Temperature
Temperature is the measure of thermal energy. (TR01)
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Virus (Relevant Virus)
A virus used in process evaluation studies that either is the virus, or of the same species as a virus known to or possible to contaminate the cell substrate or any other reagents or materials used in the production process. (TR47)
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Temperature Controlled
The sequence of transportation events, from the manufacturer of the API up to the receipt of the final packaged product by the end user, which maintains temperature sensitive products within approved temperature specifications. Maintaining temperature control during these transportation events assures that product quality is maintained. (TR39)
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Temperature-Controlled Distribution
Material handling and movement of goods from an origin site to a receiving site, where the goods are kept within a specified temperature range using active and/or passive systems. (TR58)
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Temperature Probe/Sensor
A generic term used to describe any type of temperature measuring device that works through contact with the material or atmosphere to be measured. [Synonyms: Load Probe, Heat Penetration Probe, Temperature Distribution Probe, Drain Probe] (TR48)
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Temperature Excursion
Any event in which product is exposed to temperatures outside of the recommended storage and/or transport temperature range. (TR39)(TR58)
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Temperature Probe
A sensor (e.g., thermocouple or resistance temperature detector (RTD)) that has been specifically designed to measure temperature. Temperature probes may be control, resident, surface mounted, validation, mapping, or permanent. (TR61)
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Temperature Distribution
Temperature measurement of the heating medium (e.g., forced hot air) across the chamber load zone. (TR01) (TR03) (TR30) (TR48)
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Temperature Monitor
A unit that measures the prevailing temperature. Several types exist, including: • Stationary monitors installed in (cold) storage warehouses or storage facilities; • Mobile monitors that include: • Chemical indicators that change color when exposed to temperature over time • Electronic indicators that indicate temperature excursions, but provide little or no summary data • Electronic or mechanical data loggers that record and store temperature data for retrieval after arrival • Transmitting monitors that transmit near real-time data and excursion events using wireless/satellite interfaces and software for “logical analysis” of data. (TR58)
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Temperature Sensitive Products
Products whose quality may be adversely affected by temperature extremes (e.g., frozen, refrigerated, and certain controlled room temperature products). (TR39)
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Temperature-Controlled Ocean Container
An actively cooled metal box, most commonly 20 or 40 foot long which can be easily transferred between different modes of transportation, such as ships, trains and trucks. Sometimes it is called a reefer container or intermodal container. (TR58)
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Temperature-Controlled Ocean Container (Reefer, Intermodal Container)
An actively cooled metal box (commonly 20 or 40 ft long) that can be easily transferred between different modes of transportation, such as between ships, trains, and trucks. (TR64)
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Temperature Profile
Anticipated ambient temperature variation and duration to which product may be exposed during transportation. (TR39)
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Technical Diligence
The means by which the technical capabilities of the SUS, its supplier and its fit with the end user are verified. It is complimentary to a quality audit program and becomes a recurring theme over the implementation process and subsequent routine procurement. (TR66)
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Unit Operation
A discrete step or manipulation in a manufacturing process where process and operating parameters are defined to achieve a specific process objective. [Synonym: process step] (TR74)(TR14)
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Transfectoma
Cells expressing exogenous proteins or reporter genes, produced by the transfection of continuously growing cells with gene expression constructs. (TR50)
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Viable
Alive and able to be cultured in the laboratory. (TR69)
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Throughput
The amount of solution that passes through a filter, described as volume per membrane area. [Synonym: capacity.] (TR15) The amount of solution that passes through a filter. It is described as volume through the membrane area. [Synonym: capacity] (TR26)
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Vapor
The gaseous form of materials that are normally liquids or solids at room temperature and pressure. (TR51)
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Viable but Nonculturable (VBNC)
Unable to be cultured in the prevailing test conditions but nonetheless capable of cell division and carrying out metabolic functions (TR69)
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Thumb Pad
Disk at end of plunger rod. (TR73)
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Toxicity Studies (also referred to as “Tox” studies)
In vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions with the primary goals of identifying the following: 1) an initial safe dose and subsequent dose escalation schemes in humans; 2) potential target organs for toxicity and for the study of whether such toxicity is reversible; and, 3) safety parameters for clinical monitoring after the appropriate dosing and administering schedule is followed (relevant to the drug being studied). In toxicity studies, the test animals are examined by histological or serological methods in order to identify toxic, mutagenic, or teratogenic effects of the drug. It is sometimes possible to collect physiological data from the animals prior to sacrifice. Some toxicity studies may be performed using cell culture methods. Toxicity studies are also described by the U.S. FDA as “nonclinical laboratory studies” and by ICH as “preclinical safety evaluations”.
