Glossary

The plural of Bacterium

Single-celled microorganisms measured in high purity water by several means: culturing, high power microscope, or Scanning Electron Microscope (SEM). The value is reported as Colony Forming Units (CFU), or colonies per milliliter or per liter. The bacteria in the water act as particle contamination on the surface of the product, or as a source of detrimental by-products.

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

A virus that infects bacteria. Also called simply phage. Altered forms are used in DNA cloning work, where they are convenient vectors. The bacteriophages most used are derived from two “wild” phages, called M13 and lambda.Lambda phages are used to clone segments of DNA in the range of around 10-20 kb. They are lytic phages, i.e., they replicate by lysing their host cell and releasing more phages. On a bacteriological plate, this results in a small clear zone – a plaque. Some lambda vectors have also been developed which are expression vectors. The M13 system can grow inside a bacterium, so that it does not destroy the cell it infects but causes it to make new phages continuously. It is a single-stranded DNA phage, and is used for the Sanger di-deoxy DNA sequencing method. Both of these phages grow on Escherichia coli as a host bacterium.

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

(USP) 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.

Common name for the class Schizomycetes: minute (0.5-5 µm), unicellular organisms, without a distinct nucleus. Bacteria are prokaryotes, and most of them are identified by means of Gram staining. They are classified on the basis of their oxygen requirement (aerobic vs anaerobic) and shape (spherical = coccus; rodlike = bacillus; spiral = spirillum; comma-shaped = vibrio; corkscrew-shaped = spirochaete; filamentous). Bacteria usually reproduce asexually, by simple cell division, although a few undergo a form of sexual reproduction, termed conjugation. A few bacteria can photosynthesize (including green-blue cyanobacteria), some are saprophytes and others are parasites and can cause diseases. They are major agents of fermentation, putrefaction and decay, and frequently a source of contamination in tissue culture. In plant pathology, strains of bacteria causing disease in specific plant cultivars are called pathovars.Most of the forms are variously grouped under generic names such as: Alcaligenes, Dialister, Escherichia, Klebsiella, Kurthia, Pasteurella, Salmonella, and Shigella.

Baculoviruses are a class of insect virus which have been used to make DNA cloning vectors for gene expression in eukaryotic cells. Baculoviruses have a gene which is expressed at very high levels late in their infection cycle, filling the nucleus of the cell with many-sided bodies full of a protein which is not needed to produce more viruses, but is necessary for the virus’s spread in the wild. In a vector cloning system, this gene is replaced by one that the biotechnologist wants expressed.Production of the protein can be up to 50% of the cells’ protein content, and several proteins can be made simultaneously, so that multi-sub-unit enzymes can be made by this system. Being an animal expression system, baculoviruses produce proteins that are glycosylated (addition of carbohydrates) like the proteins in animals, making it an attractive option for the production of biopharmaceuticals. In addition, baculoviruses are non-infective and non-pathogenic to vertebrates.

Brief Adverse Effect Report Review (CDRH)

Pressure-driven separation devices that remove particulate matter larger than 1 micrometer using an engineered porous filtration media. They are typically constructed of a non-rigid, fabic filtration media housed in a pressure vessel in which the direction of flow is from the inside of the bag to outside.

Bacteriological Analytical Manual

Range of frequencies used for transmitting a signal. A band can be identified by the difference between its lower and upper limits, i.e. bandwidth, as well as by its actual lower and upper limits; e.g., a 10 MHz band in the 100 to 110 MHz range.

The transmission capacity of a computer channel, communications line or bus. It is expressed in cycles per second (Hz), and also is often stated in bits or bytes per second.

Building Assessment Program

(ISO) A code representing characters by sets of parallel bars of varying thickness and separation that are read optically by transverse scanning.

Biomedical Advanced Research and Development Authority

Instrument used to measure atmospheric pressure.

One whose pressure and density are related by an equation of state that does not contain the temperature as a dependent variable.

British Association of Research Quality Assurance

Means employed to provide separation.

A fluid used to separate environment from product such as water or condensate in a double mechanical seal.

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

An open system that can exchange contaminants with the surrounding area, and cannot be decontaminated to the extent possible in an isolator system.

A system of physical partitions that affords Grade 5 protection by partially separating its interior from the surrounding environment, utilizing airflow.