EP2490809B1 - Verbesserte systeme für die übertragung zwischen einer kammer und einem behälter - Google Patents

Verbesserte systeme für die übertragung zwischen einer kammer und einem behälter Download PDF

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Publication number
EP2490809B1
EP2490809B1 EP10770611.1A EP10770611A EP2490809B1 EP 2490809 B1 EP2490809 B1 EP 2490809B1 EP 10770611 A EP10770611 A EP 10770611A EP 2490809 B1 EP2490809 B1 EP 2490809B1
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EP
European Patent Office
Prior art keywords
container
door
data
chamber
opening
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
EP10770611.1A
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English (en)
French (fr)
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EP2490809A1 (de
Inventor
Stéphanie Armau
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.)
Sartorius Stedim Aseptics SAS
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Sartorius Stedim Aseptics SAS
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Publication of EP2490809A1 publication Critical patent/EP2490809A1/de
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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L1/00—Enclosures; Chambers
    • B01L1/02—Air-pressure chambers; Air-locks therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/54—Labware with identification means
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/025—Align devices or objects to ensure defined positions relative to each other
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/141—Preventing contamination, tampering
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/023—Sending and receiving of information, e.g. using bluetooth
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/02—Identification, exchange or storage of information
    • B01L2300/024—Storing results with means integrated into the container
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/046—Function or devices integrated in the closure

Definitions

  • the invention relates to improvements made to transfer systems, with isolation from the external environment, of a certain content between an enclosure and a container. Improvements are worth whatever the direction of the transfer. However, in practice, it is understood that, all other things being equal, the transfer always takes place in the same direction.
  • BIOSAFE® Basic Synchronization Agent
  • FR-A-2 787 190 which describes a sealed junction device comprising two enclosures provided, respectively, with an access opening equipped with a door cooperating with a flange and with locking means on their respective flange; connecting means making it possible to link the two enclosures and to form a passage between them, without risking introducing any element therefrom from the external environment; and a mechanism for detecting when the seal between the two enclosures and the external environment is no longer ensured.
  • Transfers such as those which can be carried out by such systems, may be necessary in a number of technical fields, in particular but not exclusively in the biopharmaceutical field.
  • the invention is particularly interested in this field, as in those which can be considered analogous in view of the requirements imposed.
  • the content - to be transferred or transferred - is not in itself crucial with regard to the invention except that it is intended to, and therefore must be able to be transferred.
  • it may for example be a sterile object such as a container, a container element such as a stopper, a syringe, but also environmental control elements, or even waste. products during a manufacturing or processing operation, waste that needs to be transferred in order to eliminate it ...
  • Transfers such as those considered here, take place within the framework of more complex processes in which the certain content undergoes one or more operations before and / or after the transfer. These operations consist of manufacturing, processing, handling, use, measurement, control, analysis, or other ...
  • an enclosure comprising a wall provided with the same plurality of openings, connection interfaces, doors, assembly means, door operating means. , and the same plurality of transfer systems.
  • the container of the transfer system can be partially flexible and movable, such as a pocket.
  • the container In the case of transfer from the container to the enclosure, at the start, the container is filled with its contents is disassembled from the enclosure and the first door and the second door are in the closed state.
  • the operator brings the container closer to the enclosure and assembles them by making their interfaces and their respective assembly means cooperate.
  • the container is then mounted on the enclosure and accessible to the operator. If necessary, these operations are fully or partially automated.
  • the operator can actuate the actuating means, for example rotate the lever (s) which form part thereof.
  • this operation is fully or partially automated.
  • the actuation controls the first operating means which move the first door from its closed state to its open state.
  • the movement of the first door concomitantly that of the second door.
  • the two doors are brought from the closed state to the open state.
  • the container is in sealed communication - isolated from the outside environment - with the enclosure via their two open openings.
  • the operator can then transfer the contents of the container into the enclosure via the two openings in a sealed manner - isolated from the outside environment -. Or, as before, this operation is fully or partially automated.
  • the operator can actuate the actuating means, which controls the first operating means which move the first door from its open state to its closed state and concomitantly which move the second from its open state to its closed state.
  • the operator can then disassemble the container from the enclosure. Or, as before, this operation is fully or partially automated.
  • the container is, or is not, for single use and then discarded after the use that has been made of it.
  • the radio-identification system is also known, commonly known as RFID (Radio Frequency IDentification), which comprises, on the one hand, a transponder or RFID tag, which can be in the form of a label having a substrate or the like bearing an antenna and an electronic chip and, on the other hand, a transceiver or reader, capable of activating the transponder located at a short distance.
  • RFID Radio Frequency IDentification
  • the transponder can receive and respond to radio requests sent by the transceiver.
  • RFID technology is used for identification, traceability, authenticity control, localization of electronic door opening, access control, communication.
  • the document WO2008 / 069846 describes a plastic container and a preform having an encapsulated RFID insert.
  • the document EP-A-1583048 describes a method for manufacturing a container having an RFID element.
  • EP-A-1887581 and EP-A-2012323 refer to the sterilization or radiation of a pharmaceutical device with an RFID tag.
  • the document US-A-2003/0072676 describes a pocket for containing a blood product with an RFID tag.
