HU216406B - Vessel having a plurality 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

EXTRACT

The present invention relates to a multi-chamber vessel. The container is mainly used for medicinal purposes. The vessel body (1) is made of plastic and has separating members which divide the vessel body (1) into chambers (la, lb) and allow connection between the chambers (la, lb) if necessary. At least one chamber (1a) is surrounded by a housing (5) which forms a closed space (7) around the chamber (1a). The cover (5) is made of a flexible film with moisture and gas barrier properties. The container is a cheap, high-quality, efficient and easy-to-use waste.

Figure 1

HU 216 406 B

The length of the description is 16 pages (including 9 pages)

HU 216 406 Β

The present invention relates to a multi-chamber vessel. This vessel is mainly used for medicinal purposes. In particular, the present invention relates to a multi-chamber flexible plastic container in which liquid compositions, powder formulations or solid compositions are contained and separated by compartments such that connection between the chambers is possible if desired.

The use of multi-chamber, flexible plastic vessels, as well as separating elements for dividing the vessel into chambers and allowing connection between chambers, is known. Such containers generally, even in very small amounts, allow moisture or gas to penetrate, and therefore the container, together with a desiccant, must be placed in an expensive outer bag, which must have moisture and gas barrier properties when stored separately in a hygroscopic and an unstable antibiotic or similar drug; and a liquid preparation such as physiological saline, glucose or the like, or dilution.

The desiccant, which absorbs water from the liquid preparation, cannot keep the hygroscopic drug completely dry and also causes the liquid composition to concentrate. Because of this drawback, it is not customary to place the hygroscopic and unstable antibiotic or similar drug and the liquid formulation separately in a flexible plastic container.

Because of this, drugs such as antibiotics that become unstable over time are stored in waterproof and gas-tight ampoules or similar containers before use.

When the drug is administered to a patient, it is mixed with, diluted in, or dissolved in physiological saline, glucose, or other solvent or diluent stored separately.

However, this method is difficult in practice and there is a risk of bacterial infection during the treatment process. Therefore, containers have been developed which consist of a glass ampoule containing an unstable antibiotic and a flexible plastic container containing a solution liquid fixed to the ampoule. There is a piercing needle between the two parts of the container. (See, for example, Japanese Patent Specification HEI 2-1277, not yet tested.) The advantage of these vessels is that their contents can be easily aseptically mixed. However, it is difficult to dispose of the used container as the container has to be separated by a very complicated process into a glass ampoule, a flexible container part and a punching device in order to be disposed of. Thus, the same problem arises as with the recent prominence of medical waste, ie the requirement of easy disposal of waste.

Other multi-chamber containers for storing other readily oxidizable drugs, such as tryptophan-containing amino acid solution and sugar solution or electrolyte solution, are known (see, for example, SHO 63-20550). This type of container needs to be placed in an expensive, moisture and gas tight outer pouch with an oxygen absorber for storage.

In this case, the latter formulation (sugar or electrolyte solution), which the absorbent capsules must act on, is also placed in the outer pouch along with the drug. The outer pouch should therefore have a larger volume, an oxygen absorber with a higher oxygen scavenging capacity or a greater amount of absorber, and more moisture and gas barrier material. The disadvantage is the higher cost.

SUMMARY OF THE INVENTION It is an object of the present invention to provide a multi-chamber, flexible plastic container for use in the storage and storage of hygroscopic or oxidizable liquid compositions, powder formulations and solid compositions.

It is a further object of the present invention to provide a container in which less expensive moisture and gas barrier films are used, which is therefore inexpensive.

It is a further object of the present invention to provide a container of the type described, which does not contain a glass ampoule and can therefore be disposed of easily.

Yet another object of the present invention is to provide a container in which at least one chamber contains a hygroscopic or oxidizable liquid, powder or solid pharmaceutical composition; only this chamber is separated from external moisture and water and is designed to prevent oxidation or moisture uptake of the formulation without the addition of an oxygen absorber or desiccant.

These objects are accomplished in accordance with the present invention by comprising a multi-chamber vessel for receiving liquid, powder, or solid material, which is divided into compartments by means of separating elements so that connection between the chambers is possible, forming a plurality of plastic vessels. At least one of the chambers is surrounded by a sealed circumferential envelope forming a closed space around the chamber. The other chamber and the other chambers have no casing. The casing is made of flexible film with moisture and gas barrier properties. The separating members have at least one weak closure portion which can be easily opened by increasing the internal pressure by pressing the chamber.

