CA1231920A - Container having a selectively openable seal line and peelable barrier means - Google Patents

Abstract

Abstract Container Having a Selectively Openable Seal Line and Peelable Barrier Means A two chamber container for the separate storage and selective mixing of two components is disclosed. The container includes two outer flexible thermoplastic sheets and an inner, diaphragm sheet. A unique seal line structure is formed between one of the outer sheets and the inner, diaphragm sheet. A peelable barrier structure such as a sheet of aluminum foil with an inner layer of adhesive is secured to the exterior surface of the exterior wall of the container at that portion of the other of the outer sheets which defines one of the chambers of the container. The peelable barrier sheet permits the use of lower cost materials for the remainder of the container structure while both (1) permitting visual inspection of the chamber contents and (2) providing high moisture, gas and light barrier properties.

Description

3~3~) Description Container Having a Selectivel~ Openable Seal Line and Peelable Barrier Means Background of_the Invention In the medical field it is often necessary to mix two separate components such as a mixture of a drug and a diluent or a mixture of dextrose and amino acids. Such mixtures must often be stored separately. In the case of amino acids and dextrose, for example, the mixture is not stable over long time periodsO Such instability may also be the case for the mixture of a drug and a diluent.
Also, some drugs lose their efficacy when stored in a liquid diluent and must be stored dry, such as a powdered drug stored in a drug vial Gf standard construction. Some components are sterilized differently and for this rea~on may be combined only after each component is ~eparately sterili~ed. For example, most liquid diluents, such as sterile water or sterile dextrose solution, are sterilized ~,

-2-by steam steriliza ion, or autoclaving. The heat generated during such a sterilization procedure may destr~y the efficacy of many powdered drugs which must be sterilized by other means.
In addition to maintaining two component~ separately during storage, there i5 a need for a quick and easy means for selectively mixing the two components, in a closed system under sterile conditions. It is Xnown to provide a multiple chamber container of flexible plastic sheet with a heat seal dividing the container into two or more chambers. Such is shown, for example, in U.S. Patent No.
4,396,383 to Hart, assigned to the assignee of the present invention, directed to a container which employs franqible valves between the heat seal to allow for selective communication and mixing between the two compon2nts ~tored in the two chambers.
Other means for establishing a closed system for the separate storage and selective mixing of two componen~s is shown in copending U.S. Patent No. 4,410,321 of Pearson, et al and assigned to the assignee of the present invention. The device shown therein utilizes a preferably plastic junc-tion about the end portions of container and chamber access means to allow for the separate ~torage an~ selec-25 tive mixing of two components such as a powdered drug anda llquid diluent.
It is desirable to provide a multiple chamber closed system which does not require additional elements inte-~rated into he container to form the openable valve 30 between the comp~rtment~. Such are shown, for example, in U.S~ Patent Nos. 3,950,158, 4,00009g6 and ~,225,330~ In each of these patent~ there i8 disclosed a multiple chamber container which has a line of weakness, such as a ~core line in plastic material, which break~ upon the application of pressure.

Tear tabs or tear strips for plastic packaging are also known, such as shown in U.S. Patent No. 2,991,000.
Such tear tabs provide ready access to the contents of a container but also involve the use of a relatively compli-cated seal structure. U.S. Patent No. 3,983,994 discloses a peelable seal broken by pulling upon tabs located out-side of the container.
~upturable seal lines such as shown in the above named patents may all suffer from the common problem of ruptur-ing before communication between the two chambers is intended. The rupturable seal lines are designed to be weaker than the remainder of the container so that upon the application of force the rupture line breaks first.
It i5 also desirable to provide a multiple chamber closed container having a selectively openable seal line between the chambers which when closed virtually eliminates the transmission of moisture into one of the chambers from either outside of the container or from the other chamber. Such a requirement may be necessary when, for example, a powdered drug is stored in one of the chambers of the container.

3 ~t3,~

Summary of the Invention The present invention is directed to a two chamber container for the separate storage and selective mixing of components and includes first and second sheets. The second sheet serves as a diaphragm between the first sheet and a third sheet of material opposite the first sheet.
The first and third sheets are sealed about their peripheries and form the exterior wall of the container.
The container further includes a unique selectively openable seal line formed between the first and the second diaphragm sheet, preferably in a chevron-type configuration. The seal line is exceptionally resistant to unintentional opening but is easy to open upon the application of a specific force. The seal line provides a seal between the first and second sheets ~hich breaks in a predetermined manner, rupturing the second sheet so that the opening which will be formed can be anticipated in both shape and size. This container includes barrier means such as a sheet o foil with an inner adhesive layer which is secured to the exterior surface of the exterior wall of the container at that portion o the third sheet which defines the first chamber. The barrier means preferably comprises a virtually absolute barrier to gas, liquid and light.
The barrier means may be peeled away, exposing a portion of the third sheet underneath the barrier means, the third sheet having sufficient clarity to permit visual inspection of the contents of the first chamber.
The inner surfaces of the first and second sheets are thermoplastic, having substantially identical melt-flow characteristicsY The inner surfaces of the two sheets are secured to each other at a seal formed by a focused energy source, such as radio~frequency energy, which melts the inner surfaces at the seal. The seal describes the seal line in cross-section.

The peelable barrier sheet may permit at least one o.
the three sheets of the container to be made from relatively lower cost materials such as polyvinyl chloride or ethylene vinyl acetate, instead of relatively higher 5 cost laminate stxuctures which wou1d otherwise be necessary to maintain proper barriers to moisture, gas and light and for which it may be difficult to maintain sufficient clarity to visually inspect the container contents. The peelable barrier sheet may be removed 10 immediately before use of the container to allow for visual inspection, the barrier means permitting the use of less expensive, clear, one layer material structures.
An aspect of the invention is as follows:

,i ~

3~
5a A container having two chambers f~r the separate storage and selective mixing of two components, compris-ing:
(a) a first sheet including ti) a first inner surface of a thsrmo-plastic material, and (ii) a first outer surface, (b) a second, diaphragm sheet including (i) a second inner surface of a thermo-plastic material, said second inr.er surface hav-ing melt-flow characteristics substantially identical with the melt-flow characteristics of said first inner sur~ace, and (ii) a second outer surface;
(c) said second, diaphragm sheet sealed about at leas~ a portion of its periphery to ~aid first sheet and to a third sheet opposite said first sheet;
(d) said first sheet and saicl third sheet sealed about their entire peripherias, forming the e~terior wall of said container;
(e) an externally, selectively, manually openable seal line between said first and said second, diaphragm sheets, said openable seal line extending across the width of said container, wherein a cross section taken through said seal line, psrpendicular to said seal line at the cross section defines a seal, said seal formed by applied pressure and a focused energy source, which melts said first and second inner surfaces at said seal, said seal defining ~i) a bead area of increased thickness at a break end of said seal, between said first and second inner surfaces, said bead area of increased thic~ness coextensive with said first .~, 5b and second inner surfaces along less than all of the surface of said bead area, (ii) a break line inwardly of said break end, between said second, diaphragm sheet and said bead area of increased thickness, the thick-ness of said seal at said break line being at the least not substantially less than the thickness of said second sheet, and ~iii) an arcuate depression having a concave downwaxd surface extending from substantially adjacent said break line to a minimum seal thickness point;
(f) a permanent liné of securement between said second and third sheets extending substantially parallel to and the length of said openable seal line;
(9~ at least said second, diaphragm sheet, said openable seal line, said permanent line of securement and said third sheet defining a first chamber for holding the first component;
(h) at least said first sheet, said openable seal line, said permanent line of securement and said second, diaphragm sheet defining a second chamber for holding the second component;
(i) barrier means secured to the exterior surface of the exterior wall of said container, at one of that portion of said third sheet which defines said first chamber and ~hat portion of said first sheet which defines said second chamber;
(j) wherein said barrier means comprises a virtually absolute barrier to at least one of gas, liquid and light;
(k) whereby manual separation of said first and second sheets near said openable seal line will rupture said seal line and said second ~heet, placing said first and second chambers in open communication.

