Glossary

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.

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

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

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. In the interest of clarifying the existing confusion between the terms “isolators” and “barriers”, and providing authoritative implementation and validation of isolation technology, the Parenteral Drug Association (PDA) published in October 2000 the Draft for Technical Report No. 34 “Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products”. 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.NOTE: Isolators, whether operated in a closed or open manner, offer significant advantages over barrier systems: isolators can be decontaminated using reproducible and validated methods, isolators do not allow the ingress of airborne contamination from the surrounding environment, and the introduction of personnel borne contamination into the isolator is precluded. In contrast, a barrier system is an open system that can exchange unfiltered air with the surrounding environment, can only be manually disinfected, and is directly accessed by gowned personnel.

Building Automation System

A key component of DNA and RNA molecules. Four different bases are found in DNA: adenine (A), cytosine (C), guanine (G), and thymine (T). In RNA, uracil (U) substitutes for thymine. Also known as nitrogenous bases. A base, a phosphate molecule and a sugar joined together constitute a nucleotide.

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-). Strong bases or alkalis are irritating and may damage tissue.

Substance whose chemical reaction characteristic is to establish new bonds by the donation of electron pairs.