DE69325801T2 - CONTAINERS WITH A VARIETY OF CHAMBERS - Google Patents

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. <IMAGE>

Description

The present invention relates to containers with a plurality of chambers primarily for use in the field of medicine and more particularly to flexible plastic containers with a plurality of chambers for accommodating liquid preparations, powder preparations or solid preparations and a dividing device which divides the container into the chambers and allows communication between the chambers if necessary.

Heretofore, flexible plastic containers have been used in the medical field which have a plurality of chambers and a partitioning means which divides the containers into chambers and allows communication between the chambers. Since such a container tends to allow penetration of moisture or gas even if it is only a very small amount, there arises a need to place the container together with a desiccant in an expensive outer bag having barrier properties against moisture and gas when the container is used to separately store an antibiotic or similar drug which is hygroscopic and becomes unstable with the passage of time and a liquid preparation such as physiological saline, glucose or similar solution or dilution.

Nevertheless, the desiccant which absorbs water from the liquid preparation fails to completely dry the hygroscopic drug and further causes the concentration of the liquid preparation. Because of this disadvantage, it has not been practiced to store the hygroscopic and unstable antibiotic or similar drug and the liquid preparation separately in the flexible plastic container.

For this reason, drugs such as antibiotics, which become unstable over time, are stored in moisture- and gas-impermeable vials and similar containers before use. When it is to be administered to the patient, the drug is mixed, diluted or dissolved in physiological saline, glucose solution or a similar dissolving liquid or diluent, which is stored separately.

However, this procedure is laborious to perform and involves the risk of contamination with bacteria during the handling process. Therefore, containers have been developed that comprise a glass vial containing an unstable antibiotic and a flexible plastic container part that dissolving liquid and is adjacent to the glass vial in combination with the same with a piercing needle provided therebetween (see, for example, Japanese Unexamined Patent Publication HEI 2-1277). These containers have the advantage that the contents can be easily mixed together aseptically, whereas difficulties are encountered in disposal of the container because a very complicated process is required to separate the container into the glass vial, the flexible container part and the piercing tool for disposal. Accordingly, the container poses a problem in the disposal of medical waste which is currently attracting attention, that is, the problem that it does not satisfy the requirement of easy disposal.

Containers are also known which have a plurality of chambers for accommodating another drug which is easily oxidized, such as an amino acid solution containing tryptophan and a sugar or electrolyte solution (see, for example, Japanese Unexamined Patent Publication SHO 63-20550). The container of this type must be stored in an expensive outer bag with moisture and gas barrier layer together with an oxygen absorbent. In this case, the latter preparation (sugar or electrolyte solution), which does not need to be acted upon by the absorbent, is also stored in the outer bag together with the drug. The outer bag therefore requires a larger capacity, an oxygen absorbent with a larger capacity to absorb oxygen, or a larger amount of absorbent and a larger amount of moisture or gas barrier material, and thus has the disadvantage of increased cost.

EP-A-263571 and EP-A-109983 also disclose plastic containers with one or a plurality of chambers which are completely covered with an enveloping device having moisture and gas barrier properties.

The earlier, non-prepublished European patent application EP-A-513364 discloses a plastic container with container parts forming a plurality of chambers, wherein at least one container part has no covering and at least one container part has a covering, wherein the covering is made of a flexible film with moisture and gas barrier properties and forms a closed space around the covered container part, wherein the closed space contains a drying agent and/or an oxygen absorbing agent.

An object of the present invention is to provide a flexible plastic container with a plurality of chambers, which is suitable for housing and Can be used for storage of liquid preparations, powder preparations or solid preparations which are hygroscopic or susceptible to oxidation.

Another object of the present invention is to provide such a container which can be manufactured using a reduced amount of expensive moisture and gas barrier film and which is accordingly inexpensive.

Yet another object of the present invention is to provide a container of the mentioned type which need not enclose a glass vial and is therefore easy to dispose of.

