Patent Publication Number: US-8979817-B2

Title: Multi-chamber container with seal breach detection

Description:
REFERENCE TO OTHER APPLICATION 
     This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/507,712, filed Jul. 14, 2011, which is incorporated by reference in its entirety. 
    
    
     BACKGROUND OF THE DISCLOSURE 
     The present disclosure relates generally to the field of containers such as containers for medical and/or biological solutions. The present disclosure relates specifically to a multi-chamber container configured to provide an indication that a seal breach between chambers has occurred. 
     Certain solutions (e.g., medical solutions) are formed by mixing or combining together two or more components prior to use. For some such solutions, it is desirable keep the solution components separate during various steps of processing and/or separate until ready to be used. The solution components may be combined once the need for the components to be separated has passed and/or before use of the solution. Solution components may be separated for a variety of reasons including stability, to ensure compatibility and to prevent premature reaction between solution components. Further, such solutions may be stored in containers having multiple compartments separated by a peelable or frangible seal. In some applications, each compartment of the container may hold a different solution component, and when mixing of the solution components is desired, the seal between the separate compartments is broken allowing the solution components to mix. 
     SUMMARY 
     In one aspect, the present disclosure is directed to a container comprising opposed first and second sheets sealed along a peripheral edge to define an interior chamber comprising a top edge, a bottom edge and first and second opposing lateral edges. There are at least first and second frangible seals located in the interior chamber, forming separate first, second and third compartments in the interior chamber. The third compartment is located between the first and second compartments, the third compartment being defined by the first and second frangible seals and at least a portion of the top and bottom peripheral edges. The third compartment comprises an indicator adapted to detect premature breach of one or both of the at least first and second frangible seals. 
     In another aspect, the present disclosure is directed to a method of forming a container having a seal breach detection indicator. The method comprises the steps of sealing first and second opposing sheets at their peripheral edges to form an interior chamber comprising a top edge, a bottom edge and first and second opposing lateral edges and forming at least first and second frangible seals between the opposing sheets to define first, second and third compartments in the interior chamber. The third compartment is located between the first and second compartments and is defined by the at least first and second frangible seals and at least a portion of the top and bottom peripheral edges. The method further comprises filling the first chamber with a first solution and filling the second chamber with a second solution and detecting the presence of at least one of the first and second solutions in the third chamber to determine premature breach of at least one of the first and second frangible seals. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a front view of a multi-chamber container according to an exemplary embodiment. 
         FIG. 2  is a cross-sectional view of the multi-chamber container of  FIG. 2 . 
         FIG. 3  is a front view of a multi-chamber container according to another exemplary embodiment. 
         FIG. 4  is a flow-diagram showing the method making a multi-chamber container and fluid combination according to an exemplary embodiment. 
         FIG. 5  is a flow-diagram showing a method of making and use of multi-chamber container and fluid combination according to another exemplary embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure provides a general description of multi-chamber containers configured to provide an indication that a seal breach between chambers has occurred as well as methods for making such containers. The embodiments disclosed herein also provide a general description of the various components that may be contained in the multiple chambers. These embodiments are only exemplary, and may be embodied in various forms. Therefore, specific details disclosed herein are not to be interpreted as limiting the subject matter of the invention which is set forth in the accompanying claims. 
     In one embodiment, a multi-chamber container, in accordance with the present disclosure, includes at least one frangible seal in the container interior chamber, thus forming at least two chambers in the interior chamber. More preferably however, the multi-chamber container includes at least two frangible seals, thus forming first, second and third chambers in the container interior chamber. It is also contemplated that the multi-chamber container may include more than two frangible seals, such that the container interior chamber may be divided into more than three compartments. In other words, the multi-chamber container is not limited to a particular number of frangible seals and/or compartments in the interior of the container. In addition, the frangible seals and multiple compartments are not limited to any particular shape, size or configuration. In one example, the frangible seals may be substantially linear, curved, zig-zag, serpentine or the like. It will also be appreciated that the compartments may also have various shapes, including, but not limited to rectangular, square, triangular, circular, or any combination thereof. 
