Glossary

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.

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.

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.

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)

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.