In the container of the invention, a conventional material, such as a non-oxidizing and non-hygroscopic liquid, powder or solid composition, is placed around the container chambers in an unsheathed chamber. This chamber is not surrounded by a moisture and gas barrier and therefore has poor moisture and gas barrier properties. However, the material contained therein can be stored for a long time, as in ordinary plastic containers, since the material is a regular material.

The special material, such as an oxidizing and / or hygroscopic liquid, powder or solid composition, is placed in a sealed chamber. The vessel body forming the chamber is made of plastic. Its waterproofing and gas tightness are typical of plastics, but rather low. It has poor moisture and gas barrier properties. The enclosure enclosure, on the other hand, is made of a special foil impermeable to moisture and gas, so that despite its poor moisture and water barrier properties, the special material can be stored for long periods without degradation.

HU 216 406 Β

Accordingly, the container of the present invention, although made of flexible plastic material, can be used without problems for the storage of hygroscopic and over time unstable drugs such as antibiotics and liquid preparations such as solvents or diluents.

The container of the present invention has an expensive gas-tight housing made of special foil. However, this wrapper is only localized on the container and requires a small amount of expensive, special foil. This minimizes the increase in packaging costs. An additional cost reduction is that there is no need for an oxygen absorber or desiccant in the envelope around the body of the vessel.

The chambers of the vessel of the present invention are separated by at least one weak closure portion which can be opened by externally applied pressure and thus the chambers can be interconnected. The ingredients of the drugs can therefore be mixed aseptically without contact with the outside air.

The container body and the shell forming the container are flexible, easy to deform and thus easier to dispose of the container as compared to containers containing glass or metal.

Preferably, the vessel has at least two weak closures spaced apart from one another and has a weld sealed thread between adjacent weak closures.

Preferably, there is gas or dry gas injected in the enclosure within the enclosure within the enclosure.

Preferably, the weak closure portion or closures are formed by direct welding of opposing inner surfaces of the flexible plastic film forming the vessel body. Advantageously, a facing film is provided between the opposing inner surfaces.

The flexible plastic film forming the vessel body preferably comprises an outer layer, an intermediate layer and an inner layer. The outer layer is a linear low density polyethylene, the intermediate layer is a linear low density polyethylene and ethylene / α-olefin elastomeric resin blend, the inner layer is a linear low density polyethylene and polypropylene resin blend.

Preferably, the casing comprises an outer layer, an intermediate layer, and an inner layer. The outer layer is a biaxially oriented polyethylene terephthalate film, the intermediate layer is a silica-coated polyvinyl alcohol film, and the inner layer is low density polyethylene.

Preferably, the outer surface of the housing has a film with an aluminum layer.

The invention will now be described in more detail with reference to the accompanying drawings, in which:

Figure 1 is an enlarged vertical sectional view of an embodiment of the container of the invention;

Figure 2 is a front view of the container of Figure 1;

Figure 3 is an enlarged sectional view of detail A of Figure 1;

Figure 4 is an enlarged sectional view of detail B of Figure 1;

Figure 5 is an enlarged sectional view of the "C" portion of Figure 1;

Figure 6 is a schematic of the steps of an exemplary preferred method of making the container of Figure 1;

Figure 7 is a sectional view of a portion of a plastic container body of another embodiment of the container of the present invention;

Figure 8 is a sectional view of a portion of the shell of another embodiment of the container of the invention;

Figure 9 is a vertical sectional view of a further embodiment of the container of the invention;

Figure 10 is an enlarged sectional view of another version of the weak closure;

-all. Fig. 4 is a perspective view of a container according to the invention enclosed in an outer pouch for storage or transport;

Figure 12 is a vertical sectional view of a further embodiment of the container of the invention;

Figure 13 is a schematic of the steps of another exemplary preferred method of making the vessel of the invention.

Figures 1 and 2 illustrate an embodiment of the invention comprising two weak closures.

In the embodiment shown in Figure 1, the flexible plastic container body 1 has a discharge head 2.

