EP3125252B1

EP3125252B1 - Hatch to establish a communication between two chambers for processing under sterile conditions

Info

Publication number: EP3125252B1
Application number: EP16182106.1A
Authority: EP
Inventors: Antonio Bonita; Alessia Zanelli
Original assignee: Comecer SpA
Current assignee: Comecer SpA
Priority date: 2015-07-30
Filing date: 2016-07-29
Publication date: 2018-12-05
Anticipated expiration: 2036-07-29
Also published as: ITUB20152635A1; EP3125252A1; DK3125252T3; ES2702051T3

Description

The present invention concerns a hatch to establish a communication between two chambers for processing under sterile conditions.
In particular, the present invention is advantageously, but not exclusively, applied in communication passages between two isolators of the type used for the handling of radiopharmaceuticals to which the following description will explicitly refer without loss of generality.
It is a well-known practice to establish communication between two internal work chambers of two isolators by providing, in a wall of each of the two chambers, an opening having the same section and positioning the two isolators adjacent to each other with the two openings one opposite the other by means of the interposition of a frame, which acts as a spacer element, and two annular gaskets closed to form a pack between the two opposite faces of the frame and two peripheral portions of the wall outer surface which surround the two openings. The pack formed, in the following order, by the wall of the first isolator, by a first gasket, by the frame, by the second gasket and by the wall of the second isolator is closed by means of through bolts or screws tightened in one of the two walls.
The communication passage between the two isolators created by means of the above-mentioned pack of elements is normally provided with a hatch mounted inside one of the two chambers, which closes the passage by means of the interposition of a further annular gasket in abutment.
The two gaskets of the pack of elements and the further gasket guarantee the seal of the communication passage and, respectively, of the hatch in the closing position, and therefore guarantee the sterility inside the pair of isolators.
Over time the gaskets inevitably lose their sealing characteristics and have to be replaced. Replacement of the two gaskets in contact with the frame is fairly laborious because, due to the way they are positioned, they are difficult to access and require separation of the two isolators, with consequent loss of sterility.
United States Patent No. 6,779,567 B1 discloses a transfer port apparatus to enable a worker to transfer one or more objects through a sealed passageway provided in the apparatus from one sealed chamber into another sealed chamber. The transfer port apparatus is adapted to be coupled to a movable canister and a stationary isolator. Expandable airtight seals are deflated, doors are removed and an object is transferred into the airtight clean working environment established in the isolator through the sealed passageway established in transfer port apparatus following coupling of canister to isolator using transfer port apparatus. After the object is moved, doors are replaced and expandable airtight seals are inflated creating a substantially airtight seal. The movable canister can be uncoupled from the transfer port apparatus.
The object of the present invention is to provide a hatch to establish a communication between two isolators, which is free from the drawback described above and, at the same time, is easy and inexpensive to manufacture.
According to the present invention, a hatch is provided to establish a communication between a first and a second chamber for processing under sterile conditions and a method for mounting a communication hatch between a first and a second chamber for processing under sterile conditions, as defined in the attached claims.
The present invention will now be described with reference to the accompanying drawings, which illustrate a non-limiting embodiment example thereof, wherein:

figures 1 and 2 illustrate, according to the same perspective view, the hatch of the present invention in open and closed configuration respectively;
figures 3a and 3b illustrate, according to a view along a vertical section plane, two isolators positioned adjacent to each other before mounting of the hatch of figure 1 and, respectively, the same two isolators communicating with each other by means of the hatch of figure 1;
figure 4 illustrates a detail of figure 3b;
figure 5 illustrates some parts of the hatch of figure 1 according to a front exploded view;
figure 6 illustrates a detail of figure 5; and
figure 7 illustrates the same parts as figure 5, but according to a rear exploded view.