  • the document EP-A-2,080,553 relates to a method and a system for locating and identifying test tubes placed in a receiving support through the use of labels attached to the outside wall of these test tubes and having a barcode. More particularly, the method comprises a succession of steps consisting in scanning the bar codes in order to detect the corresponding identification data and determine the position of each test tube in the receiving support; if necessary, read the additional data recorded on RFID chips produced behind the labels; and correlating the identification data, the positioning data and the additional data of each test tube.
  • the invention provides a solution to these needs and it finds a particularly well suited application in the biopharmaceutical field but can be applied in other similar fields where the same needs arise.
  • the transfer system further comprises means for writing data in the marker means, functionally associated with the opening and / or closing of the first door of the enclosure.
  • the data reading means and / or the data writing means are located at least during operation of the transfer system, or with a view to this operation, at a short distance from the marking means, namely at short distance from the first door or at least from a zone through which the container passes in order to assemble it within the enclosure or to locate the container during this assembly.
  • the data reading means and / or the data writing means are carried by the enclosure, at least substantially adjacent to the first door of the enclosure or to the passage or location area of the container during of its assembly to the enclosure.
  • the data reading means and / or the data writing means are not directly carried by the enclosure, but located away from it.
  • the data reading means and / or the data writing means are fixedly arranged or are movable, in particular portable.
  • the means for storing the data read and / or the means for producing an output signal as a function of the data read or stored and / or the means for controlling the opening of the first door are, or not, carried by the enclosure.
  • the marker means and the data reading means communicate by radio, infrared or wired link. It is the same for the writing means and the marking means.
  • the marker means are of the read / rewrite type or of the read only type.
  • the marker means are a RFID transponder or tag.
  • the means for producing an output signal also provide a visual or audible signal perceptible by the operator.
  • the invention relates to a production line comprising an enclosure comprising a wall provided with the same plurality of openings, connection interfaces, doors, assembly means, maneuvering means of the door, and the same plurality of transfer systems, each as just described, functionally arranged from upstream to downstream, the line operating step by step in relation to each transfer system.
  • the means for controlling the opening of one of the doors of the enclosure are responsive to the signal received from the means for producing an output signal from a transfer system. placed upstream.
  • control means are programmed not to allow - and even prevent - the command to open the first door, if the exit signal means that the container in question must not be used to a transfer.
  • the method also includes a step in which, thanks to the writing means, the means markers a datum corresponding to the fact that the container has already been used for a transfer and must not be used for another subsequent transfer.
  • a plurality of relative information is written on the marking means. the container in question and its contents.
  • data is written on the marking means concerning the prior assembly of the container considered in relation to a first initial door of the enclosure, so as to prohibit any opening of a first subsequent door in the event of subsequent assembly of the container considered in relation to this first subsequent door.
  • the subject of the invention is a container specially intended for a transfer system or a production line as previously described, which comprises a wall forming an envelope, an assembly flange, annular, fixed tightly to the wall forming an envelope around an opening and provided with assembly means capable of cooperating with the first assembly means of the enclosure, a door arranged on the flange and arranged to be in the state closed or in the open state, means for maneuvering the door to move it from one state to another, functionally associated with the first door of the enclosure and marker means capable of storing data.
  • the envelope wall is flexible and the flange is rigid.
  • the marker means are of the read / rewrite type or of the read only type.
  • the marker means are a transponder or RFID tag.
  • the marking means are rigidly fixed and in a manner normally inseparable from the wall forming an envelope.
  • This embodiment may have as execution characteristics that the marking means are fixed to the wall forming an envelope and placed at least substantially in the surface thereof; that they are fixed to this wall by an adhesion means interposed between them; that they are located in the vicinity of the flange, the second opening, the second door and / or in an area of the container having less flexibility such as an area for welding the wall on itself; that they are located on the side of the exterior face of the wall forming an envelope.
  • the marking means are rigidly fixed and normally inseparable from the assembly flange.
  • This other embodiment may have as execution characteristics that the marking means are attached to the assembly flange and fixed to it by an adhesion means interposed between them or fixed to the flange by inlaying and forced pressing after completion of the flange or fixed to the flange during the production thereof by injection.
  • the marking means can be placed in a receiving cavity formed in the assembly flange, so as to present a front face substantially coplanar with the face of the flange lying around the cavity, in particular a cavity s opening on the front face of the flange forming a connection interface with an interface of the enclosure.
  • the marking means are trapped in a pocket attached to and rigidly fixed in a manner normally inseparable from the container.
  • This other embodiment may have as execution characteristics that the pocket is fixed to the wall forming an envelope and / or to the flange; that the pocket is located in the vicinity of the flange, the second opening, the second door and / or in an area of the container having less flexibility such as an area for welding the wall on itself; and, as the case may be, that the pocket is located on the side of the exterior face or of the interior face of the envelope wall.
  • the marking means are connected to the container by a flexible or rigid link, such that they cannot be untimely dissociated from the container with which they form an inseparable whole.
  • the invention relates to an enclosure specially intended for a transfer system or a manufacturing line as previously described, which comprises a first wall provided with a first opening and with a first connection interface, a first door arranged to be in the closed state or in the open state where, respectively, it closes or opens the first opening, first means of assembly, first means of operating the first door to move it from one state to another, external means for actuating, controlling the first maneuvering means, and in that it is functionally associated with means for reading data at short distance, means for storing the data read, means for producing an output signal which is a function of the data read or stored, and means for controlling the opening of the first door responsive to the signal received, means for producing an output signal.
