EP3259760B1 - Device enabling transfer between a container and a cell and method of use - Google Patents

Description

Field of the invention

The invention relates to devices for sealingly connecting a container to a containment enclosure, in order to transfer products or materials between these two volumes, while preserving their confinement vis-à-vis the external atmosphere.

Prior art and problems posed

Devices of this type are commonly used in many sectors of industry and research, almost every time it is necessary to isolate a particular area inside a containment. This is particularly the case, because of the hazardous or contaminating nature of the atmosphere, or the products contained in this zone, or, on the contrary, because the sterile atmosphere contained in this zone is likely to be contaminated by air outside environment. Such situations arise in particular in the nuclear, pharmaceutical and medical fields.

On the other hand, we know, by the French patent 2 931993 , a double sealed transfer door, for a transfer of a container to a cell. It comprises a cell flange in which is mounted a cell door having a seal and a container flange into which the container door is mounted. The device comprises means for securing the container flange with the cell flange. The cell door is in two parts, namely a lid held on the flange, by mechanical means and a floating part, forming a seal holder, which can move in translation relative to the lid. Springs are interposed between the cover of the cell door and the floating portion of the cell door.

• de compliquer la porte de cellule en deux parties, avec l'obligation de créer des étanchéités entre ces pièces par quatre membranes ;
• une étanchéité de ces membranes pratiquement incontrôlable, in situ, ce qui impose soit l'interruption du confinement, ou l'interchangeabilité, c'est-à-dire que la double porte constituée par la porte de cellule et la porte du conteneur d'interchangeabilité, passe diamétralement par le passage utile de la porte du conteneur d'interchangeabilité, ce qui impose son développement ;
• l'étanchéité de la détection de la présence de la porte de conteneur est réalisée de façon classique par une membrane supplémentaire ; et
• l'incompatibilité de ce système, avec les systèmes existants, et, en particulier, celui qui est le plus répandu à ce jour, le système à double porte de transfert étanche.

This device has several disadvantages, which are the following:

• to complicate the cell door in two parts, with the obligation to create sealing between these parts by four membranes;
• a sealing of these membranes practically uncontrollable, in situ, which imposes either the interruption of the confinement, or interchangeability, that is to say that the double door constituted by the cell door and the door of the container of interchangeability, passes diametrically through the useful passage of the door interchangeability container, which requires its development;
• the sealing of the detection of the presence of the container door is conventionally performed by an additional membrane; and
• the incompatibility of this system, with existing systems, and, in particular, the one that is most prevalent so far, the dual-door transfer system waterproof.

On the other hand, by the document FR 2,931,993 a double sealed transfer door is known from a container to a cell. The device comprises means for securing the container flange with the cell flange. The cell door is in two parts, namely a lid held on the flange by mechanical means and a floating portion forming a seal holder movable in translation relative to the lid. Springs are interposed between the cover of the cell door and the floating portion of the cell door.

By the document FR 2,777,982 , there is known a waterproof transfer device with integrated decontamination by ultraviolet radiation. An ultraviolet ray distribution ring implanted on the cell flange is used opposite the seal of the cell door. This allows ultraviolet decontamination of the uncertainty zone.

Finally, by a patent document in the name of CENTRAL RESEARCH LABORATORIES, a waterproof transfer device is known to decontaminate by "high temperature zone". It uses a heating ring implanted on the flange of cell opposite the seal of the cell door. This allows high temperature decontamination of the uncertainty zone.

In the devices described by the last two documents, the cell flange is specific to the type of sterilization or decontamination chosen, thus making the flange / cell door assemblies not allowing any possible evolution of the sterilization or decontamination mode, without practicing at the same time. their replacement. This is also valid in case of technical failure. The consequences are significant, regardless of the cost of these sets, the interchangeability for stopping the operation of the cell or the insulator, as well as packaging machines. This loss of containment maintenance requires the revalidation of the facilities.

The object of the invention is to overcome these disadvantages, by proposing a transfer device between a container and a confinement cell of different type.

Object of the invention

For this purpose, the invention relates to a transfer device between a container and a containment cell, the containment cell comprising a cell flange and a cell door mounted in the cell flange, the cell flange being mounted tight on a wall of the containment cell.

• la porte de cellule comportant un joint à lèvres monté sur une couronne porte-joint interchangeable sous confinement,
• un moyen souple assurant la continuité de l'étanchéité entre la couronne porte-joint et la porte de cellule,
• une couronne d'interface joint, également interchangeable sous confinement, la couronne d'interface joint assurant l'interface d'étanchéité avec le joint à lèvres de la couronne porte-joint, les couronnes d'interface joint et porte-joint étant solidaires l'une de la porte de cellule et l'autre de la bride de cellule, grâce à des liaisons à baïonnette, permettant un démontage et un remontage rapide sous confinement, la porte de cellule possédant, en partie supérieure, un joint torique créant une étanchéité sur le redent de la bride de cellule, ce qui permet de maintenir l'étanchéité de la cellule lors de l'interchangeabilité des couronnes interchangeables qui sont amovibles.

According to its main characteristic:

• the cell door having a lip seal mounted on an interchangeable seal ring under confinement,
• a flexible means ensuring the continuity of the seal between the seal ring and the cell door,
• a joint interface ring, also interchangeable under confinement, the sealed interface ring providing the sealing interface with the seal ring of the seal ring, the joint interface rings and seal holder being secured to the one of the cell door and the other of the cell flange, through connections to bayonet, allowing disassembly and rapid reassembly under confinement, the cell door having, in the upper part, an O-ring creating a seal on the redent of the cell flange, which allows to maintain the tightness of the cell during the interchangeability of interchangeable crowns that are removable.

Preferably the cell flange is in two parts, namely a fixed part connected to a wall of the cell and a movable part receiving the container flange.

Preferably the movable portion of the cell flange receiving the container flange has a low amplitude axial displacement, the container flange having lugs, said movable portion of the cell flange having lug receiving housings of the flange of the container. container for locking the container on the containment cell flange by rotation while avoiding compression of the lip seal of the seal ring.

