EP0065469B1 - Verfahren zur Gefriertrocknung von Flüssigkeiten und ihre Anwendung - Google Patents

Verfahren zur Gefriertrocknung von Flüssigkeiten und ihre Anwendung Download PDF

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Publication number
EP0065469B1
EP0065469B1 EP82400943A EP82400943A EP0065469B1 EP 0065469 B1 EP0065469 B1 EP 0065469B1 EP 82400943 A EP82400943 A EP 82400943A EP 82400943 A EP82400943 A EP 82400943A EP 0065469 B1 EP0065469 B1 EP 0065469B1
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EP
European Patent Office
Prior art keywords
liquid
neck
container
wall
bag
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.)
Expired
Application number
EP82400943A
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English (en)
French (fr)
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EP0065469A2 (de
EP0065469A3 (en
Inventor
Annie Bedout
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Individual
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Individual
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Publication date
Application filed by Individual filed Critical Individual
Priority to AT82400943T priority Critical patent/ATE36645T1/de
Publication of EP0065469A2 publication Critical patent/EP0065469A2/de
Publication of EP0065469A3 publication Critical patent/EP0065469A3/fr
Application granted granted Critical
Publication of EP0065469B1 publication Critical patent/EP0065469B1/de
Expired legal-status Critical Current

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    • 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
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing

