Title:
Seal tamper indicator for multi-compartment packaging
Kind Code:
A1


Abstract:
This invention relates to a system and method of detecting any compromise to the seal separating the compartments in two-compartment flexible packages. Such seal tamper indicating system may include a middle seal area configured to form an interface compartment between the two main compartments, the interface compartment providing a visual indicator of whether a seal has been compromised. In another embodiment, a flow valve device may be connected between two compartments, the normally closed position of the valve providing the sealing between the two compartments until the contents of the two compartments are ready to be mixed.



Inventors:
Sharon, Igal (Caesaria, IL)
Inbar, Michael (D.N. Shimkin, IL)
Application Number:
09/942702
Publication Date:
06/06/2002
Filing Date:
08/30/2001
Assignee:
SHARON IGAL
INBAR MICHAEL
Primary Class:
Other Classes:
206/568
International Classes:
B65D47/30; B65D79/02; B65D81/32; (IPC1-7): B65D25/08
View Patent Images:



Primary Examiner:
LUONG, SHIAN TINH NHAN
Attorney, Agent or Firm:
Jones Day (New York, NY, US)
Claims:

We claim:



1. A flexible two-compartment container system for storing two or more components of a formulation to be kept separate until ready to be mixed provided with a seal tamper indicating feature comprising: a flexible container formed by two sheets of a substantially flexible material interengaged in a face-to-face configuration with peripheral edges being sealed in a non-peelable manner; a middle seal band dividing the container into two main compartments, each compartment holding one or more components of the formulation; the middle seal band formed by a pair of peelable seals extending across the full width of the container and establishing a flow communication between the two main compartments when the peelable seals are unsealed; the peelable seals being spaced apart and parallel to each other forming an interface compartment between the two peelable seals so that a presence of one or both contents of the two main compartments in the interface compartment provides an indication of any compromise of the peelable seals separating the two main compartments.

2. A flexible two-compartment container system according to claim 1, wherein at least one of the two sheets of the flexible material is transparent or translucent at the interface compartment portion.

3. A flexible two-compartment container system according to claim 1, wherein the interface compartment is in a vacuum condition.

4. A flexible two-compartment container system according to claim 1, wherein the interface compartment is filled with air or some other gas at a pressure above atmospheric pressure.

5. A flexible two-compartment container system according to claim 2, wherein the interface compartment contains a material that changes color upon interaction with air, water, or one or both of the contents of the two main compartments.

6. A flexible two-compartment container system according to claim 1, further comprising: a pair of pull tabs provided for separating the peelable seals apart; each pull tab having a base frame, the base frame of each pull tab being secured to exterior surface of the flexible container in register with the middle seal band so that a pull tab is attached to each side of the container opposing each other; whereby the peelable seals are unsealed by pulling the pull tabs apart and separating the peelable seals.

7. A flexible two-compartment container system according to claim 6, wherein the base frames are hingeably attached to the pull tabs.

8. A flexible two-compartment container system for storing two or more components of a formulation to be kept separate until ready to be mixed provided with a seal tamper indicating feature comprising: a flexible container formed by two sheets of a substantially flexible material interengaged in a face-to-face configuration with peripheral edges being sealed in a non-peelable manner; a middle seal band extending across the full width of the container defining two main compartments, each compartment holding one or more components of the formulation; the middle seal band formed by an external sealing clip; the external sealing clip having an upper leg and a lower leg, each leg having an inside surface and an outside surface where the legs are oriented such that the inside surfaces face each other; a first pair of sealing ridges provided on the inside surface of the upper leg and a second pair of sealing ridges provided on the inside surface of the lower leg where the two sets of sealing ridges cooperate to form a pair of seals across the full width of the container forming the middle seal band separating the two main compartments when the upper and lower legs are closed across the flexible container; the pair of seals forming an interface compartment between the seals so that a presence of one or both contents of the two main compartments in the interface compartment provides an indication of any compromise of the pair of seals.

9. A flexible two-compartment container system according to claim 8, wherein the upper and lower legs are hingeably joined to each other at one end.

10. A flexible two-compartment container system according to claim 9, wherein the upper and lower legs are further provided with snap closure tab mechanisms at the end opposite from the hingeably joined end.

11. A flexible two-compartment container system according to claim 8, wherein at least one of the two sheets of the flexible material is transparent or translucent at the interface compartment portion, and the upper leg and the lower leg each has at least one open window area through which the interface compartment is visible.

12. A flexible two-compartment container system according to claim 8, wherein the interface compartment is in a vacuum condition.

13. A flexible two-compartment container system according to claim 8, wherein the interface compartment is filled with air or some other gas at a pressure above atmospheric pressure.

14. A flexible two-compartment container system according to claim 8, wherein the interface compartment contains a material that changes color upon interaction with air, water, or one or both of the contents of the two main compartments.

