MXPA06009901A

MXPA06009901A - Peelable seal closure assembly

Info

Publication number: MXPA06009901A
Application number: MXPA/A/2006/009901A
Authority: MX
Inventors: Gollier Paulandre; Balteau Patrick; Houwaert Vincent; Shang Sherwin
Original assignee: Balteau Patrick; Gollier Paulandre; Houwaert Vincent; Shang Sherwin
Priority date: 2004-03-03
Filing date: 2006-08-31
Publication date: 2007-04-20

Abstract

The present invention provides a peelable seal for a multi-chambered container including a first edge and a second edge. At least one of the first edge or second edge includes a stress bearing portion and a non-stress bearing portion.

Description

SEALABLE ASSEMBLY OF SEALABLE SEAL Background of the Invention The present invention relates to a container for delivering fluids. In particular, it refers to an assembly for access to a fluid for a container of flowable materials in which an assembly conduit has a closed inlet by a peelable seal structure. The peelable seal is activatable by applying a fluid pressure to the structure of the peelable seal. This assembly can be used in containers of flowable materials and has proven to be particularly useful with single chamber and multi-chamber medical solution containers. Multi-chamber containers having sub-chambers separated by a peelable seal, frangible seal or other fluid-connecting device, are widely used to separately store two or more components that are mixed within the container prior to the administration of the mixed solution. to a patient. The components may be in powder or liquid form, and typically are mixed together so as to form a therapeutic solution. Such solutions can include intravenous solutions, nutritional solutions, drug solutions, intravenous solutions, parenteral solutions, dialysis solutions, pharmacological agents that include gene therapy and chemotherapeutic agents, and many other fluids that can be administered to a patient.

Due to concerns regarding stability, compatibility, or others, some medical solutions have to be stored separately prior to their administration to a patient.

These solutions can be stored in separate containers, but they are often stored in separate chambers of a single container. Chambers and solutions are often separated by a frangible thermosel. Examples of such containers are described in the Patents of the United States Nos. 5,209,347; 5, 176,634; and 4,608,043. Said prior art containers have frangible seals to allow the seal to be broken by manual pressure against the sides of the bag to force the contents to break the seal and allow mixing between the components. The peelable seals are among the frangible seals used that allow the seal to be separated by pulling on opposite sides of the container, or by squeezing the side walls of the container. The container with cameras is typically made of a continuous material of flexible polymeric materials. Numerous polymer films have been developed for use in such containers, and may be a monolayer structure or a multilayer structure. The containers may also have multiple continuous materials in which the continuous materials are joined along peripheral edges and the flat surfaces of the continuous materials are not necessarily fixed together. The monolayer structure can be made by co-extrusion, extrusion lamination, lamination, or any other suitable means. The multilayer structures may include layers such as a contact layer with the solution, a scratch resistant layer, a barrier layer to prevent the permeation of oxygen or water vapor, tie layers, and other layers. The selection of the appropriate film depends on the solution that must be contained within the container. The container is typically formed by placing one or more sheets of polymeric film in mechanical agreement at their peripheral portions and sealing the outer periphery so as to form a fluid-tight bag. Peripheral seals are permanent and therefore do not peel. The sheets are sealed by heat sealing, radio frequency sealing, thermal transfer welding, adhesive sealing, solvent bonding, ultrasonic welding or laser welding. Blow extrusion is another method used to prepare the bag. The extrusion by blown is a process that provides a tube of extrudato in movement that leaves of an extrusion matrix. The air under pressure inflates the tube. The longitudinal ends of the tube are sealed to form the bag. It is possible to form a peelable seal in the container that has a lower peel strength than the seal, by various methods such as the use of a heat sealing temperature lower than that used to form the peripheral seal. A peelable seal typically has a peeling strength initial or peak required to initiate separation of the peelable seal, and a plateau force to propagate the separation. Prior to steam sterilization, these forces are substantially the same. After the container with chamber has been filled with solution, it is typically sterilized by steam at a temperature of 121 ° C. During steam sterilization, a tension is applied to the edges of the peelable seal. When a tension is applied to the peelable seal at a temperature above the softening point of the content material during sterilization, a deformation occurs at the edge of the seal. The deformation reduces the stress concentrations at the edge of the seal, whereby the peak force required to initiate the peeling of the peelable seal is increased. After water vapor sterilization, the peak peel strength can be significantly less than the plateau force. This increased peak peeling force is detrimental to the use of the multi-chamber container by hindering the initiation of peeling to open the container. This is especially the case for those patients who use medical solutions that could be disabled or senile and unable to provide the necessary force to start barking. In addition, the peak peeling force is difficult to control; in some containers it is easy to start the peeling in the peelable seal, and in other containers it is almost impossible to start peeling by hand.

Brief Description of the Invention A transport assembly for flowable materials is described herein having a conduit having a wall defining a first path for transporting flowable materials and having an entry for the path and an exit from the path; and a multilayer structure defining a first continuous material and a second continuous material connected together along an interface close to the inlet, the multilayer structure is capable of moving from a sealed position to an activated position in response to materials delivered under pressure to the structure along a second trajectory different from the first trajectory in order to allow the flowable materials to enter the entrance. Also described herein is a closure assembly for a container having opposite side walls defining a chamber therebetween, and a conduit having a portion extending into the interior of the chamber and having an inlet for the fluid, portions facing sides of the side walls are interconnected along a peelable seal on the entrance in order to define a closure. Also described herein is a content for draining materials having a pair of opposed side walls defining a chamber therebetween, opposite portions of opposed side walls being sealed together throughout a peelable seal so as to define at least two separate sub-chambers, and a conduit having a portion extending into the interior of the chamber and having an inlet for the fluid, the fluid inlet being closed by a portion of the peláble seal. Also disclosed herein is a method for mixing two components stored separately in sub-chambers of a dual chamber container, which includes the following steps: (1) providing a fluid container having a first chamber, a second chamber a peelable seal that divides the first chamber with respect to the second chamber, and a device for access to the fluid having an inlet for the fluid positioned within the chamber, the fluid inlet being closed by a first portion of the peelable seal; (2) activating a second portion of the peelable seal to provide a fluid path between the first chamber and the second chamber without activating the first portion; and (3) activating the first portion of the peelable seal to open the fluid inlet. These aspects and attributes, in addition to others, of the present invention, will be set forth with reference to the following drawings and accompanying specification.

Brief Description Of FIGS. FIG. 1 is a plan view of a multi-chamber container including a peelable seal; FIG. 2 is a cross-sectional view along the lines 2-1 of FIG. 1; FIG. 3 is a cross-sectional view of a multilayer structure; The FI G. 4 is a cross-sectional view of another embodiment of a multilayer structure; FIG. 5 is a graph that shows strength vs. typical displacement for a peelable seal, before and after sterilization; FIG. 6 is a cross-sectional view of a peelable seal having a serrated edge; FIG. 7 is an enlarged top view of a peelable seal; FIG. 8 is a cross-sectional view of a peelable seal; FIG. 9 is a graph of strength vs. displacement for a peelable seal; FIG. 1 0 is a cross-sectional view of a peelable seal; FIG. 1 1 is a graph of strength vs. displacement for the seal of FIG. 1 0; FIG. 1 2 is a cross-sectional view of a peelable seal: FIG. 1 3 is a plan view, schematic, of a peelable seal; FIG. 14 is a plan view, schematically, of a peelable seal; FIG. 1-5 is a plan view, schematic, of a peelable seal; FIG. 16 is a plan view, schematically, of a peelable seal; FIG. 1 7 is a plan view, schematically, of a peelable seal; FIG. 1 8 is a top view, schematically, of a peelable seal; The FI G. 1 9 is a schematic view of a three chamber confederator with peelable seals separating the chamber, and an administration port, one end of which is embedded in the peelable seal; FIG. 20 is a schematic view of a peelable seal; FIG. 21 is a schematic view of a peelable seal; FIG. 22 is a schematic view of a peelable seal; FIG. 23 is a plan view of a peelable seal having a width that varies along the length of the seal; FIG. 24 is an exploded view of a peelable seal having a texture; FIG. 25 is a cross-sectional view of a closure assembly; FIG. 26 is a cross-sectional view of a closure assembly; FIG. 27 is a cross-sectional view of a closure assembly; FIG. 28 is a perspective view of a container having an administration port; FIG. 29 is an exploded isometric view of an administration port; FIG. 30 is a sectional view of a cover of the administration port; FIG. 31 is a sectional view of a user removing a cap from the administration port FIG. 32 is a sectional view of a needle inserted in the port; FIG. 33 is a plan view of a peelable seal container with an access member in a deactivated position; FIG. 34 is a plan view of a peelable seal container with an access member in an activated position; FIG. 35 is a container of multiple chambers with a peelable seal conduit separating two containers from the container; FIG. 36 is a structure of layers before the initiation of barking; FIG. 37 is the structure of layers during peeling; and FIG. 38 is the previous layer structure, now completely delaminated.