  • the enclosure carries the data reading means and / or the means for storing the data read and / or the means for producing an output signal as a function of the data read or stored and / or the means for controlling the opening of the first door.
  • the data reading means are at least substantially adjacent to the first door.
  • the invention relates to a transfer system 1 which comprises an enclosure 2 and a container 3.
  • system is meant the fact that the enclosure 2 and the container 3 are functionally associated to provide the transfer function.
  • the invention also relates to the enclosure 2 and the container 3, as they are specially intended to be part of the transfer system 1.
  • Such a transfer system 1 can exist as such and operate by itself. It can also be integrated into a manufacturing line 4 which comprises a plurality of n transfer systems 1, some parts of which are common, these transfer systems 1 being arranged with each other, both structurally and functionally.
  • Such a transfer system 1 is intended to ensure the transfer of certain content C as appropriate, either from the container 3 (initial location) to the enclosure 2 (final location), or from the enclosure 2 (initial location) to container 3 (final location), isolating it during this transfer from the outside environment.
  • Such a transfer system 1 is very particularly suitable for the biopharmaceutical field. However, such a transfer system can be used in other technical fields where the same needs arise.
  • the enclosure 2 will now be described in a possible but non-limiting embodiment given purely by way of example.
  • the enclosure 2 is typically intended to be able to carry out such or such desired operation on the content C by isolating it from the outside environment. For example, it involves filling or emptying a content C constituting a container, or even assembling it with one or more other parts, or even recovering a waste with a view to eliminating it ... Consequently, enclosure 2 is for repeated use. Being able to be quite bulky (for example of the order of one or more meters per side) it is fixed, permanently.
  • the enclosure 2 comprises a first wall 5 (or a set of walls), rigid, externally limiting a first space 6, closed, which is more or less large, as required.
  • the enclosure 2 is quite large (for example of the order of one or more meters on a side) and it is fixed.
  • first is used to qualify what relates to enclosure 2
  • second is used to qualify what relates to container 3.
  • the first wall 5 is provided with a first opening 7 intended to allow the passage of the content C in the desired direction between the enclosure 2 and the container 3, and therefore having the dimension allowing this passage.
  • the first wall 5 comprises a first connection interface 8, such as a seat formed by the external face of the wall 5 around the first opening 7, with which is intended to cooperate a second interface 9 of the container 3.
  • a first connection interface 8 such as a seat formed by the external face of the wall 5 around the first opening 7, with which is intended to cooperate a second interface 9 of the container 3.
  • the enclosure 2 also comprises a first door 10 arranged and mounted on support means 11, so that it can be moved between a position where it is in the closed state and closes the first opening 7, and another position where it is in the open state and does not close the first opening 7.
  • the enclosure 2 also includes first assembly means 12, intended to cooperate with second assembly means 13 of the container 3.
  • the enclosure 2 also includes first means for operating the first door 10 to move it from one state to another, and means for actuating and controlling these first operating means, for example placed at the outside the enclosure 2.
  • a manufacturing line 4 it comprises an enclosure delimiting a common space 6 for a plurality of n openings 7, n interface 8, n doors 10 and n assembly means 12.
  • the container 3 will now be described in a possible but non-limiting embodiment given purely by way of example.
  • the container 3 is typically intended to be able to perform a function of packaging, storage, handling, transport of the content C by isolating it from the outside environment, that is to say because the content C is there initially and must be transferred to enclosure 2 either because the content is finally there, having been transferred there from enclosure 2.
  • container 3 can also provide a treatment space function, the content C therein undergoing one or more treatments, such as for example, sterilization.
  • the container 3 In the case where the container 3 is the initial location of the content C - with regard to the transfer in question -, the container 3 could have been implemented - in particular be filled with the content C - well before the transfer proper. Conversely, in the case where the container 3 is the final location of the content C - with regard to the transfer in question -, the container 3 a can be implemented - in particular be emptied of the content C - well after the transfer proper .
  • the container 3 is most often for single use.
  • the container 3 is able to be moved relative to the enclosure 2, for example from a preparation or storage location remote from the enclosure 2, to a location where the container 3 is assembled to the enclosure 2.
  • the container 3 is at least partially flexible, of relatively small size, for example manipulated by an operator.
  • the container 3 forms a sort of pocket.
  • the container 3 comprises a second wall 14, flexible, externally limiting a second space 15, closed, capable of containing the content C.
  • the second wall 14 is provided with a second opening 16 intended to allow the passage of the content C in the desired direction between the enclosure 2 and the container 3, and therefore having the dimension allowing this passage.
  • the second wall 14 includes the second connection interface 9.
  • the second opening 16 is such that, when the container 3 is assembled to the enclosure 2, it is in communication with the first opening 7.
  • the second connection interface 9 is complementary to the first connection interface 8.
  • the second opening 16 and the second connection interface 9 can be produced in a rigid annular flange 17 around which the second wall 14 is fixed in sealed manner.
  • the container 3 also has a second door 18 arranged and mounted so that it can be moved between a position where it is in the closed state and closes the second opening 16, and another position where it is in the open state and n does not close the second opening 16.
  • the container 3 also includes the second assembly means 13, intended to cooperate with the first assembly means 12 of the enclosure 2, so as to be able to produce a fixed, removable and sealed assembly of the container 3 on the enclosure 2 .