15. A flexible two-compartment container system for storing two or more components of a formulation to be kept separate until ready to be mixed provided with a seal tamper indicating feature comprising: a flexible container formed by two sheets of substantially flexible material interengaged in a face-to-face configuration with peripheral edges being sealed in a non-peelable manner; an external sealing clip having an upper leg, a lower leg, and a center member, each leg having an inside surface and an outside surface where the legs are oriented such that the inside surfaces face the center member from opposite sides of the center member; a sealing ridge provided on the inside surface of the upper leg, a second sealing ridge provided on the inside surface of the lower leg, and sealing ridges on both sides of the center member, where the sealing ridges on the upper and lower legs cooperate with the sealing ridges on the center member to form a pair of seals across the full width of the container, one of the seals formed by the center member and the upper leg and the other seal formed by the center member and the lower leg, when the container is positioned between the center member and the two legs, and are closed across the flexible container; an interface compartment formed between the pair of seals so that a presence of one or both contents of the two main compartments in the interface compartment provides an indication of any compromise of the pair of seals.

16. A flexible two-compartment container system according to claim 15, wherein the upper and lower legs are hingeably joined to the center member at one end.

17. A flexible two-compartment container system according to claim 16, wherein the upper and lower legs are further provided with snap closure tab mechanisms at the end opposite from the hingeably joined end.

18. A flexible two-compartment container system according to claim 15, wherein at least one of the two sheets of the flexible material is transparent or translucent at the interface compartment portion.

19. A flexible two-compartment container system according to claim 15, wherein the interface compartment is in a vacuum condition.

20. A flexible two-compartment container system according to claim 15, wherein the interface compartment is filled with air or some other gas at a pressure above atmospheric pressure.

21. A flexible two-compartment container system according to claim 15, wherein the interface compartment contains a material that changes color upon interaction with air, water, or one or both of the contents of the two main compartments.

22. A two-compartment container system for storing two or more components of a formulation to be kept separate until ready to be mixed provided with a seal tamper indicating feature comprising: two compartments of a container each containing one or more components of a formulation; a flow valve mechanism connecting the two compartments, the flow valve mechanism comprising, a valve body provided with two flow openings, each flow opening substantially surrounded by a sleeve for connecting to a compartment, a central chamber within which a valve member sits; the valve member having a flow channel and manipulable between two positions, a closed position where the flow valve mechanism forms a fluid-tight seal between the two compartments, and an open position wherein the flow channel allows a flow communication between the two compartments; and the flow valve mechanism being formed of a rigid transparent or translucent material, so that a presence of one or both contents of the two compartments in the flow channel provides an indication of any compromise of the fluid-tight seal between the two compartments.

23. A two-compartment container system according to claim 22, wherein the flow channel contains a material that changes color upon interaction with air, water, or one or both of the contents of the two compartments.

Description:

FIELD OF THE INVENTION

[0001] This invention relates to pre-packaged multi-compartment flexible packages, each compartment holding a separate component for later mixing, and more particularly to single-use multi-compartment flexible packages holding two different components.

BACKGROUND OF THE INVENTION

[0002] Various multi-compartment packaging are used in applications where a solution, a formulation or a mixture (hereinafter “formulation”) is prepared by mixing two or more constituents where it is desirable to keep the constituents apart until just before use. A container which can separately store two constituents until the formulation is to be made and dispensed, and also allow the mixing and dispensing to be performed in the same container is known. For example, U.S. Pat. No. 6,089,389 describes a two-compartment container that can store two components in two separate compartments until they are ready to be mixed and dispensed.

[0003] U.S. Pat. No. 3,983,994 to Wyslotsky, the disclosure of which is hereby incorporated by reference, describes a flexible two-compartment package with a separable or peelable seal dividing the package into two compartments. Peelable seal refers to a seal formed between two sheets of flexible material, as here, that can be separated with some application of force without damaging the integrity of the flexible packaging material. Wyslotsky's package has two sheets of flexible material fitted together in a face-to-face arrangement with sealed peripheral edges. A peelable seal in the middle of the package across the width of the package divides the package into two compartments, each compartment containing components to be mixed. A pair of pull tabs are attached to the exterior surface of the package, in a center location where the middle peelable seal line is located. The user pulls outwardly on the pair of pull tabs to break the peelable seal to allow the contents of the two compartments to mix. Other examples of flexible two-compartment packages do not utilize pull tabs, and the dividing seal may be broken by squeezing one or both of the two compartments.

[0004] Pre-packaged flexible two-compartment packages are typically used in applications where it is desirable to keep the components of a formulation separate until just prior to use. An example of such application may be found in certain first aid instant ice packs. In such ice packs, two chemicals are kept separate in the two compartments until the user squeezes one or both of the compartments to activate the ice pack. The resulting increased pressure inside the compartments breaks the peelable seal allowing the two previously separate chemicals to mix and form a solution, via an endothermic reaction, resulting in a cold pack.

[0005] In those applications where it is desirable to keep the components separate until mixing is desired, the integrity of the seal between the compartments is important. Any unwanted failure of the seal would result in premature mixing of the components.

[0006] Thus, there is a need for a multi-compartment package which can provide a robust and strong seal particularly where the seal separates two or more compartments holding two or more different components, in a flexible packaging or container. There is also a need for multi-compartment packages or containers to indicate whether the seal separating the compartments has been compromised.

SUMMARY OF THE INVENTION

[0007] This invention in one embodiment is directed to a system for and method of detecting whether a seal in multi-compartment packages has been tampered with, compromised, has or otherwise failed. The packages may preferably be pre-packaged, single-use, flexible multi-compartment packages, which separately store two or more components separated by a peelable or separable seal to be mixed in the future. The present invention in one embodiment provides an improvement on pre-packaged flexible two-compartment packages such that the user can tell whether the integrity of the seal separating the two compartments has been compromised.