More preferably, the mobile part of the cell flange comprises at least three centering guide columns sliding in the cell flange, the mobile part of the cell flange comprising at least three helical ramps in which are engaged rotating rollers. on a control ring mounted concentrically to the movable portion of the cell flange and to the cell flange, the cell flange having rollers which roll in a circular groove of the control ring to provide angular mobility as well as the axial retention of the control ring relative to the cell flange, the control ring having at least three centering rollers which ensure its radial retention vis-à-vis the cell flange.

Advantageously, the helical ramp of the movable part of the cell flange comprises a first bearing which makes it possible, by a sectorial rotation of the control ring, to bring the container closer to the cell flange, which has the effect of ensuring a compression lip seals and to perfect the seal between the container flange and the cell flange, the control ring comprising, in the case of a container head for punching, a second bearing for performing the punching.

Advantageously, a device for catching up the clearance is located between the cell door and the container door, this device making it possible to ensure the plating of the container door on the seal of the cell door and to perfect the seal between the doors. this device can be of the spring type or of the positive action mechanical type by pinch effect due to rocking levers actuated by a central pivot.

Advantageously, the principle of "up and down" at the level of the first bearing makes it possible to apprehend large-diameter assemblies thanks to the fact of the quasi-cancellation of the locking and unlocking torque.

Advantageously, the cell door comprises a detection by a rotary transmission of the presence of a container door, this detection comprising a probe mounted at the end of a lever, this lever being fixed at one end around a pivoting axis under the action of the probe pushed by the presence of the container door, this axis having two O-rings ensuring the seal between the fork of the fork chamber with its index which is in contact with the interior atmosphere of the cell and the chamber of the movement of the sensor of presence of container door in contact with the outside atmosphere of the confinement cell, a sealed cover completing this seal, the pivoting axis under the action of the probe having a fork in which is placed an index, said index penetrating into an orifice of the cell door, the index having a squeegee seal, the presence of the port e container pivoting the shaft and fork so that the index finger is released from the orifice, which allows the opening of the cell door.

According to one embodiment, a handle ensures the indexing or de-indexing of the cell door, which allows a rotation of the central pivot which actuates rocking levers by a system of rollers and ramps of the catching of the interplay. door, the sealing of the central pivot vis-à-vis the cell door being provided by an O-ring.

According to another embodiment, the sealed transfer device comprises a security guaranteeing the impossibility of removing the container when the double door formed by the cell door and the container door is open, said safety being ensured by two cleats trapping a container ear in the rotational movement of the ear at the end of locking the container, said security comprising a master cleat and a slave cleat, the master cleat being mounted on a master shaft which passes through sealing the cell flange, the master shaft being integral at one of its ends with a master link rod connected to a master intermediate rod connected to a transmission pivot receiving a slave intermediate link connected to a slave latch link which has the effect of simultaneously releasing the maintenance of the cell door of these two link-locks, because the slave lock-rod is secured to the traversing shaft of the slave cleat which in turn rotates the slave cleat immobilizing the rear of the ear of the container, thus preventing its unlocking, a latch immobilizing the transmission pivot from or opening of the cell door, so the slave cleat prohibiting the unlocking of the container.

• on stérilise et on emballe sous atmosphère stérile la couronne porte-joint ou la couronne d'interface ou les deux simultanément dans des sachets étanches;
• on place la couronne porte-joint ou la couronne d'interface joint ou les deux, ainsi que les outillages nécessaires, dans une boîte de service équipée d'une enveloppe interne en plastique transparent et de moyens de manipulation, de transfert et de ventilation/filtration ;
• on présente et on connecte la boîte de service sur le dispositif de transfert ;
• on indexe la boîte de service ;
• on démonte la couronne porte-joint ou la couronne d'interface joint ou les deux à remplacer ;
• on stérilise l'intérieur de la boîte de service et l'extérieur des sachets étanches qu'elle contient, ainsi que l'intérieur de l'enveloppe interne étanche comprenant gants et sac d'évacuation ;
• on ouvre les sachets et on extrait la couronne porte-joint ou la couronne d'interface joint ou les deux neuves à mettre en place et on agit de même pour le sachet d'outillage ;
• on met en place la ou les couronnes porte-joint et d'interface joint ;
• on évacue par sac thermosoudable l'ensemble du matériel ;
• on équipe la boîte de service d'un dernier sac sur le rond de sac extérieur et de gants sur les ronds de gants extérieurs ;
• on désolidarise la ventilation/filtration ;
• on détache l'enveloppe interne étanche de l'intérieur de la boîte ;
• on désindexe la boîte de service ;
• on déconnecte la boîte de service ;
• on l'obture par une tape, et
• on évacue la boîte de service, ainsi que son système de ventilation/filtration.

Finally, the invention relates to a method of changing a seal carrier ring and a joint interface ring part of a sealed transfer device. This process comprises the following steps:

• sterilizing and packing under sterile atmosphere the seal ring or the interface ring or both simultaneously in sealed bags;
• the seal ring or the attached ring gear or both, as well as the necessary tools, are placed in a service box equipped with a transparent plastic inner casing and handling, transfer and ventilation means. filtration;
• the service box is presented and connected to the transfer device;
• the service box is indexed;
• removing the seal ring or the joint interface ring or both to be replaced;
• the inside of the service box and the outside of the sealed sachets it contains are sterilized, as is the inside of the sealed inner envelope comprising gloves and an evacuation bag;
• the bags are opened and the seal ring or the attached interface crown or the two new ones to be removed is removed and the tool bag is likewise acted upon;
• the seal and joint interface crown (s) are put in place;
• the entire equipment is removed by heat-sealable bag;
• the service box is equipped with a last bag on the outside bag and gloves on the outside glove rings;
• the ventilation / filtration is separated;
• detaching the sealed inner envelope from the inside of the box;
• the service box is de-indexed;
• the service box is disconnected;
• it is closed by a tape, and
• the service box is evacuated, along with its ventilation / filtration system.

