WO2011048031A1 - Container for pharmaceutical material - Google Patents

Container for pharmaceutical material

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
Grant status
Application
Patent type
Prior art keywords
plates
carrier
bag
pharmaceutical
plastic
Prior art date
Application number
PCT/EP2010/065571
Other languages
German (de)
French (fr)
Inventor
Michael Schorpp
Dorothee Ambrosius
Matthaeus Mueller
Franz Nothelfer
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

Links

Classifications

    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25DREFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT COVERED BY ANY OTHER SUBCLASS
    • F25D31/00Other cooling or freezing apparatus
    • F25D31/001Plate freezers
    • AHUMAN NECESSITIES
    • A47FURNITURE; DOMESTIC ARTICLES OR APPLIANCES; COFFEE MILLS; SPICE MILLS; SUCTION CLEANERS IN GENERAL
    • A47BTABLES; DESKS; OFFICE FURNITURE; CABINETS; DRAWERS; GENERAL DETAILS OF FURNITURE
    • A47B3/00Folding or stowable tables
    • A47B3/02Folding or stowable tables with foldable cross legs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/16Holders for containers
    • A61J1/165Cooled holders, e.g. for medications, insulin, blood, plasma
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25DREFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT COVERED BY ANY OTHER SUBCLASS
    • F25D2331/00Details or arrangements of other cooling or freezing apparatus not provided for in other groups of this subclass
    • F25D2331/80Type of cooled receptacles
    • F25D2331/801Bags
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F28HEAT EXCHANGE IN GENERAL
    • F28FDETAILS OF HEAT-EXCHANGE AND HEAT-TRANSFER APPARATUS, OF GENERAL APPLICATION
    • F28F3/00Plate-like or laminated elements; Assemblies of plate-like or laminated elements
    • F28F3/12Elements constructed in the shape of a hollow panel, e.g. with channels
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F28HEAT EXCHANGE IN GENERAL
    • F28FDETAILS OF HEAT-EXCHANGE AND HEAT-TRANSFER APPARATUS, OF GENERAL APPLICATION
    • F28F9/00Casings; Header boxes; Auxiliary supports for elements; Auxiliary members within casings
    • F28F9/007Auxiliary supports for elements
    • F28F9/0075Supports for plates or plate assemblies

Abstract

The invention relates to a carrier for pharmaceutical packaging, comprising two planar parallel plates (1) connected to each other by means of two scissor joints (2), such that the distance between the plates can be changed, wherein each joint comprises means (3) allowing the joint to be fixed.

Description

TANKS FOR PHARMACEUTICAL MATERIAL

BACKGROUND OF THE INVENTION

TECHNICAL FIELD

The invention relates to an apparatus for shipping, storing and handling of frozen pharmaceutical products. In particular, the invention relates to a container for shipping, storing and handling of frozen biopharmaceutical material.

STATE OF THE ART

With advance of the biotechnology industry and the increased demands on the flexibility and cost effectiveness of the quantities produced in biotechnology products disposable packaging get a more and more important. These single-use packaging materials also offer the advantage in addition to the reduced validation costs that they can product across all be used, eliminated the elaborate cleaning procedures throughout and the investment costs for new production can be reduced by several times.

Biopharmaceutical materials are filled with increasing frequency, so-called liquid form in specific bags "Bags" single-use packaging made of flexible plastic. The bags consist of several plastic layers, each having different characteristics. These include mechanical stability, flexibility, low gas permeability, etc . Special features must have the plastic layer that comes into direct contact with the product. Movies that are currently showing the most stable properties such as EVA (Ethylene vinyl Acetate) or LDPE (low density poly Ethylene). the complex structure of a bag to an example of outward (1) to the inside (9) are represented:

1 . ) nylon

2.) LLDPE

3.) LLDPE

4.) Nylon

5.) EVOH (Ethylene Vinyl OH) 6) Nylon

7.) LLDPE

8.) LLDPE

9.) LDPE

Often, however, provides the liquid storage in bags sufficient long-term stability, allowing the biopharmaceutical material to minimize harmful influences such as chemical degradation must be frozen. To slow reaction kinetics as far as possible, a sufficiently low storage temperature must be selected. However, bags show a greatly reduced mechanical stability at temperatures less than -10 ° C. A small shock is usually already sufficient to cause small cracks that lead during thawing of biopharmaceutical materials in the total loss of the contents.

To mechanical stress to avoid the frozen bags, solutions are offered on the market already, which should provide the greatest possible protection bag. . The patented Celsius®-system from Sartorius Stedim (US patents 6,453,683;

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 the side against shocks.

