Glossary Terms (Simple List)
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Bacterial Endotoxin
Endotoxins are fever producing substances commonly found in the cell wall of certain Gram-negative bacteria. (TR3)
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Bacterial Endotoxin Test (BET)
Assay for measuring active endotoxin by combining a liquid test sample with Limulus amebocyte lysate (LAL) reagent and measuring the resulting proportional reaction via visual, turbidimetric, chromogenic, or other validated means of detection. (TR3)
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Bacteriophage
A bacteriophage is any one of a number of viruses that infect bacteria. The term is commonly used in its shortened form, “phage”. (TR41) (TR 47)
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Ballotini
Small glass beads (spheres) obtainable in a range of sizes, used in the recovery of spores from paper carriers. (TR51)
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Barrier System
A system of physical partitions that affords ISO 5 protection by partially separating its interior from the surrounding environment utilizing airflow. (TR22) (TR62)
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Batch
A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified acceptance criteria, and is produced according to a single manufacturing order during the same cycle of manufacture (TR38)
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Batch Filtration Process
In a batch filtration process, the entire volume to be filtered is held in a single feed tank. The retentate stream is recycled back to that single feed tank. (TR15)
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Batch Oven
A convection oven with a chamber or chambers where items are dry-heat sterilized or depyrogenated as a single load in a discontinuous process. The oven typically uses one or more filters to remove air particles. (TR3)
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Batch Process
A process where there are no streams flowing into or out of a controlled volume, as opposed to a continuous process. In a batch filtration process, the feed solution is reduced in volume due to permeation of filtrate through the filter. There is no continuous addition of feed solution to the feed vessel. (TR45)
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Batch Record Review
Review by the quality control unit of the batch manufacturing record for accuracy and completeness and for absence of derivation from the approved manufacturing and testing processes. The batch record is inclusive of all in-process testing and release records for a batch. (TR88)