Pharmaceutical Drug Manufacturers

BAC (Bacterial Artificial Chromosome)
A vector used to clone DNA fragments (100-kb to 300-kb insert size; average, 150-kb) in E. Coli cells. Based on naturally occurring F-factor plasmid found in the bacterium E. coli.

Background Contamination
Contamination introduced accidentally in reagents, dilution water, solvents, rinse water, etc., which can be confused with constituents in samples being analyzed.

Background Environment
The environment that surrounds a critical area.

Back-up Copy
A magnetic copy of data, software, user-developed application, or operating parameters associated with an automated system and not considered the original.

Backward Compatibility
A new version of a computer program that can use files and data created with an older version of the same program. A computer is said to be backward compatible if it can run the same software as the previous model. Backward compatibility is important because it eliminates the need to start over when you upgrade to a newer product, but is sometimes sacrificed in favor of a new technology.
Backwash
The countercurrent flow of water through equipment, usually to clean or to recover performance, such as in a resin bed (flow-in at the bottom of the exchanger unit and out at the top) to clean and reclassify the bed after exhaustion. This process of reversing flow may also be applied to filters in order to force contaminants out of plugged pores and passages.

Bacteria
The plural of Bacterium.

Bactericide
An agent that kills vegetative bacteria but not mycobacteria or spores.

Bacteriophage
A virus that exclusively infects bacteria. A protein coat surrounds the genome (DNA or RNA). One of the bacteriophages most extensively studied is the lambda phage, which is also one of the most important viral vectors used in rDNA work. Lambda promoters have been used to express eukaryotic proteins in E.coli.

Bacteriostatic
Inhibiting growth of bacterial organisms without necessarily killing them or their spores.

Bacteriostatic Water
For Injection, U.S.P. Water that serves the same purposes as Sterile Water for Injection, it meets the same standards, with the exception that it may be packaged in either single-dose or multiple-dose containers of not larger than 30-mL size.

Bacterium
Any of a large group of microscopic organisms having round, rod-shaped, spiral, or filamentous unicellular or noncellular bodies that are often aggregated into colonies, are enclosed by a cell wall or membrane (prokaryotes), and lack fully differentiated nuclei. Bacteria range in size from 0.4µm to 2.0µm and may exist as free-living organisms in soil, water, organic matter, or as parasites in the live bodies of plants. Some are disease producing, but most perform necessary functions such as digestion, fermentation, and nitrification. Most of the forms are variously grouped under generic names such as: Alcaligenes, Dialister, Escherichia, Klebsiella, Kurthia, Pasteurella, Salmonella, and Shigella.

Barometer Instrument used to measure atmospheric pressure.

Barrier Isolator
A containment device that utilizes barrier technology for the enclosure of a controlled workspace. There are two main types of isolator: 1. Type 1 Isolator: An isolator designed to protect the product from process-generated and external factors that would compromise its quality. 2. Type 2 Isolator: An isolator designed to protect the product from process-generated and external factors that would compromise its quality and to protect the operator from hazards associated with the product.

Barrier Technology
The technology of using separating environments, whether protecting the world from a product or the product from the world. Containment, barrier isolation and isolation all refer to the same technology, which is enclosing an environment. There are, however, some redefining terms that are gaining favor: 1. Containment - protect the world from the product (as in the case of highly potent compounds or a toxic). 2. Isolation - protect the product from the world (as in the case of a sterile product). 3. ISO 14644-7 "Minienvironments and Isolators" will define further levels of devices

Base
An electropositive element or radical that unites with an acid to form a salt. Or, a substance that when dissolved in water, dissociates to produce one or more hydroxyl ions (OH-).

Base Pair (bp)
Two nucleotides that are in different nucleic acid chains and whose bases pair by hydrogen bonding. In DNA, the nucleotide bases are adenine (A) that always pairs with thymine (T) and guanine (G) which pairs with cytosine (C). In RNA molecules, adenine (A) joins the uracil (U). Two strands of DNA are held together in the shape of a double helix by the bonds between these pairs.