[0008] In a flexible two-compartment package of one embodiment of the present invention, a middle seal band is formed in such a way that a third compartment or “interface compartment” is formed between the two main compartments. If one or more of the seals between the interface compartment and the two main compartments are compromised, the contents of one or both of the main compartments will leak into the interface compartment. In one embodiment of the invention, leakage into the interface compartment may be visually detected for example by forming the flexible package, and more preferably at least the interface compartment portion of the flexible package, of transparent or translucent material so that the leaked material is visible to the user.

[0009] The interface compartment may be filled with air or some other gas at or above atmospheric pressure, or evacuated. In the embodiment where the interface compartment is in a vacuum condition, the interface compartment would normally be in a flattened state. If one or more of the seals between the interface compartment and the two main compartments are compromised, the contents of the main compartments will leak into the interface compartment and cause it to expand providing both a visible and a tactile indication that the seal has been compromised. In this embodiment, the package, and more particularly the interface compartment, may be constructed from an opaque material since the physical condition of the expanded interface compartment will tell the user that the seal has been compromised.

[0010] Where the interface compartment is filled with air or some other gas at a pressure above atmospheric pressure, failure of one or more of the seals between the interface compartment and the two main compartments will cause the interface compartment to deflate. Hence, this embodiment also may be constructed from an opaque material since the physical condition of the deflated interface compartment will tell the user whether the seal has been compromised.

[0011] In another embodiment, the interface compartment may contain a material that, upon interaction with one or both of the contents of the two main compartments, changes color which can provide another form of visual indication that the seal has been compromised. The interface compartment may, for example, contain a material which turns a color when exposed to air. The material may be placed in the interface compartment under vacuum and the main compartment may be filled with components in air, and if the seal is broken, air will infiltrate into the interface compartment causing the material in the interface compartment to turn a color providing a visual indication that the seal has been tampered with, compromised, or has otherwise failed.

[0012] Alternatively, the interface compartment may contain a material which turns a color when exposed to water or moisture. The material may be placed in the interface compartment under a desicated environment and the main compartments may be filled with components where at least one of the components is water. If the seal is broken, water will infiltrate into the interface compartment causing the material in the interface compartment to turn a color.

[0013] In another embodiment of the present invention, a flow valve mechanism is placed between two compartments to form a two compartment system with each compartment holding different material. The flow valve mechanism is normally in a closed position and keeps the contents of the two compartments separated until they are to be mixed just prior to use. The flow valve mechanism preferably is made from rigid transparent material, such as transparent plastic, so that when the valve is in an open position, the contents of the two compartments passing through the valve is visible. Thus, any accidental or unwanted opening of the valve mechanism would leave traces of the contents of the compartments in the valve mechanism providing a visual indication that the seal has been compromised.

[0014] The invention will now be illustrated in some specific embodiments in accordance with the invention. It will be appreciated by those skilled in that art that the same principle is also applicable in other applications and areas where it is desired to separately store two or more components of a formulation and it is desired to be able to detect whether the temporary seal separating the two compartments has failed, been compromised, or otherwise tampered with.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 is a perspective view of a flexible two-compartment package with an interface compartment which functions as a seal tamper indicator;

[0016] FIG. 2A is a perspective view of another embodiment of a flexible package provided with pull-tabs to facilitate separating a peelable seal between the two compartments;

[0017] FIG. 2B is a perspective view of the flexible package of FIG. 2A showing the pull-tabs in an up position;

[0018] FIG. 3A is a perspective view of another embodiment of a flexible package where the seal between the two compartments is created by an external sealing clip; the drawing illustrates the sealing clip before it is clipped onto and forms a seal in the package;

[0019] FIG. 3B is a perspective view of the flexible package of FIG. 3A illustrating the alignment of the sealing clip and its sealing ridges in relation to the middle seal region of the flexible package;

[0020] FIG. 3C is a perspective view of the flexible package of FIGS. 3A and 3B where the external sealing clip is fully engaged with the flexible package, sealing the middle seal region and separating the package into two compartments;

[0021] FIGS. 3D-3G show cross-sectional views of an external sealing clip illustrating some examples of different raised ridge structures in a fully closed position;

[0022] FIG. 3H is a perspective view of another embodiment of the external sealing clip;

[0023] FIG. 4A is a perspective view of a flexible two-compartment package with a different embodiment of the external sealing clip where the sealing clip has a two-piece structure;

[0024] FIG. 4B is a perspective view of the flexible package of FIG. 4A with the two-piece external sealing clip clipped onto and sealing the compartments of the flexible package;

[0025] FIG. 5 is a perspective view of another embodiment of the sealing clip;

[0026] FIG. 6A illustrates a perspective view of a flexible two-compartment package with an interface compartment where the seals between the two compartments and the interface compartment are created by a double-clipping external sealing clip; the drawing illustrates the sealing clip before it is clipped onto the package;

[0027] FIG. 6B illustrates a perspective view of the flexible package of FIG. 6A with the double-clipping extgernal sealing clip in a fully closed position;

[0028] FIG. 6C illustrates a side view of the flexible package of FIG. 6A with the external sealing clip in a fully closed position.

