Sterility Assurance Level (SAL)
Probability that a batch of product is sterile. (TR28) Probability of a single viable microorganism occurring on or in an item after sterilization. Note: The term SAL takes a quantitative value, generally 10-6. When applying this quantitative value to assurance of sterility, an SAL of 10-6 has a lower value but provides a greater assurance of sterility than an SAL of 10-3. (TR3) (TR61)
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Storage Temperature
The temperature range listed on the medicinal product label specified for long term storage. (TR39)
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Summative/Validation Testing
Evaluative testing providing evidence to show that representative users in the expected use conditions can perform all essential and critical tasks required for safe and effective use of the device. (TR73)
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Storage
The retention of pharmaceutical products in a location such as a warehouse; the storing of pharmaceutical products up until their point of use. (TR53)
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Substrate
Primary construction material of a surface to be cleaned or disinfected. (TR70)
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Supply Chain
The process by which a drug product is shipped and distributed from the manufacturer to the end user. (TR39)
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Survivor Curve
Graphical representation of the inactivation of a population of microorganisms with increasing exposure to a microbicidal agent under stated conditions. (TR01) (TR3) (TR51) (TR61)
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Sterilizing Grade Filter
A filter intended for terminal processing of sterile liquids that has been tested under worst-case actual processing conditions for the ability to retain a minimum challenge of 107 cells of Brevundimonas diminuta per cm2 of filter area. (TR41) A filter that reproducibly removes all test microorganisms from the process stream, producing a sterile effluent. (TR75) A filter that reproducibly removes test microorganisms from the process stream, producing a sterile filtrate. (TR26)
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System Integrity Test
Any test designed to detect leaks or other breaches in system integrity that might compromise operator safety or system sterility (or sanitary status). [Synonym: leak test.] (TR61)
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Sterilizer 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. (TR30)
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Superheated Water Process
A sterilization process in which the heating medium is superheated water that is continuously circulated with air overpressure. This process requires air overpressure to keep the water in a liquid state. [Synonyms: water cascade, water spray process, water immersion process, water submersion process, raining water process, steam-air-water process] (TR01)
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Sterilization
A process used to render a product free of viable organisms with a specified probability. (TR01) (TR30) (TR69) A process by which something is rendered sterile (i.e., moist heat, dry heat, chemical, irradiation); normally validated at 106 organism reduction. (TR70) Validated process used to render product free from viable microorganisms (TR13) (TR26)
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Suitability, system
Acceptance criteria for a valid reported result(s). [Synonym: Assay quality control] (TR57)
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Store
A store is a temperature-controlled and / or temperature- monitored warehouse, chamber, or cabinet where pharmaceutical products are stored. (TR58)
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Sterile
Absence of life; usually refers to absence of viable microorganisms. Note: In practice, no such absolute statement regarding the absence of microorganisms can be proven. (TR22) (TR62) The absence of viable microorganisms. (TR44) (TR70)
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System Integrity Test (System Pressure Hold Test)
A system integrity test in which the system is pressurized to a predetermined level with filter sterilized compressed air or other compressed gas, after which the system is isolated and the amount of pressure loss over time is measured. (TR61)
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Sterile Boundary
The sterile boundary is the demarcation in a system between the portion of the system that requires sterile contact surfaces (e.g., sterile side of filters and downstream piping) and the rest of the system (e.g., upstream side of filters, condensate drain lines). (TR61)
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Stirred-Cell Filtration
A surrogate for tangential flow filtration where shear is achieved by rapidly stirring the solution immediately adjacent to the membrane. Typically the stirring is accomplished by mechanical means, such as through the use of a stir bar or impeller. (TR15)
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Sterilizer Specification (Functional Specification (FRS))
A description of functional attributes and operational characteristics of the system that will ensure fulfillment of the user requirements. [Synonym: Functional Requirement Specification, Functional Design Specification] (TR48)
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Strain
A specific isolate of a species that is maintained in pure culture and is serotypically, genotypically, or chemotaxonomically characterized to differentiate it from other strains of the same species. The strain is representative of the species and provides a reference for the species based on its historic isolation, characterization, and deposition in recognized culture collections. (TR13)
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Surfactant
A soluble compound that reduces the surface tension of a liquid or reduces interfacial tension between two liquids (causing formation or micelles) or between a liquid and a solid. [Synonym:Wetting Agent] (TR45) (TR26)
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Sterilization Process
A process used to render a product free of viable organisms with a specified probability. (TR3)
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System, Open
A system which fails to meet one or more of the criteria which define a closed system. (TR28)
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Sub-Contractor
An individual or company hired by the transport service provider to perform the actual shipment. The shipper and the sub-contractor do not necessarily have a contractual agreement. (TR39)
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Stress Studies (Degradation Pathway Studies)
Studies undertaken to elucidate the intrinsic stability of the drug substance and/or drug product; part of the development strategy and normally carried out under more severe conditions (e.g., high or low pH or oxidation levels, or shaking) than those used for accelerated testing. (TR57-2)
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Sterility Test
Test performed to determine if viable microorganisms are present. (TR28) (TR62)
