WO1985004574A1

WO1985004574A1 - Disposable container, such as a disposable formula package/nurser

Info

Publication number: WO1985004574A1
Application number: PCT/US1985/000579
Authority: WO
Inventors: James L. Cabernoch; Leonard A. White
Original assignee: Baxter Travenol Laboratories, Inc.
Priority date: 1984-04-12
Filing date: 1985-04-05
Publication date: 1985-10-24
Also published as: EP0176591A1; ZA852699B

Abstract

A disposable container such as a nurser which includes a collapsible pouch (21) having a feeding unit of nursing formula (22) sealed within the pouch (21) and a nurser nipple (23) or other access assembly sealed onto the outside surface of the pouch (21), which assembly is structured to easily gain access to the nursing formula (22) or other fluid when desired while maintaining the formula in a generally aseptic and hermetically sealed condition and while permitting the disposable nurser and nursing formula to be stored for extended periods of time under room temperature conditions.

Description

Disposable Container, Such as a Disposable Formula Package/Nurser

This invention generally relates to improved disposable nurεers for feeding food formula to infants or the like. More particularly, this invention relates to disposable nursers that also function as the distribution packages for the formula, the nursers having a collapsible pouch within which a unit of food formula is εealed and having a nurser nipple assembly secured onto the outside surface of a panel of the pouch. In an especially important aspect of this invention, the nipple assembly is structured to combine with the pouch to provide a shelf-stable package for a feeding unit of formula sealed therewithin in a manner to provide an aseptic or sterile product that^'can be autoclaved if desired and stored under room temperature conditions without detrimentally affecting the formula, which nipple assembly is further structured in order to readily gain fluid-passing access between the inside of the pouch and a tip portion of the nipple assembly when it is desired to feed the formula unit.

Numerous and various nursers have long been in widespread use for the purpose of feeding food formulas, typically having a substantially liquid consistency, to infants and the like, wherein the food formula is removed from the body of these devices through a nipple having an orifice through the tip portion thereof. Prior attempts have been made to provide a body and nipple assembly that is inexpensive and that can be readily manufactured on a mass scale. Other important considerations include having a body and nipple assembly that is readily sterilizable, such as by autoclave procedures, prior to and during filling of the body portion with formula, while also being able to withstand heating procedures, for example heating the container within a pan of boiling water, that are customarily practiced prior to feeding of the formula to the infant. When it is desired to provide a nurser that also functions as a formula storage package, further difficulties are encountered in connection with how to provide access to the interior of the body portion in a manner such that the food formula remains securely and hermetically sealed within the body portion during sterilization or aseptic treatment, storage, heating and handling while still providing easy access to the food formula when it is desired to feed the formula to the infant or the like. It is especially important that these structures resist unintentional access to the formula which would lead to leakage or to possible spoilage or contamination.

These types of concerns and shortcomings are controlled by the present invention by providing the food formula, within a sealed collapsible pouch having a membrane area on a panel thereof and by providing a nurser nipple assembly that is sealed onto the panel and over the membrane area. The nurser nipple assembly is structured such that, prior to feeding use thereof, there is no open access passageway between the nurser nipple assembly and the inside of the pouch. Instead, the membrane area functions as a barrier that withstands handling and treatment such as heating and/or autoclaving, while still permitting access therethrough for feeding. When desired, a holder may be included by mechanical attachment to the nipple assembly and/or pouch in order to support a flexible pouch during warming and/or feeding. t is accordingly a general object of this invention to provide an improved disposable nurser. Another object of this invention is to provide a disposable nurser which prevents the entry of air thereinto to thereby reduce the likelihood that an infant will ingest air while nursing therefrom. Another object of the present invention is to provide an improved disposable nurser that is especially suitable for sterile or aseptic filling and/or packaging operations and can provide unit-feeding packaging and storage thereof for extended periods of time without substantial risk of contamination or leakage.

Another object of this invention is to provide an improved infant nurser that includes a sealed, collapsible pouch which, if desired, may be readily supported by mechanical attachment to a semi-rigid holder generally enclosing the pouch.