Description of the _awin~s Fig. 1 is a cross-sectional view of the selectively openable seal line, illus~rating ~he formed seai.
Fig. 2 is an enlarged, fragmentary croæs-sectional view illustrating the seal shown in Fig. 1 and the break line and break end.
Fig. 3 i5 a cross-sectional view of the seal line as in Fig. 1, after the seal has been broken a~ the break line.
Fig. 4 is a perspective view of a container, including the openable seal line disposed between the container exterior and a pull tab.
Fig. 5 is a perspective view of a container similar to that ~hown in Fig. 4.
Fig. 6 is a perspective view of the container shown in Fig. 5, during opening of the seal along the seal line.
Fig. 7 is a cro s-sectional schematic view illustrat-ing the sealing die before forming the selectively open-able seal line.
Fig. B is a cross-sectional view illustrating the formed seal and sealing die.
Fig. 9 is a perspective view of a sealing die.
Fig. lO is a cross-sectional view taken at line lQ-lO
Of Fig. 9-Fig. lOA is a cross- ectional view of the selectively openable seal line in Fig. 6, made with the die of Figs. 9 and lO, taXen at line lOA-lOA of Fig. 6 and illustrating the seal and mirror im~ge ~eal.
Fig. 11 is a perspective view of a ~ontainer having an inner diaphragm sheet and the selectively openable seal line.
Fig. llA is a cross-sectional view taXen along the length of the container as shown at line llA 11~ of Fig.
11, but after the seal line has been broken.

Fig. 1~ is a perspective, cutaway ~iew oE the con-tainer of Fig~ 11.
Fig. 13 is a cross-sectional view of the openable seal line and permanent line of securement taken at lin~ 13-13 of FigO 11, illustrating the formed seal.
Fig. 14 is an ~nlarged, fragmentary side elevational view of a portion of the seal line of the container shown in Fig~ 11.
Fig. 15 is a cutaway perspective view of a sealing die utiliæed in making the openable seal line of the container of Fig. 11.
Fig. 16 is a top plan view of the sealing die shown in Fig. 15.
Fig. 17 is a cross-sectional view taken along line 17-17 of Fig. 16.
Fig. 18 is a schematic view illustrating the manu-facturing process for the container.
Fig. 19 is a side elevational view of an alternate structure to the container o Fig. 11.
Fig. 20 is a perspective view of a further modified container.
Fig. 21 is a perspective view of a still further modified container.
Fig. 22 is a cutaway view of the container illustrated in Figl 21.
E`ig. 23 is a perspective view of a container utilizing peelable barrier means.
Fig. 24 is a perspective view of the container as in Fig. 23, with the peelable barrier means partially peeled away.
Fig. 25 is a cutaway view of the container shown in Fig. ~3.
Fig. 26 is an alternate embodiment of the container shown in Fig. 23.

Detailed Description of the PreEerred Embodiments Referring to Figs. 1 through 6 and lOA, and particularly Figs. 4 and 5, there are illustrated con-tainer- 30 and 31 having pull taps 32 and 33, respec-tively, utilizing the unique selectively openable seal line 34. The seal line 34 includes seal line portion 34A
and mirror image seal line portion 34B.
A cross-section of the seal line portion 34A is seen in Figs. 1 through 3. A cross-section of the seal line 34 is seen in Fig. lOA. These Figures show the formed seal 36 between a first sheet 38 and a 6econd sheet 40. In o~her words, the seal is the cross-section of the seal line.
The first sheet 38 corresponds to the pull tabs 32, 33 of the containers 30, 31, respectively. The second sheet 40 corresponds to the sidewalls 41, 4~ of the containers 30, 31, respectively. The seal 36 illustrated in Figs. 1 through 3 may also be utilized in the containers shown in Figs. 11, 19, 20, 21, 23 and 26.
The first sheet 38 includes a first inner surface 44 of a thermoplastic material and a first outer surface 46.
The second eheet 40 includes a second inner surface 48 of a thermoplastic material and a second outer surface 50.
The second inner surface 48 has melt-flow characteristics substantially identical with the melt~flow characteristics of the first inner surface 44. Preferably, the first and second inner surfaces 44, 48 are made of the same material. As will be seen later, the first and second sheets may be laminated or coextruded structures including multiple layers of materials to impart different propertie~ to the sheets.
The first and second inner ~urfaces 44, 48 are secured to each other at the seal 36. The seal 36 and therefore the seal line 34 are formed by a focused energy source ., which melts the irst and second inner surfaces 44, 48 at the seal 36. Preferably, the focused energy source is radio-frequency ~RF) energy applied through a unique seal-ing die 52, seen, for exam~le, in Figs. 7 and 8. The term "focused energy" is not meant to include conductive heat energy but may include ultrasonic energy. The seal 36 is also preferably made by applied pressure as well as by the focused energy.
The unique seal 36 formed between the sheets 38, 40 at the inner surfaces 44, 48, respectively is illustrated in Figs. 1 through 3, showing th~ formed seal 36 along a cros~-section taken through the seal line 34, at portion 34A, perpendicular to the seal line 34. Referring to Fig.
2, this seal 36 includes a bead area of increased thick ness 54 at a break end 56 of the seal 35, between the first and second inner surfaces 44, 48, respecti~ely. The bead area of increased thickness 54 is coextensive with the first and second inner surfaces 44, 48 along less than all of the surace of the bead area. Thus, in Figs. 1 through 3 there is shown a space between the first and second sheets 38, 40 to the left of the break end 56.
Unlike what might be expect~d, the seal 36 breaks at a break line 58 which is di~posed inwardly of the break end 56 and between the second ~heet 40 and the bead area of increased ~hickness 54. The break line 5~ defines the boundary between the second ~heet 40 and the bead area 54. The width of this boundary area defined by the break line 5~ is at the least not substantially less than the thickness of the second sheet 40. In fact, the width of the boundary ar~a may be equal to or greater than the thicknes~ of the second sheet 40.
The seal 36 further includes an arcuate depression 60 including a concave downward surface 62 extending from substantially adjacent ~he break line 58 to a minimum seal thickness point 64. It is important to note that the seal does not break at the minimum seal thickness point 64.
The distance between the minimum seal ~hickne~s point 64 and the first outer surface 46 is preferably not less than the thickness of the first sheet 38 and at the most not substantially greater than the thickness of the first sheet.
The arcuatP depr~ssion 60 preferably also includes a concave upward surface 66 extending upwardly from the minimum seal thickness point 64~ away from the concave downward surface 62.
The seal 36 also preferably includes a b~veled s~rface 68 defined by the second outer surface 50, beyond the concave upward surface 66. The beveled surface 68 preferably begins adjacent the concave upward surface 66.
The thickness of the seal 36 increases along the beveled surface 68 from the concave upward surface 66 to a bevel end 70 of the 6eal 36.
The bevel end 70 may be defined in part by a secondary bead area 72 of excess material. The second ~heet 40 extends away from the seal 36 intermediate the beveled surface 68 and the secondary bead area 72~
The thickness of the second sheet 40 is at the most not substantially greater than the thickness of the first sheet 3~. Preferably, the thickness of the second sheet 40 is less than the thickness of the first sheet and, most preferably, at least about 0.003 in. less than the thick ness of tne first sheet 38. For illustration purposes only and not as a limitation, the first sheet may have a thickness of 0.015 in. and the second sheet may have a thickness of 0.010 in.
By way of example only, and not intended as limiting the invention, the following are other sample ~easurements for the seal 36. The width of th~ arcuate depre~sion may ~ q3~