[0029] FIG. 7A illustrates a perspective view of a preform showing the two-compartment flexible package of FIGS. 1-5 at an intermediate stage of construction;

[0030] FIG. 7B illustrates a perspective view of a preform showing the two-compartment flexible package of FIG. 6B at an intermediate stage of construction;

[0031] FIG. 7C is a perspective view of another embodiment of a preform showing the two-compartment flexible package of FIGS. 1-5 at an intermediate stage of construction;

[0032] FIGS. 7D and 7E illustrate a perspective view of examples of a flexible package provided with a screw capped dispensing opening.

[0033] FIG. 7F illustrates a perspective view of a flexible package of FIG. 7C provided with tearing notches.

[0034] FIGS. 8A-8F illustrate a flow valve embodiment of the seal tamper indicator in a closed position;

[0035] FIGS. 9A-9F illustrate the flow valve device of FIGS. 8A-8F in an open position;

[0036] FIG. 10 is an exploded view of the flow valve device of FIGS. 8A-9F;

[0037] FIGS. 11A-11F illustrate a second embodiment of the flow valve device as a seal tamper indicator in a closed position; and

[0038] FIGS. 12A-12F illustrate the flow valve device of FIGS. 11A-11F in an open position.

DETAILED DESCRIPTION OF THE INVENTION

[0039] FIG. 1 illustrates an embodiment of the invention where a flexible two-compartment package is provided with a middle seal band 3 separating the package into two main compartments 1 and 2. The middle seal band 3 is divided into three sections: two end sections 7; an interface compartment section 8 between two end sections 7; and edge (or periphery) section 4 framing the interface compartment section. End sections 7 are sealed in a non-peelable, preferably permanent, manner. As described in the Wyslotsky patent, this kind of sealing is well known in the trade and can be accomplished by, for example, adhesives, heat welding, ultrasonic welding, bonding, ultrasonic bonding, or heat sealing. Edge section 4 is sealed in a weaker peelable manner as compared to sections 7. The peelable sealing is also well known in the trade and may comprise, bonding, adhesives, ultrasonic bonding, or heat sealing. Peelable sealing along edges 4 and non-peelably sealed end sections 7 form contiguous sealed band 3 which divides the package into two main compartments 1 and 2. Interface compartment 8 is formed between the peelable seals formed along edges 4. The two main compartments hold different components of a formulation to be kept separate until ready to be mixed. The particular placement of the middle seal band 3 along the length of the flexible package may be adjusted to control the proportional size of the two main compartments in order to accommodate varying proportions of components that may be required by different formulation.

[0040] To mix the contents of the two main compartments prior to use, the user may squeeze one or both of the two main compartments. The resulting increased pressure inside the squeezed compartment will break the peelable seals along the edges 4 creating a channel in between sections 7 and creating a flow communication between the two main compartments.

[0041] If the peelable seals along edges 4 fail prematurely, accidentally, or are otherwise compromised, the contents of one or both of the two main compartments will leak into interface compartment section 8. The presence of the material in interface compartment 8 provides an indication to the user that one or more of the peelable seals have failed. This is a valuable feature for containers used in applications where it is not desirable to mix the constituents of the formulation too far in advance of the actual use.

[0042] There are a number of ways that the leakage of contents into the interface compartment section may be detected by the user. For example, the flexible package may be constructed from a transparent or translucent material, in which case the user can visibly detect the existence of material in the interface compartment. The interface compartment may also be evacuated before the peelable seal along edges 4 is formed. The interface compartment would then normally be in a flattened state and a seal failure along edges 4 would cause the contents of the main compartments to leak into the interface compartment causing it to expand. The expanded interface compartment would provide a visual as well as a tactile indicator of the unwanted seal failure. Hence, in this embodiment, the package may be constructed from an opaque material since existence of material in the interface compartment does not have to be visually detected but rather the physical condition of the interface compartment (expanded or un-expanded) provides the physical and tactile indicator.

[0043] The interface compartment may also be filled with air or some other gas at a pressure higher than the atmospheric pressure so that the interface compartment would normally be in a fully expanded bubble-like state. In this case, any failure of the seals along edges 4 would cause the interface compartment to deflate. Since, this embodiment also provides a seal tamper indication which does not rely on detecting the presence of material in the interface compartment but rather its physical condition, the flexible package may be made from an opaque material. It can be appreciated that the flexible material may be of either a one layer or a multi-layer construction. In multi-layer variety, each layer may consist of different type of material and the layers are typically laminated into one sheet.

[0044] In one embodiment, the interface compartment may contain a material that, upon interaction with one or both of the contents of the two main compartments, turns a color which can provide another form of visual indication that the seal has been compromised. The interface compartment may, for example, contain a material which turns a color when exposed to air. The material may be placed in the interface compartment under vacuum and the main compartment may be filled with components in air, and if the seal is broken, air will infiltrate into the interface compartment causing the material in the interface compartment to turn a color.

[0045] Alternatively, the interface compartment may contain a material which turns a color when exposed to water or moisture. The material may be placed in the interface compartment under a desicated environment and the main compartments may be filled with components where at least one of the components is water. If the peelable seals along edges 4 fail, water will infiltrate into the interface compartment causing the material in the interface compartment to turn a color.