Another object of the present invention is to provide an autoclavable formula package/nurεer.

Another object of the invention is to provide such a container for fluid, not limited to a nursing container, and including an access assembly other than a nipple assembly.

These and other objects of the invention will be apparent from the following detailed description, including the drawings, wherein: Figure 1 is a plan view of a particular embodiment of a disposable nurser according to this invention;

Figure 2 is a side elevation view of the device illustrated in Figure 1;

Figure 3 is an end view of the device illustrated in Figure 1;

Figure 4 is a longitudinal sectional view along the line 4-4 of Figure 1;

Figure 5 is a perspective view of an additional embodiment according to this invention; Figure 6 is a longitudinal sectional view along the line 6-6 of Figure 5; Fiςure 7 is a transverse sectional view along the line 7-7 of Figure 5;

Figure 8 is a transverse sectional view of a further alternative embodiment of the invention as generally shown in Figure 5;

Figure 9 is an exploded perspective view of the nurser of Figure 1 in combination with a mechanically- attachable holder sleeve and a protective end cap;

Figure 10 is an.enlarged, partial sectional view of the nipple-end portion of the device illustrated in Figure 9;

Figure 11 is a generally exploded perspective view of a pouch generally in accordance with Figure 1, in combination with an alternative holder; Figure 12 is an exploded perspective view of a pouch of the type illustrated in Figure 1, in combination with a further alternative holder;

Figure 13 is a longitudinal sectional view of the combination of a holder with a pouch nurser as generally illustrated in Figure 5;

Figure 14 is a longitudinal sectional view of the combination of an alternative holder and a pouch nurser generally according to Figure 5;

Figure 15 is a perspective view of a further holder in combination with a nurser pouch according to this invention;

Figure 16 is a longitudinal sectional view along the line 16-16 of Figure 15;

Figure 17 is a longitudinal sectional view of an additional embodiment of a combined holder and nurser according to this invention;

Figure IB is a perspective view of a further embodiment of a nurser having a semi-rigid collapsible container; Figure 19 is a sectional view along the line 19-19 of Figure 18; Figure 20 is a perspective view of the embodiment shown in Figure 18, wherein the semi-rigid container is collapsing; and

Figure 21 is a βectional view along the line 21-21 of Figure 20.

Although various embodiments of this invention are generally illustrated herein, each includes a sealed pouch, generally designated as 21, 21a, 21b or 21c, nursing formula 22 sealed therewithin, and a nurser nipple assembly, generally designated as 23, which is securely fastened onto the outside surface of the sealed pouch. In a typical embodiment, a feeding unit, for example eight ounces of formula, which may be milk, a milk-type product, a juice, water, or the like, 22 will substantially fill the sealed pouch 21, 21a, 21b, 21c.

Each nurser nipple assembly 23 is securely sealed onto a portion of the sealed pouch 21, 21a, 21b, 21c to thereby define a membrane 24 of said sealed pouch.

The nurser nipple assembly 23 illustrated in Figure 4 is of the piercing type and includes a spike 25 that is longitudinally movable within the nurser nipple assembly 23. By manipulation of the spike 25 or associated portions of the nurser nipple assembly 23, the spike 25 moves downwardly until it punctures the membrane 24, at which time, nursing formula 22 is free to enter a bore 26 within the spike 25, into an extending portion 27 of the nurser nipple assembly 23 and out of the nurser nipple assembly 23 through an orifice 28, thereby collapsing the pouch 21, 21a, 21b, 21c as formula 22 is removed therefrom. Until the spike 25 is thus manipulated, the nursing formula 22 is hermetically and at least aseptically sealed within the sealed pouch 21, 21a, 21b, 21c. Further details regarding the various nurser nipple assemblies 23 and associated spikes 25 that are suitable for use in the combination of this invention are found in copending U.S. patent application filed on the same date as this application, in the name of Leonard A. White, entitled "Self-Opening Nipple Construction and Nursing Container", owned by the assignee of the present application. The disclosure of this copending application is hereby incorporated by reference hereinto.