Detailed Description Of The Invention The present invention is capable of forms of modality in many different ways. The preferred embodiments of the invention are described with the understanding that the present invention is to be understood as an exemplification of the principles of the invention and are not intended to limit the broad aspects of the invention to the forms of mode illustrated. FIGS. 1 and 2 show the container 10 having a first side wall 12 and a second side wall 14 having a permanent peripheral seal 13 and a closing assembly 15. The container has a chamber 16 which is divided into a first sub-chamber 18 and a second sub-chamber 20 by a peelable seal 22. The seal 22 extends longitudinally of the container from the end seam 24 to the end seam 25. The seal is effective to separate components such as two liquids., a solid and a liquid, two gases, a gas and a liquid, and a gas and a solid. As best seen in FIG. 2, the closure assembly 15 has a conduit 30 having a fluid flow path, an inlet for the fluid, 32, and an outlet for the fluid, 34. A first portion 40 of the peelable seal 22 extends over the inlet. of the fluid, 32, to seal the conduit against the flow of the fluid either inward towards the chamber or outwardly from the chamber. The first portion 40 of the peelable seal can sometimes receive the peelable closure or closure designation. As described in more detail below, the peelable seal 22 has an activating force of the peelable seal required to move the seal from a closed or sealed position to an open or activated position. The peelable seal 22 is designed to first activate along a second portion 42 of the peelable seal followed by activation of the first portion 40. The second portion 42 is separated at a certain distance from the first portion 40, in order to ensure the mixing of the components of the first and second sub-chambers, 18, 20, before the entrance of the outlet conduit 32 opens, and is placed in communication with fluids with mixed content. AND? In a preferred embodiment of the invention, the second portion 42 is arranged centrally, for example, along the length and width dimensions of the container. The closure 40 is capable of blocking the fluid traveling both in the entering direction and in the exiting direction, through the conduit 30. For the single or multiple chamber fluid containers, the peelable seal 22 will block an incoming or outgoing flow of water. fluid, until the flow of the fluid has been pressurized above the activation force of the descortezamiento. Therefore, the peelable seal protects against undesired ingress or egress of fluids from the container. The Side Wall Materials and the Layer Structures The container 10 is preferably made primarily of flexible polymeric materials, although the container could contain non-polymeric materials such as metal tinsels, without departing from the invention. Numerous polymeric films have been developed for use in containers. Suitable films may be of a monolayer structure or of a multilayer structure. The monolayer structure can be made of a simple polymer, or a mixture of polymers. The Multilayer structures may include layers such as a solution contact layer, a scratch resistant layer, a barrier layer to prevent permeation of oxygen or water vapor, tie layers, or other layers. It is also considered the use of more than one continuous film material for each of the side walls, or both. The selection of the appropriate film depends on the solution or the solutions to be contained within the container. Suitable polymeric materials are generally selected from the homopolymers and copolymers of polyolefins, polyamides, polyesters, polybutadiene, copolymers of styrene and hydrocarbons, polyimides, polyester-polyethers, polyamide-polyethers, to mention a few. The seal layer for a multi-chamber container should exhibit bimodal behavior. The expression "bimodal behavior" means that the material is capable of forming a permanent seal under an assembly of sealing or manufacturing conditions and a peelable seal under a second assembly of sealing conditions or man ufacture. The seal layer may be a homophasic homopolymer, or a matrix-phase polymer system. Suitable homophasic homopolymers include polyolefins and more preferably polypropylene and more preferably a copolymer of propylene and ethylene as described in EP 0875231, which is incorporated herein by reference. It is also possible to have a seal layer that has walls 12 and 14 of. different materials that are not compatible with each other. The US Patent Application UU No. 10/351, 004, incorporated herein by reference, discloses that containers made of such incompatible material, in some cases, do not easily form permanent seals. These problems can be overcome by wrapping a section of a side wall over an outer surface of the opposite side wall and joining it thereto. This sealing method is described in U.S. Patent No. 6,024,220 which is incorporated herein by reference and which forms a part hereof. Suitable matrix-phase polymer systems will have at least two components. The two components can be mixed together or they can be produced in a two-phase reactor process. Typically, both components will have different melting points or glass transition temperatures. In the case where one of the components is amorphous, its glass transition temperature will be lower than the melting point of the other components. Examples of matrix-phase polymer system. Suitable include a component of a homopolymer or copolymer of a polyolefin and a second component of a copolymer of styrene and hydrocarbon. Another suitable matrix-phase system includes mixtures of polyolefins such as polypropylene with polyethylene, or polypropylene with a high isotactic index (crystalline) with polypropylene with a lower isotactic (amorphous) index or a polypropylene homopolymer with a propylene copolymer and α-olefin. Suitable polyolefins include homopolymers and copolymers obtained by the polymerization of α-oiefins containing from 2 to 20 carbon atoms, and more preferably from 2 to 10 carbon atoms. Thus, suitable polyolefins include polymers and copolymers of propylene, ethylene, butene-1, pentene-1,4-methyl-1-pentene, hexene-1, heptene-1, octene-1, nonene-1 and decene-1. It is more preferable that the polyolefin be a polyethylene homopolymer or copolymer. Suitable polypropylene homopolymers can have an amorphous, isotactic, syndiotactic, atactic, hemi-isotactic or stereoblock character. In a preferred form of the invention, the polypropylene homopolymer is obtained using a single site catalyst. Suitable propylene copolymers are obtained by polymerizing a propylene monomer with an α-olefin having from 2 to 20 carbon atoms. In a more preferred embodiment of the invention, propylene is copolymerized with ethylene in a weight amount of from about 1% to about 20%, more preferably from about 1% to about 10%, and more preferably, from 2% to about about 5% by weight of the copolymer. The propylene and ethylene copolymers can be random or block copolymers. The propylene copolymer can also be obtained using a single-site catalyst. It is also possible to use a mixture of copolymers of a- olefin and α-olefin in which the propylene copolymers can vary in the amount of carbons in the α-olefin. For example, the present invention contemplates blends of propylene and α-olefin copolymers in which one copolymer has a 2-carbon α-olefin and another copolymer has a 4-carbon α-olefin. It is also possible to use any combination of α-olefins of 2 to 20 carbon atoms and more preferably 2 to 8 carbon atoms. Therefore, the present invention considers mixtures of copolymers of propylene and α-olefin in which a first and second α-olefins have the following combination of carbon numbers: 2 and 5, 2 and 6, 4 and 6, 4 and 8. The use of more than. two copolymers of polypropylene and α-olefin in the mixture. Suitable polymers can be obtained by a "catalloy" process. Suitable ethylene homopolymers include those having a density greater than 0.915 g / cc and include low density polyethylene (LDPE), medium density polyethylene (MDPEW), and high density polyethylene (H DPE). Suitable ethylene copolymers are obtained by polymerizing ethylene monomers with an α-olefin having from 3 to 20 carbons, more preferably from 3 to 10 carbons and more preferably from 4 to 8 carbons. It is also desirable that the ethylene copolymers have a density measured by ASTM D-792 of less than about 0.915 g / cc and more preferably of less than about 0.910 g / cc, and more preferably, less than approximately 0.900 g / cc. Said polymers sometimes receive the denomination of VLDPE (very low density polyethylene) or ULDPE (ultra low density polyethylene). It is preferable that the ethylene α-olefin copolymers be produced by a single-site catalyst, and more preferably, a metallocene catalyst system. It is believed that the single-site catalysts have a simple, sterically and electronically equivalent catalyst position, unlike the Ziegler-Natta catalysts which are known to have a mixture of catalyst sites. Such single-site catalyzed ethylene-α-olefins are sold by Dow under the trademark AFFINITY, by DuPont Dow under the trademark ENGAGE (R), by Eastman Kodak under the trade name MXSTEN, and by Exxon under the trademark EXACT . These copolymers will sometimes receive the designation m-ULDPE. Suitable ethylene copolymers also include copolymers of ethylene and lower alkyl acrylate, copolymers of ethylene and alkyl acrylate substituted by lower alkyl, and copolymers of ethylene and vinyl acetate having a vinyl acetate content of about 8. % to about 40% by weight of the copolymer. The term "lower alkyl acrylates" refers to comonomers having the formula indicated in Diagram I: agrama The group R refers to alkyls having 1 to 17 carbons. Thus, the term "lower alkyl acrylates" includes, but is not limited to, methyl acrylate, ethyl acrylate, butyl acrylate, and the like. The term "alkyl-substituted alkyl acrylates" refers to comonomers having the formula indicated in Diagram 2: Diagram 2 R-i and R2 are alkyls having from 1 to 17 carbon atoms and may have the same amount of carbons or a different number of carbons. Thus, the term "alkyl-substituted alkyl acrylates" includes, but is not limited to, methyl methacrylate, ethyl methacrylate, methyl ethacrylate, ethyl ethacrylate, butyl methacrylate, butyl ethacrylate, and the like. Suitable polybutadienes include the 1, 1, and 1, 4, 1,3-butadiene addition products (these products will be referred to collectively as polybutadienes). In a more preferred embodiment of the invention, the polymer is a 1,2-addition product of 1,3-butadiene (they will be designated from now on, such as 1,2-polybutadienes). In a more preferred embodiment of the invention, the polymer of interest is a syndiotactic 1,2-polybutadiene and more preferably, a syndiotactic 1,2-polybutadiene of low crystallinity. In a preferred embodiment of the Invention, the low crystallinity syndiotactic polybutadiene will have a crystallinity of less than 50%, more preferably less than about 45%, and even more preferably, less than about 40%, and it is more preferable that the crystallinity will be about 13. % to about 40%, and more preferably from about 15% to about 30%.

