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EP2195718B1 - Dispositif de régulation thermique - Google Patents

Dispositif de régulation thermique Download PDF

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Publication number
EP2195718B1
EP2195718B1 EP08801557A EP08801557A EP2195718B1 EP 2195718 B1 EP2195718 B1 EP 2195718B1 EP 08801557 A EP08801557 A EP 08801557A EP 08801557 A EP08801557 A EP 08801557A EP 2195718 B1 EP2195718 B1 EP 2195718B1
Authority
EP
European Patent Office
Prior art keywords
control device
temperature control
wall section
temperature
solution 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
EP08801557A
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German (de)
English (en)
Other versions
EP2195718A1 (fr
Inventor
Benjamin Böbst
Frank Boettger
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.)
Apotheker Vetter and Company Arzneimittel GmbH Ravensburg
Original Assignee
Apotheker Vetter and Company Arzneimittel GmbH Ravensburg
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 Apotheker Vetter and Company Arzneimittel GmbH Ravensburg filed Critical Apotheker Vetter and Company Arzneimittel GmbH Ravensburg
Publication of EP2195718A1 publication Critical patent/EP2195718A1/fr
Application granted granted Critical
Publication of EP2195718B1 publication Critical patent/EP2195718B1/fr
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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
    • A61J1/14—Details; Accessories therefor
    • A61J1/16—Holders for containers
    • A61J1/165—Cooled holders, e.g. for medications, insulin, blood or plasma