With more particular reference to the embodiment of pouch 21 as illustrated in Figures 1 through 4, the sealed pouch 21 is made from a single sheet of flexible material that is a barrier film and includes an integral end panel 29 which includes the membrane 24. This integral end panel 29 is integral with opposing flexible side panels 31, 32. Side panels 31, 32 are sealed to each other in order to form sealed longitudinal edges 33, 34 and sealed end edge 35 which, typically, is formed after the nursing formula 22 is filled into the pouch 21. By this structure, the integral end panel 29 is generally concave, the nurser nipple assembly 23 being located on a generally flat surface including the membrane 24 within the concave integral end panel 29. Typically, pouch 21 is autoclavable.

Regarding the fully closed pouch 21a illustrated in Figures 5, 6 and 7, such is made of a single sheet of flexible material and also may be autoclavable. When autoclavability is not especially critical, the flexible material may be a film such as a laminate of polypropylene and Saran, polypropylene and foil, and the like. Nurser nipple assembly 23 is secured to one of two opposing flexible side panels 36, 37, these side panels 36, 37 being sealed to each other along opposing transverse edges 38, 39 and a longitudinal lap seal 41. Typically, the nursing formula 22 will be filled into the closed pouch 21a before one of the transverse sealed edges 38, 39 is formed. The nurser nipple assembly 23 is sealed in liguid-tight fashion onto one of the flexible side panels 36, 37, typically before the flexible sheet is folded into the opposing side panels 36, 37 and before the transverse seals 38, 39 are formed. In this embodiment, the fully closed pouch 21a includes longitudinal ςussetts 42. A protective overcap 43 of molded polyproplyene or the like may be provided over the nurser nipple assembly 23.

The fully closed pouch 21b shown in Figure 8 is of a two-piece construction having longitudinal gussetts 44. Opposing longitudinal sealed edges 45, 46 can be used to join panels of different materials. When desired, a generally clear top panel 47 may be provided, for example of a material such as a laminate of polypropylene and Saran, while the body panel 48 may be made of a less transparent material which may possess barrier properties that are superior to those of the top panel 47, an exemplary body panel 48 being a laminate of polypropylene, foil and polyester.

While sealed flexible pouches 21, 21a and 21b provide advantageous means for storing units of nursing formula 22 and are capable of being used for feeding infants or the like upon appropriate manipulation of the nurser nipple assembly 23, typically it will be desired to combine such fully closed pouches with a support or holder that can be readily mechanically affixed thereto in order to provide additional support during heating and the like and in order to enhance the ease with which the device may be grasped during feeding and the like.

Figures 9 and 10 illustrate a semi-rigid holder 49 that is shaped and sized to generally overlie a structure such as the sealed pouch 21. For example, the holder 49 may have a cross-section that is generally oval or circular, and it may be injection molded or the like and have a longitudinal opening 50 to permit observation of the level of formula 22 within the pouch 21. Typically, the pouch 21 will be inserted through an open end 51 and dropped through an opening 52 on the opposite end, upon which a lip 53 of the opening 52 is mechanically inserted into an annular groove 54 of the nurser nipple assembly 23. A fusion molded or thermoformed overcap 55 is preferably included to safeguard the nipple assembly 23 from tampering, damage or contamination.

The holder 49a of Figure 11 includes a circular threaded lip 60 and a tapering surface 61 to provide a structural transition between the holder 49a, which for example may be oval in cross-section, and the circular threaded lip 60. Bolder 49a may be blow molded and generally transparent. A threaded collar 62 matingly engages the threaded lip 60, and collar 62 has an annular ridge 63 which matingly engages an annular slot 64 of the nurser nipple assembly 23.