Base Sequence
The order of nucleotide bases in a DNA molecule.

Base Sequence
Analysis A method, sometimes automated, for determining the base sequence.

Baseline
In some analytical procedures a sample is dissolved in water or combined with other reagents for analysis. A "blank" or standard consisting of the same reagents may be analyzed without sample present. This provides a comparative reference point, or baseline, so that the test results can be attributed solely to the sample itself.

Baseline® Pharmaceutical Engineering Guides (ISPE)
A series of industry publications developed in partnership with the US Food and Drug Administration (FDA). Each volume in the series is a collaborative effort of industry leaders representing a broad cross-section of manufacturers and other industry experts. The Guides document current industry practice for facilities and systems used for production of pharmaceutical products and medical devices. They are intended to:

• Establish a baseline approach to new and renovated facility design, construction, commissioning, and qualification that is based upon clear understanding of the type of product and its manufacturing process.
• Prioritize facility design features based upon the impact on product and process.
• Avoid unnecessary spending on facility features that do not contribute to consistent production of quality products.

The Guides include five product manufacturing operation based guides (vertical guides), and three support system/function based guides (horizontal guides):

1. Volume I - Bulk Pharmaceutical Chemicals (1996)

2. Volume II - Oral Solid Dosage Forms (1998)

3. Volume III - Sterile Manufacturing Facilities (1999)

4. Volume VI - Biotech (in progress)

5. Volume -Oral Liquids and Aerosols

6. Volume IV - Water and Steam Systems (in progress)

7. Volume V - Commissioning and Qualification Guide (in progress)

8. Volume VII - Packaging and Warehousing

Basidiomycetes
Reproduce by basidiospores, which are extended from the stalks of specialized cells called the basidia. The class comprises Photobasidiomycetes (smuts and rusts) and the Hymenomycetes (mushrooms and puffballs).

Basis of Design
A design document that describes what the purpose of a given system is and how the system will accomplish its required task. This document is created and approved before the issuance of bid specifications and is often used to develop them. Until the system is developed this is a conceptual document.

Batch
A specific quantity of material produced in a process or series of processes so that is expected to be homogeneous within specified limits. In the case of continuous production a batch may correspond to a defined fraction of the production, characterized by its intended homogeneity. The batch size may be defined either by fixed quantity or the amount produced in a fixed time interval.

Batch Number
A unique combination of numbers and/or letters which specifically identify a batch or lot and from which the production and distribution history can be determined.

Batch Fermentation
The process in which a fixed volume of sterile medium in a vessel is inoculated with a desired organism. The broth is fermented for a defined period to completion, without further additions of media. After discharging the batch, the fermenter is cleaned and rebatched with medium for another cycle. Two other types of fermentation cycles are fed batch and continuous.

Batchwise Control The use of validated in-process sampling and testing methods such that results prove the process has done what it purports to do for the specific batch concerned, assuming control parameters have been appropriately maintained.

Bed
Column of carbon, sand, chromatography, or ion exchange resins through which a liquid passes during operation.

Bed Depth
The height of the exchange or capture material in a column after proper backwashing for effective operation.

Bed Expansion
The effect produced during backwashing; resin particles separate and rise in the column. Regulating backwash flow may control bed expansion caused by the increase in space between resin particles.

Binary Explosive
An explosive material composed of separate components, each of which is safe for storage and transportation and would not in itself be considered as an explosive.

Bioactivity
A protein's ability to function correctly after it has been delivered to the active site of the body (in vivo).

Bioassay
The determination of the biological activity of a substance (e.g. a drug) by observing its effect on an organism (or organ) compared to a standard preparation.

Bioaugmentation
A strategy involved in bioremediation that increases the activity of an organism to break down or metabolize a pollutant. This involves reseeding a waste site with bacteria as they die.

Bioburden
The level and type of microorganisms which may be present in raw materials, API (Active Pharmaceutical Ingredient) starting materials, intermediates, or APIs which have defined limits and should not affect the quality of the API. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.