be about 0.02 in. The bevel may extend away from the arcuate depression 60 at an angle of approximately 5~ from horizontal~ The width of the seal rom the beginning of the arcuate depression 60 to the bevel end 70 may be about 1/8 in.
As stated earlier, the first and second inner surfaces 44, 48 are preferably of the same material. It is believed that polyvinyl chloride, ethlyene vinyl acetate ~n (EVA) and SARAN are all materials which work well in making the seal 36. The entire sheets may be made of these materials or just the inner surfaces.
While the mixing of the material from the first and second ~heets 38, 40 at the seal 36 is not known, it is believed to approximate the phantom boundary line 74 seen in Fig. 2. In one test, the first sheet 38 was dyed a distinctly different color than the second sheet 40. The seal 36 was then made, resulting in a boundary such as shown at line 74. Thus, it is believed that the bead area of increased thickness 54 comprises material from both of the first and second sheets 38, 40. However, it is also believed, but not knowr~ that the break line 58 comprises material only from the second sheet 40. Thus, the phantom break line 58 illustrated in Fig. 2 is not intended to be a part o~ phantom boundary line 74.
Reerring now to Figs. 7-10 there are illustrated sealing dies for making the seal lines such as the seal line 34 shown in the containers 30, 31 illustrated in Figs. 4-6, as well a~ the method for making the seal line. The sealing die 52 includes a metal die head 76 and an unheated or cold plate 18 opposite the die head 76.
The first and second sheets 38, 40 are mounted between the die head 76 and the plate 78 during formation of the seal line 34.

Figs. 7 and 8 illustrate the metal die head in ~ross-section. The metal die head 76 has first and second die sides 80, 82, respectively. Immediately adjacent the first die side 80 is a convex rounded projection 84. The eonvex rounded projection 84 merges at one side thereof into the first die side 80 at a first die side end 86.
The convex rounded projection 84 further includes a point of maximum projection 88. A bevel 90 extends from the rounded projection 84 to the second die side 82 at a second die side end 92. The bevel 90 recedes rom the point of maximum projection 88 in the vertical direction.
For purposes of this application, thP words "horizontal"
and "vertical" are made with reference to the drawings only. It should be understood that, for example, the seal line 34 may be formed with the sheets 38, 40, metal die head 76 and unheated plate 78 oriented ninety degrees or any angle rom that shown in Figs. 7 and 8.
The vertical distance between the point of maximum projection 88 on the rounded projection 84 and the second die aide end 92 is preferably greater than the vertical distance between the point of maximum projec~ion 88 and the first die ~ide end 86. It is believed that the vertical distance between ~he first die side end 86 and the point of maximum projection 88 should not be greater than the thickness of the second sheet 40. The bevel 90 extends ~way from the rounded projection 84 at approxi-mately 5 from horizontal. The vertical distance between the first die side end 86 and the point of maximum projec-tion 88 may be in the range from about 0.007 to about 0.008 in. for exarnple. The rounded projection 84 may have a width of about 0.020 in. The width of the sealing die between the first and second die sides 80, 82 may be about 1/8 in. These sample measurements of the sealing die would be appropriate when utilizing ~ir~t and second sheets 38, 40 having thicknesses of about 0.015 and 0 010 in., re~pectively.
As stated above, the eeal 36 and resulting sPal line 34 are formed by mountins the first and second sheets 38, 40 between the metal die head 76 and unheated plate 78.
Focused energy is applied through the die head 76 and is p~eferably radio-frequency (RF) energy. The die head 75 is lowered into contact with the second sheet 40.
Pressure may be applied simultaneously with the ocused energy. After the seal 36 is formed, the metal die head 76 is lifted away, such as shown in Fig. 8.
The specific seal lines shown in the containers of Figs. 4-6 include, in addition to the seal 36, a mirror image seal 36' substantially identical to the seal 36.
The mirror image seal 36' is a cross-section of ~he seal line portion 34B. Figs. 9 and 10 illustrate the die 98 for such a seal line 34. Referring bacX to Fig. 6, the seal line begins at a seal line opening end 94. The seal 36 and the mirror image seal 36' commence from the common Qeal line opening end 94 which corresponds to the sealing die end 96 of the sealing dle 98 illustrated in Figs. 9 and lQ. 'Fhe portion~ 34A, 34B of the seal line 34 initially extend away from each other from the seal line opening end 94 at an angle le~s than 180.
The seal line 34 utilized in the container of Figs.

4-6 is best illustrated in Fig. lOA, showing ~oth the seal 36 and the mixror image seal 36'. The cross-section of the combined seal 36 and mirror image seal 36' illustrated in Fig. lOA is the preferred embodiment for the seal line 34 used with the tear tab arrangement of the containers shown in Figs. 4-6. Here, the seal break li~e 58 and the mirror image breaX line 58' are separated by the seal arcuatP depression 6Q and the mirror image seal arcuate J

depression 60'. This arrangement corresponds with the sealing die 98 illu~trated in Figs. 9 and 10.
It is possible that the qeal and mirror image seal could be reversed such that the seal arcuate depression and the mirror image seal arcuate depression are separated by the seal break line and the mirror image break line.
In such a construction, the break lines would thus be in the inner, facing portions of the seal line as opposed to the outer, opposit~ portions ~f the seal line illustrated in Fig. lOA. Preferably, the seal line portions 34A, 34B, corresponding to the seal 36 and mirror image ~eal 36', respectively, initially extend away from each other at an angle not greater than about 90. The portion 3BA shown in Fig. lOA co~responds to the inner area 33A of the pull tab 33 shown in Fig. 6. The portion 40A corresponds to the inner area 42A of the container sidewall 42 which is removed with the tab 33. The inner area 42A is secured to the tab 33 along the seal line 34.
As seen in Fig. 6, the seal line portions 34A, 34B, after initially extending away from each other from the seal line opening end 94, extend in substantially parallel relation at a distance between break lines 5~, 58' of not greater than about one-half inch, in the preferred embodi-ment~
The sealing die 98 illustrated in Figs. 9 and 10 or producing the combined s~al 36, 36' illustrated in Fig.
lOA includes both a metal die head 76 and a mirror imag2 metal die head 76', each including, respectively, first die sides 80, 80' and second die sides 82, 82'. The die head 76 may be the same as the die head 76 shown in Figs.
7 and 8 as part of the sealing die 52. While a seal and seal line can be made from the sealing die 52, the sealing die 98 is utilized with the seal lines 34 ~hown in the containers 30, 31.