Figure 12 includes an end cap 65, which may be generally oval as illustrated, and includes an annular ridge 63 sized and structured for general mating relationship with annular slot 64 of the nurser nipple assembly 23. While holders 49, 49a, 49b may be made of any suitable semi-rigid material such as molded, extruded or thermoformed polymers, whether transparent or not, holder 49b is especially well-suited to be made of a cellulosic material such as paperboard. With reference to Figure 13, a combination of sealed pouch 21a and nurser nipple assembly 23 is mechanically attached to a re-usable holder 66. The illustrated holder 66 is generally on the order of the holders 49, 49a, 49b of Figures 9, 11 and 12. It is to be noted that, due to the offset of the nurser nipple assembly 23 with respect to the transverse edges 38, 39 of the sealed pouch 21a, at least the transverse edge 38 is folded over generally against the flexible side panel 37. further type of holder 67 is illustrated in

Figure 14, which holder 67 is especially suitable for disposable nursers such as those including sealed pouch 21a. A hook closure assembly 68 is included wherein a transverse edge 39 of the sealed pouch 21a is grasped by the hook closure assembly 68. Bolder 67 may be made of thermoplastic sheet, coated paperboard or the like. In use, the nurser nipple assembly 23 is passed through opening 69 and mechanically held in place, this-being accomplished while the holder 67 is generally opened. Thereafter, the holder 67 is generally closed while engaging the transverse edge 39 within the hook closure assembly 68.

A snap down holder 71, shown in Figures 15 and 16, will typically be constructed of a somewhat rigid material, for example an injection molded polymer such as a polypropylene. The sealed end edge 35 of the sealed pouch 21 is gripped by corrugations such as the illustrated ridges 72, which corrugations grasp the sealed end edge 35 more tightly as side panels 73, 74 of the holder 71 are folded toward each other along a web hinge 75, until such time as teeth 76 projecting from the side panel 73 meshingly engage teeth 77 projecting from the side panel 74 to thereby lock the nurser nipple assembly 23 between generally U-shaped openings 78, 79. Figure 17 illustrates a further holder 81 which includes an end opening 82 through which the nurser nipple assembly 23 projects, while sealed end edge 35 of the sealed pouch 21 is tucked into a channel 83, after which a tab 87 projecting from a wrap-around extension 84 of side panel 85 is secured to the other side panel 86 such as by the tab 87 and a slot 88. Other fastening arrangements may be used, such as Velcro pads or the like. Certain nurser nipple assemblies can include opposing nipple protector flaps 89, which can be folded on themselves and back through the end opening 82, which assists in holding the nipple in position.

The nurser nipple assembly 23 is sealed onto an outside portion of the sealed pouch 21, 21a, 21b, 21c by any of various procedures. Included are energy sealing techniques such as heat sealing, sonic sealing, RF sealing or the like. Solvent sealing or adhesive bonding may also be suitable for some assembly needs. With reference to the embodiment illustrated in Figures 18 through 21, in this embodiment a container body, generally designated as 21c, is made from a single sheet of semi-rigid material that is appropriately folded and sealed. A nurser nipple assembly 23 is sealed thereonto over the membrane 24, which may include a thinned condition below the spike 25, particularly if the pouch includes a cellulosic layer. An overcap 91 may be included in order to protect the nurser nipple assembly 23. Although the body 21c is made from a semi-rigid sheet, its generally known construction is collapsible. More particularly, bottom end flaps 92 and top end flaps 93 are tack welded to the container body 21c. By breaking the tac welds and opening the flaps 2 and 93, the container body 21c can be transformed from the shaped, fully closed structure illustrated in Figures 18 and 19 to the collapsing condition of the opened container body 21c illustrated in Figures 20 and 21. Body 21c may be made of a generally thermoplastic polymer such as a polyolefin, or it may be made of a generally cellulosic material such as paperboard, in which case it is typically advantageous to laminate or overcoat the paperboard with a synthetic polymer, particularly one that exhibits thermoplastic properties. Body 21c may be made of transparent or translucent polymeric materials, which permits observation of the level of the liquid nursing formula 22 within the container body 21c. When the container body 21c is made of a generally opaque material such as a cellulosic paperboard or the like, observation of the liquid level can be achieved by laminating a generally transparent material to the inside surface of the container body 91 and by die cutting the opaque layer or layers to thereby form windows 94.