The plastic container body 1 is made of two flexible foil sheets 3 superimposed so that the outer peripheral edges of the foils are welded.

The foil 3 is not a special foil but an inexpensive plastic foil commonly used in the medical field to produce flexible plastic containers.

Figure 3 shows a film 3 consisting of two layers. The outer layer 3 is a mixture of polyethylene (hereafter simply "PE") and the inner layer 3b is a mixture of PE and polypropylene (hereafter simply "PP").

As shown in Fig. 1, the plastic container body 1 has two weak closure portions 8a, 8b which are transverse to the container at an intermediate portion of the height of the container and are formed by welding.

The weak closure portion 8a, 8b is configured such that the opposing faces of the foil can be separated, if necessary, by applying the internal pressure of the vessel, which is increased by pressing the vessel. The closing force of the weak closing portions must be less than the closing force of the peripheral edge portion of the vessel body.

The inside of the plastic container body 1 is divided by the weak closure 8a, 8b into an upper chamber la and a lower chamber lb. The upper vessel portion 1A forming the upper chamber la is surrounded by a shell 5, while the lower vessel portion 1B forming the lower chamber lb is not provided with such a shell 5.

The cover 5 is made of a special foil 6 impermeable to moisture and gas. Figure 5 shows an example of a special film 6. It is a multilayer film consisting of an outer layer 6a and an inner layer 6b. The outer layer 6a is a highly moisture- and gas-tight aluminum-coated film, such as an aluminum laminated or aluminum-galvanized film, or a two-layer film consisting of polyvinylidene chloride and polypropylene (PP). The outer layer 6a is polyvinylidene cl 3

EN 216 406 Β rid) can be replaced by silica-coated polyvinyl alcohol film.

As shown in Fig. 1, the special foil 6 of the cover 5 consists of two sheets which surround the upper container portion 1A. The portions of the circumferential portions of the sheets of foil 6 that are not in contact with the upper vessel portion 1A are welded to one another, while the portions contacting the vessel portion 1A are welded to the outer surface of the vessel portion 1A at the edge portions 6c. As shown in Fig. 1, the connected lower edge portions 6c are between the weak closing portions 8a, 8b.

Between the closure portions 8a, 8b there is a substantially sealed response portion 9. Figure 4 shows a larger scale of the welded joint. The lower edge portion 6c of the shell 5 is welded to the response portion 9 between the closure portion 8a, 8b. This avoids the possibility of increasing the closing force of the weak sealing member 8a, 8b as a result of the welding operation. In the case of one type of closure, the lower edge of the shell 5 is welded to the vessel body 1 above the weak closure. Accordingly, it is desirable to weld the edge portion so as to prevent as much as possible an increase in the closing force of the weak closing member, or to easily separate the closing member in the event of an increase in the closing force. This condition can be ensured by properly selecting the sheath material and by properly determining the welding conditions such as temperature, time, and pressure. There are serious limitations to this.

In the present embodiment of Figures 1 and 4, the lower edge portion 6c of the shell 5 may be welded to the body 1 without adversely affecting the closing force of the weak closure portion 8a, 8b. This has the advantage that the material of the cover 5 and the welding conditions can be chosen more freely than when a closure part is used.

Furthermore, in the present embodiment, wherein the lower edge portion 6c of the shell 5 is welded between the two weak closure portions 8c, 8b to the response portion 9, the lower edge portion 6c is welded at a greater distance from the chamber 1a, lb of the vessel body. as shown in Figure. This eliminates the possibility that the heat of the welding operation will thermally degrade the pharmaceutical compositions contained in the chamber 1a, 1b. Many of the pharmaceutical compositions which are hygroscopic or oxidizable are thermally degradable. On the other hand, the lower edge of the shell 5 can be welded to the body of the vessel without the risk of thermal degradation of such a composition. Even if one of the two weak closures opens, the other closure prevents the two chambers from engaging.

For example, a hygroscopic and / or oxidizable powder composition 10 is placed in the upper container portion 1A and a conventional liquid composition 11 in the lower container portion 1B.

The welding temperature for closures is highest in the entire circumference of the plastic container body 1, as well as in the upper edge and side edges of the casing 5, lower in the lower peripheral parts welded to the casing body 1 and lower in all closures 8a, 8b. of the closure the weakest bonding strength of the weak closure portions 8a, 8b.

