|
You can always search for entries (regexp permitted). |
|
View Glossary |
|
B| There are 98 entries in the glossary. |
| Pages: 1 2 3 4 5 » |
| 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. |
| | |
| Back-up Copy | A magnetic copy of data, software, user-developed application, or operating parameters associated with an automated system and not considered the original. |
| | |
| Background Contamination | Contamination introduced accidentally in reagents, dilution water, solvents, rinse water, etc., which can be confused with constituents in samples being analyzed. |
| | |
| Background Environment | The environment that surrounds a critical area. |
| | |
| Backward Compatibility | 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. |
| | |
| Backwash | 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. |
| | |
| Bacteria | The plural of Bacterium. |
| | |
| Bactericide | An agent that kills vegetative bacteria but not mycobacteria or spores. |
| | |
| Bacteriophage | A virus that exclusively infects bacteria. A protein coat surrounds the genome (DNA or RNA). One of the bacteriophages most extensively studied is the lambda phage, which is also one of the most important viral vectors used in rDNA work. Lambda promoters have been used to express eukaryotic proteins in E.coli. |
| | |
| Bacteriostatic | Inhibiting growth of bacterial organisms without necessarily killing them or their spores. |
| | |
| Bacteriostatic Water | For Injection, U.S.P. 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. |
| | |
| Bacterium | Any of a large group of microscopic organisms having round, rod-shaped, spiral, or filamentous unicellular or noncellular bodies that are often aggregated into colonies, are enclosed by a cell wall or membrane (prokaryotes), and lack fully differentiated nuclei. Bacteria range in size from 0.4µm to 2.0µm and may exist as free-living organisms in soil, water, organic matter, or as parasites in the live bodies of plants. Some are disease producing, but most perform necessary functions such as digestion, fermentation, and nitrification. Most of the forms are variously grouped under generic names such as: Alcaligenes, Dialister, Escherichia, Klebsiella, Kurthia, Pasteurella, Salmonella, and Shigella. |
| | |
| Barrier Isolator | A containment device that utilizes barrier technology for the enclosure of a controlled workspace. There are two main types of isolator: 1. Type 1 Isolator: An isolator designed to protect the product from process-generated and external factors that would compromise its quality. 2. Type 2 Isolator: 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. |
| | |
| 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 devices |
| | |
| Base | 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-). |
| | |
| Base Pair (bp) | Two nucleotides that are in different nucleic acid chains and whose bases pair by hydrogen bonding. In DNA, the nucleotide bases are adenine (A) that always pairs with thymine (T) and guanine (G) which pairs with cytosine (C). In RNA molecules, adenine (A) joins the uracil (U). Two strands of DNA are held together in the shape of a double helix by the bonds between these pairs. |
| | |
| Base Sequence | The order of nucleotide bases in a DNA molecule. |
| | |
| Base Sequence (ii) | Analysis A method, sometimes automated, for determining the base sequence |
| | |
| Baseline | In some analytical procedures a sample is dissolved in water or combined with other reagents for analysis. A "blank" or standard consisting of the same reagents may be analyzed without sample present. This provides a comparative reference point, or baseline, so that the test results can be attributed solely to the sample itself. |
| | |
| Baseline® Pharmaceutical Engineering Gui | A series of industry publications developed in partnership with the US Food and Drug Administration (FDA). Each volume in the series is a collaborative effort of industry leaders representing a broad cross-section of manufacturers and other industry experts. The Guides document current industry practice for facilities and systems used for production of pharmaceutical products and medical devices. They are intended to: - Establish a baseline approach to new and renovated facility design, construction, commissioning, and qualification that is based upon clear understanding of the type of product and its manufacturing process.
- Prioritize facility design features based upon the impact on product and process.
- Avoid unnecessary spending on facility features that do not contribute to consistent production of quality products.
- The Guides include five product manufacturing operation based guides (vertical guides), and three support system/function based guides (horizontal guides):
- 1. Volume I - Bulk Pharmaceutical Chemicals (1996)
- 2. Volume II - Oral Solid Dosage Forms (1998)
- 3. Volume III - Sterile Manufacturing Facilities (1999)
- 4. Volume VI - Biotech (in progress)
- 5. Volume -Oral Liquids and Aerosols
- 6. Volume IV - Water and Steam Systems (in progress)
- 7. Volume V - Commissioning and Qualification Guide (in progress)
- 8. Volume VII - Packaging and Warehousing
|
| | |
|
|
Glossary V2.0 |