  • the container 3 also includes second means for maneuvering the second door 14 to move it from one state to the other, functionally associated with the first door 10, capable of opening or closing the first door. 10 causes, respectively, the opening or closing of the second door 14.
  • these means are magnets.
  • the content C to be transferred is not in itself crucial with regard to the invention except that it is intended to, and therefore must be able to be transferred. It may for example be a sterile object such as a container, a container element such as a stopper, a syringe, but also environmental control elements, or even waste produced during operation. manufacturing or processing, waste that needs to be transferred in order to eliminate it ...
  • the content C most often undergoes one or more operations before and / or after the transfer (manufacturing, processing, handling, use, measurement, control, analysis, or the like ). All these operations and the details thereof constitute as much information (or data) specific to the content C, and in part at least to the container 3 which received it, that it is important to be able to trace.
  • the transfer does not only concern a single content C and a single container 3, but a multiplicity, which it is also important to be able to individualize, distinguish and identify.
  • the identification of the content C subject of the transfer in one or more sets of contents and that of the container 3 object of the transfer in one or more sets of containers 3, also constitute as much information (or data) specific to the content C or to the container 3 who received it, which it is important to be able to trace. As before, there may be information (or data) from which it follows that a transfer should not be able to take place.
  • the process can involve several enclosures 2, and therefore several transfer systems 1, or a manufacturing line 4 also comprising several transfer systems 1, at least several first doors 10 ( figure 4 ).
  • the system 1 comprises, in addition to the enclosure 2 and the container 3 filled or intended to receive the content C, a certain number of means functionally integrated into the enclosure 2 and the container 3 which are now described .
  • the system 1 firstly comprises marking means 19, carried by the container 3, capable of storing the data D.
  • the system 1 then comprises means for reading data D at short distance 20, functionally complementary to the marking means.
  • It also includes means for storing the data D read 21, means for producing an output signal as a function of the data D read or stored 22, and means 23 for controlling the opening of the first door 10 and therefore the second gate 18, responsive to the output signal received from the means for producing an output signal 22.
  • the transfer system 1 also comprises writing means 24 of data D in the marker means 19, functionally associated with the opening and / or closing of the first door 10 of the enclosure 2, or with an event linked to this opening and / or closing.
  • the marker means 19 are of the read / rewrite type.
  • the writing means 24 can write in the marking means 19 data corresponding to the fact that the corresponding container 3 has been used for a transfer and therefore assembled with a first door 10 of an enclosure 2. This data then becomes part of all the data D stored by the marker means 19 of the container 3.
  • the reading means 20 of the enclosure 2 with which this new transfer is envisaged will read the data corresponding to the fact that the corresponding container 3 has been used for a previous transfer, the means 22 for producing an output signal will then produce an output signal taking account of this data and, according to the programming made, the control means 23 will not allow - and even prevent - the opening of the first door 10, guaranteeing a single use of the container 3.
  • the reading means 20, and the writing means 24 when they are provided are located, at least during the operation of the transfer system 1 - or with a view to this operation -, at a short distance from the marking means 19 and therefore of the container 3 considered. Consequently, the reading means 20, and the writing means 24 when they are provided, are located, at least during the operation of the transfer system 1 - or with a view to this operation -, at a short distance from the first door 10 of the enclosure 2, or at least of a zone 25 which is the zone for the passage of the container 3 - and more particularly marking means 19 - with a view to its assembly to the enclosure 2 or the zone of location of the container 3 - and more particularly of the marking means 14 - during this assembly to the enclosure 2.
  • This short distance is that resulting from the method and the means of communication between the marking means 19 and the reading means 20 and between the writing means 24 and the marking means 19, in the embodiment providing for such writing means 24. This short distance is the one that allows the transmission.
  • the marker means 19 and the reading means 20, such as the writing means 24 and the marker means 19 communicate by radio, infrared or wire connection.
  • the short distance considered can be of the order of ten or a few tens of centimeters.
  • the reading means 20 and the writing means 24 are carried directly or indirectly by the enclosure 2, in particular the first wall 5 and, more especially, are at least substantially adjacent - namely in the immediate vicinity or near - at the first door 10 of enclosure 2 ( figure 1 ) or in zone 25.
  • the reading means 20 and the writing means 24 can be fixedly arranged.
  • the reading means 20, and possibly the writing means 24, while being located, at least during the operation of the transfer system 1 - or with a view to this operation -, at a short distance from the means markers 19 and therefore of the container 3 considered, are not directly carried by the enclosure, but located away from it ( figure 2 ).
  • the reading means 20 are movable, in particular portable, while being located, at least during the operation of the transfer system 1 - or with a view to this operation -, at a short distance from the marking means 19 and therefore of the container 3 considered.
  • the reading means 20 can take the form of what is commonly called a reading “shower”.
  • Such marker means 19 can thus occupy a rest position possibly distant from the door 10 and be brought closer together during the operation of the transfer system 1, or with a view to this operation.
  • the position of use of the marker means 19 in the form of a "shower” is shown in solid lines and the rest position in broken lines.
  • the writing means 24 are also movable.
  • the storage means 21 and / or the means for producing a signal 22 and / or the control means 23 are, or not, carried by the enclosure 2, in particular by its first wall 5. Good of course, there are the necessary functional links between all the means.