Each die head 76, 76' includes a convex rounded pro-jection 84, 84' merging at one side thereof into its respective first die side 80, 80' at a re~pective first die side end 86, 86'. Each conYex rounded projection 84, 84' has a corresponding point of maximum projection, 88, 88'. A bevel 90, 90' extend~ from each of its respective rounded projections 84, 84' to its respective second die side 82, 82' at a respective second die side end 32, 92'.
As di~cussed relative to Figs. 7 and 8, each of the bevels 90, 90' recedes from the respective point of maximum pro-jection B8, 88' in the vertical dir~ction. The die head 76 and mirror image die head 76' correspond to the seal line portion 34A and the mirror image seal line portion 34B of the seal line. The die head 76 and mirror image die head 76' converge at a se~ling die end 96 correspond-ing to the seal line opening end 94.
Vertical distance between each point of maximu~ pro-jection ~8, 88' and its respective ~econd die sidP end 92, 92 t i8 greater than the vertical distance between each point of maximum projection 88, 88' and the respective first die side end 86, 86'.
It should be noted that although the seal line 34 is made by the æealing die 98 in the preferred construction for the tear tab arrangement on the containeræ shown in Fig~. 4-6, it is quite possible to construct the tear tab arrangem~nt utilizing only thP seal line 34A comprising the seal 36 without the mirror image seal 36'. The con-struction of such a se~l line would be made with the sealing die 52 shown in Figs. 7 and 8 without the mirror 3G image metal die head 76'. The resulting seal line could be a straight line. Whereas th0 seal line 34, shown for example in Fig. 6, creates an open area when openedJ a single seal line portion 34A would create a tear line in the bag material when opened, as opposed to an op~n area.

3.~$~3 Also, it is belie~ed that the single seal lins portion 34A
may be more su~ceptible ~o inadvertent opening than is the seal line 34 having both seal 36 and mirror image se~l 36'.
The container 30, 31 described above may be used for storage where quick access i8 necessary. For example, the containe~s may be used to store "61ush", a partially frozen medical solution used during surgery. ~he con-tainer may have an outer wrap which is removed outside the operating circle. The tear tab may be broken by a sterile operator within the operating circle.
Referring now to Figs. 11-14, there is shown a uniyue multiple-chamber container 100. The container 100 includ~s a first sheet 102, a second, diaphra~m sheet 104 and a third sheet 106. The first sheet 102 and the second sheet 104 correspond to the sheets 38 and 40 respectively in the discus~ion relative to Figs. 1-3.
The first sheet 102 includes a fir~t inner surface lOB
and a first outer surface 110. The second, diaphragm sheet 104 includes a second inner surface 112 and a second outer surfac0 114. The thlrd sheet 106 includes a third inner surface 116 and a third outer surface 118.
The first, second and third sheets 102, 104, 106 are sealed together about their peripheries. The second diaphragm sheet 104 is sealed about at least a portion of its periphery such as shown in Fig. 19, discussed below, but in the preferred embodiment i5 sealed about its entire periphery, intermediate the first and third sheets 102, 106, as seen in Figs. 11 and llA. The first and third sheets 102, 106 form the exterior wall of the container 100 .
The sheets 102, 104, 106 are preferably flexible and it is preferred that each sheet is made at leas~ partially of a thermopla~tic. The peripheries of ~he first, second ~ ~3 ~