Description of figures

• la figure 1 est une vue schématique d'une enceinte étanche et d'un conteneur qui s'adapte à cette enceinte étanche ;
• la figure 2 représente diverses réalisations d'un nez de bride de cellule ;
• la figure 3 représente un conteneur accouplé sur une cellule, double porte ouverte ;
• la figure 4 représente le transvasement d'un produit dans une cellule ;
• la figure 5 est une vue en coupe d'une couronne porte-joint interchangeable et d'une couronne porte-joint fixe ;
• les figures 6A à 6C sont relatives à l'ensemble d'une bride de cellule et d'une porte de cellule ;
• la figure 7 est une vue de détail qui montre la fixation d'une boîte de service sur la bride de cellule ;
• la figure 8 représente une vue coupe d'un conteneur bidirectionnel verrouillé sur une bride de cellule ;
• la figure 9 représente une vue en coupe d'un conteneur unidirectionnel poinçonné sur une bride de cellule ;
• la figure 10 représente une vue d'une rampe hélicoïdale .
• la figure 11 est une variante de réalisation du dispositif représenté sur la figure 9, dont la fonction de prise en charge par la porte de cellule des portes de conteneurs est distincte ; l'une pour les portes de conteneur bidirectionnel et l'autre pour la porte de conteneur unidirectionnel.
• les figures 12 et 13 sont des vues en perspective qui montrent un dispositif de détection par un palpeur de la présence de la porte de conteneur ;
• la figure 14A est une vue d'une poignée qui assure l'indexage ou le dés-indexage du pivot central de la porte de cellule et de la commande positive de rattrapage de jeu entre la porte de cellule et la porte de conteneur ;
• la figure 14B est une vue en coupe selon la ligne a-a (figure 14A) des positions d'indexages de la poignée ;
• la figure 15 est une vue en coupe selon la ligne XV-XV de la figure 14A ;
• la figure 16 est une vue de détail montrant une rampe prévue à une extrémité d'un levier basculant ;
• la figure 17 est une vue en coupe montrant le rattrapage de jeu du type à ressort à lame entre porte de cellule et porte de conteneur et entre porte de conteneur et bride de conteneur;
• la figure 18 est une vue en coupe selon la ligne XVIII-XVIII de la figure 17 ;
• la figure 19 est une vue en coupe selon la ligne XIX-XIX de la figure 17 ;
• la figure 20 est une vue en coupe à travers le dispositif de sécurité garantissant l'impossibilité de retirer le conteneur lorsque la double porte formée par la porte de cellule et la porte de conteneur est ouverte ;
• la figure 21 est une vue selon la flèche XXI de la figure 20 ;
• la figure 22 est une vue en coupe selon la ligne XXII-XXII de la figure20 ;
• les figures 23 et 24 sont des vues de détail montrant le mécanisme des biellettes verrou ;
• les figures 25A à 25F sont des vues schématiques qui illustrent les étapes successives du procédé conforme à l'invention de remplacement d'une couronne porte-joint et/ou d'une couronne d'interface-joint.

Other features and advantages of the present invention will appear better on reading the description which follows made with reference to the appended figures. In these figures:

• the figure 1 is a schematic view of a sealed enclosure and a container that fits this sealed enclosure;
• the figure 2 represents various embodiments of a cell flange nose;
• the figure 3 represents a container coupled to a cell, double open door;
• the figure 4 represents the transfer of a product into a cell;
• the figure 5 is a sectional view of an interchangeable seal ring and a fixed seal ring;
• the Figures 6A to 6C relate to the assembly of a cell flange and a cell door;
• the figure 7 is a detail view showing the attachment of a service box to the cell flange;
• the figure 8 represents a sectional view of a bidirectional container locked on a cell flange;
• the figure 9 is a sectional view of a unidirectional container punched on a cell flange;
• the figure 10 represents a view of a helical ramp.
• the figure 11 is an alternative embodiment of the device shown in the figure 9 , whose function of handling by the cell door of the container doors is distinct; one for bidirectional container doors and the other for unidirectional container door.
• the Figures 12 and 13 are perspective views that show a sensing device by a feeler of the presence of the container door;
• the figure 14A is a view of a handle that indexes or de-indexes the central pivot of the cell door and the positive play catch control between the cell door and the container door;
• the Figure 14B is a sectional view along the line aa ( figure 14A ) indexing positions of the handle;
• the figure 15 is a sectional view along line XV-XV of the figure 14A ;
• the figure 16 is a detail view showing a ramp provided at one end of a rocking lever;
• the figure 17 is a sectional view showing spring-type clearance play with blade between cell door and container door and between container door and container flange;
• the figure 18 is a sectional view along the line XVIII-XVIII of the figure 17 ;
• the figure 19 is a sectional view along line XIX-XIX of the figure 17 ;
• the figure 20 is a sectional view through the safety device guaranteeing the impossibility of removing the container when the double door formed by the cell door and the container door is open;
• the figure 21 is a view according to arrow XXI of the figure 20 ;
• the figure 22 is a sectional view along the line XXII-XXII of the figure20 ;
• the Figures 23 and 24 are detail views showing the mechanism of the tie rods;
• the Figures 25A to 25F are schematic views that illustrate the successive steps of the method according to the invention for replacing a seal ring and / or an interface-seal ring.

Detailed description of an embodiment of the invention

On the figure 1 2 is a sealed cell having a wall 3. A cell flange 4 is sealingly mounted in the wall 3 of the cell 2. A cell door 6 is housed inside the flange of the cell. cell 4. The cell door 6 is hinged by a hinge 8 on the cell flange. A container 10 having a container body 12 and a container flange 14 connected to the container body 12 can be coupled to the cell flange 4. A container door 16 is housed inside the container flange. The container flange can be stowed on the cell flange by a bayonet connection, and likewise, the container door 16 can be secured to the cell door 6 by a bayonet connection. An object 18, placed in the container 10, can be introduced into the sealed cell 2 when the container 10 is docked on the cell 2 and the double door constituted by the container door 16 and the cell door 6 is pivotally opened. hinge 8.

The cell flange 4 has a cell flange nose 20. It is shown in FIG. figure 2 various embodiments of this nose. Reference 20 designates a cell flange nose with spoiler, reference 20-1 a flange nose of cell with punch, reference 20-2 a cell flange nose with a heating element, reference 20-3 a cell flange nose with UV element, reference 20-4 a cell flange nose with a diffuser element of sterilant product.

