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FAQ > Glossary of Terms > B Series > Biosafety Level
 

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Pharmaceutical & Cleanroom Glossary of Terms

BAC(Bacterial Artificial Chromosome), Background Contamination, Background Environment, Back-up Copy, Backward Compatibility, Backwash, Bacteria, Bactericide, Bacteriophage, Bacteriostatic, Bacteriostatic Water, Bacterium, Barrier Isolator, Barrier Technology, Base, Base Pair(bp), Base Sequence, Baseline Pharmaceutical Engineering Guides, Basidiomycetes, Basis of Design, Batch, Batch Number, Batch Fermentation, Bed, Bed Depth, Bed Expansion, Binary Explosive, Bioactivity, Bioassay, Bioaugmentation, Biochemical Oxygen Demand(BOD), Biocide, Biodegradable, Bioequivalency, Biogenerator, Biohazard, Bioinformatics, Biologic, Biological Barrier, Biological Impurities, Biological Indicators, Biological Oxygen Demand(BOD), Biological Reactivity Tests - In Vivo, Biological Safety Cabinets(BSCs), Biologics, Biomass, Biometabolism, Biometrics, Bionics, Biopharmaceuticals, Bio Processing, Bioprocessing Engineering, Biopsy, Bio Pure Water, Biosphere, Bioreactor, Biosafety Level, Biosynthesis, Biotechnology, Biowaste Inactivation, BLA(Biologics License Application), Blank, Blind Weld, Blood Borne Pathogens, Blood Carpuscle, Blood Plasma, Blood Platelets, Blood Serum, Blow Down, Blow(Form) Fill - Seal, BME(Basic Medium Eagles), BPC(Bulk Pharmaceutical Chemical), BSA(Bovine Serum Albumin), BSE(Bovine Spongiform Encephalopathy), BSD(Bovine Viral Diarrhea), Braze Welding, Brazing, Brakethrough, Breath Control Shields, Broad Spectrum, Broth, Btu(British Test Unit), Bubble Point Test, Buffer, Buffer Prep, Building Occupancy Classification(California Building Code), Bulk Handling, Bulk Oxygen System, Byte, Bioburden, Biochemistry, Blinding


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Biosafety Level
The National Institutes of Health (NIH) specifies physical containment levels and defines Biosafety Levels in their "Guidelines for Research Involving Recombinant DNA Molecules" - Appendix G - May 1999. There are four biosafety levels for operations performed with infectious agents:
1. BL1: Practices, safety equipment, and facilities appropriate for work performed with defined and characterized strains of viable microorganisms not known to cause disease in healthy adult humans. The Basic Laboratory. This laboratory provides general space in which work is done with viable agents that are not associated with disease in healthy adults. Conventional laboratory designs are adequate. Areas known to be source of general contamination, such as animal rooms and waste staging areas, should not be adjacent to patient care activities. Public areas and general offices to which non-laboratory staff requires frequent access should be separated from spaces, that primarily support laboratory functions.

2. BL2: Practices, safety equipment, and facilities appropriate for work performed with a broad spectrum of moderate risk agents present and associated with human disease of varying severity. The Basic Laboratory. This laboratory provides general space in which work is done with viable agents that are not associated with disease in healthy adults. Conventional laboratory designs are adequate. Areas known to be sources of general contamination, such as animal rooms and waste staging areas, should not be adjacent to patient care activities. Public areas and general offices to which non-laboratory staff requires frequent access should be separated from spaces, which primarily support laboratory functions.

3. BL3: Practices, safety equipment, and facilities appropriate for work performed with indigenous or exotic agents where the potential for infection by aerosols is real and the disease may have serious or lethal consequences. Just walking through the area and breathing the air could infect one. The Containment Laboratory. This laboratory has special engineering features that make it possible for laboratory workers to handle hazardous materials without endangering themselves, the community, or the environment. The unique features that distinguish this laboratory from the basic laboratory are the provisions for access control and a specialized ventilation system. The containment laboratory may be an entire building, a single module, or complex of modules within a building. In all cases, a controlled access zone from areas open to the public separates the laboratory.

4. BL4: Practices, safety equipment, and facilities appropriate for work performed with dangerous and exotic agents that pose a high individual risk of life-threatening disease. Exposure to the skin could cause infection. The Maximum Containment Laboratory. This laboratory has special engineering and containment features that allow activities involving infectious agents that are extremely hazardous to the laboratory worker or that may cause serious epidemic disease to be conducted safely. Although the maximum containment laboratory is generally a separate building, it can be constructed as an isolated area within the building. The laboratory's distinguishing characteristic is that it has secondary barriers to prevent hazardous materials from escaping into the environment. Such barriers include sealed openings into the laboratory, airlocks or liquid disinfectant barriers, a clothing-change and shower room contiguous to the laboratory, a double door autoclave, a biowaste treatment system, and a treatment system to decontaminate exhaust air.