  • the marker means 19 are a transponder or RFID tag.
  • the means for producing a signal 22 also provide a visual or audible signal perceptible by the operator, so as to inform the latter of the state in which the transfer system 1 is located. , and in particular the effective completion of the opening of doors 10 and 18, where appropriate the effective completion of the transfer of the content C in the desired direction.
  • a manufacturing line 4 ( figure 4 ), it comprises a single enclosure 2, having a wall 5 provided with the same plurality of n openings (7a, 7b ... 7n), connection interfaces (8a, 8b ... 8n), doors (10a, 10b ... 10n), assembly means (12a, 12b ... 12n), means for operating each door (10a, 10b ... 10n).
  • Such a production line 4 thus comprises a plurality of n transfer systems (1a, 1b ... 1n) arranged functionally from upstream to downstream, the first in the operating order being the system (7a, 8a, 10a, 11a, 12a) and the last (7b, 8b, 10b, 11b, 12b).
  • Such a production line is intended to operate step by step in relation to each transfer system (1a, 1b ... 1n).
  • a first container 3a is assembled with the first transfer system 1a, in order to transfer the content Ca, for example in the direction of the container 3 towards the enclosure 2, then, that a second container 3b is assembled with the second transfer system 1b, and so on up to the n th container 3n to the nth transfer system 1n.
  • Each transfer system (1a, 1b ... 1n) corresponds to a work station to implement an operational step in the envisaged process.
  • all the containers (3a, 3b ... 3n) are first structurally assembled with the corresponding transfer systems (1a, 1b ... 1n), their implementation for the respective transfers occurring, in a staggered manner in time.
  • a cabinet 26 connected to the enclosure 2 contains the means necessary for the operation of the line 4.
  • the invention makes it possible, in the case of a manufacturing line 4 as just described, to control the operation of each transfer system (1a, 1b ... 1n).
  • control means (23a, 23b ... 23n) of the opening of one - or each - of the doors (10a, 10b ... 10n) of the manufacturing line 4 are responsive to the signal received from the means for producing a signal (22A, 22b ... 22n) from a transfer system (1a, 1b ... 1n) placed upstream. In this way, one avoids making one or more transfers as soon as it would be unjustified because a previous transfer would not have been made.
  • the transfer system 1 is programmed and the method of its implementation organized so that the control means 23 do not allow - and even prevent - the control of the opening of the first door 10, if the output signal means that the container 3 considered must not be used for a transfer.
  • This can have several causes, linked for example to the process of developing the content C and of the container 3, to the very identity of these (mixture of batches), to improper handling, the fact that container 3 or its content C is not authentic, or even a transfer of content C which should not take place for any reason whatsoever
  • the method also includes a step in which, thanks to the writing means 24, the marker means 19 data corresponding to the fact that the container 3 was used for a transfer and therefore assembled with a first door 10 of an enclosure 2. As already indicated, this data then forms part of the set of data D stored by the marker means 19 of the container 3.
  • the transfer system 1 is programmed and the method of its implementation organized so that, in such a case, the control means 23 do not allow - and even prevent - the command to open the first door 10, to so that it is guaranteed that the container 3 is indeed for single use and cannot be reused later for a transfer.
  • the method for implementing the transfer system 1 is such that, as the manufacturing process of the at least one container 3 progresses, preparation of its content C, filling with the content C, and processing, to write on the marker means 19, a plurality of information relating to the container 3 considered and to its content 4. This thus ensures the desired traceability, before, during and after the transfer.
  • the container 3 also includes the marking means 19, capable of storing data.
  • marker means 19 are in the form of a label such as an RFID tag, the embodiments being able to be adapted to the case of other forms of marker means 19.
  • the marking means 19 are attached to and rigidly fixed to the external face 14a of the (second) wall 14 forming an envelope, being placed at least substantially in the surface thereof, an adhesion means 28 - such that glue or equivalent - being interposed between them.
  • This embodiment must be compatible with the fact that the wall 14 can have a much greater flexibility than that of the marking means 19.
  • the marking means 19 are located in the vicinity of the flange 27, of the second opening 16, of the second door 18 and / or in a zone of the container 3 having less flexibility such as a zone for welding the wall 14 on itself. This embodiment must moreover ensure a fixing which is normally inseparable from the holding means 19 to the wall 14.
  • the marking means 19 are attached to and rigidly fixed to the flange 27 in a normally indissociable manner, in a receiving cavity 29 formed in the flange 27, an adhesion means 30 - such as glue or the like - being interposed between them, at the bottom of the cavity 29.
  • the cavity 29 and the marker means 19 can be of complementary dimensions so that on the one hand the marker means 19 are protected laterally and that, on the other hand, their face free front 31 is at least substantially coplanar with the face 32 of the flange 27 situated around the cavity 29, in this case its front face 32 forming an interface 9.
  • the front face 31 of the marking means 19 does not project from the front face 32 of the flange 27, so as not to hinder, or prevent, the mounting of the container 3 on the enclosure 2.
  • a third possible realization is a variant of the second.
  • the marking means 19 are not fixed to the flange 27 by an adhesion means such as that described above, but are fixed by inlaying and forced insertion into the receiving cavity 29 having a projecting edge 33 in the form of a lip. holding, ensuring the maintenance of the marking means 19 at the bottom of the receiving cavity 29.