Biochemical Oxygen Demand (BOD)
(also see: BOD (Biochemical Oxygen Demand))

Biochemistry

The study of chemical processes in living things. Despite the dramatic differences in the appearance of living things, the basic chemistry of all organisms is strikingly similar. Even tiny, one-celled creatures carry out essentially the same reactions that each cell of a complex organism, such as man, carries out.

Biocide
An agent that can kill all pathogenic and non-pathogenic living organisms, including spores. More general than bacteriocide, biocide includes insecticides and any compound toxic to any living thing.

Biodegradable
Material that can be broken down by biological action.

Bioequivalency
A scientific basis on which generic and brand name drugs are compared with one another. Drugs are bioequivalent if they enter circulation at the same rate when given in similar doses under similar conditions.

Biogenerator
A contained system, such as a fermentor, into which biological agents are introduced along with other materials so as to effect their multiplication or their production of other substances by reaction with the other materials. Biogenerators are generally fitted with devices for regulation, control, connection, material addition, and material withdrawal.

Biohazard
An infectious agent(s), or part thereof, presenting a real or potential risk to human, other animals, or plants, directly through infection or indirectly through disruption of the environment.

Bioinformatics
The use of computers in the life sciences, electronic databases of genomes and protein sequences, and computer modeling of biomolecules and biologic systems.

Biologic
A therapeutic agent derived from living things.

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.

Biological Impurities
Impurities resulting from living matter (bacteria, virus, algae, protozoa, microfungi) and their by-products, including pyrogens (endotoxins).

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.

Biological Oxygen Demand (BOD)
(also see: BOD (Biological Oxygen Demand))

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°).

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.

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…"

Biomass
Organic matter grown by the photosynthetic conversion of solar energy.

Biomass
The entire assemblage of living organisms (both plant and animal), of a particular region, considered collectively.

Biometabolism
Physical and chemical processes that occur within a cell or an organism, for example, the conversion of nutrients into energy.

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.

Bionics
An interscience discipline for constructing artificial systems, which resemble or have the characteristics of living systems.

Biopharmaceuticals
Ethical pharmaceutical drugs derived through bioprocessing.

Bioprocessing
The creation of a product utilizing a living organism.

Bioprocess Engineering
Process that uses complete living cells or their components (e.g., enzymes, chloroplast) to effect desired physical or chemical changes.

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.

Biopure Water
Water that is sterile, pyrogen free and has a total solids content of less than 1 ppm.

Biosphere
All the living matter on or in the earth, the oceans and seas, and the atmosphere.

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.

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)

Biosynthesis
The production, by biological synthesis or degradation, of compounds by a living organism (e.g. amino acid synthesis, nucleotide synthesis).

Biotechnology
An industry that creates, develops, and markets a variety of techniques that use living organisms, or substances from those organisms, to make or modify a product by microbial and biochemical processes. A common misconception is that biotechnology refers only to recombinant DNA or gene splicing work. Recombinant DNA is only one of the many techniques used to derive products for organisms, plants, and parts of both for the biotechnology industry. A list of areas covered by the term biotechnology would more properly include: plant tissue culture, cell fusion techniques (especially for the production of monoclonal antibodies), enzyme systems, plant breeding, meristem culture, fermentation, and others.

Biotechnology
A process of applying genetic engineering (recombinant DNA), hybrid (monoclonal antibody), hybridization (gene probes), bioelectric, etc. to commercial applications in pharmaceutical, chemical, medical diagnostic device, food, animal and plant industries.

Biotechnology
Products Large molecules that are not manufactured by means of chemical synthesis but rather produced by means of fermentation and/or recovery, sourced from genetically engineered products.

Biowaste Inactivation
The inactivation or "killing" of biological organisms using heat or chemicals. This step is done at the end of the processing to ensure that there are no living organisms remaining in the effluent that is sent to the sanitary sewer system. Heat is usually applied at 130ºC (266ºF) for mammalian cells. Chemicals used include caustic or acid.