Definitions

  • the invention relates to a tempering device according to the preamble of claim 1.
  • Temperature control of the type discussed here are known. They are used in particular for pharmaceutical solution containers in which, in particular for preparing for sterile filtration, solutions are mixed or solids are dissolved in solvents, preferably in water.
  • the temperature of the solution in the pharmaceutical solution container is of particular importance, since it influences, for example, the solubility of solids in a solvent. The temperature may also affect the stability of the ingredients found in the solution.
  • the dissolution of solids in solvents and the mixing of solutions is carried out in solution containers in the form of pressure vessels or boilers. A temperature of the solution is carried out by double-jacketed solution container.
  • Such solution containers have two wall regions arranged concentrically to one another, wherein the solution to be mixed or the solvent intended to dissolve a solid can be introduced into the space bounded by the first wall region.
  • a medium suitable for tempering is introduced, the temperature of which is preferably regulated by means of a thermostat. The temperature of the temperature-controlled medium is transferred via the first wall region to the medium in the solution container.
  • a tempering of the type discussed here is also off US 4,213,498 known. It comprises at least one wall section into which a heatable medium can be introduced, wherein it can be attached to the solution container and removed from it again.
  • the temperature-controlled medium serves to bring the content of the solution container to a desired temperature, ie to cool or to heat.
  • thermally conductive grease can be provided between wall section and solution tank.
  • the object of the invention is therefore to provide a tempering device for a pharmaceutical solution container, which avoids the disadvantages mentioned above.
  • the tempering device for pharmaceutical solution container, which has the features mentioned in claim 1.
  • the tempering device has at least one wall section into which a heatable medium can be introduced. It can be attached to the outside of the solution container and removed from this again.
  • the tempering device proposed here can advantageously be used in conventional pharmaceutical solution containers of various sizes and shapes are used. It is conceivable, for example, to place it like a jacket around the solution container and to remove it again from the solution container after completion of the tempering process. Characterized in that the temperature-controlled medium is provided in at least one wall section, contamination with the solution located in the solution container is excluded.
  • the tempering device can also be designed as disposable tempering device for use in sterile rooms.
  • a tempering which is characterized in that it has at least one inlet and at least one outlet.
  • the at least one inlet and the at least one outlet open into the at least one wall section, into which the temperature-controllable medium, referred to below as medium only, can be introduced. Via the inlet, a medium can thus be introduced into the wall section and led out again via the outlet.
  • a tempering device which is characterized in that the tempering device has a thermostat.
  • the medium which can be introduced into the at least one wall section of the tempering device can be heated or cooled to a specific temperature.
  • a tempering device which is characterized in that at least the at least one wall portion comprises a temperature-resistant material or consists of this. This advantageous embodiment ensures that even with strong heating or cooling of the medium located in the wall section, the temperature control is not damaged.
  • a tempering device is also preferred, which can be attached to the pharmaceutical solution container with at least one belt and / or with at least one hook-and-loop fastener. In this way, the temperature control can be very easily attached to a conventional solution container and removed again.
  • the tempering device can also be fastened in various other ways to a pharmaceutical solution container by simple means.
  • the temperature device has an overpressure device by means of which, in particular, the at least one wall section of the tempering device can be adapted to the solution container. When the overpressure device is actuated, the inner diameter of the tempering device, which finally adapts to the circumference of the pharmaceutical solution container, changes so that the tempering device bears firmly against the solution container.
  • a tempering device which is characterized in that water, alcohol and / or silicone oil can be used as heatable medium. For a given medium, it is then only necessary to design the tempering device so that its properties are stable with respect to the medium used.
  • a tempering device is preferred in which at least the at least one wall section is flexible. Due to the flexibility of the tempering device, at least in some areas, it is advantageously possible to use this for differently shaped solution containers. It is also conceivable to provide a prefilled tempering device, which is connected via a corresponding connection only with a thermostat or the like must become. In particular, it can be provided that the tempering device has flexible plastic or at least partially consists of this. The use of flexible plastic offers the advantage that the tempering device on the one hand is flexible in use and on the other hand favorable in the manufacturing process.
  • a tempering device which is characterized in that the at least one wall section for the realization of channels is rib-shaped.
  • a serpentine formed channel is provided, which is flowed through by a medium.
  • a tempering device is also preferred, which is characterized in that an inner side of the tempering device resting against the solution container has a smooth surface. Due to this advantageous embodiment, a particularly good heat transfer from the tempering device to the pharmaceutical solution container is possible.
  • a tempering device which is ⁇ -sterilizable and / or steam-sterilizable is particularly preferred. This advantageous embodiment makes it possible to use the tempering several times, for example for use in sterile rooms.
  • tempering device in which a plurality of inlets and outlets are provided.
  • the multiple inlets and outlets preferably cooperate with a plurality of separate wall sections.
  • a circulation of the medium is effected in the at least one wall section. It is provided that the medium flows from the inlet of the at least one wall section to its outlet and thus a circulation in the wall section is effected.
  • a plurality of mutually separate wall sections are provided which serve to receive a temperature-controlled medium. It is also conceivable to introduce different temperable media into the separate wall sections. In each of the wall sections, a separate circulation of the medium to be tempered is preferably effected.
  • a tempering device which is characterized in that its applied to the solution container inside consists of a thermally conductive material or is coated with such a material. Furthermore, the outside of the inner side, that is, the side of the tempering device facing away from the solution container, preferably consists of an insulating material or is coated with such a material.
  • This embodiment has the advantage that on the one hand little heat is released to the environment of the tempering and on the other hand there is a good heat transfer between the tempering and the pharmaceutical solution container.
  • a tempering device is preferred in which the at least one wall section is designed to be multi-layered.
  • a layer arranged parallel to it can be provided, into which, for example, compressed air for realizing an overpressure device can be introduced.
  • FIG. 1 shows a perspective view of a tempering device 1 for pharmaceutical solution container with at least one wall section 3, in which a temperature-adjustable medium can be introduced.
  • the at least one wall section 3 here extends over the entire surface of the tempering device 1. However, it may also be provided that the wall section 3 extends only in a region of the tempering device 1.
  • the tempering device 1 has at least one inlet 5 and at least one outlet 7, which are in fluid communication with the at least one wall section 3.
  • a temperature-controlled medium such as water and / or alcohol and / or silicone oil can be introduced into the wall section 3.
  • the tempering device 1 preferably interacts with a thermostat, not shown here, which regulates the temperature of the temperature-controlled medium located in the wall portion 3.
