In research and clinical treatment Biosafety addresses the safe handling and containment of infectious microorganisms and hazardous biological materials. Two important factors in design of biosafety systems are containment and risk. The fundamentals of containment include practices for working with microbiological materials, safety equipment, and facility features that protect laboratory workers, the environment, and the public.
The US Centers for Disease Control and Prevention defines four safety levels for facilities that handle potentially hazardous microbes: Biosafety Level 1 (BSL 1), BSL 2, BSL 3 and BSL 4. The specifications for each level are combinations of laboratory practices and techniques, presence of safety equipment, and architectural features of the buildings. When assigning levels to facilities, managers and regulators take into account planned operations and the documented and suspected routes of transmission of the infectious agents.
BSL-1 calls for a basic level of containment that relies on standard microbiological practices with no special primary or secondary barriers recommended, other than a sink for hand washing. Most materials that cannot cause human disease are kept in a BSL-1 area.
BSL-2 is the most common level in clinical, diagnostic, and other laboratories that work with the broad spectrum of indigenous moderate-risk agents that are present in the community and associated with transmittable human disease. The primary hazards to personnel working with these agents include accidental percutaneous or mucous membrane exposure and ingestion of infectious materials. Sharps are also a hazard to workers, a risk for both laceration injury and for allowing infection to enter the body. Hand washing sinks and waste decontamination rooms or areas, must be available to reduce the risk of environmental contamination.
BSL-3 deals with practices, safety equipment, and facility design and construction for clinical, diagnostic, teaching, research, or production facilities in which work is done with pathogens that can become aerosolized and threaten respiratory transmission, if those pathogens can cause serious infection.
BSL 4 deals with practices, safety equipment, and facility design and construction as applicable for work with dangerous and exotic agents that pose a high risk of life-threatening disease, especially ones that can become airborne in fine particulates. Labs that handle viruses such as Marburg or Congo-Crimean hemorrhagic fever are BSL-4.
The term containment refers to methods for safely managing infectious materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents. Laboratory personnel training, safety practices, and techniques must be supplemented by facility design and engineering features, as well as safety equipment. Containment can be primary or secondary.
The protection of personnel and the immediate laboratory environment from exposure to infectious agents is provided by responsible microbiological technique and the use of safety equipment such as hoods. Research facilities sometimes vaccinate their personnel for an increased level of protection.
Secondary containment are measures to protect the environment outside the laboratory from exposure to infectious materials. Most secondary containment plans employ a combination of facility design and operational practices. The three elements of containment are laboratory practice and techniques, safety equipment, and building and campus architecture. When developing a secondary containment plan, engineers employ a risk assessment of the planned activities with consideration of pathogens or organisms on site.
Waste from BSL1 and BSL2 facilities can be sent off-site with no decontamination under industry guidelines. However many facilities do treat this waste to kill living cells and disable viruses before sending the waste off-site. BSL3 and BSL4 operations that work with infectious microorganisms must have a process to decontaminate waste before it leaves the facility.
IQ - Installation Qualification
PQ - Performance Qualification
FAT - Factory Acceptance Testing
SAT - Site Acceptance Testing
OQ - Operation Qualification