Prefilled Syringe
A syringe that has been prefilled to contain a specific dose of medication. (TR73)
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Prefillable
Syringes and associated components considered as starting material for the filling and assembling process of a prefilled syringe. (TR73
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Prefilled
Syringe assembly after being filled with pharmaceutical product and being closed. (TR73)
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Thumb Pad
Disk at end of plunger rod. (TR73)
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Use-related Risk Analysis
A systematic assessment of all of the user steps involved in using the device with particular consideration of the potential use errors, their associated clinical consequences along with the risk-mitigation strategies, and the method of validating the risk-mitigation strategies. (TR73)
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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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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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Plunger Stopper-Barrel Interface
Circumferential contact points between the ribs of the plunger stopper and the inner diameter of the syringe barrel. (TR73)
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Plunger Rod
Portion of the plunger assembly which provides a thumb pad for depressing the plunger and is attached to the plunger stopper inside the syringe barrel. (TR73)
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Plunger
The combined components of the plunger rod and plunger stopper. (TR73)
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Nest (Tub Nest)
Rigid plastic support placed into a tub to keep syringes upright with sufficient separation to allow for easy manipulation by manual or automated fill-line systems. (TR73)
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Needle-Safety Device
A safety feature or mechanism that effectively reduces the risk of an exposure incident (e.g., accidental needlestick). (TR73)
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Needle Shield (Needle Cover)
Rigid or flexible polymeric substance used to seal and protect the needle. (TR73)
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Needle (Cannula)
A thin, hollow, metal tube commonly used with a syringe to inject substances into the body. (TR73)
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Leachable
A chemical component that migrates from a contact surface into a drug product or process fluid during storage or normal use conditions. The term leachable is often erroneously used to describe an extractable. (TR14) (TR26) Leachables are organic and inorganic chemical entities that migrate from a packaging/delivery system, packaging component, or packaging material of construction into an associated drug product under normal conditions of storage and use or during accelerated drug product stability studies. Leachables are typically a subset of extractables or are derived from extractables. (TR54-4) Chemical substances that are leached, from product-contact or non-product-contact materials, under typical process conditions and detected in final dosage. Leachables may be a subset of extractables, and can include their reaction or breakdown products. (TR66) Organic or inorganic chemical entity that migrates from pharmaceutical container closure system components into a drug product formulation. (TR73)
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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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Formative Usability Evaluation
Observed actual or simulated use of early prototypes to help reliably identify product conceptspecific, use-related hazards that may have been missed by other methods. (TR73)
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Extractable
A chemical component that is removed from a material by application of an artificial or exaggerated force (e.g., solvent, temperature, time). The term extractable is often erroneously used to describe a leachable. (TR14) (TR15) (TR26) (TR41) (TR45) Chemical substances that can be extracted from components of material process fluid contact surfaces by exertion of an exaggerated force (e.g., organic solvent, extreme elevated temperature, ionic strength, pH, contact time, etc.) Extractables may represent most but not all of the potential leachables that may be seen in process fluids. (TR66) Extractables are organic and inorganic chemical entities that can be released from a pharmaceutical packaging/delivery system, packaging component, or packaging material of construction under laboratory conditions. (TR54-4) Organic or inorganic chemical entity that is forced out of container closure system materials and components under laboratory experimental conditions. (TR73)
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Elastomer
Thermoplastic material formulation (that may or may not contain rubber/natural latex) derived from elastic polymer; often used interchangeably with the term “rubber.” (TR73)
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Contextual Inquiry
Ethnographic research method used to observe and analyze behaviors in actual end-use contexts (actual environments and use scenarios). (TR73)
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Component, Secondary
Element of the assembled prefilled syringe (plunger rod, backstop, or safety system) that interacts with the primary components and provides functionality to the delivery system. (TR 73)
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Component, Primary
Element of the assembled prefilled syringe (needle, plunger stopper and tip closure, or adhesive) directly in contact with the drug. (TR 73)
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Break-loose Force
Energy required to initiate plunger movement within the syringe barrel upon injection. (TR 73)
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Backstop (Finger Plate or Thumb Plate)
Feature that enhances the area to hold the syringe and is usually designed to avoid accidental removal of the plunger from the back. By design, it may also serve as a flange extender to facilitate holding of the syringe during injection. (TR 73)
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