EP2490809A1 - Improvements to systems for the transfer between a chamber and a container - Google Patents
Improvements to systems for the transfer between a chamber and a containerInfo
- Publication number
- EP2490809A1 EP2490809A1 EP10770611A EP10770611A EP2490809A1 EP 2490809 A1 EP2490809 A1 EP 2490809A1 EP 10770611 A EP10770611 A EP 10770611A EP 10770611 A EP10770611 A EP 10770611A EP 2490809 A1 EP2490809 A1 EP 2490809A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- container
- door
- data
- enclosure
- 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.)
- Granted
Links
- 238000012546 transfer Methods 0.000 title claims description 141
- 239000003550 marker Substances 0.000 claims abstract description 24
- 230000000295 complement effect Effects 0.000 claims abstract description 9
- 238000000034 method Methods 0.000 claims description 31
- 238000004519 manufacturing process Methods 0.000 claims description 30
- 238000003860 storage Methods 0.000 claims description 14
- 230000008569 process Effects 0.000 claims description 10
- 238000002347 injection Methods 0.000 claims description 7
- 239000007924 injection Substances 0.000 claims description 7
- 238000011144 upstream manufacturing Methods 0.000 claims description 7
- 238000004891 communication Methods 0.000 claims description 6
- 238000012545 processing Methods 0.000 claims description 5
- 238000002360 preparation method Methods 0.000 claims description 4
- 230000004044 response Effects 0.000 claims description 3
- 230000000007 visual effect Effects 0.000 claims description 3
- 229960000074 biopharmaceutical Drugs 0.000 description 5
- 239000002699 waste material Substances 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
- 230000006870 function Effects 0.000 description 4
- 238000009413 insulation Methods 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 238000011282 treatment Methods 0.000 description 4
- 239000000243 solution Substances 0.000 description 3
- 238000004458 analytical method Methods 0.000 description 2
- 230000007613 environmental effect Effects 0.000 description 2
- 239000003292 glue Substances 0.000 description 2
- 238000005259 measurement Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- 238000004026 adhesive bonding Methods 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000010836 blood and blood product Substances 0.000 description 1
- 229940125691 blood product Drugs 0.000 description 1
- 238000013500 data storage Methods 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000008570 general process Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 230000009131 signaling function Effects 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
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 the transfer systems, with insulation of the external environment, of a certain content between an enclosure and a container.
- the improvements are worth whatever the direction of the transfer. However, in practice, it is understood that, all things being equal, the transfer always intervenes in the same direction.
- BIOSAFE ® mask One of these systems is known under the BIOSAFE ® mask, this system not being exclusive of others. Systems of this type are also described, in particular in documents FR-A-1346486, EP-A-0688020, FR-A-2782071 and WO00 / 36610.
- the content - to be transferred or transferred - is not in itself crucial in the light of the invention except that it is intended to, and therefore must be, transferable.
- it may be for example a sterile object such as a container, a container element such as a cap, a syringe, but also environmental control elements, or even waste products during manufacturing or processing operations, waste that must be transferred in order to eliminate them ...
- Transfers occur as part 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 ...
- the enclosure of the transfer system may for example be rigid, fixed, and of greater or lesser size and comprise, typically:
- a first wall for example rigid, provided with a first opening, for example circular, and a first connection interface, for example a flange device;
- a first door for example in the form of a disk, mounted for displacement and arranged to be in the closed state or in the open state where, respectively, it closes or opens the first opening;
- first assembly means for example associated with the first connection interface
- first means for operating the first door to move it from one state to another for example in the form of an arm, lever or the like;
- external operating means for example in the form of one or more levers, for controlling the first operating means.
- an enclosure comprising a wall provided with the same plurality of openings, connection interfaces, doors, assembly means, means for operating the door , and the same plurality of transfer systems.
- the container of the transfer system may be partially flexible and movable, such as a pocket.