  • At least the at least one wall section 3 of the tempering device 1 preferably has a temperature-resistant material or consists of this, so that damage to the tempering device 1 is prevented at a temperature of the medium located in the wall section 3 to very high or very low temperatures.
  • FIG. 1 makes it clear that the at least one wall section 3 is formed rib-shaped.
  • the ribs are connected to each other in a serpentine manner such that a channel 9 is formed in the wall section 3, which extends from the inlet 5 to the outlet 7.
  • a medium which enters the at least one wall section 3 via the inlet 5 is guided in the channel 9 in the direction of the arrows 11 and then led out of the wall section 3 via the outlet 7.
  • the medium preferably passes from the outlet 7 to the temperature controller, not shown here, in particular to a thermostat. This results in a cycle of the temperature-controlled medium from the thermostat to the wall section 3 via the inlet 5 and via the outlet 7 back to the thermostat.
  • the medium circulates in the wall section 3, the thermostat ensuring that the medium has a desired temperature.
  • the channel 9 in the at least one wall section 3 can be realized in various ways and have different shapes or courses in the wall section 3.
  • the serpentine shape of the channel 9 may be, for example edgewise with respect to a solution container or even horizontally.
  • the tempering device 1 has a plurality of wall sections 3, in each of which a channel 9 is formed.
  • the tempering device 1 has in this way a plurality of separate from each other arranged channels 9, each having its own inlet 5 and a separate outlet 7.
  • each wall section 3 is a separate circuit of temperature-controlled medium available.
  • wall sections 3 which each have an inlet and an outlet and thus their own circuit, prevents a medium on its way through a wall section 3 changes its temperature too much. This may be the case in particular if the path through the wall section is too long.
  • a plurality of wall sections 3 are provided, in which the medium has to travel a shorter distance until it arrives again at the thermostat.
  • the tempering device 1 can also have sensors which measure the temperature of the medium located in the wall section 3 at any location in the tempering device 1 or also outside thereof.
  • FIG. 2 shows an embodiment of a tempering device 1.
  • the same parts are provided with the same reference numerals, so far as the description to FIG. 1 is referenced.
  • FIG. 1 shows a solution container 13, which is surrounded by a tempering device 1.
  • the solution container 13 is preferably used for mixing solutions or for dissolving solids in solvents such as water.
  • the resulting pharmaceutical solution should also be storable in the solution container 13 at a certain temperature.
  • the temperature control device 1 proposed here is advantageously suitable.
  • the tempering device 1 is preferably flexible, for example made of a flexible plastic and can be flexibly adapted to different shapes and sizes of solution containers 13.
  • the tempering device 1 can be attached to the solution container 13 in various ways.
  • the tempering device 1 is fastened by means of a belt 15 to the solution container 13.
  • the belt 15 may be incorporated into the temperature control device 1 and is preferably provided with a hook and loop fastener, not shown here, which allows a particularly simple attachment of the temperature control device 1 to the solution container 13.
  • a hook and loop fastener can also be provided directly on the tempering 1 without belt.
  • the belt 15 shown here is purely exemplary, a fastening device for the temperature control device 1 proposed here can be realized in various ways. It is crucial that the temperature control device 1 can be attached in a simple manner to a solution container 13 and easily removed again from the solution container 13.
  • the tempering 1 is preferably made flexible, in particular, it has a flexible plastic or at least partially made of this.
  • This embodiment of the tempering device 1 allows a particularly flexible adaptation to a wide variety of solution container. It is understood that the present invention is not limited to the tempering device 1 shown here, but this may also be arbitrarily formed in their shape and size.
  • the tempering device 1 is here about a solution container 13 around quasi like a coat can be arranged and fastened by means of a suitable fastening means on this. It is also conceivable, however, a closed embodiment of the temperature control device 1, so that it is überstülpbar example of a solution container.
  • the voltage applied to the solution container 13 inside the temperature control device 1 preferably has a smooth surface at least in the region of at least one wall section 3, so that a particularly large contact surface of the tempering 1 results on the solution container 13, whereby the temperature transfer of the at least one wall section 3 the solution container 13 is particularly good.
  • the tempering device 1 is preferably designed so that it is ⁇ -sterilizable and / or steam sterilizable, this makes it possible in an advantageous manner, the tempering 1, especially in a sterile environment to use several times.
  • the voltage applied to the solution container 13 inside of the tempering 1 is at least in the region of at least one wall portion 3 made of a thermally conductive material or coated with such a material.
  • the temperature transition between the tempering device 1 and the solution container 13 can be substantially improved.
  • the temperature of the pharmaceutical solution contained in the solution container 13 is further improved in that a temperature compensation between the tempered medium contained in the wall section 3 and the environment is reduced.
  • FIG. 3 shows a schematic representation of another embodiment of a tempering 1 in plan view. Identical parts are provided with the same reference numerals, so that reference is made to the description of the preceding figures.
  • FIG. 3 shows a tempering device 1, wherein the at least one wall portion 3 is formed in multiple layers.
  • at least one channel 17 is formed by the multi-layered design of the wall portion 3, in which a medium can be introduced.
  • the channel 17 preferably has an access, not shown here.
  • the at least one channel 17 can be provided to record, for example, compressed air for the realization of a pressure device 19.
  • the overpressure device 19 can be realized in such a way that compressed air can be introduced into a plurality of channels 17 formed by a multi-layered design of the tempering device 1. If the tempering device 1 is to be attached to a solution container 13, compressed air can be introduced into the channels 17 via the access, whereby the channels 17 expand and the tempering device 1 becomes smaller in its inner diameter. In the event that the temperature control device 1 is no longer needed, the air from the channels 17 can be left out again. The inner diameter of the tempering device 17 thus increases and the tempering device can be removed from the solution container 13.
  • the overpressure device 19 can also be realized by another suitable medium which can be introduced into the channel 17.
  • the temperature control device 1 is preferably ⁇ -sterilizable and / or steam-sterilizable. However, it can also be provided to provide the tempering device 1 as disposable tempering device, which is disposed of after a single use to ensure the sterility of a sterile room.
  • the tempering device 1 can be pre-filled, so that only a corresponding temperature control device must be connected to the inlet or to the outlet in order to make the temperature control device 1 operational.
  • the tempering device 1 can be made in various shapes and sizes be. As already stated, it is also conceivable to provide a plurality of separately arranged wall sections 3 with separate inlets and outlets.
  • the tempering device 1 proposed here has the advantage that a conventional solution container 13 can be stored in a temperature-controlled manner without double casing of the most varied of shapes and sizes without requiring a double-jacket solution container which requires extensive manufacture.
  • the temperature control device 1 proposed here can be produced particularly inexpensively. Contamination of the present in the solution container 13 pharmaceutical medium with the temperature controlled in the tempering device 1 is excluded by the here proposed separately from the solution tank 13 running tempering device 1 otherwise. Furthermore, the complex purification process of the known double-chamber solution container is completely eliminated.
  • the tempering device 1 can be easily attached to a solution container 13 in an advantageous manner and after completion of the tempering easily removed again from the solution container 13.