     The multi-chamber container may be used to hold any material for which it is desirable to provide a separation between two or more materials. While one or more of the multiple chambers may contain medical or therapeutic solutions (or parts of solutions) for the storage and/or preservation of blood components, one or more of the other multiple chambers may contain blood or the blood components themselves. Of course, it is also contemplated that one or more of the multiple chambers may contain other materials in various forms, including solids, gels, liquids, powders and the like, or combinations thereof. 
     More specifically, referring to  FIGS. 1-3 , a multiple chamber or multiple compartment container  10  is shown according to an exemplary embodiment. In the embodiment shown, container  10  includes a first chamber, shown as first compartment  12 , and a second chamber, shown as second compartment  14 , that provide for separate storage of solutions, substances, components, etc., within container  10 . Container  10  also includes a third chamber, shown as third compartment  16 , located between first compartment  12  and second compartment  14 . In the embodiment shown in  FIGS. 1-3 , third compartment  16  separates compartment  12  from compartment  14  such that fluid must pass through compartment  16  in order to move between compartments  12  and  14 . 
     In the embodiment of  FIGS. 1-3 , container  10  includes a first frangible seal  18  and a second frangible seal  20 . Seal  18  is located between first compartment  12  and third compartment  16 , and seal  20  is located between the second compartment  14  and the third compartment  16 . Seals  18  and  20  hermetically seal the interfaces between third compartment  16  and first and second compartments  12  and  14 , respectively. Seals  18  and  20 , when unbroken, prevent fluid from flowing out of first and second compartments  12  and  14  past seals  18  and  20 , respectively. 
     As shown in the exemplary embodiment of  FIG. 1 , first compartment  12  holds a first material, shown as solution A, and second compartment  14  holds a second material, shown as solution B. It may be desirable for solutions A and B to be separated for a variety of reasons including increasing stability of the solutions, preventing unwanted and/or premature reactions between solutions, ensuring compatibility of the solutions at the time of use, etc. In the embodiment shown, compartment  16  does not include a solution and is substantially empty or devoid of liquid material, and as explained below, compartment  16  functions to provide an indication of whether seals  18  and  20  have been breached. 
     Referring to  FIG. 2 , a cross-sectional view of container  10  taken along line  2 - 2  in  FIG. 1  is shown. As shown in  FIG. 2 , container  10  is shown as a bag-type container formed from two sheets of flexible (e.g., a plastic or polymer) material, shown as first sheet  22  and second sheet  24 . To form container  10  the left lateral edges of sheets  22  and  24  are sealed together by seal  26 , and the right lateral edge of sheets  22  and  24  are sealed together by seal  28 . Referring back to  FIG. 1 , the upper edges of sheets  22  and  24  are sealed together by upper seal  30 , and the lower edges of sheets  22  and  24  are sealed together by lower seal  32 . In contrast to frangible seals  18  and  20 , seals  26 ,  28 ,  30  and  32  are non-frangible seals and form a tight bond that forms a hermetic seal around the periphery of container  10 . Together, outer seals  26 ,  28 ,  30  and  32  form a peripheral or outer seal of container  10 . In one embodiment, container  10  may be formed from a single sheet of flexible material folded back on its self such that one of the lateral edges of the container is defined by the fold and the other lateral edges of the container are defined by seals between adjacent sections of the folded sheet of material. 
     As shown in  FIG. 2 , the chamber of first compartment  12  is defined by the inner surfaces of portions of sheets  22  and  24 . As shown in  FIG. 1 , the left lateral edge of first compartment  12  is defined by seal  26 , and the right lateral edge of first compartment  12  is defined by frangible seal  18 . The upper edge of first compartment  12  is defined by the portion of upper seal  30  between seal  26  and frangible seal  18 , and the lower edge of first compartment  12  is defined by the portion of lower seal  32  between seal  26  and frangible seal  18 . In one embodiment, the outer edge of compartment  12  is defined by the portion of the outer seal of container  10  on the opposite side of frangible seal  18  from third compartment  16  and the inner edge of compartment  12  is defined by seal  18 . 