We have shown on the figure 3 the container 10 accosted to the sealed cell 2. The container flange 14 is connected to the cell flange 4 by a bayonet connection. The double door 6, 16 is open inside the cell 2. The object 18, present in the container 10, has been transferred inside the cell.

We have shown on the figure 4 transferring inside the sealed cell 2, from the container 10, a large quantity of product, for example drug capsules 22. The capsules 22 are disposed inside a flexible envelope 10 bis connected with sealingly to the container flange 14. When the container flange is approached on the cell flange, and the sealed double transfer door 6, 16 is open ( Fig. 4 ), the capsules 22 are poured inside the cell into a container 24.

We have shown on the Figure 6A a sealed transfer device according to the present invention. In this device, the movable portion 30, in the form of a ring, receives the container flange (not shown). The movable part 30 has an axial displacement. It goes up and down with a small amplitude, for example a few millimeters. It comprises receptacles 39 for receiving the container lugs for locking the containers by about 60 ° rotation, while avoiding the compression of the lip seals allowing virtually the cancellation of the locking torque due to these seals. With this device, the locking of containers by operators and operators is easier, and decreases all the risk of rotational drive due to locking and possible contamination between the portion of the lip seal 28 and the 20. The movable portion 30 in the form of a ring comprises a plurality of guide columns 31, for example three, sliding in the body of the cell flange 4. The mobile part 30 comprises several helical ramps 32 (see FIG. figure 10 ), for example three. Rollers 33 are rotatably mounted on a control ring 34 mounted concentrically to the container receiving ring and to the cell flange 4. The angular mobility of the control ring 34 as well as its axial retention is ensured by rollers 35 mounted rotating on the body of the cell flange 4. A handle, or a jack, makes it possible to ensure the rotational movement of the control ring 34. The control ring 34 comprises less three centering rollers 37 which ensure its radial retention vis-à-vis the cell flange 4.

It is thus possible to admit a greater service or accidental pressure inside the sealed enclosure 2 than outside the enclosure. The compression of the lip seals is limited by the fact that the rollers 33 roll on the helical ramp only until the flat bearing 38 for the bidirectional containers 10, that is to say the reusable containers. In the case of a container head in one piece (unidirectional container, non-reusable), intended to be stamped, a complementary elevation of the container 10bis of the figure 4 is accomplished by the second bearing 42, allowing the realization of the punching. Advantageously, the helical ramp system provides a force reduction for manually performing the punching operation of the container, the container flange and the container door are in one piece.

• une première sélection de course correspondant à la rampe 36 suivie du palier plat 38 concernant les conteneurs bidirectionnels. Cette première course correspond à la course de compression du joint à lèvres 28 ;
• une deuxième sélection de course, correspondant à la pente 40 suivie du palier plat 42, concernant les conteneurs unidirectionnels, c'est-à-dire les conteneurs à usage unique dont la bride et la porte sont en une seule pièce sur la bride de cellule au moment du verrouillage. La bride de conteneur et la porte de conteneur se séparent lors du mouvement de monte et baisse de la couronne mobile 26, ce qui correspond à la course de la phase dite de poinçonnage.

It is possible, if necessary, to add a motorized control with an electromechanical ram, for example, provided with a selection of races:

• a first race selection corresponding to the ramp 36 followed by the flat bearing 38 concerning bidirectional containers. This first stroke corresponds to the compression stroke of the lip seal 28;
• a second race selection, corresponding to the slope 40 followed by the flat bearing 42, concerning the unidirectional containers, that is to say the disposable containers whose flange and the door are in one piece on the cell flange at the time of locking. The container flange and the container door separate during the up and down movement of the movable ring 26, which corresponds to the stroke of the so-called punching phase.

We find, on the Figure 6A , the seal-seal ring 20 of the cell flange 6, also called the nose of the cell flange. In the example shown, the nose is a cell flange nose of insulating material with a heating element. An O-ring 44 provides a seal between the nose 20 and the cell flange 4. There is also the interchangeable seal ring 27. On the cell door 6 is fixed an ear piece 7 which carries first ears 46a allowing the hooking of the bidirectional and unidirectional container door when locking these containers on the movable part of the cell flange by rotation of the latter. An O-ring 58 provides a seal between the cell door 6 and a redent 61 of the cell flange 4. The lip seal 28 seals between the seal ring 27 and the nose of the interface-crown. 20, on the one hand and between the seal ring 27 and the container door, not present on the Figure 6A , on the other hand.

A flexible means 50, here constituted by a thin wall of the cell door 6, makes it possible to push the seal ring 27 towards the interface-seal ring 20 under the action of the springs 48.

Second ears 130 of the earpiece 7 support those of the disposable container door, while the ears 46a support those of the multipurpose container door. These second ears make it possible to split the cycle of the unidirectional containers from that of the bidirectional ones.

We have shown on the Figure 6B a fixed seal ring 27 of the cell door. This seal ring 27 carries a lip seal 28 and an O-ring 29 sealing on the end of the flexible means 50. The seal 28 seals between the interface ring of the cell flange and the seal. container door.

The Figure 6C which is a section following the cut line aa of the Figure 6A represents holding lugs 46b which axially hold down a lip seal supporting member 9 adjoining the flexible means 50 of the cell door 6 so that the tip of the lip seal 28 is in correspondence with the nose of the crown interface-seal 20, this under the effect of springs 48.

We have shown on the figure 7 a detail view showing the attachment of a service box to the cell flange 4. The service box serves to allow to introduce or extract the seal rings or the nose of the cell flange 4. It is designated by the reference 64 the housing ears 66 of the service box. An O-ring present in a groove 68 of the ear 66 of the service box provides a seal between the ear of the service box and the cell flange 4.

We have shown on the figure 8 a bidirectional container locked on a cell flange. The container door 16 is locked by a bayonet connection 80 on the container flange 14, which itself is locked by its lugs 82 to the movable part 30 of the cell flange 4.