and third sheets 102, 104, 106 may be sealed with a standard heat ~eal.
An externally, manually breakable line of securement 120 is made between the first sheet 102 and the second, diaphragm sheet 104. The breakable line of securement 120 may be the selectively openable seal line ha~ing the seal 36 discussed above, in order to provide an extremely secure seal which is not aasily opened unintentionally but which may be selectively opened when desired. Also, the selectively openable seal line, such as discussed with reference to Figs. 1-10, for example, opens in a predeter-mined manner without creation of loose material which could contaminate the container contents. However, the breakable line of securement 120 may be of some alternate construction. In order to provide quick communication and mixing between the components in the two chambers of the conta:iner 100, the breaXable line of securement 120 ex~ends across the entire width of the container, although this is not necessary to the operation of th~ container.
The breakable line of secursment 120 has a substantially chevron ~hape.
Port means ~uch as a tubular port assembly 122 may be mounted in the container 100 to communicate with the interior of the container 100. The tubular port assembly 122 may include a sealing membrane ~not shown) capable of being pierced by, for example, the cannula or spike o a parenteral administration set for delivery of the con-tainer contents through the administration set to the intravenous system of a patient.
The second, diaphragm sheet 104, the breakable line of securemen 120 and the third sheet 106 together define a first chamber 124 for holding the first component 126 to be stored. The first sheet 102, the breakable line of securement 120 and the second, diaphragm sheet 104 together define a seeond chamber 128 for holding the second component 130 to be stored.
~lthough not necessary, it is highly pre~erred that the container 100 also include a permanent line of secure-ment 132 between the second, diaphragm sheet 104 and the third sheet 106. The permanent line of securement 132 extends substantially parallel to and substantially the length of, the breakable line of securement 120. With the inclusion of the permanent line of securement 132 the first chamber 124 and second chamber 128 are further defined by the permanent line of securement 132. The permanent line of securement 132 may be a standard heat seal, for example, such as ~hown by the seal 134 in Fig.
13. The seal 134 refers to the cross-sectional configura-tion of the permanent line of securement 132. A
cross-sectional view of the breakable line of securement 120 is the breakable sea~ 136 which is illustrated, for example, in Figs. llA and 13 as the seal 36 of the seal line 34. 0nP again, however, it should be noted that the breakable line of securement 120 may include seal lines other than the.unique seal line 34.
Fig. 12 is an enlarged fragmentary view o ~he seal ~tructure of the container 100. The two phanto~ lines correspond to the two ends 134A, 134B of the heat seal 134. The solid line closest to the phantom line repre-sents the break end 56 of the seal 136. The other solid line represents the secondary bead area 72.
As illustrated in Fig. 11, it may be desirable to extend the breakable line of securement 120 entirely across the container~ spanning the peripheral seal 138 of the first and second sheets 102, 104. This creates a first chamber portion 104A of the second, diaphragm sheet 104. Thus, the second chamber 128 is exclusiYe of a boundary with the first chamber 124 at the first chamber portion 104A of the second diaphragm sheet.
Similarly, it would then be desirable to extend the permanent line of ~ecurement 132 entirely across the container 100, spanning the peripheral seal 140 of the second and third sheets 104, 106, thereby creating a second chamber portion 104B of the ~econd ~heet bounded in part by the permanent line of securement 132. Thus, the first chamber 124 is then exclusive of any boundary with the second chamber 128 at the second chamber portion 104B
of the second sheet. When, as is preferred, the breakable and permanent lines of securement 120, 132 both extend entirely across the container, a common portion 104C of the second sheet is thereby created. With this configura-tion, the first and second chambers 124, 128 share a boundary only at the common portion 104C Qf the second sheet 104.
Such a configuration has at least two disti~ct advantayes. First, the two components 126, 130 do not overlap. Thus, if it is desirable to inspect the con-tainer content6 before mixing and the container wall is transparent or translucent, it is possible to inspect each component separately without also viewing the other component. Secondly, and more importantly, such a structure drastically limits the common border of the two chambers 124, 128 This is impor~ant for limiting the transmission of moisture or gas into one of the chambers from the other through the material of the second sheet 104. The ar~a is thus limited to the breakable and permanent lines of sec~rement 120, 132 and the commcn por-tion 104C of the second sheet 104.
In this regard, the container may be made rom a vhriety of different plastic materials. The~e include, without limitation, polyvinyl chloride, ethlyene vinyl acetate (EVA) and SARAN O What appears to be important when making the selectively openable seal line 34, which may be used as the breakable line of securement 120, is that the first inner surface 108 of the ir~t sheet 102 and ~he second inner surface 112 of the second sheet 104 be thermoplastic materials having similar or identical melt-flow characteristics, in order to enable manufacture of the unique seal 36, 136.
Further, in medical applications such as when amino acids and dextrose are stored in the two chambers, it is important to limit oxygen transmission through the con-tainer wall into the chambers as well as limit moisture transmission through the container walls and across the diaphragm sheet 104. An even more critical example includes use of the container 100 to store~ for example, dextrose or saline solution in the first chamber 124 and a powdered drug in the second chamber 128. In this applica-tion it is imperative that virtually no moisture be trans-mitted into the second chamber 128 containing the dry drug. In order to limit the transmission of moisture from the solut.ion in the irst chamber across the common por-tion 104C into the second chamber, it i8 desirable to utiliæe various laminate structures in making the con-tainer and especially in making the second diaphragm sheet 104. Two examples of exceptional moi~ture and gas trans-mission barrier materials are SARAN and aluminum foil.
The ~econd sheet 104 may be manufactured with a layer of, for example, SARAN or foil or other high barrier property material, allowing the inner surface 112 of the diaphragm Rheet 104 to be maintained as a thermoplastic material æimilar to the material of the înner surface 108, in order to permit a proper seal between the first and sec~nd sheets 102, 104.

~21-However, it must be remembered that the first and third sheets 102, 106, as well as the second sheet 104, may also be laminate structures comprising at least two or more layers of material. This is especially important in the medical field, such as when amino acid ~olution and dextrose solution may be stored in the two chambers 124, 128. Here, it is desirable to prevent the transmission of air into the container through the wall and to prevent the loss of liquid out of the container.
The use of laminate structures becomes Pven more critical when a dextrose or saline solution, for example, is stored in the first chamber 124 and a powdered dry drug is stored in the second chamber 128. Here, it is critical that virtually no moisture reaches the dxy p~wdered dxug The saline solution stored in the adjacent chamber is limited to transmission through the common portion 104C of the diaphragm sheet 104. If a high vapor and moisture barrier such as SARAN or metal foil i5 used in all three sheets, virtually no moi~ture from the liquid in the first chamber or from outside the container should reach the dry powdered drug in the second chamber.
It may be seen that the container 100 provides an excellent means for the separate storage of two components. A nurse or other operator may selectively mix the two components by simply grasping the first and third sheets (i.e~, the outside wall of the container) and manually separating the two sheets, pulling them in opposite directions, near the braakable line of secure-mentO This action will rupture the breakable line of securement 120 and therefore the second sheet 104 as well, placing the first and second chambers 124, 128 in open communication, as best seen in Fig. llA. The advantages of utilizing the selectively openable seal line 34 as the breakable line of securement 120 in the container 100 are now readily apparent. The seal line 34 is not believed susceptible to opening upon the application of unintended forces such as may be commonly found during shipment, storage and handling of the container both to and in a hospital. The selectively openable seal line 34 may, however be easily opened by the manual separation of the first and third sheets near the seal line. The seal line 34 breaks in a predetermined manner.
It is also believed that the unique container structure utilizing the permanent line o securement 132 closely parallel to or opposite the breakable line of securement 120 ~reatly facilitates the easy selective breaking of the second sheet, because the common portion 104C is stretched between the permanent ~eal 134 and the breakable seal 136. The breakable seal 136 ruptures, placing the two chambers in communication. When the permanent line of securement 132 is not incl~ded, the opening action by the operator is the ~ame except that the first and second, instead of first and third sheets are grasped. The second shee~ i5 grasped from the container-exterior, so that the second and third sheet~
are folded between the thumb and index finger of one hand.
When the selectively openable seal line 34 is utilized a5 the breakable line of securement 120 in the container lO0, the seal line 34 may be manufactured utilizing the sealing die 142 illustrated in Figs. lS-17. The sealing die 142 is similar to the sealing die 98 except that, instead of changing from initially a chevron shape to two parallel lines, such as portions 34A, 34B, the general chevron shape is used or th~ entire sealing die and thus the entire line of ~ecurement 120. The chevron shape preerably at leas~ begins at an angle of less ~han 90~
and may widen to an angle of less than 1~0~ The sealing die 142 illustrated in Figs. 15-17 includes a sealing die end 144 shown in greater detail than the sealing die end 96 of the sealing die 98 but which may also be used in the sealing die 98. The sealing die end 144 is the point at which the die head 146 and mirror image die head 146' converge and corresponds to the seal line opening end 148 of the breakable line of ~ecurem~nt 120 when the openable æeal line 34 is employed. The die head and mirror image die head 146, 146' include, about the sealing die end 144, an end convex rounded projection 150 which is substan-tially wider than and which narrows into the convex rounded projections 152, 152' of the die heads 146, 146'.
Further included i6 a flat 154, intermediate the end convex rounded projection 150 and the bevel 156, 156', the flat 154 narrowing .. o a point 155, 155' in both the die head 146 and mirror image die head 146' whereat the bevel 156, 156' begins adjacant the rounded projec~ion 152, 152'. The width of the bevel 156, 156' remains constant throughout the entire length of the sealing die, including the sealing die end 144.
When the selectively openable seal line 34, 120 is made utilizing the sealing die 142, a ~eal line opening end 148 results which include~ an opening arcuate depression which is substantially wider than and which narrows into the seal arcuate depression 60 and mirror image arcuate depression 60'. As an example, the width of the opening arcuate depression at the opening end 148 may be about 0.04 in. and may narrow to about 0.02 in. at the arcuate depression 60 and mirror arcuate depression 60' seal~ The seal line 34, 120 will thus also have an open-ing end seal 148 having a corresponding seal flat surface in~ermediate the concave upward surface 66 and the beveled surface 68. The flat surface will narrow to a point into the seal line portion 34A and mirror image seal line portion 34B of the seal line 34, 1~0 whereat the beveled surface 68 of the seal 136 begins adjacent the concave upward surface. It follows that the width of the beYeled surface 68 of the seal line 34, 120 shall remain constan~
through the entire length of the æeal line when the seal-ing die 142 is employed. The seal line opening end 148 corresponds to the tip of the ohevron shape.
As a simple test to assure that the breakable line of securement 120 has not been even partially opened, a tack seal 158 may be provided between the first and second sheets 102, 104 and spaced from the ~eal line op~ning end 148, the ~eal line opening end 148 most probably being the weakest point in the breakable line 34, 120~ The tack seal 158 will break before the breakable line 120 opens~
The tack seal, which may be a small-area, w2ak heat seal, makes a small but audible noise when broken. Thus, if the noise is heard when breaking the line of securement 120, one knows that the seal line opening end 14a has not been disturbed.
Referring now to Fig. 18, there is illustrated a ~chematic view-of the manufa~turing proc~dure for the con-tainer 100.
A continuous supply of the first, second and third sheets 102, 104, 106 is provided, typically in the form or xoll atock. The sheets are aligned 8uch that the first and third sheets 102, 106 are substantially eoextensive, with the second sheet intermediate the fir6t and third heets. For purposes of illu~tration only, the fir~t and third sheets may be ethlyene vinyl acetate having a thicX-ness of 0.015 in. The second sheet 104 may have inner and outer surfaces of ethlyene vinyl acetate and an inner layer of SARAN ox foil, the second ~heet 104 having a thicknes6 of about 0,010 in, 3 ~ ~r~