     As shown in  FIG. 2 , the chamber of second compartment  14  is defined by the inner surfaces of portions of sheets  22  and  24 . As shown in  FIG. 1 , the right lateral edge of second compartment  14  is defined by seal  28 , and the left lateral edge of second compartment  12  is defined by frangible seal  20 . The upper edge of second compartment  14  is defined by the portion of upper seal  30  between seal  28  and frangible seal  20 , and the lower edge of second compartment  14  is defined by the portion of lower seal  32  between seal  28  and frangible seal  20 . In one embodiment, the outer edge of compartment  14  is defined by the portion of the outer seal of container  10  on the opposite side of frangible seal  20  from third compartment  16  and the inner edge of compartment  14  is defined by seal  20 . 
     As further shown in  FIG. 2 , the cavity of third compartment  16  is defined by the inner surfaces of portions of sheets  22  and  24 . As shown in  FIG. 1 , the left and right lateral edges of third compartment  16  are defined by frangible seals  18  and  20 , respectively. The upper edge of third compartment  16  is defined by the portion of upper seal  30  between frangible seals  18  and  20 , and the lower edge of third compartment  16  is defined by the portion of lower seal  32  between frangible seals  18  and  20 . In the embodiment shown in  FIGS. 1 and 3 , compartments  12 ,  14  and  16  are substantially rectangular compartments in which frangible seals  18  and  20  are parallel to the left and right lateral edges of container  10 . In other embodiments, container  10  and compartments  12 ,  14  and  16  may be other shapes as desired for a particular application. 
     When mixing of solutions A and B is desired, frangible seals  18  and  20  are broken allowing solutions A and B to mix within container  10 . In the embodiment shown, seals  18  and  20  are peelable seals that can be broken with the application appropriate force, and seals  18  and  20  are configured such that the force that opens seals  18  and  20  will not break the outer peripheral seal of container  10 . 
     As noted above, in one embodiment, while frangible seals  18  and  20  are intact, third compartment  16  is substantially devoid of liquid. Thus, compartment  16  acts to provide an indication of whether either seal  18  or seal  20  has been broken or breached by providing an inspection area that will show if fluid from compartments  12  or  14  is present in compartment  16 . For example, if upon inspection, liquid is discovered within compartment  16 , this indicates that seal  18  and/or seal  20  has been breached, and appropriate action can be taken based on the detection. For example, in one embodiment, container  10  may be discarded if compartment  16  indicates that a premature or unintentional breach of one or more of the seals has occurred. 
     In one embodiment, inspection of compartment  16  for the presence of fluid may occur via visual inspection by a user (e.g., a worker at a manufacturing or filling facility for container  10 , a health care professional administering the contents of container  10  to a patient, etc.). In another embodiment, inspection of compartment  16  for the presence of fluid may occur via a device or system configured to detect the presence fluid within compartment  16 . For example, the device may be a machine vision system configured to detect diffusion of light caused by the presence of fluid droplets. In another embodiment, the device may be an ultrasound based device configured to detect propagation of sound waves through liquid droplets. 
     In various embodiments, container  10  may be configured to facilitate detection of liquid within compartment  16 . For example, the portion of the material of container  10  located between frangible seals  18  and  20  may be transparent, forming a window that allows the user to see into compartment  16 . In one such embodiment, container  10  may be made from a polymer or plastic material, and the portion of the polymer or plastic material that forms compartment  16  may be a transparent polymer material that allows the user/machine to easily see through the material of compartment  16 . In one such embodiment, the portion of the polymer or plastic material of container  10  that forms compartment  16  may have a smooth outer finish to increase light transmission through compartment  16 . In one such embodiment, the material of compartment  16  may have a smooth outer finish such that compartment  16  is transparent, and the material of compartments  12  and  14  is textured or “frosted” such that the material of compartments  12  and  14  is translucent or opaque. 