90 has designated the opening control handle of the double door 6, 16. This comprises a handle pushbutton 92 biased in the extended position by a helical spring 94 which is supported, at one of its ends, on a handle cap 96. The handle pusher 92 has, at its end located towards the coil spring 94, a frustoconical portion 98. The handle pusher 92 is received in a handle body 100 rotatably mounted around a axis XX. The handle body 92 is mounted on a pivoting arm 102, itself mounted on a central pivot 104. A screw 106, of axis XX, ensures the clamping of the handle body 100 on the pivoting arm 102 and on the central pivot 104. A pin 108 immobilizes the pivoting arm 102 in rotation relative to the central pivot 104, and a pin 110 immobilizes the handle body 100 in rotation with respect to the pivoting arm 102. A sealing washer 112 provides a seal between the screw 106 and the central pivot 104, while an O-ring 114 provides a seal between the central pivot 104 and the cell door 6 in which the central pivot is mounted.

An index 116 is slidably mounted parallel to the axis XX within a hole which passes through the handle body. The index 116 is movable between an output position, represented on the figure 8 wherein a lower end of the index finger 116 enters a housing formed in the cell door 6 and a retracted position in which the lower end of the index finger 116 is outside the housing formed in the cell door 6. The other end (upper end) of the index 116 follows the profile of the tapered portion 98 of the handle pusher. A coil spring urges the index finger 116 towards its extended position, applied against the profile of the tapered portion 98 of the pusher The position of the handle pusher 92 determines the position, taken in or out of the index 116. When the upper end of the index is applied against the larger diameter portion of the frustoconical portion 98, the index 116 is in the extended position. On the contrary, when the upper end of the index 116 is applied against the smaller diameter portion of the frustoconical portion 98, the index 116 is in the retracted position. When the index finger 116 is in the retracted position, the assembly 90 opening control handle of the double door can rotate freely about the axis XX. On the other hand, when the index 116 is in the extended position, the assembly 90 opening control handle of the double door is immobilized in rotation with respect to the cell flange 4.

We have shown on the figure 9 a unidirectional container punched on a cell flange and on the figure 10 , a sectional view along the line YY of the figure 9 . A unidirectional container is a container in which the container flange and the container door are made in one piece before punching the container door. In the figure 9 , the sealing interface ring of the cell flange 6 is a ring 20-1 with punch. To punch the container door 16, the handle 120 is rotated, rotatably mounted around the axis of rotation 122, about the axis XX of the central pivot 104. The handle 120 carries with it the control ring 34 on which it is fixed. The roller 33 is pivotally mounted on the control ring. When the handle 120 rotates the control ring 34, the roller 33, which is driven by the control ring, travels the helical ramp 32 (see figure 10 ). The roller 33 passes first a first bearing 36, then a second bearing 40. The first bearing is about 10 °, while the second bearing is about 30 °. This has the effect of raising the movable portion 30, which slides along the guide columns 31. The movable portion 30 raises the container flange 14 and the press on the punch 20-1. Thus the unidirectional container in one part is cut into two parts, namely a container flange 14 and a container door 16.

The handle 120 has an indexing system not shown on the figure 9 , it indexes the control ring 34 vis-à-vis the cell flange 4 in the position bottom of the movable portion 30 and the index at the end of the first level and the second level.

A mechanical selector or the like, not shown, makes it possible to select the connection of a bidirectional container or a unidirectional container.

We have shown on the figure 10 a sectional view along the line YY of the figure 9 . This figure shows the shape of the helical ramps 32 in which the rollers 33 move. This ramp consists of a first bearing 36 and a second bearing 40. The first bearing 36 extends over an angle at the center of 10 °. approximately, while the second bearing 40 extends over a center angle of about 30 °. Thus, in total, the helical ramp 32 extends over an angle at the center of 40 °. Each bearing comprises a horizontal part, 38 for the bearing 36 and 42 for the bearing 40 corresponding to the axial stroke depending on the type of container used. This allows, by a sectorial rotation of the control ring 34, to slightly raise the container 10 and ensure compression of the lip seals. This has the effect of perfecting the seal between the container flange 14 and the cell flange 4.

We have shown on the figure 11 a different version of that of the figure 9 , a unidirectional container punched on a cell flange. In this embodiment, the container door 16, instead of being supported by the receiving ears 46 common to the container doors, is supported by arms 130, for example four, which extend the central pivot. 104, when opening the double door 6, 16 by the pivoting of the assembly 90 opening control handle of the double door 6, 16.

The Figures 12 and 13 illustrate a device for sensing by a feeler the presence of the container door. It is necessary to provide a safety device to prevent opening of the cell door if a container is not docked on the cell flange or if a container is not equipped with its door. The device comprises an inter-door detection index 140. A cleaning wiper O-ring 141 is mounted on the index 140. At its base, the index 140 comprises a notched portion 142. Two lugs 144, forming a fork, integral with each other. an inter-door pivot pivot 146 penetrate into the notch 142. An arm 148, integral with a end of the inter-door swing pivot axis 146, is urged in rotation in the direction of clockwise by a helical spring 150. Two seals 151, for example O-rings, ensure the sealing of the inter-door safety axis. A probe 152 is mounted on the arm 148. The position of the probe on the arm is adjustable through a thread. The end of the probe is supported on the container door 16 if it is present. In the opposite case, the probe 152 is in the extended position. In this position of the probe, the index finger 140 enters an orifice 154 provided in the pivoting arm 102 (see FIG. figure 14 ). When a container with its door is present, the probe 152 is in the retracted position because it is prevented from leaving by the presence of the container door 16. On the contrary, the output position of the probe 152 signals the absence of the door container 16 or container, which causes the penetration of the index 140 in the port 154 of the pivot arm 102 and therefore the blocking of the opening of the cell door.

A door inter-door sealing cover 156 is secured to the cell door by screws 158. A seal 160 provides a seal between the sealed cover 156 and the cell door.

We have shown on the figure 14A a view similar to the figure 8 (The cell door shown does not include the flexible member 50), which shows a view of the handle 90 which indexes or de-indexes the central pivot of the cell door. Note in this figure, the index 140, described above with reference to Figures 12 and 13 , in the out position. The index finger 140 enters the hole 154 formed in the pivoting arm 102. In this manner, the opening handle assembly 90 of the double door 6,16 is immobilized.

