Glossary

Bacillus

A type of lymphocyte (B lymphocyte) produced and matured in the bone marrow, and normally involved in the production of antibodies to combat infection. During infections, individual b-cell clones multiply and are transformed into plasma cells, which produce large amounts of antibodies against a particular antigen on a foreign microbe.

Biovailability/Bioequivalence

Bacterial Artificial Chromosome

Large segments of DNA, 100,000 to 200,000 bases, from another species cloned into bacteria. Once the foreign DNA has been cloned into the host bacteria, many copies of it can be made.

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.

A rod-shaped bacterium.

A bacterium commonly used as a host in recombinant DNA experiments. Important because of its ability to secrete proteins.

Naturally occurring soil bacterium that generates a protein toxic to a variety of lepidoptera, such as corn borers, but is harmless to people and animals.

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

(also see: Background Medication)

The environment within the test enclosure.

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

The environment that surrounds a critical area

An average or expected amount of a substance or radioactive material in a specific environment, or typical amounts of substances that occur naturally in an environment

A medicinal product that is administered to each of the subjects (independent of treatment assignment) to treat the indication that is the object of the study. This therapy is generally considered the current standard of care. Background medication is considered a NIMP.

Count produced by a discrete-particle counter due to internal or external unwanted electronic signal when no particles exist.

The process by which electronic data and document stores are regularly copied and retained for the purpose of restoration following a problem. Back-up copies are generally retained for a short term.

Keeping a safe copy of information (usually done on a regular basis) so that in can be recovered in the event of loss due to human error, hardware or software failure, data corruption, theft, sabotage, or natural disaster. Backup copies need to be stored and maintained with the same degree of care as live data, as this is what the data becomes when it is restored from the backup copy.Backup copies are often employed for short-term recovery with an archive used for long-term storage. However, an electronic archive also should have a backup. Another distinction between backup and archive is that the backup will contain copies of master records, whereas the archive is deemed to contain the master records.

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.

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.

The process of flowing water in the opposite direction from normal service flow through a filter bed or ion exchange bed. The purpose of backwashing a sand filter is to clean it by washing away all the material it has collected during its service cycle. The purpose of backwashing a carbon filter is also to clean it, but primarily to eliminate flow channels that might have formed and to expose new absorption sites.

Bulk Activities Postapproval Changes

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. (also see: Pyrogen)

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. (also see: Pyrogen)