Figure 6 shows a preferred exemplary process for making the container of Figures 1 and 2. The procedure is set forth below in Figures 6a-6e. with the help of figure.

First, FIG. 3A, the two plastic film sheets of FIG. 3 are superimposed so that their inner layers 3b are in contact. The three sides of the assembly are welded at a temperature of about 170 ° C to about 200 ° C to form the plastic body 1. Subsequently, the weak sealing portions 8a, 8b are formed in the intermediate portion of the vessel body at a temperature of about 110 ° C to about 130 ° C and the emptying head 2 is connected to the body. Subsequently, the upper vessel portion 1A forming the upper chamber and the lower vessel portion 1B forming the lower chamber separated from the vessel portion 1A.

Subsequently, a liquid composition 11 is filled into the lower container portion 1B through its non-sealed portion. As shown in FIG. 1A and 1B, the sealed portions of the two container portions 1A and 1B are sealed, followed by sterilization heating. For this, high pressure steam, hot water or the like is used.

Then, one side of the upper vessel portion 1A in an aseptic atmosphere is shown in FIG. FIG. 3A is cut to open this portion and dried if necessary.

Subsequently, FIG. 5a, a cover 5 made of the special foil of FIG. 5 is placed in the upper container portion 1A and welded on three sides. The lower edge portions 6c along the weak closure portions 8a, 8b are welded at a temperature of about 130 ° C to 135 ° C in the intermediate portion between the closure portions 8a, 8b to avoid welding of the lower edge portions over the weak closure portions. One side of the shell 5 corresponding to the open side of the upper container portion 1A also remains open.

Finally, a powder composition, such as an antibiotic, is placed in an aseptic atmosphere in the upper vessel portion 1A and the vessel portion 1A and the shell 5 are sealed on the open side. 6e. Figure 2B shows the resulting vessel having two chambers.

Before sealing the opening, it is desirable to replace the air in the space with N ₂ to remove oxygen. For example, the weak closure portions may be formed by clamping a heated forming tool with a cylinder to the vessel body. The tool may have two ridges at predetermined distances, and the tool may be heated to a temperature controlled by an electric heater.

A liquid composition may be incorporated into the shell portion 1A and the liquid or powder composition may be included in the shell portion 1B, for example by a method similar to the previous method. To prepare a container containing these compositions, an emptying head 2 is connected to the body of the container, the specified compositions are placed in the appropriate container portion ΙΑ, 1B, the filling openings are sealed, the contents are autoclaved and 5 shells are attached to the upper container 1A. the side opening of the casing.

HU 216 406 Β

In the containers according to the invention and produced by the process of Figure 6, the upper container portion 1A is made of a plastic film having an outer PE layer and an inner layer of a mixture of PE and PP. Thus, vessel portion 1A allows moisture and gas (e.g., oxygen) to pass, albeit in very small amounts. The upper container portion 1A, on the other hand, is provided with a special cover 5 made of a foil with moisture and gas barrier properties, and as a result the cover 5 eliminates the aforementioned disadvantage of the upper container portion 1A. Accordingly, a hygroscopic and / or oxidizable powder composition may be stored for a long period of time in the upper 1A vessel portion, although the vessel portion is made of plastic. The weak sealing portion 8a, 8b separating the upper container portion 1A and the lower container portion 1B is the smallest of all closures. Therefore, when the vessel portion is pressed to increase its internal pressure, the increased pressure separates the two closures 8a, 8b. As a result, the two vessel portions 1A and 1B are joined together, and the liquid composition and powder formulation in the respective vessel portions 1A and 1B can be mixed aseptically into the appropriate solution.

Powder formulations for use in the above embodiment include, for example, antibiotics, anticancer preparations, steroids, antithrombotic agents, fibrinolytics, vitamins and the like which are hygroscopic, oxidizable and thermally degradable. Liquid formulations which may be used include saline, glucose, and the like, and the like.

Generally, a plastic multi-layer film having the structure shown in Figure 3 is used to make the plastic container body, but a single layer or multi-layer film made of at least one combination of PE, PP and mixtures of these resins may also be used.

