WO1993021890A1

WO1993021890A1 - Vessel having a plurality of chambers

Info

Publication number: WO1993021890A1
Application number: PCT/JP1993/000558
Authority: WO
Inventors: Fujio Inoue; Masamitsu Izumi; Shigetoshi Kashiyama
Original assignee: Otsuka Pharmaceutical Factory, Inc.
Priority date: 1992-05-03
Filing date: 1993-04-28
Publication date: 1993-11-11
Also published as: JP3079403B2; ATE182464T1; HU9400012D0; CA2112661A1; ES2133399T3; PT101262B; TW216768B; HU216406B; CN1082881A; NO934910D0; PT101262A; PH31343A; EG20103A; AU654442B2; FI935972A0; EP0639364A4; HUT68420A; CN1065742C; DK0639364T3; RU2103987C1

Abstract

A vessel having a plurality of chambers for use mainly in the medical field, wherein the interior of the main body of a flexible plastic vessel is partitioned into a plurality of chambers by use of a partitioning means permitting suitable communication between the chambers, out of respective vessel portions of the main body of the plastic vessel, which constitute the plurality of chambers, at least one vessel portion has no cover and at least another vessel portion has a cover, said cover covering the peripheral surface of said vessel portion through a tightly sealed space portion and being formed of flexible film having moisture-proof and gas barrier properties, so that the easily disposable vessel having the plurality of chambers, which is inexpensive and high in quality and performance can be provided.

Description

Specification

Double room container

Technical field

The present invention mainly includes a multi-chamber container used in the medical field, more specifically, a plurality of chambers for accommodating a liquid agent, a powder agent, or a solid agent, and each chamber is partitioned by a partitioning means capable of communicating as appropriate. Flexible double-chamber containers made of plastic.

Tricks te

Conventionally, flexible plastic multi-chamber containers having a partitioning means that can be used in the medical field have a tendency to transmit moisture and gas in a very small amount, and therefore have a hygroscopic time-lapse property. When a chemically unstable drug such as an antibiotic and a solution such as a saline solution or a dextrose solution or a solution such as a diluent are stored separately in a flexible plastic multi-compartment container. For this purpose, it is necessary to put the multi-chamber container together with a desiccant in an expensive moisture and gas barrier outer bag. However, since the desiccant absorbs the moisture of the liquid, the moisture-absorbent drug cannot be dried sufficiently, and the liquid concentrates. Conventionally, it has been difficult to separate a drug such as an antibiotic and a liquid into a flexible plastic double-compartment container and store it. Had not been done.

Therefore, drugs such as antibiotics that are unstable over time should be stored in a container such as a vial that is impermeable to moisture and gas, and dissolved in physiological saline solution or putu sugar solution that is stored separately when used. Liquid or diluent mixed with or dissolved and administered to patients ο

However, in the above method, the operation is complicated, and there is a risk of bacterial contamination during the operation. Containers that have been combined together via a puncture needle have been developed (for example, see Japanese Patent Application Laid-Open No. 2-12777). This container has the advantage that the mixing operation can be performed aseptically on the stool, but at the time of disposal, it takes a lot of time to separate the glass pial, the flexible container and the communication device, and the disposal process Therefore, there is a problem that the demand for easy disposal of medical waste currently being closed cannot be satisfied.

Furthermore, in the case of a multi-chamber container containing another oxidizable drug, for example, an amino acid solution containing tryptophan and a sugar / electrolyte solution (for example, see Japanese Patent Publication No. 63-250550). Must be stored in expensive water and gas barrier outer bags with oxygen scavengers to prevent aging. Absent. In this case, since a chemical agent (sugar and electrolyte solution) that does not need to act as an oxygen absorber is also added, the space capacity is increased, and an oxygen absorber having a large oxygen absorbing capacity is used, or A large amount of oxygen scavenger must be used, and a large amount of water and gas barrier outer bags are required, resulting in high costs.

Disclosure of the invention

An object of the present invention is to provide a flexible plastic double-compartment container which can be used for storing and preserving a liquid, a powder or a solid having hygroscopicity or oxidizability.

Another object of the present invention is to provide a multi-chamber container of this type which uses less expensive water and gas barrier film and is therefore inexpensive.

Yet another object of the present invention is to provide such a multi-chamber container which does not need to have a glass vial and is therefore easy to dispose of.

