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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Steam Orifice
A specifically sized hole (e.g., 1/32 or 1/ Supply Chain inch diameter) to allow condensate or steam to pass through. [Synonyms: flow orifice, steam bleed.] (TR60)
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Statistically Determined Limits
Limits calculated from historical data that takes into account the distribution of the data (i.e., normal, log-normal, exponential, etc), the variability of the data, and the sample size of the data set. These can be two-sided or one-sided. The mean (average) plus and/or minus 3 standard deviations or a confidence interval for the mean are not statistically correct methods for setting these limits. The correct method is to calculate a statistical tolerance interval as described in Hahn and Meeker, 1991. (TR38)
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Steam Air Mixture (SAM) Process
A sterilization process in which the heating medium used to heat the load is in a mixture of air and steam that is typically used for liquid loads. This addition of air results in an air overpressure condition. (TR01)
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Significant Body of Information
A significant body of information on the stability of the drug product is likely to exist after 5 years of commercial experience for new molecular entities, or 3 years of commercial experience for new dosage forms (TR38)
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Stability-Indicating Analytical Method
A test procedure that is able to discern changes in an analyte due to degradation processes. It is capable of accurately measuring changes in the product that can occur under conditions of physical or chemical stress. (TR57)
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Static Monitoring
Monitoring of the environment in the absence of normal operations. This includes having the equipment installed and operational when no personnel are present. Per the EU and ISO standards, this is synonymous with “at rest.” (TR13)
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Soil
The chemical or microbiological materials left on process equipment after completion of process manufacturing, but before initiation of the cleaning process. (TR29)
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Standard Pressure
A pressure of 1 atmosphere (14.70 psi or 760 mm of mercury) to which measurements of quantities dependent on pressure are often referred. (TR45)
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Single 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 Z1.4-2003. (TR43)
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Sporulation
The formation of a spore. (TR51)
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Slip Sheest
Plastic sheets often made of polyethylene and sometimes used in distribution/transportation warehouse and shipping systems to separate pallet loads of product. Slip sheets may be important due to the ability of polyethylene to concentrate TBA in proximity to product. (TR55)
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Slurry (noun)
A homogenous distribution of resin particles in a liquid. (TR14)
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Sterilizer Specification (User Requirement Specification (URS))
A description of features and performance requirements of a system that will fulfill the needs of the end user. (TR48)
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Syringeability
The qualities required for delivery of the syringe contents at a given injection rate via a needle of a predetermined gauge and length that enables optimal injection conditions for the drug product, taking into account the product’s physical properties, flow rate, injection force, and needle gauge. (TR73)
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SUS Interchangeability
Functionally equivalent substitution of an alternative SUS, for an existing SUS design providing a contingency or process improvement with equivalent process performance and product quality. The end user is responsible to evaluate and determine if appropriate quality requirements are met for their application. (TR66)
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Sterility Assurance
The probability or likelihood that something is sterile. (TR44)
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Stringer Pallet
A pallet that uses a frame of three or four parallel pieces of lumber (called stringers). The top decks are affixed to the stringers to create the pallet structure. (TR55)
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Superiority
A comparison with the primary objective of showing that the result from one method is superior to the method being compared. This is usually demonstrated by showing that the true difference is likely to lie between zero and the upper equivalence margin. (TR57)
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Storage Solution
A solution typically selected to control bioburden during column storage. (TR14)
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System Suitability Evaluations
Physical evaluations (e.g., chamber integrity or air removal) conducted on a scheduled frequency to demonstrate ongoing control of the sterilizer system. (TR01)
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Surrogate Fluid
A model process fluid used in a small-scale validation study. The fluid is intended to either match or resemble an actual process fluid as closely as is feasible. (TR41)
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Steribag
Sealing bag made at least partly of steam-permeable material to wrap and seal containers for sterilization (e.g., tub-nest configurations). (TR73)
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Superheated Steam
Steam that is at a higher temperature than that indicated by the equilibration curve for the vaporization of water (at a given pressure).(TR01) (TR61)
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System D-value
D-value of a BI when measured in a specified gas generator/separative enclosure combination operating within a defined sporicidal vapor-phase decontamination cycle. (TR51)
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Superheated Water
Water in a liquid phase at a tempe- rature above 100°C requiring overpressure to maintain this state. (TR01)
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System Integrity Test (System Vacuum Hold Test)
A system integrity test in which the system under test is evacuated to a predetermined setpoint and the system is isolated from the external environment. The decay in vacuum level over time is measured. (TR61)
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Tailing
Deviation from first-order death kinetics in a microbial population observed when the logarithm of the number of survivors is plotted against time. The “tail” of the survivor curve represents organisms surviving for times in excess of those that would be predicted from first-order kinetics. (TR51)
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Suitability (Machinability)
Physical interactions of components with equipment and environment. (TR73)
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Sterilizer Specification (Design Specification (DS))
A set of specifications and information related to the installation features including equipment, hardware and software) of the system that will ensure the realization of the user requirements. [Synonym: Detailed Design Specification (DDS] (TR48)
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System Integrity Test (Mass Flow Integrity Test)
A system integrity test that measures the mass flow needed to maintain a given pressure. (TR61)
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Sterilization Cycle
A sequence of defined operating parameters (e.g., time, temperature and pressure) and conditions required to render an item sterile. (TR01) (TR30) (TR48) A sequence of defined operating parameters (e.g., time and temperature) required to render an item sterile. (TR3)
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