[0046] FIGS. 2A and 2B illustrate a variation of the package of FIG. 1. The interface compartment section 8 of this embodiment has the same structure as and functions in the same manner as the interface compartment in the flexible package of FIG. 1 and provides indication to the user of any unwanted failure of the peelable seals separating the two main compartments. In this embodiment, each side of the flexible package has a base frame 6 with pull tab 5 attached to middle seal band 3. The base frame and pull tabs are preferably constructed from a rigid plastic. The pull tab is hingeably attached to the base frame and each base frame is aligned over and attached to the peelable seals formed along edges 4.

[0047] The base frame 6 is attached to the packaging in such a manner that the peelable seals along the edges 4 will break and peel apart with a lower force than the force required to break the bond between the base frame and the package. Prior to use, the pull tab is in a folded down position as shown in FIG. 2A for ease of storage. When ready for use, the user flips up the pull tabs, as shown in FIG. 2B, and pulls them in opposite directions, breaking the peelable seals under the base frame and permitting flow communication between the two main compartments.

[0048] FIGS. 3A, 3B, and 3C illustrate a different embodiment of the packaging system of the present invention where the seal dividing the flexible package into two compartments is formed by an external sealing clip 10. The sealing clip has an upper leg 12 and a lower leg 14 that are hingeably joined to each other at one end and having a snap closure tab mechanism 16 at the opposite end of the legs. The legs 12 and 14 are preferably joined by a living hinge as shown but may be joined by other mechanisms and ways. The sealing clip is preferably constructed so that it is more rigid than the flexible package, and may be made, for example, from a rigid plastic.

[0049] To form a seal along middle seal band 3 and form two compartments for the components, the package preform is placed between the upper and lower legs of the sealing clip so that longitudinal axis 50 of the sealing clip is aligned over the region where middle seal band 3 is located. As shown in FIG. 3C, the sealing clip is then closed and locked in place by the snap closure tab mechanism 16 which forms a pair of dividing seals 18 (shown in FIG. 3B) across the full width of the flexible package. The location of the pair of dividing seals 18 is shown by a pair of dashed lines in FIG. 3B.

[0050] The mechanism by which the sealing clip may form the pair of dividing seals 18 can be seen in FIGS. 3A, and 3D-3G. The upper and lower legs of the sealing clip have open skeletal frame structures and each leg may have a pair of longitudinal frame members 11 with two cross frame members 19. The cross frame members divide the open space between the two longitudinal frame members into three open window areas A, B, and C, and function as stiffening structural members. As can be seen in FIG. 3A, the sealing clip is provided with a pair of raised sealing ridges 22 along the length of its longitudinal frame members on the inside surfaces of the upper and lower legs. The length of the ridges are preferably longer than the width of the flexible package so that the dividing seals formed by the ridges span the full width of the package, dividing the package into two main compartments.

[0051] Upon closure of the sealing clip, the raised sealing ridges of the upper and lower legs cooperate to engage in a locking manner. The cross-sectional views of the sealing clips in fully closed and locked positions shown in FIGS. 3D-3G illustrate some examples of the profile of the raised sealing ridges that would enable the locking engagement. Ridges with profiles other than those described by FIGS. 3D-3G may also provide the locking engagement. The profiles of the raised sealing ridges are shaped to allow locking of the lower and upper legs of the sealing clip and resist unlocking of the sealing clip.

[0052] When the sealing clip is installed and locked on a flexible package as shown in FIG. 3C, the flexible package is captured between the raised sealing ridges of the upper and lower legs of the sealing clip. The locking mechanism of the sealing clip maintains sufficient compression force on the captured portion of the flexible package to form a pair of liquid-proof mechanical seals along the raises ridges. Once the sealing clip is installed, an interface compartment is created between the pair of mechanical seals formed by the ridges. This interface compartment, represented as regions labeled 7 and 8 in FIG. 3C, functions as a seal tamper indicator.

[0053] The flexible package of this embodiment is preferably made from a transparent or translucent material so that if the dividing seals fail, the contents of one or both of the main two compartments will leak into the interface compartment and serve as a visual indicator of a seal failure. The open window areas A, B, and C of the sealing clip allow the user to visually monitor the interface compartment for any evidence of a seal failure.

[0054] In a variation of this embodiment, middle seal band 3 is non-peelably sealed in two end sections 7 as in the embodiment of FIG. 1. The sealing clip is then clipped on to the middle seal region, forming a pair of mechanical seals, as described above. The pair of seals formed by the ridge mechanism connects with the two permanently sealed end sections 7 forming a continuous seal across the full length of the middle seal band and dividing the flexible package into two separate compartments 1 and 2. In this embodiment, the raised sealing ridges of the upper and lower legs of the sealing clip may not extend the entire width of the package. As shown in FIG. 3C, the central section between the sealed end sections 7 forms an interface compartment 8 which functions as an indicator for seal failure.

[0055] The interface compartment section 8 of this embodiment functions in the same manner as the interface compartment in the flexible package of FIG. 1 and provides indication to the user of any unwanted failure of the seals separating the two main compartments, or if the sealing clip is unlocked and placed back on the package, the contents of one or both of the main two compartments will leak into the interface compartment and provide visual evidence of the seal tampering. Open window area B in the middle of the sealing clip allows the user to visually monitor the interface compartment for any evidence of a seal failure.