Still another object of the present invention is to shut off only a chamber containing a liquid, powder, or solid chemical having hygroscopicity or oxidizability from external moisture and oxygen, and enclose a deoxidizer and a desiccant. An object of the present invention is to provide a multi-chamber container capable of preventing oxidation and moisture absorption of the substance without performing the above-mentioned steps.

The present invention provides a liquid preparation, a powder preparation, Or a multi-chamber container which is provided with a plurality of chambers for accommodating a solid agent and which is partitioned by a partition means capable of appropriately communicating between the chambers, wherein a flexible plastic container body is provided. At least one of the plurality of chambers formed by the container body is covered by a cover whose peripheral edge is sealed so as to form a closed space around the chamber; The cover is made of a flexible film having a moisture and gas barrier, and the communicable partition means is formed by pressing the chamber so as to increase the internal pressure. Provided is a multi-compartment container characterized by being formed of at least one weak seal portion which can be easily peeled off.

In the multi-chamber container of the present invention, in each chamber of the container, a chamber without a cover contains a usual substance, for example, a liquid agent, a powder agent or a solid agent having no oxidizability and no Z or hygroscopicity. The above chamber is not covered with a moisture and gas impermeable cover, so it is inferior in moisture and gas barrier properties. However, since it contains normal substances, the stored contents can be stored for a long time like ordinary plastic containers.

On the other hand, special substances such as oxidizable and / or hygroscopic liquids, powders or solids are stored in the covered room. The plastic container body that forms the above chamber is extremely It has very little moisture and gas permeability inherent to plastic, and is inferior in moisture and gas barrier properties. However, since the cover covering the periphery of the above chamber is made of a moisture and gas impermeable special film, regardless of the lack of moisture and gas barrier properties of the plastic container body, the special substance Can be maintained for a long time without fear of deterioration.

Thus, the multi-chamber container of the present invention, despite being made of a flexible plastic, contains a drug that is hygroscopic and unstable over time, such as an antibiotic, and a liquid such as a dissolving solution or a diluting solution. It can be applied without any hindrance to the intended use.

Further, although the multi-chamber container of the present invention has a gas-impermeable cover made of an expensive special film, the copper is merely provided in a part of the container, so that the cost is high. The use of special films may be small. Thus, the increase in packaging costs can be minimized. Further, since it is not necessary to enclose an oxygen scavenger or a desiccant between the container body and the cover, the cost can be reduced.

Further, in the multi-chamber container of the present invention, the plurality of chambers are separated by the weak seal portion, and the weak seal portion is peeled off by the external pressing force to allow the chambers to communicate with each other. And can be mixed while maintaining sterility. In addition, since the plastic container body and the cover that make up the container are both flexible and easily deformed, they do not need to be separated, and are easier to dispose of than containers made of glass or metal.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is an enlarged vertical sectional view showing a multi-chamber container according to one embodiment of the present invention.

FIG. 2 is a front view of the same.

FIG. 3 is an enlarged sectional view of a portion A in FIG.

FIG. 4 is an enlarged sectional view of a portion B in FIG. 1 ^

FIG. 5 is an enlarged sectional view of a portion C in FIG.

FIG. 6 is an explanatory view showing an example of a preferred method of manufacturing the container of the present invention shown in FIG. 1 in the order of steps.

FIG. 7 is a cross-sectional view of a part of a plastic container main body of a double copy container according to another embodiment of the present invention.

FIG. 8 is a partial cross-sectional view of a cover of a multi-chamber container according to another embodiment of the present invention.

FIG. 9 is a longitudinal sectional view of a multi-chamber container according to still another embodiment of the present invention.

FIG. 10 is an enlarged longitudinal sectional view showing another example of the weak seal portion. FIG. 11 is a diagram for storing or transporting the multi-chamber container according to the present invention. FIG. 4 is a perspective view showing a state where the battery pack is sealed in an outer bag.

FIG. 12 is a longitudinal sectional view of a multi-chamber container according to still another embodiment of the present invention.

FIG. 13 is an explanatory view showing another example of the preferred production method of the container of the present invention in the order of steps.

BEST MODE FOR CARRYING OUT THE INVENTION Various embodiments of the present invention will be described below with reference to the accompanying drawings.

1 and 2 show an example of the embodiment of the present invention of a two weak seal portion type.

According to the present embodiment, as is apparent from FIG. 1, a flexible plastic container main body 1 is provided, and the container main body 1 is provided with an opening 2.