- Such a container may comprise, typically:
- a second wall provided with a second opening similar to the first opening which, when the container is assembled to the enclosure, is in communication with the first opening, and a second connection interface, for example a flange device , complementary to the first connection interface;
- a second door arranged to be in the closed state or in the open state where, respectively, it closes or opens the second opening
- second assembly means adapted to cooperate with the first assembly means so as to produce a fixed, removable and sealed assembly of the container on the enclosure;
- the container In the case of the transfer of the container to the enclosure, initially, 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 cooperating their interfaces and their respective assembly means. The container is then mounted on the enclosure and accessible to the operator. Where appropriate, these operations are automated in whole or in part. In this situation, the operator can actuate the actuating means, for example rotate the lever or levers that are part. Alternatively, this operation is automated in whole or in part. The actuation, whatever the manner in which it is achieved, controls the first means of maneuver that move the first door from its closed state to its open state. The movement of the first door causes concomitantly that of the second door. Thus, the two doors are brought from the closed state to the open state. In this situation, the container is in tight 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 external environment -. Or, as before, this operation is automated in whole or in part.
- the operator can actuate the actuating means, which controls the first maneuvering means that move the first door from its open state to its closed state and concomitantly that 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 automated in whole or in part.
- the container is, or is not, disposable and then discarded after the use made of it.
- RFID Radio Frequency IDentification
- a transponder or RFID tag which may 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, able to activate the transponder located at a short distance.
- the transponder can receive the radio requests transmitted by the transceiver and respond to them.
- RFID technology is implemented for identification, traceability, authenticity checking, location, electronic door opening, access control, communication.
- WO2008 / 069846 discloses a plastic container and a preform having an encapsulated RFID insert.
- EP-A-1583048 discloses a method for making a container having an RFID element.
- EP-A-1887581 and EP-A-2012323 refer to the sterilization or radiation of a pharmaceutical device having an RFID tag.
- EP-A-1850289 discloses the application of an RFID system for the workflow of blood transfusion centers.
- US-A-2003/0072676 discloses a bag for containing a blood product provided with an RFID tag.
- EP-A-2 080 553 relates to a method and system for locating and identifying test tubes placed in a receiving medium by the use of labels affixed to the outer wall of these test tubes and having a barcode. More particularly, the method comprises a succession of steps of scanning the bar codes so as to record the corresponding identification data and determine the position of each test tube in the receiving medium; if necessary, read the additional data recorded on RFID chips made 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 finds a particularly well-adapted application in the biopharmaceutical field but can be applied in other analogous areas where the same needs arise.
- the invention relates to a system for transferring a certain content in one direction or the other between an enclosure and a container at least partially flexible and able to be moved relative to the enclosure ,
- the enclosure comprising:
- a first wall provided with a first opening and 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,
- ⁇ the container comprising:
- a second wall provided with a second opening which, when the container is assembled to the enclosure, is in communication with the first opening, and a second complementary connection interface of the first connection interface
- a second door arranged to be in the closed state or in the open state where, respectively, it closes or opens the second opening
- second assembly means adapted to cooperate with the first assembly means so as to achieve a fixed, removable and sealed assembly of the container on the enclosure
- This transfer system is such that it also comprises, functionally integrated:
- ⁇ marker means carried by the container, able to memorize data
- ⁇ means for producing an output signal based on the read or stored data
- ⁇ means for controlling the opening of the first door and therefore the second door, responsive to the output signal received from the means for producing an output signal.
- the transfer system further comprises data writing means 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 the operation of the transfer system, or for this purpose, at a short distance from the marking means, namely at short distance from the first door or at least a passage zone of the container for assembly to the enclosure or location of 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 the zone of passage or location of the container when from 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 arranged in a fixed manner or are movable, especially portable.
- the means for storing the read data and / or the means for producing an output signal according to the data read or stored and / or the means for controlling the opening of the first door are, or not, worn by the enclosure.
- the marking means and the data reading means communicate by radio, infrared or wired connection. It is the same for the writing means and the marking means.
- the marking means are read / rewrite type or read-only type.
- the marking means are a transponder or RFID tag.
- the means for producing an output signal also provide a visual or audible signal perceptible by the operator.
- the subject of the invention is a production line comprising an enclosure comprising a wall provided with the same plurality of openings, connection interfaces, doors, assembly means, means of maneuvering of the door, and the same plurality of transfer systems, each as just described, arranged functionally from upstream to downstream, the line operating step by step in connection with 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 of a transfer system. placed upstream.