In a preferred embodiment of the invention, the low crystallinity syndiotactic 1,2-polybutadiene will have a melting point measured in accordance with ASTM D 3418 from about 70 ° C to about 120 ° C. Suitable resins include those sold by JRS (Japan Synthetic Rubber) under the type designations: JRS RB 810, JSR RB 820 and JRS RB 830. Suitable polyesters include the polycondensation products of di- or polycarboxylic acids and polyhydroxy alcohols or alkylene oxide. In a preferred embodiment of the invention, the polyester is a polyester ether. Suitable polyester ethers are obtained by reacting 1,4-cyclohexane dimethanol, 1,4-cyclohexane dicarboxylic acid and polytetramethylene glycol ether, and will receive the generic designation PCCE. Eastman sells appropriate PCCEs under the commercial designation ECDEL. Suitable polyesters further include polymeric elastomers than with block copolymers of a hard crystalline segment of polybutylene terephthalate and a second segment of soft (soft) polyester glycols. Said polyester elastomers are sold by DuPont Chemical Company under the trade designation HYTRE (R). Suitable polyamides include those resulting from the ring opening reaction of lactates having 4-12 carbons. This group of polyamides therefore includes nylon 6, nylon 10, and nylon 12. Acceptable polyamides also include the aliphatic polyamides that result from the condensation reaction of di-amines having a carbon number within a range of 2. -13, the aliphatic polyamides resulting from a di-acid condensation reaction having a carbon number in a range from 2 to 13, the polyamides resulting from the condensation reaction of fatty acid dimers, and copolymers containing amides . Thus, suitable aliphatic polyamides include, for example, nylon 6,6, nylon 6, 109, and dimer fatty acid polyamides. Suitable styrene and hydrocarbon copolymers include styrene and various substituted styrenes including alkyl-substituted styrene and halogen-substituted styrene. The alkyl group may also contain from 1 to about 6 carbon atoms. Specific examples of substituted styrenes include alpha-methylstyrene, β-methylstyrene, vinyltoluene, 3-methylstyrene, 4-methylstyrene, 4-isopropylstyrene, 2,4-dimethylstyrene, o-chlorostyrene, p-chlorostyrene, o-bromostyrene, 2-chloro -4-methylstyrene, etc. Styrene is the best known. The hydrocarbon portion of the styrene and hydrocarbon copolymer includes conjugated dienes. The conjugated dienes that can be used are those containing from 4 to about 10 carbon atoms and more generally from 4 to 6 carbon atoms. Examples include 1, 3-butadiene, 2-methyl-1-butadiene (isoprene), 2,3-dimethyl-1,3-butadiene, chloroprene, 1,3-pentadiene, 1,3-hexadiene, etc. . Mixtures of these conjugated dienes can also be used, for example mixtures of butadiene and isoprene. The preferred conjugated dienes are isoprene and 1,3-butadiene. The copolymers of styrene and hydrocarbons can be block copolymers including di-block, tri-block, multiblock, star block and mixtures thereof. Specific examples of diblock copolymers include styrene-butadiene, styrene-isoprene, and the hydrogenated derivatives thereof. Examples of triblock polymers include styrene-butadiene-styrene, styrene-isoprene-styrene, alpha-methylstyrene-butadiene-alpha-methylstyrene, and alpha-methylstyrene-isoprene-alpha-methylstyrene, and the hydrogenated derivatives thereof. The selective hydrogenation of the block copolymers can be carried out by a variety of well known processes including hydrogenation in the presence of catalysts such as Raney nickel, noble metals such as platinum, palladium, etc. , and soluble transition metal catalysts. Suitable hydrogenation processes that can be used are those in which the diene-containing polymer or copolymer is dissolved in a hydrocarbon diluent such as cyclohexane and hydrogenated by reaction with hydrogen in the presence of a soluble hydrogenation catalyst. Such procedures have been described in U.S. Patent Nos. 3,119,189 and 4,226,952, the disclosures of which are incorporated herein by reference and form part thereof. Copolymers Particularly useful block solvents are the styrene-isoprene-styrene hydrogenated block copolymers, such as a styrene- (ethylene / propylene) -styrene block polymer. When a polystyrene-polybutadiene-polystyrene block copolymer is hydrogenated, the resulting product resembles a regular copolymer block of ethylene and 1-butene (EB). As indicated above, when the conjugated diene is isoprene, the resulting hydrogenated product resembles a block of regular ethylene-propylene copolymer (EP). An example of a selectively hydrogenated copolymer, commercially available, is KRATON G-1652 which is a hydrogenated SBS triblock comprising 30% end blocks of styrene and one half block equivalent is a copolymer of ethylene and 1-butene ( EB). This hydrogenated block copolymer frequently receives the designation SEBS. Other suitable SEBS or SIS copolymers are those sold by Kurrary under the designation SEPTON R) and HYBRAR. It may also be desirable to use block copolymers of styrene and modified hydrocarbons by grafting by grafting a α, β-unsaturated monocarboxylic acid reagent onto the block copolymers selectively hydrogenates described above. The block copolymers of the conjugated diene compound and aromatic vinyl are grafted with α, β-unsaturated dicarboxylic acid or monocarboxylic acid reagent. Carboxylic acid reagents include carboxylic acids per se and their functional derivatives such as anhydrides, amides, metal salts, esters, etc. , which are capable of being grafted onto the selectively hydrogenated block copolymer. The grafted polymer will usually contain from about 0.1 to about 20%, and more preferably from about 0.1 to about 10% by weight, based on the total weight of the block copolymer and the carboxylic acid reagent of the grafted carboxylic acid. Specific examples of monobasic carboxylic acids include acrylic acid, methacrylic acid, cinnamic acid, crotonic acid, acrylic anhydride, sodium acrylate, calcium acrylate and magnesium acrylate, etc. Examples of dicarboxylic acids and useful derivatives thereof include malic acid, malic anhydride, fumaric acid,. mesaconic acid, itaconic acid, citraconic acid, itaconic anhydride, citraconic anhydride, monomethyl maleate, monosodium maleate, etc. The styrene and hydrocarbon copolymer can be modified with an oil such as the modified SEBS oil sold by Shell Chemical Company under the trade designation KRATON G2705. In FIG. 3 shows a monolayer film 49 having a seal layer, 50, an intermediate layer, 52 and an outer layer, 54. Link layers 56 can be used to secure the seal layer 50 to the intermediate layer 52 and to secure the intermediate layer 52 to the outer layer 54. In a preferred embodiment of the invention the seal layer is a polypropylene blend. an ethylene α-olefin copolymer and a styrene-hydrocarbon copolymer. In a more preferred embodiment of the invention, the polypropylene is a copolymer of ethylene polypropylene, the ethylene-olefin copolymer is an LLDPE having a density less than 0.915 g / cc and the styrene-hydrocarbon copolymer is a block copolymer , and preferably a triblock copolymer of styrene-ethylene-styrene or a mixture of a triblock SEBS with a diblock SEBS as minor component. The relative proportions of the components are preferably from about 55% to 75% of the PP by weight, from 5% to 20% by weight of the LLDPE, and from 10% to 20% by weight of the SEBS. The ternary mixture of the seal layer is capable of forming a permanent seal at a temperature of approximately 123 to 128 ° C. A permanent seal is achieved at sealing temperatures above 160 ° C. The intermediate layer 52 can be selected from any of the aforementioned polyamides, and it is more preferable that it be a mixture of about 85 to 98% polyamide 6 and 2 to 15% polyamide 616T. The outer layer 54 is selected from polypropylene polymer, and it is more preferable that it is a copolymer of propylene ethylene with an ethylene content of less than 6% by weight of the copolymer. The details of the film 49 have been set forth in more detail in the patent application Serial 09 / 439,826, filed on November 12, 1999, which is hereby incorporated in its entirety, by way of reference, and forms part of the the same. In FIG. 4 shows another suitable film having three layers, an outer layer 60, the intermediate layer 62 and the seal layer 64. The outer layer is a polypropylene composition made in reactor, having a first component and a second component. The first component is a polypropylene homopolymer and is present in a composition by weight of 20%. The second component is an ethylene-propylene rubber (20% ethylene and 80% propylene) and is present in a 60% by weight amount of the composition. Suitable products for the outer layer are sold by Mitsubishi Chemical Company under the trade name Zelas 7023. The Zelas 7023 is the subject of the US Patent Application Publication. U U Do not, . 2001/003441 6 A1, which is incorporated herein by reference in its entirety and forms part of the present. The intermediate layer 62 a polymer mixture of Zelas 7023 at 70% by weight and 30% by weight of a random copolymer of styrene and butadiene that has been hydrogenated. Suitable randomized styrene and butadiene copolymers are sold by JSR under the tradename Dynaron 2320 P. The outer layer 64 is a 60% by weight polymer blend of Zelas 7023 and 40% e? weight of a random copolymer of propylene and ethylene such as the copolymer sold under the trade designation Novatec EG 7C. The film of FIG. 4 exhibits a bimodal behavior with barking seals that are formed at sealing temperatures of approximately 125 ° C, and permanent seals are obtained at approximately 160 ° C. Other suitable films for this application include those described in U.S. Patent Applications. Nos. 5,849,843; 5,998,019; 6,083,587; 6,297,046; 5, 139, 831; 5,577,369, and U.S. Patent Application No., 20003/0077466 A1, which are hereby incorporated by reference in their entirety and form a part hereof. The container 10 is typically formed by placing one or more sheets of polymeric film forming the first side wall and the second side wall 14 in mechanical agreement at their peripheral portions and sealing their periphery 13 so as to form a fluid-tight bag. The sheets are typically sealed by heat sealing, radio frequency sealing, heat transfer welding, adhesive sealing, glued by. solvent, and ultrasonic or laser welding. The extrusion by blowing. It is another method that can be used to prepare the bag. Blown extrusion is a process that provides an extrudate moving tube that leaves the extrusion die. The air under pressure inflates the tube. The longitudinal ends of the tube are sealed way to form the bag. The blown extrusion only requires seals along two peripheral surfaces, in which the single or multiple sheet registration method requires seals along one, three or four peripheral surfaces to form the bag. Peelable Seal The peelable seal 22 is preferably formed by heat sealing, but may be made by any of the aforementioned sealing or welding methods, or by any other suitable method. The peelable seal 22 is peelable in the sense that it can be peeled off by hand pressure to separate the first side wall 12 and the second side wall 14 so as to allow fluid communication between the first chamber 18 and the second chamber 20, with which the components contained in them are mixed. The peelable seal 22 is peeled off eg by grasping the first side wall 12 and the second side wall 14 of the container 10, and then separating them, or by squeezing or pressing the first side wall 12 and second side wall 14 so as to force the fluid present in the chambers 18 and 20 against the peelable seal 22 with sufficient force to separate the peelable seal 22. The peelable seal 22 is strong enough to withstand external stresses without the occurrence of a peeling by the usual squeezing during handling, embarkation or accidental falls. In a preferred embodiment of the invention, the peelable seal it will have an activation force of the descortezamiento that falls within the range of approximately 3 N / 1 5 mm to approximately 1 5 N / 1 5 mm. The peelable seal may have variable barking activation forces across its length. In a preferred embodiment of the invention, the firing activation force of the first portion 40 of the peelable seal will be greater than that of the second portion 42. This will promote the activation of the second peelable seal portion before the first portion so of ensuring the mixing of any components in the chambers before the enclosure is opened to allow fluid to flow through the inlet 32. In a preferred embodiment of the invention, the trimming activation force of the first portion 40 of the peelable seal 22 is about 1 N / 1 5 mm to about 5 N / 1 5 mm greater than the peel activation force of the second portion 42 of the peelable seal 22. It is desirable that the peelable seal 22 be capable of adhesive release in place of a cohesive release. The adhesive release of the peelable seal means that the first side wall 12 is separated from the second side wall 14 without removing any significant portion of one wall with the other. The release generates a minimum of particles in order to minimize contamination of the components of the chamber 16 with residual particles of plastic material. The peelable seal 22 has edges 70 and 72. The peelable seal 22 is shows in FIGS. 1 and 14 extending in the longitudinal dimension of the container, but could also extend between the lateral edges as shown in FIG. 13. Alternatively, the peelable seal 22 can be contained completely within the first side wall 12 and second side wall 14, and not intersect any part of the peripheral seal 13 (FIG 6). It is further contemplated that the peelable seal 22 may extend from a corner, a side edge, or a longitudinal edge, and terminate elsewhere in the container 10 (FIGS 15 and 17). The peelable seal 2 can be located anywhere between the first side wall 12 and the second side wall 14, depending on the relative sizes of the desired chambers 18 and 20. Chambers 18 and 20 may be filled with a medicament or other components to form therapeutic solutions, which include intravenous solutions, nutrient solutions, drug solutions., intravenous solutions, parenteral solvents, dialysis solutions, pharmacological agents that include gene therapy and chemotherapy agents, and many other fluids that can be administered to a patient. The components can be liquid, in the form of powder, lyophilized tablet, or other suitable form. The components are introduced into the container 10 and chambers 18 and 20 by any conventional means, such as administration through a dedicated access port for each chamber 18 and 20. The edges 70 and 72 of the peelable seal abut the fluid in cameras 18 and 20.

