Protective device for covering an interface between sterile chambers

A protective device (20) is provided to equip a sterile enclosure (1) configured to be placed in communication with another sterile enclosure (2) so as to allow objects to be transferred from one enclosure to the other. The protective device (20) covers an interface defined between the sterile enclosures (1, 2).

The present invention relates to a protective device for protecting a sterile enclosure likely to be placed in communication with another sterile enclosure so as to allow objects to be transferred from one enclosure to the other.

To make a distinction between these two enclosures, the first enclosure mentioned will henceforth be known as the “first enclosure”, while the second enclosure mentioned will henceforth be known as the “second enclosure”.

The first enclosure may in particular be an enclosure in which work needs to be performed on sterile components, and the second enclosure may in particular be an enclosure allowing these sterile components to be transferred, before or after said work is finished.

The invention finds a particularly advantageous application in enclosures used for assembling syringe parts. The first enclosure is the one in which this assembly is performed, and the second enclosure generally comprises a flexible bag made of a plastic material, for receiving parts or collections of parts that are to be transferred.

To place them in communication with one another, these enclosures comprise flanges for sealed connection of one enclosure to the other and are equipped with access doors accommodated, with sealing, in these flanges.

In an existing type of enclosure, described in documents FR 98 15850 and FR 98 15851 in the name of the Applicant Company, the peripheral edges of the doors of the two enclosures press closely together when the enclosures are connected, via a seal that at least one of these doors comprises, then these doors are connected together by magnetic means and by pulling a vacuum between the doors. The contaminated space delimited by these doors and these peripheral edges is thus confined. Means are then actuated to release these doors and place the two enclosures in communication with one another.

These existing enclosures are satisfactory in practice, but it has been possible to observe that there are still some risks of the working enclosure becoming contaminated.

U.S. Pat. No. 4,310,034 describes a device for connecting a container for transporting nuclear fuel to a horizontal unloading wall, using a funnel that comes into contact with the region of the container forming the seat of the door of said container.

The present invention sets out to overcome this essential drawback by providing a protective device capable of eliminating any risk of contamination of a first enclosure by a second enclosure following these enclosures being placed in communication with one another.

The present invention relates to a protective device for protecting a sterile enclosure likely to be placed in communication with another sterile enclosure so as to allow sterile parts to be transferred from one enclosure to the other for the purpose of working on these parts, characterized in that it comprises:a protective component having a wall capable, when engaged in the openings delimited by the seats of the doors of the enclosures, of covering the interface where these two seats meet, without contact with this interface or with the surrounding regions, andpositioning means allowing this wall to be positioned with respect to this interface in this contactless covering position.

This protective component is contained in one of the enclosures and is placed in this contactless covering position immediately after the doors of the enclosures have been opened. It makes it possible to prevent any of the objects being transferred, of the packagings of these objects and/or of the gloves or garments of the operator from coming into contact with the seal located at the interface where the seats of the doors meet.

This is because there is a risk that seal might be touched or moved, even very slightly, by said objects, packagings, gloves or garments when these are transferred from one enclosure to the other. Such contact or movement, should it occur, would break the integrity of the contact of this seal with the surfaces against which this seal is applied, and would therefore place a contaminated space in communication with the atmosphere in the enclosures.

The invention thus makes it possible to completely eliminate this risk of contact or of movement and therefore solves the remaining risks of contamination that the enclosures according to the prior art exhibit.

As a preference, said positioning means consist of one or more regions of the protective component, which are shaped to bear against the component delimiting the seat of one of the doors, at sterile locations thereof.

This positioning is thus achieved in a particularly simple way, particularly by the operator using just one hand.

According to one preferred embodiment of the invention, the protective device comprises at least one arm for supporting the protective component, which arm is connected on the one hand to this protective component and on the other hand to one of the walls of an enclosure, this arm allowing the protective component to be moved between said contactless covering position and a retracted position.

The protective component can thus easily be moved between its contactless covering and retracted positions and, in its retracted position, does not hamper the work performed in the enclosure.

The support arm may in particular be mounted so that it can pivot on the wall of the enclosure to which it is connected.

Advantageously, the protective device comprises means allowing the protective component to be immobilized in said contactless covering position, so that any risk of this component moving while objects are being transferred is eliminated.

