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WO2011048031A1 - Contenant pour matériel pharmaceutique - Google Patents

Contenant pour matériel pharmaceutique Download PDF

Info

Publication number
WO2011048031A1
WO2011048031A1 PCT/EP2010/065571 EP2010065571W WO2011048031A1 WO 2011048031 A1 WO2011048031 A1 WO 2011048031A1 EP 2010065571 W EP2010065571 W EP 2010065571W WO 2011048031 A1 WO2011048031 A1 WO 2011048031A1
Authority
WO
WIPO (PCT)
Prior art keywords
carrier
plates
pharmaceutical
packaging
carrier according
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.)
Ceased
Application number
PCT/EP2010/065571
Other languages
German (de)
English (en)
Inventor
Michael Schorpp
Dorothee Ambrosius
Matthaeus Mueller
Franz Nothelfer
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.)
Boehringer Ingelheim International GmbH
Original Assignee
Boehringer Ingelheim International 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
Application filed by Boehringer Ingelheim International GmbH filed Critical Boehringer Ingelheim International GmbH
Publication of WO2011048031A1 publication Critical patent/WO2011048031A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D31/00—Other cooling or freezing apparatus
    • F25D31/001—Plate freezers
    • A—HUMAN NECESSITIES
    • A47—FURNITURE; DOMESTIC ARTICLES OR APPLIANCES; COFFEE MILLS; SPICE MILLS; SUCTION CLEANERS IN GENERAL
    • A47B—TABLES; DESKS; OFFICE FURNITURE; CABINETS; DRAWERS; GENERAL DETAILS OF FURNITURE
    • A47B3/00—Folding or stowable tables
    • A47B3/02—Folding or stowable tables with foldable cross legs
    • 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 or plasma
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2331/00—Details or arrangements of other cooling or freezing apparatus not provided for in other groups of this subclass
    • F25D2331/80—Type of cooled receptacles
    • F25D2331/801—Bags
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F28—HEAT EXCHANGE IN GENERAL
    • F28F—DETAILS OF HEAT-EXCHANGE AND HEAT-TRANSFER APPARATUS, OF GENERAL APPLICATION
    • F28F3/00—Plate-like or laminated elements; Assemblies of plate-like or laminated elements
    • F28F3/12—Elements constructed in the shape of a hollow panel, e.g. with channels
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F28—HEAT EXCHANGE IN GENERAL
    • F28F—DETAILS OF HEAT-EXCHANGE AND HEAT-TRANSFER APPARATUS, OF GENERAL APPLICATION
    • F28F9/00—Casings; Header boxes; Auxiliary supports for elements; Auxiliary members within casings
    • F28F9/007—Auxiliary supports for elements
    • F28F9/0075—Supports for plates or plate assemblies