[0056] FIG. 3H illustrates a variation of the sealing clip of FIGS. 3A-3D. In this embodiment, the upper and lower legs of the sealing clip do not have an open skeletal structure. The legs are provided with only one open window area B, rather than the three open windows seen in the sealing clip of FIGS. 3A-3C. This embodiment can provide a more rigid structure than the embodiment with three open windows and depending on the rigidity of the material selected for the sealing clip, it might be necessary to use the more rigid embodiment to achieve adequate sealing.

[0057] FIGS. 4A and 4B illustrate another variation of the sealing clip of FIGS. 3A-3C. In this embodiment, upper leg 24 and lower leg 26 of the sealing clip are provided in two separate pieces. When clipped onto the flexible package the dividing seal across the width of the package is formed by a ridge mechanism similar to that of the sealing clip of FIGS. 3A-3C. A pair of raised sealing ridges 22 provided along the longitudinal frame member of the lower leg unit can be seen in FIG. 4A. A corresponding pair of raised sealing ridges are also provided on the upper leg but are not visible in the perspective drawing of FIG. 4A.

[0058] The upper and lower legs are also provided with tabs 28 at each end. When the upper and lower legs are clipped together, the tabs align with each other and are joined together to lock the upper and lower legs of the sealing clip in place as shown in FIG. 4B. The tabs may be joined by any suitable methods such as, for example, heat welding or ultrasonic welding. In order to remove the sealing clip and unseal the two compartments, joined tabs 28′ may need to be cut or broken off, or alternatively require the user to apply force to separate the joined tabs. Thus, the tabs may indirectly serve as an additional seal tamper indicator since breakage or separation of the joined tabs indicate that the sealing clip may have been opened.

[0059] Once the sealing clip is in place, as shown in FIG. 4B, the region between the pair of seals formed by the pair of ridge mechanisms form the interface compartment that functions as seal tamper indicator. The interface compartment is represented as regions labeled 7 and 8 in FIG. 4B. The open window areas A, B, and C of the sealing clip permit the user to visually monitor the interface compartment for any evidence of a seal failure in the same manner as the embodiment of the invention illustrated in FIGS. 3A, 3B, and 3C.

[0060] In a variation of this embodiment, middle seal band 3 is non-peelably sealed in two outer sections 7. The sealing clip is then clipped onto the middle seal band, the ridge mechanisms of the sealing clip preferably forming a pair of mechanical seals across the full length of the middle seal band. Alternatively, the ridge mechanism may be configured to seal the center section in between the sealed end sections 7 without extending the full length of the middle seal band.

[0061] FIG. 5 illustrates a variation of the two-piece sealing clip of FIGS. 4A and 4B. In this embodiment, the upper and lower legs of the two-piece sealing clip may be provided with snap closure mechanisms 30 at each end rather than tabs. This snap closure mechanism may be similar to that used in the embodiment of FIGS. 3A, 3B, and 3C.

[0062] FIG. 5 illustrates another feature of the sealing clips that may be varied. The sealing clip illustrated in FIG. 5 is provided with only one open window area B, similar to the embodiment of the sealing clip shown in FIG. 3H. This embodiment would provide a more rigid structure than the embodiments with three open windows and depending on the rigidity of the material selected for the sealing clip, it might be necessary to use the more rigid embodiment to achieve adequate sealing.

[0063] FIGS. 6A-6C illustrate another embodiment of the invention utilizing a sealing clip with a flexible package. In this embodiment, sealing clip 50 has a center member 56 having two opposite ends 51 and an upper leg 52 and a lower leg 54 which are hingeably attached to the center member at the opposite ends of the center member. The hinge mechanism 57 attaching the upper and lower legs to the center member 56 may be a living hinge. The upper and lower legs are provided with a raised sealing ridge 60, similar to the raised sealing ridges illustrated in FIGS. 3D3G. The center member 56 is provided with corresponding raised sealing ridges that mate with the raised sealing ridges of the upper and lower legs. In FIG. 6A, only the raised ridge 60 of the lower leg 54 is visible. Although, only one raised sealing ridge per leg is illustrated, it would be obvious to one skilled in the art that more than one raised sealing ridges may be provided on each leg. As described above for the illustrations of FIGS. 3D-3G, when the upper and lower legs are closed, the raised sealing ridges of the leg members engage the corresponding raised sealing ridges of the center member 56 in a locking manner. The sealing clip 50 may be provided with snap closure tabs 58 on the upper and lower legs and corresponding openings 59 on the two ends 51 of the center member 56 for engaging the snap closure tabs 58 in a locking manner.

[0064] As illustrated in FIG. 6A, in this embodiment, a flexible package is placed between the center member 56 of the sealing clip and one of the two leg members. The flexible package is then folded over onto itself so that one side of the flexible package is placed between the center member 56 and the other of the two leg members of the sealing clip.

[0065] Then the upper and lower leg members are closed and locked, each leg member forming a seal along its raised sealing ridge. FIG. 6B depicts the flexible package with the sealing clip 50 fully engaged, dividing the flexible package into three compartments: main compartments 1 and 2, and an interface compartment 8. As in the other embodiments of the invention described above, the main compartments each hold a component material for a formulation to be kept separate until ready to be mixed. The interface compartment 8 of this embodiment functions in the same manner as the interface compartments in the flexible packages of FIGS. 1-5 and provides indication to the user of any unwanted failure of one or both of the seals separating the two main compartments.