     In some embodiments, compartment  16  may include one or more indicator devices or materials configured to provide an indication that seals  18  and/or  20  have been prematurely breached and that unintended mixture of solutions A and B has occurred. In one such embodiment, compartment  16  may include an indicator material that provides an indication (e.g., a color change) that fluid has entered compartment  16 , and if the breach has occurred at an unintended time (e.g., during processing, shipping, storage, etc. of container  10 ), container  10 , with a premature breach of seal  18  or  20 , can be disposed of prior to use of the solution. 
     In various embodiments, the indicator material can be any material capable of providing an indication that either seal  18  or  20  has been breached. For example, the indicator material may change color based on the presence of liquid, based on the pH of solutions A and B, the ion concentration of solutions A and B, the presence of specific molecules/chemicals of solutions A and B, etc. The indicator material may be any suitable type of material including, a solid material, a fluid material (e.g., a liquid, a liquid solution, a gas, a gaseous solution, etc.), a powdered material, etc. In one embodiment, the indicator material may provide a first indication specific to the presence of solution A and a second indication specific to the presence of solution B allowing the user to tell whether seal  18 , seal  20  or both seals  18  and  20  have been breached. In one such embodiment, compartment  16  may include a first indicator material responsive to the presence of solution A and a second indicator material responsive to solution B. The first indicator material and/or the second indicator material may be the same or they may be different, and may also be responsive to the presence of both solutions A and B. 
     In some embodiments, the indicator material or materials may be located in areas of container  10  other than the chamber within compartment  16 . For example, the indicator material may be incorporated into the polymer material that forms compartment  16 . In this embodiment, incorporation of the indicator material within the matrix of the polymer material may prevent the indicator material from mixing with the solution following intentional breach of seals  18  and  20 . In another embodiment, an indicator material may be located within seals  18  and  20 , and the indicator may provide a localized indication that fluid has traversed seal  18  and  20 . In one such embodiment, the indicator material may be a strip of indicator material embedded within seals  18  and  20  that extends a portion of and/or the entire length of seals  18  and  20 . 
     Container  10  includes one or more ports, shown as ports  34  and  36 , in  FIG. 1 . Ports  34  and  36  traverse the outer peripheral seal of container  10  adjacent to compartments  12  and  14 . Ports  34  and  36  provide for fluid communication with compartments  12  and  14 , respectively. As such, ports  34  and  36  provide an access point allowing fluids to be moved into or out of compartments  12  and  14 , and ports  34  and  36  may be used to fill compartments  12  and  14  with solutions A and B, respectively. Following mixture of solutions A and B, port  34  and/or  36  may be used to remove the mixed solution from container  10  for use in the appropriate application. Ports  34  and  36  may include one or more structure (seals, valves, etc.) to control movement of fluid through the ports and to maintain the sterility of the solutions within container  10 . 
     In one embodiment, container  10  may include one or more dedicated input or fill ports and one or more dedicated output ports. The fill ports may be configured and/or positioned to allow the separate components or solutions to be filled into the separate compartments of container  10 , and the dedicated output port may be configured and/or positioned such that fluid can be removed from container  10  only after breach of seals  18  and/or  20  have occurred. 
     As shown in  FIG. 3 , in one embodiment, container  10  may include dedicated input ports and a dedicated output port. For example, container  10  may include an output port, shown as port  38 , that traverses the outer peripheral seal of container  10  adjacent compartment  16  and provides fluid communication with compartment  16 . With output port  38  in communication with compartment  16 , the solution of container  10  can only be removed if the solution is present in compartment  16 . Further, ports  34  and  36  may be configured to ensure that fluid is allowed to flow only one-way into compartments  12  and  14 , and port  38  may be configured to permit fluid flow only one-way out of compartment  16 . In some embodiments, ports  34  and  36  may include a one-way valve (e.g., a check valve) that allows fluid to flow only into compartments  12  and  14 . Port  38  may include a one-way valve (e.g., a check valve) that allows fluid to flow only out of compartment  16  through port  38 . The one-way valves in the ports ensure that only ports  34  and  36  may be used for filling container  10  and that only output port  38  can be used to deliver fluid from container  10 . 