Definitions

  • the subject of the invention is a method of packaging and using a liquid to be lyophilized in a flexible bag. It finds application in particular in the medical field where such a bag, constituting a container, can contain physiological liquids such as blood plasma, preserved in the lyophilized state.
  • Patent FR-A-2 456 674 presents such a bag intended to contain a medical liquid, for example a sodium chloride solution comprising two sheets of soft plastic material and a cylindrical body of rigid plastic material serving as a neck.
  • a medical liquid for example a sodium chloride solution
  • patent US-A-2,642,866 discloses a blood container produced using a single flexible sheet and a rigid neck fixed to said flexible sheet by the two ends of the sheet folded over one another.
  • patent GB-A-730,148 presents a freeze-drying container produced in the form of a glass container surmounted by a plug 15. The freeze-drying operation is carried out in a chamber, the plug being already engaged. in the neck but not being completely sealed so as to allow the evacuation of the vapor.
  • French patent FR-A-2 284 842 discloses a process for lyophilizing liquid products by using a flexible bag. This process makes it possible to package a flexible pouch composed of two thermally bonded walls comprising an opening by mechanical spacing at the two free ends of each wall. These bags containing the liquid to be lyophilized are deposited horizontally on supports. A device for spreading the walls allows, during the vaporization phase, the evaporation of the gases from the bag. This device has the disadvantage of requiring an installation with mechanical means for spacing the walls and in particular ensuring that the free ends of the two walls are raised enough to keep the liquid inside the pocket. This process is particularly used to make large doses, especially in the food sector.
  • the present invention provides a solution of considerable technical interest compared to pre-existing techniques by allowing lyophilization to be carried out directly in containers in the form of flexible bags in which the product can be stored, without transfer, from lyophilization to in use, under conditions of complete aseptic.
  • the container is partially filled with liquid
  • the container is placed in a substantially horizontal position on a support of the lyophilization device, so that a first wall and the neck are in contact with said support, the two walls being kept apart from each other only through the neck in the vicinity thereof,
  • the opening of the neck is hermetically sealed
  • said container is stored until direct use of the conditioned liquid.
  • the neck is closed by positioning a closure plug made of elastic material.
  • the flexible pouch is produced, most simply, by an envelope made of a flexible plastic material, sterilizable, and preferably transparent, formed of two flat sheets welded to one another around their periphery, except on one sides, at the point of passage of the neck, where they are each welded around half of the neck to surround it completely and ensure sealing.
  • the neck itself will generally also be made of plastic and its rigidity may be obtained, for example, by giving it a cylindrical shape with a sufficiently thick wall or by providing it with appropriate ribs.
  • an internal passage section with a diameter of at least 10 mm, preferably between 20 mm and 60 mm, for a liquid capacity of 100 ml to 2 liters, preferably with a section of the order from 0.001 to 0.05 times the internal surface of the pocket considered flat; the latter ratio is between 0.5% and 2% in the best cases.
  • a similar pocket can also be produced by blowing (of polyolefin or polyurethane resins for example) or by any other process suitable for generating a flexible plastic container with a large neck.
  • the spacing of the second wall is produced by mechanical means cooperating with said second wall. These means make it possible to separate the two walls of the flexible bag from one another and to keep them in this position, horizontally at a spacing distance which can be, for example, of the same order of magnitude as the diameter of the rigid neck, generally between 20 and 60 mm.
  • the lyophilization of any liquid is generally carried out in two essential stages.
  • the first consists in suddenly freezing the liquid, at a temperature below minus 30 ° C, and the second consists in extracting the water from the frozen liquid by sublimation by heating it under vacuum.
  • the usefulness of the temporary spacing means is felt from the first stage.
  • the bag containing the liquid to be frozen is placed in the lyophilization installation, in a substantially horizontal position, flat on a surface slightly inclined to the horizontal, or housed in a slightly hollow cavity, so that the liquid meets on one of the two opposite walls, and that the rigid neck is released from the volume of liquid and that the latter nevertheless offers a large free surface.
  • the spacing means make it possible to lift the upper wall above this free surface.
  • the subsequent sublimation step requires only a relatively short treatment time because the water sublimes quickly from this large free surface of the frozen liquid, advantageously kept free by lifting the upper wall of the bag by means of 'spacing, and the water vapor is easily evacuated through the orifice of the largely dimensioned neck.
  • Particular embodiments of the container according to the invention may comprise on the flexible pocket at least one tab or loop formed externally on at least one of the two opposite walls of the pocket.
  • tabs or loops can be designed to cooperate with, for example, a hook provided in the freeze-drying installation to lift the upper wall of the bag in its center, or with an independent stiffening element capable of being engaged through it and then maintain the top wall of the pocket in a bell shape.
  • the neck can advantageously be closed, after lyophilization, by a plug made of elastic material, in particular rubber, which can be punctured without breaking the '' sealing by an injection needle.
  • the container may be advantageous to provide the container with inlet and outlet fittings embedded in the plastic, which are ready to be put into service when the lyophilized liquid is reconstituted for use.