The plastic container body 1 is obtained by welding two superposed flexible plastic films 3 and 3 at the peripheral edge.

The film 3 is not special, and an inexpensive plastic film generally used in the medical field to form a flexible plastic container is used.

As an example of film 3, Fig. 3 shows the outer layer 3a of polyethylene (hereinafter abbreviated as PE), PE and polypropylene. (Hereinafter abbreviated as PP) and an inner layer 3b of the blend are shown.

As shown in FIG. 1, in the plastic container body 1, two weak seal portions 8a and 8b extending in the lateral direction are formed at the intermediate portion in the height direction by applying a welding means.

The weak seal portions 8a and 8b are used to appropriately open the container by using the pressure in the container increased by applying a pressing means or the like, and the welding strength is determined by the welding strength of the peripheral portion of the container body 1. It must be smaller than the wearing strength.

The interior of the plastic container body 1 is divided into two upper and lower chambers 1a and 1b by weak seal portions 8a and 8b. The upper container section 1A forming the upper chamber 1a is provided with a force bar 5 so as to cover the periphery thereof, and the lower container section 1B forming the lower chamber 1b has such a force bar. No power par 5 is provided.

The force pad 5 is composed of a special film 6 having excellent moisture and gas impermeability. As an example of the special film 6, Fig. 5 shows the outer layer 6a.Aluminum processed film such as aluminum film, aluminum vapor-deposited film, etc., which have excellent moisture and gas impermeability, and polyvinylidene chloride and polypropylene ( PP), and a multilayer film in which the inner layer 6b is made of polyethylene. Outer layer 6a, polyvinylidene chloride is polyvinyl alcohol It may be replaced with a silica-deposited film.

As shown in FIG. 1, the cover 5 is composed of two special films 6, 6 arranged so as to cover the periphery of the upper container 1A. Of these, the portion not in contact with the upper container 1A is welded between the films 6, 6, and the portion in contact is welded to the outer surface of the upper container 1A. The lower edge welds 6c, 6c of the films 6, 6 are located between the weak seals 8a, 8b as shown in FIG.

O o

There is a space between the two weak seal portions 8a and 8b, and the space 9 is not substantially sealed. The lower edge 6c of the force bar 5 is welded to the space 9 between the weak seals 8a and 8b. This welding situation is shown in an enlarged scale in FIG. Since the lower edge 6c of the force par 5 is welded to the space 9 between the weak seal portions 8a and 8b, there is a danger of increasing the welding strength of the weak seal portions 8a and 8b during the welding operation. Sex is lost. In the case of a seal type, the lower edge of the cover is welded to the container body 1 on the weak seal, so that the welding strength of the weak seal is not increased or increased as much as possible. However, it is desirable to perform the welding operation under conditions that do not affect easy peelability. Such condition setting depends on the selection of the material of the cover, the welding temperature, and the welding temperature. It is possible by selecting welding conditions such as welding time and welding pressure, but it is quite limited. If two weak seals are used as shown in Fig. 1 and Fig. 4, the lower edge 6c of the cover 5 can be attached to the container body 1 without adversely affecting the welding strength of the weak seals 8a and 8b. Since welding can be performed, there is an advantage that the degree of freedom in selecting the material of the cover and selecting the welding conditions is wider than in the case of a single weak seal portion. Further, the lower edge welded portion 6c of the force pad 5 welded to the space between the two weak seals 8a and 8b is, as is clear from FIG. 4, the respective chambers la and 1b of the container body 1. Is relatively large. As a result, the risk of heat denaturation of the chemicals contained in the chambers 1a and 1b due to heat during the welding operation is alleviated. There are many easily denatured chemicals that have hygroscopicity and easy oxidation, but even those easily denatured without the danger of heat denaturation, the container body at the lower end of the cover 5 Welding to 1 becomes possible. Also, even if an external force is accidentally applied and one weak seal is peeled off, communication between the two chambers can be prevented by the other weak seal.

The upper container 1 A with the cover 5 contains a hygroscopic and / or easily oxidizable powder 10, for example, and the lower container 1 B without power 5 contains, for example, a normal liquid 11. Is contained o The welding temperature during welding of each part is highest at the entire peripheral edge of the plastic container body 1 and the upper edge and both sides of the cover 5, and then at the welding point between the plastic container body 1 and the lower edge of the cover 5. High, weak seals 8a, 8b are the lowest of these. As a result, the welding strength of the weak seal portions 8a and 8b becomes the weakest among the above-mentioned portions.