Another object of the present invention is to provide such a container in which at least one of the chambers contains a liquid, powdered or solid medicinal preparation which is hygroscopic or susceptible to oxidation, only this chamber being separated from moisture and oxygen from the outside and being adapted to prevent the preparation from oxidizing or absorbing moisture without any oxygen absorbent or drying agent being enclosed therein.

Other features of the present invention will become apparent from the following description.

The present invention provides a container having a plurality of chambers for accommodating a liquid, powdered or solid preparation and a dividing device which divides the container into the chambers and allows communication between the chambers when required, the container comprising a flexible body made of plastic and having container parts which form the plurality of chambers, at least one, but not all, of the chambers being enclosed in an envelope made of a flexible film having moisture and gas barrier properties to form an enclosed space around the enveloped chamber(s), the enclosed space containing an inert gas and/or dry gas but not accommodating a desiccant and/or oxygen absorbing agent, the other chamber(s) being without an envelope.

In a specific embodiment, the container is characterized in that it comprises a flexible plastic container body forming the plurality of chambers, at least one of the chambers being enclosed in a casing with a welded perimeter to form a closed space therein around the chamber, the other chamber or chambers being without casing, the casing being made of a flexible plastic film with moisture and gas barrier properties is manufactured, the dividing device is formed by at least one section with a weak weld which is easy to open by pressing the chamber to give an increased internal pressure.

In the container of the present invention, a common substance such as a liquid, powder or solid preparation which is not susceptible to oxidation or hygroscopic is housed in the unencased chamber among the chambers of the container. This chamber is not enclosed in a moisture and gas impermeable enclosure and thus has low moisture and gas barrier properties, whereas the substance contained therein can be preserved for a long period of time as in conventional plastic containers since the substance is a common one.

On the other hand, a special substance such as a liquid, powder or solid preparation which is susceptible to oxidation and/or hygroscopic is housed in the chamber enclosed in the enclosure. The container body forming the chamber is made of plastic, has moisture and gas permeability inherent to plastics, albeit very slight, and has low moisture and gas barrier properties. However, the enclosure enclosing the chamber is made of a special film which is impermeable to moisture and gas, so that the special substance can be stored for a long period of time free from degradation, despite the low moisture and gas barrier properties of the plastic container body.

Accordingly, the container of the present invention, although made of flexible plastic, is easily usable for storing medicines such as antibiotics which are hygroscopic and become unstable over time, and liquid preparations such as dissolving solutions or diluents.

The container of the present invention has the gas-impermeable cover made of expensive special film, whereas the cover around the container is provided only locally and therefore can be made using a small amount of the expensive special film. This serves to minimize the increase in cost in packaging. A further cost reduction can be achieved because there is no need to enclose an oxygen absorbent or desiccant in the cover around the container body.

The plurality of chambers of the container of the invention are separated by at least one weak weld section which is maintained by a pressure applied from the outside used, can be opened, allowing the chambers to communicate with each other. Drug components can therefore be mixed together aseptically while kept out of contact with outside air. The plastic container body and the cover which make up the container are both flexible and easily deformable, so that the container can be disposed of more easily without the need for separation than containers which use glass or metal.

Fig. 1 is an enlarged vertical sectional view showing the container according to an embodiment of the invention;

Fig. 2 is a front view of the same;

Fig. 3 is an enlarged cross-sectional view of part A in Fig. 1;

Fig. 4 is an enlarged cross-sectional view of part B in Fig. 1;

Fig. 5 is an enlarged cross-sectional view of part C in Fig. 1;

Fig. 6 is a diagram explaining step by step a preferred example of the process for manufacturing the container of the invention shown in Fig. 1;

Fig. 7 is a cross-sectional view of a portion of the plastic container body of the container according to another embodiment of the invention;

Fig. 8 is a cross-sectional view of a portion of the enclosure of the container according to another embodiment of the invention;

Fig. 9 shows a vertical section of the container according to another embodiment of the invention;

Fig. 10 is an enlarged cross-sectional view of another example of the weak weld portion;

Figure 11 is a perspective view of the container of the invention enclosed in an outer bag for storage or transportation;

Fig. 12 shows a vertical section of the container according to another embodiment of the invention;

Fig. 13 is a diagram explaining step by step another preferred example of the process for manufacturing the container of the invention.