  • neither the neck provided for freeze-drying nor its stopper is useful once the freeze-drying has been carried out, and to facilitate storage and handling of the filled bags, it is often advantageous to eliminate this neck with its stopper by welding and cutting the walls under the base of the neck.
  • the container for lyophilized liquid is intended to receive blood plasma which is introduced in the liquid state before lyophilization, then which undergoes the lyophilization operations therein, is stored there in the lyophilized state, until the reconstitution of the liquid and its use made directly from the same container.
  • This container consists of a flexible plastic bag which is shown in plan in Figure 1.
  • the bag is limited by two opposite walls 1 (the upper wall only being visible in the figure) which are made of flexible sheets of material plastic such as polyvinyl chloride, joined to each other according to a welded joint plane 2, according to a substantially rectangular outline.
  • the container On one side of the pocket which can be designated as the upper side, as in the position adopted in the figure, the container has a neck 6, constituted by a cylindrical plastic nozzle, which is welded between the two sheets , so that it provides a sealed passage through the joint plane 2.
  • the wall of this cylindrical neck is thick enough to be rigid.
  • the neck 6 is closed on the outside of the container by a conventional closure assembly, of a type commonly used on other containers intended to contain physiological liquids, comprising a cap. of elastic material 8, protected by a metal capsule 7, crimped on an external annular projection 10 of the neck 6.
  • the plug 8 is made for example of rubber, its elasticity allowing it to be passed through by an injection needle without breaking the tight closure from the pocket.
  • the protective cap 7 com carries a tamper-evident tab 9, easy to tear to provide access to the stopper.
  • a light 3 is formed through the two sheets of plastic material welded together in the joint plane.
  • the figure also shows an example of a loop formed in the center of one of the walls 1 of the pocket, by a tab 4 arranged longitudinally and welded at its ends 5 to the plastic sheet constituting this wall.
  • the pocket is firstly partially filled with plasma to be lyophilized, while it is suspended by the neck 6 in the vertical position of the figure.
  • the neck remaining open the pocket is placed flat on a horizontal support, however slightly inclined to keep the neck 6 out of the liquid volume, just above the free level of the liquid.
  • the latter covers a surface which corresponds substantially to that of the walls 1.
  • the lower wall on which the container is lying in this position is that which does not include the tab 4.
  • an element is engaged which may in particular be a hook provided in the freeze-drying installation and which makes it possible to lift the upper wall of the bag so as to free it from the free level of liquid.
  • the container is brought into this position in the freeze dryer.
  • the liquid plasma is frozen there by sudden cooling to a temperature of minus 40 to minus 80 ° C.
  • the frozen product is reheated to, for example, 27 ° C. while maintaining a vacuum of the order of 0.2 to 0.1 torr in the freeze dryer. The product is thus freed from the water it contains by sublimation.
  • the bag is closed by placing the plug 8 on the neck 6, then crimping the capsule 7.
  • the container as shown can be produced with necks having an internal diameter of 25 mm or 20 to 30 mm in dimensions ranging from 10 cm to 17 cm for the width and from 15 cm to 30 cm for the length. These dimensions are particularly suitable for capacities of between 200 and 500 ml of plasma to be lyophilized. But it is also possible to adapt the container to capacities outside these limits by varying the dimensions of the pocket and those of the neck.
  • the container according to the invention has all the advantages of flexible, flat pockets, compared to rigid bottles. In addition, it even has advantages for lyophilization on them: it is complete and rapid thanks to the large exchange surface offered by the free level of the product when the liquid has been allowed to spread in the coated pocket at dish.
  • the container according to the invention can be produced in numerous variants compared to the embodiment which has been described and shown.
  • the tab 4 is only one example among the many means which can be used to allow, temporarily during freeze-drying, to separate the two walls of the flexible bag from one another by lifting the upper wall .
  • the leg 4 could be replaced by several analogous legs juxtaposed or by a flexible continuous duct welded transversely to the upper wall, and the cooperating suspension hook could be replaced by a rigid curved metal element or by a U-shaped pin.
  • one of the branches would be linked in this way temporarily to the upper wall while the other would be linked in the same way to the lower wall of the pocket.
  • the container is not used only for lyophilization of physiological liquids but that it can also be used for other liquids, pharmaceutical or food products for example.
  • the pocket is from the outset devoid of the tab 4 of the previous embodiment. It has indeed been found that the best solution for obtaining the necessary spacing during freezing of the upper wall of the bag is to inflate the container beforehand, by injection of an inert gas under pressure.
  • This gas can for example be nitrogen, which is introduced into the pocket of the same way as the liquid, by a filling needle passing through the plug of elastic material.
  • the container of FIG. 2 comprises, in addition to the previous one, on the side opposite the neck, two fittings embedded in the plastic of the walls. These two connections 11 and 12 are intended to serve for the entry of water and the exit of the reconstituted liquid when the latter is used. Just cut the plastic extensions that surround them to clear the end of each fitting.
  • Each comprises a tube 13 made of rigid plastic, provided with a safety membrane 14 which ensures the sterility of the content until the last moment.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Vaporization, Distillation, Condensation, Sublimation, And Cold Traps (AREA)
  • Drying Of Solid Materials (AREA)