We also note, on the figure 14A , the presence of the handle push button 180 by which an operator, whose thumb is shown inside a glove connected to the wall of the cell, moves the handle pusher in the tube 182, which allows to unlock the index 116 and to allow the rotation of the assembly 90 control handle opening the double door about the axis XX in a sector of about 15 ° represented on the Figure 14B . The rotation of the pivoting arm 102 is limited by the bridge 183. At the end of rotation it abuts on the bridge 183, releasing thumb pressure on the handle push button 180. The spring 94 pushes forward the handle pusher 92 which acts on the index 116 which falls into a second hole. This immobilizes in rotation the handle assembly 90 opposite the cell door 6. In this position, it is possible to open the double door 6,16 inside the cell by pivoting around the door. hinge 8.

The plating disk 185 has an axial displacement along the axis XX on the figure 14A . It is held in the down position by the helical spring 187. On the cell door 6 are mounted four rocking lever assemblies 189 pivoting about an axis 191. Four rollers 193 are rotatably mounted on the veneer disc 185. The ends 189a tilting levers 189 comprise an inclined cam profile on which the rollers 193 roll, which causes the tilting levers 189 to pivot in the opposite direction of that of the clockwise. The spring 201 maintains the rocking lever 189 in a neutral position for unrestricted locking of the container door to the cell door, the rollers 193 at the beginning of the inclined cam profile. The ends 189b bear on the container door, not present on the figure 14A , and press against the lip seal 28 mounted on the seal ring 26. This positive backlash between the cell door and the container door strengthens the compression seal of the lip seal of the cell door.

On the Figure 14B 116-1 shows the index in the cell door position, or double door, closed on the cell flange. Reference 116-2 shows the index in the cell door position, or double door, open on the cell flange.

We have shown on the figure 15 a sectional view along line XV-XV of the figure 14A . The veneer case 195 is mounted in a mortise 197 immobilized by the screw 199. It is shown in FIG. figure 16 a sectional view along line XVI-XVI of the figure 14A . This figure shows the cam profile 189a on which the roller 193 rolls after the race 203. When the roller passes from the bottom of the ramp to the top 189a of the ramp, position shown on the figure 16 the plating lever 189 pivots about its axis 191 and plates the container door 16 against the cell door 6.

We have illustrated on Figures 17 to 19 non-positive backlash between container door and cell door on the one hand, and between container door and flange of container on the other hand. Regarding the catch-up clearance between container door and cell door, each lug has at its center a leaf spring 205 terminated by a crimped pin 207, curved shape. The spring 205 is mounted in a spring housing 209. It is held by a screw 210. A slight notch 211 under each lug of the container door 16 creates a hard point under the action of the spring 205, which avoids the container door to unlock from the cell door 6. The force exerted by the spring leaf 205 on the container door results in a pressure of the container door on the lip seal, which improves the seal between this two elements.

As regards the clearance of clearance between the container door and the container flange, each lug 215 is under the action of at least one spring plunger 217 mounted on the container door 16 ensuring, when the container door is locked on the container flange, keep the container flange pressed up. The container door is held in rotation by the indentations 219 in which the pushers 217 engage. The upward maintenance of the container door is essential, it avoids discovering the tip of the seal of the container flange, to contaminate it in the case of sterile or to risk contaminating the outside in the case of nuclear.

We have shown on the figure 18 a sectional view along the line XVIII-XVIII of the figure 17 and on the figure 19 , a sectional view along line XIX-XIX of the figure 17 . These figures show the cell door 6, the container door 16, the leaf spring 205, the light impression 211 intended to receive the pin crimped at the free end of the leaf spring, and the screw 210 holding the spring leaf 205.

We will now describe the safe system for stopping the container in rotation by trapping one of its ears.

The figure 22 is a sectional view of the immobilization security of the locked container on the cell door. It is necessary that the container can not be removed when the double door formed by the cell door 6 and the container door 16 is open. It is to this end that the security of immobilization of Figures 20 to 24 . The security comprises two cleats, namely a master cleat 221 and a slave cleat 223. The master cleat and the slave cleat trap one of the ears 225 of the container 10 and thus prevent any rotation of the container. To obtain this lock, the ear 225 passes in front of the slave cleat (by turning counterclockwise). The slave cleat 223 is in the erased position to allow passage to the ear 225 of the container. Then the ear arrives on the second cleat, namely the master cleat 221, which is in its original position, not erased. The container lug 225 rotates the master latch, which has the effect of rotating the master traversing shaft 227 on which the master latch 221 is mounted ( figure 20 ). The master thru-shaft passes through the cell flange 4. An o-ring seal 229 seals between the master thru-shaft 227 and the cell flange 4. At its end, inner cell side, the thru-shaft 227 is secured to a master latch link 231 which in this same rotation releases the holding of the cell door of its cell flange. The master latch link 231 is connected to a master intermediate link 233 ( figure 23 ) connected itself to a transmission pivot 235 receiving a slave intermediate link 237 connected to the slave latch link 239 which releases the second holding of the cell door. The slave latch link 239 is integral with the traversing shaft of the slave latch which in turn rotates the slave latch 223, immobilizing the ear 225 of the container 10, thus preventing its unlocking.

From the beginning of the opening of the double door, it releases a latch 241 (see figure 23 ) actuated by a spring (not shown) which makes it penetrate into a notch 243 located in the transmission pivot 235. Advantageously, the holding and the plating of the cell door 6 on its cell flange 4 are made in three points: the hinge 8 and the two links master and slave lock, which ensures a better stability and a better distribution of the plating force.

It should be noted that the stop of the container 10 via its ears 225 is formed by pins (not shown) mounted in the three remaining ears of the movable portion of the cell flange 4. These pins serve as a stop in end of locking or unlocking of the container. They avoid putting the master cleats 221 and slave 223 under constraint.