7 illustrates a three-layer film 35 having an outer layer 31, an intermediate layer 33 and an inner layer 34. The outer layer 31 is a linear low density polyethylene (hereinafter referred to as "LLDPE"). Intermediate layer 33 is a mixture of LLDPE and a less crystalline (or amorphous) ethylene / α-olefin elastomer resin. The top layer 34 is a mixture of LLDPE and PP resin.

Depending on the type of pharmaceutical composition to be stored, the low molecular weight materials contained in the LLDPE in the inner wall are expected to interact with the composition over time and to produce a reaction product that will negatively affect the patient. The LLDPE used for the inner layer 34 is therefore pretreated under vacuum at high temperature and thus the volatile matter removal and stripping process reduces the proportion of low molecular weight materials to 30 carbon atoms, not more than a specified value. In this way, the interaction between the pharmaceutical composition and the inner layer is advantageously prevented.

If each layer of the triple layer 35 foil has a sufficient amount of high density polyethylene (HDPE), which is required for better heat resistance of the foil, vessels that can withstand high temperatures of at least 121 ° C, such as high pressure steam, may be formed. or sterilization with hot water.

One or more layers of polyvinylidene chloride, polyethylene terephthalate (PET) film, aluminum-coated foil, ethylene-vinyl alcohol copolymer (EVOH) or silica-coated foil may be used as the special wrapping foil. Preferably, at least one layer of the film is a silica-coated film because it is transparent and highly water and gas impermeable.

An example of such a moisture and gas barrier film is shown in Figure 8. It is a three-layer film 46 having an outer layer 43 of biaxially oriented PET film, an intermediate layer 44 of silicon-coated polyvinyl acetate (PVA) film and an inner layer 45 of low density polyethylene (LDPE). The three layers are joined by methane adhesive resin. If the casing is to be welded directly to the plastic vessel body, it is desirable to apply at least a multilayer film to the casing so that the material of the innermost layer of the casing is the same as the material of the outer layer of the plastic vessel body. For example, if the outermost layer of the vessel body is LLDPE, it is desirable that the innermost layer of the shell is LLDPE.

In the embodiment described above, although the powder compartment and the uncoated compartment chamber have a liquid in the chamber of the enclosed container, the powder and liquid compositions may be interchangeable, depending on their intended use.

For example, in the case where the liquid composition is a cysteine or tryptophan oxidizable amino acid composition or the like and the powder composition is a sugar, an electrolyte or a mixture thereof, the envelope portion comprises a liquid composition and the other portion portion.

For example, in the case where the first liquid composition is oxidizable, such as an amino acid or vitamin composition containing cysteine or tryptophan, and the other liquid composition is a sugar or electrolyte composition, the envelope portion comprises a liquid composition and the other portion portion.

In another example, the first liquid composition is a readily oxidizable fat emulsion or the like, the second composition is a sugar or electrolyte composition.

It is also possible to place a solid composition in one portion and a liquid composition in the other portion. Other examples of such powdered, liquid, and solid formulations are various formulations and drugs administered intravenously or as an intestinal solvent (tube or oral administration).

The casing may also be made wholly or partly of aluminum-coated foil to protect the interior from light. The aluminum foil used as the wrapper may, if desired, be partially or completely detachable when the composition is used.

The previously described embodiment is a two-chamber container in which a liquid composition and a powder composition are individually stored.

HU 216 406 Β

The vessel may have more than two chambers. An example of such a container is shown in Figure 9. Within the enclosure 5 is a vessel portion 1A 'having two chambers 1a and 1a _{2 for} receiving two kinds of powder formulations (or a powder formulation and a solid formulation). A liquid formulation is contained in the unsheathed container portion IB. In addition to powder or solid formulations, multiple compartments may be provided for liquid formulations. These chambers have weak sealing portions between them.

When an oxidizing, liquid, powder or solid composition is introduced into the enclosed chamber Ia, it is expedient to introduce an inert gas such as nitrogen gas, carbon dioxide gas or argon gas into the space around the vessel body 1 within the enclosure. When a hygroscopic liquid, powder, or solid composition is introduced into the chambers la, it is desirable to introduce dry air, dry nitrogen gas, or the like into this space. When inert gas is introduced, the air in space is replaced by the inert gas. This prevents oxidation more effectively. When dry gas is introduced, the air in the space is replaced by the dry gas, which improves moisture resistance.