The breakable line of securement 1~0 is then formed.
If the container to be formed employs the ~penable s~al line 34 as the breaXable line of securement 120, a sealing die such as the sealing die 142 i5 brought into contact with the second, diaphragm sheet 104 on the opposite side of the first sheet 102. An unheated ~r cold flat plate 160 preerably of metal is disposed against the first sheet 102 opposite from the second sheet 104. The focused energy is then applied through the sealing die 142.
If the breakable line of s~curement 120 does not employ the openable seal line 34, but instead utilizes a weakened seal line ~uch as may be made by forming a line of thinner material, the unique Realing die 142 may b~
replaced with the appropriate known die to produce such a weakened seal line.
In the preferred embodiment using the openable seal line 34, the seal line 34 is formed utilizing a RF Sealing Machine, Model No. KF62/SP40, sold by Solidyne, Inc~ of Bay ShorP, New York. The sealing machine is listed at 6,000 watt~ and the RF energy i~ applied at 27 Megahertz, within 8ix percent.
The sealing die 142 is in contact with the second sheet 104 typically for a period of as much as five or six seconds, although the contact time may be as little as about three seconds and may be ~till further reduced. The RF energy i5 pre~erably applied somPwhere in the middle of the contact time psriod and may be applied ~or about one second or longer.
The openable seal line 34, illustrated by the seals 36, 136 in cross-section, i~ formed with the application of relatively little pressure. For example, a peripherial heat seal 138, 140 sealing the peripheries of the sheets may involve the use of as much as 500 psi. The openable seal line 34 utilizes pressure of probably less than 25 psi. The ealing machine may be set to include a stop on the die approximately 0.004 in. into the 6econd sheet 1040 It may indeed be possible to make the seal 36, 136 without the application of any pressure whatsoever. It is pre$erred tha~ the unheated or cold plate 160 is main-tained at a relatively cold temperature by, or example, water cooling the plate 160. The cold plate serves to prevent or dras~ically reduce any indentation of the outer surface 110 of the first sheet 102, i.e., it reduces the effect of the RF energy at the outer surface 110. After the seal line is formed, ~he ealing die 142 and cold plate 160 are disengaged and the three sheets, the first and second sheets now being attached, travel to the next station, where the permanent line of securement 132 is formPd. The permanent line of securement may be formed with a standard flat ealing die 162 shaped to create a permanent line of securement 132 which runs parallel to the breakable line of securement 120. The permanent line of securement 132 may be made upon the application of heat and pressure and may utilize RF energy. The standard sealing die 162 may be urged against the third outer surface 118. A glass buffer 164 may be inserted between the first and second sheet~ 102, 104. The glass buffer 164 preferably has a cut-out end 166 corresponding with the breakable line of securement 12G, so that the buffer 164 may be brought fairly close, if not adjacent to, the breaXable line of securement 120. An additional glass buffer (not shown) may also be employed adjacent the first outer surface 110 of the first shee~ 102.
The sheets ar~ then translated to another station to permanently seal the first and third sheets about their peripheries and to ~eal at least a portion of the periphery o~ the second sheet~ Typically, and as shown in Fig. 18, the second Rheet 104 is pro~ided from roll stock of the same thickness as the first and third sheets 102, 104. However, as shown later in FigO 19, the second sheet may be narrower, thus not extending the entire length of the finished container. However, taking the mo~t typical case utiliziny the full width second 6heet, the peripheral seals 138, 140 between the first ~nd second ~heets and the second and third sheets, respectively, are formed. These seals may be made in a typical known manner utilizing heat and pressure, the pressure perhaps approaching 500 psi, as stated earlier. Typically, the container is cut away from the supply material along the outer boarders of the peripheral seals 138, 140. This may be performed during the same step as forming the peripheral seals.
In the preferred embodiment, the peripheries of the 1~ sheets are sealed except for openings into the first and second chambers. These openings are used to both fill the first and second chambers 124, 128 with the components 126, 130. Also, port means such as a tubular port assembly 122 may be inserted through the openings about which standard heat seals may be made to close both the chambers and form the finished product.
The finished ~ontainer 100 i~ thus formed which, depending upon h~ respective materials and laminate structures of the first, second and third sheets, provides sterility, moi~ture and ~apor barrier~ both between the fir~t and ~econd chambers and between the container and the environment. These qualities are all crucial when employing medical substances in the two chambers. The container is thus capable of maintaining the components 126, 130 in sterile condition.
Referring once more to Fig. 19~ ~here .i8 shown an alternate embodiment of the container 166. The con~ainer 166 may be substantially identical to the con~ainer 100, utilizing first and third sheets 168 and 172 and including a breakable line of securement 174 and a permanent line of securement 176. A tubular port assembly 178 may als3 be provided. Here, howe~er, the second, diaphragm shee~ 170 does not extend the full length o the container 166 from the administrati~n port end 180 to the hanger end 182.
Instead, the roll stock for ~he ~econd sheet and thus the second sheet itself is wide enough o provide breaXable and permanent lines of securement 174, 176 which may be identical to the breakable and permanent lines of secure-ment 120, 132.
Such a configuration is not as desirable as the con-tainer 103 previously described because the components stored in the container may be disposed on both the inner and outer surfaces 184, 186 of the second sheet of both the first and second chambers 188, 190. This is true both before and after separation of the breakable line 174 and mixing of the components.
Reerring now to Figs. 21 and 22, thera is illustrated a further alternate container 192~ The container 192 may be identical to the container 100 except that there are a plurality of both breakable and permanent lines o secure-ment.
~he container 192 includes first, second and third sheets 194, 196 and 198, Although the breakabl0 lines of sesurement 200, 202 may includP various types o~ selec-tively breakable lines, the breakable lines of ~ecurement 200, 202 are illustrated in Figs~ 21 and 22 and will be described hereafter as embodying the unique seal line 8uch as designat0d above as seal line 34, havîng cross-sectional seal~ 204, 206, respectively, which are the same as both previously designated seals 36 and 136. A
plurali~y of pPrmanent lines of securement 208, 210 are provided ~ich are substantially coexten~ive with and parallel to the respective breakable lines of securement 200, 202.
The container 192 includes a ~irst chamber 212, a second chamber 214 and a third chamber 216. Here, the third chamber 216 is defined in part by the first and second sheets 194, 196 as is the first chamber 212. The second chamber 214 is defined in part by the second and third sheets 196, 198.
The first chamber 212 is defined by the second, diaphragm sheet 195, the openable seal line 202, the first sheet 194 and the permanent line of securement 210. The third chamber 216 is defined by the second sheet 196, the openable seal line 200, the first shee-t 194 and the permanent seal line 208.
The second chamber 214 is defined by the second sheet 196, the third sheet 198, both openable seal lines 200, 202 and both permanent seal lines 208, 210~
As shown in Figs. 21 and 22, the second chamber 214 serves as a buffer. Although there is room for storage, it is not intended that any component be stored in the second chamber 214. The container 192 includes first and second common portions 196A, 19~B of the second sheet 196. The container 192 hus se~regates components 218, 220 which may be stored in the first and third chambers 212, 216 to an even gr~ater extent that the segregation of the two components in the container 100.
Mixing of the components 218, 220 is affected in the same manner as with the container 100. The first and third sh~ets 194, 198 are pulled apart near the lines of securement 200, 202, 208, 210, thus rupturing the second sheet 196 at the break lines 222 and 224. Upon rupture of the second sheet 196 at the bxeak lines 222, 224, the first, second and thi.rd chambers are placed in open communicatlon. W~th the breakable lines of securement ~ ~3.~

