EP1712859B1 - Procédé pour faire fonctionner des installations de lyophilisation avec une chambre et avec dispositifs de chargement et de déchargement, et installations appropriées de ce type - Google Patents

Procédé pour faire fonctionner des installations de lyophilisation avec une chambre et avec dispositifs de chargement et de déchargement, et installations appropriées de ce type Download PDF

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Publication number
EP1712859B1
EP1712859B1 EP06005688.4A EP06005688A EP1712859B1 EP 1712859 B1 EP1712859 B1 EP 1712859B1 EP 06005688 A EP06005688 A EP 06005688A EP 1712859 B1 EP1712859 B1 EP 1712859B1
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EP
European Patent Office
Prior art keywords
loading
transfer table
freeze
chamber
containers
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP06005688.4A
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German (de)
English (en)
Other versions
EP1712859A3 (fr
EP1712859A2 (fr
Inventor
Hubert KLÜTSCH
Johannes Selch
Jörg Rosenbaum
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.)
GEA Lyophil GmbH
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GEA Lyophil GmbH
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Filing date
Publication date
Application filed by GEA Lyophil GmbH filed Critical GEA Lyophil GmbH
Publication of EP1712859A2 publication Critical patent/EP1712859A2/fr
Publication of EP1712859A3 publication Critical patent/EP1712859A3/fr
Application granted granted Critical
Publication of EP1712859B1 publication Critical patent/EP1712859B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B25/00—Details of general application not covered by group F26B21/00 or F26B23/00
    • F26B25/001—Handling, e.g. loading or unloading arrangements
    • F26B25/003—Handling, e.g. loading or unloading arrangements for articles
    • 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 method for operating freeze-drying plants having a chamber and loading and unloading devices and systems designed for this type having the features of the preambles of the independent patent claims.
  • the containers pass from a filling device via a conveyor belt to the freeze-drying chamber.
  • the filling device operates substantially continuously, while the loading of the shelves is discontinuous. It is therefore necessary to provide a buffer zone for the containers between the filling device and the chamber. It consists, for example, of a plurality of conveyor belt loops adapted to the buffer requirement.
  • the loading of the chamber or the shelves is carried out by means of a transfer table and a slide system, through a closable loading opening therethrough, which is part of a wall or door of the freeze-drying chamber.
  • the transfer table In its operating position, connects the levels of the conveyor belt and the loading surface to be loaded.
  • the containers are still open.
  • a plug which has a recess for the removal of water vapor during freeze-drying.
  • the plug is closed in the still closed chamber by moving the shelves together.
  • the unloading of the shelves follows, also with the aid of the transfer table and the slide system.
  • the containers are fed to a device in which they are provided with caps.
  • Freeze-drying mainly serves the preservation of pharmaceutical products, so that the requirements for sterility are very high. Freeze drying systems are therefore located in clean rooms or they are equipped with so-called isolators.
  • the insulator space which is preferably formed by transparent wall sections, encloses those regions of the freeze-drying installations in which clean-room conditions must be maintained.
  • These include above all the means, in particular conveyor belts, which serve to supply the still open container from the filling device to the chamber, and the area in front of the chamber in which the loading and unloading are.
  • the means of transport between the freeze-drying chamber and the device for the final closure of the container with caps are housed in the insulator.
  • the products to be freeze-dried are generally more or less temperature-sensitive.
  • the shelves are therefore already set during the loading phase to low temperatures (for example - 20 ° C).
  • the temperature of the product in the plurality of containers at the beginning of the freeze-drying process is as uniform as possible.
  • the aim is therefore to keep the heat exchange between the interior of the chamber or the shelves therein and the outer clean room or the insulator interior small. This happens on the one hand by the choice of the smallest possible loading opening. It extends across the width of the chamber and has a height that is only slightly greater than the height of the loading means (Tranfertisch, slide system). If the temperature sensitivity of the product is particularly high, the loading opening between each of the loading strokes or partial drawers must also be closed.