The pharmaceutical compositions in the container may, over time, be very stable through a water- and gas-tight foil covering the chamber or chambers, which must be moisture-proof and non-oxidizing, and by introducing gas or dry gas into the enclosure around the body of the container. and, unlike usual practice, do not add oxygen absorber and / or desiccant into the space.

It is not always necessary to have two weak closures, but more than two and one closure. In addition, the weak closure need not always be rectilinear but may also be V-shaped, directed approximately toward the center of the enclosed chamber. In this case, by manually applying pressure to one of the chambers, the weak closing portion opening force is concentrated on the V-shaped portion and consequently the drug components can be mixed open with the weak closing portion at relatively low pressure. However, in this case there is a risk that the closure part may be unintentionally separated during storage or transport of the container. Therefore, welding conditions must be carefully defined.

In the embodiment described above, the weak sealing portion is formed by directly bonding the inner layers of the two foil sheets forming the vessel body. Alternatively, the weak sealing portion is formed by welding the two foil sheets together with a multilayer insert film held between them. Figure 10 shows a modification using a double-layered foil. The figure shows a single layer or multilayer film 3 constituting the container, a high strength welding sheet 18 on one side of the innermost layer 3, and a low welding sheet 19 on the innermost layer of the sheet 3 on the other side. The corresponding portion of the foil 3 and the foil sheet 19 form the weak sealing portions 21a and 21b. For example, if the film 3 is a single layer PE or PP film, the material of the film sheet 18 is the same as the material of the film 3, i.e. PE or PP, and the film sheet is made of a mixture of PE and PP. Two liners can be used and each has two weak sealing portions. The cover 5 may be welded under cover with the weak closure provided the weak closure is held weak. Alternatively, the casing is secured to the container body by means of an adhesive or the like.

It is advantageous to store or transport the container according to the invention in the weak closure part 8a, 8b and wrap it in an outer pouch 50. Folded in two, the closure is protected against opening under pressure by the weight of the stacked vessels, or by impact when dropped.

As shown in FIG. 12, the discharge head 2 'may be formed at one end of the chamber la' containing the powder composition 10. In this case, the chamber 1b 'containing the liquid, such as a solvent, is closed. If the discharge head is formed in a chamber containing a liquid, such as a solvent, there is a risk that, particularly in an emergency, only the liquid is added without mixing with the powder formulation. The danger of this can be eliminated by forming the discharge head in a chamber containing a powder composition such as an antibiotic.

Another preferred process for making the container according to the invention is illustrated in Figures 13a-13j. with reference to FIG.

13a. FIG. 3A shows that a hole 2a is formed in the bilayer plastic film 3 as in FIG. 3 for the discharge head.

13b. As illustrated in FIG. 1A, a discharge head 2 is welded to the outer layer, i.e. the PE layer, of the film 3, overlapping the hole 2a. The foil 3 is then double-folded along a straight line through the discharge head 2 as shown in FIG. .

13d. 2a, the two wings of the foil 3 are welded at about 170 ° C to about 200 ° C around their peripheral portions - omitting the filler apertures 35a and 36, to form the plastic container body 1. The filler port 35a, 36 serves for a pharmaceutical formulation and a powder formulation. The filling opening 35a can be closed and only the filling opening 36 remains closed.

Subsequently, FIG. As shown in FIGS. 2 to 4, at the welding temperature of about 110 ° C to about 130 ° C, two parallel, weak sealing portions 8a and 8b are formed between the vessel body, between which is a portion 9. Preferably, the weak closure 8b is 10 mm wide and the weak closure 8c is approximately 5 mm wide.

This results in an upper vessel portion 1A and a lower IB portion separated by a weak closure portion 8a and 8b. The liquid composition 11 is then filled through the filler opening 36 into the lower container portion IB, and the two filler openings 35a and 36 are shown in FIG. as shown in FIG. This is followed by autoclave sterilization.

Thereafter, 13g. As illustrated in FIG. 3B, the sterilized body is dried outside, the portion at the filler port 35a is cut off in an aseptic atmosphere to open the filler port 35a, and clean air is introduced through the filler hole 35a into the upper container portion 1A.

HU 216 406 Β

Subsequently, 13h. 10a, powder composition 10 is filled into the upper container portion 1A through the filling opening 35a under aseptic conditions, and the filling opening 35a is sealed.