- the subject of the invention is a method for implementing a transfer system as described above, in which:
- the data written on the marking means is read by the data reading means, and the data read is stored by the storage means,
- the control means are programmed to not allow - and even prevent - the control of the opening of the first door, if the output signal means that the container in question should not be implemented to a transfer.
- the method also comprises a step in which, thanks to the writing means, one writes in the means means a data corresponding to the fact that the container has already been used for a transfer and shall not be used for another subsequent transfer.
- the marking means a plurality of information relating to the container in question and its contents.
- the data relating to the prior assembly of the container considered in relation to a first initial gate of the enclosure is written on the marking means, so as to prohibit any opening of a first subsequent door in case of subsequent assembly of the container in question in relation to this first subsequent door.
- the subject of the invention is a container specifically intended for a transfer system or a production line as previously described, which comprises an envelope wall, an assembly flange, annular, fixed sealingly to the wall forming envelope around an opening and provided with assembly means adapted to cooperate 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 operating the door to move from one state to another, functionally associated with the first door of the enclosure and marking means capable of storing data.
- the envelope wall is flexible and the flange is rigid.
- the marking means are read / rewrite type or read-only type.
- the marking means are a transponder or RFID tag.
- the marking means are fixed rigidly and normally inseparable to the wall forming envelope.
- marking means are fixed on the wall forming envelope and placed at least substantially in the surface thereof; they are fixed on 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 a lesser flexibility such as a weld zone of the wall on itself; they are located on the side of the outer face of the wall forming envelope.
- the marking means are fixed rigidly and normally inseparable to the assembly flange.
- 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 inlay and force sink after completion of the flange or attached to the flange when producing it by injection.
- the marking means can be placed in a receiving cavity formed in the assembly flange, so as to have a front face substantially coplanar with the face of the flange located around the cavity, in particular a cavity. 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 fixed rigidly normally inseparable to the container.
- This other embodiment may have as performance features that the bag is attached to the wall forming envelope and / or the flange; that the pocket is located in the vicinity of the flange, the second opening, the second door and / or in a zone of the container having a lesser flexibility such as a weld zone of the wall on itself; and, depending on the case, that the pocket is located on the side of the outer face or the inner face of the envelope wall.
- the marking means are connected to the container by a flexible or rigid link, such that they can not be unintentionally dissociated from the container with which they form an indissociable assembly.
- the subject of the invention is an enclosure specially designed for a transfer system or a manufacturing line as previously described, which comprises a first wall provided with a first opening and a first opening. 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 assembly means, first means for maneuvering the first door to move it from one state to another, external means for actuating, controlling the first operating means, and in that it is functionally associated with means for reading data at short distances, means storage of the read data, means for producing an output signal according to the data read or stored, and means for controlling the opening of the first responsive door to the signal received from the means for producing an output signal.
- the enclosure carries the data reading means and / or the data storage means read and / or the means for producing an output signal according to 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 gate.
- FIG. 1 is a schematic view symbolically representing a transfer system according to the invention, comprising an enclosure, a container, a content, marker means, reading means, storage means, means for producing a output signal function, control means; in this embodiment, the reading means, storage, production of an output signal and control are fixedly carried by the enclosure in the vicinity of its door.
- FIG. 2 is a simplified schematic view illustrating the case where the reading means, while being located, at least during the operation of the transfer system - or with a view to this operation - at a short distance from the marking means and the container considered, are not directly worn by the enclosure, but located away from it.
- FIG. 3 is a simplified schematic view similar to FIG. 2, illustrating the case where the reading means are movable, in particular portable, and in the form of a reading "shower", which can occupy a rest position (broken lines); and a position of use (solid line).
- FIG. 4 is a simplified schematic view of a production line comprising a common enclosure and several transfer systems arranged from upstream to downstream.
- FIG. 5 is a schematic plan view of a container illustrating a first embodiment of the arrangement of the marker means with the container.
- FIG. 6 is a sectional view, partial and on a larger scale of Figure 5, along the line VI-VI.