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  • Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (17)

  1. Dispositif d'équilibrage de température (1) pour récipients de solution pharmaceutiques (13), avec au moins une section de paroi (3) dans laquelle un milieu pouvant être équilibré en température peut être introduit ; dans lequel il peut être appliqué à l'extérieur sur le récipient de solution (13) et peut être de nouveau retiré de celui-ci, caractérisé en ce qu'il présente un dispositif de surpression (19) au moyen duquel le diamètre interne de l'au moins une section de paroi (3) peut être adapté au récipient de solution (13).
  2. Dispositif d'équilibrage de température selon la revendication 1, caractérisé en ce que l'au moins une section de paroi (3) est réalisée de manière multicouches.
  3. Dispositif d'équilibrage de température selon la revendication 2, caractérisé en ce qu'au moins un canal (17) qui présente un accès pour un milieu sous pression est réalisé par la réalisation multicouches de la section de paroi (3).
  4. Dispositif d'équilibrage de température selon la revendication 3, caractérisé en ce que le canal (17) est réalisé de manière à pouvoir être évasé.
  5. Dispositif d'équilibrage de température selon la revendication 1 ou 2, caractérisé en ce que la section de paroi (3) présente une seconde couche dans laquelle un milieu sous pression peut être introduit.
  6. Dispositif d'équilibrage de température selon l'une quelconque des revendications précédentes, caractérisé en ce qu'il présente au moins une entrée (5) et au moins une sortie (7) qui débouchent dans l'au moins une section de paroi (3).
  7. Dispositif d'équilibrage de température selon l'une quelconque des revendications précédentes, caractérisé en ce qu'il présente un thermostat.
  8. Dispositif d'équilibrage de température selon l'une quelconque des revendications précédentes, caractérisé en ce qu'au moins l'au moins une section de paroi (3) présente un matériau résistant aux températures ou se compose de celui-ci.
  9. Dispositif d'équilibrage de température selon l'une quelconque des revendications précédentes, caractérisé en ce qu'il peut être appliqué sur le récipient de solution (13) avec au moins une sangle (15) et/ou au moins une fermeture agrippante.
  10. Dispositif d'équilibrage de température selon l'une quelconque des revendications précédentes, caractérisé en ce que de l'eau et/ou de l'alcool et/ou de l'huile de silicone peuvent être utilisés en tant que milieu pouvant être équilibré en température.
  11. Dispositif d'équilibrage de température selon l'une quelconque des revendications précédentes, caractérisé en ce qu'au moins l'au moins une section de paroi (3) est flexible et/ou qu'il présente du plastique flexible ou se compose au moins par région de celui-ci.
  12. Dispositif d'équilibrage de température selon l'une quelconque des revendications précédentes, caractérisé en ce que l'au moins une section de paroi (3) est réalisée en forme de nervure pour la réalisation de canaux (9).
  13. Dispositif d'équilibrage de température selon l'une quelconque des revendications précédentes, caractérisé en ce qu'un côté interne du dispositif d'équilibrage de température (1) reposant sur le récipient de solution (13) présente une surface lisse.
  14. Dispositif d'équilibrage de température selon l'une quelconque des revendications précédentes, caractérisé en ce qu'il peut subir une stérilisation y et/ou une stérilisation à la vapeur.
  15. Dispositif d'équilibrage de température selon l'une quelconque des revendications précédentes, caractérisé en ce que plusieurs entrées et sorties (5, 7) sont prévues et/ou une circulation du milieu pouvant être équilibré en température est entraînée dans l'au moins une section de paroi (3).
  16. Dispositif d'équilibrage de température selon l'une quelconque des revendications précédentes, caractérisé en ce que son côté interne reposant sur le récipient de solution (13) se compose d'un matériau conduisant la chaleur ou est enduit d'un tel matériau, et que le côté externe opposé au côté interne, détourné du récipient de solution (13) se compose d'un matériau isolant ou est enduit d'un tel matériau.
  17. Dispositif d'équilibrage de température selon l'une quelconque des revendications précédentes, caractérisé par plusieurs sections de paroi (3) séparées les unes des autres qui servent à la réception d'un milieu pouvant être équilibré en température.
EP08801557A 2007-08-28 2008-08-09 Dispositif de régulation thermique Active EP2195718B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102007040487A DE102007040487A1 (de) 2007-08-28 2007-08-28 Temperiereinrichtung
PCT/EP2008/006593 WO2009030343A1 (fr) 2007-08-28 2008-08-09 Dispositif de régulation thermique

