WO1993021890A1 - Poche dotee de chambres multiples - Google Patents

Poche dotee de chambres multiples Download PDF

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Publication number
WO1993021890A1
WO1993021890A1 PCT/JP1993/000558 JP9300558W WO9321890A1 WO 1993021890 A1 WO1993021890 A1 WO 1993021890A1 JP 9300558 W JP9300558 W JP 9300558W WO 9321890 A1 WO9321890 A1 WO 9321890A1
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WO
WIPO (PCT)
Prior art keywords
chamber
container
cover
chambers
weak seal
Prior art date
Application number
PCT/JP1993/000558
Other languages
English (en)
Japanese (ja)
Inventor
Fujio Inoue
Masamitsu Izumi
Shigetoshi Kashiyama
Original Assignee
Otsuka Pharmaceutical Factory, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26405772&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO1993021890(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to EP93911945A priority Critical patent/EP0639364B1/fr
Priority to DE69325801T priority patent/DE69325801T2/de
Priority to DK93911945T priority patent/DK0639364T3/da
Priority to CA002112661A priority patent/CA2112661C/fr
Priority to RU93058573A priority patent/RU2103987C1/ru
Application filed by Otsuka Pharmaceutical Factory, Inc. filed Critical Otsuka Pharmaceutical Factory, Inc.
Priority to KR1019940700005A priority patent/KR100209830B1/ko
Priority to US08/170,215 priority patent/US5423421A/en
Priority to AU42709/93A priority patent/AU654442B2/en
Publication of WO1993021890A1 publication Critical patent/WO1993021890A1/fr
Priority to NO934910A priority patent/NO303815B1/no
Priority to FI935972A priority patent/FI107694B/fi
Priority to GR990402171T priority patent/GR3031088T3/el

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3261—Flexible containers having several compartments
    • B65D81/3266—Flexible containers having several compartments separated by a common rupturable seal, a clip or other removable fastening device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2024—Separating means having peelable seals

Definitions

  • 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.
  • 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.
  • 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.
  • a desiccant absorbs the moisture of the liquid, the moisture-absorbent drug cannot be dried sufficiently, and the liquid concentrates.
  • 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.
  • 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.
  • 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).
  • an amino acid solution containing tryptophan and a sugar / electrolyte solution for example, see Japanese Patent Publication No. 63-250550.
  • a chemical agent sucgar and electrolyte solution
  • 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.
  • 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.
  • a multi-compartment container characterized by being formed of at least one weak seal portion which can be easily peeled off.
  • 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.
  • the stored contents can be stored for a long time like ordinary plastic containers.
  • 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.
  • a drug that is hygroscopic and unstable over time such as an antibiotic
  • a liquid such as a dissolving solution or a diluting solution. It can be applied without any hindrance to the intended use.
  • 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.
  • the increase in packaging costs can be minimized.
  • the cost can be reduced.
  • 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.
  • 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.
  • 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.
  • 1 and 2 show an example of the embodiment of the present invention of a two weak seal portion type.
  • 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.
  • 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.
  • PE polyethylene
  • PP polypropylene
  • 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.
  • a special film 6 having excellent moisture and gas impermeability.
  • 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.
  • the cover 5 is composed of two special films 6, 6 arranged so as to cover the periphery of the upper container 1A.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the three sides of the cover 5 are welded to the upper container 1 A using the special film shown in FIG. 5
  • 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.
  • welding is performed.
  • One side of the cover 5 is opened like the one side of the upper container 1A.
  • 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.
  • 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.
  • liquid is stored in container 1A with cover 5 and liquid or powder is stored in container 1B without cover
  • a predetermined substance is accommodated in each of the container parts 1A and 1B, and after filling holes are closed, heat sterilization is performed.
  • the cover 5 may be attached to the upper container 1A, and the side opening of the cover may be sealed.
  • 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 cover 5 made of a special film of moisture and gaseous uniformity
  • 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.
  • 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.
  • 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 / ⁇ -polyethylene.
  • LLDPE linear low-density polyethylene
  • the middle layer 33 is composed of LLDPE and low-crystalline (or non-crystalline) ethylene / ⁇ -polyethylene.
  • 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.
  • 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.
  • HDPE high-density polyethylene
  • 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.
  • the outer layer 43 was biaxially stretched as shown in FIG.
  • the intermediate layer 44 is silica-deposited PVA
  • the inner layer 45 is low-density polyethylene (LDPE)
  • each layer is a three-layer film 46 fixed with urethane-based adhesive resin.
  • Permeable and gas impermeable barrier films can be mentioned.
  • the cover 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.
  • 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.
  • cysteine or tributophane are used as the former liquid, respectively.
  • 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.
  • the former liquid preparation such as a fat emulsion
  • a liquid oxidizing substance, for the latter liquid agent is a sugar-electrolyte solution or the like.
  • 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).
  • 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.
  • the aluminum processed film used for the cover may be partly or entirely peelable as needed at the time of use.
  • 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.
  • the air in the space is replaced with the inert gas, so that the effect of preventing oxidation is roughly ensured.
  • 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.
  • the space between the container body and the cover can be further protected by inert gas or drying.
  • 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.
  • 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.
  • 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.
  • 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.
  • ⁇ 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
  • 19 is the opposite side.
  • the film 3 is a single-layer film of PE or PP
  • 18 is the same sheet of PE or PP
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • one of the films 6, 6 is transparent and the other is opaque.
  • 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.
  • the width of the welded portion l A t the peripheral especially both side portions of the upper container section 1 A 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.
  • 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.
  • 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.
  • 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.