Containers are frequently filled at pressures of up to 60 pounds per square inch (60 psi, 4.2 kg / cm2). After filling with the solution, the container 10 is typically sterilized with steam. Sterilization typically takes place at a temperature of 121 ° C. In FIG. 5 shows a typical force versus displacement graph for a peelable seal 22 having right edges 70 and 72. The axis of the xs of FIG. 5 shows the displacement along the length of the peelable seal 22. The "y" axis shows the force necessary to peel the peelable seal 22 at specific points along its length. Curve 74 is the force vs. displacement curve before steam sterilization. Curve 76 is the force vs. displacement curve after steam sterilization. As can be seen from curve 74 of FIG. 5, a force 77 is required to initiate peeling of peelable seal 2 prior to steam sterilization. This force 77 is the same as the force of plateau 78, which is necessary to propagate the barking after its initiation. As shown in curve 76, after water vapor sterilization, a peak stripping force 80 is required to initiate stripping of the peelable seal 22. The peak stripping force 80 is significantly larger than a plateau force 82 necessary to propagate the barking. The peak peeling force 80 occurs due to sterilization. Sterilization can cause the boiling of the solution in the chambers 18 and 20 of the container 10. The boiling can cause the expansion of the fluids in the chambers 18 and 20, and thereby produces stresses in the first and second side walls 12 and 14, separating them. When a tension is applied to the peelable seal at a temperature above the softening point of the container material, a deformation occurs at the edge seals 70 and 72. The deformation may also take place due to water expansion and / or shrinkage. the material of the container due to crystallization, or in the case of stretched container films, the relaxation of tensions. This deformation reduces the stress concentration at the seal edges, 70 and 72, thereby increasing the force necessary to break the peelable seal 22 to initiate the debarking process. This peak peeling force 80 is detrimental to ease of use. In addition, and due to the variable nature of the causes, the peak peeling force 80 is variable and difficult to control. Some seals 22 may be too easy to activate, peel off during shipping, ordinary handling, or falls. In other seals 22 it may be almost impossible to start peeling by hand. The present invention overcomes these problems by reducing the peak barking force 80 necessary to initiate debarking at the seal edges 70 and 72. It has been found that this is achieved by changing the seal edges 70 and 72, forming a right angle over at least the stamp portion peelable 22 where debarking should begin. This reduces the length of the peelable seal 22 that is exposed to stresses during its exposure to high temperatures during steam sterilization. Therefore, the peak barking force 80 occurs only over limited portions of the peelable seal 22. FIG. 6 shows a cross-sectional view of a peelable seal 90 according to an embodiment of the present invention prior to steam sterilization. The first side wall 92 and the second side wall 94 of a container are sealed in the seal 90. The seal 90 defines the chambers 96 and 98 in the container. FIG. 7 is an enlarged view of the seal 90 of FIG. 6 before steam sterilization. The seal 90 has a sealed area 90, a first seal edge, 102, and a second seal edge, 104. The first seal edge, 102, and the second seal edge, 104, have saw teeth, and have exterior tips 106 and angled columns 108 that extend in angles from and between the outer tips 106. The columns 108 are inserted into the inner points 1 10 whereby they connect to the outer tips 106. Between the outer points 1 10 and the outer points 106 there is a depth 1 12. FIG. 7 shows both the first seal edge 102 and the second seal edge 104 with saw teeth, it is considered that only one or the other of the first edge seal 102 or second edge seal 104 may have saw teeth according to the present invention (FIG 18). It is also considered that the teeth can be presented over the whole of the seal 90 length or only in selected sections. It is preferred that the saw teeth be separated from the peripheral seal 13 of the container 10 in order to allow the peeling of the permanent seal 13. In FIG. 8 a cross-sectional view of seal 90 is shown after steam sterilization performed along line 120 of FIG. 7 which inserts the inner points 1 10. As shown in FIG. 98, an angular connection 122 between the first side wall 92 and the second side wall 94 occurs at the interior points, and is maintained after steam sterilization. FIG. 9 is a graph of forces vs. displacements for the peelable sawtooth seal 90 of one embodiment of the present invention. The x-axis shows the displacement along the length of the seal 90. The y-axis shows the force required to skin the seal 90 at the points along the length of the seal 90. The curve 124 is the force vs. displacement curve before steam sterilization. An initiation force 126 is necessary to initiate propagation. The force increases in an essentially linear manner up to a maximum plateau force 120 to propagate the debarking. In FIG. 9 a curve 130 is also shown showing the force vs. displacement for the peelable seal on sawtooth 90 after steam sterilization. Curve 130 demonstrates the peak peel strength 132. The peak force of debarking 132 is greater than the initiation force 126 before sterilization; however, it is less than a maximum propagation force 134 would need to continue the debarking process. This results in greater ease of use of the container, since less force is required to start the debarking process than with a seal with linear seal edges. During the sterilization, only the outer tips 106 (FIG 7) are subjected to stresses to deformation and not the inner points 1 10 or angular columns 108. The outer points 106 are subjected to tension because the tension of the film is in its maximum at the outer tips 106. Therefore. therefore, the stress concentrations present when the seal 90 is made are reduced only in the outer points 106, and not in the angular columns 108 or inner tips 1 10. Therefore, the stress concentration is retained in the inner tips 1 10. The outer points 106 define an outer zone carrying stresses of the peelable seal 90. The outer points 106 carry the stress caused by sterilization to water vapor. The interior points 1 10 and the angular columns. they define an internal non-tensioning zone of the seal 90. The creation of a stress-bearing zone can also be carried out by seal edges of other configurations, such as a scalloped edge edge (FIGS 20 and 22) or a trapezoidal shaped edge (FIG 21), another polygonal or geometric shape.

