Technical Jargon: Terms used, which you should know

Dear friends, I am writing some blogs which will describe the technical terms which many a time are very much needed to be understood. These are helpful and there are many terms of which I am trying to give some important terms.  Some of these may be new while some may be which you are familiar with. Please do give your comments & suggestions on this effort.

Technical Jargon: Terms used, which you should know

Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and are present in the drug product in a modified form intended to furnish the specified activity or effect.

API (Active Pharmaceutical Ingredient)
Also called Drug Substance. Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that when used in the production of a drug becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.

Agarose Gel Electrophoresis
A method used to separate, identify, and purify molecules of different molecular weight and/or structure. It is specifically applied to the separation of protein or DNA fragments where it is rapid, simple, and accurate, and the separated molecules can be visualized directly by staining with dyes. The electrophoretic migration rate of molecules through agarose gel is dependent on the following parameters:
1. Molecular size: molecules pass through the gel at rates that are inversely proportional to the log of their molecular weight.
2. Agarose concentration: a molecule of a given size migrates at different rates through gels containing different concentrations of agarose.
3. Molecular conformation: a molecule of the same molecular weight but of a different conformation will migrate at different rates. Generally, closed circular or globular forms will migrate faster than linear forms.
4. Electric current: at low voltages the rate of migration is proportional to the voltage, but as the voltage is increased the rate of migration of high molecular weight fragments is increased differentially.

Airborne Particulate Cleanliness Classes
Statistically allowable number of particles equal to, or larger than 0.5µm in size per cubic foot of air. According to ISO 14644-1, a classification number, N, shall designate airborne particulate cleanliness.

Analytical Data Interchange (ANDI)
A generic file format. It was common practice before CFR 21 Part 11 to save information from analytical instruments in this file format. The disadvantage now is that the approach does not allow replaying of data on a different system to yield the same result.

Arithmetic Average Roughness (Ra)

The arithmetic average height of roughness component irregularities from the mean line measured within the sample length (L). This measurement conforms to ANSI/ASME B46.1 "Surface Texture - Surface Roughness, Waviness and Lay". Ra (formerly known as AA or Arithmetic Average in the U.S., and CLA Centerline Average in the U.K.) is usually expressed in microinches (µin), and performed by moving a stylus or profilometer in a straight line along the surface. A consistent and measurable surface finish can be specified for a desired roughness i.e., 9-11 microinch.

"At-Rest" Cleanroom

ISO 14644-1 defines "at rest" occupancy state as "condition where the installation is complete with equipment installed and operating in a manner agreed upon by the customer and supplier, but with no personnel present".European Community (EC) defines "at rest" state as "the condition where the installation is complete with production equipment installed and operating but with no operating personnel present". The Medicines Inspectorate, however, further clarifies, "It should normally be taken to mean that ventilation systems are operating and other equipment is present in an operational condition but not in use".

Auger Electron Spectroscopy (AES)

An alternative surface analysis that can detect all elements with an atomic number greater than that of helium with the additional ability to analyze sub micron-diameter features. It is not as quantitative as ESCA and cannot determine the chemical state of an element. The primary advantage of Auger is that when combined with etching, a chemical depth profile can be measured rapidly and can image the distribution on the surface of spatial limitation resolution of 100 to 1,000 angstroms (depending on the equipment capability).

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.

Bactericide

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

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

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 devicesBiodegradable
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.

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.

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).

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.

Calcium Carbonate Equivalent
The value obtained when salts are calculated in terms of equivalent quantities of calcium carbonate. This is a convenient method of reducing all salts to a common basis for comparison.