EP0065469A2 - 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
EP0065469A2
EP0065469A2 EP82400943A EP82400943A EP0065469A2 EP 0065469 A2 EP0065469 A2 EP 0065469A2 EP 82400943 A EP82400943 A EP 82400943A EP 82400943 A EP82400943 A EP 82400943A EP 0065469 A2 EP0065469 A2 EP 0065469A2
Authority
EP
European Patent Office
Prior art keywords
liquid
neck
container
pocket
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.)
Granted
Application number
EP82400943A
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English (en)
French (fr)
Other versions
EP0065469B1 (de
EP0065469A3 (en
Inventor
Annie Bedout
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.)
Individual
Original Assignee
Individual
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
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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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
    • A61J1/05—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 invention relates to a container for liquid to be lyophilized produced in the form of a flexible bag. It finds application in particular in the medical field, where such a container may contain physiological liquids such as blood plasma, preserved in the lyophilized state.
  • the invention therefore provides a solution of considerable technical interest by allowing lyophilization to be carried out directly in receptacles in the form of flexible bags in which the product can be stored, without transfer, from lyophilization to use, under conditions of complete aseptic.
  • the invention provides a container for liquid to be lyophilized produced in the form of a flexible bag, characterized in that it comprises a rigid neck sealingly passing through the envelope of the flexible bag, largely dimensioned to allow the evacuation of the vapor produced during the lyophilization of a liquid received in the bag.
  • 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 the one side, at the step 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 can be obtained for example by giving it a cylindrical shape with sufficiently thick walls or er. providing it with appropriate ribs.
  • an internal passage section with a diameter of at least 10mm, preferably between 20 mm and 60 mm, for a liquid capacity of 100 ml to 2 liters, preferably with a section of the order of 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.
  • means are also provided to allow the bag to be kept in an inflated position, temporarily during the lyophilization operations.
  • These are means which can be described as "mechanical” and which make it possible to separate two opposite walls of the flexible bag from one another and to keep them in this position, horizontally at a distance l one of the other which can be, for example, of the same order of magnitude as the diameter of the rigid neck, is generally between 20 and 60 millimeters.
  • the lyophilization of any liquid is generally carried out in two essential stages.
  • the first consists in freezing the liquid suddenly, 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 utility The unity of the temporary spacing means is felt from the first step.
  • 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 clear 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 outwardly 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 for lifting 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 be advantageously closed, after lyophilization, by a plug made of elastic face, in particular in rubber, which can be perforated without breaking the seal 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.
  • the neck provided for lyophilization or its stopper are L tiles once performed lyophilization, and to facilitate the storage and handling of filled pouches is often advantageous to élimirer this neck with its stopper by welding and cut walls under the base of the neck.
  • the lyophilized liquid container 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 L : liquid and its use which is carried out 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 shown 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 making it possible to pass through it by an injection needle without breaking the tight closure this pocket.
  • the protective cap 7 has a tamper-evident tab 9, which is easy to tear to provide access to the stopper.
  • a lumen 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 bag is first of all 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 lyophilization installation and which allows the upper wall of the bag to be raised 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 empties 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 pocket is closed by fitting 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. 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 many ways 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 in the same way as the liquid, by a filling needle passing through the material cap. elastic.
  • a plug having two positions, one completely closing the neck, the other releasing a gas evacuation duct. It is in this second position that the plug is brought in for the lyophilization operation, so that the vapor is evacuated through the cleared conduit.
  • the container of Figure 2 on the other hand, in addition to the previous one, on the side opposite the neck, has 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. It is enough to cut off the plastic extensions which cover 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.

Landscapes

  • 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)
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
FR8110069 1981-05-20
FR8110069A FR2506264A1 (fr) 1981-05-20 1981-05-20 Recipient sous forme de poche souple pour liquide a lyophiliser et procede d'utilisation

Publications (3)

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

Family

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)

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

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0426475A1 (de) * 1989-11-01 1991-05-08 Cryopharm Corporation Blutbeutel zur Gefriertrocknung und Verfahren zur Verwendung
DE4405965A1 (de) * 1994-02-24 1995-08-31 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
US6003566A (en) * 1998-02-26 1999-12-21 Becton Dickinson And Company Vial transferset and method
US6090093A (en) * 1997-09-25 2000-07-18 Becton Dickinson And Company Connector assembly for a vial having a flexible collar
US6213994B1 (en) 1997-09-25 2001-04-10 Becton Dickinson France, S.A. Method and apparatus for fixing a connector assembly onto a vial
GB2361709A (en) * 2000-04-26 2001-10-31 Moorlodge Biotech Ventures Ltd Vessel for transporting micro organisms

Families Citing this family (3)

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

Citations (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
GB730148A (en) * 1953-08-04 1955-05-18 Armour & Co Improvements in or relating to closures for lyophilization containers
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
FR2281276A1 (fr) * 1974-08-06 1976-03-05 Behringwerke Ag Procede de fabrication d'un recipient pour matiere lyophilisee ferme dans des conditions steriles
GB1428373A (en) * 1972-06-12 1976-03-17 Smith & Nephew Res Containers
FR2284842A1 (fr) * 1974-09-11 1976-04-09 Nestle Sa Perfectionnement apporte la lyophilisation des produits solides, liquides ou pateux
FR2456674A1 (fr) * 1979-05-18 1980-12-12 Terumo Corp Recipient en matiere plastique pour liquide medical

Patent Citations (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
FR2281276A1 (fr) * 1974-08-06 1976-03-05 Behringwerke Ag Procede de fabrication d'un recipient pour matiere lyophilisee ferme dans des conditions steriles
FR2284842A1 (fr) * 1974-09-11 1976-04-09 Nestle Sa Perfectionnement apporte la lyophilisation des produits solides, liquides ou pateux
FR2456674A1 (fr) * 1979-05-18 1980-12-12 Terumo Corp Recipient en matiere plastique pour liquide medical

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0426475A1 (de) * 1989-11-01 1991-05-08 Cryopharm Corporation Blutbeutel zur Gefriertrocknung und Verfahren zur Verwendung
DE4405965A1 (de) * 1994-02-24 1995-08-31 Bernd Hansen Infusionsbehälter mit zwei Anschlüssen
US5520677A (en) * 1994-02-24 1996-05-28 Hansen; Bernd Infusion container with two connections
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
US6090093A (en) * 1997-09-25 2000-07-18 Becton Dickinson And Company Connector assembly for a vial having a flexible collar
US6213994B1 (en) 1997-09-25 2001-04-10 Becton Dickinson France, S.A. Method and apparatus for fixing a connector assembly onto a vial
US6003566A (en) * 1998-02-26 1999-12-21 Becton Dickinson And Company Vial transferset and method
GB2361709A (en) * 2000-04-26 2001-10-31 Moorlodge Biotech Ventures Ltd Vessel for transporting micro organisms

Also Published As

Publication number Publication date
EP0065469B1 (de) 1988-08-24
EP0065469A3 (en) 1983-06-22
FR2506264A1 (fr) 1982-11-26
ATE36645T1 (de) 1988-09-15
DE3278928D1 (en) 1988-09-29
FR2506264B1 (de) 1985-01-04

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