     Generally, first and second sheets  22  and  24  may be made of any suitable material such as, for example, a flexible material, and the first sheet  22  may be made of the same or a different material as the second sheet  24 . More specifically, the material used for the first and/or second sheets  22  and  24  may vary depending on the fluids to be stored in the first and/or second compartments  12  and  14 . In some examples, the first and second sheets  22  and  24  may each include a single layer plastic sheet. Alternatively, in other examples, the first and second sheets  22  and  24  may each include a multilayer plastic sheet. Additionally, the type of material used for the first and/or second sheets  22  and  24  may depend on the method (e.g., heating method, welding method, etc.) used to form seals  18  and  20  and/or the outer peripheral seal of container  10 . Some methods of forming peelable seals and/or the outer peripheral seal of container  10  include, for example, direct heat sealing and/or RF sealing. In some examples, the first and second sheets  22  and  24  may be made of a RF-responsive plastic material or RF-responsive resin material to enable RF-welding to be utilized to form the outer peripheral seals  26 ,  28 ,  30  and  32  of container  10  and/or frangible seals  18  and  20 . Generally, RF-responsive resins are resins that may be heated by RF energy. 
     In some exemplary embodiments, the first and second sheets  22  and  24  have a thickness between about 1 mil and 10 mils depending on the type of sheets used (e.g., a single plastic sheet or a multilayer plastic sheet). A multilayer sheet may include a plurality of different plastic films adhered to one another to form a single sheet, which has properties not possessed by a single plastic sheet. The first and second sheets  22  and  24  may be made of multilayer sheets if, for example, the fluid to be contained in the first and/or second compartments  12  and/or  14  is only compatible with particular types of materials (e.g., particular types of plastics) and/or the fluid to be contained in the first and/or second compartments  12  and/or  14  requires a material (e.g., plastic) that is substantially impenetrable to air, oxygen and/or moisture. 
     In other examples, the first and second sheets  22  and  24  may be plastic or polymer sheets and specifically, may be a single layer of polyvinylchloride (PVC) film having a thickness of between about 3 mils and 18 mils. Typically, PVC film is compatible with whole blood as well as blood products and also may be used as a contacting surface for a wide variety of therapeutic solutions. Additionally, the PVC film is RF-responsive (e.g., RF-welding may be utilized to form the outer peripheral seals  26 ,  28 ,  30  and  32  of container  10  and/or frangible seals  18  and  20 ). However, any other suitable material or plastic resin may be utilized to produce the first and/or the second sheets  22  and/or  24  such as, for example, non-PVC materials, non-DEHP materials, polyolefins, polyamides, polyesters, polybutadiene, styrene and hydrocarbon copolymers and mixtures thereof. 
     In some embodiments, the seals  18  and  20  may be formed by a direct heat sealing method, a RF sealing method or an ultrasonic welding method. To form peelable seals  18  and  20 , a sealing die bar may be brought into contact with the outer surface of sheets  22  and/or  24  at the location where seals  18  and  20  are to be formed. The die bar is then energized with, for example, heat energy, RF energy, ultrasonic energy, etc., causing sheets  22  and  24  to melt together to form the desired peelable seal. In one embodiment, peelable seals  18  and  20  may be formed after the outer peripheral seal of container  10  has been formed. In one embodiment, the formation of seals  18  and  20  may include the positioning of a mesh material between sheets  22  and  24  prior to the formation of seals  18  and  20 . Use of a mesh material between sheets  22  and  24  may allow for formation of a peelable seal with desirable break or breach characteristics. Various embodiments of container  10  and formation of peelable seals  18  and  20  are disclosed in U.S. Patent Publication No. US 2009/0214807, filed Feb. 24, 2009, which is incorporated herein by reference in its entirety. 
     While the embodiments of seals  18  and  20  discussed above relate primarily to frangible, peelable seals, formed by melt-sealing together opposing polymer sheets, other suitable sealing structures may be used. For example, seals  18  and  20  may be peelable seals formed by a liquid tight adhesive material. In another exemplary embodiment, seals  18  and  20  may be formed by opposing groove and ridge structures that are configured to releasably interlock to form a fluid tight seal (e.g., a Zip-Loc type sealing structure). 
