C C96070 Stability Study Data File Type Terminology C96087 Photostability Drug Study A study conducted to determine the extent of effect that exposure to light has on a pharmaceutical product. Photostability A Photostability study would be a one time study. C C96077 Stability Study Method Type Terminology C96102 Compendial Method Standardized methods and specification testing for generic pharmaceutical raw materials and finished products. Compendial Official compendial method. C C96077 Stability Study Method Type Terminology C96103 Proprietary Method An analysis that contains protected intellectual property preventing full disclosure of information about the method and/or restricting or limiting the use or distribution of the method or materials for its performance without express permission or licensing. Proprietary Company method. C C96080 Stability Container Closure System Terminology C96113 Child Resistant Metal Container Closure Metal closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly. Child-resistant, Metal Metal closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly. C C96080 Stability Container Closure System Terminology C96114 Child Resistant Plastic Container Closure Plastic closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly. Child-resistant, Plastic Plastic closure that is designed or constructed to be significantly difficult for children under five years of age to open and not difficult for normal adults to use properly. C C96080 Stability Container Closure System Terminology C96115 Continuous Thread Metal Container Closure Metal closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal. Continuous Thread, Metal Metal closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal. C C96080 Stability Container Closure System Terminology C96116 Continuous Thread Plastic Container Closure Plastic closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal. Continuous Thread, Plastic Plastic closure turned onto a corresponding thread on the top or mouth of a container, whether it be glass, plastic or metal. C C96080 Stability Container Closure System Terminology C96117 Tamper Evident Metal Container Closure A closure/finish of a closure/container system designed to make it difficult to achieve the first removal of a closure from a container without it being detectable by subsequent users that the package seal has been breached (e.g., aluminum overseal). Tamper-evident, Metal A closure/finish of a closure/container system designed to make it difficult to achieve the first removal of a closure from a container without it being detectable by subsequent users that the package seal has been breached (e.g., aluminum overseal). C C96080 Stability Container Closure System Terminology C96118 Tamper Evident Plastic Container Closure A closure that shows the package has been opened and the product has been exposed to the outside environment. Tamper-evident, Plastic A closure that shows the package has been opened and the product has been exposed to the outside environment. C C96080 Stability Container Closure System Terminology C96119 Vacuum Sealed Metal Container Closure Metal closures used on packages where the pressure inside the package is less than atmospheric. Vacuum, Metal Metal closures used on packages where the pressure inside the package is less than atmospheric. C C96080 Stability Container Closure System Terminology C96120 Tamper Evident Composite Container Closure Composite tamper-evident closures usually consist of a metal disk with a plastic skirt. The plastic skirt is perforated or weakened in some manner so that when the closure is removed, this section is designed to break and either remain on the container or attached to the closure to indicate the package has been opened. Tamper-evident, Composite Composite tamper-evident closures usually consist of a metal disk with a plastic skirt. The plastic skirt is perforated or weakened in some manner so that when the closure is removed, this section is designed to break and either remain on the container or attached to the closure to indicate the package has been opened. C C96080 Stability Container Closure System Terminology C96121 Vacuum Sealed Plastic Container Closure Plastic closures used on packages where the pressure inside the package is less than atmospheric. Vacuum, Plastic Plastic closures used on packages where the pressure inside the package is less than atmospheric. C C96080 Stability Container Closure System Terminology C96122 Vacuum Sealed Composite Container Closure Metal/Plastic closures used on packages where the pressure inside the package is less than atmospheric. Vacuum, Composite Metal/Plastic closures used on packages where the pressure inside the package is less than atmospheric. C C96080 Stability Container Closure System Terminology C96123 Press-On / Twist-Off Metal Container Closure Closure with a stepped, skirted drawn shell with an inside curl. The closure is lined with an annular plastisol material designed to provide a proper seal along the top and side surfaces of the glass container finish. The closure uses a special plastisol material that, following application, takes a permanent impression of the glass threads ensuring cam-off and reseal. Press-on/twist-off, Metal Closure with a stepped, skirted drawn shell with an inside curl. The closure is lined with an annular plastisol material designed to provide a proper seal along the top and side surfaces of the glass container finish. The closure uses a special plastisol material that, following application, takes a permanent impression of the glass threads ensuring cam-off and reseal. C C96080 Stability Container Closure System Terminology C96124 Press-On Composite Container Closure A metal/plastic composite cap composed of a plastisol lined metal disk, assembled to a plastic band. The closure requires a simple glass bead finish common on bowls, tumblers and carafes. Press-on, Composite A metal/plastic composite cap composed of a plastisol lined metal disk, assembled to a plastic band. The closure requires a simple glass bead finish common on bowls, tumblers and carafes. C C96080 Stability Container Closure System Terminology C96125 Crown Metal Container Closure A non-threaded shallow draw metal closure that normally has 21 corrugations on the outer edge, which function to engage the container when applied. The crown is only 1/4" high when manufactured and does not have a rolled edge or wire. The crown is manufactured 26mm worldwide and can be applied to either a threaded finish or a solid ring pry-off finish. Crown, Metal A non-threaded shallow draw metal closure that normally has 21 corrugations on the outer edge, which function to engage the container when applied. The crown is only 1/4" high when manufactured and does not have a rolled edge or wire. The crown is manufactured in 26mm worldwide and can be applied to either a threaded finish or a solid ring pry-off finish. C C96080 