Embodiments of the present invention will be described below with reference to the accompanying drawings.

Figures 1 and 2 show an embodiment of the invention of the type having two sections with weak weld.

Referring to Fig. 1, which shows the embodiment, indicated at 1 is a flexible plastic container body having an outlet nozzle 2.

The plastic container body 1 is made from two superimposed layers of flexible plastic film 3 by heat-welding the layers together along the outer peripheral edges thereof.

Film 3 is not a special film, but is an inexpensive plastic film that is generally used for the production of flexible plastic containers in the medical field.

Fig. 3 shows an example of the film 3 which comprises two layers, i.e. an outer layer 3a made of polyethylene (hereinafter referred to simply as "PE") and an inner layer 3b made of a mixture of PE and polypropylene (hereinafter referred to simply as "PP").

As can be seen in Fig. 1, the plastic container body 1 has two weakly welded sections 8a, 8b which extend across the container at an intermediate part of its height and are formed by heat welding.

The weak weld parts 8a, 8b are adapted so that the opposing layers of film can be separated from each other when necessary by using the internal pressure of the container which is increased, such as by pressing the container. The weld strength of the weak weld parts must be lower than that of the peripheral edge portion of the container body 1.

The interior of the plastic container body 1 is divided by the sections 8a, 8b with a weak weld into two chambers 1a, 1b, a lower and an upper one. The upper container part 1A, which forms the upper chamber 1a, is enclosed in a casing 5, while the lower container part 1B, which forms the lower chamber 1b, is not provided with such a casing 5.

The cover 5 is made of a special film 6 which is impermeable to moisture and gas. Fig. 5 shows an example of a special film 6, i.e. a multilayer film having an outer layer 6a and an inner layer 6b made of PE. The outer layer 6a is an aluminum-covered film, such as an aluminum-laminated film, an aluminum-deposited film with high moisture and gas impermeability, or a two-layer film composed of polyvinylidene chloride and polypropylene (PP). The polyvinylidene chloride forming the outer layer 6a can be replaced by a polyvinyl alcohol film on which silicon dioxide is deposited.

Referring to Fig. 1, the wrapper 5 comprises two layers of the special film 6 arranged to surround the upper container part 1A. Of the peripheral portions of the layers of film 6, the portions not in contact with the upper container part 1A are heat-welded to each other, while the portions in contact with the part 1A are heat-welded to the outer surface of the part 1A as indicated at 6c, 6c. As can be seen in Fig. 1, the connected lower edge portions 6c, 6c are arranged between the weakly welded parts 8a, 8b.