Definitions

  • the invention relates to an apparatus for shipping, storing and handling frozen pharmaceutical products. More particularly, the invention relates to a container for shipping, storing and handling frozen biopharmaceutical material.
  • once-usable packaging materials are becoming increasingly important.
  • these once-usable packaging materials offer the advantage that they can be used across products, that the costly cleaning procedures are completely eliminated and the investment costs for new production plants can be reduced many times over.
  • Biopharmaceutical materials in liquid form are increasingly being filled in certain bags, once usable flexible plastic packaging materials
  • the bags consist of several plastic layers, each of which has different properties, including mechanical stability, flexibility, low gas permeability, etc Special characteristics must be the plastic layer that comes into direct contact with the product Films that currently have the most stable properties are eg EVA (Ethylene Vinyl Acetate) or LDPE (Low Density Poly Ethylene) outside (1) to the inside (9) are shown:
  • liquid storage in bags does not provide sufficient long-term stability so that the biopharmaceutical material can be minimized to minimize deleterious effects, e.g. chemical degradation must be frozen.
  • a sufficiently low storage temperature must be selected.
  • bags show greatly reduced mechanical stability. A small impact is usually sufficient to cause small cracks that lead to the total loss of content when the biopharmaceutical materials thaw.
  • 6,684,646; 6,698,213; 6,786,054 and 6,945,056) provides a protective frame in which the bag is frozen and protects it from impact from the side.
  • EnviroCooler® offers freezer containers, which are also designed to ensure safe transport under controlled temperature conditions, and which are described in US Pat. No. 5,924,302.
  • the fundamental disadvantage of this construction is the lack of specificity with regard to the geometry of the goods to be transported, the durability, the inability to clean and above all the further necessary packing of the frozen and thus extremely sensitive bags.
  • a solution for the lack of specificity with respect to the geometry is proposed in a document of the company Human Genome Sciences Inc. (WO2007 / 139873).
  • WO2007 / 139873 a special container is described, which corresponds to the exact dimensions of the CELSIUS® bags with associated frame. By using plastic materials, this container is easy to clean.
  • Figure 1 shows a carrier according to the invention with two plane-parallel plates (1), which are connected by two scissor hinges (2) with each other so that the distance between the plates is variable.
  • guides for the joint ends are set up on the plates.
  • a locking screw (3) By means of a locking screw (3), the joint and thus the distance between the plates can be fixed.
  • Figure 2 shows an embodiment with a molding (4) for suspending a bag.
  • FIG. 3 shows a carrier according to the invention, which is covered with a plastic sheath (6).
  • each joint means (3) contains, which allow a fixing of the joint.
  • a means is a locking screw or locking lever, optionally also a quick-release mechanism or a device for achieving a detected torque.
  • the plates are preferably made of a thermally conductive material, preferably of a metal, more preferably of steel, in particular V2A.
  • the dimensioning of the carrier is suitably adapted to the size of the bags used.
  • a good adaptation to common bag sizes for example, in a carrier with plate dimensions of 0.5 - 0.6 m x 0.7 -0.8 m (width x length), in a preferred embodiment 0.530 m x 0.710 m.
  • the joints can for example be designed so that a light plate spacing between 0.01 m and 0.30 m is adjustable.
  • At least one of the plates has means (4) for attaching a pharmaceutical container.
  • a means may be a suitable shape of the plate in the form of a hook or a recess, in which the bag can be hung.
  • the carrier has a carrying handle (5).
  • the carrier when the carrier contains the packaging material containing the biopharmaceutical material, the carrier may be enveloped in a protective sheath, preferably a plastic film, in particular a gas-impermeable plastic film.
  • a further embodiment therefore relates to the described carrier, characterized in that it is enveloped by a gas-impermeable plastic film (6).
  • the invention relates to a method for freezing pharmaceutical preparations which are liquid at temperatures above 0 ° C., in particular aqueous solutions of pharmaceutical active substances, comprising the steps a. a flexible pharmaceutical packaging material is placed between the plates of a carrier as described above, and optionally attached to the carrier, with a predetermined distance of the plates adjusted via the scissors hinges and the hinges fixed in this position;
  • the packaging material is filled with the liquid pharmaceutical preparation in an amount such that more than 50%, preferably more than 80%, of the surface of the packaging material rests on the plates in a conclusive manner;
  • the preparation is frozen in the package between the plates of the carrier using the plates of the carrier for heat exchange.
  • the pharmaceutical preparation thus treated is stored and / or transported in the frozen state in the carrier.
  • An advantage of the carrier according to the invention is that it allows the setting of a predefined distance of the plates and thus adaptable to different bag sizes and quantities.
  • the bag preferably a plastic bag, can be placed between the plates and is filled in the carrier with a quantity of fluid sized such that a majority of the bag surface has conclusive contact with the plates, preferably more than 50%, more preferably more than 80%. the bag surface.