The figure 20 represents a sectional view passing through the axis of the master traversing shaft 227. It shows the transmission of the angular movement of the master cleat 221 to the master traversing shaft 227 connected to the master latch link 231 which itself transmits the movement by the intermediate link master 233 and slave 237 fixed to the transmission pivot 235. The slave link 237 is itself connected to the second link link 239 articulated on its axis 245 connected to the slave cleat 223. This action has the effect of releasing the cell door 6 of the locking links 231 and 239 leaving their housing 247 (see Fig. 23 ) allowing the angular movement of the pivoting arm 102 actuated by the handle 90 from the beginning of the rotation of the pivoting arm 102, held in position by the roller 251 of the pusher axis 249 in a ramp 253 (see FIG. figure 21 ) on the safe housing 255. This action is performed during the race 257. Continuing the rotation of the handle 90 detaches the cell door 6 through the ramp 253. This action is symbolized by the race 259 called the extraction, and in the opposite direction, called the plating stroke.

In the case of punching a pin P fitted on the movable portion 30 rotates in its upper position the slave cleat 223, which prevents the unlocking of the disposable container.

From the beginning of rotation of the pivoting arm 102, the pusher axis 249 releases the latch 241 hinged about the axis 261 mounted on the latch support 263. The axis 261 is immobilized axially by two pins 265. The support latch is secured inside the safe housing 255 by two screws 267. (see FIG 24 )

We illustrated on the FIGS. 25A to 25F the different steps of the process of interchangeability of the seal carrier crowns and joint interface rings, applicable to the sterile medium. According to the invention, the cell flange 4 comprises ears 270 for quarter-turn locking of a bayonet connection of an intervention glove box called a service box 272. The service box 272 is preferably monobloc and made of a transparent material. The inside of this box is covered with a flexible plastic transparent envelope 290 facilitates cleaning, avoids contamination of the walls of the box, it has the handling gloves 276 and a discharge bag 293 allowing under confinement by thermo welding the evacuation of the objects after the intervention, the rounds of glove and bag are double, a part inside allowing the maintenance of the flexible envelope and part to the outside. It has handling means such as a glove station 276 and transfer heat-sealable bag 293 mounted on a double oval bag 294 round and filtration and sterilization 278.

The method of changing a seal ring and / or a joint interface ring is as follows.

Beforehand, the intervention is prepared by providing the necessary equipment, tools and parts to interchange (seal ring and / or joint interface ring). This material, for example a joint interface ring, or nose 20a, is previously sterilized and packaged a sealed bag 280. These bags are introduced into the service box 272 before making its connection to the cell flange 4. The service box 272 is presented, the service box is connected, for example by a quarter-turn bayonet connection or by clamp. We index the service box. The seal ring 26 or the joint interface ring 20b to be replaced is removed and placed inside the service box 272. The interior of the service box and the outside of the sachets are biologically decontaminated. 280 as well as the exposed surfaces on the cell flange and the cell door by disassembly of the crowns (joint and seal holder). The sachets are then opened, as shown by the arrow F, tearing off the flap Scotch 282, and the crown is removed to set up, namely the joint interface ring 20a in the example we do the same for the bag tooling. The crown 20a is placed in place of the crown 20b which has been extracted and deposited. The various elements are evacuated in the following order: by heat-sealable bag 293 adjacent to the flexible envelope, the replaced crown (s) and the bags and tools (the service box is completely empty).

The box of a bag 295 is fitted to the outer bag ring 294 and gloves 291 to the outer rounds of glove 292 ( figure 25C ).

The ventilation / filtration 278 is uncoupled from the flexible envelope by heat sealing a flexible sleeve attached to the envelope and then to the box ( figure 25D ).

The flexible envelope is removed from the inside of the box by means of the gloves 291, it is folded so as to introduce it into the bag 295 and is evacuated by heat-sealing the bag ( Figures 25E and 25F ).

The service box 272 is de-indexed, disconnected and the orifice is closed by tape 298.

Finally, the service box 272 and its ventilation / filtration system are evacuated.

Advantages of the invention

The invention overcomes the disadvantages set forth in the paragraphs "prior art and problems posed".

The entire cell flange / cell door can be composed as a puzzle, in line with the chosen use.

In addition, the device according to the invention is compatible with most existing systems.

It offers the possibility of receiving seal rings, interchangeable joint-seal crowns under containment, using a service box.

All the sealed bushings are of the type with rotary joints, whose sealing is guaranteed for life, unlike the use of a membrane.

The cell door is in one piece, the part of which supports the seal ring allows an axial stroke through the flexible means 50, which is integral with the cell door.

The cell flange is in two parts, one of which may be of the conventional type or provided with a "rise-and-fall" system in the case of containers, called unidirectional, this mechanism obviously allowing the connection of a conventional bidirectional container.

On the other hand, the device allows to expand the technological offer of the cell flange / cell door assembly by interchangeable modules.

Concerning the nose of the joints of the cell flange, it is possible to equip them with a diffuser of sterilizing product or decontamination, or with an ultraviolet element of the type of that described in the document FR 2 777 882 A , or a heating element of the type of the CENTRAL RESEARCH LABORATORY document, or with a punching element, or with a spoiler for a specific joint, or with a suction system.

Regarding the seal ring, its lip seal may be of different materials, depending on the technical specifications of the junction and in line with the type of a corresponding nose. Thus, it is possible to envisage a silicone seal for a cell flange nose with a heating element, an EPDM seal for use in the pharmaceutical field, for general use.

Claims (10)

1. A transfer device enabling transfer between a container (10) and a confinement cell (2), the confinement cell including a cell flange (4) and a cell door (6) mounted in the cell flange (4), the cell flange being mounted sealably on a wall (3) of the confinement cell, the container (10) including a container flange (14) and a container door (16),
   characterized in that:

   - the cell door including a lip seal (28) mounted on an interchangeable seal-carrier ring (27) under confinement;

   - a flexible means (50) providing the continuity of the sealing between the seal-carrier ring (27) and the cell door (6);

   - a seal interface ring (20), also interchangeable under confinement, the seal interface ring (20) providing the sealing interface with the lip seal (28) of the seal-carrier ring (27) and the seal-interface ring (20), the seal-carrier (27) and seal-interface (20) rings being secured one to the cell door (6) and the other to the cell flange (4), owing to bayonet connections, allowing a fast disassembly and reassembly under confinement, the cell door (4) having, in the upper portion;

