Patent Publication Number: US-2023140385-A1

Title: Blood product storage system with sealable bag

Description:
BACKGROUND 
     The present invention relates to blood product storage systems, and more particularly to bags and containers for storing a blood product in a controlled atmosphere. 
     A method and device for preserving blood or its components in a gas medium under pressure and system for the same is described in PCT Publication No. WO2012/177820, which is incorporated herein by reference in its entirety. According to the &#39;820 publication, the blood or blood components are placed in a bag that is made of a xenon gas-permeable material. The bag is then placed into a hermetically-sealed cylindrical chamber into which xenon-containing gas (with a xenon content of at least 65 vol. %) is fed under pressure until the pressure in the chamber reaches the approximate of 3.5 to 5 bars, after which the chamber is placed in storage at a temperature within the range from 3-6° C. Bags that are made of the gas-permeable material are designed to allow xenon to pass through the bag for the implementation of this method. In this method, the xenon-containing gas (fed under pressure into the chamber) passes through the bag wall, after which the blood or blood components in the bag are partially or fully saturated with xenon. 
     Movement of the chamber that contains the pressurized gas can be cumbersome between users, for example, between a blood bank facility and a hospital. In addition, such a chamber may require a significant amount of gas to be pumped into the container in order to create suitably high pressures. According to another method, described in U.S. Publication No. 2018/0249703, which is incorporated herein by reference in its entirety, the gas-permeable bag containing the blood or blood components is placed into a secondary bag, which in turn is filled with a xenon-containing gas system. This “bag-in-bag” assembly is then placed into a pressure chamber, and a second gas, which may be ordinary compressed air, is introduced into the chamber to elevate the pressure of the xenon-containing gas system in the secondary bag and in turn cause the xenon to pass through the gas-permeable bag. 
     It has been found, however, that filling the secondary bag with the xenon-containing gas system and preventing subsequent leaking of the gas system can be difficult to accomplish. For example, existing one-way gas fill valves tend to be relatively expensive for use in a disposable product, complex to manufacture, and are difficult to properly seal with the thin walls of the secondary bag. In view of the current state of the art, there remains a need for a device which provides storage conditions for preserving blood products and cellular cultures in a gas medium under pressure that is reliable, inexpensive, and easy to use in the blood bank and hospital environment. 
     SUMMARY 
     The present disclosure provides, in one aspect, a system for storing a blood product including an inner container configured to contain the blood product, wherein the inner container is permeable to a gas system, and an outer container including a first end, a second end opposite the first end, a cavity defined between the first and second ends, an inlet in fluid communication with the cavity, and a valve operable to control a flow of the gas system through the inlet. The inner container is insertable into the cavity through the first end, the first end is sealable to hermetically seal the inner container within the cavity, and the outer container is made of a material that is impermeable to the gas system. 
     In some embodiments, the valve includes a sleeve extending into the cavity and having a perforation, and the gas system is configured to flow into the cavity through the sleeve and the perforation when a gas system source is connected to the inlet. 
     In some embodiments, the sleeve is configured to collapse when a pressure within the cavity is greater than a pressure at the inlet. 
     In some embodiments, the outer container includes a first sheet of material and a second sheet of material sealed together at the second end, and the inlet extends through the second end. 
     In some embodiments, the valve includes a flexible membrane and a orifice formed in the flexible membrane. 
     In some embodiments, the membrane is configured to expand to open the orifice when a gas system source is connected to the inlet. 
     In some embodiments, outer container includes a transparent window. 
     In some embodiments, the inner bag is visible through the transparent window when the inner bag is hermetically sealed within the cavity. 
     In some embodiments, the valve includes external threads. 
     In some embodiments, the first end of the outer container includes an interlocking closure. 
     In some embodiments, the gas system includes xenon. 
     In some embodiments, the outer container comprises metal foil. 
     In some embodiments, the valve is sealed inside the cavity when the first end is sealed. 
     In some embodiments, a compartment is disposed within the outer container and filled with the gas system, the compartment including an inner wall facing the cavity. The valve includes a hole formed in the inner wall and a tab a tab removably coupled to the inner wall such that the tab covers and seals the hole, and the tab is removable to open the hole and permit the gas system to diffuse from the compartment into the cavity. 