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  • General Health & Medical Sciences (AREA)
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Abstract

Une poche, dotée de plusieurs chambres, s'utilise essentiellement dans le domaine médical. L'intérieur du corps principal de cette poche de matière plastique souple est compartimenté en plusieurs chambres grâce à l'utilisation d'un dispositif de comportimentage qui permet une communication appropriée entre lesdites chambres délimitées par les parties respectives de cette poche de matière plastique souple. Une partie de la poche au moins est dépourvue de recouvrement et une autre partie est pourvue d'un recouvrement, lequel recouvre la partie périphérique de ladite partie par un espace dûment étanchéifié constitué par un film souple étanche à l'humidité et aux gaz. Ceci permet d'obtenir une poche facile à éliminer, dotée de plusieurs chambres, économique, dont les qualités et caractéristiques sont de haute tenue.
PCT/JP1993/000558 1992-05-03 1993-04-28 Poche dotee de chambres multiples WO1993021890A1 (fr)

Priority Applications (11)

Application Number Priority Date Filing Date Title
AU42709/93A AU654442B2 (en) 1992-05-03 1993-04-28 Vessel having a plurality of chambers
DE69325801T DE69325801T2 (de) 1992-05-03 1993-04-28 Behälter mit einer vielzahl von kammern
DK93911945T DK0639364T3 (da) 1992-05-03 1993-04-28 Beholder med et antal kamre
CA002112661A CA2112661C (fr) 1992-05-03 1993-04-28 Recipient a compartiments multiples
RU93058573A RU2103987C1 (ru) 1992-05-03 1993-04-28 Многокамерная емкость
EP93911945A EP0639364B1 (fr) 1992-05-03 1993-04-28 Poche dotee de chambres multiples
KR1019940700005A KR100209830B1 (ko) 1992-05-03 1993-04-28 다수의 챔버를 갖는 저장용기
US08/170,215 US5423421A (en) 1992-05-03 1993-04-28 Containers having plurality of chambers
NO934910A NO303815B1 (no) 1992-05-03 1993-12-30 Beholder med flere kammere
FI935972A FI107694B (fi) 1992-05-03 1993-12-31 Säiliö, jossa on useita kammioita aineen säilyttämiseksi
GR990402171T GR3031088T3 (en) 1992-05-03 1999-08-26 Vessel having a plurality of chambers.