  • EP 0 618 417 A1 describes a loading and unloading system for a freeze dryer according to the preamble of the independent claims.
  • the present invention has for its object to reduce the loading time of the freeze-drying chamber of a freeze-drying plant, without the freeze-drying products in terms of temperature sensitivity to endanger and without having to compromise on the quality of the final product.
  • the periods of time in which a heat exchange between chamber interior and exterior takes place are shorter.
  • the desired thermal decoupling can be improved in the context of the invention by further measures that can be implemented individually, in pairs or together. One of these measures is to close at least part of the loading opening during the unavoidable loading pauses, that is, between the plurality of loading strokes.
  • Further measures relate to the mechanical / thermal contact between the transfer table and the loading plate located in loading. Appropriately, this contact is limited to the smallest possible contact surfaces.
  • This contact is limited to the relatively short time intervals in which the actual loading strokes or the actual Beladeteilschübe take place.
  • the latter is achieved in that the transfer table is equipped in the region of its front edge with one or more liftable edge portions.
  • the thermal contact between loading space to be loaded and transfer table is thereby limited to the absolutely necessary time intervals.
  • FIGS. 1a, b . 2a to h and 3 show vertical sections through embodiments of a freeze-drying plant according to the invention.
  • FIG. 4 shows exemplary embodiments for the mutually facing edges of the transfer table and a footprint.
  • the wall of the freeze-drying chamber in which the loading opening is located at 1 1, the loading opening itself with 2, the interior of the chamber with 3, therein vertically-displaceable shelves with 4 and examples of thereon vials with 5 designated.
  • the shelves are usually heated and cooled. Coolant connections and also the means which allow the desired vertical movements of the shelves 4 - be it for adjustment to the loading height or for closing the containers 5 - are not shown.
  • the means for loading and unloading the shelves 4 include a conveyor belt 6, a transfer table 7 and a loading slide 8.
  • the components are all shown schematically, from the loading slide 8 only the front strip. Actuators are not shown for reasons of clarity. You can be trained in the way it is in the DE 103 07 571.2 A1 is described.
  • the outside of the loading opening 2 outer space is generally designated 10. It is either part of a clean room in which the freeze-drying plant is located, or an insulator.
  • the freeze-drying chamber partially shown has a first door 11, by means of which the loading opening 2 can be completely and tightly closed. It is hinged above the loading opening 2 pivotable about a horizontal axis.
  • FIG. 1 a shows the door 11 in its closed position, FIG. 1b in their open position.
  • FIG. 1 a also shows the transfer table 7 in its rest position, FIG. 1b in his operating position.
  • the transfer table 7 In its rest position, the transfer table 7 is in an inclined position below the loading level.
  • drive means he is in its operating position ( FIG. 1b ) and pivoted. In this position, it connects the levels of conveyor belt 6 and to be loaded footprint 4.
  • the location of the loading opening 2 is chosen so that the transfer table 7 rests in its operating position of the lower edge of the loading opening 2.
  • the loading opening 2 is associated with a further closing means. It is a vertically sliding sliding door 12, which is arranged above the loading opening 2. In connection with the description of the loading process according to the invention on the basis of FIGS. 2a to 2h will be discussed in more detail on the function of the sliding door 12. In principle, it is possible to equip the loading opening 2 with only one door, which has the functions of both the described doors 11, 12.
  • the stack of piles is located in the lower part of the freeze-drying chamber.
  • This is moved to the loading height ( FIG. 2 a) .
  • the transfer table 7 is already in its operating position.
  • Containers 5 delivered via the conveyor belt 6 are formatted on the transfer table with the aid of the loading slider or pusher 8 in such a way that they permit a loading thrust.
  • the thermal decoupling of the interior 3 of the freeze-drying chamber from the exterior 10 is achieved, on the one hand, by the sliding door 12 being lowered and thereby closing the region of the loading opening 2 lying above the transfer table 7.