These immobilizing means may, for example, comprise at least one latch or, if the device comprises a pivoting arm such as the aforementioned, blocking or clamping means acting between this arm and the axle of pivoting or between this axle and the bracket used for mounting this axle on the corresponding wall of the enclosure.

FIG. 1depicts a sterile enclosure1to which another sterile enclosure2is intended to be connected so as to allow objects to be transferred from the enclosure2to the enclosure1or vice versa.

The enclosure1is an enclosure in which work is to be performed on sterile components, for example assembling syringe parts. The enclosure2for its part is an enclosure allowing these sterile components to be transferred before or after said work has been completed. In the example depicted in the drawing, this enclosure2is a one-use enclosure, as will become apparent later on.

Each enclosure1,2comprises walls3,4respectively, which delimit its interior volume, a respective circular flange5or6and a respective access door7or8. The flanges5,6form the stationary frames that accommodate the doors7,8, with sealing, and are able to be connected together to place the enclosures1and2in communication, after which the doors7,8are opened.

As shown more specifically inFIG. 3, the flange5of the enclosure1has a circular rim10projecting radially inward which forms sealing bearing surfaces against which a circular seal11mounted on the door7comes into close contact when this door7is in the closed position.

The flange5also comprises fingers12projecting from its face external to the enclosure1, allowing the flange6to be positioned with respect to it.

The door7comprises an annular rib13for mounting the seal11and a central boss14projecting axially from its exterior face.

This door7is also connected to an arm15mounted so that it can pivot on one of the walls3. This arm15allows the door7to pivot between the closed position depicted inFIG. 1and a wide open position in which this door7is folded back against one of the walls3.

This enclosure1also comprises a protective device20formed of an annular component21and of an arm22for supporting this component21.

The component21comprises a portion25of frustoconical shape and a portion26of circular shape.

FIG. 8shows that the portion25is sized so that, when the door7is in the open position, said portion can be engaged through the seat delimited by the flange5so as to cover the regions of the flange5that form this seat, to just beyond the exterior face of the rim10and of the seal50that the flange6has, and without contact with these regions.

Thus, the wall of the portion25is able, when engaged in the openings delimited by the seats of the doors (7,8) of the enclosures (1,2), to cover the interface where these seats meet, without contacting this interface or the surrounding regions, that is to say the regions of the flange5forming the seat of the door7as far as beyond the exterior face of the rim10and of the seal50that the flange6has.

The circular portion26is, for its part, shaped so that it comes into abutment against the side of the flange5that faces the interior of the enclosure1so as to position the portion25axially with respect to the flange5in this contactless covering position.

The arm22is mounted so that it can pivot on one of the walls3of the enclosure1and allows the component21to move between this contactless covering position and a retracted position shown inFIG. 1, in which the device20is folded back against one of the walls3and does not hamper work inside the enclosure1.

The enclosure1further comprises assemblies30for locking the door7in the closed position, one of which assemblies is visible inFIGS. 4 and 5.

With reference to these figures, each assembly30comprises a shaft31mounted so that it is free to rotate in a bore passing through the flange5, a latch32wedged onto one end of the shaft31protruding into the enclosure1, and a lever33wedged onto the other end of the shaft31, which protrudes from the enclosure1. The latch32has the shape of a paddle and can occupy either an angular position in which it presses the door7against the flange5or an angular position in which it is situated radially outside this door7to allow movements thereof.

The shaft31also comprises, on the outside of the flange5, as visible inFIG. 5, a latch34also in the shape of a paddle and two radial fingers35,36wedged onto it. Thus, as can be understood from reference toFIGS. 4 and 5, the latch34can occupy either an angular position in which it presses the flange6against the flange5or an angular position in which it is situated radially outside this flange6to allow the latter to be set in place or removed with respect to the flange5.FIG. 5shows that the latch34is angularly offset from the latch32so that the latch34is retracted when the latch32holds the door7against the flange5and so that this latch34bears against the flange6before the latch32releases the door7.

The radial fingers35,36are also angularly offset and allow operation of pins40,41,42which are described later on, for unlocking/locking the door8.

As regards the enclosure2, the walls4are produced in the form of a bag made of a flexible and impervious plastic material.

The flange6has a tubular skirt45for its sealed connection to said bag, a wall46projecting radially outward and intended to be applied against the flange5and collaborate with the latch34, and an intermediate region47forming the seat that accommodates the door8.