- FIG. 7 is a schematic plan view of a container illustrating a second embodiment of the arrangement of the marking means with the container.
- FIG. 8 is a partial sectional view and on a larger scale of Figure 7, along the line VII- VII.
- FIG. 9 is a schematic sectional view of a container illustrating a third embodiment of the arrangement of the marking means with the container.
- FIG. 10 is a partial view on a larger scale of Figure 9.
- FIG. 10 is a schematic sectional view of a container illustrating a fourth embodiment of the arrangement of the marking means with the container.
- Figure 12 is a partial view on a larger scale of Figure 1 1 showing the presence of a lid to be removed after injection.
- FIG. 13 is a schematic plan view of a container illustrating a fifth embodiment of the arrangement of the marker means with the container.
- FIG. 14 is a sectional view, partial and on a larger scale of Figure 5, according to the line XIV-XIV.
- the invention relates to a transfer system 1 which comprises an enclosure 2 and a container 3.
- the term "system” means 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 on its own. It can also be integrated in a production 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 a certain content C according to the case, either from the container 3 (initial location) to the chamber 2 (final location) or the chamber 2 (initial location) to the container 3 (final location), isolating it during this transfer of the external environment.
- Such a transfer system 1 is particularly suitable for the biopharmaceutical field. But, such a transfer system can be used in other technical fields where the same needs arise.
- the enclosure 2 is now described in a possible but nonlimiting embodiment given purely by way of example.
- the chamber 2 is typically intended to perform 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 to assemble it to one or more other parts, or to recover a waste for the purpose of eliminating it ...
- enclosure 2 is for repeated use. Being able to be rather voluminous (for example of the order of one or several meters of 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 larger or smaller, as required.
- the enclosure 2 is quite large (for example of the order of one or more meters side) and is fixed.
- first is used to describe what concerns the enclosure 2
- second is used to describe what concerns the 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 chamber 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 outer 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 outer 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 chamber 2 also comprises a first door 10 arranged and mounted on support means 1 1, 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 comprises first assembly means 12 intended to cooperate with second assembly means 13 of the container 3.
- the chamber 2 also comprises first means of maneuvering the first door 10 to move it from one state to another, and means for actuating and controlling these first means of maneuver, for example placed at the door. 2.
- a manufacturing line 4 it comprises an enclosure defining a common space 6 for a plurality of n openings 7, n interface 8, n gates 10 and n assembly means 12 .
- the container 3 is now described in a possible but nonlimiting embodiment given purely by way of example.
- the container 3 is typically intended to be able to perform a function of packaging, storage, handling, transporting the content C by isolating it from the external environment, or because the content C is initially there and must be transferred to the chamber 2 is because the content is finally there, having been transferred from the enclosure 2.
- the container 3 can also ensure a treatment space function, the content C therein undergoing one or more treatments, such as for example, a sterilization.
- the container 3 is the initial location of the content C - with regard to the transfer of which is - the container 3 could be implemented - in particular be filled with the content C - well before the actual transfer. Conversely, in the case where the container 3 is the final location of the content C - with regard to the transfer of which - is the container 3 may be implemented - in particular be emptied of the content C - well after the actual transfer . Insofar as the transfer process envisaged here must be carried out with insulation in relation to the external environment, the container 3 is most often disposable.
- the container 3 is able to be moved relative to the chamber 2, for example from a location of preparation or storage remote from the chamber 2, to a location where the container 3 is assembled to the chamber 2.
- the container 3 is at least partially flexible, of relatively small size, for example manipulable by an operator.
- the container 3 forms a kind of pocket.
- the container 3 comprises a second wall 14, flexible, externally limiting a second space 15, closed, able to contain 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 has the second connection interface 9.
- the second opening 16 is such that, when the container 3 is assembled to the enclosure 2, it communicates 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 made in a rigid annular flange 17 around which is fixed in a sealed manner, the second flexible wall 14.
- the container 3 also comprises a second door 18 arranged and mounted so as to 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 not close the second opening 16.