  • the lying below the transfer table 7 area of the loading opening 2 is closed by the fact that the transfer table the lower edge of the loading opening 2 rests.
  • the transfer table 7 is equipped with a liftable edge portion 13, which will be described in detail below. This is in its raised position, so that a heat transfer between the already cold shelves 4 and the transfer table 7 does not take place.
  • FIG. 2h corresponds to FIG. 2 b. It shows the preparation of the first Beladeteilschubs the second footprint 4. The further loading process takes place in the same manner as it to the FIGS. 2c to 2f has been described.
  • FIG. 3 shows more details.
  • One way of actuating the edge portions 13 comprises a lever system 16 operated by the sliding door 12. With the closing movement of the sliding door 12, a first, the transfer table 7 enforcing lever 17 is moved downward. This downward movement causes a longitudinal movement of a parallel to the transfer table 7 to the edge portion 13 extending lever rod 16. Below the edge portion 13, the movement of the lever rod 18 is translated into a rotational movement of a further lever 19 which touches the underside of the edge portion 13 with its free end.
  • the lever system 16 is formed overall such that the downward movement of the sliding door 12 causes lifting of the edge portion 13. The reverse movement takes place when the upward movement of the sliding door 12 releases the lever 17, by the weight of the edge portion thirteenth
  • lever system 16 is shown schematically and housed below the transfer table 7. However, it is expedient to accommodate the lever system 16 at least partially in bores or recesses in the transfer table 7, so that it is able to close the area of the loading opening 2 lying below the transfer table 7 in its operating position by closing the lower edge of this opening 2 rests.
  • the edge portions 13 should - regardless of whether they are raised or maintained during the loading breaks their operating position - have only a minimal surface contact with the loading surface 4 to be loaded.
  • the free edges of the edge portions 13 end in thin tongues 20, which in the operating position of the edge portions 13 projections 21 (FIGS. Figures 3 and 4 ) Lie. These are located on the end of the transfer table 7 facing the shelves 4.
  • the projections 21 have a cylindrical portion 22 (near the platform) and a conical section 23. Get the edge portions 13, which have a slightly downwardly inclined position in their rest position, during the approach of the transfer table 7 In the vicinity of the shelves 4, the tongues 20 first touch the conical sections 23. On this they slide on and are raised until the transfer table 7 has reached its operating position. In this position, the tongues 20 are the cylindrical portions 22 virtually linear, so with the smallest surface contact on.
  • the dimensions of the elements described are chosen so that a gapless and stepless transition from the transfer table 7 is ensured on the shelves 4.
  • transfer table 7 On edge portions of the type described could be dispensed with, if possible by other means a gap-free and stepless demarcation of transfer table 7 and to be loaded footprint 4 could be achieved. Likewise, mechanical contact between the transfer table 7 and the loading surface 4 to be loaded during the loading pauses could also be achieved in that the transfer table 7 is moved back only by a small distance. In the illustrated embodiments, however, this is not possible because the mutual position of transfer table 7 and conveyor belt 6 must be maintained between the load strokes.
  • a plurality of adjacent edge portions 13 and projections 20 are present ( FIG. 4 ), so that minor and unavoidable unevenness of the relatively wide shelves 4 can be compensated.
  • the transfer table 7 It is equipped with heat transfer barriers, which consist of a poorly heat-conductive material, eg plastic. These are strip-shaped sections 25, 26, which extend parallel to the end face of the transfer table 7. The first section 25 is located where the transfer table 7 rests in its operating position of the lower edge of the loading opening 2. The second section lies in the plane of the sliding door 12. The thermal barriers 25, 26 thus prevent not only a cold flow from near the area of the transfer table 7 to the area remote from the pitch, but also to the chamber wall 1 (section 25) and to the sliding door 12 (section 26).
  • the above-described loading device is also used in the discharge of the shelves 4. As a rule, however, it is no longer necessary to ensure thermal decoupling of the interior 4 from the exterior 10.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Molecular Biology (AREA)
  • Drying Of Solid Materials (AREA)

