EP3509956B1 - Logement pour contenant flexible - Google Patents

Logement pour contenant flexible Download PDF

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Publication number
EP3509956B1
EP3509956B1 EP18705541.3A EP18705541A EP3509956B1 EP 3509956 B1 EP3509956 B1 EP 3509956B1 EP 18705541 A EP18705541 A EP 18705541A EP 3509956 B1 EP3509956 B1 EP 3509956B1
Authority
EP
European Patent Office
Prior art keywords
housing
foam
container
arrangement according
flexible container
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
EP18705541.3A
Other languages
German (de)
English (en)
Other versions
EP3509956A1 (fr
Inventor
Thomas Wurm
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Single Use Support GmbH
Original Assignee
Single Use Support GmbH
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
Priority claimed from ATGM50100/2017U external-priority patent/AT15857U1/de
Application filed by Single Use Support GmbH filed Critical Single Use Support GmbH
Priority to EP22153960.4A priority Critical patent/EP4032824A1/fr
Publication of EP3509956A1 publication Critical patent/EP3509956A1/fr
Application granted granted Critical
Publication of EP3509956B1 publication Critical patent/EP3509956B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/02—Internal fittings
    • B65D25/10—Devices to locate articles in 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
    • A61J1/1468—Containers characterised by specific material properties
    • 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
    • A61J1/16—Holders for containers
    • A61J1/165—Cooled holders, e.g. for medications, insulin, blood, plasma
    • 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
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/14—Linings or internal coatings
    • 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
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/02—Wrapped articles enclosed in rigid or semi-rigid containers
    • 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
    • B65D77/00—Packages formed by enclosing articles or materials in preformed containers, e.g. boxes, cartons, sacks or bags
    • B65D77/04—Articles or materials enclosed in two or more containers disposed one within another
    • B65D77/06—Liquids or semi-liquids or other materials or articles enclosed in flexible containers disposed within rigid containers
    • 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
    • B65D81/02—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 specially adapted to protect contents from mechanical damage
    • B65D81/022—Containers made of shock-absorbing material
    • 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
    • B65D81/02—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 specially adapted to protect contents from mechanical damage
    • B65D81/05—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 specially adapted to protect contents from mechanical damage maintaining contents at spaced relation from package walls, or from other contents
    • B65D81/107—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 specially adapted to protect contents from mechanical damage maintaining contents at spaced relation from package walls, or from other contents using blocks of shock-absorbing material
    • B65D81/113—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 specially adapted to protect contents from mechanical damage maintaining contents at spaced relation from package walls, or from other contents using blocks of shock-absorbing material of a shape specially adapted to accommodate contents
    • 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
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • 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

