Glossary Terms (Simple List)
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CFU: Genome Copy Ratio
The relationship between the number of colony forming units counted on solid media and the number of genome copies measured using a method suitable for quantitative assessment of genomic DNA. (TR50)
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CGMP Record (FDA)
When generated to satisfy a CGMP requirement, all data become a CGMP record. You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements, including, but not limited to, §§ 211.100(b) and 211.160(a). FDA expects processes to be designed so that quality data is created and maintained and cannot be modified. (TR80)
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Challenge Concentration
The concentration in Colony Forming Units/mL of the test microorganism in the challenge fluid. (TR75)
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Challenge Fluid
The carrier fluid in which the test microorganism is suspended and delivered to the test filter. (TR75)
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Challenge Level
The concentration of the test microorganism applied to the test filter (per centimeter squared) or the total number of cells applied to the test filter at the completion of the challenge. (TR75)
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Challenge Volume
The volume of challenge fluid applied to the test filter. (TR75)
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Chamber
The primary component of a sterilizer that contains the items to be sterilized. The chamber is a pressure rated vessel. (TR1) (TR 48)
The primary structural element of a sterilizer that contains the products to be sterilized. The chamber is a pressure (positive and/or negative) rated vessel. (TR30)
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Chamber Cold Spot
The location(s) within the load zone that achieves the lowest process lethality (F0) and/or the lowest distribution temperatures during the sterilization process. (TR01)
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Chamber Heat-Up Time
The elapsed time measured from the introduction of steam in the heat-up phase (“steam on”) to the point when the temperature of the heating medium within the chamber reaches the exposure temperature set point. (TR01)
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Chamber Leak Test
A test conducted to evaluate possible air infiltration to the chamber under vacuum. [Synonym: Vacuum Leak Test] (TR1) (TR48)