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Surface Tension
The tendency of the surface of a liquid to contract to the smallest area possible under defined conditions. It is expressed as dynes per centimeter. (TR26)
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System, Closed
A “closed” system is sterilized-in-place or sterilized while closed prior to using a validated procedure, is pressure and/or vacuum tight to some pre-defined leak rate maintained through the length of the campaign, can be utilized for its intended purpose without breach to the integrity of the system, can be adapted for fluid transfers in and/or out while maintaining asepsis, is connectable to other closed systems while maintaining integrity of all closed systems (e.g., Rapid Transfer Port, steamed connection, etc.), is safe guarded from any loss of integrity by scheduled preventative maintenance and utilizes sterilizing filters for sterilization of process streams which are integrity tested and traceable to each product lot. (TR28)
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Sterilizer Specification
Documents that define sterilizer system attributes and how they should be met. (TR48)
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Sterilization Run
Execution of a sterilization cycle. (TR01)
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Syncytial Forming Units (SfU)
A clumping of fused neighboring cells (syncytia) caused by viral infection when viral fusion proteins are transported to the surface of the infected cells and cause the host cell membrane to fuse with neighboring cells. The number of syncytia is directly correlated to the number of infectious virus particles. (TR47)
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Stringer
A continuous, longitudinal, solid or notched beam-component of a pallet used to support deck components, often identified by location as the outside or center stringer. (TR55)
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Process Qualification
Documented verification that a system is capable of consistently performing or controlling the activities of the processes it is required to perform or control, according to written and preapproved specifications, while operating in its specified operating environment. (TR3)
Confirming that the manufacturing process as designed is capable of reproducible commercial manufacturing. (TR54) (TR60) (TR54-5)
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Sieving Coefficient (S0)
The ratio of the filtrate concentration of component i (Ci,f) to the bulk or feed concentration of component i (Ci,b) as in the following equation: S = Ci,f/Ci,b Where S = 1 for a freely passing solute, typically a low molecular weight solute S = 0 for a solute that is fully retained by the membrane [Synonym: transmission; product transmission] (TR15)
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Reference Strain
A well characterized, widely accepted preparation of viable organisms that is used to validate a microbiological assay. (TR50)
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Reagent
For analytical procedures, any substance used in a reaction for the purpose of detecting, measuring, examining, or analyzing other substances. (TR57)
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Risk Management
The systematic application of quality management policies, procedures and practices to the tasks of assessing, controlling, communicating and reviewing risk. (TR44) (TR54) (TR54-2) (TR55) (TR67) (TR54-5)
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Relative Accuracy
Attribute determined after demonstration of precision, linearity, and specificity under deliberately varied conditions, such as across a range of sample dilutions in the presence of matrix interference. (TR57-2)
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Retentate Pressure
The pressure measured at the outlet (retentate) side of the tangential flow filter device containing unfiltered material. (TR15)
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Residual Fit
Signed difference between an observed value and the fitted value used to detect nonlinearity, unequal variances, and outliers. (TR57-2)
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Risk Management Report
Report that summarizes the outcomes of the QRM process. (TR54) (TR54-2) (TR54-5)
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Rework
Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent). (TR74)
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Registration Stability Lots
The lots of drug substance manufactured to establish the stability profile in support of the regulatory filing. (TR56)
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Retain (Retention) Samples
Intermediate and final and finished product samples that are stored for the intent of repeating any in-process or release analysis. Typically this is twice the amount of material that is required to perform these. (TR56)
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Risk Evaluation
The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale to determine the significance of the risk (TR30) (TR54-2) (TR44) (TR58) (TR54-5)
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Risk Communication
The sharing of information about risk and risk management between the decision maker and other stakeholders. (TR44)
The sharing of information about risk and risk management between the decision maker and other stakeholders. (TR54-2) (TR54-5)
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Reference Standard
A characterized biological material developed to monitor the performance of an assay. For example, the standards for NAT assays may be nucleic acid templates such as plasmids, genomic DNA, cellular or in vitro synthesized RNA. (TR50) The defining characteristics of a reference standard are: 1) it is stable; 2) it performs similarly (e.g., on dilution) to test materials in the assay; and 3) it is homogeneous. (TR57) A reference standard, or reference material, is a substance prepared for use as the standard in an assay, identification, or purity test. It should have a quality appropriate to its use. It is often characterized and evaluated for its intended purpose by additional procedures other than those used in routine testing. For new drug substance reference standards intended for use in assays, the impurities should be adequately identified and/or controlled, and purity should be measured by a quantitative procedure. (TR63)
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Revalidation
Repeating partial or full validation of a process after a process change is implemented. Re-validation is change-based, not time-based. (TR14) (TR3) (TR42)
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Risk Identification
The systematic use of information to identify potential sources of harm (hazards) referring to the risk question or problem description.(TR44) (TR54-2) (TR58) (TR54-5)
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Reproducibility
The precision among multiple laboratories (collaborative studies, usually applied to standardization of methodology). (TR57) The precision between laboratories, for example, through collaborative studies. (TR33)
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