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B| There are 98 entries in the glossary. |
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| Biologic | A therapeutic agent derived from living things. |
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| Biological Barrier | An impediment (naturally occurring or introduced) to the infectivity and/or survival of a microbiological agent or eukaryotic cell once it has been released into the environment. |
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| Biological Impurities | Impurities resulting from living matter (bacteria, virus, algae, protozoa, microfungi) and their by-products, including pyrogens (endotoxins). |
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| Biological Indicators | Resistant microorganisms placed into or on various materials to confirm that a sterilization process is effective. They may for instance be placed within a filter in order to determine if a proposed autoclave cycle is effective. After autoclave, they are removed and culture tests are performed to see if the microorganisms were killed. |
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| Biological Reactivity Tests, In Vivo | This classification is based on responses to a series of in vivo tests for which extracts, materials and routes of administration are specified. Six Plastic Classes are defined: - 1. Class I - Uses a specified dosage of an extract of sample in Sodium Chloride Injection applied either intravenously or intracutaneously into a mouse or a rabbit.
- 2. Class II - Same as Class I but in addition uses an extract of sample in 1 in 20 Solution of Alcohol in Sodium Chloride Injection applied either intravenously or intracutaneously into a mouse or a rabbit.
- 3. Class III - Same as Class II but in addition uses an extract of sample in Polyethylene Glycol 400, and an extract of sample in Vegetable Oil, both applied either intraperitoneally or intracutaneously into a mouse.
- 4. Class IV - Same as Class II but in addition uses an extract of sample in Vegetable Oil applied intraperitoneally or intracutaneously into a mouse or a rabbit. Also uses implant strips of sample into a rabbit.
- 5. Class V - Same as Class II but in addition uses an extract of sample in Polyethylene Glycol 400, and an extract of sample in Vegetable Oil applied intraperitoneally or intracutaneously into a mouse or a rabbit.
- 6. Class VI - Same as Class V but in addition uses implant strips of sample into a rabbit.
- These tests are designed to determine the biological response of animals to elastomerics, plastics and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test. Three tests are described:
- 1. Systemic Injection Test - Designed to determine the systemic biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.
- 2. Intracutaneous Test - Designed to determine the local biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.
- 3. Implantation Test - Designed to evaluate the reaction of living tissue to the plastic and other polymers by the implantation of the sample (specimen under test) itself into animal tissue. With the exception of the Implantation Test, the procedures are based on the use of extracts that, depending on the heat resistance of the material, are prepared at one of the three standard temperatures: 50°, 70°, and 121°. Therefore, the class designation of a plastic must be accompanied by an indication of the temperature of extraction e.g., IV - 121°, which represents a class IV plastic extracted at 121°).
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| Biological Safety Cabinets (BSCs) | Bench-top or freestanding cabinets with unidirectional airflow used for handling materials that present a health hazard. The National Institutes of Health (NIH) Guidelines classify them as: - 1. Class I - A negative pressure, ventilated cabinet for personnel protection having an inward flow of air away from the operator. The exhaust air is filtered through a HEPA filter (located at rear or top) either into the laboratory or to the outside. This cabinet is designed for general microbiological research with low and moderate risk agents (BL-2 and BL-3 agents), and is used in three operational modes:
- a) With a full width open front. The face velocity of the inward flow of air through the full width open front is at least 75' feet per minute.
- b) With an installed front closure panel (having four 6-inch diameter openings) without gloves. The face velocity of the inward flow of air through the openings will increase to approximately 150' feet per minute.
- c) With an installed front closure panel equipped with arm-length rubber gloves, and inlet air pressure relief for further protection. In this configuration, it is necessary to install a make-up air inlet fitted with a HEPA filter in the cabinet.