Claims (7)

1. Verfahren zur Konditionierung und zur Anwendung einer Flüssigkeit, das auch ihre Gefriertrocknung umfasst, innerhalb dessen
- man zur Aufnahme der Flüssigkeit während der Konditionierung und während der Anwendung denselben Behälter verwendet, der in Form eines weichen Beutels realisiert ist, der eine erste und eine zweite Wand (1) besitzt, die entlang ihrer äusseren Kontur 82) verschweisst sind, um eine Hülle und einen festen Hals (6) zu bilden, der diese Hülle abdichtend durchbricht, um so eine Öffnung der Hülle zu bilden.
- und während der Verpackensphase:
man teilweise den Behälter mit der Flüssigeit füllt,
man den Behälter in einer im wesentlichen horizontalen Position auf einem Support der Gefriertrocknungseinrichtung anordnet, so dass eine erste Wand und der Hals mit dem Support in Kontakt sind und die beiden Wände gegeneinander nur durch den Hals in dessen Bereich auseinandergespreizt sind,
man die zweite Wand in dem Bereich anhebt, der nicht auseinandergespreizt ist, so dass die Flüssigkeit, die im wesentlichen auf der ersten Trennwand aufliegt, ihre Oberfläche frei liegen hat ausser dort, wo sie in Kontakt mit der zweiten Trennwand ist,
man die Flüssigkeit bis zum Gefrieren abkühlt,
- man sie im Vakuum erwärmt, wobei durch den Hals der sublimierte Dampf dem Gefriergut entzogen wird,
man die Öffnung des Halses hermetisch verschliesst,
man den Behälter bis zur unmittelbaren Benutzung der konditionierten Flüssigkeit aufbewahrt;
- und während der Benutzungsphase:
man die Flüssigkeit rekonstituiert, indem man Wasser in den Behälter gibt, ohne die Wasserdichtigkeit zu zerstören,
man aus dem Behälter die rekonstituierte Flüssigkeit entnimmt.
2. Verfahren nach Anspruch 1, dadurch gekennzeichnet, dass man den Hals durch das Einstekken eines Stopfens (8) verschliesst, der aus elastischem Material besteht.
3. Verfahren nach Anspruch 2, dadurch gekennzeichnet, dass man Wasser mittels einer Nadel durch den Stopfen in die Hülle unter hermetischem Verschluss injiziert und dass man auf die gleiche Weise die rekonstituierte Flüssigkeit entnimmt.
4. Verfahren gemäss Anspruch 1, dadurch gekennzeichnet, dass das Abspreizen der zweiten Wand durch mechanische Mittel erfolgt, die mit der zweiten Trennwand zusammenwirken.
5. Verfahren gemäss Anspruch 1, dadurch gekennzeichnet, dass das Abspreizen der zweiten Wand durch Injektion von Inertgas unter Druck durch eine Verschlussvorrichtung des Halses bewirkt wird, die vor der Phase der Konditionierung angebracht wird, wobei diese Verschlussvorrichtung eine erste Position zum Einfüllen von Flüssigkeit und Gas in den Beutel besitzt.
6. Verfahren gemäss Anspruch 5, dadurch gekennzeichnet, dass das Evakuieren der Gase während der Konditionierungsphase durch die Einstellung der genannten Verschlussvorrichtung in einer zweiten Position erfolgt, wobei ein Evakuierungsrohr angeschlossen ist.
7. Verfahren nach einem der vorstehenden Ansprüche 1-6, dadurch gekennzeichnet, dass man nach der Konditionierungsphase den Hals von dem Rest des Beutels, der das gefriergetrocknete Produkt enthält, abtrennt, und den Beutel luftdicht verschliesst, wobei dieser dazu Eintritts- und Austrittsanschlüsse für die Benutzungsphase, die Rekonstitution und die Entnahme der Flüssigkeit besitzt.
EP82400943A 1981-05-20 1982-05-19 Verfahren zur Gefriertrocknung von Flüssigkeiten und ihre Anwendung Expired EP0065469B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT82400943T ATE36645T1 (de) 1981-05-20 1982-05-19 Verfahren zur gefriertrocknung von fluessigkeiten und ihre anwendung.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR8110069A FR2506264A1 (fr) 1981-05-20 1981-05-20 Recipient sous forme de poche souple pour liquide a lyophiliser et procede d'utilisation
FR8110069 1981-05-20

Publications (3)

Publication Number Publication Date
EP0065469A2 EP0065469A2 (de) 1982-11-24
EP0065469A3 EP0065469A3 (en) 1983-06-22
EP0065469B1 true EP0065469B1 (de) 1988-08-24