The carrier zone of. tensions in FIG. 20 and 22 are the ridges 140 of the festoons 142. The non-stress carrying region includes the gutters 144 and the inclined edges 146 of the festoons 142. The stress-carrying zone in FIG. 121 is created by the flat portions 150 of the trapezoids 152. The non-stress bearing zone includes the interior points 154 and sides 156 of the trapezoids 152. The present invention also considers other seal designs that create a stress-bearing zone and a zone not carrying tensions. In the sawtooth seal embodiment of FIGS. 6 and 7, the first side wall 12 and the second side wall 14 of the container are first separated at the inner points 1 10. The angular connection at the inner points 1 10 further facilitates the separation of the first side wall and second side wall 14 . As a result of that, (FIG.9), the peak barking force 132 is less than the plateau force 134 to propagate the seal 90, which is the sum of the individual forces required to break the seal 90 at the inner points 1 10, angular columns 108 and outer points 106. Since the outer points 106 are a small length compared to the overall length of the seal, the contribution of the points 106 is small when compared to that contributed by the inner points 1 10 and columns 108. this, the plateau force 134 is reduced compared to a peelable seal 90 having linear edges 70 and 72. This allows the provision of various lengths along the length of the seal peelable The forces for the activation of the peelable seal are reduced in the areas of the serrated teeth, which allows the activation of the second portion 42 of the peelable seal before the first portion 40 (FIG 1), It also improves the reproducibility of the force barking peak 132. However, seal 90 is strong enough to protect seal 90 against debarking during normal handling. Similar to the scalloped stamp edges (FIG 20 and 22) and trapezoidal (FIG 21), the side walls of the container are initially separated in the non-stress bearing region such that the peak peel force is inferior to plateau strength. For the saw-tooth seal edge embodiment of FIG. 7, an important factor in reducing the peak peeling force 132, is the depth 1 13 of the saw teeth. The depth 1 12 controls the slope of the curve of the debarking force 130 before reaching the plateau value 134. The depth 1 12 must be large enough to allow separation between the peak barking force 132 and the plateau force 134. The minimum depth to reduce the peak barking force 132 is highly dependent on the values of the plateau sealing force 134, ie, for peak barking forces, a greater depth 1 12 is necessary. The other factors include properties of the materials that make up the container 10, filling volume, filling pressure, and tension that takes place during the process of sterilization. The greater the volume, the greater the initiation force, and the higher the filling pressure, the greater the initiation force. The amount of sawtooth per unit length is also a factor in determining the reduction of the peak barking force 132. The larger the number of saw teeth, the greater the peak barking force 132. A compromise must be made between the barking force and the ability of the seal to withstand normal handling. Experiments have indicated that saw teeth with a 90 degree angle, outer points 196 separated by 8 mm, and a depth of 12 mm by 4 mm achieve an acceptable peaking peak strength 132. Similarly, for modal forms such as the scalloped shape (figures 20 and 22) or trapezoidal shape (FIG.21) for the seal edges, the depth between the stress-bearing zone and the non-stress-bearing zone is to be controlled to balance the strength of barking and normal handling. In another embodiment, the present invention includes a seal 160. FIG. 10 shows a cross-sectional view of seal 160 before sterilization to water vapor-r. The seal 160 includes a first seal 162 and a second seal 164. The second seal 164 is preferably located in a central portion 166 of the first seal 162. The seal 160 separates the chambers 18 and 20 from the container 10. The first seal 162 also has a less barking force than that of the second seal 164. It is preferable that the force of separation of the first seal is of the order of 5 N / 15 mm, while the force of separation of the second seal is of the order of 15 N / 15 mm. The seal 160 is preferably created by heat sealing the first side wall and second side wall 12 and 14, and by varying the temperature along the seal 160, such that the temperature to create the seal 164 is greater than the temperature. of the first seal 162. This causes the first side wall and the second side wall 12 and 14 and the second seal 164 to adhere to each other more in the second seal 164 than the first seal 162. In turn, this requires a greater force to separate the first side wall and the second side wall 12 and 14 in the second seal 164 to the first seal 162. The first seal 162 has a first edge 170 and a second edge 172 that are in contact, each of them, with the fluid in the chambers 18 and 20. FIG. 11 shows a force versus displacement plot for seal 160. Curve 174 shows force vs. displacement before steam sterilization. Curve 176 shows force vs. displacement after steam sterilization. As shown in FIG. 11, the initial peak force 178 of the first seal 162 after the steam sterilization is still lower than the maximum plateau force 180 of the second seal 164. When the sterilization has been carried out, a deformation of the edges will take place. First . and second 170 and 172. This will increase the debarking force at the edges first and second 170 and 172 of the first seal 162. Therefore, even if a peak peeling force at the first and second edges 170 and 172 appears with a value that is three times the plateau value of the first seal 162, it will remain below the peak peeling force required to separate the second seal 164 in the central portion. Therefore, a peak peeling force will not occur at the second seal 164. The seal 160 is created by heat sealing the second seal 164 at a temperature higher than that of the first seal 162. On a similar principle, in another embodiment, shown in the FIG. 132, a seal 180 has a gradient of peel force along the width of seal 180. Seal 180 has first and second edges 182 and 184, and a central portion 186 between first and second edges 182 and 184. Force barking at the first and second edges 182 and 184 is lower, preferably three times smaller, than the barking force at the central portion 186. As with seal 160 described above, seal 180 is created by a heat seal that has a temperature gradient across its width, greater in the middle and lower at the edges. A gradient may be obtained, for example, by a matrix having heating elements separated by a layer of insulating material, and where the temperature of the central heating element is greater than at the edges. Therefore, when a peak peeling force occurs at edges 182 and 184, which remains below the peeling force in the central portion 186. The peeling force at the edges 182 and 184 is preferably 5 N / 15 mm, and in the central portion 186 is approximately 15 N / 15 mm. In this way, even if the edges 182 and 184 of the seal 180 undergo an increase of three times the barking force, it remains equal to or lower than in the central portion 186. Therefore, no peak peeling strength is present. . It is also possible to vary the activation force of the debarking seal along the length of the peelable seal by varying the width of the seal along its length, as shown in FIG. 23. The wider seal portions 187 will be activated at greater forces than the thinner sections 188. In the embodiment of FIG. 23, the wider seal portion 187 is positioned in the vicinity of the administration port, and the weaker seal portion 188 is positioned distally of the administration port so as to ensure that the mixing of the entire contents of the chambers by the activation of the thin sections 188 takes place before the activation of the wider seal portion 187. It is also possible to vary the resistance of the debarking of the seal by varying the sealing temperature along the peelable seal, increasing the resistance of the peelable seal when the temperature increases, assuming of course that the temperature is not so high as to damage the film.