FIG. 6 shows an example of a preferred method of manufacturing the container of the present invention shown in FIGS. 1 and 2, which is described below with reference to (a) to (e) of FIG.

As shown in Fig. 6 (a), first, two plastic films shown in Fig. 3 are laminated together with the inner layers 3b together, and the three layers are welded at a welding temperature of about 170 to 200 ° C. Make the plastic container body 1 without sealing the periphery. Next, weak sealing portions 8a and 8b are formed in the middle portion of the container body 1 at a welding temperature of about 110 to 130 ° C., and a mouth portion 2 is attached. Then, the container body 1 is divided into an upper container section 1A forming an upper chamber and a lower container section 1B forming a lower chamber.

Next, after filling the liquid material 11 from the unsealed part of the lower container part 1B into the inside, as shown in Fig. 6 (b), seal the unsealed parts of both container parts 1A and 1B, and Perform heat sterilization such as steam sterilization or hot water sterilization.

After the heat sterilization process, as shown in Fig. 6 (c), Forcibly open one side of the upper container 1A under aseptic conditions, and then dry if necessary.

Next, as shown in FIG. 6 (d), the three sides of the cover 5 are welded to the upper container 1 A using the special film shown in FIG. 5 At this time, the lower edge 6c to be welded along the weak seals 8a and 8b is located at an intermediate position between these weak seals, and is set so as not to overlap with the weak seals. At 3 5, welding is performed. One side of the cover 5 is opened like the one side of the upper container 1A.

10 Next, powder 10 such as antibiotics was added to the upper container under aseptic conditions.

The multi-chamber container of the present invention can be obtained as shown in FIG.

When sealing the opening, N is used to remove oxygen in the space. Substitution is preferred. The weak seal portion can be formed, for example, by pressing a heated weak seal portion forming mold against the container body by a cylinder device, and the mold is disposed at a predetermined interval from an electric heater. It can be provided with two ridges whose temperature can be adjusted.

For example, if liquid is stored in container 1A with cover 5 and liquid or powder is stored in container 1B without cover For example, after attaching the mouth part 2 to the container body 1 in the same process as in the above production example, a predetermined substance is accommodated in each of the container parts 1A and 1B, and after filling holes are closed, heat sterilization is performed. . After heat sterilization, the cover 5 may be attached to the upper container 1A, and the side opening of the cover may be sealed.

In the multi-chamber container of the present invention obtained from the production example shown in FIG. 6, the upper container part 1A is made of a plastic film in which the outer layer is made of PE and the inner layer is made of a blend of PE and PP. It is configured to allow very little moisture and gas (eg, oxygen) to permeate. Since the upper container 1A is provided with the cover 5 made of a special film of moisture and gaseous uniformity, the above-mentioned weak point of the upper container 1A is covered by the function of the cover 5. Thus, in the upper container 1A, a hygroscopic and Z- or oxidizable powder can be stored for a long period of time irrespective of whether it is made of plastic. The weak seal portions 8a and 8b, which separate the upper and lower container parts 1A and 1B, are the parts having the lowest welding strength among the welded parts of the respective parts, and therefore press the container part and reduce the pressure in the container. If the pressure is increased, the weak seal portions 8a and 8b are peeled off by this pressure, the two container portions 1A and 1B are in communication with each other, and the liquid material and the powder material contained in the two container portions 1A and 1B are separated. Mix under aseptic conditions to form the desired solution. Examples of the powders of the above examples include hygroscopic, easily oxidizable and easily denatured powders such as antibiotics, anticancer agents, steroids, thrombolytic agents, vitamins and the like. And a solution such as a physiological saline solution and a pseudosugar solution.

As a normal film for plastic containers, besides the multilayer film having the configuration shown in Fig. 3, use a single-layer or multilayer film composed of one or more combinations selected from PE, PP, and their mixed resins. Is also possible. For example, as shown in FIG. 7, the outer layer 31 is composed of linear low-density polyethylene (hereinafter abbreviated as LLDPE), and the middle layer 33 is composed of LLDPE and low-crystalline (or non-crystalline) ethylene / α-polyethylene. And a three-layer film 35 in which the inner layer 34 is made of a mixed resin of LLD Ε and Ρ.