A space portion 9 is provided between the welded portions 8a, 8b which is substantially unwelded. Fig. 4 shows the heat-welded joint on an enlarged scale. The lower edge portion 6c of the casing 5 is welded to the space portion 9 between the weld portions 8a, 8b. This avoids the likelihood that the heat-welding process gives the weak weld portions 8a, 8b an increased weld strength. In the case of the single weld portion type, the lower edge portion of the casing 5 is welded to the container body 1 above the weak weld portion. Accordingly, it is desirable to weld the edge portion under such a condition that the weld strength of the weak weld portion is prevented from increasing to the greatest extent possible, or that the weld portion can be easily separated without any problems even if the weld strength increases. Such a condition can be set by selecting appropriate material for the jacket and setting the heat-welding conditions in terms of temperature, time and pressure, although this involves considerable limitations. In the case of the present embodiment shown in Figs. 1 and 4, the lower edge portion 6c of the jacket 5 can be welded to the container body 1 without adversely affecting the weld strength of the weak weld portions 8a, 8b. This leads to the advantage that the material for the jacket 5 and the welding conditions can be selected with greater freedom than in the case of the single weld portion. Furthermore, in the present embodiment in which the lower edge portion 6c of the casing 5 is welded to the space portion 9 between the two portions 8a, 8b with a weak weld, the welded connection of the lower edge portion 6c is arranged at a greater distance from the chambers 1a, 1b of the container body, as can be seen from Fig. 4. This eliminates the Likelihood that the heat of the welding process will thermally degrade the drugs housed in the chambers 1a, 1b. Drugs which are hygroscopic or susceptible to oxidation include many which are susceptible to thermal degradation, whereas the lower edge portion of the envelope 5 can be welded to the container body without any likelihood of thermal degradation of such a drug. Even if one of the two weakly welded portions is opened, the other portion will prevent the two chambers from communicating with each other.

For example, a powder preparation 10 which is hygroscopic and/or susceptible to oxidation is housed in the coated upper container part 1A, while, for example, an ordinary liquid preparation 11 is housed in the non-coated lower container part 1B.

The temperature at which the welds are formed is highest for the entire peripheral portion of the plastic container body 1 and the upper edge portion and the side edge portions of the casing 5, less high for the lower edge portions of the casing 5 welded to the container body 1, and lowest for the weak weld portions 8a, 8b. Accordingly, the weak weld portions 8a, 8b have the lowest bonding strength of all the welds.

Fig. 6 shows a preferred example of a method for producing the present container shown in Figs. 1 and 2. The method will be described below with reference to Fig. 6 (a) to (e).

First, as shown in Fig. 6 (a), two sheets of plastic film shown in Fig. 3 are superposed so that the inner layers 3b, 3b are brought into contact with each other, and three sides of the assembly are heat-welded at a temperature of about 170 to about 200°C to prepare a plastic container body 1. Next, the weak-weld portions 8a, 8b are formed at an intermediate portion of the container body at a temperature of about 110 to about 130°C, and a discharge port 2 is attached to the body. Accordingly, an upper container part 1A providing an upper chamber and a lower container part 1B separated from the part 1A and providing a lower chamber are formed.

Then, a liquid preparation 11 is filled into the lower container part 1B through the non-welded part thereof. As shown in Fig. 6 (b), the non-welded welded portions of the two container parts 1A, 1B are welded, followed by heating for sterilization using high pressure steam, hot water or the like.

Thereafter, one side of the upper container part 1A is cut open in an aseptic atmosphere, as shown in Fig. 6 (c), to open this part, which is then dried if necessary.

Next, as shown in Fig. 6d, using the special film shown in Fig. 5, an envelope 5 is provided over the upper container part 1A and heat-sealed at its three sides. The lower edge portions 6c extending along the weak-sealed portions 8a, 8b are heat-sealed at a temperature of about 130 to 135°C at an intermediate region between the two portions 8a, 8b to prevent the heat-sealing of the lower edge portions from taking place over the weak-sealed portions. One side of the envelope 5 corresponding to the open side of the upper container part 1A is similarly left open.

Finally, a powder preparation 10, such as antibiotics, is placed in the upper container part 1A in an aseptic atmosphere, and the part 1A and the envelope 5 are then welded at the open side. Fig. 6 (e) shows the container thus obtained, which has two chambers.

It is desirable to replace the air in the space with N2 to remove oxygen before the opening is welded. The weak weld portions may be formed, for example, by pressing a heated weld forming die against the container body by means of a cylinder device. The die may have a structure having two weld peaks spaced a predetermined distance apart and may be heated to a controlled temperature by means of an electric heater.

