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)
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Subvisible particle
A particle with a size <100 µm in diameter. (TR85)
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Sterile/Microbial Barrier
The purported location on a container closure system beyond which no microorganism can pass under conditions qualified for the barrier. (TR86)
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Subject Matter Experts (SMEs)
Individuals with specific technical expertise such as engineers, quality experts, automation specialists, scientists, etc. (TR54-5)
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Suspensions
A suspension is a biphasic preparation consisting of solid particles dispersed throughout a liquid phase. Some suspensions are prepared and ready for use, and others are prepared as solid mixtures intended for reconstitution with an appropriate vehicle just before use. (TR79)
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Supplemental Testing or Inspection
Destructive reconstitution, dilution, transfer, clearing, solubilizing, filtration, screening, or sieving that allows a product to be visually examined or evaluated microscopically to determine the presence, type, and size of foreign particulate contamination present within the product, container, or device. (TR79)
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Sub-Visible Particle Range
Particulate matter sized below the visible particle 70% probability of detection threshold are considered in the sub-visible range, typically <100- 150 μm. (TR79)
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Semiautomated Inspection
Consists of machine-assisted handling and presentation of filled containers to allow for human visual inspection. (TR79)
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Static (at rest)
BFS machine line with conveyor belts at rest but with air shower and room ventilation in operation, extruder (heated, not running) and mold carriage in standby. No operating personnel present. (TR77)
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Supplier
The entity with whom the agreement of the quality level is made and the transaction of purchase is made; the last link in the chain of manufacturers and distributors. The supplier may be the manufacturer.(TR76)
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Sampling Plan True AQL
The quality of product for which the percent of lots expected to be accepted (Pa) is 95.0. These values are found in Tables X-A-1 to X-R-1 in ANSI/ASQ Z1.4.(TR76)
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Systems (in computer or related systems) (WHO)
A computerized system collectively controls the performance of one or more automated processes and/or functions. It includes computer hardware, software, peripheral devices, networks and documentation, e.g., manuals and standard operating procedures, as well as the personnel interfacing with the hardware and software, e.g., users and information technology support personnel.(TR80)
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Systems (in computer or related systems) (FDA, attributed to ANSI)
People, machines, and methods organized to accomplish a set of specific functions. Computer or related systems can refer to computer hardware, software, peripheral devices, networks, cloud infrastructure, operators, and associated documents(e.g., user manuals and standard operating procedures).(TR80)
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Static Record Format (WHO)
A static record format, such as a paper or pdf record, is one that is fixed and allows little or no interaction between the user and the record content (TR80)
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Static Record Format (MHRA)
A "fixed" record such as paper or pdf. (TR80)
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Static Record Format (FDA)
A fixed-data document such as a paper record or an electronic image.(TR80)
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Standard Deviation
<p>The statistical measure of the dispersion of the data. (TR57) </p>
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Spore
A bacterial dormant form that is highly resistant to adverse conditions. Fungal spores are not highly resistant; their susceptibilities are closer to vegetative microorganisms. (TR13)
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Specification
A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. (TR14)
A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. Drug product and drug substance specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities (TR38) (TR57)
A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use. Drug product and drug substance specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities (TR69)
A list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance, drug product, or materials at other stages of its manufacture should conform to be considered acceptable for its intended use. “Conformance to specification” means that the drug substance and drug product, when tested according to the listed analytical procedures, will meet the acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval. (TR56) (TR74)
A list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a material should conform to be considered acceptable for its intended use (17). (TR60-3)(TR88)
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Stability Budget
A stability budget considers the results of long-term, accelerated, freeze-thaw, and temperature cycling studies to determine the amount of time out of storage that a drug substance may experience without any significant risk to its quality. Firms have used the idea of a stability budget to assign permissible time out of storage for packaging and labeling operations for refrigerated drug products for some time. This concept has been expanded in the present document to include storage and distribution as well. (TR53)
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Specified Microorganisms
Microorganisms with limit tests for absence in 1 or 10 g of a drug product, as described in USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms and USP <1111> Microbiological Quality of Nonsterile Pharmaceutical Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. (TR67)
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Stakeholder(s)
Any individual, group or organization that can affect, be affected by or perceive itself to be affected by a risk. Decision makers might also be stakeholders. For the purposes of this guideline, the primary stakeholders are the patient, health-care professional, regulatory authority, and industry (ICH Q9). (TR54) (TR54-2)
Any individual, group, or organization that can affect, be affected by, or perceive itself to be affected by a risk. Decision makers might also be stakeholders. (TR54-5)
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Sporicidal Vapor Phase Decontamination