Definitions

  • the present invention relates to an arrangement made up of a housing and a flexible container arranged therein and filled with a liquid, in particular a drug.
  • a liquid in particular a drug.
  • other liquids that occur in the (bio)pharmaceutical production process can also be transported using a flexible container in such a housing.
  • the DE 2258163 A1 discloses a flexible container according to the preamble of claim 1 which can be emptied while maintaining a vacuum.
  • the EP 1 396 440 A1 discloses a carton in which packaging bags filled with liquid are stored. In order to cushion shocks, a thin layer of foam is provided in the box.
  • Flexible containers with which medicines are transported in a housing are also referred to as “single use bags”. This is mostly done in the frozen state, with the flexible container being placed in the housing prior to freezing. The liquid is then frozen by cooling the assembly.
  • the volume expansion during freezing (about 8%) creates a pressure on the housing and the flexible container that should not be underestimated. This introduces the risk of mechanical damage and consequent leakage of the mechanical container.
  • the object of the present invention is to reduce the mechanical stress on the flexible container and the housing compared to the prior art when freezing.
  • an elastic foam in other words: by at least one body made of elastic foam - with which the housing is lined. According to the invention, this essentially completely compensates for the volume expansion of the container arranged in the housing that occurs when it freezes.
  • a housing according to the invention in which a liquid, in particular a drug, is filled into the flexible container, the filled container is placed in the housing and the liquid is frozen by cooling the assembly of housing and container.
  • the flexible container does not have to be completely filled.
  • Liquids that can be transported in flexible containers are e.g. B. Protein solutions, end products of a purification, antibody solutions and other high-quality intermediate products in the pharmaceutical production cycle, as well as of course drugs themselves.
  • the foam has a decreasing elasticity with decreasing temperature below the freezing point. It can also be provided that the foam essentially cures at a temperature between 0°C and -30°C, preferably between -5°C and -25°C and particularly preferably between -10°C and -20°C .
  • the foam is designed in such a way that the curing process is reversible.
  • the elasticity of the foam is available again, thereby providing a degree of protection from impact on the flexible container when it is removed from the housing.
  • the housing can in principle be reused if desired.
  • the curing of the foam can also be referred to as setting. It is not a question of hardening during the production of the foam, but of changing the elasticity properties under the influence of cold.
  • the housing is lined with the foam in such a way that the container—preferably including any add-on parts—is completely surrounded by the foam when the container is arranged in the housing. This means that not only the flexible container, but also the attachments can be better protected against damage.
  • a foam block in the housing can be advantageous, which can accommodate the add-on parts (by deformation).
  • the housing can be essentially cuboid. This can facilitate easy stacking of the housing, for example.
  • the flexible container 2 is arranged inside the housing 1 .
  • the housing 1 is lined with foam 3 and a foam block 5 . If the liquid within the container 2 freezes, the container 2 expands. This expansion in volume is absorbed by the foam 3 and the foam block 5, so that between the container 2 and the housing 1 no tension—or at least an insignificant tension—is created.
  • Attachments 4, z. B. hoses and valves and the like are arranged above or within the foam block 5, which can accommodate them due to its elasticity or flexibility.
  • the housing 1 is designed to be completely enclosing.
  • the housing 1 can be made of plastic and/or metal.
  • the cover layers are each made of stainless steel and the side walls are made of polyethylene (specifically: high-density polyethylene, HDPE).
  • a closure or seal could also be attached, whereby manipulation during the transport process or in the warehouse can be ruled out or at least made visible.
  • the foam 3 can preferably be designed in such a way that it is relatively resilient and flexible at room temperature (and low negative temperatures) and hardens at lower temperatures ( ⁇ 15° C. and colder) and encloses the container 2 arranged in the housing 1 and protects it from relative movement .
  • the container 2 protected in this way cannot be bent or compressed because the movement relative to the housing 1 is prevented. As a result, breakage and leaks in the container 2 made of plastic, for example, can be prevented.
  • So-called visco-elastic foam for example, can be used as the foam, which hardens at certain negative temperatures.
  • housing 1 and filled container 2 can be frozen, for example, by contact cooling systems or circulating air cooling systems or in some other way.
  • contact cooling systems the top surfaces of the housing 1 (also referred to as the “shell”) lie on cooled surfaces.
  • circulating air cooling systems the housing 1 is flushed with cooled air.
  • the individual sides of the housing 1, in particular the top surfaces (that is to say at the top and bottom), can be made of relatively thin material, in particular steel, in order to achieve rapid heat conduction (or cold conduction).
  • the housing 1 according to the invention can be reused, in particular if the foam 3 is designed in such a way that curing at low temperatures is reversible.
  • the housing 1 can be easily dismantled for simple recycling measures.

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Food Science & Technology (AREA)
  • Buffer Packaging (AREA)
  • Packages (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)

Claims (9)

  1. Ensemble composé d'un boîtier (1) et d'un contenant (2) flexible disposé dans celui-ci et rempli d'un liquide, en particulier d'un médicament, dans lequel le boîtier (1) est habillé au moins en partie d'une mousse (3, 5) élastique, caractérisé en ce que le boîtier (1) est habillé de telle sorte avec la mousse (3, 5) qu'une expansion de volume survenant lors de la congélation du contenant (2) disposé dans le boîtier (1) est compensée sensiblement en totalité par la mousse (3, 5).
  2. Ensemble selon la revendication 1, caractérisé en ce que la mousse (3, 5) présente une baisse de l'élasticité au fur et à mesure que la température baisse sous le point de congélation.
  3. Ensemble selon l'une quelconque des revendications précédentes, caractérisé en ce que la mousse (3, 5) est choisie de telle sorte qu'elle durcit sensiblement à une température entre 0 °C à -30 °C, de manière préférée entre -5 °C et -25 °C et de manière particulièrement préférée entre -10 °C et -20 °C.
  4. Ensemble selon la revendication 3, caractérisé en ce que la mousse est choisie de telle sorte que le processus du durcissement est réversible.
  5. Ensemble selon l'une quelconque des revendications précédentes, caractérisé en ce que le boîtier (1) est habillé de telle sorte de la mousse (3, 5) que le contenant (2) - de préférence y compris d'éventuels composants rapportés (4) - est entouré en totalité de la mousse (3, 5) quand le contenant (2) est disposé dans le boîtier (1).
  6. Ensemble selon la revendication 5, caractérisé en ce qu'un bloc de mousse (5) est prévu dans le boîtier (1) pour loger les composants rapportés (4).
  7. Ensemble selon l'une quelconque des revendications précédentes, caractérisé en ce que le boîtier (1) est réalisé sensiblement en forme de carré.
  8. Utilisation d'un ensemble selon l'une quelconque des revendications 1 à 7, dans laquelle un liquide, en particulier un médicament, est rempli dans le contenant (2) flexible, le contenant (2) rempli est disposé dans le boîtier (1) et le liquide est congelé par le refroidissement de l'ensemble composé du boîtier (1) et du contenant (2).
  9. Utilisation selon la revendication 8, caractérisée en ce qu'au moins une couche supplémentaire de mousse (3, 5) est disposée dans le contenant (2) quand le contenant (2) flexible est rempli seulement à une partie de sa contenance.
EP18705541.3A 2017-01-16 2018-01-15 Logement pour contenant flexible Active EP3509956B1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP22153960.4A EP4032824A1 (fr) 2017-01-16 2018-01-15 Logement pour un récipient souple