Stability Container Closure System Terminology C96126 Lug Metal Container Closure Closure with an ability to be applied and removed with a partial turn. The closure can also be produced with vacuum buttons that can clearly indicate to the packer if a vacuum has been effectively drawn following the closure application. Lug, Metal Closure with an ability to be applied and removed with a partial turn. The closure can also be produced with vacuum buttons that can clearly indicate to the packer if a vacuum has been effectively drawn following the closure application. C C96080 Stability Container Closure System Terminology C96127 Roll On Metal Container Closure A tamper-evident closure produced as an unthreaded shell containing a liner. It is applied to the proper finish on a plastic or glass container by the bottler, using a roll-on capping machine that forms a thread in the closure matching the bottle thread. Roll-on, Metal A tamper-evident closure produced as an unthreaded shell containing a liner. It is applied to the proper finish on a plastic or glass container by the bottler, using a roll-on capping machine that forms a thread in the closure matching the bottle thread. C C96080 Stability Container Closure System Terminology C96128 Flip-Top Dispensing Plastic Container Closure A hinged single or dual flap closure for controlled product dispensing. Flip-Top (Dispensing), Plastic A hinged single or dual flap closure for controlled product dispensing. C C96080 Stability Container Closure System Terminology C96129 Hinged Dispensing Plastic Container Closure A closure with a lid that is hinged to the top of a closure and opens to expose a dispensing orifice. Hinged (Dispensing), Plastic A closure with a lid that is hinged to the top of a closure and opens to expose a dispensing orifice. C C96080 Stability Container Closure System Terminology C96130 Linerless Plastic Container Closure A closure that incorporates a specific molded-in feature such as rings, plugs or flexible sections. These features achieve a seal by conforming to one or more of the sealing surfaces on the container neck finish. Linerless, Plastic A closure that incorporates a specific molded-in feature such as rings, plugs or flexible sections. These features achieve a seal by conforming to one or more of the sealing surfaces on the container neck finish. C C96080 Stability Container Closure System Terminology C96131 Pump Dispensing Plastic Container Closure Closure dispensing pumps are used to dispense product from containers. Pump (Dispensing), Plastic Closure dispensing pumps are used to dispense product from containers. C C96080 Stability Container Closure System Terminology C96132 Push-Pull Dispensing Plastic Container Closure A two-piece dispensing closure that includes a base member the lower portion of which is designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. The spout member may be moved upward and downward to open and close the dispensing passageway. Push-pull (Dispensing), Plastic A two-piece dispensing closure that includes a base member the lower portion of which is designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. The spout member may be moved upward and downward to open and close the dispensing passageway. C C96080 Stability Container Closure System Terminology C96133 Snap-On Cap Plastic Container Closure A non-threaded closure that is pressed onto the package finish with a protruding feature that mates with a similar protruding feature on the closure to secure the closure to the package. Snap-on Cap, Plastic A non-threaded closure that is pressed onto the package finish with a protruding feature that mates with a similar protruding feature on the closure to secure the closure to the package. C C96080 Stability Container Closure System Terminology C96134 Snip-Tip Dispensing Plastic Container Closure Conical closure that is turned onto a container. The tip is cut off to open the container. Snip-tip (Dispensing), Plastic Conical closure that is turned onto a container. The tip is cut off to open the container. C C96080 Stability Container Closure System Terminology C96135 Toggle-Swing Dispensing Plastic Container Closure A closure with a lower part attaches securely and seals the container. The upper part provides a second movable portion which functions in a rocker-like pivotal motion between an open and a closed position. Toggle-swing (Dispensing), Plastic A closure with a lower part attaches securely and seals the container. The upper part provides a second movable portion which functions in a rocker-like pivotal motion between an open and a closed position. C C96080 Stability Container Closure System Terminology C96136 Trigger Spray Dispensing Plastic Container Closure Closure designed to dispense product from containers by spraying the product when a trigger is pulled. Trigger Sprayer (Dispensing), Plastic Closure designed to dispense product from containers by spraying the product when a trigger is pulled. C C96080 Stability Container Closure System Terminology C96137 Twist Open/Close Dispensing Plastic Container Closure Two-piece dispensing closure that has a lower portion designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. Rotating the spout member opens and closed the container. Twist Open/Close (Dispensing), Plastic Two-piece dispensing closure that has a lower portion designed to attach and seal securely to a container finish and the upper portion of which is designed to receive a dispensing spout member. Rotating the spout member opens and closed the container. C C96080 Stability Container Closure System Terminology C96138 Valved Dispensing Plastic Container Closure Dispensing closure incorporating a product-flow controlling valve within the orifice. Product will not dispense from the package until sufficient squeezing pressure is applied to the flexible container to cause the valve to open. Valved (Dispensing), Plastic Dispensing closure incorporating a product-flow controlling valve within the orifice. Product will not dispense from the package until sufficient squeezing pressure is applied to the flexible container to cause the valve to open. C C96080 Stability Container Closure System Terminology C96139 Stopper Container Closure Object used to plug opening of container. Stopper Object used to plug opening of container. C C96080 Stability Container Closure System Terminology C96140 Tie Container Closure Line, ribbon, or cord used for fastening, or drawing the container closed. Tie Line, ribbon, or cord used for fastening, or drawing the container closed. C C96082 Stability Study Storage Condition Terminology C96148 Proprietary Storage Condition Storage conditions according to protocols set by a business or company. Proprietary Company defined. C C96077 Stability Study Method Type Terminology C96164 Code of Federal Regulations Method A method described in the Code of Federal Regulations. CFR Regulation Method dictated by CFR.