   - an O-ring (44) creating sealing on the stop of the cell flange (4), which makes it possible to keep the sealing of the cell during the interchangeability of the interchangeable rings that are removable.
2. The sealed transfer device according to claim 1, characterized in that the cell flange (4) is in two parts, namely a stationary part connected to a wall (3) of the cell (2) and a movable part (30) receiving a container flange (14).
3. The sealed transfer device according to claim 1, characterized in that the movable part (30) of the cell flange receiving the container flange (14) has an axial travel with a small amplitude, the container flange (14) having lugs, said movable part (30) of the cell flange (4) including housings (39) for receiving the lugs of the container flange (14) allowing the locking of the container on the confinement cell flange (2) by rotation while avoiding the compression of the lip seal (28) of the seal-carrier ring (27).
4. The sealed transfer device according to any one of claims 2 to 3, characterized in that the movable part (30) of the cell flange (4) includes at least three centering guide columns (31) sliding in the cell flange (4), the movable part (30) of the cell flange including at least three helical ramps (32) in which rollers (33) are engaged mounted rotating on a control ring (34) mounted concentrically with respect to the movable part of the cell flange and to the cell flange, the cell flange (4) including rollers (35) that roll in a circular groove of the control ring (34) so as to provide the angular mobility as well as the axial maintenance of the control ring (34) relative to the cell flange (4), the control ring (34) including at least three centering rollers (37) that provide its radial maintenance with respect to the cell flange (4).
5. The sealed transfer device according to claim 4, characterized in that the helical ramp (32) of the movable part (30) of the cell flange includes a first bearing (36) that makes it possible, through a sectorial rotation of the control ring (34), to bring the container (10) closer to the cell flange (4), which results in providing a compression of the lip seals and improving the sealing between the container flange (14) and the cell flange (4), the control ring (34) including, in the case of a container head intended for punching, a second bearing (40) making it possible to perform the punching.
6. The sealed transfer device according to any one of claims 1 to 5, characterized in that a gap adjusting device is located between the cell door (6) and a container head (16), said device making it possible to ensure the pressing of the container door (16) on a seal (213) of the cell door and to improve the sealing between said doors, said device being able to be of the spring-type (205) or of the mechanical type with positive action by pinching effect due to tilting levers (189) actuated by a central pivot.
7. The sealed transfer device according to any one of claims 1 to 6, characterized in that the cell door (6) includes a detection by rotary transmission of the presence of the container door (16), said detection comprising a feeler (152) including of fork (144) in which an index (140) is placed, mounted at the end of the lever (148), said lever being fastened to an end around an axle (146) pivoting under the action of the feeler pushed by the presence of the container door (16), said axle including two O-rings (151) providing the sealing between the travel chamber of the fork (144) with its index (140) that is in contact with the atmosphere inside the cell and the chamber for the travel of the container door (16) presence feeler in contact with the outside atmosphere of the confinement cell (2), a cover mounted sealed (156) completing this sealing, the axis (146) pivoting under the action of the feeler, said index penetrating an orifice (154) of a pivoting arm (102), the index (140) including a cleaning scraper seal (141), the presence of the container door causing the axle and the fork (144) to pivot such that the index (140) is freed from the orifice (154), which allows the cell door to open.
8. The sealed transfer device according to any one of claims 1 to 7, characterized in that a handle (90) provides the indexing or de-indexation of the cell door (6), which allows a rotation of the central pivot (104), which actuates the tilting levers (189) by a system of rollers (193) and ramps (189a) for adjusting the inter-door gap, the sealing of the central pivot (104) with respect to the cell door (6) being provided by an O-ring (114).
9. The sealed transfer device according to any one of claims 1 to 8, characterized in that it includes a safety guaranteeing the impossibility of removing the container (10) when the double door formed by the cell door (6) and the container door (16) is open, said safety being provided by two cleats (221, 223) capturing a container lug (225) in the rotational movement of the lug at the end of locking of the container (10), said safety comprising a master cleat (221) and a slave cleat (223), the master cleat being mounted on a master shaft (227) that passes in a sealed manner through the cell flange (4), the master shaft (227) being secured at one of its ends to a master connecting rod-bolt (231) connected to an intermediate master connecting rod (233) connected to a transmission pivot (235) receiving an intermediate slave connecting rod (237) connected to a slave connecting rod bolt (239), which results in simultaneously freeing the maintenance of the cell door of these two connecting rod-bolts (231, 239), since the slave connecting rod-bolt (239) is secured to the shaft passing through the slave cleat, which in turn pivots the slave cleat (223) immobilizing the back of the lug (225) of the container, thus preventing it from unlocking, a latch immobilizing the transmission pivot once the cell door is opened, therefore the slave cleat (223) prohibiting the unlocking of the container (10).
10. A method for changing a seal-carrier ring and a seal interface ring belonging to a sealed transfer device according to any one of claims 1 to 9, characterized in that it includes the following steps:

    - sterilizing and packaging, under sterile atmosphere, the seal-carrier ring (27) or the interface ring (20), or both at the same time, in sealed pouches (280) ;

    - placing the seal-carrier ring (27) or the seal interface ring (20) or both, as well as the necessary tools, in a service kit (272), equipped with a sealed inner enclosure (290) made from transparent plastic, and transfer handling and ventilation/filtration means;

    - presenting and connecting the service kit (272) on the transfer device;

    - indexing the service kit (272);

    - disassembling the seal-carrier ring (27) or the seal interface ring (20) or both to be replaced;

    - sterilizing the inside of the service kit (272) and the outside of the sealed pouches (280) that it contains, as well as the inside of the sealed inner enclosure (290) comprising gloves and removal bag;

    - opening the pouches (280) and removing the seal-carrier ring (27) or the seal interface ring (20) or both new ones to be placed, doing the same for the tool pouch;

    - placing the seal-carrier (27) and seal interface (20) ring (s) ;

    - using the heat-sealable bag (295) to remove all of the material;

    - equipping the service kit with a last bag (295) on an outer bag circle (294) and gloves (291) on an outer glove circle (292);

    - separating the ventilation/filtration;

    - detaching the sealed inner enclosure (290) from the inside of the kit;

    - removing it using the heat-sealable bag (295);

    - de-indexing the service kit;

    - disconnecting the service kit;

    - closing it with tape (298);

    - removing the service kit and its ventilation/filtration system.

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