Claims (10)

  1. Procédé de fonctionnement d'une installation de lyophilisation comprenant une chambre dans laquelle se trouvent des emplacements (4) disposés les uns au-dessus des autres, ainsi que des dispositifs de chargement et de déchargement ;
    la chambre possède une ouverture de chargement (2) équipée de moyens de fermeture (11, 12) et à travers laquelle les emplacements (4) situés dans la chambre sont chargés de récipients (5) ;
    le dispositif servant à charger les emplacements (4) de récipients (5) est situé en amont de l'ouverture de chargement (2) et comprend une bande transporteuse (6) destinée à acheminer les récipients (5), une table de transfert (7) pouvant se déplacer entre une position de travail et une position de repos et destinée à couvrir l'espace libre entre la bande transporteuse (6) et l'emplacement (4), ainsi qu'un poussoir de chargement (8) destiné à transférer une pluralité de récipients (5) par poussée de la bande transporteuse (6) à l'emplacement (4) par l'intermédiaire de la table de transfert (7),
    dans lequel la table de transfert (7) conserve sensiblement sa position de travail pendant le chargement des emplacements (4), le contact mécanique et thermique entre la table de transfert (7) et les emplacements (4) étant limité aux périodes pendant lesquelles s'effectue la poussée de chargement proprement dite, caractérisé en ce qu'un ou plusieurs segments de bordure (13) fixé(s) de façon articulée au côté frontal libre de la table de transfert est ou sont relevé(s) après une poussée de chargement et abaissé(s) avant la poussée de chargement suivante.
  2. Procédé selon la revendication 1, caractérisé en ce qu'au moins la région de l'ouverture de chargement (2) située au-dessus de la table de transfert (7) est fermée après une poussée de chargement.
  3. Procédé selon la revendication 2, caractérisé en ce que la partie supérieure de l'ouverture de chargement (2) est fermée au moyen d'une porte coulissante (12) dont le mouvement de fermeture détermine le relèvement des segments de bordure (13).
  4. Procédé selon la revendication 2 ou 3, caractérisé en ce que la région de l'ouverture de chargement (2) qui se trouve au-dessous de la table de transfert (7) est fermée par le fait que la table de transfert (7), dans la dernière phase de son mouvement vers sa position de travail, s'appuie sur le bord inférieur de l'ouverture de chargement (2).
  5. Installation de lyophilisation comprenant une chambre dans laquelle se trouvent des emplacements (4) disposés les uns au-dessus des autres, ainsi que des dispositifs de chargement et de déchargement ;
    la chambre possède une ouverture de chargement (2) équipée de moyens de fermeture (11, 12) et à travers laquelle les emplacements (4) qui se trouvent dans la chambre sont chargés de récipients (5) ;
    les dispositifs destinés à charger les emplacements (4) de récipients (5) sont placés en amont de l'ouverture de chargement (2) et comprennent une bande transporteuse (6) destinée à l'acheminement des récipients (5), une table de transfert (7) pouvant se déplacer entre une position de travail et une position de repos et destinée à couvrir la distance entre la bande transporteuse (6) et l'emplacement (4), ainsi qu'un poussoir de chargement (8) destiné à transférer une pluralité de récipients (5) par poussée de la bande transporteuse (6) à l'emplacement (4) par l'intermédiaire de la table de transfert (7),
    caractérisée en ce que les moyens de fermeture (11) déjà existants ou d'autres moyens de fermeture (12) de l'ouverture de chargement (2) sont constitués et peuvent être actionnés de façon telle que, lorsque la table de transfert (7) est engagée, au moins la région de l'ouverture de chargement qui est située au-dessus de la table peut être fermée,
    la table de transfert (7) présente dans la région de son bord avant un ou plusieurs segments de bordure (13) pouvant être relevés et
    le mouvement des segments de bordure (13) est couplé au mouvement de la porte coulissante (11).
  6. Installation de lyophilisation selon la revendication 5, caractérisée en ce qu'un système de leviers (16) sert à coupler les mouvements de la porte coulissante (11) à ceux des segments de bordure (13).
  7. Installation de lyophilisation selon la revendication 5 ou 6, caractérisée en ce que la table de transfert (7) est équipée d'au moins une barrière thermique (25, 26) qui s'étend parallèlement à son côté frontal.
  8. Installation de lyophilisation selon la revendication 7, caractérisée en ce que la ou les barrière(s) thermique(s) (25, 26) est ou sont constituée(s) de segments en matière plastique en forme de bande.
  9. Installation de lyophilisation selon la revendication 7 ou 8, caractérisée en ce qu'une barrière thermique (26) se trouve à la hauteur de la porte coulissante (11) lorsque la table de transfert (7) se trouve dans sa position de travail.
  10. Installation de lyophilisation selon la revendication 7, 8 ou 9, caractérisée en ce qu'une barrière thermique (25) se trouve à la hauteur du bord inférieur de l'ouverture de chargement (2) lorsque la table de transfert (7) se trouve dans sa position de travail.
EP06005688.4A 2005-04-13 2006-03-21 Procédé pour faire fonctionner des installations de lyophilisation avec une chambre et avec dispositifs de chargement et de déchargement, et installations appropriées de ce type Expired - Lifetime EP1712859B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102005017140A DE102005017140A1 (de) 2005-04-13 2005-04-13 Verfahren zum Betrieb von Gefriertrocknungsanlagen mit einer Kammer und mit Be- und Entladeeinrichtungen sowie dafür geeignet ausgebildete Anlagen dieser Art