Since the protective frame of Celsius® system at the front and rear remains open, however, freezing containers, for example, by the company. EnviroCooler ® available that will also ensure safe transportation under controlled temperature conditions, and which are described in US Patent 5,924,302. The basic disadvantage of this design is the lack of specificity regarding the geometry of the transported goods, the durability, the lack of ability to clean and above all further necessary packing of frozen and therefore extremely sensitive Bags. One solution to the lack of specificity with respect to the geometry is proposed in a publication of the company. Human Genome Sciences Inc. (WO2007 / 139873). Here, a special vessel is described, corresponding to the exact dimensions of the Celsius® bags with attached frame. The use of plastic materials of these containers can be easily cleaned. However, the problem of packing bags of frozen remains. The system described in US 6,453,683 has the considerable disadvantage that the bag without a special Einfriermaschine can not be brought into a form in which this place can be stored saving, because the bag is not per se through the frame in one for storage optimized shape is placed. The storage of the located in the frame, frozen bags without further protective sleeve continues to offer the risk of mechanical damage.

The system described in the document WO2007 / 139873 provides the ability to store bags economically and to ship. However, the freezing in the container is not possible in a reasonable time, due to the poor thermal convection in the interior of the container. Also, the freezing of the bags with a Einfrieranlage in the interior of the container is not possible by the design of the container.

Both systems show the common drawback of the other, that the bag in the frozen state of a person must be transported from the Einfrieranlage to the contactor shell, at least, which is a risk in the sensitivity of the frozen bags.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 shows a carrier according to the invention having two plane-parallel plates (1), which are connected by two scissor joints (2) to each other so that the distance between the plates is variable. These are set up on the plates guides for the joint ends. By means of a locking screw (3) can be fix the joint and thus the distance of the plates.

Figure 2 shows an embodiment with a formation (4) for suspending a bag.

Figure 3 shows a carrier according to the invention, which is covered with a plastic sheath (6). DESCRIPTION OF THE INVENTION

The present invention overcomes disadvantages of the systems described in the prior art. There is a carrier for pharmaceutical packaging as shown in Figure 1, consisting of two plane-parallel plates (1), which are connected by two scissor joints (2) together so that the distance between the plates is variable, wherein each hinge means (3) includes allowing a fixing of the joint. Preferably, in such a means is a locking screw or locking lever, optionally also to a quick release mechanism or a device to achieve a detected torque. The plates are preferably made of a heat conductive material, preferably a metal, more preferably steel, in particular V2A. The Dimensionerung the support is appropriate and adapted to the size of the bags used. A good adaptation to continuous bag sizes consisting for example in a carrier plate with dimensions from 0.5 to 0.6 mx 0.7 -0.8 m (width x length) in a preferred embodiment, 0.530 x 0.710 m. The joints may be configured, for example, so that a light-plate distance between 0.01 m and 0.30 m is set.

In a preferred embodiment, at least one of the plates on a means (4) for fixing a pharmaceutical container. Such means may be a suitable shaping of the plate is approximately in the shape of a hook or a recess into which the bag may be hung. Furthermore, it is advantageous if the carrier has a carrying handle (5).

For additional protection, the carrier, when containing the packaging material with the biopharmaceutical material to be coated with a protective sheath preferably a plastic film, in particular a gas-impermeable plastic film. A further embodiment relates to the carrier described characterized in that it is enveloped by a gas-impermeable plastic film (6).

Since the carrier is held in the inventive benefits extended period of time at temperatures below the freezing point, it is important that the materials used are resistant to cold, preferably to -85 ° C. In another aspect, the invention relates to a method for freezing of pharmaceutical preparations which are liquid at temperatures above 0 ° C, especially aqueous solutions of active pharmaceutical ingredients, comprising the steps a. a flexible pack pharmaceutical agent is placed between the plates of a support as described above, and optionally attached to the carrier, wherein a predetermined distance between the plates via the shear joints set and the joints are fixed in this position;

b. the packaging material is filled with the liquid pharmaceutical preparation in an amount such that more than 50%, preferably more than 80% of the packaging material surface rest positively on the plates;

c. the preparation is frozen in the packaging material between the plates of the carrier, wherein the plates of the carrier are used for heat exchange.

Preferably, the thus treated pharmaceutical preparation is stored in a frozen state in the carrier and / or transported.