; 200, 202 spanning virtually the entire width of the con-tainer 192, a homogenous mixture o~ the components 218, 220 m~y be obtained almost immediately.
Referring now to Fig. 20, there is shown a container 226 including first, second and third chambers 228, 230, 232 for ~he storage of first component 234, second component 236 and third component 238, respectively. The container 226 includes first, second and third sheets 240, 242, 244 as with containers 100, 192.
The first and second cham~ers 228, 230 are separated in the same manner as the first and third chambers 212, 216 in the container 192. The first and second chambers 228, 230 are separated by two breakahle lines of secure-ment 246, 248 and two permanent lines of securPment 250, 252, ~hereby creating a fourth, barrier or buffer chamber 254 like the second, buffer chamber 214 in the container 192.
Similarly, th2 second and third chambers 230, 232 are separated by two breakable lines of securement 256, 25~
and two permanent lines of securement 260, 262, defining a fifth barrier ~hamber 264.
Although the container 226 utilizes the double barrier configuration between component containing chambers as with the container 192, the three component container 226 may be constructed with single breakable and permanent line~ of securement between chambers 228 and 230 and between chambers 230 and 232. However, the double barrier configuration which includes the fourth and fifth barrier or buffer chambers 254, 264, creates an extra assurance 3D that there will be no transfer of one component ~rom chamber to chamber during storage.
The barrier chambers~ such as the chamber 214 in the container 19 and the cham~ers 254, 264 in the container 226 serve an additional, important function. These t~

barrier chambers provide a visual test that no mois-ture transmission has occurred between the component containing chambers. By inspecting the barrier chambers immediately before mixing, the nurse or other operator can detect moisture in the barrier chambers. If moisture is found, the operator may dispose of the container because of the possibility of moisture transmission between component containing chambers. Only the portion of the first and third sheets about the lines of securement need be trans-10 parent in order to utilize this test procedure. However, even if not used as a test of moisture transmission, the barrier chambers provide added assurance that each component-containing chamber is secure.
The container 226 illustrated in Fig. 20, as well as 15 the oontainer 192 of Figs. 21 and 22 may be manufactured in the same manner as shown in Fig. 18. Port means such as tubular port assemblies 266A, 266B, 266C may be pro-vided to fill and/or provide access to each of the three chambers.
As discussed above, laminate structures employing virtually absolute moi~ture, air and sterility barriPrs, such as SARAN and foilt may be used when medical sub-stances are stored in the containers. However, when laminate structures are used, the chances of maintaining a 25 transparent or translucent sheet is decreased, both because of the greater variety of material used, e.gO, foil, and due to the fact that there are various layers in the ~tructure. It may, however, be desirable to visually inspect the contents of each chamber before mixing to 30 assure the operator that the container contents are in good condition. This may be especially important when the container i6 used to store medical substances. It may be particularly desirable to inspect a chamber containing a dry powdered drug for the presence of any moisture what~