In another embodiment shown in FIG. 24, the peelable seal is created with a textured seal matrix to create a pattern 1 89 on the surface of the side walls along the peelable seal. Pattern 189 has individual elements 1 91. The size, shape, texture and density of the individual elements can influence the resistance of the peelable seal. The greater the height or depth of the elements, the weaker the resistance of the peelable seal will be. The higher the density per unit area of the elements, the lower the resistance of the peelable seal. The elements may be protuberances extending from the flat surface of the side wall, or they may be indentations extending from the flat surface in a planar direction opposite the protuberances. The pattern shown in FIG. 24 has an increasing density of elements with increasing distances from the closure assembly. This is to ensure that activation of the peelable seal takes place at a remote site of the closure assembly to ensure mixing before delivering the mixed content to the patient. Closing Assemblies FIGS. 1 and 2 show the closure assembly 15 including the conduit 30 having an inlet 32 and an outlet 34 with a closure 40. The closure can be opened or activated with respect to the pressure in the chamber, or can be activated by the provision of fluid under pressure from outlet 34 to inlet 34 at the inlet and through the conduit. In a preferred embodiment of the invention, The closure will be positioned within the chamber 16 and activated by the fluid in the chamber. This activation technique uses the fluid flowing along a different trajectory of the path 31 of the conduit. In a preferred form of the invention (FIG 25), the conduit is an assembly of a membrane tube 2090 concentrically mounted within a port 190 tube. The port tube / membrane tube assembly has a portion of the tube of port extending into the chamber 16 and a portion of the membrane tube extending outwardly from the end seal outside the container 10. The side walls 12, 14 are fixed to an exterior surface of the port tube, typically by heat sealing . In a preferred form of the invention, the port tube 190 is a multilayer structure and more preferably has a first layer 192 and a second layer 194. The first layer 192 should be made of a non-PVC material that is capable of be sealed to the side walls 12, 14 of the container 10, and preferably sealed to the side walls 12, 14 of the container 10, and preferably sealed by radio frequency sealing techniques, but other techniques such as sonic welding, sealing could be used by induction of thermal transfer, and the like, without departing from the scope of the present invention. In a preferred embodiment of the invention, the first layer 192 is a polymer blend of: (a) from about 25% to about 50% by weight, and more preferably, from about 30% to about 40%, of the first layer a first polyolefin selected from the group consisting of polymers containing propylene; (b) from about 0% to about 50% by weight, and more preferably from about 5% to 40% by weight, of the first layer is a second polyolefin of an olefin-containing polymer or copolymer and more preferably is a ethylene-α-olefin copolymer; (c) from about 0% to about 40% by weight, and more preferably from about 10% to about 40% by weight, of the first layer is a radio frequency sensitive polymer selected from the group consisting of polyamides, ethylene copolymers and acrylic acid, copolymers of ethylene methacrylic acid, polyimides, polyrethanes, polyesters, polyureas, ethylene vinyl acetate copolymers with a content of vinyl acetate comonomer from 18% to 50% by weight of the copolymer, copolymers of ethylene and methyl acrylate with a content of methyl acrylate comonomer from 18% to 49% by weight of the copolymer, ethylene vinyl alcohol with a vinyl alcohol comonomer content of 15% to 70% mole percent of the copolymer; and (d) from about 0% to about 40% by weight, and more preferably from 10% to about 40% by weight, of the first layer is a thermoplastic polymer. A particularly suitable mixture for the first layer 192 of the port tube is a four component mixture having the following components by weight: approximately 10% by weight. about 40%, and more about about 30%, is a dimer fatty acid polyamide, from about 0% to about 50% and more preferably still from about 0% to about 10%, is a polyethylene of ultra low density, about 25% to about 50%, and more preferably still about 30% to about 40%, is a polypropylene and from about 10% to about 40%, and more preferably still about 30%, is a styrene-ethylene block copolymer - butylene styrene with a maleic anhydride functionality. The second layer 194 of the port tube 190 is a non-PVC containing material that is capable of being solvent adhered to the membrane tube 200. In a preferred embodiment of the invention, the second layer 194 is a mixture of multiple components of the following components by weight: from about 25% to about 55%, and more preferably from about 33% to 52%, is a thermoplastic elastomer, from about 20% to about 45%, and more preferably from about 25% to about 42%, is a polyester and polyether block copolymer, of about 0% to about 15% and more preferably from about 5% to about 12% by weight of the second layer, is an ethylene copolymerized with lower alkyl vinyl esters and preferably vinyl acetate, from about 0% to about 10% by weight. weight and more preferably of about 1% to about 5% by weight of the second layer, is a propylene-containing polymer, and from about 0% to about 35% by weight, is a polymer selected from the group consisting of ABS block copolymer (acrylonitrile butadiene styrene) ), styrene ethylene butylene copolymer, styrene acrylonitrile copolymer and olefin or polymers containing cyclic olefin and bridged polycyclic olefin. A particularly suitable mixture of the second layer 194 of the port tube is a five-component mixture having from about 33% to about 35% SEBS (Kraton 1660), from about 25% to about 29%, of block copolymers. polyester and polyether (Hytrel), from about 5% to about 9% EVA, from about 1% to about 3%, of polypropylene and from about 28% to about 32%, of ABS. Another suitable mixture of the second layer 194 of the port tube is a four component mixture having from about 48% to about 52%, of SEBS, of about 36% to about 42%, of polyether polyester block copolymer, of about 8% to approximately 12%. of EVA, and from about 1% to about 4%, of polypropylene. As shown in FIG. 25, the first layer 192 has a greater thickness than the second layer 194. In a preferred embodiment of the invention, the first layer will have a thickness of about 15 thousand to about 40 thousand, and more preferably from about 20 thousandths to about 30 thousandths. The second layer 194 will have a thickness of about 2 mils to about 12 mils and more preferably still about 5 mils to about 10 mils. The membrane tube 200 should be made from a material that does not contain PVC, and should be capable of bending, preferably by solvent bonding techniques, to the port tube 190. In a preferred embodiment, the membrane tube 200 is a multilayer structure. The membrane tube 200 has an outer layer 202 and an inner layer 204. The outer layer 202 is of a material selected from the same materials as those indicated for the second layer 194 of the port tube. Similarly, the inner layer 204 of the membrane tube 200 is selected from the same materials as the first layer 192 of the port tube 190. A particularly suitable inner layer of the tube membrane is a mixture of 4 components by weight of the inner layer 204 that varies slightly with respect to the first most preferred layer of the port tube. The components are by weight of the inner layer 204 as follows: 40% polypropylene, 40% ultra-light density polyethylene, 10% polyamide or 10% SBS. However, it should be understood that the inner layer 204 of the membrane tube could also be selected therebetween. components and weight ranges that the aforementioned for the first layer of the port tube. In a preferred form of the invention, the outer layer of the membrane tube 200 should have a thickness of about 15 thousandths and more preferably from about 20 thousandths to about 30 thousand. The inner layer 204 of the membrane tube 202 should have a thickness of about 2 mils to about 12 mils, and more preferably from about 5 mils to about 10 mils. FIG. 26 shows an alternative embodiment of the membrane tube having three layers. In addition to the outer layer 202 and inner layer 204 shown in FIG. 25, FIG. 26 shows an intermediate layer 210 interposed between them. The intermediate layer 210 is preferably a thermoplastic elastomer and more preferably a modified styrene-ethylene-butadiene-styrene block copolymer sold by the Shell Chemical Company under the product designation KRATON G2705. The intermediate layer 210 may also be a blend of about 99% to about 70% of a thermoplastic elastomer and about 1% to about 30% of a propylene-containing polymer. And in yet another preferred form of the invention (FIG 27), the port tube 190 is a multilayer structure and more preferably has a first layer 192 and a second layer 194. The first layer 192 should be made of a material that does not contain PVC that is capable of being sealed to side walls 12 and 14 of container 10. In a preferred embodiment of the invention, first layer 192 is a polymer blend of (a) of about 25. % to about 50%, more preferably from about 30% to about 40%, by weight of the first layer, is a first olefin selected from the group consisting of polypropylene and polypropylene copolymers; (b) from about 0% to about 50%, more preferably from about 5% to about 40% by weight of the first layer, is a second polyolefin of a polymer or copolymer containing α-olefin and more preferably is a copolymer of ethylene and α-olefin; (c) from about 0% to about 40%, more preferably from about 10% to about 40% of the first layer, is a radio frequency sensitive polymer, selected from polyamides, ethylene acrylic acid copolymers, ethylene copolymers and methacrylic acid, polyimides, polyurethanes, polyesters, polyethers, ethylene vinyl acetate copolymers with a content of vinyl acetate monomer from 12% to 50% by weight of the copolymer, ethylene copolymers and methyl acrylate with a content of methyl acrylate monomer from 12% to 40% by weight of the copolymer; ethylene vinyl alcohol with a vinyl alcohol monomer content of 12% to 70% in mole percent; and (d) from about 0% to about 40%, more preferably from about 10% to about 40% > , by weight of the first layer, is a thermoplastic elastomer. The second layer 194 of the port tube 190 is a non-PVC containing material that is capable of solvent bonding to the membrane tube 200. In a preferred embodiment of the invention, the second layer 194 is a thermoplastic elastomer or a mixture of elastomers. thermoplastics in an amount by weight - from about 80% to about 100% and a propylene-containing polymer of from about 10% to about 20% by weight of the second layer 194. It is also desirable, but optional, that the second layer 194 is Soften slightly at autoclave temperatures so that when the assembly of port tube and membrane tube is steam sterilized, the port tube will adhere more closely to the membrane tube. As shown in FIG. 27, the first layer 192 has a greater thickness than the second layer 194. In a preferred embodiment of the invention, the first layer will have a thickness of about 15 thousandths to about 40 thousandths and more preferably about 20 thousandths to about 30 thousandths. The second layer will have a thickness of about 2 mils to about 10 mils, and more preferably about 3 mils to about 7 mils. The membrane tube 200 should be made of a material that does not contain PVC and should be able to adhere to the port tube 199, preferably by the use of size gluing techniques. Solvent bonding is well known in the art. Solvent sizing typically includes applying a solvent to a polymeric material to partially dissolve the polymer. While in this dissolved state the dissolved polymer material is placed in contact with a material, such as another polymer, to which the polymer material must adhere. Solvents suitable for solvent bonding of the materials of the present invention include at least the following solvents: cyclohexane, cyclohexanone, toluene, tetrahydrofuran, eumeno, xylenes, diethyl benzene, decalin, tetralin and amyl benzene, to mention a few. Therefore, to join / glue solvent by, the membrane tube 200 to the port tube 190, a portion of the membrane tube 200 that is to be in contact with the port tube is exposed to the solvent, typically by immersion of the Relevant portion of the membrane tube in the solvent. The membrane tube 200 is then pressurized into the port tube where a strong joint is formed. In a preferred form of the invention, the membrane tube 200 is a multi-layer structure having an outer layer 220, a core layer 222 and an inner layer 224. In a preferred embodiment of the invention, the outer layer 220 is a polymer blend of (a) from about 0% to about 60%, more preferably from about 20% to about 55% and more preferably from about 30% to about 50% by weight of the outer layer, is a polyolefin, and: (b) from about 40% to about 100% by weight of the outer layer, is a thermoplastic elastomer. Also, in a preferred form of the invention, the core layer 222 is a blend of polymers of (a) from about 35% to about 100%, more preferably from about 50% to about 90%, and more preferably about 70 % to about 90% by weight, the core layer is a thermoplastic elastomer, and (b) from about 0% to about 65%, more preferably from about 10% to about 50%, and more preferably from about 10% to about about 30%, by weight of the core layer is a polyolefin. Also, in a preferred form of the invention, the inner layer 224 is a blend of polymers of: (a) from about 25% to about 55%, more preferably from about 25% to about 40%, by weight of a layer inside, it is a polyolefin; (b) from about 10% to about 50%, more preferably from about 0% to about 40%, and more preferably from 0% to about 20%, by weight of the inner layer, is a polyolefin selected from polymers or copolymers containing α-olefin and more preferably is a copolymer of ethylene and α-olefin; (c) from about 0% to about 40% by weight, more preferably from about 15% to about 40%, of the inner layer, is a radio frequency sensitive polymer selected from polyamides, ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters , polyureas, ethylene vinyl acetate copolymers with a vinyl acetate content of 12% to 50% by weight of the copolymer, ethylene-methyl acrylate copolymers with a content of methyl acrylate comonomer of 12% to 40% by weight of the copolymer, ethylene vinyl alcohol with a vinyl alcohol comonomer content of 12% to 70% by molar weight of the copolymer; and (d) from about 0% to about 40%, more preferably from about 15% to about 49%, by weight of the inner layer, is a thermoplastic elastomer. In a preferred form of the invention, the outer layer 220 will have a thickness from about 3 mil to about 15 mil, and more preferably from about 3 mil to about 10 mil. The core layer 222 will have a thickness of about 10 thousand to about 35 thousand and more preferably about 10 thousandths about 30 thousandths. The inner layer 224 will have a thickness of about 3 mils to about 15 mils, and more preferably about 5 mils to about 10 mils. Medication Port In the F1G. In general terms, a perspective view of a container 301 having a first end 323 and a second end 324 is shown in broad terms. The container 301 may be peripherally sealed and may have a liquid 305 or other solution in an interior of the container 301. The container 301 may have a port 302 having a first end 318 and a second end 319. The illustrated container 301 is in a usual position for use. More specifically, container 301 may be positioned vertically and may have medication port 302 elevated above a management port 315 in actual use. Additionally, a strap 312 may be provided for eg a hook for hanging the container 301. Referring now to FIG. 29, the port 302 may have a housing 303 which may have a wall 325. It is preferable that the port is a medication port through which a medication can be added or a solution can be removed from the container 301. The housing 303 and the wall 325 can be made of for example rubber, plastic material or any other material generally known to those skilled in the art. Additionally, the housing 303 can be made of a rigid polypropylene which can reduce the risk that a needle 307 (FIG. 32) pierces the wall 325. In addition, the housing 3093 can be made of materials capable of resisting gamma radiation before sterilization as a final stage of the manufacturing process. Materials resistant to gamma radiation they allow a "pre-sterilization" and a reduction of the exposure time in the autoclave. As illustrated in the F IG. 29, wall 325 may be circular. The wall 325 of the housing 303 may have a first end 326 and a second end 327. The end follower 327 of the wall 325 may be integrally formed with the second end 31 9 of the medication port 302. Additionally, the first end 326 of the wall 325 may be integrally formed with a cap 309 in which the cap 309 may be separated from the first end 326, which will be described in greater detail below. The first end 326 of the wall 325 may also have a lip 339 projecting inward towards a center of the housing 303. The lip 339 may be in contact with a septum 304. The lip 339 may also secure the septum. 304 within the housing 303 by friction or, alternatively, the septum 304 may be sealed to the lip 339. The lip 339 of the wall 325 may have an inner circumference 347 and an outer circumference 314, as shown in FIG. 29. The wall 325 may have a height 328 and may have a first circumference 330 at the first end 326 and a second circumference 332 at the second end 327. Additionally, the first circumference 330 at the first end 326 of the wall 325 may be smaller than the second circumference 332 at the second end 327 of the wall 325. The circumference more small 330 on the first end 326 of the wall 325 may result in the wall 325 being hammered. More specifically, a taper 331 may result in the wall 325 that slopes inward toward the center of the housing 303. The septum 304 of the medication port 302 may be located within the wall 325 of the housing. Additionally, the septum may be in contact with an interior wall 350 of the housing 303, as shown in FIG. 30. Septum 304 can be made, for example, of rubber, plastic material or any other material generally known to those skilled in the art. Additionally, the septum 304 can be made of a polyisoprene material that can allow resealing of the septum 304 after piercing the septum 304 by, for example, the needle 307. As illustrated in FIG. 29, the septum 304 may be circular. The septum 304 may have a height 335 and may have a first circumference 336 and a second circumference 337. Additionally, the septum 304 may have a first end 333 and a second end 334. The first circumference 336 at the first end 333 of the septum 304 , may be smaller than second circumference 337 at second end 334. Smaller circumference 336 at first end 333 may result in septum 304 tapering. More specifically, a tapered wall 338 may result as shown in FIG. 29, in which an opening in an upper side of the septum 304 is larger than in a center of the septum 304. The first end 333 of the septum 304 may be in contact with the lip 339 of the wall 325. The lip 339 may secure the septum 304 in place within the housing 303, and may provide a hermetic seal to the septum 304. liquids between the septum 304 and the wall 325 of the housing 303. The septum 304 may also have a target area 316 that can assist a health care provider or another person to insert a needle 307 into the septum 304 for example. Of course, it is possible to use a cannula or other object to pierce the septum 304. The target area 316 can also be colored, for example red, to form a contrast with another color, for example, black, of the housing 303. The use of Different colors may result in target area 316 becoming more visible and differentiable to the health care provider or to another person. As also illustrated in FIG. 29, a recess 321 may be located within a target area 316 of the first end 333 of the septum 304. A cavity 321 may assist the health care provider or another person in providing a location of reduced strength for inserting the needle 307 through the septum. 304. The target area 316 may also have a slit 354 in place of, or in addition to, a cavity 321. A cavity 321 can be formed by an inner wall 308 in the targeted area 316 of the septum 304. More specifically, the wall 308 may have a first circumference 351 in the first end 333 of the septum and a second circumference 352 in a valley 353 within the septum 304. The first circumference 351 in the first end 333 of the septum 304 may be greater than the second circumference 352 in the valley 353 in the septum 304. The difference in the circumferences may result in the inner wall 308 being tapered. The health care provider or another person can pierce the septum 304 to establish fluid communication with the liquid 305 in the container 305. A support ring 317 can support the septum 304 when an object, for example the needle, is pressed down on the septum 304. As illustrated in FIG. 29, the support ring 317 may resemble, for example, a ring. More specifically, when the person providing medical care, or another, inserts an object through the septum 304, a pressure is exerted on the septum 304. The support ring. 317 may allow the pressure to be diverted from the outer periphery of the septum 304 onto the support ring 317. As a result, the septum 304 may be able to withstand a greater pressure with the support ring than without the support ring 317 The support ring 317 can be made of, for example, rubber, plastic material or any other material generally known to those skilled in the art. The support ring 317 may be circular and may have a first outer circumference 344, a second circumference outer 349, and inner circumference 345. Additionally, support ring 317 may have a first end 340 and a second end 341. The first outer circumference 344 may be on the first end 340, and a second outer circumference 349 may be on the second end 341. The first outer circumference 344 may be larger than the second outer circumference 349. As a result, the ring Support 317 can taper down. More specifically, the support ring 317 may have a tapered 348. The first outer circumference 344 and the second outer circumference 349 of the support ring may be in contact with the inner wall. 350 of the housing 303, as shown in FIG. 30. The support ring 317 may also have a height 342 which may be less than the height 328 of the wall 325. The inner circumference 345 of the support ring 317 may form a hollow interior area 343 through which the needle 307 or another object may extend after piercing the septum 304. The first end 340 of the support ring 317 may be in contact with the second exterior 224 of the septum 304. Additionally, the second end 341 of the support ring 317 may be in contact with a lip 313 in the container 301. The housing 303 may also have a cover 309 that may be made, for example, of rubber, plastic material or any other material generally known to those skilled in the art. The cover 309 of the housing 303 may have a coating 311 having a circumference 346. The lid 346 may also have a ring handle 310. As illustrated in FIG. 29, the lid 31 1 and the ring handle 310 can be circular. The ring handle 310 of the lid 309 may have a hollow opening 306 through which a user may insert eg a finger or a hook. The cover 31 1 of the lid 309 may also have a separation line 320. The separation line 320 may be a perforation, a grooved line or another line of weakness formed between the cover 31 1 and the lip 339 of the wall 325. This separation line 320 may be formed on the circumference 346 of the lid 31 1. More specifically, the separation line 320 can provide a circumferential point at which the cover 31 1 can be removed from a remainder of the housing 303. The cover 31 1 can be integrally formed with the ring handle 310 by a connector 322 such as it is generally shown in FIG. 29. The connector 322 can be secured to the lid 31 1, and the ring handle 310 in such a way that a debarking force can break the separation line 320. In FIG. 30 illustrates a mode of medication port 302 of the present invention with lid 309 secured to wall 325 of housing 303. More specifically, in FIG. 30 the medication port 302 is illustrated before the removal of the cap 309.