An advantage of the carrier of the invention is that it allows the setting of a predefined distance between the plates and thus be adapted to different bag sizes and capacities. The bag, preferably a plastic bag can be inserted between the plates and is filled in the carrier with an amount of liquid which is dimensioned so that a large portion of the bag surface has positive contact with the plates, preferably more than 50%, particularly preferably more than 80% the bag surface. Which allows a good heat transfer through the plates as a heat exchanger in the freezing phase and an optimized storage volume. The liquid containing packaging material is then frozen, expediently by immersing the support is introduced with the packaging means, the liquid contained therein in a Einfrieranlage (plate freezers).

However, the bag can also be filled outside the carrier, is introduced into filled state into the carrier and are subsequently frozen. Therefore, the present invention relates to a method for freezing of pharmaceutical preparations which are liquid at temperatures above 0 ° C in a further aspect, especially aqueous solutions of active pharmaceutical ingredients, comprising the steps a. a carrier as described above is adjusted to a maximum distance between the plates; b. a filled with a liquid pharmaceutical preparation of pharmaceutical flexible packaging material is introduced into the carrier; c. the plates are moved towards one another so far, that more than 50%, preferably more than 80% of the packaging material surface rest positively on the plates and fixed in this position; d. the preparation is frozen in the packaging material between the plates of the carrier, wherein the plates of the carrier are used for heat exchange.

Preferably, the carrier is aligned horizontally before the plates are moved toward each other (step (c)). Particularly suitable for the present invention, packaging, freezing, storing and transporting aqueous protein solutions.

The invention described herein provides the following options:

Complete Cases where the Bag

o can be clamped in a liquid state

o can be frozen without having to remove the bag from the bag again

o can be frozen in a universal Einfrieranlage (normal plate freezers)

o can be frozen by the use of a thermally conductive material into a cooling chamber

o must not be transported without full protection after freezing, ie protected at all times after bottling

o due to the continuously variable height (defined by the degree of filling of the bag) the best possible storage volume has

The carrier can be used for any available on the market, the carrier bag is reusable

The carrier is easy to clean. Embodiment: performing the freezing

In the following example, a carrier with the dimensions of 0.710 x 0.530 m is used (length x width of the plates), which is universally usable for many currently available on the market plastic bag. It will also accept (width x length) is a plastic bag measuring 0.654 x 0.431 m. The filling volume of the inserted into the protective sheath plastic bag can be continuously varied. The lower limit of filling of the plastic bag is defined by the force resulting from the filling level of swelling of the plastic bag and should not be less than a thickness of 0.035 m. The upper limit of filling is only limited by the maximum fill volume of the plastic bag used.

The carrier gem. Fig. 1, 2 is completely ascended to a plate spacing of 0.275 m and placed vertically on the opposite side of the handle. Following is the light on the side-mounted screws fixing the degree of opening of the carrier so that a collapse is no longer possible. In the run-tailored, cold stable foam parts are acc. Fig. 1 (7) inserted in the appropriate clamping devices. The clamping device are slightly stretched, so that the inserted foam moldings can be pushed with slight pressure into and fixed.

The filled with an aqueous protein solution and labeled on the handle plastic bag which corresponds to the aforementioned parameters relating to the type and size, filling volume is suspended in the protective sheath in a standing condition in the holder provided from above. After hanging the protective sheath is the located therein plastic bags placed with the handle-side down horizontally on a table, so that the plastic bag can take lying its full areal extent. The tubes located on the plastic bag are placed into the previously jammed foam parts and thus fixed. The lateral fixing screws are loosened, and the upper side of the contactor casing is lowered slowly onto the plastic bag. The lateral fixation screws are tightened with a defined torque of 10 Nm. The construction of the protective sheath gives the user the freedom to introduce them either in a special Einfrieranlage for further processing, these easy to lay only in a freezing cell to freeze the biopharmaceutical content. Is a special Einfrieranlage used, it should be structured as a plate cooler which together drives its cooling plates in either horizontal or vertical position. An example of a suitable plate coolers are lyophilisators, to each other the cooling plates in a horizontal position. The variant of the vertical plate cooler can be used by Einfrieranlagen for ground beef or offshore plate cooler for immediate freezing of fish. Here, too, cooled, mutually perpendicular plates move together to ensure optimum heat transfer to the intermediate Good.

The variant of the horizontal plate cooler to be further described. The

Protective sheath is placed between two cooling plates, which have the maximum distance from one another. A guide rail or the like contained in the system ensures that the protective sleeve is located with the plastic container disposed therein without canting plan on the cooling plate. Yes the design of the Einfrieranlage several plastic bags can be frozen simultaneously.