  • the free front faces 31 and 32 is at least substantially coplanar and, preferably, the front face 31 of the marking means 19 does not project the front face 32 of the flange 27. This embodiment offers the advantage of ensuring an inseparable attachment of the holding means 19 to the flange 27.
  • the marker means 19 are trapped in a pocket 35 - for example a plastic bag having a certain flexibility - and this pocket 35 is in turn attached to and rigidly fixed in a manner normally inseparable from the external face 14a of the ( second) wall 14 forming an envelope by bonding or welding at 36.
  • This embodiment has the advantage that the marker means 19 are protected by the wall constituting the pocket 35.
  • the pocket 35 is fixed to the flange 27, or it is partly fixed to the (second) wall 14 and partly to the flange 27.
  • the pocket 35 - and therefore the marker means 19 - is located in the vicinity of the flange 27, the second opening 16, the second door 18 and / or in an area of the container 3 having less flexibility such as a weld zone of the wall 14 on itself.
  • the pocket 35 is located not on the side of the external face 14a of the wall 14 forming an envelope, but on the side of its internal face.
  • the marker means 19 are connected to the container 3 by a flexible or rigid link of varying length.
  • This embodiment offers the advantage of making it possible to separate the marker means 19 from the container 3 proper. This realization must be done in such a way that the marker means 19 cannot be untimely dissociated from the container 3, with which they must form an inseparable whole.
  • the marker means 19 are not in physical contact with the content C of the container and are placed towards the outside of it. This constructive arrangement or any other similar aims to prevent the marker means 19 from being damaged as a result of contact with the content C, or even, conversely, that the content C is deteriorated as a result of contact with the marker means 19.
  • the marker means 19 must, in any event, be structurally associated with the container 3 so as to form with it a normally inseparable assembly. Indeed, it is important that one cannot remove holding means 19 coming from a certain container 3 in order to associate them with another.

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Analytical Chemistry (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
  • Warehouses Or Storage Devices (AREA)

Claims (20)

  1. System zum Transferieren (1) eines bestimmten Inhalts (C) in eine Richtung oder die andere zwischen einer Kammer (2) und einem Behälter (3), welcher in der Lage ist, bezüglich der Kammer (2) verlagert zu werden,
    wobei die Kammer (2) umfasst:
    - eine erste Wand (5), welche mit einer ersten Öffnung (7) und einer ersten Verbindungsschnittstelle (8) versehen ist,
    - eine erste Tür (10), welche dazu angeordnet ist, sich in dem geschlossenen Zustand oder dem offenen Zustand zu befinden, in welchen sie die erste Öffnung (7) schließt bzw. öffnet,
    - erste Anbringungsmittel (12),
    - erste Mittel zum Manövrieren der ersten Tür (10), um sie zu veranlassen, von einem Zustand in den anderen überzugehen,
    - und Betätigungsmittel zum Anweisen der ersten Mittel zum Manövrieren,
    wobei der Behälter (3) umfasst:
    - eine zweite Wand (14), welche mit einer zweiten Öffnung (16), welche wenn der Behälter (3) an der Kammer (2) angebracht ist, in Kommunikation mit der ersten Öffnung (7) ist, und an einer zweiten Verbindungsschnittstelle (9) angebracht ist, welche komplementär zu der ersten Verbindungsschnittelle (8) ist,
    - eine zweite Tür (18), welche dazu angeordnet ist, sich in dem geschlossenen Zustand oder dem offenen Zustand zu befinden, in welchem sie die zweite Öffnung (16) schließt bzw. öffnet,
    - zweite Anbringungsmittel (13), welche in der Lage sind, mit den ersten Anbringungsmittel (12) in einer Weise zusammenzuwirken, dass eine feste, lösbare und dichte Anbringung des Behälters (3) an der Kammer (2) hergestellt wird,
    - und zweite Mittel zum Manövrieren der zweiten Tür (18), um sie zu veranlassen von einem Zustand in den anderen überzugehen, welche betriebsmäßig der ersten Tür (10) zugeordnet sind, welche derart eingerichtet sind, dass das Öffnen oder Schließen der ersten Tür (10) das Öffnen bzw. das Schließen der zweiten Tür (18) antreibt,
    wobei das System in der Lage ist, wenn der Behälter (3) an der Kammer (2) angebracht ist, und sobald die erste Tür (10) und die zweite Tür (18) in den offenen Zustand überführt sind, den Inhalt (C) von einer anfänglichen Position, welche entweder in dem Behälter (3) oder in der Kammer (2) liegt, und zu einer finalen Position zu transferieren, welche entweder in der Kammer (2) oder in dem Behälter (3) liegt, in einem von der Außenumgebung isolierten Zustand, dadurch gekennzeichnet, dass es ferner betriebsmäßig integriert umfasst:
    - Markierungsmittel (19), welche an dem Behälter (3) getragen sind, welche in der Lage sind, Daten zu speichern,
    - Lesemittel (20) für Daten auf kurze Distanz, welche betriebsmäßig komplementär zu den Markierungsmitteln (19) sind,
    - Speichermittel (21) für die gelesenen Daten,
    - Mittel zum Erzeugen eines Ausgangssignals (22) als Funktion der gelesenen oder gespeicherten Daten, und
    - Mittel zum Anweisen des Öffnens der ersten Tür (10) und damit der zweiten Tür (18), welche auf das Ausgangssignal reagieren, welches von den Mitteln zum Erzeugen eines Ausgangssignals (22) empfangen wird.