     In various embodiments, frangible seals  18  and  20  are seals formed between sheets  22  and  24  that are configured to allow the user or production machinery to break the seals by manipulating container  10  in order to mix together the contents of compartments  12  and  14 . For example, seals  18  and  20  may be breached by grasping the outer surfaces of sheets  22  and  24  and applying an outwardly direct force (i.e., a force directed outwardly away from the outer surface of container  10 ) causing sheets  22  and  24  to separate at seals  18  and  20 . In one such embodiment, container  10  may include one or more structures (e.g., grasping tabs) extending from the outer surface of container  10  that facilitates grasping and separation of seals  18  and  20 . As another example, seals  18  and  20  may be breached by applying pressure to compartments  12  and  14  such the liquid within compartments  12  and  14  force seals  18  and  20  to rupture. 
     As mentioned above, container  10  may be used to hold any solution for which it is desirable to provide separation between two components. In one embodiment, solution A and solution B may be components of a therapeutic solution (e.g., a drug solution, nutraceutical solution, blood solution, blood component solution, saline solution, etc.) separated within container  10 . For example, solution A and solution B may be components of a platelet storage media or platelet additive solution (PAS) (e.g., PAS 1, PAS 2, PAS 3, PAS 4, PAS 5, etc.), and/or InterSol platelet additive solution offered by Fenwal, Inc. The platelet storage medium is preferably an aqueous storage solution that includes one or more nutrients and buffer(s) in a salt solution. Thus, for example, one of the container compartments (e.g. Solution A) may include a portion of the platelet additive solution, including acetate, citrate, phosphate, potassium and/or bicarbonate, while the other compartment (e.g. Solution B) may include a second portion of the solution, such as glucose, magnesium, calcium, saline and/or other components if desired. Once combined (such as by rupturing one or more of the frangible seals to combine the first and second portions (e.g. Solutions A and B)) the final storage solution preferably includes a mixture of some or all of the above-mentioned components, with the pH of the final storage solution preferably ranging from 6.5-7.5. 
     In an alternative exemplary embodiment, solution A and solution B may be components a red blood cell preservative or storage solution such as, for example, Adsol, SAG-M and/or ESOL, also offered by Fenwal, Inc. Thus, for example, one of the compartments A or B may include sodium citrate, sodium phosphate, adenine, mannitol and/or sodium chloride and the other of compartments A or B may include at least glucose, along with other components if desired. Once combined (such as by rupturing one or more of the frangible seals to combine the first and second portions of the solution) the final red blood cell storage solution preferably includes a mixture of some or all of the above-mentioned components, with the pH of the final storage solution preferably ranging from 7.4 to 8.4. 
     It is also contemplated that, in addition to the containers described above in which a blood component storage/preservative solution is contained in first and/or second compartments (which portions may be pre-combined in a single compartment or combined at a later time to form a final additive/storage solution for blood or blood components including platelets and/or RBC), the container may include an additional frangible seal forming an additional compartment that may contain, for example, whole blood or a particular blood component(s). Thus, during use, at least one of the frangible seals may be broken to allow the various solution components to be combined to form a final solution. The additional frangible seal may also be broken to allow the blood or blood component, such as platelets and/or RBCs, to mix with the solution. The breaking of the various frangible seals may be performed simultaneously or in a selected order to allow for mixing of the solution and blood/blood components in a particular sequence. 
     In other exemplary embodiments, at least one of the compartments, such as first compartment  12  may contain blood or a blood component (e.g., red blood cells, white blood cells, plasma, platelets, combinations thereof, etc.) and another of the multiple compartments, such as the second compartment  14 , may contain a treating fluid or treating device (e.g., a pathogen inactivation solution or compound). In other exemplary embodiments, first compartment  12  may contain blood or a blood component and second compartment  14  may contain a preservative solution. Specifically, first compartment  12  may receive red blood cells and second compartment  14  may contain a red blood cell preservative or storage solution such as, for example, Adsol, SAG-M and/or ESOL described above. 