BLA (Biologics License Application)
The required application for marketing a biologic product in the United States. Most biopharmaceuticals are biologics.

Blank
A preliminary analysis omitting only the sample to provide an unbiased reference point or baseline for comparison. It is important to minimize extraneous contamination that could be confused with constituents in the sample itself.

Blind Weld
A "blind weld" is defined as a pipe or tube joint welded automatically in which there is no physical way to inspect the weld either visually or with a borescope.

Blinding Clinical trial technique in which, to eliminate bias in a research study, subjects and/or clinical investigators remain unaware of which investigational product is provided.

Blood-Borne Pathogens
Infectious microorganisms that are carried in the blood of infected humans or animals and that can be transmitted through contact with infected blood, body fluids, tissues, or organs. Blood-borne pathogens are implicated in diseases such as malaria, syphilis, brucellosis, tuberculosis, hepatitis B, and AIDS (Acquired Immunodeficiency Syndrome). Workplace transmission of a blood-borne pathogen can occur via accidental inoculation with a contaminated "sharp" exposure through open cuts, skin abrasions, and mucous membranes of eyes and mouth indirect transmission (e.g., touching mouth, eyes, nose or open cuts with contaminated hands).

Blood Corpuscle
A cell that circulates in the blood.

Blood Plasma
Blood from which all blood corpuscles, with the exception of platelet cells, have been removed (e.g. by centrifugation) resulting in a clear, straw-colored fluid, which clots as easily as whole blood.

Blood Platelets
Small, disc-shaped, metabolically active cells circulating in the blood. They are essential in the blood clotting process since they aggregate to form a plug on the injured surface of the blood vessel.

Blood Serum
The liquid expressed from clotted blood or clotted blood plasma.

Blowdown
The bleeding-off of fixed quantities of accumulated feed water to reduce concentrated impurities. If these impurities are permitted to accumulate, they may pass through the distillation process and contaminate the distillate or foul the distillation system.

Blowdown
The withdrawal of water from an evaporating water system to maintain a solids balance within specified limits of concentration of those solids.

Blow (Form) Fill, Seal
Refers to machines that combine formation of a plastic container by blow molding, aseptic filling of a liquid product and sealing of the final package. In the U.S., a major company is ALP, or Automatic Liquid Packaging (Weiler Engineering) and in Europe, Rommilog.

BME (Basic Medium Eagles)
One of the most common tissue culture media composed of isotonic salts, carbohydrates and vitamins. When combined with animal serum. BME is a good medium for cell proliferation.

BOD (Biochemical Oxygen Demand)
The amount of oxygen required to oxidize the dissolved organic matter in a water sample by aerobic (bacterial) decay. A measure of the oxygen depletion that would result from discharging organic impurities into a waterway.

BOD (Biological Oxygen Demand)
The oxygen used in meeting the metabolic needs of aerobic organisms in water containing organic compounds.

BPC (Bulk Pharmaceutical Chemical)
A pharmaceutical product derived by chemical synthesis, in bulk form, for later dispensing, formulation or compounding, and filling in a pharmaceutical finishing facility.

Breakthrough Passage of a substance through a bed, filter, or process designed to eliminate it. For ion exchange processes, the first signs are leakage of ions (in mixed beds, usually Silica) and the resultant increase in conductivity. For organic removal beds, usually small, volatile compounds (Trihalomethanes (THMs) are common in activated carbon).

BSE (Bovine Serum Albumin)
A blood protein that makes up approximately 55-65% of the proteins in the bovine serum. Used as a size marker on gels and as carrier protein.

BSE (Bovine Spongiform Encephalopathy)
Sometimes called "Mad Cow Disease". A disease of cattle presumably caused by a virus or other unidentified entity that affects the brain and causes the cow to behave erratically. Prevalent in parts of Europe but not in the United States. BSE is a contaminant that is undesirable in bovine sera. It is not known whether the causative agent can be filtered out since the causative agent itself is not known. In humans, it is believed to cause Creutzfeld-Jacob, a disease affecting the nervous system.