     The present disclosure provides, in another aspect, a system for storing a blood product including an inner container configured to contain the blood product, wherein the inner container is permeable to a gas system, an outer container including a sealable end and a cavity configured to receive the inner container through the sealable end prior to sealing the end, wherein the outer container is impermeable to the gas system, a compartment disposed within the outer container and filled with the gas system, the compartment including an inner wall facing the cavity and a hole formed in the inner wall, and a tab removably coupled to the inner wall such that the tab covers and seals the hole. The tab is removable to open the hole and permit the gas system to diffuse from the compartment into the cavity. 
     In some embodiments, the tab extends through the sealable end of the outer container. 
     In some embodiments, the compartment is integrally formed with the outer container. 
     The present disclosure provides, in another aspect, a method of storing a blood product, including inserting an inner container containing the blood product into a cavity of an outer container through an open end of the outer container, the inner container being permeable to a gas system and the outer container being impermeable to the gas system, opening a hole within the cavity, introducing the gas system into the cavity through the hole, and sealing the open end of the outer container to hermetically seal the inner container within the cavity of the outer container. 
     In some embodiments, the hole is located on a compartment within the cavity, the compartment containing the gas system, and opening the hole includes pulling on a tab extending through the open end of the outer container. 
     In some embodiments, sealing the open end includes partially heat sealing the open end prior to opening the hole, and fully heat sealing the open end after opening the hole. 
     Other features and aspects of the disclosure will become apparent by consideration of the following detailed description and accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a top view of a storage system according to an embodiment of the present disclosure. 
         FIG.  2    is a schematic cross-sectional view of the storage system of  FIG.  1   . 
         FIG.  3    is an internal view illustrating a valve of the storage system of  FIG.  1   . 
         FIG.  4    is a schematic cross-sectional view illustrating an edge seal of the storage system of  FIG.  1   . 
         FIG.  5    is a schematic illustration of a storage system according to another embodiment of the present disclosure. 
         FIG.  5 A  is an enlarged detail view illustrating a valve of the storage system of  FIG.  5   . 
         FIG.  6    is a perspective view of a storage system according to an embodiment of the present disclosure. 
         FIG.  7    is a schematic cross-sectional view of the storage system of  FIG.  6   . 
         FIG.  8    is a perspective view illustrating heat sealing of an outer container of the storage system of  FIG.  6   . 
     
    
    
     Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. 
     DETAILED DESCRIPTION 
       FIGS.  1 - 2    illustrate a storage system  10  according to an embodiment of the present disclosure. The storage system  10  includes a first or inner container  14  ( FIG.  2   ) and a second or outer container  18  configured to receive the inner container  14  therein. In the illustrated embodiment, the outer container  18  is a flexible bag that includes a cavity sized and shaped to be able to fully contain the inner container  14  within the cavity of the outer container  18 . The illustrated inner container  14  is configured as a flexible bag used to store a biological material, and more specifically, a blood product or cellular culture such as a platelet concentrate for later use in an organism. 
     The inner and outer containers  14 ,  18  of the illustrated storage system  10  are made of different materials or combinations of materials. More particularly, the inner container  14  is made of a flexible material that is permeable to a gas system, which in some embodiments may include xenon, a mixture of xenon and oxygen, or other gases suitable for enhancing preservation of the biological material contained within the inner container  14 . 
     In some embodiments, the xenon content of the gas system is at least 5 vol. %. In some embodiments, the xenon content of the gas system is up to 99.99999 vol. %. In some embodiments, the xenon content of the gas system is at least 5 vol. % and up to about 99.99999 vol. % (e.g., 5 vol. %, 5.00001 vol. %, 5.00002 vol. % . . . 99.99998 vol. %, 99.99999 vol. %) and any value or range there between. In some embodiments, the xenon content of the gas system is from about 50-99.999 vol. %. In some embodiments, the xenon content of the gas system is from about 55-99 vol. %. In some embodiments, the xenon content of the gas system is from about 60-98 vol. %. In some embodiments, the xenon content of the gas system is from about 70-97 vol. %. In some embodiments, the xenon content of the gas system is from about 79-95 vol. %. In some embodiments, the oxygen content of the gas system is about 0-50 vol. % (e.g., 0 vol. %, 0.0001 vol. %, 0.0002 vol. % . . . 49.9998 vol. %, 49.9999 vol. %, 50 vol. %) and any value or range there between. In some embodiments, the oxygen content of the gas system is about 0.1-45 vol. %. In some embodiments, the oxygen content of the gas system is about 2-40 vol. %. In some embodiments, the oxygen content of the gas system is about 3-30 vol. %. In some embodiments, the oxygen content of the gas system is about 5-21 vol. %. In some embodiments, the gas system includes 0-5% by volume (e.g., 0%, 0.0001%, 0.0002% . . . 4.9998%, 4.9999%, 5%) and any value or range therebetween of a gas that is other than xenon or oxygen (e.g., carbon dioxide, noble gas, nitrogen). In some embodiments, the gas system of xenon, CO2 and optionally containing nitrogen. In some embodiments, the gas system includes at least 9 vol. % xenon (e.g., 9-99 vol. %), at least 1 vol. % CO2 (e.g., 1-10 vol. %) and optionally N2 (e.g., 0-90 vol. %). In another embodiment, the gas system includes at least 95 vol. % xenon (e.g., 9-99 vol. %), at least 1 vol. % nitrogen and/or CO2. In some embodiments, xenon volume percent is greater than the volume percent of CO2, and the nitrogen volume content, when included, can be greater than or less than the volume content CO2. 