By a method similar to the foregoing exemplary method, for example, a liquid preparation can be placed in the wrapped container part 1A and a liquid or powdered preparation in the unwrapped container part 1B. The container accommodating these preparations can be manufactured by attaching an outlet nozzle 2 to the container body, then placing the specified preparations in the respective container parts 1A, 1B, closing the filling openings, sterilizing the contents by means of an autoclave, then attaching a wrapper 5 to the upper container part 1A and then welding the side opening of the wrapper.

In the containers of the present invention manufactured by the methods shown in Fig. 6, the upper container part 1A is formed of a plastic film comprising an outer layer of PE and an inner layer of a mixture of PE and PP, so that the container part 1A allows the passage of moisture and gas (e.g. oxygen) although in a very small amount. However, the upper container part 1A is provided with the cover 5 made of a special film having moisture and gas barrier properties, with the result that the cover 5 functions to eliminate the above disadvantage of the upper container part 1A. Accordingly, a powder preparation which is hygroscopic and/or susceptible to oxidation can be preserved for a long period of time when housed in the upper container part 1A, even though this part is formed of plastic. The weak weld portions 8a, 8b separating the lower and upper container parts 1A, 1B have the lowest weld strength of all the welds. Therefore, when the container part is pressed to increase the internal pressure of the container part, the increased pressure separates the weak weld portions 8a, 8b, allowing the two container parts 1A, 1B to communicate with each other, whereby the liquid preparation and the powder preparation within the respective container parts 1A, 1B can be mixed together in a solution under aseptic condition as intended.

Examples of powder preparations for use in the above embodiment are antibiotic, anticancer, steroid, antithrombotic, fibrinolytic, vitamin and similar preparations which are hygroscopic and susceptible to oxidation and thermal degradation. Examples of useful liquid preparations are physiological saline solutions, glucose solutions and similar dissolving solutions or diluents.

While the usual film for making the plastic container body is a multilayer film of the structure shown in Fig. 3, a single-layer or multilayer film made of at least one combination of resins selected from PE, PP and mixtures of these resins can also be used.

Fig. 7 shows, by way of example, a three-layer film 35 comprising an outer layer 31 of linear low density polyethylene (hereinafter referred to as "LLDPE"), an intermediate layer 33 of a resin blend of LLDPE and low crystalline (or amorphous) ethylene/α-olefin elastomer, and an inner layer 34 of a resin blend of LLDPE and PP.

Furthermore, depending on the type of medicinal product to be enclosed, there is a likelihood that low molecular weight substances contained in the LLDPE contained in the inner layer of the inner wall may interact with the drug over time, possibly producing a reaction product that would be harmful to the patient. Accordingly, the LLDPE to be used for the inner layer 34 is pretreated at high temperature in vacuum by a volatile matter removal and stripping process to thereby reduce the content of low molecular weight substances up to about 30 carbon atoms to not more than a predetermined value, whereby the interaction between the drug and the inner layer can be favorably prevented.

Further, if an appropriate amount of high density polyethylene (HDPE) is incorporated into each layer of the three-ply film 35 as required to give the film improved heat resistance, containers with high stability can be formed to withstand sterilization using, for example, high pressure steam or hot water at a high temperature of at least 121°C.

It is possible to use single-layer or multi-layer films made of polyvinylidene chloride, polyethylene terephthalate (PET), aluminum-covered film, ethylene-vinyl alcohol copolymer (EVOH) or silicon dioxide-deposited film as special films for the wrapping. Preferably, silicon dioxide-deposited film is used to form at least one layer of the film because of its transparency and high impermeability to moisture and gas.

Fig. 8 shows a moisture and gas impermeable barrier film as an example of such a film, i.e., a three-layer film 46 comprising an outer layer 43 of biaxially oriented PET film, an intermediate layer 44 of silica-deposited PVA film and an inner layer 45 of low density polyethylene (LDPE), and in which these three layers are bonded together with a urethane adhesive resin. When the wrapper is to be directly welded to the plastic container body, it is desirable to use a multi-layer film at least for the wrapper so that the material of the innermost layer of the wrapper is the same as the material of the outermost layer of the plastic container body, whereby a satisfactory heat weld can be formed. For example, if the outermost layer of the container body is LLDPE, it is desirable to use LLDPE for the innermost layer of the casing.