  2. System zum Transferieren (1) nach Anspruch 1, dadurch gekennzeichnet, dass es ferner Schreibmittel (24) für Daten in den Markierungsmitteln (19) umfasst, welche betriebsmäßig dem Öffnen und/oder dem Schließen der ersten Tür (10) der Kammer (2) zugeordnet sind.
  3. System zum Transferieren (1) nach einem der Ansprüche 1 und 2, dadurch gekennzeichnet, dass die Lesemittel (20) für Daten und/oder die Schreibmittel (24) für Daten wenigstens während des Betriebs des Systems zum Transferieren (1) oder im Hinblick auf diesen Betrieb in kurzer Distanz zu den Markierungsmitteln (19) angeordnet sind, das heißt in kurzer Distanz zu der ersten Tür (10) oder der wenigstens einen Durchgangszone (25) des Behälters (3) im Hinblick auf seine Anbringung an der Kammer (2) oder der Position des Behälters (3) während dieses Anbringens.
  4. System zum Transferieren (1) nach Anspruch 3, dadurch gekennzeichnet, dass die Lesemittel (20) für Daten und/oder die Schreibmittel (24) für Daten entweder an der Kammer (2) getragen sind oder wenigstens im Wesentlichen benachbart zu der ersten Tür (10) der Kammer (2) oder zu der Durchgangszone oder der Position des Behälters (3) während seines Anbringens an der Kammer (2).
  5. System zum Transferieren (1) nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass die Schreibmittel (20) für Daten und/oder die Lesemittel (24) für Daten nicht direkt von der Kammer (2) getragen sind sondern abseits von ihr platziert sind, indem sie entweder in fester Weise oder in lösbarer Weise angeordnet sind, insbesondere tragbar.
  6. System zum Transferieren (1) nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, dass die Speichermittel (21) für gelesene Daten und/oder die Mittel zum Erzeugen eines Ausgangssignals (22) als Funktion der gelesenen oder gespeicherten Daten und/oder die Mittel zum Anweisen des Öffnens der ersten Tür (10) durch die Kammer (2) getragen sind oder nicht.
  7. System zum Transferieren (1) nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, dass die Markierungsmittel (19) entweder vom Lese/Wiederbeschreib-Typ oder vom Nur-Lese-Typ sind.
  8. System zum Transferieren (1) nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, dass die Markierungsmittel (19) ein RFID-Transponder oder - Etikett sind.
  9. Verfahren zum Ausführen eines Übertragungssystems (1) nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, dass es die folgenden Schritte umfasst:
    - Schreiben von Daten hinsichtlich des betreffenden Behälter (3) oder seines Inhalts (C) auf die Markierungsmittel (19),
    - Annähern des Behälters (3) an die Kammer (2), wobei ihre Türen (10, 18) in dem geschlossenen Zustand sind,
    - Anbringen von ihnen, indem ihre Schnittstellen (8, 9) und ihre Anbringungsmittel (12, 13) jeweils zum Zusammenwirken veranlasst werden,
    - Auslesen der auf die Markierungsmittel (19) geschriebenen Daten mittels der Lesemittel (20) für Daten und Speichern der gelesenen Daten D mittels der Speichermittel (21),
    - Erzeugen eines Ausgangssignals als Funktion der gelesenen oder gespeicherten Daten, und
    - Anweisen des Öffnens der ersten Tür (10) und somit der zweiten Tür (18) als Reaktion auf das Ausgangssignal.
  10. Verfahren nach Anspruch 9, dadurch gekennzeichnet, dass die Mittel zum Anweisen (23) dazu programmiert sind, das Anweisen des Öffnens der ersten Tür (10) nicht zu erlauben - oder gar zu verhindern - wenn das Ausgangssignal anzeigt, dass der betrachtete Behälter (3) nicht für einen Transfer zu verwenden ist.
  11. Verfahren nach einem der Ansprüche 9 und 10, dadurch gekennzeichnet, dass im Verlauf des Herstellungsvorgangs des wenigstens einen Behälters (3), der Vorbereitung eines Inhalts (C), des Füllens mit dem Inhalt (C) und der Behandlung, auf die Markierungsmittel (19) eine Mehrzahl von Informationen bezüglich des betrachteten Behälters (3) und seines Inhalts (C) geschrieben werden.
  12. Behälter (3), welcher speziell für ein System zum Transferieren (1) eines bestimmten Inhalts (C) in einer Richtung oder der anderen zwischen dem Behälter (3) und einer Kammer (2) nach einem der Ansprüche 1 bis 8 vorgesehen ist, dadurch gekennzeichnet, dass er eine Wand (14), welche eine flexible Hülle bildet, einen steifen ringförmigen Anbringungsflansch (27), welcher in dichter Weise an der Wand (14) befestigt ist, welcher eine Hülle um eine Öffnung (16) herum bildet und mit Anbringungsmitteln (13) versehen ist, welche in der Lage sind, mit den ersten Anbringungsmitteln (12) der Kammer (2) zusammenzuwirken, eine Tür (18), welche an dem Flansch (27) bereitgestellt und dazu eingerichtet ist, sich in dem geschlossenen Zustand oder dem offenen Zustand zu befinden, Mittel zum Manövrieren der Tür (18), um sie zu veranlassen, von einem Zustand in den anderen überzugehen, welche betriebsmäßig der ersten Tür (10) der Kammer (2) zugeordnet sind, und Markierungsmittel (19) umfasst, welche in der Lage sind, Daten zu speichern.