With more particular reference to the structure of the container body 21c, such is made from a single sheet of generally semi-rigid material that is generally transversely folded along a transverse edge 95, such transverse folding being into two generally equal panels which include side panels 96. A bottom seal 97 joins these panels at a location generally opposite of the transverse edge 95. Longitudinal seals 98 complete joining of the panels, such seals 98 running between the folded transverse edge 95 and the bottom seal 97. Nurser nipple assembly 23 can, as illustrated, be generally oval in cross section so that it does not overlie the transverse folded edge 95.

When it is desired to dispense liquid nursing formula 24, the user removes the overcap 91, if provided. Next, the bottom end flaps 92 and the top end flaps 93 are broken from their releasable adherence to the body 21c, after which the container body is moved to its opened configuration by, for example, pulling in opposite directions on the respective longitudinal seals 98, at which time the bottom end flaps 92 and top end flaps 93 become open corners 92a and 93a, respectively. When the end flaps 92, 93 are transformed into the open corners 92a, 93a, the entire body 21c is able to become generally flattened, which flattening may continue as the liquid nursing formula 22 is removed through the nipple orifice 28.

While various particular embodiments of the invention have been described herein, it will be apparent to those skilled in the art that various modifications thereof may be made without departing from the true spirit and scope of the invention.

Accordingly, it is intended by the appended claims to -12- cover all such modifications and equivalents which embody inventive features as defined in the claims.

Claims

Clai s

1. A disposable formula package/nurεer, comprising: a pouch having opposing side panels sealed to each other into a fully closed package, said fully closed package including sealed edges joining said side panels into the sealed pouch; liquid nursing formula sealed within said fully closed package; a nurser nipple assembly sealed onto the outside surface of the sealed pouch; and a membrane defined on said pouch by the nurser nipple assembly, said nurser nipple assembly including means for selectively gaining access to nursing formula within said pouch through said membrane and through a tip portion outside orifice of the nurser nipple assembly, said selective access gaining means also maintaining the fully closed condition of said fully closed package.

2. The disposable formula packaςe/nurser of claim 1, wherein said means for selectively gaining access to the nursing formula includes means within the nipple assembly for puncturing said membrane, said puncturing means providing a passageway through said membrane between the tip portion outside orifice of the nipple assembly and the nursing formula within the pouch.

3. The disposable formula package/nurser of claim 1, further including a semi-rigid outer shell generally surrounding the sealed pouch, and wherein the nurser nipple assembly is mechanically attached to an aperture through said outer shell.

4. The disposable formula package/nurser of claim 1, wherein said fully closed package is a shelf- stable package.

5. The disposable formula package/nurser of claim 1, wherein said fully closed package is hermetically and aseptically sealed.

6. The disposable formula package/nurser of claim 1, wherein said fully closed package is autoclaved.

7. The disposable formula package/nurser of claim 1, wherein said sealed pouch includes an integral end panel that is integral with said side panels, and wherein said nurser nipple assembly is sealed to said integral end panel.

8. The disposable formula package/nurser of claim 1, wherein said sealed pouch includes a generally concave flexible end panel that is integral with said side panels, and wherein said nurser nipple assembly is sealed to said integral end panel.

9. The disposable formula package/nurser of claim 1, wherein said sealed pouch is ςusseted.

10. The disposable formula package/nurser of claim 1, wherein said nurser nipple assembly includes a protruding nipple member and an overcap generally overlying said nipple member.

11. The disposable formula package/nurser of claim 1, wherein said pouch is flexible.

12. The disposable formula package/nurser of claim 1, wherein said pouch is semi-rigid.

13. The disposable formula package/nurser of claim 1, further including a semi-rigid outer shell generally surrounding and supporting the sealed pouch, wherein said semi-rigid outer shell includes a hook closure assembly that grasps a sealed edge of the pouch, and said semi-rigid outer shell includes an opening through which said nurser nipple assembly protrudes and to which said nurser nipple assembly is mechanically attached.