     The outer container  18  is made of a material and/or includes a film or coating that is impermeable to the gas system. For example, in some embodiments, the outer container  18  is not permeable to xenon and any of the primary components of air (e.g., oxygen, nitrogen, carbon dioxide, water vapor, etc.). In some embodiments, the outer container  18  is made of one or more layers of thin film material, such as one or more layers of metal foil (e.g., aluminum foil or the like). 
     Referring to  FIG.  1   , the outer container  18  includes a first end  22   a , a second end  22   b  opposite the first end  22   a , and first and second sides  22   c ,  22   d  extending between the ends  22   a ,  22   b . The outer container  18  includes first and second sheets  26   a ,  26   b  joined and sealed together at the sides  22   c ,  22   d  and at the second end  22   b  (e.g., by heat sealing, an adhesive, or the like) ( FIG.  2   ). Generally, the outer container  18  is open at the first end  22   a  so that the inner container  14  can be inserted into the cavity of the outer container  18 . It should be understood, however, that any of the ends  22   a ,  22   b  or sides  22   c ,  22   d  of the outer container  18  may define the opening into the outer container  18 , with the other ends  22   a ,  22   b  and sides  22   c ,  22   d  being sealed. Furthermore, in some embodiments, the first and second sheets  26   a ,  26   b  may be portions of a single contiguous sheet of material folded over at one of the ends  22   a ,  22   b  or sides  22   c ,  22   d.    
     Once the inner container  14  is inserted into the outer container  18 , the open end or side of the outer container  18  (i.e., the first end  22   a  in the illustrated embodiment) can be sealed. For example, in the illustrated embodiment, the first end  22   a  is provided with an adhesive strip  27  located on each of the first and second sheets  26   a ,  26   b  ( FIG.  2   ). The adhesive strips  27  are pressure sensitive, such that pressing the adhesive strips  27  of the sheets  26   a ,  26   b  together seals the first end  22   a  of the outer container  18 . In some embodiments, the first end  22   a  may be folded over—to define a fold  28 —before pressing the adhesive strips  27  together, which may improve the strength of the seal ( FIG.  4   ). In yet other embodiments, the first end  22   a  may additionally or alternatively be sealed by welding the sheets  26   a ,  26   b  together, or via any other suitable method. In some such embodiments, the adhesive strips  27  may initially hold the first end  22   a  closed to facilitate subsequent welding. Once the first end  22   a  of the outer container  18  is closed and sealed, the cavity of the outer container  18  is hermetically sealed. 
     With reference to  FIGS.  2 - 3   , the outer container  18  includes an inlet  30  and a filling valve  34  for controlling gas flow through the inlet  30 . In the illustrated embodiment, the inlet  30  and filling valve  34  are located at the second end  22   b  of the outer container  18 . In some embodiments, the inlet  30  may extend through a seam in the second end  22   b  of the outer container  18 . The illustrated filling valve  34  extends from the inlet  30  and into the cavity of the outer container  18 . The filling valve  34  includes first and second sheets of material  38   a ,  38   b , bonded together at their perimeters to form sleeve or tube having an open end facing away from the cavity to define the inlet  30  and a sealed end opposite the inlet  30 . The sheets of material  38   a ,  38   b  may be made of the same material as the sheets  26   a ,  26   b  forming the outer container  18 , which simplifies construction of the outer container  18  and filling valve  34 . In other embodiments, the filling valve  34  may be formed from a single sheet of material rolled into a sleeve or tube shape and sealed. 
     The filling valve  34  includes a perforation  42  located within the chamber of the outer container  18 . As described in more detail below, a gas system introduced through the inlet  30  may flow into the outer container  18  through the perforation  42 . 