The destruction of inactivation of microbial spores using a vapor or gaseous agent. (TR51)
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Steam Heat-treated Wooden Pallets
Pallets in which the wood has been heated to achieve a minimum core temperature of 56 °C (132.8 °F) for at least 30 min. Pallets treated via this method bear the initials HT (heat treated) near the International Plant Protection Convention (IPPC) logo. This is one of the methods required for international shipment. (TR55)
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Single-Use Component (SUC)
An individual part designed to perform a particular function when assembled into a single-use system. (TR66)
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Similar
Having a general likeness. (TR38)
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Site Acceptance Testing
The SAT is a series of tests that are performed as part of commissioning after the unit has been installed in the final location. (TR48)
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Stability
The capacity of a drug substance or a drug product to remain within specifications established to ensure its identity, strength, quality, and purity throughout the retest period or expiration dating period, as appropriate. (TR39) The chemical/biological fidelity of an analyte in a given solvent/matrix under specific conditions. (TR57)
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Steam in Place Cycle
A sequence of defined steps and operating parameters (e.g., time, temperature, and pressure) performed in situ on equipment and/or systems to provide a given sterility assurance level (SAL) or defined sanitization level. (TR61)
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Steam: Plant Steam
Steam of undefined chemical or biological quality produced from a boiler, usually containing boiler additives, without further treatment. [Synonym: Factory Steam, House Steam, Industrial Steam] (TR48)
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Sonication
In the context of this Technical Report, the technique is used for dispersing viruses by use of sound-wave energy. (TR47)
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Single-Use System (SUS)
An engineered process equipment solution, most commonly assembled from components made using polymeric materials, which together create a system or unit operation designed for one time or campaign use. (TR66)
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Size Exclusion
A technique which separates particles based on diameter. (TR41)
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Sporicidal Process
A process that destroys or inactivates microbial spores. (TR51)
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Steam-in-Place (SIP)
The process of applying clean pressurized steam to a stationary piece of equipment in order to sterilize it. (TR41)
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Steam Trap
A self-actuating, automatic device that removes condensate and air from the system. (TR61)
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Spore Log Reduction (SLR)
The number of log reductions (10-fold changes) of spores from the initial population. For the overkill sterilization method, one targets a spore log reduction of 12 to achieve 1 x 10-6 probability of a survivor when using a biological indicator having a population of 1 x 106. (TR61)
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Signal Detection Theory
A means to quantify the ability to discern between signal and noise. According to the theory, there are a number of determiners of how a detecting system will detect a signal, and where its threshold levels will be. The theory can explain how changing the threshold will affect the ability to discern, often exposing how adapted the system is to the task, purpose or goal at which it is aimed. (TR55)
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Steam: Pure Steam
Collected condensate that complies with the Compendial requirements for Water for Injecton (WFI). [Synonyms: clean steam, high quality steam] (TR01) (TR61) (TR48)
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Sonicate
To use sound energy to agitate particles; generally used to accomplish mixing or cleaning. (TR70)
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Steam: Process Steam
Process steam is similar to plant steam, except the steam is generated using a controlled feed water source to which no volatile additives (amines or hydrazines) have been introduced. Process steam may be appropriate for moist heat sterilization of liquid loads where the containers are filled and sealed prior to sterilization. (TR48)
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Steam Sterilization
Sterilization by flowing saturated steam through a vented vessel or system. (TR45)
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Staked Needle
Nonremovable, fixed needle attached to syringe body/cone with adhesive. (TR73)
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State of Control
A condition in which the set of controls consistently provides assurance of continued process performance and product quality. (TR57)
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Specific Model Virus
Virus that is closely related to the known or suspected virus (same genus or family), having similar physical and chemical properties as those of the observed or suspected virus. (TR41)
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Slurry (verb)
To mix resin particles in a liquid to achieve a homogenous liquid suspension. (TR14)
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Stability Profile
The physical, chemical, biological, and microbiological behavior of a drug substance or drug product as a function of time when stored under the defined environmental conditions of an approved protocol. (TR39)
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Spiking
The addition of a small known amount of a known compound to a standard, sample, or placebo, typically for the purpose of confirming the performance of an analytical procedure or the calibration of an instrument. (TR57)
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Sporicide
A compound that destroys all vegetative microorganisms and bacterial and fungal spores. (TR70)
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Specificity
The ability of an analytical procedure to accurately measure or detect a target analyte in the presence of other components in the sample matrix. (TR50) The ability to assess unequivocally the analyte in the presence of components that may be expected to be present. Typically these might include impurities, degradants, matrix, etc. Lack of specificity of an individual analytical procedure may be compensated by other supporting analytical procedure(s). (TR57) The ability to detect a range of microorganisms, which demonstrate that the method is fit for its intended use. (TR33)
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