14. The disposable formula package/nurser of claim 1, further including a semi-rigid outer shell generally surrounding and supporting the sealed pouch, wherein said semi-rigid outer shell includes generally opposing semi-rigid panels joined together by hinge means, means associated with said hinge means for grasping a sealed edge of the pouch, and clasping means on the semi-rigid panels for closing the semi-rigid panels onto each other at an end of the shell opposite to said hinge means.

15. The disposable formula package/nurser of claim 14, wherein said grasping means includes an opening for receiving said nurser nipple assembly.

16. The disposable formula package/nurser of claim 1, further including a semi-rigid outer shell generally surrounding and supporting the sealed pouch, wherein said semi-rigid outer shell includes an opening through an end thereof for receiving said nurser nipple assembly, an internal channel generally opposite to said end opening for receiving a sealed edge of the pouch, and external means for closing said semi-rigid outer shell.

17. A semi-rigid holder for a disposable formula package/nurser, comprising: a semi-rigid shell including generally opposing semi-rigid panels joined by hinge means along an end thereof; an opening through at least one of the opposing semi-rigid panels, said opening being sized and structured for receiving and for mechanically supporting a nurser nipple assembly of a disposable formula package/nurser; and means for grasping a sealed edge of the disposable formula package/nurser.

18. The semi-rigid holder of claim 17, wherein said grasping means is a hook closure assembly having members at free ends of the opposing semi-rigid panels.

19. The semi-rigid holder of claim 17, wherein said hinge means includes internal corrugations that are included in said grasping means.

20. The semi-rigid holder of claim 17, further including clasping means for closing the semi-rigid panels onto each other, said clasping means being generally opposite to said hinge means•

21. The semi-rigid holder of claim 20, wherein said clasping means includes said opening.

22. The semi-rigid holder of claim 17, wherein one of said semi-rigid panels partially overlaps the other of said semi-rigid panels, and further including means associated with said overlapping panels for closing said one panel over said other panel.

23. A method for making a disposable formula package/nurser,- comprising: selecting a section of flexible film; locating a nurser nipple assembly onto said flexible film section and defining a membrane portion on said flexible film; sealing the nurser nipple assembly onto said flexible film and over the membrane portion; forming said flexible film section into a flexible pouch member having the nurser nipple assembly sealed over the outside of the membrane portion; filling a feeding unit of a liquid feeding formula into the flexible pouch member; sealing the liquid feeding formula within the flexible pouch; and treating the flexible pouch member to impart an aseptic condition to the formula package/ nurser.

24. The method of claim 23, further including preparing a nurser nipple assembly that includes forming a nipple-shaped member, and inserting a piercing member within the nipple-shaped member with an orientation such that the piercing member engages the membrane portion and avoids damage to the nipple-shaped member.

25. The method of claim 23, wherein said treating step includes sterilizing the flexible film prior to said filling step, said nurser nipple assembly is sterilized and then attached under aseptic conditions during the nurser nipple assembly sealing step, and said filling step is carried out under aseptic conditions.

26. The method of claim 23, wherein said treating step includes autoclaving the sealed pouch member, the liquid feeding formula therewithin and the nurser nipple assembly sealed thereonto.

27. A disposable container for aseptic fluid, comprising: a pouch having opposing side panels sealed to each other into a fully closed package, said fully closed package including sealed edges joining said side panels into the sealed pouch; a fluid sealed within said fully closed package; an access assembly sealed onto the outside surface of the sealed pouch; a membrane defined on said pouch by the access assembly, said access assembly including means for selectively gaining access to the fluid within said pouch through said membrane and through a tip portion outside orifice of the access assembly, said selective access gaining means also maintaining the fully closed condition of said fully closed package; and a semi-rigid outer shell generally surrounding and supporting the sealed pouch, wherein said semi-rigid outer shell includes a hook closure assembly that grasps a sealed edge of the pouch, and said semi-rigid outer shell includes an opening through which said access assembly protrudes and to which said access assembly is mechanically attached.

