Glossary Terms (Simple List)
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Nuclease
An enzyme capable of cleaving the phosphodiester bonds between the nucleotide subunits of nucleic acids. (TR47)
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Nucleic Acid Amplification Technique (NAT)
A method for detection, and in some cases, quantification of target organisms via detection of organism specific nucleic acid. PCR or polymerase chain reaction is a common NAT method that is based on amplification of targeted sequences using primers and specialized DNA polymerases. (TR50)
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Nucleic Acid Sequence Based Amplification (NASBA)
An isothermal amplification method targeting RNA in which amplifications of RNA occurs via DNA intermediates. Each of the DNA templates can make 100 to 1000 copies of RNA amplicons, potentially resulting in the production of greater than a billion amplicons. (TR50)
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Nucleic Acid Standard
A sample with a precisely measured content of specific nucleic acid. A nucleic acid standard can be serially diluted to assess the limit of detection of an NAT assay or to create a standard curve for Q-PCR to determine the concentration of target nucleic acid. (TR50)
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Objectionable Microorganism
According to 21 CFR 211.113 objectionable microorganisms can be: product related or recipient related. Please see glossary for "product related" or "recipient related" for additional information. (TR67)
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Occult Contamination
A cell culture contamination not immediately apparent by visual inspection or other obvious indicators. (TR50)
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Occurrence
The likelihood that the cause of the failure will happen, resulting in harm to the patient. The likelihood that a unit operation that could potentially cause a failure, happens in such a way that does cause the failure. The FMEA rating scale that defines the frequency of a failure mode. (TR44)
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Occurrence (O)
Probability that an event that leads to harm will occur. (TR54-2) (TR54-3)
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Odor Perception
Odors are perceived through stimulation of receptor cells and nerve endings of the trigeminal nerve in the olfactory epithelium, which lie in a small area in the upper reaches of the nasal cavity. Odors are perceived directly through the nose (orthonasal) or during gestation when volatile odorous organaohalogens reach the olfactory centers through the nasopharyneal passage (retonasal). (TR55)