[0066] In all the embodiments discussed above, the flexible package may be constructed from a cylinder or a sleeve of flexible material, preferably a polymer material, which may preferably come as a long continuous preform. In preparing the package, the cylinder or sleeve of flexible material of a desired width is cut to a desired length and then is sealed along middle seal band 3 utilizing any one of the sealing methods described above. This process will result in a substantially flattened rectangular shaped package with two main compartments 1 and 2, each compartment having openings 40 and 42 respectively. Such interim stages are illustrated in FIGS. 7A and 7B, where FIG. 7B depicts the use of the sealing clip embodiment of FIG. 6A. Each of the two main compartments are filled with the appropriate content material through openings 40 and 42, and then the openings are sealed permanently in a non-peelable manner along the outer edges. Alternatively, the two compartments may be filled and sealed serially. In other words, the first compartment may be filled with a first material and then sealed, followed by the second compartment being filled with a second material and then sealed. In the embodiment of FIG. 7A, the package may be rotated after filling and sealing the first compartment in order to fill and seal the second compartment, whereas rotation would be unnecessary in the embodiment of FIG. 7B.

[0067] In another embodiment, shown in FIG. 7C, the sleeve preform for the flexible package may be constructed from two separate sheets of flexible material. The two separate sheets of flexible material are first fitted together in a face-to-face arrangement and two longitudinal sides 44 and 46 are sealed in a non-peelable manner. The term “face-to-face arrangement” refers to assembling two flat sheets together so that one of the two faces of each sheet come together like to pages in a book. The resulting structure is a flexible container with two open ends 40 and 42 similar to the cylinder of flexible material discussed above. In this embodiment, the two sheets of flexible material may be different types. For example, one sheet may be transparent and the other may be opaque. One or both of the sheets may also be multi-layer laminated sheets of flexible material if appropriate. The sleeve preform may also be fabricated by taking a single sheet of flexible material and folding it over onto itself so that the side edges are aligned and thereafter sealing the side edge in a non-peelable manner. Hence, from this stage on, the flexible package may be constructed into a two-compartment package with a seal tamper indicator as discussed with reference to FIGS. 7A and 7B.

[0068] The flexible two-compartment package may also be provided with different mechanisms for dispensing the formulation once it is mixed. For example, the package may be provided with a nipple 20 for feeding a baby with baby formula as illustrated in FIGS. 1, 2A, 3A, 4A, and 5. Alternately or additionally, a screw cap 47 or other stopper in a dispensing opening 48 may be provided as illustrated in FIGS. 7D and 7E. Alternatively or additionally, the package may be provided with tearing notches 49 to facilitate opening the package after the mixing operation is performed as illustrated in FIG. 7F. FIG. 7F depicts an example of the flexible package of FIG. 7C provided with tearing notches 49 in the nonpeelably sealed regions 44 and 46. The user may also simply cut off one end of the package to dispense the contents.

[0069] FIGS. 8A-8F and 9A-9F illustrate another embodiment of the present invention where a flow valve mechanism is used as a seal tamper indicator between two compartments. The flow valve device 100 comprises a valve body 102 provided with two flow openings 114 and 118 to allow flow of materials there through. In this embodiment, the two flow openings are aligned along flow axis 110 and are provided with sleeves 104 and 108 respectively. The sleeves are used to connect the valve device to two compartments, so that the valve body sits in between the two compartments, each compartment holding different material for mixing at a later time. The compartments connected to the valve device may be of any type, rigid or flexible.

[0070] The flow valve device is provided with a valve member 112 which sits within the valve body's central chamber 106 located between the two flow openings Valve member 112 is configured to rotate within central chamber 106 of the valve body. Valve member 112 is provided with a flow channel 116 so that when the flow channel is in alignment with the two flow openings (i.e. the valve device is in open configuration), the two compartments connected by the valve device are in flow communication.

[0071] One of ordinary skill in the art would appreciate that the flow openings are not required to be aligned along an axis as illustrated in this embodiment. The flow openings may be oriented in any direction relative to each other as long as they can be in flow communication with each other through flow channel 116.

[0072] FIGS. 8A-8F illustrate the valve device in a closed position where valve member 112 is positioned so that flow channel 116 is not aligned with flow openings 114 and 118 and valve member 112 prevents any flow through the valve device. Valve member 112 forms a seal with the interior wall of central chamber 106 to prevent the contents of the two components from entering the interior of valve body 102 when the valve member is in the closed position.

[0073] FIGS. 9A-9F illustrate the valve device in an open position. In this configuration, valve member 112 has been rotated 90° from the closed position so that flow channel 116 is parallel with flow axis 110 and in alignment with the two flow openings 114 and 118 in the valve body, permitting flow communication between the two compartments through the valve device. As shown in FIGS. 9C-9F, the valve member 112 may be provided with a handle 120 to facilitate rotating the valve member between the closed and open position. The handle may be shaped like an elongated raised ridge as shown in FIGS. 9C-9F and may be located on the valve member in a parallel alignment with flow chamber 116 so that the position of the handle indicates whether the valve is in an open or closed position.