  • This allows a good heat transfer through the plates as a heat exchanger in the freezing phase and an optimized storage volume.
  • the packaging-containing liquid is then frozen, expedient by the carrier with the packaging material and the liquid contained therein in a freezing (plate freezer) is introduced.
  • the present invention relates to a method for freezing pharmaceutical preparations that are liquid at temperatures above 0 ° C, in particular aqueous solutions of pharmaceutical agents, comprising the steps a. a carrier as described above is set to a maximum plate distance; b. a flexible pharmaceutical packaging filled with a liquid pharmaceutical preparation is introduced into the carrier; c. the plates are moved towards each other so that more than 50%, preferably more than 80% of the surface of the packaging material rest in a conclusive manner on the plates and fixed in this position; d. the preparation is frozen in the package between the plates of the carrier using the plates of the carrier for heat exchange.
  • the carrier is aligned horizontally before the plates are moved toward each other (step (c)).
  • the present invention is particularly suitable for packaging, freezing, storing and transporting aqueous protein solutions.
  • o can be frozen in a universal freezer (normal plate freezer)
  • o can be frozen by using a thermally conductive material in a cold room
  • the carrier can be used for every bag available on the market.
  • the carrier is reusable
  • the carrier is easy to clean.
  • Exemplary embodiment execution of the freezing process
  • the following example uses a carrier measuring 0.710 m by 0.530 m (length x width of plates) which is universally applicable to many plastic bags currently available on the market. It will also assume a plastic bag measuring 0.654 m by 0.431 m (length x width).
  • the filling volume of the inserted in the protective plastic bag can be varied continuously.
  • the lower filling limit of the plastic bag is defined by the bulge resulting from the degree of filling of the plastic bag and should not fall below a thickness of 0.035 m.
  • the upper filling limit is limited only by the maximum filling volume of the plastic bag used.
  • the carrier gem. Fig. 1, 2 is completely raised to a plate spacing of 0.275 m and placed vertically on the opposite side of the handle. It follows the on the side mounted screws easy fixation of the degree of opening of the wearer, so that a collapse is no longer possible.
  • Fig. 1 (7) inserted in the clamps provided for this purpose.
  • the clamping device are slightly overstretched, so that the inserted foam moldings can be pushed and fixed with slight pressure.
  • the filled with an aqueous protein solution and labeled on the handle plastic bag which corresponds to the above parameters in terms of type and size, filling volume is suspended in the protective cover in a standing condition in the designated holder from above.
  • the protective cover with the plastic bag in it is placed horizontally on a table with the handle side down, so that the plastic bag lying down can assume its full, flat extent.
  • the hoses located on the plastic bag are inserted into the previously clamped foam parts and thus fixed. Loosen the side mounting screws and slowly lower the top of the contactor sleeve onto the plastic bag.
  • the lateral fixing screws are tightened with a defined torque of 10 Nm.
  • the construction of the protective sleeve gives the user the freedom to either put it into a special freezing facility for further processing or simply place it in a freezing cell to freeze the biopharmaceutical content.
  • a special freezing system it should be constructed like a plate cooler, which moves its cooling plates either in a horizontal or vertical position.
  • An example of a suitable plate cooler are lyophilizers whose cooling plates are in a horizontal position to each other.
  • the variant of the vertical plate cooler can be used by freezing equipment for minced meat or off-shore plate cooler for immediate freezing of fish. Again, cooled, perpendicular to each other plates together to ensure optimum heat transfer to the intermediate Good.
  • Contact sleeve is placed between two cooling plates, which have the maximum distance to each other.
  • An in-plant guide rail or the like ensures that the protective cover with the plastic container therein is flat without tilting on the cooling plate. Yes, after running the freezer, several plastic bags can be frozen at the same time.
  • the cooling plates which are held absolutely horizontally by a special design, are moved together with a defined contact pressure, so that all the cooling plates rest on the protective covers with full surface. This ensures optimum heat transfer from the plastic bag via the protective cover to the cooling plates.
  • the contact pressure is defined by the total weight to be moved, which is composed of the degree of loading of the freezing system, the degree of filling of the filled plastic bags and the weight of the cooling plates. The contact pressure must be selected in such a way that all cooling plates rest on the protective sheaths without gaps when the collapse is complete.
  • the cooling plates After completion of the freezing process, the conditions defined by special temperature programs and dependent on the degree of filling of the system, the cooling plates are moved apart again up to their maximum distance.
  • the protective cover with the inner plastic bag is removed from the handle and inserted into a pre-tempered transport container.