The skirt45has a groove formed from its exterior face, accommodating hooping48which allows said bag to be joined in a sealed manner to it.

The wall46comprises notches49formed from its outer edge and intended to accommodate the fingers12when the flange6is brought into contact with the flange5with a view to connecting the enclosure2to the enclosure1. These fingers12and notches49thus form means for positioning the flanges6,5with respect to one another.

The intermediate region47forms, as shown byFIG. 2, a groove for receiving a seal50which provides sealing between this flange6and the door8. This seal50has a mounting part51engaged in this groove, a front part52projecting slightly beyond the axial end face of the flange6, and bearing surfaces53for accommodating the peripheral region8aof the door8.

Furthermore, asFIGS. 4 and 5show, the flange6comprises two radial bores55,56configured such that they are in line with the fingers35and36when the flange6is in contact with the flange5, as shown inFIG. 4.

The door8comprises a recess60formed from its exterior face, so as to be able to accommodate snugly the boss14of the door7, and has a peripheral rib61forming a ridge, intended to bear snugly against the seal11when the enclosures1and2are connected together.

This door8further comprises two blind radial bores65,66of the same diameters as the bores55and56and which, when this door8is in the closed position shown inFIGS. 4 and 5, come respectively to face these bores55and56.

The aforementioned locking pins40,41,42are engaged snugly in the bores55,56,65,66but with the possibility of sliding therein.

As can be seen inFIGS. 4 and 5, before the enclosure2is connected with the enclosure1, the pin40is partially engaged in the bore55so that its radially internal end lies flush with the internal radial face of the flange6. It has a length such that its part protruding from the flange6is, when the flanges6and5are mated, in the angular displacement travel of the finger35and can be pushed in the radially internal direction of the flange6by this finger35during this travel.

Also before connecting the enclosure2with the enclosure1, the pin41is partially engaged in the bore56. It has a length such that when the flanges6and5are mated, its part protruding from the flange6is in the angular displacement travel of the finger36and can be pushed in the radially internal direction of the flange6by this finger36during this travel; the length of this pin41is also equal to the length of the bore56.

Also before connecting the enclosure2with the enclosure1, the pin42is partially engaged in the bore56, behind the pin41, and in the bore66. It thus holds the door8in the closed position.

In practice, as shown byFIG. 6, the flanges5and6are mated and positioned with respect to one another by the engagement of the flange6on the fingers12and of the boss14in the cavity60. The doors7and8are then connected together by appropriate means such as magnetic means and/or the pulling of a vacuum between the doors.

The levers33are then turned in the clockwise direction shown inFIG. 5so as to engage the latch34behind the wall46and so as to disengage the latch32from behind the door7. At the same time, the finger36presses against the pin41so as to fully engage the latter in the bore56, this driving the pin42into the bore66and releasing the door8.

The arm15can then pivot to bring the door7and the door8connected to it into the open position as shown inFIG. 7.

The device20is then pivoted from its retracted position shown inFIGS. 6 and 7to its aforementioned contactless covering position shown inFIG. 8. In this position, the portion26of the component21rests against the interior face of the flange5and the portion25covers the interface where the flanges5and6meet, particularly the rim10and the seal50. The objects or parts contained in one enclosure can then be transferred into the other enclosure without the risk of contact or of movement, even very slight, with or of the seal50, and therefore without the risk of placing the atmosphere of the enclosures1,2in communication with the contaminated region isolated by this seal50.

To close and separate the enclosures1,2again, the device20is brought into the retracted position and then the doors7and8are brought back into contact with their respective seats, after which the levers33are turned in the counterclockwise direction shown inFIG. 5, which causes the door7to be blocked by the latch32and the flange6to be released by the latch34. During this movement, the finger35bears against the pin40, which it pushes completely into the bore55and therefore into the bore65, and this locks the door8. The flange6is then separated from the flange5in such a way as to extract the boss14from the cavity60.

As is apparent from the foregoing, the invention makes an appreciable improvement to the prior art, by providing a protective device20capable of eliminating any risk of an enclosure1becoming contaminated by the other enclosure2when these enclosures have been brought into communication with one another.

It goes without saying that the invention is not restricted to the embodiment described hereinabove by way of example but that, on the contrary, it encompasses all alternative forms of embodiment thereof that fall within the field of protection defined by the claims appended hereto.