Also, depending on the drug to be enclosed, the drug may interact with the low-molecular-weight substance contained in the LLD used in the inner layer of the inner wall over time, producing a reaction product that adversely affects the patient. There is. Therefore, the LLD used for the inner layer 34 is pretreated at a high temperature and under reduced pressure by, for example, a vent pellet method to remove a low molecular weight substance having about 30 or less carbon atoms to a specific amount or less. The drug and inner layer fill Thus, it is possible to suitably prevent the interaction of the system.

Furthermore, if an appropriate amount of high-density polyethylene (HDPE) is added to each layer of the three-layer film 35 as needed to improve the heat resistance of the film, the temperature can exceed 121 ° C. Thus, a multi-chamber container with excellent molding stability that can withstand high-temperature sterilization such as high-pressure steam sterilization and hot water sterilization can be manufactured.

Special films for the cover include polyvinylidene chloride, polyethylene terephthalate (hereinafter abbreviated as PET), aluminum fluorinolem, ethylene vinyl alcohol copolymer (EVO), It is also possible to use single-layer or multi-layer sheets of the vapor-deposited film. Among them, a silicon vapor-deposited film is transparent and has excellent moisture impermeability and gas impermeability. Therefore, it is preferable to form at least one layer of a sheet.

For example, the outer layer 43 was biaxially stretched as shown in FIG.

PET T. The intermediate layer 44 is silica-deposited PVA, the inner layer 45 is low-density polyethylene (LDPE), and each layer is a three-layer film 46 fixed with urethane-based adhesive resin. Permeable and gas impermeable barrier films can be mentioned.

Here, when welding the plastic container body and the cover, at least the cover must be multilayered in order to improve the welding. It is desirable that the material of the innermost layer of the cover be the same as the material of the outermost layer of the plastic container body. For example, if the outermost layer of the plastic container body is LLDPE, it is desirable to use LLDPE for the innermost layer of the cover.

In the above embodiment, the powder was sealed in the chamber of the container portion covered with the power bar, and the liquid was sealed in the chamber of the container portion not covered with the cover. It is also possible to enclose instead of the agent.

An example of encapsulating a liquid in a chamber of a container covered with a force par, and enclosing a powder in a chamber of another container, such as an amino acid preparation to which cystine or tritophan is added as a liquid, etc. And a sugar or electrolyte as a powder or a mixture thereof.

As an example of enclosing a liquid in a chamber of a container covered with a cover and another liquid in a chamber of another container, for example, cysteine or tributophane are used as the former liquid, respectively. Examples of the added amino acid preparation include a readily oxidizable substance such as an amino acid preparation and a vitamin preparation, and the latter liquid preparation includes a sugar-electrolyte solution.

As another example, the former liquid preparation such as a fat emulsion is used. A liquid oxidizing substance, for the latter liquid agent, is a sugar-electrolyte solution or the like.

Further, it is also possible to enclose a solid agent in one of the chambers of the container and a liquid agent in the chamber of the other container. Furthermore, examples of the above-mentioned powders, liquids, and solids include various other nutrients and therapeutic agents to be administered intravenously or enterally (tube or oral).

In addition, if the substance enclosed in the chamber of the container part covered with the cover has photodegradability, use aluminized film on part or all of the cover to shield the inside from light. You may. In addition, the aluminum processed film used for the cover may be partly or entirely peelable as needed at the time of use.

Further, the above-described embodiment is an example of a two-chamber container enclosing a liquid agent and one kind of powder agent, but can be applied to two or more chambers. Figure 9 shows an example. Inside the cover 5, a container 1A 'having chambers 1a and 1 & ₂ for enclosing two kinds of powders (or a powder and a solid) is arranged. Liquid material 11 is stored in container part 1B without a cover. Not only powders and solids but also multiple chambers for liquids can be provided. Provide a weak seal at the partition between these chambers.o When a liquid material, powder material, or solid material that is easily oxidizable is sealed in the chamber 1a covered with the cover, nitrogen gas, carbon dioxide gas, and argon gas should be filled in the space between the container body 1 and the force par 5. It is desirable to fill an inert gas such as. When a liquid material, a powder material or a solid material having a hygroscopic property is sealed in the chamber 1a, it is preferable that a dry gas such as dry air or dry nitrogen gas is sealed in the space. When the inert gas is sealed, the air in the space is replaced with the inert gas, so that the effect of preventing oxidation is roughly ensured.When the dry gas is sealed, the air in the space is replaced with the dry gas. Since it is replaced, the moisture-proof effect is further ensured.