Although according to the preceding embodiment, a powder preparation in the chamber of the enveloped container part and a liquid in the chamber of the container part enclosed without a coating, the powder preparation and the liquid preparation can be replaced by each other, depending on the intended purpose.

For example, in the case where the liquid preparation is an amino acid preparation or the like containing cysteine or tryptophan added thereto and susceptible to oxidation, and the powder preparation is a sugar, an electrolyte or a mixture of the same, the liquid preparation is housed in the covered container part, with the powder preparation being enclosed in the other container part.

For example, a liquid preparation is enclosed in the enclosed container part with another liquid preparation in the other container part, if, for example, the former liquid preparation is susceptible to oxidation, such as an amino acid preparation containing cysteine or tryptophan, or a vitamin preparation, and the latter liquid preparation is a sugar or electrolyte preparation.

Another example is such that the former liquid preparation is an easily oxidizable fat emulsion or the like and the latter preparation is a sugar or electrolyte preparation.

Furthermore, it is possible to enclose a solid preparation in one of the container parts and a liquid preparation in the other container part. Other examples of such powdered, liquid or solid preparations are various nutritional preparations and medicinal products that are administered intravenously or enterally (tubing or oral administration).

A further covering may be made locally or entirely of an aluminium-covered foil to shield the interior from light. The aluminium-covered foil used for the covering may be made locally or entirely peelable when the preparation is to be used, if so desired.

While the foregoing embodiment is a container having two chambers for individually accommodating a liquid preparation and one kind of powder preparation, such a container may be provided with more than two chambers, for example as shown in Fig. 9. Inside the casing 5, a container part 1A' is arranged having chambers 1a₁, 1a₂ for accommodating two kinds of powder preparations (or a powder preparation and a solid preparation). A liquid preparation is accommodated in the container part 1B without a casing. It is possible to provide a plurality of chambers for liquid preparations, besides powder or solid preparations. Between these chambers, weak weld portions are provided.

In the case where a liquid, powdery or solid preparation susceptible to oxidation is enclosed in the envelope chambers 1a, it is desirable to enclose an inert gas such as nitrogen gas, carbon dioxide gas or argon gas in the space within the envelope 5 around the container body 1. When a liquid, powdery or solid preparation susceptible to hygroscopicity is enclosed in the chambers 1a, it is desirable to enclose dry air, dry nitrogen gas or a similar dry gas in the space. When the inert gas is enclosed, the air in the space is replaced by the inert gas. This ensures a greater effect of preventing oxidation. When the dry gas is enclosed, the air in the space is replaced by dry gas, thus ensuring an enhanced moisture-proof effect.

The medicinal preparations contained in the container can be given high stability despite the passage of time by the moisture and gas impermeable film covering the chamber or chambers which must be moisture-free and free from oxidation and further by the confinement of the inert gas or dry gas in the space within the envelope around the container body without adding an oxygen absorbent and/or desiccant into the space unlike the current practice.

Two weak-weld sections need not always be formed, but more than two weld sections or a single weld section may be provided. Further, the weak-weld section need not always be straight, but may be V-shaped so as to project approximately toward the center of the envelope chamber. In this case, when a chamber is pressed by hand, the force acting to open the weak-weld section is concentrated on the V-shaped section, with the result that the drug components can be mixed together by opening the weak-weld section at a relatively low pressure. In this case, however, there is a likelihood that separation may occur inadvertently in the weld section during storage or transportation of the container, so that it is desirable to carefully determine the heat-welding condition.