The definition does not include studies using human subjects or clinical studies, field trials in animals, or any basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics as described in ICH S6 and 21 CFR Part 58 (GLP). (TR56)
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Transmission Electron Microscopy (TEM)
A microscopy technique whereby a beam of electrons is transmitted through an ultra-thin specimen, interacting with the specimen as it passes through it. An image is formed from the electrons transmitted through the specimen, which are magnified and focused by an objective lens, and appear on an imaging screen. (TR41)
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Velocity
The average linear rate of fluid flow equal to the volumetric flow rate divided by the cross-sectional area of the flow channel. (TR15)
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Value Stream Map
A tool used to document, analyze, understand and improve the flow of information or materials required to produce a product or service for a customer as it makes its way through the value stream. (TR68)
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Tissue Culture Infectious Dose – TCID50
The dilution of virus that results in the probability of infection of 50% in replicate tissue-culture inoculations. (TR41)
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Titer Reduction (TR)
A measure of the degree to which a particular filter removes a microorganism under specified test conditions. Calculated as the ratio of the total number of microorganisms used to challenge the filter divided by the total number of microorganisms that passed through the filter. (TR75)
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Transport Service Provider
Contracting party who mediates or executes the transportation of medicinal products on behalf of the shipper. (TR39)
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Temperature-Controlled Truck or Trailer
A cargo box attached to a truck chasse or as a trailer pulled by a truck that is equipped with a temperature control unit (TCU) to provide active cooling or heating control inside the box. Refrigerated trucks or trailers are sometimes referred to as “reefers”. The temperature control units are typically powered by an integrated engine or gen-set and not the engine that is used to propel the truck. (TR58) A cargo box attached to a truck chassis or consisting of a trailer pulled by a truck that is equipped with a TCU to provide active cooling or heating control inside the box (refrigerated trucks or trailers are sometimes referred to as “reefers”). (TR64)
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Unidirectional Air Flow Hood (UAFH)
A cabinet designed to protect materials from operator and environmental contamination. Also referred to as laminar air flow hood. (TR62)
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Transcription-Mediated Amplification (TMA)
An isothermal NAT method that can amplify RNA or DNA targets a billion-fold in less than one hour. TMA technology uses two primers and two enzymes: RNA polymerase and reverse transcriptase. (TR50)
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Ultrafiltration Membranes
Membranes that retain particles whose sizes are measured by molecular weight, with retention ranges from 1,000 to 1,000,000 (Daltons). (TR41)
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Transportation Service Providers (TSP)
Companies that physically transport the product. (TR52)
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Vapor Phase Hydrogen Peroxide (VPHP)
A disinfection system in which 35% hydrogen peroxide is changed to a vapor phase and used for bioburden reduction of a chamber or items in a chamber. (TR70)
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Virus (Non-specific Model Virus)
A virus used for characterization of viral clearance of the process when the purpose is to characterize the capacity of the manufacturing process to remove and/or inactivate viruses in general, i.e., to characterize the robustness of the purification process. (TR47)
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Viral Clearance
Elimination of a target virus by removal of viral particles or by inactivation of viral infectivity. (TR41)
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Trend Analysis
Analysis of environmental data over time indicating a shift; adverse trends require investigation. (TR70) A review performed in response to an alert or action condition. This review provides an analysis of specific environmental monitoring data to identify adverse trends.(TR13)
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Tub
Plastic box that contains a vertically oriented syringe nest and is sealed with a lid. (TR73)
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Terminal Sterilization
A process whereby product is sterilized within its sterile barrier system. (TR01 The application of a lethal agent to sealed, finished drug products for the purpose of achieving a predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e., a probability of a nonsterile unit of less than one in a million). A process where the material is sterilized in its final packaged configuration. (TR13)