In figures 1 and 2, the number 1 generically indicates, overall, the hatch of the present invention, which can be installed between two isolators (not illustrated) to define a sealed communication passage between two internal chambers of the two isolators. The hatch 1 comprises a supporting frame 2 which acts as a supporting frame for a single door 3, which moves between an opening position of the passage (figure 1) and a closing position of the passage (figure 2). The door 3 consists, for example, of a sheet of clear glass. In the opening position illustrated by figure 1 the door 3 is inside one of the two chambers.
With reference to figures 1 and 2, the hatch 1 comprises an annular gasket 4, preferably of the dynamic expansion type, and in particular of inflatable type, to create a seal along a peripheral surface 5 (figure 1) of the door 3, transverse to the plane of the door 3, when the latter is in the closing position. The side of the gasket 4 facing towards the chamber in which the door 3 is in the opening position is covered by a front frame 6.
Again with reference to figures 1 and 2, the hatch 1 comprises a movement system 7 mounted on the supporting frame 2 to connect the door 3 to the supporting frame 2 in a movable manner so that the door 3 can move between the opening position and the closing position by means of a roto-translatory movement.
In particular, the supporting frame 2 comprises two supporting elements 8 (figure 2) projecting laterally from a vertical side of the supporting frame 2, and two horizontal guides 9 projecting frontally from the two respective horizontal sides of the supporting frame 2. The movement system 7 comprises two articulated mechanisms 10 which connect a vertical side 3a of the door 3 to the supporting elements 8. The movement system 7 further comprises two sliding mechanisms 11 which connect the other vertical side 3b of the door 3 in a sliding manner along the guides 9.
In further detail, each articulated mechanism 10 comprises a lever 12 hinged to a respective supporting element 8 to rotate about a vertical axis 12a and an arm 13 connected to the lever 12 by means of an elbow joint 14 and fixed to the vertical side 3a. The movement system 7 comprises a shaft 15 (figure 2) coaxial to the axis 12a, passing through two holes (not visible) provided in the two supporting elements 8 and integral with the two levers 12 to define a common hinge thereof. Each sliding mechanism 11 comprises a slide 16 coupled in a sliding manner with a respective guide 9, and an arm 17 having a first end hinged to a respective slide 11 to rotate about an axis parallel to the axis 12a and the opposite end fixed to the vertical side 3b.
Lastly, the movement system 7 comprises an electric motor 18 the drive shaft of which is coaxial and integral with the shaft 15. Operation of the motor 18 causes rotation of the levers 12 and therefore of the door 3. The door 3 is constrained to slide along the guides 9 and therefore the rotation is accompanied by a translation.
In figure 3a, the number 19 indicates a chamber of a first isolator and 20 the chamber of a second isolator positioned next to and connected to the first one. Reciprocal communication is established between the two chambers 19 and 20 through a first opening 21 obtained in a wall 23 of the chamber 19 and a second opening 22 obtained in a wall 24 of the chamber 20. The walls 23 and 24 are positioned adjacent to each other by the interposition of spacer elements 25 and with the openings 21 and 22 coaxially opposite each other. The opening 22 has a larger cross section than that of the opening 21 to allow assembly and disassembly of the hatch 1 from the inside of the chamber 20 without having to disconnect and move the two isolators away from each other.
Figure 3b shows the two isolators of figure 3a with the hatch 1 mounted between the two openings 21 and 22 to connect them to each other and thus define a sealed communication passage between the chambers 19 and 20.
Figure 4 illustrates a detail of the hatch 1 mounted between the openings 21 and 22 along the same vertical section plane as figure 3b. For greater clarity, in figure 4 some parts of the hatch 1 and of the chambers 19 and 20 have been removed. Figures 5 and 7 illustrate two front and rear exploded views respectively of the hatch 1, without the door 3 and the movement system 7 for greater clarity. Figure 5 shows the holes 8a in the supporting elements 8 which are crossed by the shaft 15 of the movement system 7 (figures 1 and 2). Figure 6 shows a detail of a part of the hatch 1 of figure 5.