In this way, by covering the chamber in the container body where moisture proofing and oxidation prevention are required with the moisture and gas impermeable film, the space between the container body and the cover can be further protected by inert gas or drying. By sealing gas or the like, high stability over time of the drug can be achieved without adding an oxygen scavenger and a desiccant in the space as in the related art.

The number of weak seal portions is not limited to two, but may be two or more, or may be one. Further, the weak seal portion does not necessarily have to be a straight line, and for example, may have a V-shape such that the vicinity of the center of the chamber covered with the cover projects. In this way, you can press on one of the chambers by hand during use When a force is applied, the force for peeling off the weak seal concentrates on the V-shaped portion, so that the medicine can be mixed by peeling the weak seal with a relatively small pressing force. However, in this case, there is a risk of inadvertent peeling during storage or transportation of the multi-chamber container, so it is desirable to particularly examine the welding conditions.

In the above-described embodiment, the weak seal portion is formed by a so-called direct welding method in which the inner surfaces of two sheets constituting the container body are directly welded to each other. A so-called multilayer insert film sandwiching welding method may be used in which the multilayer insert film is welded to form a weakly sealed portion while sandwiching the multilayer insert film. Figure 10 shows an example using a two-layer insert film. In this case, ^ 3 is a film for forming a container consisting of a single-layer film or a multilayer film, 18 is a sheet having a strong thermal adhesion to the innermost layer of the above-mentioned film 3, and 19 is the opposite side. This is a sheet having a low thermal adhesive force to the innermost layer of the film 3 and weak seal portions 21a and 21b are formed between them. For example, when the film 3 is a single-layer film of PE or PP, 18 is the same sheet of PE or PP, and 19 is a mixed resin of PE and PP. 21a and 21b are weak seal portions. Insert film is weak seal It may be bisected according to the part. In addition, the cover 12 may be welded over the weak seal portion of the multilayered ink film, but the condition is that the weak sealing property of the container body is maintained. The cover may also be adhered to the container body 5 with an adhesive or an adhesive.

When the multi-chamber container of the present invention is stored or transported, it is preferable that the container be folded in two at the weak seal portions 8a and 8b and sealed in the outer bag 50 as shown in FIG. In this way, by folding in two, unnecessary peeling of the weak seal portion due to heavy pressure due to stacking during storage or external force such as “10 drop” can be prevented.

In addition, as shown in Fig. 12, the mouth 'portion 2' is provided in the chamber 1a 'for containing the powdered drug 10 such as an antibiotic, and the chamber 1b' for containing the drug 11 such as a solution is closed. You may make it. 15 If an opening is provided in the chamber that contains the solution such as the solution, there is a risk that in the case of an emergency, only the solution such as the solution is administered first without performing the mixing operation by mistake. However, as described above, by attaching the mouth 2 ′ to a room containing a powder drug such as an antibiotic, there is an advantage that the above danger can be avoided.

Next, another preferred method for producing the container of the present invention will be described with reference to FIGS. 13 (a) to 13 (j). As shown in FIG. 13 (a), a hole 2a for a mouth portion is formed in a two-layer type plastic film 3 shown in FIG.

Next, as shown in Fig. 13 (b), after the mouth 2 is attached to the hole 2a by applying welding means on the outer layer of the film 3, that is, on the PE side, as shown in Fig. 13 (c). Then, the film 3 is folded around the mouth 2 so that two sheets are stacked.

Next, as shown in Fig. 13 (d), the periphery of the two stacked films 3 is welded at a welding temperature of about 170 to 2 mm, leaving the filling ports 35 and 36 for chemicals and powders. Seal at 0 ° C to obtain plastic container body 1.

The filling port 35 among the filling ports 35 and 36 may be formed in a later step.

Next, as shown in FIG. 13 (e), two weak seal portions 8 a and 8 b which are parallel to each other with an interval portion 39 are provided at an intermediate portion of the container body 1, with a welding temperature of about 110. Formed at ~ 130 ° C. The appropriate width of the weak seal part is about 10 mm for the weak seal part 8b, and about 5mm for the weak seal part 8a.

Next, as shown in Fig. 13 (f), of the upper and lower container parts 1A and 1B separated by the weak seal parts 8a and 8b, the filling port 36 is provided in the lower container part 1B. After filling the liquid material 11 through, both filling ports 35 and 36 are sealed, and high-pressure steam sterilization is performed. Next, as shown in Fig. 13 (g), after completion of the sterilization, the outside of the container body 1 is dried, and the filling port 35 is urged under aseptic conditions to refill the filling port 35. Open, and the inside of upper container 1A is dried and cleaned by blowing clean air through b.

