Historian
A type of database designed to archive automation and process data. (TR84)
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Host Cells/Parental Cells
A non-transfected cell substrate that is generally well-characterized and banked. It can be manipulated to generate a cell substrate for production of a biological medicinal product. (TR83)
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Hybrid Approach (WHO)
The use of a computerized system in which there is a combination of original electronic records and paper records that comprise the total record set that should be reviewed and retained.(TR80)
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Hemagglutination
A clumping together or agglutination of red blood cells. In the context of this Technical Report hemagglutination indicates presence of virus that binds to erythrocytes. (TR47) The clumping of red blood cells by binding to virus particles. The hemagglutination reaction is used in cell-based in vitro assays as an end point for virus detection. (TR71)
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Hydrophilic
Literally “water loving.” A filter that will wet with aqueous solutions to allow flow at a low pressure differential. (TR26)
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Harvest Testing
The screening of a biopharmaceutical bulk cell culture harvest for any adventitious contaminants, including mycoplasma, before further processing. (TR50)
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Hybridization
The formation of a double-stranded complex of complementary strands of nucleic acids (e.g., a primer and single-stranded DNA or RNA) (TR50)
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Hazard
The potential source of harm. (TR44) (TR54) (TR54-2) (TR58) (TR61)
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Hazard Analysis and Critical Control Points (HACCP)
A systematic, proactive, and preventative tool for assuring product quality, reliability, and safety (TR54-3) (TR54) A management system in which potential hazards are addressed through the identification and control of key risk factors (critical control points) of the biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. (TR55)
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Hydraulic Shock
See definition for Pressure Shock. (TR45)
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Human Factors
A science discipline that examines human psychological, social, physical, and biological characteristics to evaluate the design, operation, or use of products or systems for optimizing human performance, health, safety, and/or habitability. [Synonym: Ergonomics] (TR62)(TR80)
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High-Efficiency Particulate Air (HEPA) Filter
A type of air filter that must satisfy certain standards of efficiency such as those set by the United States Department of Energy (DOE). The air filter must remove 99.97% of all particles greater than 0.3 micrometer from the air that passes through it. (TR62) (TR70)
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Heat Penetration
Heat penetration testing is a temperature measurement that is used to evaluate the amount of energy that has been transferred to the materials that are to be sterilized within the load. For measurements of heat penetration, the probes should be placed on or in the load items being evaluated. (TR01) (TR3) (TR30) (TR48)
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Hazardous Situation(s) [Cause(s
Circumstances in which people, property, or the environment is exposed to a hazard. (TR54-2)
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Half-Cycle Qualification
A qualification method that uses fifty percent of the exposure time to demonstrate sterilization cycle efficacy. The physical and biological lethality values achieved in the half-cycle exposure time are doubled to project the lethality that will be achieved by the full cycle.(TR01)
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Henry’s Law Constant
Henry’s law can be put into mathematical terms (at constant temperature) as p=kH x c, where p is the partial pressure of the solute, i.e.. TBA in the gas above the solution, c is the concentration of the solute and kH is a constant with the dimensions of pressure divided by concentration. The constant, known as Henry’s law constant, depends on the solute, the solvent and the temperature. (TR55)
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Hemadsorption
Adherence of red blood cells to virus-specific antigens on the surface of infected cells. In cellbased in vitro assays the reaction is used as an end point for virus detection. (TR47) (TR71)
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Health Hazard Evaluation (HHE)
A tool for classifying a voluntary recall by a firm. The HHE guides the US FDA in determining the risk to the public from the defective product and appropriate actions for the firm and the FDA to take to protect public health. (TR55)
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Highly Hazardous Drug Active
A drug active that can cause serious adverse effects at typical doses. Those adverse effects are generally not related to the main therapeutic activity of the drug, and includes effects such as carcinogenicity, mutagenicity, genotoxicity, reproductive hazards, allergenicity, and cytotoxicity. (TR29)
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Heat-up Phase
The phase of a sterilization cycle that occurs prior to the exposure phase. Process parameters are developed for this phase in order to meet applicable user requirements for load conditioning (e.g., air removal and preheating.) (TR01) (TR3) (TR48) (TR61)
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Hydraulic Pressure
Pressure that results from forcing liquid through an orifice, pipe or other channel. (TR45)
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HETP (Height Equivalent to the Theoretical Plate)
A measurement of column packing efficiency or integrity, calculated from the column height divided by the number of theoretical plates. (TR14)
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Heat
Energy that is transferred as a result of a temperature difference between an object and its surrounding. (TR01) (TR3)
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Heating, Ventilating, and Air-Conditioning (HVAC)
Refers to technology of indoor and automated environmental control. (TR70)
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Heat-Treated Wood Pallets
Two types of methods to include kiln drying versus steam heat. (TR55)
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Heat Transfer
Energy that is transferred as a result of a temperature difference between an object and its surroundings. (TR48)
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Historical Data
For purposes of this guidance, data on impurities or physical attributes from three or more consecutive, representative pre-modification batches. (TR38)
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Hold-Up Volume (Residual Volume, Nonexpellable Volume, Dead Volume)
Amount of fluid remaining in the syringe when the plunger has reached the end of travel within the barrel. (TR73)
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Hazard and Operability Analysis (HAZOP)
A structured, systematic and qualitative technique for examination of a planned or existing process or operation in order to identify and evaluate problems that may represent risks to personnel or equipment, or prevent efficient operation. (TR54)
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High Density-Polyethylene (HDPE)
A linear polymer, HDPE is prepared from ethylene by a catalytic process. The absence of branching results in a more closely packed structure with a higher density and somewhat higher chemical resistance than low-density polyethylene (LDPE). (TR55)
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Harm
Damage to health, including damage occurring from loss of product quality or availability. (TR44) (TR54) (TR54-2) (TR54-4) (TR68)
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Hydrophobic
Literally “water fearing.” A filter that repels aqueous and other high-surface tension fluids and therefore cannot be wetted unless subjected to a high pressure differential. When prewetted with low surface tension fluid, such as alcohol, the membrane will allow water flow at a low pressure differential. (TR26)
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