Publications (2)

Publication Number Publication Date
EP2195718A1 EP2195718A1 (fr) 2010-06-16
EP2195718B1 true EP2195718B1 (fr) 2012-10-31

Family

ID=40032751

Family Applications (1)

Application Number Title Priority Date Filing Date
EP08801557A Active EP2195718B1 (fr) 2007-08-28 2008-08-09 Dispositif de régulation thermique

Country Status (8)

Country Link
US (1) US20100206888A1 (fr)
EP (1) EP2195718B1 (fr)
JP (1) JP5453265B2 (fr)
CA (1) CA2697715A1 (fr)
DE (1) DE102007040487A1 (fr)
ES (1) ES2397137T3 (fr)
PT (1) PT2195718E (fr)
WO (1) WO2009030343A1 (fr)

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Publication number Priority date Publication date Assignee Title
WO2013097861A1 (fr) * 2011-12-29 2013-07-04 Service-Teknikker.Dk Aps Système de commande de la température d'un bioréacteur
JP2013180030A (ja) * 2012-03-01 2013-09-12 Medikit Kk 医療用器具保温器
DE102021106966A1 (de) * 2021-03-22 2022-09-22 Barkey Gmbh & Co. Kg Vorrichtung und Verfahren zum Temperieren eines Temperiergutes

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Also Published As

Publication number Publication date
ES2397137T3 (es) 2013-03-05
PT2195718E (pt) 2013-01-23
JP5453265B2 (ja) 2014-03-26
EP2195718A1 (fr) 2010-06-16
WO2009030343A1 (fr) 2009-03-12
US20100206888A1 (en) 2010-08-19
JP2011500107A (ja) 2011-01-06
CA2697715A1 (fr) 2009-03-12
DE102007040487A1 (de) 2009-03-05

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