Publications (3)

Publication Number Publication Date
EP1712859A2 EP1712859A2 (fr) 2006-10-18
EP1712859A3 EP1712859A3 (fr) 2011-11-02
EP1712859B1 true EP1712859B1 (fr) 2013-10-30

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US (1) US7421801B2 (fr)
EP (1) EP1712859B1 (fr)
DE (1) DE102005017140A1 (fr)

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DE10307571A1 (de) * 2003-02-22 2004-09-02 Steris Gmbh Einrichtung mit einer Stellfläche
DE102008020705A1 (de) 2008-04-24 2009-10-29 Gea Lyophil Gmbh Be- und Entladevorrichtung für eine Produktbehandlungseinrichtung
DE202009000109U1 (de) 2009-02-13 2010-07-22 Krones Ag Begrenzungsleiste für auf einer Auflagefläche gruppierte Artikel
NL2003338C2 (en) * 2009-08-07 2011-02-08 Ima Life Srl Method and assembly for handling containers in a freeze dryer.
RU2476790C2 (ru) * 2011-05-31 2013-02-27 Общество с ограниченной ответственностью "АКАДЕМФАРМ" Способ лиофилизационной сушки фармацевтических препаратов
RU2476791C1 (ru) * 2011-07-05 2013-02-27 Федеральное государственное учреждение здравоохранения Волгоградский научно-исследовательский противочумный институт Роспотребнадзора Способ лиофильной сушки эритроцитарного диагностикума
TW201420464A (zh) * 2012-11-26 2014-06-01 Ind Tech Res Inst 傳送裝置
ITMI20131016A1 (it) * 2013-06-19 2014-12-20 I M A Ind Macchine Automatic He S P A Sistema di alimentazione in una macchina liofilizzatrice per il settore farmaceutico
DE102015009866B4 (de) * 2015-08-03 2020-11-26 Accurro Gmbh Übergabeeinheit zum Schaffen einer Transportverbindung zwischen einer Gefriergutzuführanlage und einer Gefriertrocknungsanlage
CN107629943A (zh) * 2017-11-09 2018-01-26 中国科学院武汉病毒研究所 一种可进行生物安全操作的冷冻干燥装置
PH12022550094A1 (en) * 2020-12-30 2022-11-21 Msv Systems & Services Pte Ltd Apparatus, transfer method, chamber and frame for semiconductor burn-in process
WO2022223389A1 (fr) * 2021-04-19 2022-10-27 Sbm Schoeller Bleckmann Medizintechnik Gmbh Installation de lyophilisation
CN113932566B (zh) * 2021-09-22 2022-10-14 东富龙科技集团股份有限公司 一种自调节式板层过渡板结构
CN115682646B (zh) * 2022-11-22 2024-05-14 中玉制药(海口)有限公司 注射用双氯芬酸钠利多卡因冻干设备及其制备方法

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Publication number Publication date
US7421801B2 (en) 2008-09-09
EP1712859A3 (fr) 2011-11-02
EP1712859A2 (fr) 2006-10-18
US20060254076A1 (en) 2006-11-16
DE102005017140A1 (de) 2006-10-19

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