- 2. Class II - A ventilated cabinet for personnel and product protection having an open front with inward airflow for personnel protection (75' to 100' feet per minute), and HEPA filtered downward unidirectional airflow for product protection. The exhaust air is filtered through a HEPA filter for environmental protection. For selection and procurement of Class II cabinets refer to standards developed by the National Sanitation Foundation, Ann Arbor, Michigan. Cabinets are further classified as:
- a) Type A - Suitable for microbiological research in the absence of volatile or toxic chemicals and radionuclides (BL-2 and BL-3), with 70% recirculated air through HEPA. They are exhausted through HEPA into the laboratory or to the outdoors via a "thimble" connection to the building exhaust system.
- b) Type B - Hard ducted to the building exhaust system, contains negative pressure plena, and face velocity of 100' feet per minute. Type B cabinets are further sub-typed into types: B1 (30% recirculated air through HEPA; exhaust via HEPA and hard ducted. BL2 and BL-3), B2 (No recirculation; total exhaust via HEPA and hard ducted. BL-2 and BL-3), and B3 (same as IIA, but plena under negative pressure to room and exhaust air is ducted. BL-2 and BL-3).
- Classes I and II should be located away from traffic patterns and doors, airflow from fans, room air supply louvers, and other air moving devices.
- 3. Class III - Closed-front ventilated cabinet of gas tight construction that provides the highest level of personnel protection from infectious aerosols, as well as protection of research materials from microbiological contaminants. The interior of the cabinet is protected from contaminants exterior to the cabinet. The cabinet is fitted with arm-length rubber gloves and is operated under negative pressure of at least 0.5 inches water gauge. All supply air is filtered through HEPA filters. Exhaust air is filtered through two HEPA filters in series or one HEPA filter and incinerator before being discharged to the outside environment. Class III cabinets are most suitable for work with hazardous agents that require Biosafety Level 3 or 4 containment. Cabinets must be connected to a double-door autoclave and/or chemical dunk tank used to sterilize or disinfect all materials exiting the cabinet, and to allow supplies to enter the cabinet.
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| Biologics | "Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product… applicable to the prevention, treatment, or cure of diseases or injuries of man…" |
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| Biomass | Organic matter grown by the photosynthetic conversion of solar energy. |
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| Biomass (ii) | The entire assemblage of living organisms (both plant and animal), of a particular region, considered collectively. |
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| Biometabolism | Physical and chemical processes that occur within a cell or an organism, for example, the conversion of nutrients into energy. |
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| Biometrics | A method of verifying an individual's identity based on measurement of his/her physical feature(s) or repeatable action(s) where those features and/or actions are both measurable and unique to that individual. The main types of biometrics are: face recognition, finger scanning, hand geometry, finger geometry, iris recognition, palm, retina, signature, and voice recognition. |
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| Bionics | An interscience discipline for constructing artificial systems, which resemble or have the characteristics of living systems. |
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| Biopharmaceuticals | Ethical pharmaceutical drugs derived through bioprocessing. |
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| Bioprocess Engineering | Process that uses complete living cells or their components (e.g., enzymes, chloroplast) to effect desired physical or chemical changes. |
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| Bioprocessing | The creation of a product utilizing a living organism. |
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| Biopsy | The gross and microscopic examination of tissues or cells removed from a living patient, for the purpose of diagnosis or prognosis of disease, or for the confirmation of normal conditions. |
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| Biopure Water | Water that is sterile, pyrogen free and has a total solids content of less than 1 ppm |
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| Bioreactor | A closed system used for bioprocessing (flask, roller bottle, tank, vessel, or other container), which supports the growth of cells, mammalian or bacterial, in a culture medium. A bacterial reaction usually is said to take place in a fermenter, and cell culture in a bioreactor. |
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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.
- (also see: Good Large Scale Practice, Containment Level, and Table II, Section II - Comparison of Good Large Scale Practice (GLSP) and Biosafety Level (BL) - Large Scale (LS) Practice)
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| Biosphere | All the living matter on or in the earth, the oceans and seas, and the atmosphere. |
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Glossary V2.0 |