With reference to figures 4 to 7, the hatch 1 comprises an inner frame 26 arranged between the openings 21 and 22 and the supporting frame 2 is mounted on the inner frame 26 so as to be positioned on the opening 22 from the inside of the chamber 20. The hatch 1 further comprises a gasket 27 interposed between the supporting frame 2 and the inner frame 26 to provide a seal exclusively between the supporting frame 2 and the inner frame 26, a gasket 28 interposed between the inner frame 26 and the wall 23 to provide a seal exclusively between the inner frame 26 and the wall 23 and a gasket 29 interposed between the supporting frame 2 and the wall 24 to provide a seal exclusively between the supporting frame 2 and the wall 24.
The inner frame 26 defines an opening 30 having its own axis 30a (figures 5 and 7) and a section substantially equal to that of the opening 21. The inner frame 26 has an outer profile which can be inserted into the opening 22 in a direction parallel to an axis of the opening 22, and in particular is such that, in use, it enters partially in the opening 22, as illustrated in figure 4. The inner frame 26 is mounted between the two openings 21 and 22 in a substantially coaxial manner to the opening 21. The door 3 in its closing position (figure 4) is arranged inside the inner frame 26, i.e. inside the opening 30.
The front face of the inner frame 26, i.e. the face of the frame 26 which faces, in use, the chamber 20, has an inner annular seat 31 and an outer annular seat 32 separated from each other by an annular projection 33 parallel to the axis 30a. The annular seats 31 and 32 have respective L-shaped transverse sections defined by opposite sides of the projection 33.
With particular reference to figure 4, the door 3 in the closing position is arranged in the area of the seat 31 and the gasket 4 is arranged in the seat 31 to provide the seal along the peripheral surface 5 of the door 3 in the closing position. The gasket 4 is retained in the seat 31 parallel to the axis 30a by the front frame 6.
In further detail, from the opening 22, the seat 32 faces towards the inside of the chamber 20 and the projection 33 projects partially from the opening 22 inside the chamber 20. The rear face of the supporting frame 2, i.e. the face that faces, in use, the chamber 19, has an inner annular portion 35 arranged in the seat 32 and an outer annular portion 36, which is coaxial with the portion 35 and is adapted to be arranged against a portion of annular inner surface 37 of the wall 24 around the opening 22. The supporting frame 2 does not cover a front face 34 of the projection 33, transverse to the axis 30a.
The front frame 6 comprises an annular-shaped front portion 38 and a rear projection 39, which is perpendicular to the front portion 38 and is also annular-shaped. The front frame 6 is arranged with the rear projection 39 in the seat 31 and with the front portion 38 against the projection 33 and the supporting frame 2. In particular, an outer face 39a of the rear projection 39 is in contact with an inner abutment 40 parallel to the axis 30a defined by the projection 33 and an outer portion 38a of the front portion 38 covers the front face 34 of the projection 33 and an inner front edge portion 41 of the supporting frame 2.
An inner portion 38b of the front portion 38, an inner face 39b of the rear projection 39 and the seat 31 transverse to the axis 30a form an annular seat having U-shaped cross section for housing the gasket 4.
The three gaskets 27-29, all annular-shaped, guarantee the seal of the communication passage between the two chambers 19 and 20. The gasket 28 is a flat silicone gasket and is interposed between a flat rear face 43 of the inner frame 26 and a portion of annular outer surface 44 of the wall 23 around the opening 21. Therefore the gasket 28 is coaxial with the axis 30a.