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Two One-Sided T-Test
A method for declaring the comparability of equivalence that is built around comparing two or more group means and their respective mean difference confidence intervals against predetermined equivalence limits. (TR57-2)
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Transition Analysis
Mathematical evaluation of the chromatogram tracing as the mobile phase changes from one solution to another. An alternative to HETP and peak asymmetry for evaluating column packing and performance. (TR14)
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Unwanted Event or Condition
Lack of sterility assurance or an unacceptable level of endotoxin that could result in harm to the patient. (TR44)
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Transport Service Agreement
A contractual agreement that describes the legal, logistical, technical and quality terms or contractual arrangements between shippers and transport services providers. Different names might be used for this type of agreement in different companies. (TR39)
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Tertiary Packaging Component
A component that is used to assemble secondary or primary packages in the form of the basic transportation unit and to provide protection against mechanical impact. Examples are corrugated cardboard boxes, but corresponding plastic boxes/containers are also used. (TR39)
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Virus
A simple, potentially pathogenic organism composed of a single type of nucleic acid (DNA or RNA) encased in a protein shell (called a capsid) and, in some cases, a lipid membrane (called an envelope). Viruses are incapable of independent replication and therefore must infect a host cell in order to propagate. (TR41)
Obligate, intercellular, replicating, infectious agents that are potentially pathogenic, possessing only a single type of nucleic acid (either RNA or DNA). They use the host cells for propagation as they are unable to grow independently, for example by binary fission, and multiplying their genomic material. (TR47) (TR83)
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Transportation Study
Study performed to generate data to evaluate the effect of temperature variation on the product during transportation on product quality. Other test, such as vibration, pressure, and drop tests, may be considered. (TR39)
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Validation
A documented program that provides a high level of scientific assurance that a manufacturing process will reliably produce acceptable product. The proof of validation is obtained through rational experimental design and the evaluation of data, preferably beginning from the process development phase and continuing through the commercial production phase. (TR01)
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria. (TR26) (TR57) (TR70) (TR74)
Documented testing, performed under highly controlled conditions, which demonstrates that a process consistently produces a result that meets predetermined acceptance a result that meets predetermined acceptance criteria. Used to test processes, methods, and systems for which conditions can be controlled in the real world (i.e., after completion of testing, when the process is in use). Transportation processes can be qualified but not validated; in the real world, it is not possible to exert control over all parameters that could affect the transportation process (e.g., weather, customs, traffic delays, mechanical failures, etc.). (TR58)
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting predetermined acceptance criteria. (Note: Validation is a lifecycle program which may include development and qualification activities for one or more elements/systems that form a process.) (TR54-5)
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria (17). (TR60-3)
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Upstream
The influent side of the filter. (TR45) (TR26)
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Touchdown PCR
A technique to reduce appearance of non-specific amplicons in PCR reactions. The earliest cycles of a touchdown PCR method have high annealing temperatures. The annealing temperature is decreased in increments for subsequent cycles until a fixed point is reached. (TR50)
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Verification
A systematic approach to verify that manufacturing systems, acting singly or in combination, are fit for intended use, have been properly installed, and are operating correctly. This is an umbrella term that encompasses all types of approaches to assuring equipment is fit for use. Approaches include qualification, commissioning and qualification, verification, system validation, or other. (TR3) (TR60)
A systematic approach to verify that manufacturing systems, acting alone or in combination, are fit for intended use, have been properly installed, and are operating correctly. This is an umbrella term that encompasses types of approaches such as qualification, commissioning and qualification, verification, and system validation. (TR60-2)
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