laboratory from general building HVAC systems. BSL-3 also segregates dirty and clean areas through separate or dedicated supply and exhaust systems and airlocks for entry and exit.

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