In the foregoing embodiment, the weak weld portion is formed directly by joining the inner layers of the two sheets constituting the container body. Alternatively, the weak weld portion may formed by heat sealing the two layers together with a multi-layered interlayer film held therebetween. Fig. 10 shows a variation in which a two-layered interlayer film is used. At 3 is indicated a container forming film which is a single-layer or multi-layer film, at 18 is indicated a layer having a high heat sealing strength on one side of the innermost layer of the film 3, and at 19 is indicated a layer having a low heat sealing strength on the innermost layer of the film 3 on the other side. The film section and the layer 19 form weak sealing sections 21a, 21b. For example, if the film 3 is a single-layer film of PE or PP, the layer 18 is made of the same material as the film 3, ie PE or PP, and the layer 19 is made of a mixture of PE and PP. Two insert films may be used, each for the two weak-weld portions. The cover 5 may be heat-welded in register to the weak-weld portion provided that the weak-weld portion is kept weak, alternatively the cover may be attached to the container body using an adhesive or the like.

The container of the invention is preferably folded in two at the weak-seal portions 8a, 8b and stored or transported enclosed in an outer bag 50. In this case, when folded in two, the seal portion is prevented from opening due to pressure under the weight of superimposed containers or due to impact when dropped.

As shown in Fig. 12, the outlet port 2' may be formed at one end of the chamber 1a' containing a powder preparation 10 such as an antibiotic. In this case, the chamber 1b' containing a liquid such as a dissolving solution is closed. If an outlet port is formed at a chamber containing a liquid such as a dissolving liquid, there is a risk that only the liquid is inadvertently administered without mixing with the powder preparation, particularly in an emergency. Such a risk can be eliminated by forming the outlet port at the chamber containing the powder preparation such as an antibiotic.

Another preferred method for manufacturing the container of the invention is described below with reference to Figs. 13(a) to (j).

As shown in Fig. 13(a), a hole 2a for a discharge nozzle is formed in a two-layer plastic film 3 similar to that shown in Fig. 3.

Next, as shown in Fig. 13 (b), an outlet nozzle 2 is attached to the outer layer, i.e., the PE layer, of the film 3 by heat welding in register with the hole 2a. The film 3 is then folded into two parts along a line through the outlet nozzle 2, as shown in Fig. 13 (c).

Then, as shown in Fig. 13 (d), the two flaps of the film 3, excluding the filling openings 35, 36 for a medicinal preparation and powder preparation, are heat-welded together at their peripheral portions at a temperature of about 170 to about 200°C, thereby obtaining a plastic container body 1. The filling opening 35 may be welded shut, and only the filling opening 36 may be left unwelded.

Next, as shown in Fig. 13 (e), two parallel weak weld portions 8a, 8b are formed at a heat-welding temperature of about 110 to about 130°C at an intermediate portion of the container body with a space portion 9 provided therebetween. To be suitable, the weak weld portion 8b is about 10 mm wide and the weak weld portion 8a is about 5 mm wide.

Accordingly, container parts 1A, 1B, an upper and a lower one, are formed, which are divided by the weakly welded sections 8a, 8b. The medicinal preparation 11 is then filled into the lower container part 1B through the opening 36, and the two filling openings 35, 36 are then welded as shown in Fig. 13 (f), followed by sterilization in an autoclave.

Next, as shown in Fig. 13 (g), the sterilized body is dried externally, the portion of the opening 35 is cut open in aseptic atmosphere to open the opening 35 again, and clean air is applied to the inside of the container part 1A through the opening 35 for drying and cleaning.

Next, as shown in Fig. 13 (h), the powder preparation 10 is filled into the upper container part 1A through the opening 35 under aseptic condition, and the filling opening 35 is then sealed.

Next, as shown in Fig. 13 (i), an envelope 5 is provided using two layers of a special film 6 shown in Fig. 5 to enclose the upper container part 1A therein. Preferably, one of the two film layers is transparent and the other layer is non-transparent.