- the container 3 also comprises the second assembly means 13, intended to cooperate with the first assembly means 12 of the enclosure 2, so as to achieve a fixed, removable and sealed assembly of the container 3 on the enclosure 2 .
- the container 3 also comprises second means for operating the second door 14 to move it from one state to another, functionally associated with the first door 10, able to open or close the first door 10 causes, respectively, the opening or closing of the second door 14.
- these means are magnets.
- the container 3 When the container 3 is assembled on the enclosure 2, and once the first gate 10 and the second gate 14 brought to the open state, it is possible to transfer the content C from its initial location to its final location while being isolated. from the outside environment.
- the content C to be transferred is not in itself crucial with respect to the invention except that it is intended for, and therefore must be able to be transferred.
- This may be for example a sterile object such as a container, a container element such as a cap, a syringe, but also environmental control elements, or even waste produced during operation manufacturing or treatment, waste that must be transferred in order to eliminate them ...
- the content C most often undergoes one or more operations before and / or after the transfer (manufacture, processing, manipulation, use, measurement, control, analysis, or other ). All these operations and the details thereof constitute as much information (or data) specific to the content C, and partly to the container 3 that received it, which it is important to be able to trace.
- the transfer does not concern a single content C and a single container 3, but a multiplicity, which is also important to be able to individualize, distinguish and locate.
- the identification of the content C object 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 container 3 who has received it, that it is important to be able to trace.
- This information constitutes D data that can be expressed, recorded, stored, read, transferred, processed and used.
- the process may involve several enclosures 2, and therefore several transfer systems 1, or a production line 4 also comprising several transfer systems 1, at least several first doors 10 ( Figure 4).
- the transfer system 1 brings, within the framework of the process in which it intervenes, the security of the transfers, the traceability of the contents C, and a solution to the problem that would pose the transfer not of the contents to be transferred but of a copy of it, the system 1 comprises, in addition to the enclosure 2 and the container 3 filled or intended to receive the content C, a number of functionally integrated means to the enclosure 2 and the container 3 which are now described .
- the system 1 comprises firstly marker means 19, carried by the container 3, able to memorize the data D.
- the system 1 then comprises short-distance data reading means D, functionally complementary to the marker means.
- It also comprises means for storing data D read 21, means for producing an output signal according to data D read or stored 22, and control means 23 for opening the first door 10 and therefore the second gate 18 responsive to the output signal received means for producing an output signal 22.
- the transfer system 1 further comprises writing means 24 data D in the marking means 19, functionally associated with the opening and / or closing of the first door 10 of the chamber 2, or an event related to this opening and / or closing.
- the marking means 19 are 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 thus assembled with a first door 10 of a chamber 2. This data is then part of all the data D stored by the marking 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 done, the control means 23 will not allow - and even prevent - the opening of the first door 10, ensuring a single use of the container 3. If, contrary to what has just been exposed such a writing in the marker means 19 is not required, there is no provision for writing means 24 and the marker means 19 may be read-only.
- the reading means 20, and the writing means 24 when they are provided are located, at least during operation of the transfer system 1 - or for this purpose - 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 in view of this operation -, at a short distance from the first door 10 of the enclosure 2, or at least one zone 25 which is the zone of passage of the container 3 - and more particularly of the marking means 19 - for its assembly to the enclosure 2 or the zone of location of the container 3 - and more particularly the marking means 14 - during this assembly to the enclosure 2.
- This short distance is that resulting from the method and 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 transmission.
- the marking means 19 and the reading means 20, such as the writing means 24 and the marking means 19 communicate by radio, infrared or wired connection.
- the short distance considered can be of the order of a dozen 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 close - to the first door 10 of the chamber 2 ( Figure 1) or to the zone 25.
- the reading means 20 and the writing means 24 may be arranged in a fixed manner.
- 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 the container 3 considered, are not directly carried by the enclosure, but located away from it ( Figure 2).
- the reading means 20 are displaceable, especially portable, while being located, at least during the operation of the transfer system 1 - or for this purpose - at a short distance from the marking means 19 and therefore of the container 3 considered.
- the reading means 20 may take the form of what is commonly referred to as a "hand shower".