13i. As shown in Fig. 5, the upper container portion 1A is enclosed by a cover 5 using two sheets of the special foil 6 of Fig. 5. Preferably, one of the two film sheets is transparent and the other is opaque. Preferably there is about 5 mm of space between the sealed bond 6d of the foil 6 and the chamber la in the upper vessel portion 1A so that the filled powder composition 10 is substantially free of heat when the foil 6 is welded to the edge of the upper vessel portion 1A. To this end, the periphery of the upper vessel portion 1A must have a lip ligation greater than 5 mm, particularly in the opposite side portions. Depending on the closing width of the film 6, this width is usually about 7 to about 10 mm.

As shown in Figure 4, the lower edge portion 6c of the shell 5 is welded between the two weak closure portions 8a and 8b in place of the response portion 9. The welding temperature is about 150 ° C to about 170 ° C for transparent films 6, and 130 ° C to 150 ° C for opaque aluminum films.

As shown in FIG. As shown in FIG. 1B, the envelope 5 surrounding the upper container portion 1A is first partially open at one side at the opening 40. A gas or dry gas introduced through the orifice 40 is introduced into the space between the housing 5 and the upper vessel portion 1A, and the orifice 40 is closed. 13j. Fig. 2B shows the resultant two-chamber and two weak closure vessels of the present invention. In the previous embodiment, the welding temperatures at each joint are adjusted to an optimum range depending on the material of the film in question and the sealing force to be achieved. Accordingly, the above temperature ranges are not limiting.

While the present invention has been described with reference to embodiments thereof, the invention is not limited in any way by these embodiments, and the invention may be practiced in various ways within its scope.

Claims (11)

PATENT CLAIMS Multi-chamber receptacle for receiving liquid, powder or solid material, which is divided into compartments by separating elements, where necessary connecting between the compartments, characterized in that it comprises a flexible plastic receptacle body (1) forming a plurality of compartments (1a, lb). ; at least one chamber (1a) being surrounded by a sealed circumferential envelope (5) forming a closed space around the chamber; the other chamber (lb) and the other chambers having no shell (5); the cover (5) being made of a flexible film (6) having moisture and gas barrier properties; the separating members have at least one weak closing part (8a, 8b) which can be easily opened by increasing the internal pressure by pressing the chamber. Multi-chamber vessel according to claim 1, characterized in that at least two weak closure portions (8a, 8b) are provided at a distance from each other and the housing (5) has a welded edge portion (6c) adjacent to the weak sealing portions (8a, 8b). between. Multi-chamber vessel according to claim 1, characterized in that the envelope (5) contains gas or dry gas injected in the space (7) around the vessel body (1). Multi-chamber vessel according to claim 1, characterized in that the chamber (1a) provided with the housing (5) contains an oxidizing and / or hygroscopic liquid, powder or solid. Multi-chamber vessel according to claim 1, characterized in that the weak sealing portions (8a, 8b) are formed by direct welding of the opposing inner surfaces of the flexible plastic film (3) forming the vessel body (1). Multi-chamber vessel according to Claim 1, characterized in that the weak sealing portion (s) (8a, 8b) is formed between the opposing inner surfaces of the flexible plastic film (3) forming the vessel body (1) and the insert foil. is formed by welding. Multi-chamber vessel according to claim 1, characterized in that the vessel body (1) is formed from a flexible plastic film having an outer layer (31) of linear low density polyethylene, a linear low density polyethylene and ethylene. an intermediate layer of olefin elastomeric resin blend (33) and an inner layer of a linear low density polyethylene and polypropylene resin blend (34). Multi-chamber vessel according to Claim 1, characterized in that the shell (5) has a film layer of silica-coated resin. Multi-chamber vessel according to claim 1, characterized in that the housing (5) has an outer layer (43) of a biaxially oriented polyethylene terephthalate film, a silica-coated polyvinyl alcohol - an intermediate layer of film (44) and an inner layer (45) of low density polyethylene. Multi-chamber vessel according to Claim 1, characterized in that the outer surface of the housing (5) has an aluminum laminated film. Multi-chamber vessel according to claim 4, characterized in that the oxidizing and / or hygroscopic material is an antibiotic.