Next, as shown in FIG. 13 (h), the powder 10 is filled under aseptic conditions into the upper container 1A through the filling port 35, and after filling, the filling port 35 is sealed.

Next, as shown in FIG. 13 (i), a power bar 5 is provided using the special film 6 shown in FIG. 5 so as to cover the periphery of the upper container 1A. Preferably, one of the films 6, 6 is transparent and the other is opaque.

When the films 6, 6 are welded to the edge of the upper container portion 1A, the welded portions 6b of the films 6, 6 are formed so that the heat does not substantially reach the filled drug 10. It is preferable to leave an interval of about 5 mm between the upper container 1A and the chamber 1a. For this purpose, the width of the welded portion l A _t the peripheral especially both side portions of the upper container section 1 A (see FIG h) is required to be greater than 5 mm, typically expects the welding width of Fi Lum 6 Is set to about 7 to 10 mm.

In addition, as shown in FIG. 4, the lower edge 6c of the film 6 constituting the cover 5 is provided between the two weak seal portions 8a and 8b. It is welded to the position of the gap 9. The welding temperature is about 150 to 170 ° C when using a transparent film 6, and 130 to 15 when using an opaque aluminized film. Welded at 0 ° C.

As shown in Fig. 13 (i), the cover 5 provided on the upper container 1A is initially partially open on one side, and through this opening 40, the cover 5 and the upper container 1 are opened. After injecting an inert gas or a dry gas into the space 7 between A, the opening 40 is sealed, and as shown in FIG. A chamber container is obtained. In the above manufacturing examples, the optimum temperature range is selected for each welding temperature depending on the material of the film, the setting of the welding strength, and the like, and is not limited to the above-mentioned welding temperature range. is not.

Although several embodiments of the present invention have been described above, the present invention is not limited to such embodiments and can be implemented in various modes without departing from the scope of the present invention. Of course.

Claims

The scope of the claims

(1) A flexible plastic container which is provided with a plurality of chambers for accommodating a liquid agent, a powder agent, or a solid agent, and is partitioned by a partition means capable of appropriately communicating between the chambers. A plurality of chambers formed by the container body, at least one of the chambers is covered with a force bar having a peripheral portion sealed to form a sealed space around the chamber; The other chamber is uncovered, the force par is made of a flexible film having water and gas barrier properties, and the communicable partitioning means is provided in the chamber so as to increase the internal pressure. A multi-chamber container characterized by being formed by at least one weak seal portion which can be easily peeled off when pressed.

2.The weak seal portion according to claim 1, wherein at least two of the weak seal portions are provided at an interval, and an edge of the force bar is welded between the adjacent weak seal portions. Double room

3. The multi-chamber container according to claim 1, wherein an inert gas or a dry gas is sealed in a sealed space between the container body and the cover.

(4) A liquid, powder, or solid agent having oxidizability and Z or hygroscopicity is contained in a chamber covered with the cover. 2. The multi-chamber container according to item 1 above.

5.The multi-chamber container according to claim 1, wherein the weak seal portion is formed by directly welding inner surfaces of flexible plastic films forming the plastic container body. .

(6) The weak seal portion is formed by welding the inner surface of the flexible plastic film forming the plastic container main body via the insert film sandwiched between the inner surfaces. Of claim 1

10 chamber container.

7 The flexible plastic film forming the plastic container body is composed of an outer layer made of linear low-density polyethylene, linear low-density polyethylene, and ethylene-α-olefin elastomer. An intermediate layer made of a resin mixed with

15. The multi-chamber container according to claim 1, comprising an inner layer made of a mixed resin of linear low-density polyethylene and polypropylene.

8. The multi-chamber container according to claim 1, wherein the cover includes a silica-deposited resin layer.

-209 The claim wherein the cover comprises an outer layer of biaxially stretched polyethylene latex, an intermediate layer of silica-deposited polyvinyl alcohol, and an inner layer of low density polyethylene. 2. The multi-chamber container according to item 1 above.

10. The double-chamber container according to claim 1, wherein the outer wall has an aluminum laminate film on an outer surface. 11. The multi-chamber container according to claim 4, wherein the drug having oxidizability and Z or hygroscopicity is an antibacterial substance.