- Such marker means 19 can thus occupy a rest position possibly remote from the door 10 and be brought together during operation of the transfer system 1, or for this purpose.
- the position of use of the marker means 19 in the form of "hand shower” is shown in solid line 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, borne by the enclosure 2, in particular by its first wall 5.
- the marking means 19 are a transponder or RFID tag.
- the means for producing a signal 22 also provide a visual or audible signal that can be perceived by the operator, so as to inform him of the state in which the transfer system 1 is located. , and in particular the effective realization of the opening of the doors 10 and 18, where appropriate the effective embodiment of the transfer of the content C in the desired direction.
- the latter comprises a single enclosure 2, having a wall 5 provided with the same plurality of n openings (7a, 7b ... 7n), interfaces connection (8a, 8b ... 8n), doors (10a, 10b ... 10n), assembly means (12a, 12b ... 12n), means for operating each door (10a, 10b) ... 10n).
- Such a manufacturing line 4 thus comprises a plurality of n transfer systems (1a, 1b ... 1n) arranged functionally from upstream to downstream, the first in the order of operation being the system (7a, 8a, 10a, 11a, 12a) and the last one (7b, 8b, 10b, 11b, 12b).
- Such a production line is intended to operate step by step in connection with each transfer system (1a, 1b ... 1 n).
- first container 3a is assembled to the first transfer system 1a, in order to transfer the content Ca, for example in the direction of the container 3 to the enclosure 2, and then, that a second container 3b is assembled to second transfer system 1b, and so on up to n 'th 3n container to n' th transfer system 1 n.
- Each transfer system (1a, 1b ... 1n) corresponds to a workstation for implementing an operating step of the envisaged process.
- all the containers (3a, 3b ... 3n) are first structurally assembled to the corresponding transfer systems (1a, 1b ... 1n), their implementation for the respective transfers involved, it, of way shifted 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 production line 4 are responsive to the signal received from the means for producing a signal (22A, 22b ... 22n) of a transfer system (1a, 1b ... 1n) placed upstream. In this way, one or more transfers are avoided since this would be unjustified because a previous transfer would not have been made.
- the method of implementation of the transfer system 1 comprises the following succession of steps: the data is written on the marking means 19 concerning the container 3 in question or its content C,
- the container 3 is assembled to the enclosure 2, by cooperating their interfaces 8, 9 and their assembly means 12, 13,
- the reading means 20 the data D written on the marking means 19 is read, and by means of the storage means 21, the data D thus read is stored,
- an output signal is produced according to the data D read and / or stored, and
- control means 23 it controls the opening of the first door 10 and therefore the second door 18, in response to the output signal.
- 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 should not be implemented for a transfer.
- This can have several causes, for example linked to the process of developing the content C and the container 3, to the very identity of these (mix of batches), to mishandling, the fact that the container 3 or its contents C is not the authentic one, or a transfer of a C content that should not take place for any reason whatsoever
- the method also comprises a step in which, thanks to the writing means 24, one writes in the a data corresponding to the fact that the container 3 was used for a transfer and thus assembled with a first door 10 of a chamber 2. As already indicated, this data is then part of the set of data D stored by the marking 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 control of the opening of the first door 10, of so that it is guaranteed that the container 3 is for single use and can not be reused later for a transfer.
- the method of implementation of the transfer system 1 is such that it allows, as and when the manufacturing process of the at least one container 3, preparation of its content C, filling with the content C, and processing, write on the marking means 19, a plurality of information relating to the container 3 in question and its contents 4. This ensures the desired traceability, before, during and after the transfer.
- the container 3 also comprises the marking means 19, able to memorize data. Now more specifically, the arrangement of the marker means 19 on the container 3 is described.
- marking means 19 are in the form of a label such as an RFID tag
- the embodiments can be adapted to the case of other forms of marking means 19.
- the marking means 19 are attached to and fixed rigidly to the outer face 14a of the (second) wall 14 forming an envelope, being placed at least substantially in the surface thereof. , an adhesion means 28 - such as glue or the like - being interposed between them.