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
AT600042017 2017-01-16
ATGM50100/2017U AT15857U1 (de) 2017-01-16 2017-05-24 Gehäuse für einen flexiblen Behälter
PCT/AT2018/060010 WO2018129576A1 (fr) 2017-01-16 2018-01-15 Logement pour contenant flexible

Related Child Applications (2)

Application Number Title Priority Date Filing Date
EP22153960.4A Division-Into EP4032824A1 (fr) 2017-01-16 2018-01-15 Logement pour un récipient souple
EP22153960.4A Division EP4032824A1 (fr) 2017-01-16 2018-01-15 Logement pour un récipient souple

Publications (2)

Publication Number Publication Date
EP3509956A1 EP3509956A1 (fr) 2019-07-17
EP3509956B1 true EP3509956B1 (fr) 2022-03-09

Family

ID=62839098

Family Applications (2)

Application Number Title Priority Date Filing Date
EP18705541.3A Active EP3509956B1 (fr) 2017-01-16 2018-01-15 Logement pour contenant flexible
EP22153960.4A Pending EP4032824A1 (fr) 2017-01-16 2018-01-15 Logement pour un récipient souple

Family Applications After (1)

Application Number Title Priority Date Filing Date
EP22153960.4A Pending EP4032824A1 (fr) 2017-01-16 2018-01-15 Logement pour un récipient souple

Country Status (5)

Country Link
US (3) US11207239B2 (fr)
EP (2) EP3509956B1 (fr)
CN (1) CN109890716B (fr)
DK (1) DK3509956T3 (fr)
WO (1) WO2018129576A1 (fr)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AT521596A1 (de) 2018-09-05 2020-03-15 Single Use Support Gmbh Kühlplattenanordnung und Verfahren
WO2020100028A1 (fr) 2018-11-12 2020-05-22 Smartfreez, Lda Isolant pour empêcher des dommages et une rupture de récipient provoqués par la congélation de solutions aqueuses contenant des matériaux biologiques
EP3926277A1 (fr) 2020-06-19 2021-12-22 Single Use Support GmbH Congélateur à plaques
EP3964453A1 (fr) 2020-09-02 2022-03-09 Single Use Support GmbH Conteneur pour réception d'un sac, procédé et utilisation
EP4014947A1 (fr) 2020-12-16 2022-06-22 Single Use Support GmbH Procédé de protection de tubes
EP4166884A1 (fr) 2021-10-15 2023-04-19 Single Use Support GmbH Plaque de refroidissement et procédé de fabrication d'une plaque de refroidissement
EP4169499A1 (fr) 2021-10-19 2023-04-26 Single Use Support GmbH Procédé et dispositif de refroidissement ou de chauffage de fluides bio-pharmaceutiques
CN114471754A (zh) * 2021-12-27 2022-05-13 利穗科技(苏州)有限公司 一种用于生物材料水溶液的容器

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Also Published As

Publication number Publication date
US20230157928A1 (en) 2023-05-25
US11602487B2 (en) 2023-03-14
EP3509956A1 (fr) 2019-07-17
US20220047457A1 (en) 2022-02-17
CN109890716B (zh) 2022-04-26
US20190224074A1 (en) 2019-07-25
EP4032824A1 (fr) 2022-07-27
CN109890716A (zh) 2019-06-14
WO2018129576A1 (fr) 2018-07-19
US11207239B2 (en) 2021-12-28
DK3509956T3 (da) 2022-04-11

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