soever or, as a further example, a chamber containing amino acids, which is a superior growth medium.
A solution to this problem is illustrated in Figs.
23-26. The container 268 shown in Fig. 24 includes first and thir~ sheets 270, 274 and a second, diaphragm sheet 272. A tubular port assembly 276 communicates ~ith the second chamber 280. The first chamber 278 and second chamber 280 are separated by a breakable line of secure-ment 282 and a permanent line of securement ~84. The breakable line of securement 282 may be the unique seal line 34.
As an e~ample, the first component 286 stored in the first chamber 278 may be ~ powdered drug and the second component 288 stored in the second chamber 280 may be a saline solution. In order to pxevent moisture trans-mission from the second chamber 280 to the first chamber 278 and to minimize moisture and vapor transmission between the fir~t and second chambers and the environment, the fixst and second ~heets 270, 272 may be laminate structures including, for example, inner and outer suraces of polyvinyl chloride and a middle layer of aluminum foil. In order to permit visual inspection of the container contents, the third sheet 274 may be trans-parent or translucent such as if made solely from a polyvinyl chloride formulation.
Over time, minute amounts of gas and moisture trans-mission may occur between the saline solution in the second chamber 280 and the environment, in such small amounts as to qtill be permissible under good medical procedure. However, the transmission of small amounts of moisture into the powder drug containing chamber 278 is not permissibleO The container 268 therefore includes a peelable barrier segment 290 which may include an ou~er layer of aluminum foil 292 and an inner ~dhesiYe layer 294. The peelable barrier segrnent 290 is secured with the inner adhesive layer 294 to that portion of the third sheet 274 forming the exterior wall of the first chamber 278. Preferably, the pealable barrier segment 290 also extends over the breakable and permanent lines of secure~
ment 282, 284.
Before breaking the breakable line of securement 282 to mix the container contents, the nurse or other operator may simply peel away a portion or all of the peelable barrier segment 290 to inspect ~he powdered drug 286 through the third sheet 274, Fig. 25 shows A cutaway view of ~he container 268, schematically illustrating the placement of the peelable barrier segment 290 over the third sheet 274.
Fig. ~6 illustrates a container 296 which is an alternate embodiment of the container 268. The container 296 includes irst, second and third sheets 302, 304 and 306, respectively. Fig. 26 schematically illustrates the placement of first and second peelable barrier segments 298t 300. The second peelable barrier segment 300 is, like the peelable barrier segment 290 of container 268, placed over that portion of the third sheet 306 which forms an exterior wall o~ the first chamber 308. The first peelable barrier segment 298 is placed over that portion of the ~irst sheet 302 which is coextensive with that portion of the second sheet 304 forming the opposite wall of the first chamber 308. The container 296 may include a dry powdered drug as the first component (not shown) stored in the first chamber 30~. The second chamber 310 may include a saline solution as the second component ~not shown). The container 296 may also include the breakable and permanent lines of securement 312, 314.
'Fhe embodiment shown in the container 296 may permit the use of relatively inexpensi~e materials such as pclyvinyl 3~

chloride, for all three sheets, without the need for laminate structures. The peelable barrier segments 298, 300 will prevent any moisture or vapor transmission between the environment and the first chamber 308. The only area through which moisture may pass into the first chamber 30B is at the common portion 304C of the second, diaphragm sheet 304. Moisture transmission rom the second chamber into the first chamber across the common portion 304C would only occur if the second sheet 304 did 1o not include the proper barrier material. When the rela-tively inexpensive straight PVC is used for the second diaphragm sheet, this moisture transmission across a common portion 304C may be minimized by utilizing the double barrier construction including multiple breakable and permanent lines and a middle barrier or "no man's land" chamber such as the chamberæ 214~ ~54, 264 of the containers 192, 226. Also, there may be applications where the sinyle barrier illustrated in Fig. 26 with a col~mon portion 304C is permissible in conjunction with the peelable barrier ~egments 298, 300 such as where the first component must'be maintained very dry but not absolutely dry or where the storage time is relatively short, minimi~ing any transmission problems across the common portion 304C.
High barrier property materials in higher CQst laminate strueture~ for the first and third sheets of the containers 100, 166, 192, 226, 268, 295 may be eliminated and substituted with the relatively lower cost materials such as one layer PVC or EVA, even when medical substances ~uch as powdered drugs are stored therein, and no peelable barrier segments need be used, if the entire container is packaged in a gas and moisture barrier overpouch~ How-ever, the use of the proper laminate structures as dis-cussed above, and the use of a peelable barrier segment ~t3~

either in conjunction with or in substi~ution of the laminate structures, may totally eliminate the need for a moisture barrier overpouch, thus substantially reducing product cost while maintainin~ a high quality container suitable or even medical use.
The containers 100, 166~ 192, 226, 268, 296 may all be used as a primary solution container for direct connection to a parenteral administration set. Stated differently, each of these containers may, after mi~ing of the components stored therein, be placed on an IV stand at a patient's bedside for direct infusion into the patient's venous system.
While several embodiments and features have been described in detail herein and shown in the accompanying drawin~s, it will be evident that various further modifi-cations are possible without departing from the scope of the invention.

Claims (9)

WHAT IS CLAIMED IS:

1. A container having two chambers for the separate storage and selective mixing of two components, compris-ing:
(a) a first sheet including (i) a first inner surface of a thermo-plastic material, and (ii) a first outer surface;
(b) a second, diaphragm sheet including (i) a second inner surface of a thermo-plastic material, said second inner surface hav-ing melt-flow characteristics substantially identical with the melt-flow characteristics of said first inner surface, and (ii) a second outer surface;
(c) said second, diaphragm sheet sealed about at least a portion of its periphery to said first sheet and to a third sheet opposite said first sheet;
(d) said first sheet and said third sheet sealed about their entire peripheries, forming the exterior wall of said container;
(e) an externally, selectively, manually openable seal line between said first and said second, diaphragm sheets, said openable seal line extending across the width of said container, wherein a cross section taken through said seal line, perpendicular to said seal line at the cross section defines a seal, said seal formed by applied pressure and a focused energy source, which melts said first and second inner surfaces at said seal, said seal defining (i) a bead area of increased thickness at a break end of said seal, between said first and second inner surfaces, said bead area of increased thickness coextensive with said first and second inner surfaces along less than all of the surface of said bead area, (ii) a break line inwardly of said break end, between said second, diaphragm sheet and said bead area of increased thickness, the thick-ness of said seal at said break line being at the least not substantially less than the thickness of said second sheet, and (iii) an arcuate depression having a concave downward surface extending from substantially adjacent said break line to a minimum seal thickness point;
(f) a permanent line of securement between said second and third sheets extending substantially parallel to and the length of said openable seal line;
(g) at least said second, diaphragm sheet, said openable seal line, said permanent line of securement and said third sheet defining a first chamber for holding the first component;
(h) at least said first sheet, said openable seal line, said permanent line of securement and said second, diaphragm sheet defining a second chamber for holding the second component;
(i) barrier means secured to the exterior surface of the exterior wall of said container, at one of that portion of said third sheet which defines said first chamber and that portion of said first sheet which defines said second chamber;
(j) wherein said barrier means comprises a virtually absolute barrier to at least one of gas, liquid and light:
(k) whereby manual separation of said first and second sheets near said openable seal line will rupture said seal line and said second sheet, placing said first and second chambers in open communication.

2. The container as in Claim 1, whereby said barrier means comprises a sheet having an inner adhesive surface securing said barrier sheet to said one of said third and first sheet portions, whereby said barrier sheet may be peeled away, exposing a portion of said one of said third and first sheet portions underneath said barrier sheet, said one of said third and first sheet portions having sufficient clarity to permit visual inspection of the contents of the underlying chamber.

3. The container as in Claim 2, wherein said barrier means comprises a foil layer.

4. The container as in Claim 3, wherein said foil layer is aluminum.

5. The container as in Claim 1, further including port means communicating with at least one of said first and second chambers.

6. The container as in Claim 1, further including second barrier means secured to the outside surface of said container exterior wall at the other of said third and first sheet portions.

7. The container as in Claim 1, wherein said first and third sheets comprise polyvinyl chloride.

8. The container as in Claim 1, wherein said first and third sheets comprise ethylene vinyl acetate.

9. The container as in Claim 1, wherein said second sheet comprises a moisture barrier between said first and second chambers.