- This embodiment must be compatible with the fact that the wall 14 may 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, the second opening 16, the second door 18 and / or in a zone of the container 3 having a lesser flexibility such as a weld zone of the wall 14 on itself. This embodiment must also ensure a normally inseparable attachment of the holding means 19 to the wall 14.
- the marking means 19 are attached to and fixed rigidly to the flange 27, normally inseparable, in a receiving cavity 29 formed in the flange 27, an adhesion means 30. such that glue or the like - being interposed between them, at the bottom of the cavity 29.
- the cavity 29 and the marking means 19 may be of complementary dimensions so that on the one hand the marking means 19 are laterally protected. and that, on the other hand, their free end face 31 is at least substantially coplanar with the face 32 of the flange 27 located around the cavity 29, in this case its front face 32 forming an interface 9.
- the front face 31 marker means 19 does not protrude 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 embodiment is a variant of the second.
- the marking means 19 are not fixed to the flange 27 by an adhesion means such as that previously described, but are fixed by inlaying and pressing force into the receiving cavity 29 having a protruding edge 33 in the form of a lip holding, maintaining the marking means 19 at the bottom of the receiving cavity 29.
- the free end faces 31 and 32 are at least substantially coplanar and, preferably, the front face 31 of the marking means 19 does not stray from 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 marking means 19 are trapped in a pocket 35 - by a plastic bag having a certain flexibility - and this pocket 35 is in turn attached to and fixed rigidly normally inseparable to the outer face 14a of the (second) wall 14 forming envelope by gluing or welding 36.
- embodiment has the advantage that the marking means 19 are protected by the wall constituting the pocket 35.
- the pocket 35 is fixed to the flange 27, or it is fixed partly to the (second) wall 14 and partly to the flange 27.
- the pocket 35 - and therefore the marking means 19 - is located in the vicinity of the flange 27, the second opening 16, the second door 18 and / or in a zone of the container 3 having a lesser flexibility such that welding zone of the wall 14 on itself.
- the pocket 35 is located not on the side of the outer face 14a of the wall 14 forming the envelope, but on the side of its inner face.
- the marking means 19 are connected to the container 3 by a flexible or rigid link more or less long.
- This embodiment offers the advantage of allowing the marking means 19 of the container 3 itself to be removed. This embodiment must be made in such a way that the marking means 19 can not be unintentionally dissociated from the container 3, with which they must form an indissociable assembly.
- the marking means 19 are not in physical contact with the contents C of the container and are placed towards the outside of it.
- This constructive arrangement or any other analog aims to prevent the marking means 19 from being damaged as a result of the contact with the content C, or, conversely, that the content C is deteriorated as a result of the contact with the marking means 19.
- the previously described embodiments are not exclusive of others, fulfilling the same function, the marking means 19 before, in any case be structurally associated with the container 3 so as to form with it a normally inseparable set. Indeed, it is important that one can not remove the holding means 19 from a certain container 3 to associate with another.
Landscapes
- 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)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0957367A FR2951516B1 (en) | 2009-10-20 | 2009-10-20 | IMPROVEMENTS IN TRANSFER SYSTEMS BETWEEN AN ENCLOSURE AND A CONTAINER. |
PCT/FR2010/051995 WO2011048295A1 (en) | 2009-10-20 | 2010-09-22 | Improvements to systems for the transfer between a chamber and a container |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2490809A1 true EP2490809A1 (en) | 2012-08-29 |