BVD (Bovine Viral Diarrhea)
Viral contaminant found in bovine sera. Able to be filtered out using 0.1 µm nylon filters.

Bovine Of, relating to, or from a cow: such as Bovine Blood: blood from a cow.

Braze Welding
A welding process using nonferrous filler metal that has a melting point below that of the base metals, but above 427ºC (800ºF). The filler metal is not distributed in the joint by capillary attraction. This type of welding has been also called Bronze welding, a misnomer.

Brazing
A metal joining process wherein coalescence is produced by use of a nonferrous filler metal having a melting point above 427ºC (800ºF), but lower than that of the base metals being joined. The filler metal is distributed between the closely fitted surfaces of the joint by capillary action.

Breakthrough
The first appearance in the effluent of an ion-exchange unit of unadsorbed components similar to those that deplete the activity of the resin bed. Breakthrough indicates that the resin is exhausted and needs to be regenerated.

Breath Control Shields
Typically made of acrylic or plastic materials, shields protect product, equipment, or the work from particulate contamination expelled by people.

Broad Spectrum
Over a wide range. A broad-spectrum disinfectant is effective against a wide range of microorganisms including bacterial spores, mycobacteria, non-lipid and lipid viruses, fungi, and vegetative bacteria.

Broth
The liquid culture medium in which fermentation or cell culture takes place.

Btu (British thermal unit)
The unit used to measure the amount of heat in a substance. One Btu is the heat required to produce a temperature rise of 1°F. in one lb. of water.

Bubble Point Test
A filter leakage test in which the filter is wetted and air pressure is applied and slowly increased until water is expelled from the largest pores and bubbles appear from a submerged tube in a downstream collection vessel. Vigorous bubbling, as opposed to a diffusional airflow or occasional bubbles, is indicative of reaching the bubble point. This visual test can be fairly accurate for low area filters, such as discs. When used to evaluate high area filters, it is subject to limitations in observation, test time, collection conditions, and pressurization rates. The bubble point test is not recommended for integrity testing of filter cartridges.

Buffer
A substance capable of neutralizing both acids and bases in solution, thereby maintaining the original acidity or causticity of the solution.

Buffer Prep
Area Section of most biotech facilities devoted to the preparation of controlled bioburden buffer solutions for use in the chromatographic separation area of those facilities.

Building Occupancy Classification (California Building Code)
Every building, whether existing or to be erected, is classified by the building official according to its use or the character of its occupancy. The occupancy groups are as follows:

1. Group A - Assembly (Section 303.1.1)

2. Group B - Business (Section 304.1)

3. Group C - Organized Camp (Section 431A)

4. Group E - Educational (Section 305.1)

5. Group F - Factory and Industrial (Section 306.1)

6. Group H - Hazardous (Section 307.1) (also see: Hazardous Occupancy - Group H)

7. Group I - Institutional (Section 308.1)

8. Group M - Mercantile (Section 309.1)

9. Group R - Residential (Section 310.1)

10. Group S - Storage (Section 311.1)

11. Group U - Utility (Section 312.1)

Bulk Handling
The transferring of flammable or combustible liquids from tanks or drums into smaller containers for distribution.

Bulk Oxygen System
An assembly of equipment, such as storage containers, pressure regulators, safety devices, vaporizers, manifolds, and interconnecting piping that has a storage capacity of more than 12,000 cubic feet (340 m³) of oxygen at normal temperature and pressure, connected in service or ready for service, or more than 25,000 cubic feet (708 m³) of oxygen, including unconnected reserve on hand at the site.

Bulk Pharmaceutical Chemical (BPC)
(also see: BPC (Bulk Pharmaceutical Chemical))

Byte
An abbreviation for binary term. A storage unit capable of holding eight bits or the space required for a single letter or number, a single character.

Pharmaceutical Abbreviations | Abbreviations in product information leaflets and literature
Acronyms | Glossary of Terms | Abbreviations used in the British Pharmaceutical