In order to keep the filled preparation 10 substantially free from heat when the film 6 is heat-sealed to the edge of the upper container part 1A, it is preferable to leave a distance of about 5 mm between the welded joint 6b of the film 6 and of the chamber 1a in the upper container part 1A. For this purpose, the connection 1A, (see Fig. 13, (h)) of the periphery of the upper container part 1A, particularly at opposite side portions thereof, must have a width of more than 5 mm. Usually, this width is about 7 to about 10 mm in view of the welding width of the film 6.

As shown in Fig. 4, the lower edge portion 6c of the envelope 5 is welded at the position of the space portion 9 between the two portions 8a, 8b with a weak weld. The welding temperature is about 150 to 170°C if the foil 6 used is transparent, or 130 to 150°C if the foil used is a non-transparent foil covered with aluminum.

As can be seen in Fig. 13 (i), the envelope 5 provided around the upper container part 1A is initially partially open on one side thereof as indicated at 40. An inert gas or dry gas is injected through the opening 40 into the space 7 between the envelope 5 and the upper container part 1A and the opening 40 is then sealed. Fig. 13 (j) shows the thus obtained container of the invention with the two chambers and two weak weld sections. In the foregoing embodiment, the heat sealing temperature for forming each joint is selectively set to an optimum temperature range according to the material of the film concerned and the weld strength aimed at. Accordingly, the sealing temperature ranges indicated above are in no way limiting.

Claims (11)

1. Container with a plurality of chambers (1A, 1B) for accommodating a liquid, powdered or solid preparation (10, 11) and a partition device which divides the container into chambers and allows a connection between the chambers when required, the container comprising a flexible body (1) made of plastic and having container parts which form the plurality of chambers (1A, 1B), at least one (1A), but not all, of the chambers (1A, 1B) being enclosed in an envelope (5) made of a flexible film (6) with moisture and gas barrier properties to form a closed space (7) around the enveloped chamber(s) (1A), the closed space (7) containing an inert gas and/or dry gas, but no desiccant and/or Oxygen absorber housed, the other chamber(s) (1B) being unenclosed. 2. Container according to claim 1, in which the dividing means is formed by at least one weak weld portion (8a, 8b) which can be easily opened by pressing the chamber (1A, 1B) to give an increased internal pressure. 3. Container according to claim 2, in which at least two weak weld sections (8a, 8b) are provided at a distance (9) and the casing (5) has a heat-welded edge (6c) between the adjacent weak weld sections. 4. Container according to claim 1, in which the enclosed chamber (1A) has housed therein a liquid, powdery or solid preparation (10, 11) which is susceptible to oxidation and/or hygroscopic. 5. A container according to claim 1, in which the weak weld portion or portions (8a, 8b) are formed by directly welding together opposite inner surfaces of a flexible plastic film (3) forming the container body (1). 6. A container according to claim 1, in which the weak weld portion or portions (8a, 8b) are formed by welding together opposing inner surfaces of a flexible plastics film (3) forming the container body (1), with an insert film held between the opposing inner surfaces. 7. A container according to claim 1, in which the container body (1) is formed from a flexible plastic film (35) comprising an outer layer (31) of linear low density polyethylene, an intermediate layer (33) of a resin blend of linear low density polyethylene and ethylene/α-olefin elastomer, and an inner layer (34) of a resin blend of linear low density polyethylene and polypropylene. 8. A container according to claim 1, in which the casing (5) comprises a layer of a resin film with deposited silicon dioxide. 9. A container according to claim 1, in which the envelope (5) comprises an outer layer (43) of biaxially oriented polyethylene terephthalate film, an intermediate layer (44) of silicon dioxide deposited polyvinyl alcohol film, and an inner layer (45) of low density polyethylene. 10. A container according to claim 1, in which the envelope (5) has an outer surface provided by an aluminum laminated foil. 11. Container according to claim 4, in which the substance (10, 11) which is susceptible to oxidation and/or hygroscopic is an antibiotic.