[0074] FIG. 10 illustrates an example of a mechanism by which valve member 112 may be engaged with valve body 102 so that the valve member may be retained within the central chamber 106 and also allow the valve member to rotate. Valve body 102 may be provided with a spindle hole 122 at the geometric center 126 of the valve body. Valve member 112 may be provided with a threaded recess 124 at its geometric center so that the recess 124 aligns with spindle hole 122 when valve member 112 is placed within central chamber 106. Once the valve member is placed within the central chamber, a spindle 128, comprising a head portion 132 and a shaft with a threaded portion 130, is inserted through spindle hole 122 and screwed into the valve member's threaded recess 124. Once spindle 128 is screwed into the valve member's threaded recess 124 and secured, the spindle functions as the axle and allows the valve member to be rotated within the central chamber of the valve body. The spindle's shaft may be provided with a non-threaded smooth portion 131 between threaded portion 130 and head portion 132 to facilitate the rotation of the valve member by providing a low friction contact between spindle 128 and spindle hole 122.

[0075] The valve device, together with two compartments connected to sleeves 104 and 108, form a packaging system similar to embodiments of FIGS. 1-6. After the two compartments are filled with components of a formulation and then connected to the valve device, the valve member is normally set in a closed position until ready for use. When ready for use, the user would rotate the valve member to an open position permitting a flow communication between the two compartments and allowing the contents to mix.

[0076] The valve device components of this embodiment are preferably made of a rigid transparent material, such as transparent plastic, so that flow channel 116 is visible. Thus, in its normally closed position, the flow channel functions like the interface compartment of the embodiments of flexible packaging illustrated in FIGS. 1-6. Any accidental opening of the valve would result in the contents of the two compartments entering the flow channel and thus give the user a visual indication that the seal has been compromised.

[0077] FIGS. 11A-11F illustrate a different embodiment of a flow valve device in a closed configuration. Valve body 152 of this embodiment is also provided with two flow openings 162 and 164 in opposing orientation, as in the embodiment of FIGS. 8A-8F, and the two flow openings are aligned along a flow axis 170 and provided with sleeves 154 and 156. Each sleeve is used for connecting the valve device to two compartments. As illustrated in FIG. 11C, the two flow openings are positioned so that the flow axis 170, is off-center from the central axis 174 of the valve device. Valve body 152 of this embodiment is provided with a central chamber 158 such that a valve member 160 sits within the central chamber 158 in orthogonal orientation to the flow axis 170. The valve member is rotatable within the valve body about the central axis 174.

[0078] The valve member 160 has a cylindrical flow channel 166 that extends through the valve member parallel to flow axis 170. The flow channel is positioned off center from the rotational axis (which is the central axis 174) of the valve member so that when the valve member is turned to a closed position the two flow openings and the flow channel are not in alignment and the valve member functions as a plug between the two flow openings, preventing any flow communication between the two containers. The valve member forms a seal with the interior chamber wall to prevent the contents of the compartments from entering the interior chamber of valve body 152 when the valve member is in the closed position. The valve member may be provided with a handle 168 which facilitates turning of the valve member between closed and open position. The handle may be located on the valve member on the side closest to the flow channel so that the position of the handle indicates whether the valve member is in open or closed position. For example, the profile view of the valve device illustrated in FIG. 11B shows that the handle is on the side opposite from the valve device's flow openings, which indicates that flow channel 166 of the valve member is not in alignment with two flow openings 162 and 164, as illustrated in FIGS. 11C and 11E, and the solid portion of valve member 160 blocks the flow communication between the flow openings.

[0079] FIG. 12A is a perspective view of the valve embodiment of FIGS. 11A-11F in an open position. FIGS. 12B-12F illustrate various views of the valve device in an open position showing the relationship among different parts of the valve device. Valve member 160 has been rotated 180° from the closed configuration so that flow channel 166 is now in alignment with the two flow openings and permits flow communication through the valve device. This will allow mixing of the contents of the two compartments connected to the valve device.

[0080] The valve device of this embodiment is preferably made from a rigid transparent material, such as transparent plastic. Thus, the flow channel of the valve member is visible and when in closed position, the flow channel functions like the interface compartment of flexible package embodiments illustrated in FIGS. 1-6. Any accidental opening of the valve device will result in the contents of the two compartments, connected to the valve device, entering the flow channel and thus give the user a visual indication that the seal has been compromised.

[0081] In another embodiment of the flow valve device of FIGS. 12A-12F, the disk-shaped valve member 160 may be a hollow body with two openings 166 (analogous to flow channel 166 in the embodiment of FIGS. 12A-12F) that are located such that two openings 166 align with flow openings 162 and 164 when the valve member is in open position. In this embodiment the hollow valve member itself functions like the interface compartment of the embodiments of the packages illustrated in FIGS. 1-6. Any accidental opening of the valve would result in the contents of the two compartments entering the hollow valve member and thus give the user a visual indication that the seal has been compromised.

[0082] Although the present invention has been described with particular reference to some embodiments, it should be understood that many variations and modifications will now be obvious to those skilled in that art, and therefore, that the scope of the invention should not be limited by the specific disclosure herein, but only by the appended claims.