     In one embodiment, at least one of the compartments, such as first compartment  12  may contain a blood component and second compartment  14  may include a compound absorption device associated with pathogen inactivation. Generally, the compound absorption device associated with pathogen inactivation may substantially remove pathogen inactivation agents, by-products of a pathogen inactivation treatment or even the pathogens themselves. 
     Referring to  FIG. 4 , a method  50  for making container  10  including, for example, a therapeutic substance or one or more solutions is shown according to an exemplary embodiment. At step  52 , container  10  is made as discussed above. At step  54 , chamber  12  is filed with solution component A and chamber  14  is filled with solution component B. As noted above, solution components A and B may be components of a platelet additive solution or storage media or alternatively, components of a RBC preservation solution. At step  56 , container  10  and its contents are sterilized. In one embodiment, container  10  is sterilized by autoclave. At step  58 , chamber  16  is inspected to detect whether either seal  18  or seal  20  has broken. In this embodiment, inspection for breakage of seals  18  and  20  occurs following autoclave because solutions A and B, if mixed, may undergo a chemical reaction during the autoclave process. As noted above, the inspection at step  58  may occur via human inspection of the chamber  16  for presence of liquid or via machine inspection of chamber  16  for the presence of liquid. If liquid is detected in chamber  16 , the container is discarded at step  60 . 
     If liquid is not detected in chamber  16 , it is likely that seals  18  and  20  remained intact before and during autoclave, and then at step  62 , seals  18  and  20  are broken allowing solution components A and B to mix. In one embodiment, seals  18  and  20  may be broken manually, and in another embodiment, seals  18  and  20  may be broken utilizing a machine or apparatus to automatically break seals  18  and  20  following inspection of chamber  16  and confirmation that chamber  16  is free from liquid. 
     In one embodiment, the seal breaking apparatus may grip the outer surfaces of container  10  and apply an outwardly directed force causing seals  18  and  20  to break. In another embodiment, the seal breaking apparatus may press on compartments  12  and  14 , causing a localized increase in fluid pressure at seals  18  and  20  that cause the seals to break. In an embodiment in which a manufacturing worker inspects chamber  16 , the user may interact with a user input device to indicate whether liquid was detected in chamber  16  at step  58 . If the user input indicates that no liquid was detected in chamber  16 , a control signal based upon the input received by the user input device is communicated to the seal breaking apparatus, and the seal breaking apparatus breaks seals  18  and  20  in response to the control signal. In an embodiment in which inspection of chamber  16  is completed using a machine inspection system, a control signal is communicated to the seal breaking apparatus if no liquid is detected within chamber  16 , and the seal breaking apparatus breaks seals  18  and  20  in response to the control signal. At step  64 , container  10  including the mixed solution is shipped to the customer. 
     Referring to  FIG. 5 , a method  70  for producing container  10  including a therapeutic substance and/or one or more solutions is shown according to an exemplary embodiment. Method  70  may be practiced for solutions in which it is undesirable to mix solution components A and B more than a short time before use. Steps  52 - 60  of method  70  are the same as the corresponding steps of method  50 . If no liquid is detected within chamber  16 , container  10  is shipped to the customer with seals  18  and  20  intact and solution components A and B remaining separated at step  72 . At step  74 , an on-site or point-of-use inspection of chamber  16  for liquid occurs via one of the inspection processes discussed above. If liquid is detected in chamber  16 , the container is discarded at step  76 . If liquid is not detected in chamber  16 , the container  10  is used at step  78 . 
     It should be understood that the present application is not limited to the details or methodology set forth in the description or illustrated in the figures. It should also be understood that the terminology is for the purpose of description only and should not be regarded as limiting. 
     Further modifications and alternative embodiments of various aspects of the invention will be apparent to those skilled in the art in view of this description. Accordingly, this description is to be construed as illustrative only. The construction and arrangements, shown in the various exemplary embodiments, are illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter described herein. Some elements shown as integrally formed may be constructed of multiple parts or elements, the position of elements may be reversed or otherwise varied, and the nature or number of discrete elements or positions may be altered or varied. The order or sequence of any process, logical algorithm, or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes and omissions may also be made in the design, operating conditions and arrangement of the various exemplary embodiments without departing from the scope of the present invention.