28. The container of claim 27, wherein said means for selectively gaining access to the fluid includes means within the access assembly for puncturing said membrane, said puncturing means providing a passageway through said membrane between the tip portion outside orifice of the access assembly and the fluid within the pouch.

29. The container of claim 27, further including a semi-rigid outer shell generally surrounding the sealed pouch, and wherein the access assembly is mechanically attached to an aperture through said outer shell.

30. The container of claim 27, wherein said fully closed package is a shelf-stable package hermetically and aseptically sealed and is autoclaved.

31. The container of claim 27, wherein said sealed pouch includes an integral end panel that is integral with said side panels, and wherein said access assembly is sealed to said integral end panel.

32. The container of claim 27, wherein said sealed pouch includes a generally concave flexible end panel that is integral with said side panels, and wherein said access assembly is sealed to said integral end panel.

33. The container of claim 27, wherein said sealed pouch includes gussets.

34. The container of claim 27, wherein said pouch is flexible.

35. The container of claim 27, wherein said semi-rigid outer shell includes generally opposing semi-rigid panels joined together by hinge means, said hook closure assembly being associated with said hinge means, and clasping means on the semi-rigid panels for closing the semi-rigid panels onto each other at an end of the shell opposite to said hinge means.

36. A disposable container for aseptic fluid, comprising: a pouch having opposing side panels sealed to each other into a fully closed package, said fully closed package including sealed edges joining said side panels into the sealed pouch; a fluid sealed within said fully closed package; an access assembly sealed onto the outside surface of the sealed pouch; a membrane defined on said pouch by the access assembly, said access assembly including means for selectively gaining access to the fluid within said pouch through said membrane and through a tip portion outside orifice of the access assembly, said selective access gaining means also maintaining the fully closed condition of said fully closed package; and a semi-rigid outer shell generally surrounding and supporting the sealed pouch, wherein said semi-rigid outer shell includes an opening through an end thereof for receiving said access assembly, an internal channel generally opposite to said end opening for receiving a sealed edge of the pouch, and external means for closing said semi-rigid outer shell.

37. A semi-rigid holder for a disposable container comprising: a semi-rigid shell including generally opposing semi-rigid panels joined by hinge means along an end thereof; an opening through at least one of the opposing semi-rigid panels, said opening being sized and structured for receiving and for mechanically supporting an access assembly of a disposable container; and means for grasping a sealed edge of the disposable container.

38. The semi-rigid holder of claim 37, wherein said grasping means is a hook closure assembly having members at free ends of the opposing semi-rigid panels.

39. The semi-rigid holder of claim 37, wherein said hinge means includes internal corrugations that are included in said grasping means.

40. The semi-rigid holder of claim 37, further including clasping means for closing the semi-rigid panels onto each other, said clasping means being generally opposite to said hinge means.

41. The semi-rigid holder of claim 40, wherein said clasping means includes said opening.

42. The semi-rigid holder of claim 37, wherein one of said semi-rigid panels partially overlaps the other of said semi-rigid panels, and further including means associated with said overlapping panels for closing said one panel over said other panel.

43. A method for making a disposable container, comprising: selecting a section of flexible film; locating an access assembly onto said flexible film section and defining a membrane portion on said flexible film; sealing the access assembly onto said flexible film and over the membrane portion; forming said flexible film section into a flexible pouch member having the access assembly sealed over the outside of the membrane portion; filling the flexible pouch with a fluid; sealing the fluid within the flexible pouch; and treating the flexible pouch member to impart an aseptic condition to the fluid therein.

44. The method of claim 43, further including preparing an access assembly that includes forming a dispensing member, and inserting a piercing member within the dispensing member with an orientation such that the piercing member engages the membrane portion and avoids damage to the dispensing member.

45. The method of claim 43, wherein said treating step includes sterilizing the flexible film prior to said filling step, said access assembly is sterilized and then attached under aseptic conditions during the access assembly sealing step, and said filling step is carried out under aseptic conditions. -23-

46. The method of claim 43, wherein said treating step includes autoclaving the sealed pouch member, the fluid therewithin and the access assembly sealed thereonto.