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ID=9258695

Family Applications (1)

Application Number Title Priority Date Filing Date
EP82400943A Expired EP0065469B1 (de) 1981-05-20 1982-05-19 Verfahren zur Gefriertrocknung von Flüssigkeiten und ihre Anwendung

Country Status (4)

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EP (1) EP0065469B1 (de)
AT (1) ATE36645T1 (de)
DE (1) DE3278928D1 (de)
FR (1) FR2506264A1 (de)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6378714B1 (en) 1998-04-20 2002-04-30 Becton Dickinson And Company Transferset for vials and other medical containers
US6378576B2 (en) 1998-02-26 2002-04-30 Becton Dickinson And Company Vial transferset and method
US6382442B1 (en) 1998-04-20 2002-05-07 Becton Dickinson And Company Plastic closure for vials and other medical containers
US6681946B1 (en) 1998-02-26 2004-01-27 Becton, Dickinson And Company Resealable medical transfer set

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4973327A (en) * 1989-11-01 1990-11-27 Cryopharm Blood bag for lyophilization
DE4405965C2 (de) * 1994-02-24 1997-08-07 Bernd Hansen Infusionsbehälter mit zwei Anschlüssen
US5871110A (en) * 1996-09-13 1999-02-16 Grimard; Jean-Pierre Transfer assembly for a medicament container having a splashless valve
US5925029A (en) * 1997-09-25 1999-07-20 Becton, Dickinson And Company Method and apparatus for fixing a connector assembly onto a vial with a crimp cap
US6213994B1 (en) 1997-09-25 2001-04-10 Becton Dickinson France, S.A. Method and apparatus for fixing a connector assembly onto a vial
US6090093A (en) * 1997-09-25 2000-07-18 Becton Dickinson And Company Connector assembly for a vial having a flexible collar
GB2361709A (en) * 2000-04-26 2001-10-31 Moorlodge Biotech Ventures Ltd Vessel for transporting micro organisms

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2642866A (en) * 1951-02-03 1953-06-23 Arthur F Smith Blood container and method of making the same
CH323689A (fr) * 1953-07-31 1957-08-15 Antoine Rieutord Louis Marie Procédé de contrôle de la dessiccation d'un corps sous vide et dispositif pour la mise en oeuvre de ce procédé
GB730148A (en) * 1953-08-04 1955-05-18 Armour & Co Improvements in or relating to closures for lyophilization containers
GB1428373A (en) * 1972-06-12 1976-03-17 Smith & Nephew Res Containers
DE2437788A1 (de) * 1974-08-06 1976-03-04 Behringwerke Ag Verfahren zur herstellung eines steril verschlossenen behaelters mit gefriergetrocknetem material
FR2284842A1 (fr) * 1974-09-11 1976-04-09 Nestle Sa Perfectionnement apporte la lyophilisation des produits solides, liquides ou pateux
JPS5841964Y2 (ja) * 1979-05-18 1983-09-22 テルモ株式会社 プラスチック製薬液容器

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6378576B2 (en) 1998-02-26 2002-04-30 Becton Dickinson And Company Vial transferset and method
US6681946B1 (en) 1998-02-26 2004-01-27 Becton, Dickinson And Company Resealable medical transfer set
US6378714B1 (en) 1998-04-20 2002-04-30 Becton Dickinson And Company Transferset for vials and other medical containers
US6382442B1 (en) 1998-04-20 2002-05-07 Becton Dickinson And Company Plastic closure for vials and other medical containers
US6626309B1 (en) 1998-04-20 2003-09-30 Becton Dickinson France S.A. Transfer set

Also Published As

Publication number Publication date
FR2506264B1 (de) 1985-01-04
EP0065469A2 (de) 1982-11-24
DE3278928D1 (en) 1988-09-29
FR2506264A1 (fr) 1982-11-26
EP0065469A3 (en) 1983-06-22
ATE36645T1 (de) 1988-09-15

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