Landscapes

  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Combustion & Propulsion (AREA)
  • Physics & Mathematics (AREA)
  • Mechanical Engineering (AREA)
  • Thermal Sciences (AREA)
  • General Engineering & Computer Science (AREA)
  • Packages (AREA)

Abstract

L'invention concerne un support pour emballages pharmaceutiques, constitué de deux plateaux (1) à faces parallèles, reliés entre eux au moyen de deux articulations en ciseaux (2) de telle sorte que l'écartement entre les plateaux puisse être modifié. Chaque articulation contient des moyens (3) permettant de fixer l'articulation.
PCT/EP2010/065571 2009-10-19 2010-10-15 Contenant pour matériel pharmaceutique Ceased WO2011048031A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102009049942.3 2009-10-19
DE102009049942 2009-10-19

Publications (1)

Publication Number Publication Date
WO2011048031A1 true WO2011048031A1 (fr) 2011-04-28

Family

ID=43415185

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/065571 Ceased WO2011048031A1 (fr) 2009-10-19 2010-10-15 Contenant pour matériel pharmaceutique

Country Status (1)

Country Link
WO (1) WO2011048031A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12487027B2 (en) * 2018-09-05 2025-12-02 Single Use Support Gmbh Cooling plate assembly and method

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5924302A (en) 1997-03-27 1999-07-20 Foremost In Packaging Systems, Inc. Insulated shipping container
US6453683B1 (en) 2001-05-22 2002-09-24 Integrated Biosystems, Inc. Tapered slot cryopreservation system with controlled dendritic freezing front velocity
US6684646B2 (en) 2001-05-22 2004-02-03 Integrated Biosystems, Inc. Systems and methods for freezing, storing and thawing biopharmaceutical material
US6698213B2 (en) 2001-05-22 2004-03-02 Integrated Biosystems, Inc. Systems and methods for freezing and storing biopharmaceutical material
US6945056B2 (en) 2001-11-01 2005-09-20 Integrated Biosystems, Inc. Systems and methods for freezing, mixing and thawing biopharmaceutical material
WO2007104047A2 (fr) * 2006-03-09 2007-09-13 Nalge Nunc International Systeme de manipulation de conteneur flexible
WO2007103917A2 (fr) * 2006-03-06 2007-09-13 Integrated Biosystems, Inc. Systèmes et procédés utilisés pour congeler, stocker et décongeler des matières biopharmaceutiques
WO2007139873A2 (fr) 2006-05-26 2007-12-06 Human Genome Sciences, Inc. Récipient de manutention

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5924302A (en) 1997-03-27 1999-07-20 Foremost In Packaging Systems, Inc. Insulated shipping container
US6453683B1 (en) 2001-05-22 2002-09-24 Integrated Biosystems, Inc. Tapered slot cryopreservation system with controlled dendritic freezing front velocity
US6684646B2 (en) 2001-05-22 2004-02-03 Integrated Biosystems, Inc. Systems and methods for freezing, storing and thawing biopharmaceutical material
US6698213B2 (en) 2001-05-22 2004-03-02 Integrated Biosystems, Inc. Systems and methods for freezing and storing biopharmaceutical material
US6786054B2 (en) 2001-05-22 2004-09-07 Integrated Biosystems, Inc. Systems and methods for freezing, storing and thawing biopharmaceutical material
US6945056B2 (en) 2001-11-01 2005-09-20 Integrated Biosystems, Inc. Systems and methods for freezing, mixing and thawing biopharmaceutical material
WO2007103917A2 (fr) * 2006-03-06 2007-09-13 Integrated Biosystems, Inc. Systèmes et procédés utilisés pour congeler, stocker et décongeler des matières biopharmaceutiques
WO2007104047A2 (fr) * 2006-03-09 2007-09-13 Nalge Nunc International Systeme de manipulation de conteneur flexible
WO2007139873A2 (fr) 2006-05-26 2007-12-06 Human Genome Sciences, Inc. Récipient de manutention

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12487027B2 (en) * 2018-09-05 2025-12-02 Single Use Support Gmbh Cooling plate assembly and method

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