When the cap 309 is on the housing 303, the cap 309 can protect the septum 304 and can create a sterile environment for the septum 304 by sealing the septum against the surrounding environment. More specifically, when the lid 309 is secured to the wall 325 of the housing 303, dust, pathogens and other harmful substances can not access the septum 304 located within the housing 303. Additionally, when the cover 309 is in its sealed position, the septum 304 can be protected against physical damage. The cap 309 can prevent accidental damage that could otherwise occur in the septum 304 if the septum 304 is not protected. FIG. 31 illustrates one embodiment of the present invention, the cap 309 of the medication port being partially removed. The ring handle 310 of the lid 309 can be lifted, for example, by a user's finger or by means of a hook. When the user pulls on the ring handle 310, the separation line 320 may break and may allow the user to remove the lid 309. When the lid 309 has been removed, the septum 304 may be exposed. With the cover 309 removed, the septum 304 may be ready for use by penetrating the septum 304, for example, through the needle 307. In FIG. 32 illustrates an embodiment of medication port 302 of the present invention, with lid 309 removed from wall 325 of housing 303. FIG. 32 also Lustrates the needle 307 inserted through the septum 304 in order to provide a fluid communication path with the liquid 305 within the interior of the container 301. Septum 304 can be pierced by needle 307 or cannula (not shown). The needle 307 or other object can pierce the septum 304 through the targeted area 306 in the septum 304. The needle 307 or other object can then pass through the hollow interior 343 of the support ring 317. After the needle or other object has been inserted into the container 301, it is possible to add the container or remove it from the container 301, as necessary. Access Member In FIG. 33 a peelable seal container 400 having an access device 402 associated with it is shown. The access member has a piercing cannula 404 which defines a fluid path 406 therethrough, a drive member 408 for moving the cannula 404 from a deactivated position in which the piercing cannula 404 has not pierced a side wall from the container (FIG.33) to an activated position (FIG.34) in which the cannula pierces a side wall of the container, a housing portion of the fluid pipe 410 and a pipe 412 connected to the housing portion 410. A suitable access device 402 has been described in United States Patent Document No. DI-5805, which is hereby incorporated by reference in its entirety and is hereby incorporated by reference. In FIG. 35 another modality of a container is shown of peelable seal 440 'having a fluid conduit 442 between the first and second chambers, 444, 446. The fluid conduit 442 has opposite ends that have fluid outlets 448 with a peelable seal 450 formed from the side walls placed therein. it is sealed on the outlets 448 for the fluid. The upper or lower chamber can be pressed to open the seal on any of the openings to allow the contents of the chambers to mix. Use of a Dual Chamber Peelable Seal Container In FIGS. 36-38 a sequence of activation of a peelable seal is shown. FIG. 36 shows a layer structure 230 / formed from the first wall having its flat surface in contact with a flat surface of the second wall so as to define a fully rolled state. FIG. 37 shows a portion of the first wall 12 that is lifted from the second wall 14 so as to define a partially delaminated state. Finally, FIG. 38 shows the wall 12 completely disconnected from the wall 14 to define a fully delaminated state or a fully open state. As discussed in the foregoing (FIG.1), the first portion 40 of the peelable seal has a higher peelable seal activation energy than the second portion 42. To activate the container shown in FIG. 1, it is only necessary to press one of the side walls to apply a fluid pressure to the peelable seal 22. When sufficient pressure is generated the second portion 42 of the The peelable seal is delaminated, with which a fluid path is created from the first sub-chamber 18 to the second sub-chamber 20, thereby allowing the contents to mix. During the proper mixing of the components the container is pressed again to generate sufficient pressure to activate the first portion of the peelable seal to open the closure so as to place the fluid communication of the conduit with the contents of the chamber. The present invention considers having a second closure fixed to the assembly to be perforated or activated to extract the fluid from the conduit. These closures are well known in l .V containers. and CAPD containers, and are typically associated with fluid administration assemblies. Method for Manufacturing and Filling a Dual Chamber Container The container 10 is manufactured by standard heat sealing techniques. A separate roll of raw material separated from the side wall material is passed through a packaging machine in which the side walls have peripheral edges placed in mechanical agreement. Prior to sealing, the longitudinal end seams, a closure assembly 15 is inserted between the walls 12 and 14 and heat sealed in place. The seal pelab.le 22 can be formed before, during or after the permanent seal, and is preferably made under thermal conduction sealing techniques. The welding matrix for the peelable seal can have different temperatures and shapes than along its length- to achieve the desired peelable seal. It should be understood that there are several changes and modifications in the forms of modality just described that will be evident for people with expertise in the art. Said changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its anticipated advantages. Therefore, our intention is that these changes and modifications are covered by the attached claims.