The gasket 27 is an O-ring and is arranged in an annular groove 45 obtained in the seat 32. In use, the gasket 27 is pressed against the annular portion 35 of the supporting frame 2. The gasket 29 is an O-ring and is arranged in an annular groove 46 obtained in the annular portion 36 of the supporting frame 2. In use, the gasket 29 is pressed against the surface portion 37 of the wall 24. The groove 46 is substantially coaxial, and is longer than the groove 45. Consequently the gaskets 27 and 29 are coaxial with the axis 30a and the first is shorter than the second.
The inner frame 26 and the front frame 6 are preferably made of PVC. The supporting frame 2 is preferably made of stainless steel. The assembly of the three frames 2, 6, 26 together with the gaskets 27-29 is described below with particular reference to figures 5 to 7.
The supporting frame 2 comprises a plurality of pins or studs 47 projecting perpendicularly from the annular portion 35, having a threaded free end and crossing respective through holes 48 made in the seat 32 of the inner frame 26 according to axes parallel to the axis 30a and distributed outside the groove 45. The supporting frame 2 is fixed against the inner frame 26, with interposition of the gasket 27, tightening a plurality of nuts (not illustrated) on the threaded ends of the respective pins 47 from the rear face 43 of the inner frame 26. The nuts locked on the pins 47 are arranged in appropriate seats 49 on the rear face 43.
The block formed of the supporting frame 2, which carries the door 3 and the movement system 7, and of the inner frame 26 is positioned on the opening 21 and fixed to the wall 23, and in particular to the surface portion 44 (figure 4), with interposition of the gasket 28, preferably by means of screws, which cross respective through holes 50 provided along the front face 34 of the projection 33 according to axes parallel to the axis 30a and the same number of through holes 51 in the gasket 28 and which are tightened in the surface portion 44. The fastening to the wall 23 of the block consisting of supporting frame 2 and inner frame 26 entails pressing of the gasket 29 between the annular portion 36 of the supporting frame 2 and the surface portion 37 of the wall 24.
At this point, the front frame 6 is fixed to the inner frame 26 fastening the rear projection 39 to the projection 33, preferably by means of screws or pins which cross through holes 52 in the rear projection 39 having axes transverse to the axis 30a and which are tightened or, respectively, engaged by interference fit in the same number of holes 53 in the abutment 40 having axes transverse to the axis 30a. The front portion 38 of the front frame 6 covers the front face 34 of the projection 33 and therefore conceals the holes 50.
The gasket 4, once inserted inside the front frame 6, covers the inner face 39b of the rear projection and therefore conceals the holes 52.
Obviously when the hatch 1 is mounted between the two openings 19 and 20, the openings defined by the frames 2, 6, 26 and the gaskets 4, 28-29 are substantially coaxial with each other and with the axis 30a.
From the above description it follows that, firstly, the gasket 4 can be easily replaced as it is immediately accessible from the inside of the chamber 20 when the door 3 is in the passage opening position and, secondly, the other gaskets 28-29 can be easily replaced from the inside of the chamber 20 by means of simple operations described below.
Once the gasket 4 has been removed, it is possible to access the fastening means (screws or pins) that fix the front frame 6 to the outer frame 26. Once the front frame 6 has been removed, it is possible to access the fastening means (screws) which fix the inner frame 26 to the wall 23 and it is therefore possible to disassemble the block consisting of supporting frame 2 and inner frame 26, extracting it from the opening 22 towards the inside of the chamber 20. In this way the gaskets 28 and 29 are immediately released. The other gasket 27 can be replaced by disassembling the inner frame 26 from the supporting frame 2. Therefore, the gaskets 28-29 can be replaced from the inside of the chamber 20 without disconnecting the isolators and moving them away from each other.
Although the invention described above refers in particular to a precise example of use, i.e. to create a sealed communication passage between two isolators, it should not be considered limited to said example of use, since it can well be applied to connect in a sealed manner any pair of chambers for processing under sterile conditions.