After starting the plate cooler, the cooling plates absolutely horizontal held a special design are brought together with a defined contact pressure so that all cooling plates rest with full surface to the covers. Thus an optimum heat transfer from the plastic bag over the protective sheath is guaranteed on the cooling plates. The contact pressure is defined by the moved total weight, which is composed of the degree of loading of the Einfrieranlage, the filling level of the filled plastic bag and the weight of the cooling plates. The pressure must be chosen so that all cooling plates after finishing the rest moving together without a gap to the covers.

After completing the freezing of the defined time programs through special temperature and follows depending on the filling level of investment conditions, the cooling plates are moved back up to their maximum distance apart. The protective sheath to the inner plastic bag is removed from the handle and placed in a vortemperiertes transport container.

Claims

claims
1 . A carrier for pharmaceutical packaging consisting of two plane-parallel plates (1) formed by two scissor joints (2) are joined together so that the distance between the plates is variable, containing each articulation means (3) which permit fixing of the joint ,
2. Vehicle according to claim 1, characterized in that the means for fixing the joint is a locking screw.
3. The carrier of claim 1 or 2, characterized in that at least one of the plates comprising a means (4) for fixing a pharmaceutical container.
4. Support according to one of the preceding claims, characterized in that it comprises a carrying handle (5).
5. Support according to one of the preceding claims, characterized in that the plates of a heat conductive material, preferably a metal, more preferably steel, in particular V2A.
6. Support according to one of the preceding claims, characterized in that it is enveloped by a gas-impermeable plastic film (6).
7. Support according to one of the preceding claims, characterized in that the materials used to -85 ° C are cold-resistant.
8. A method for packaging, storing and / or transporting of pharmaceutical preparations which are liquid at temperatures above 0 ° C, especially aqueous solutions of active pharmaceutical ingredients, comprising the steps a. a flexible pack pharmaceutical agent is placed between the plates of a support according to one of claims 1 to 7 and optionally attached to the carrier, wherein a predetermined distance between the plates via the shear joints set and the joints are fixed in this position; b. the packaging material is filled with the liquid pharmaceutical preparation in an amount such that more than 50%, preferably more than 80% of the packaging material surface rest positively on the plates; c. the preparation is frozen in the packaging material between the plates of the carrier, wherein the plates of the carrier are used for heat exchange;
9. The method according to claim 8, characterized in that the thus treated pharmaceutical preparation in the frozen state in the carrier is stored and / or transported.
10. The method according to claim 8 or 9, characterized in that the packaging material is a plastic bag.
1. 1 A method for freezing of pharmaceutical preparations which are liquid at temperatures above 0 ° C, especially aqueous solutions of active pharmaceutical ingredients, comprising the steps a. a carrier according to one of claims 1 to 7 is set to a maximum distance between the plates; b. a filled with a liquid pharmaceutical preparation of pharmaceutical flexible packaging material is introduced into the carrier; c. the plates are moved towards one another so far, that more than 50%, preferably more than 80% of the packaging material surface rest positively on the plates and fixed in this position; d. the preparation is frozen in the packaging material between the plates of the carrier, wherein the plates of the carrier are used for heat exchange. The method of claim 1 1, characterized in that the thus treated pharmaceutical preparation in the frozen state stored in the carrier and / or is transported.
Use of a carrier according to one of claims 1 to 7 for the freezing of liquid pharmaceutical preparations in pharmaceutical flexible packaging material, preferably plastic bags.
PCT/EP2010/065571 2009-10-19 2010-10-15 Container for pharmaceutical material WO2011048031A1 (en)

Priority Applications (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 true WO2011048031A1 (en) 2011-04-28

Family

ID=43415185

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/065571 WO2011048031A1 (en) 2009-10-19 2010-10-15 Container for pharmaceutical material

Country Status (1)

Country Link
WO (1) WO2011048031A1 (en)

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 (en) * 2006-03-09 2007-09-13 Nalge Nunc International Flexible container handling system
WO2007103917A2 (en) * 2006-03-06 2007-09-13 Integrated Biosystems, Inc. Systems and methods for freezing, storing and thawing biopharmaceutical materials
WO2007139873A2 (en) 2006-05-26 2007-12-06 Human Genome Sciences, Inc. Handling container

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 (en) * 2006-03-06 2007-09-13 Integrated Biosystems, Inc. Systems and methods for freezing, storing and thawing biopharmaceutical materials
WO2007104047A2 (en) * 2006-03-09 2007-09-13 Nalge Nunc International Flexible container handling system
WO2007139873A2 (en) 2006-05-26 2007-12-06 Human Genome Sciences, Inc. Handling container

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