Claims

CLAIMS 1. An assembly for the transport of flowable materials, comprising: a conduit having a wall defining a first path for transporting flowable materials and having an entrance to the path and an exit from the path; and a multilayer structure having a first continuous material and a second continuous material connected together along an interface close to the inlet, the multilayer structure is capable of moving from a sealed position to an activated position in response to materials delivered under pressure to the structure along a second path different from the first path to allow flowable materials to enter the entrance. The assembly of claim 1, characterized in that the multilayer structure is attached to the conduit. The assembly of claim 2, characterized in that the multilayer structure has a fastening section and a sealing section, the fastening section having the conduit inserted between the first layer and the second layer, and wherein the section The sealing material has the first continuous material fixed to the second continuous material in a fluid-tight seal on the inlet. The assembly of claim 3, characterized in that the first continuous material is connected to the second material Continue along a peelable seal in the sealing section. The assembly of claim 4, characterized in that the peelable seal allows the adhesive release of the first continuous material from the continuous material material, 6. The assembly of claim 1, characterized in that the first continuous material and the second continuous material are able to form a peelable seal and a permanent seal. The assembly of claim 6, characterized in that the first continuous material comprises a polymer system in binder phase. The assembly of claim 7, characterized in that the binder polymer is a polyethylene homopolymer, a copolymer of ethylene and α-olefin, a copolymer of polyethylene, a homopolymer of polypropylene, or a copolymer of propylene and the polymer in phase is a random copolymer of styrene and hydrocarbon, a block copolymer of styrene and hydrocarbon, and a copolymer of ethylene and α-olefin. The assembly of claim 4, characterized in that the first continuous material comprises a homophase polypropylene. 10. The assembly of claim 4, characterized in that the peelable seal can be activated by a force within the range of 3 - 30 N / 15 mm. eleven . A closure assembly for a container of flowable materials, comprising: a container having opposite side walls that define a camera between them; and a duct having a portion extending towards the chamber and having a fluid inlet, facing portions of the side walls are connected together along a peelable on entry seal so as to define a closure. The assembly of claim 1, characterized in that the closure is capable of moving from a closed position to an open position in response to a fluid pressure. The assembly of claim 12, characterized in that the fluid pressure can be generated by a fluid in the chamber or by a fluid outside the chamber. The assembly of claim 13, characterized in that the peelable seal divides the chamber into at least two eub-chambers. The assembly of claim 14, characterized in that the peelable seal has a first portion proximate the closure having first force that activates the peelable seal and a second distal portion from the closure having a second peelable seal activating force. , wherein the second peelable seal activating force is smaller than the first peelable seal activating force. The assembly of claim 15, characterized in that the difference between the first peelable seal activating force and the second peelable seal activating force is greater than about 1 N / 15 mm and less than about 5 N / 15 mm. 17. A container for flowable materials, comprising: a pair of opposite side walls defining a chamber therebetween, facing portions of opposite side walls are sealed together along a peelable seal so as to define by. at least two separate sub-chambers; and a duct having a portion extending into the interior of the chamber and having a fluid inlet, the fluid inlet is closed by a portion of the peelable seal. The container of claim 17, characterized in that the peelable seal is movable from a closed position to an activated position. The container of claim 18, characterized in that the peelable seal is movable from a closed position to an activated position in response to the fluid pressure applied to the peelable seal. The container of claim 19, characterized in that the peelable seal has a first portion near the inlet having a peelable seal activating force and a second portion distal with respect to the closure having a second peelable seal activating force, that the second activating force of the peelable seal is inferior to the first activating force of the peelable seal. twenty-one . The container of claim 17, characterized in that the conduit is generally circular in cross-sectional shape and it has an axis that extends in a direction parallel to the peelable seal. 22. The container characterized in that the conduit is generally circular in cross-sectional shape and has an axis extending in a direction transverse to the peelable seal so as to define an angle. 23. The container of claim 22, characterized in that the angle is an obtuse angle. 24. The container of claim 22, characterized in that the angle is an acute angle. 25. The container of claim 22, characterized in that the angle is approximately a right angle. 26. The container of claim 17, characterized in that the peelable seal has a length, the peelable seal having a portion of sawtooth along at least a portion of its length. The container of claim 17, characterized in that the side walls are connected together along a permanent seal around the periphery of the container and the peelable seal extends between two points of the periphery. The container of claim 27, characterized in that the peelable seal has a first edge and a second edge, and the sawtooth portion is located in one of the first edge or second edge. 29. The container of claim 27, characterized in that the peelable seal has a first edge and a second edge, and a portion with saw teeth is located both on the first edge and on the second edge. 30. The container of claim 17, characterized in that the sawtooth portion is separated from the periphery. 31 The container of claim 27, characterized in that the portion with saw teeth includes internal points, external points, angular columns that connect the interior and exterior points, and a depth between the outer points and the interior points. 32. The container of claim 27, characterized in that the first side wall and the second side wall of the container form an angular joint at the interior points. 33. A method for mixing two components stored separately in sub-chambers of a dual container, characterized in that it comprises: providing a fluid container having a first chamber, a second chamber, a peelable seal that divides the first chamber with respect to. the second chamber, and a device for fluid access having a fluid inlet positioned inside the chamber, the fluid inlet being sealed in a closed position by a first portion of the peelable seal; activating a second portion of the peelable seal to provide a fluid path between the first chamber and the second chamber without activating the first portion; and activate the first portion of the peelable seal to open the fluid inlet. 34. A multi-chambered container characterized in that it comprises: a side wall defining a fluid chamber, a portion of the side wall being sealed on itself so as to divide the fluid chamber into at least two sub-chambers as length of a peelable seal; and an access member fixed to the side wall for piercing the side wall in order to provide access to the fluid chamber.