EP2490809B1 EP2490809B1 (en) | 2020-03-11 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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EP10770611.1A Active EP2490809B1 (en) | 2009-10-20 | 2010-09-22 | Improvements to systems for the transfer between a chamber and a container |
Country Status (4)
Country | Link |
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US (1) | US9545628B2 (en) |
EP (1) | EP2490809B1 (en) |
FR (1) | FR2951516B1 (en) |
WO (1) | WO2011048295A1 (en) |
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EP2572796B1 (en) * | 2011-09-20 | 2016-01-27 | Aptar France SAS | Refillable liquid cartridge system |
FR2984791B1 (en) * | 2011-12-23 | 2014-02-21 | Getinge La Calhene | INSTALLATION COMPRISING A GLOVES BOX AND A GLOVE CHANGE DEVICE INCLUDING A FOLLOWING OF THE CHANGE OF GLOVES |
US9194175B2 (en) * | 2013-07-19 | 2015-11-24 | Savannah River Nuclear Solutions, Llc | Interchangeable breech lock for glove boxes |
WO2016140920A1 (en) | 2015-03-02 | 2016-09-09 | Delaware Capital Formation, Inc. | Customizable mounting interface for a sealed transfer port |
FR3046206B1 (en) * | 2015-12-23 | 2018-01-12 | Sartorius Stedim Aseptics | METHOD FOR MANUFACTURING A SEALED CONTAINER |
US11554507B2 (en) | 2017-05-08 | 2023-01-17 | Delaware Capital Formation, Inc. | Access port having a cover |
FR3105186B1 (en) * | 2019-12-20 | 2021-11-12 | Abc Transfer | WATERPROOF CONTAINER INCLUDING A DEVICE ALLOWING REMOVABLE CONNECTION TO A SPEAKER |
DE102021201569A1 (en) * | 2021-02-18 | 2022-08-18 | Castus GmbH & Co. KG | beta containers for an alpha-beta port system |
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BE639715A (en) | 1962-11-08 | |||
FR2721289B1 (en) * | 1994-06-17 | 1996-08-30 | Idc Isolateur Denominateur | Sealed connection device between two enclosures isolated from an external environment. |
FR2782071B1 (en) | 1998-08-04 | 2000-11-03 | Idc Isolateur Denominateur Com | SINGLE USE CONTAINER |
FR2787190B1 (en) | 1998-12-11 | 2001-02-16 | Becton Dickinson France | DEVICE FOR DETECTING THE SEALING OF THE CONNECTION BETWEEN THE ELEMENTS OF A DEVICE FOR SEALING TWO ISOLATED ENCLOSURES FROM THE EXTERNAL ENVIRONMENT |
FR2787235B1 (en) | 1998-12-11 | 2001-01-19 | Becton Dickinson France | DEVICE FOR CONNECTING DOORS BETWEEN TWO ENCLOSURES ISOLATED FROM THE EXTERNAL ENVIRONMENT |
US20020183882A1 (en) * | 2000-10-20 | 2002-12-05 | Michael Dearing | RF point of sale and delivery method and system using communication with remote computer and having features to read a large number of RF tags |
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EP1429823A1 (en) | 2001-09-27 | 2004-06-23 | Gambro, Inc., | Radio frequency or electromagnetic information systems and methods for use in extracorporeal blood processing |
US20040051368A1 (en) * | 2002-09-17 | 2004-03-18 | Jimmy Caputo | Systems and methods for programming pumps |
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NL1026759C2 (en) * | 2004-04-02 | 2005-10-05 | Capturetech Benelux B V | Method for manufacturing a value container ('seal bag') with an RFID element and method for the use thereof. |
US20070008138A1 (en) * | 2004-07-20 | 2007-01-11 | Precision Dynamics Corporation | Coordinated identification of persons and/or articles via radio frequency identification cross-identification |
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FR2883266B1 (en) * | 2005-03-15 | 2007-06-15 | Isolateur Denominateur Commun | FLEXIBLE CONTAINER WITH GUIDING ELEMENT INCORPORATES |
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2009
- 2009-10-20 FR FR0957367A patent/FR2951516B1/en not_active Expired - Fee Related
-
2010
- 2010-09-22 WO PCT/FR2010/051995 patent/WO2011048295A1/en active Application Filing
- 2010-09-22 EP EP10770611.1A patent/EP2490809B1/en active Active
- 2010-09-22 US US13/503,188 patent/US9545628B2/en active Active
Non-Patent Citations (1)
Title |
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See references of WO2011048295A1 * |
Also Published As
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FR2951516A1 (en) | 2011-04-22 |
US20120219388A1 (en) | 2012-08-30 |
WO2011048295A1 (en) | 2011-04-28 |
FR2951516B1 (en) | 2012-02-03 |
US9545628B2 (en) | 2017-01-17 |
EP2490809B1 (en) | 2020-03-11 |
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