  13. Behälter (3) nach Anspruch 12, dadurch gekennzeichnet, dass die Markierungsmittel (19) steif und in normalerweise untrennbarer Weise an der Wand (14) befestigt sind, welche in der Nachbarschaft des Flanschs (27) eine Hülle der zweiten Öffnung (16) der zweiten Tür (18) bildet, und/oder in einer Zone des Behälters (3), welche eine geringere Flexibilität aufweist, als diejenige einer Schweißzone der Wand (14) an sich selbst.
  14. Behälter (3) nach Anspruch 12, dadurch gekennzeichnet, dass die Markierungsmittel (19) steif und in normalerweise untrennbarer Weise an dem Anbringungsflansch (27) befestigt sind, entweder durch ein Haftmittel (30), welches zwischen ihnen eingefügt ist, oder durch Einlegen und erzwungenes Eindrücken nach dem Bilden des Flanschs (27), oder während des Bildens des Flanschs durch Einspritzen.
  15. Behälter (3) nach Anspruch 14, dadurch gekennzeichnet, dass die Markierungsmittel (19) in einem Aufnahmehohlraum (29) platziert sind, welcher in dem Anbringungsflansch (27) bereitgestellt ist, derart, dass sie eine vordere Fläche (31) aufweisen, welche im Wesentlichen koplanar mit der Fläche des Flanschs (27) ist, welcher sich um den Hohlraum (29) herum befindet.
  16. Behälter (3) nach Anspruch 12, dadurch gekennzeichnet, dass die Markierungsmittel (19) in einer Tasche (35) eingeschlossen sind, welche in normalerweise untrennbarer Weise an dem Behälter (3) angebracht und steif daran befestigt ist, welche in der Nachbarschaft des Flanschs (27), der zweiten Öffnung (16), der zweiten Tür (18) und/oder einer Zone des Behälters (3) platziert ist, welche eine geringere Flexibilität aufweist, als diejenige einer Schweißzone der Wand (14) an sich selbst.
  17. Behälter (3) nach einem der Ansprüche 12 bis 16, dadurch gekennzeichnet, dass die Markierungsmittel (19) nicht in physischem Kontakt mit dem Inhalt (C) des Behälters (3) sind.
  18. Kammer (2), welche speziell für ein System zum Transferieren (1) eines bestimmten Inhalts (C) in einer Richtung oder der anderen zwischen einer Kammer (2) und dem Behälter (3) nach einem der Ansprüche 1 bis 8 vorgesehen ist, dadurch gekennzeichnet, dass sie eine erste Wand (5), welche mit einer ersten Öffnung (7) und einer ersten Verbindungsschnittstelle (8) versehen ist, eine erste Tür (10), welche dazu angeordnet ist, sich in dem geschlossenen Zustand oder dem offenen Zustand zu befinden, in welchen sie die erste Öffnung (7) schließt bzw. öffnet, erste Anbringungsmittel (12), erste Mittel zum Manövrieren der ersten Tür (10) um sie zu veranlassen, von einem Zustand in den anderen überzugehen, externe Betätigungsmittel zum Anweisen der ersten Mittel zum Manövrieren umfasst, und dadurch, dass ihr funktionell Lesemittel (20) für Daten auf kurze Distanz, Speichermittel (21) für die gelesenen Daten, Mittel zum Erzeugen eines Ausgangssignals (22) als Funktion der gelesenen oder gespeicherten Daten und Mittel zum Anweisen des Öffnens der ersten Tür (10) zugeordnet sind, welche auf das von den Mitteln zum Erzeugen eines Ausgangssignals (22) empfangene Signal reagieren.
  19. Kammer (2) nach Anspruch 18, dadurch gekennzeichnet, dass sie die Lesemittel (20) für Daten und/oder die Speichermittel (21) für die gelesenen Daten und/oder die Mittel zum Erzeugen eines Ausgangssignals (22) als Funktion der gelesenen oder gespeicherten Daten und/oder die Mittel zum Anweisen des Öffnens der ersten Tür (10) trägt.
  20. Kammer (2) nach einem der Ansprüche 18 und 19, dadurch gekennzeichnet, dass die Lesemittel (20) für Daten im Wesentlichen benachbart zu der ersten Tür (10) sind.
EP10770611.1A 2009-10-20 2010-09-22 Verbesserte systeme für die übertragung zwischen einer kammer und einem behälter Active EP2490809B1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0957367A FR2951516B1 (fr) 2009-10-20 2009-10-20 Perfectionnements aux systemes de transfert entre une enceinte et un conteneur.
PCT/FR2010/051995 WO2011048295A1 (fr) 2009-10-20 2010-09-22 Perfectionnements aux systemes de transfert entre une enceinte et un conteneur

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US9545628B2 (en) 2017-01-17
EP2490809A1 (de) 2012-08-29
US20120219388A1 (en) 2012-08-30
FR2951516B1 (fr) 2012-02-03
FR2951516A1 (fr) 2011-04-22
WO2011048295A1 (fr) 2011-04-28

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