     In use, the cavity of the inner container  14  is filled with the biological material to be preserved. The biological material is sealed in the inner container  14 , the inner container  14  is inserted into the cavity of the outer container  18 , through the open first end  22   a . After the inner container  14  is inserted into the cavity of the outer container  18 , the cavity of the outer container  18  is hermetically sealed by sealing the first end  22   a  (e.g., by the adhesive strips  27 , by heat sealing, or any other suitable means for forming a hermetic seal). The cavity of the outer container  18  is configured such that the inner container  14  does not need to be opened or otherwise have the integrity of the inner container  14  compromised when the inner container  14  is placed in the outer container  18 . 
     After the inner container  14  is inserted into the cavity of the outer container  18  and after the hermetic sealing of the cavity of the outer container  18  while the cavity fully contains the inner container  14 , a gas system is added to the cavity of the outer container  18 , via the inlet  30 . For example, in some embodiments, the inlet  30  can be connected to a gas filling tube which is in turn connected to a source of the gas system. 
     The valve  34  allows the gas system to freely flow into the cavity of the outer container  18 . Since the gas system at the source is at a higher pressure than the cavity, the gas pressure of the gas system inflates the valve  34  and allows the gas to travel through the valve  34  (i.e. between the sheets  38   a ,  38   b ), through the perforation  42 , and ultimately into the cavity of the outer container  18 . In some embodiments, the cavity is filled with the gas system to a pressure about 0.5-5 bars above atmospheric pressure (e.g., 1 atm.). 
     Once the cavity of the outer container  18  is pressurized to the desired pressure, the source of the gas system is disconnected from the inlet  30 . The gas backpressure inside the cavity of the outer container  18  causes the valve  34  to collapse, thereby preventing the gas system from escaping the cavity of the outer container  18 . The second end  22   b  of the outer container  18  may then optionally be sealed (such as by heat sealing or another suitable method) to permanently seal the valve  34 . 
     In some embodiments, after filling the cavity of the outer container  18  with the gas system, the storage system  10  may be placed into a pressure chamber and exposed to an elevated pressure and/or refrigerated storage environment, such as according to the methods described in U.S. Publication No. 2018/0249703 noted above. By increasing the pressure around the outer container  18 , the pressure of the gas system contained within the outer container  18  may be increased due to the flexible construction of the outer container  18 , increasing the amount of the gas system that permeates into the biological material contained within the inner container  14 . 
       FIG.  5    illustrates a storage system  110  according to another embodiment of the present disclosure. The storage system  110  is similar to the storage system  10  described above with reference to  FIGS.  1 - 4   , and features of the storage system  110  corresponding to features of the storage system  10  are given like reference numerals plus ‘ 100 .’ The following description focuses primarily on differences between the storage system  110  and the storage system  10 , and it should be understood that features and alternatives of the storage system  10  described above may be incorporated into the storage system  110  and vice versa. 
     The storage system  110  includes a second or outer container  118  configured to receive an inner container (such as the inner container  14 ;  FIG.  2   ) therein. Referring to  FIG.  5   , the outer container  118  includes a first end  122   a , a second end  122   b  opposite the first end  122   a , and first and second sides  122   c ,  122   d  extending between the ends  122   a ,  122   b . The outer container  118  is formed from first and second sheets  126   a ,  126   b  joined together at the sides  122   c ,  122   d  and at the second end  122   b  (e.g., by heat sealing, an adhesive, or the like). In some embodiments, the first and second sheets  126   a ,  126   b  may be portions of a single contiguous sheet of material folded over. 
     In the illustrated embodiment, the outer container  118  includes an interlocking closure  123  (e.g., a zip-locking closure) extending along a width of the first end  122   a . The closure  123  allows the first end  122   a  of the outer container  118  to be opened to permit the inner container to be inserted inside the outer container  118 , then closed to seal the inner container within the cavity of the outer container  118 . 
     With continued reference to  FIG.  5   , in the illustrated embodiment, the first sheet  126   a  of the outer container  118  includes a window  129 . The window  129  is transparent, such that a user can visually determine whether the inner container is present within the outer container  118 . The illustrated window  129  is centered on the outer container  118 , allowing a user to observe and read identifying information, such as labels, barcodes, or the like, placed on the inner container. In some embodiments, the inner container or at least a portion thereof may also be transparent, so that the user may observe the contents of the inner container through the window  129  in the outer container  118  (e.g., to assess the condition of the contents of the inner container). Like the remainder of the outer container  118 , the window  129  is impermeable to the gas system that may be inserted into the outer container  118 , as described below. 
