Glossary Terms (Simple List)
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Sessile Microorganisms
Microorganisms that are attached to animate or inanimate surfaces, as opposed to planktonic organisms. (TR69)
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Set Point
The target for an operational parameter. The range around the set point is commonly stated in the manufacturing procedures or batch records. (TR42)(TR60-3)
The specific temperature programmed by the user into the TCU that establishes the target temperature in the CES (cold room, truck/trailer, intermodal container, or ULD). (TR64)
The value to which an operational parameter is set. The process should operate in a range around a given a set-point that is stated in the manufacturing procedures or batch records. (TR14)
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Severity (S)
A measure of the possible consequences of a hazard. (TR44) (TR54) (TR54-2) (TR54-3)(TR54-4) (TR54-5)
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Shape factor (SF)/Circularity
Provides information on the roundness of a particle. The SF value is between 0 and 1, where 1, represents a circle. A is the area of the particle and p is the perimeter. (TR85) -
Shear
Relative motion between adjacent layers of a moving liquid. (TR69)
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Shear Rate
The velocity gradient in a flowing fluid. This value is proportional to the average linear velocity and is inversely proportional to the channel height or diameter when the recirculation is in the laminar flow regime (most TFF applications). (TR15)
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Shelf Life (also referred to as expiration dating period)
The time period during which a drug product is expected to remain within the approved shelf life specification, provided that it is stored under the conditions defined on the container label. (TR63)
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Shift
Scheduled periods of work or production, usually less than 12 hours in length, staffed by alternating groups of workers. (TR22) (TR62)
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Shipper
An individual or company who tenders products for transportation. (TR39)
The person or organization responsible for arranging transportation of goods with carriers and/or freight forwarders. (TR58)
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Shipping
The transit of any material by land, sea, or air from one site to another. This may include intraplant movements. (TR39)