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP14011392 1992-05-03
JP4/140113 1992-05-03
JP5/64669 1993-02-28
JP6466993A JP3079403B2 (ja) 1992-05-03 1993-02-28 複室容器

Publications (1)

Publication Number Publication Date
WO1993021890A1 true WO1993021890A1 (fr) 1993-11-11

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ID=26405772

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP1993/000558 WO1993021890A1 (fr) 1992-05-03 1993-04-28 Poche dotee de chambres multiples

Country Status (21)

Country Link
EP (1) EP0639364B1 (fr)
JP (1) JP3079403B2 (fr)
CN (1) CN1065742C (fr)
AT (1) ATE182464T1 (fr)
AU (1) AU654442B2 (fr)
CA (1) CA2112661C (fr)
DE (1) DE69325801T2 (fr)
DK (1) DK0639364T3 (fr)
EG (1) EG20103A (fr)
ES (1) ES2133399T3 (fr)
FI (1) FI107694B (fr)
GR (1) GR3031088T3 (fr)
HU (1) HU216406B (fr)
NO (1) NO303815B1 (fr)
PH (1) PH31343A (fr)
PL (1) PL172973B1 (fr)
PT (1) PT101262B (fr)
RU (1) RU2103987C1 (fr)
SG (1) SG44684A1 (fr)
TW (1) TW216768B (fr)
WO (1) WO1993021890A1 (fr)

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* Cited by examiner, † Cited by third party
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US5462526A (en) * 1993-09-15 1995-10-31 Mcgaw, Inc. Flexible, sterile container and method of making and using same
EP2226058B2 (fr) † 1994-03-29 2016-01-20 Fresenius AG Sachet polymère à chambres multiples d'usage médical, avec compartiments séparés par une fermeture étanche thermoscellée pelable
WO2010081174A2 (fr) * 2009-01-12 2010-07-15 Aktivpak, Inc. Produits emballés, inserts et compartiments pour le mélange aseptique de substances, ainsi que procédés pour l'utilisation avec ceux-ci
WO2010081174A3 (fr) * 2009-01-12 2010-10-14 Aktivpak, Inc. Produits emballés, inserts et compartiments pour le mélange aseptique de substances, ainsi que procédés pour l'utilisation avec ceux-ci
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CN114194576B (zh) * 2021-02-08 2023-08-25 杭州圣石科技股份有限公司 一种可实现内部气体自由交换的密封防潮包装及工艺

Also Published As

Publication number Publication date
HU9400012D0 (en) 1994-05-30
TW216768B (en) 1993-12-01
AU654442B2 (en) 1994-11-03
PT101262A (pt) 1994-06-30
EP0639364B1 (fr) 1999-07-28
HUT68420A (en) 1995-06-28
NO303815B1 (no) 1998-09-07
EG20103A (en) 1997-07-31
SG44684A1 (en) 1997-12-19
FI935972A0 (fi) 1993-12-31
EP0639364A4 (fr) 1994-10-24
FI107694B (fi) 2001-09-28
ATE182464T1 (de) 1999-08-15
PT101262B (pt) 1999-10-29
PL172973B1 (pl) 1997-12-31
AU4270993A (en) 1993-11-29
PL298768A1 (en) 1994-03-21
NO934910L (no) 1994-01-26
EP0639364A1 (fr) 1995-02-22
NO934910D0 (no) 1993-12-30
JP3079403B2 (ja) 2000-08-21
ES2133399T3 (es) 1999-09-16
FI935972A (fi) 1994-02-24
DK0639364T3 (da) 1999-11-29
DE69325801T2 (de) 1999-11-18
GR3031088T3 (en) 1999-12-31
DE69325801D1 (de) 1999-09-02
JPH0614975A (ja) 1994-01-25
PH31343A (en) 1998-07-17
RU2103987C1 (ru) 1998-02-10
CN1065742C (zh) 2001-05-16
HU216406B (hu) 1999-06-28
CA2112661C (fr) 2002-02-26
CN1082881A (zh) 1994-03-02
CA2112661A1 (fr) 1993-11-11

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