     The second end  122   b  of the outer container  118  may include an inlet  130  and a filling valve  134  for controlling gas flow through the inlet  130 . The filling valve  134  may be positioned within the inlet  130  and/or affixed to the inlet  130  in any suitable manner. In the illustrated embodiment, the inlet  130  extends from the second end  122   b  of the outer container  118  to define an elongated air channel. In other embodiments, the inlet  130  may extend through a seam in the second end  122   b  of the outer container  118  without extending beyond the second end  122   b.    
     With reference to  FIG.  5 A , the illustrated valve  134  includes a tube  139  with a first end  141   a  facing the inlet  130  and a second end  141   b  opposite the first end  141   a . The tube  139  has external threads  143  extending generally from the second end  141   b , which are configured for connection to a source of the gas system (e.g., to a regulator on a pressurized gas cylinder containing the gas system). The first end  141   a  of the tube  139 , which is disposed within the inlet  130  in the illustrated embodiment, is covered with a flexible membrane  145 . The membrane  145  includes a small orifice or pinhole  147 . As described in greater detail below, the gas system may be introduced through the valve  134  and flow into the outer container  118  through the orifice  147 . 
     In use, the cavity of the inner container (e.g., inner container  14 ;  FIG.  2   ) is filled with the biological material prior to being sealed. After the biological material is sealed in the inner container  14 , the inner container is inserted into the cavity of the outer container  118 , through the open first end  122   a . After the inner container is inserted into the cavity of the outer container  118 , the cavity of the outer container  118  is sealed by pressing on the interlocking closure  134 . The closure  134  alone may form a hermetic seal, but the closure  134  also advantageously aligns the first and second sheets  126   a ,  126   b  at the first end  122   a  to facilitate a subsequent heat sealing operation to provide a permanent hermetic seal. 
     After the inner container is hermetically sealed within the cavity of the outer container  118 , the gas system is added to the cavity of the outer container  118 , via the valve  134  and the inlet  130 . When the pressurized gas system is introduced into the valve  134 , the membrane  145  deforms outwardly, which enlarges the orifice  147  and permits the gas system to flow through the valve  134  and into the outer container  118  via the inlet  130 . In some embodiments, the cavity is filled with the gas system to a pressure about 0.5-5 bars above atmospheric pressure (e.g., 1 atm.). 
     Once the cavity of the outer container  118  is pressurized to the desired pressure, the source of the gas system is disconnected from the valve  134 . The gas backpressure inside the cavity of the outer container  118  causes the membrane  145  to contract, which in turn seals the orifice  147 . The inlet  130  of the outer container  118  may then optionally be sealed with an additional sealing step (such as by heat sealing or another suitable method) to form a permanent seal. 
     In some embodiments, after filling the cavity of the outer container  118  with the gas system, the storage system  110  may be placed into a pressure chamber and exposed to an elevated pressure and/or refrigerated storage environment, such as according to the methods described in U.S. Publication No. 2018/0249703 noted above. By increasing the pressure around the outer container  118 , the pressure of the gas system contained within the outer container  118  may be increased due to the flexible construction of the outer container  118 , increasing the amount of the gas system that permeates into the biological material contained within the inner container. 
       FIGS.  6  and  7    illustrate a storage system  210  according to another embodiment of the present disclosure. The storage system  210  is similar to the storage system  10  described above, and features and elements of the storage system  210  corresponding to features and elements of the storage system  10  are given like reference numerals plus ‘ 200 .’ The following description focuses primarily on differences between the storage system  210  and the storage system  10 , and it should be understood that features and alternatives of the storage system  10  and the storage system  110  described above may be incorporated into the storage system  210  and vice versa. 
     The storage system  210  includes a first or inner container  214  and a second or outer container  218  configured to receive the inner container  214  therein. In the illustrated embodiment, the outer container  218  is a flexible bag that includes a cavity that is sized and shaped to be able to fully contain the inner container  214  within the cavity of the outer container  218 . The illustrated inner container  214  is a flexible bag used to store blood products and/or cellular cultures, such as platelet concentrates. 
     Referring to  FIG.  6   , the outer container  218  includes a first end  222   a , a second end  222   b  opposite the first end  222   a , and first and second sides  222   c ,  222   d  extending between the ends  222   a ,  222   b . The outer container  218  includes first and second sheets  226   a ,  226   b  joined together at the sides  222   c ,  222   d  and at the second end  222   b  (e.g., by heat sealing or an adhesive). Generally, the outer container  218  is open at the first end  222   a  so that the inner container  214  can be inserted into the cavity of the outer container  218 . Thereafter, the first end  222   a  of the outer container  218  can be sealed. It should be understood, however, that any of the ends  222   a ,  222   b  or sides  222   c ,  222   d  of the outer container  218  may define the opening into the outer container  218 , with the other ends  222   a ,  222   b  and sides  222   c ,  222   d  being sealed. Furthermore, in some embodiments, the first and second sheets  226   a ,  226   b  may be portions of a single contiguous sheet of material folded over at one of the ends  222   a ,  222   b  or sides  222   c ,  222   d.    
     For example, the first end  222   a  may be provided with an adhesive strip located on each of the first and second sheets  226   a ,  226   b . Pressing the adhesive strips of the sheets  226   a ,  226   b  together seals the first end  222   a  of the outer container  218 . In some embodiments, the first end  222   a  may be folded over before pressing the adhesive strips together, which may improve the strength of the seal. In yet other embodiments, the first end  222   a  may be sealed by welding the sheets  226   a ,  226   b  together, or via any other suitable method. In some such embodiments, the adhesive strips may initially hold the first end  222   a  closed to facilitate subsequent welding. Once the first end  222   a  of the outer container  218  is closed and sealed, the cavity of the outer container  218  is hermetically sealed. 
     Referring to  FIG.  7   , the illustrated outer container  218  includes a hermetically sealed insert or compartment  260  containing a pressurized volume of a gas system, such as the gas system described above. The compartment  260  may be integrally formed as a part outer container  218  (e.g., by folding over and sealing a layer of the container  218 ). A hole  268  is formed in an interior wall  264  of the compartment  260 . The hole  268  is covered by a removable tab  272  with a length that extends through the first end  222   a  of the outer container  218 . The tab  272  hermetically seals the hole  268  in order to maintain the gas system within the compartment  260 . As such, the compartment  260  can be pre-filled with the gas system during manufacturing of the outer container  218 . In some embodiments, the gas system may be introduced into the compartment  260  through the hole  268  prior to applying the tab  272  over the hole  268  to seal the hole  268 . 
     In use, the cavity of the inner container  214  is filled with the biological material to be preserved. After the biological material is sealed in the inner container  214 , the inner container  214  is inserted into the cavity of the outer container  218 , through the open first end  222   a . The cavity of the outer container  218  is configured such that the inner container  214  does not need to be opened or otherwise have the integrity of the inner container  214  compromised when the inner container  214  is placed in the outer container  218 . 
     After the inner container  214  is inserted into the cavity of the outer container  218 , the cavity of the outer container  218  is hermetically sealed. For example, as illustrated in  FIG.  8   , the first end  222   a  of the outer container  218  may be placed in a heat sealing machine  280 . Either during or just prior to sealing, an operator removes the tab  272  by pulling on the exposed end of the tab  272  that extends through the first end  222   a  of the outer container  218 . The tab  272  detaches from the interior wall  264  of the compartment  260 , which opens the hole  268  and allows the gas system to flow out of the compartment  260  and into the internal cavity of the outer container  218 . In this way, the tab  272  and hole  268  define a valve for controlling flow of the gas system into the cavity of the outer container  218 . The first end  222   a  is then fully sealed to hermetically seal the internal cavity. In other embodiments, the first end  222   a  of the outer container  218  may be sealed using other suitable means, such as adhesives. 
     The gas system from the compartment  260  diffuses into the cavity of the outer container  218  and is able to permeate through the inner container  214  and into the biological material contained within the inner container  214 . Because the gas system is able to be introduced into the compartment  260  and sealed with the tab  272  during manufacturing of the outer container  218 , there is no need for an on-site filling container for introducing the gas system into the outer container  218 . This makes the storage system  210  versatile to use in a variety of settings, where bulk supplies of the gas system may be unavailable. 
     In some embodiments, after removing the tab  272  and sealing the first end  222   a  of the outer container  218 , the storage system  210  may be placed into a pressure chamber and exposed to an elevated pressure and/or refrigerated storage environment, such as according to the methods described in U.S. Publication No. 2018/0249703 noted above. By increasing the pressure around the outer container  218 , the pressure of the gas system contained within the outer container  218  may be increased due to the flexible construction of the outer container  218 , increasing the amount of the gas system that permeates into the biological material contained within the inner container  214 . 
     Various features of the invention are set forth in the following claims.