Claims

A hatch to establish a communication between a first and a second chamber for processing under sterile conditions, a first wall (23) of the first chamber (19) having a first opening (21) and a second wall (24) of the second chamber (20) having a second opening (22), which is arranged in front of the first opening (21) and has, compared to the latter, a larger cross section, the hatch (1) comprising: a first frame (26), which is positionable between the first opening (21) and the second opening (22), preferably so as to be substantially coaxial to the first opening (21); a second frame (2), which is mounted on the first frame (26) so as to be positioned on the second opening (22) from the inside of the second chamber (20); a first annular gasket (27) disposed between the second frame (2) and the first frame (26); a second annular gasket (28) adapted to be disposed between the first frame (26) and the first wall (23); and a third annular gasket (29) adapted to be interposed between the second frame (2) and the second wall (24) to provide a seal between the second frame (2) and the second wall (24); and being characterised in that it comprises a single door (3) movably mounted on the second frame (2) and in that the first frame (26) has an outer profile such that, in use, it enters partially into the second opening (22), the first annular gasket (27) is interposed between the second frame (2) and the first frame (26) to provide a seal between first and second frame (26, 2) and the second annular gasket (28) is adapted to be interposed between the first frame (26) and the first wall (32) to provide a seal between the first frame (26) and the first wall (23).
A hatch according to claim 1, wherein the door (3) is movable between an opening position and a closing position, in which the door (3) is arranged on the inside of the first frame (26).
A hatch according to claim 1, wherein a front face of the first frame (26) has an inner annular seat (31); the hatch (1) comprising a fourth gasket (4), preferably a dynamic expansion gasket, which is arranged in the inner annular seat (31); the door (3) being movable between an opening position and a closing position, in which the fourth gasket (4) creates a seal along a peripheral surface (5) of the door (3), which is transverse to the plane of the door (3) itself.
A hatch according to claim 3 and comprising a third frame (6), which is mounted on the first frame (26) from the inside of the second chamber (20), so as to hold, parallel to an opening axis (30a) of the first frame (26), the fourth gasket (4) in the inner annular seat (31).
A hatch according to claim 4, wherein the third frame (6) comprises a front portion (38) and a rear projection (39) perpendicular to the front portion (38) and is mounted with the rear projection (39) fixed, preferably by means of screws or pins, to an abutment (40) of the inner annular seat (31), which is substantially parallel to an opening axis (30a) of the first frame (26) .
A hatch according to claim 4 or 5, wherein said front portion (38) and said rear projection (39) of the third frame (6) have an annular shape and said fourth gasket (4) is arranged between an inner face (39b) of the rear projection (39) and an inner portion (38b) of the front portion (38).
A hatch according to any of the claims from 1 to 6, wherein a front face of the first frame (26) has an outer annular seat (32) for a first annular portion (35) of the rear face of the second frame (2); the first gasket (27) being arranged along a first annular groove (45) obtained in the outer annular seat (32) so as to be pressed, in use, against the first annular portion (35).
A hatch according to any of the claims from 1 to 6, wherein the second gasket (28) is a flat gasket adapted to be interposed between a rear face (43) of the first frame (26) and an annular outer surface portion (44) of the first wall (23) around the first opening (21).
A hatch according to any of the claims from 1 to 7, wherein the third gasket (29) is arranged along a second annular groove (46) obtained in a second annular portion (36) of the rear face of the second frame (2) so as to be pressed, in use, against an annular inner surface portion (37) of the second wall (24) around the second opening (22).
A hatch according to any of the claims from 1 to 8, wherein a front face of the first frame (26) has an outer annular seat (32) for a first annular portion (35) of a rear face of the second frame (2) and the second frame (2) is fixed to the first frame (26) by means of a plurality of threaded pins or studs (47), which project from the first annular portion (35) and extend through respective first through holes (48) in the outer annular seat (32) having axes that are parallel to an opening axis (30a) of the first frame (26).
A hatch according to any of the claims from 1 to 9, wherein the first frame (26) is fixable on an outer annular surface portion (44) of the first wall (23) around the first opening (21) by means of screws extending through respective second through holes (50) made, according to axes that are parallel to an opening axis (30a) of the first frame (26), in an annular portion (33) of the first frame (26) that is not covered by the second frame (2).
A hatch according to claim 11 and comprising a third frame (6), which is mounted on the first frame (26) from the inside of the second chamber (20) with a front portion (38) thereof covering the annular portion (33) of the first frame (26).
A hatch according to any of the claims from 1 to 11 and comprising articulated moving means (7), which are mounted on the second frame (2) so as to allow the door (3) to move between a closing position and an opening position.
A method to mount a communication hatch between a first and a second chamber for processing under sterile conditions, the method comprising:
- making a first opening (21) in a first wall (23) of the first chamber (19) and a second opening (22) in a second wall (24) of the second chamber (20), so that the second opening (22) is in front of the first opening (21) and has, compared to the latter, a larger cross section;

- using, as a first frame (26) of the hatch (1), a frame that can be positioned between the first opening (21) and the second opening (22);

- mounting, on the first frame (26), a second frame (2) of the hatch (1);
and being characterised in that the first frame (26) has an outer profile such that, in use, it enters partially into the second opening (22) and the second frame (2) supports a movable door (3), and in that it comprises:
- as the second frame (2) is being mounted on the first frame (26), interposing a first annular gasket (27) of the hatch (1) between the first frame (26) and the second frame (2) to create a seal between first and second frame (26, 2);

- mounting the first frame (26) on the first opening (21), so that the second frame (2) is placed on the second opening (22) from the inside of the second chamber (20); and

- as the first frame (26) is being mounted on the first wall (23), interposing a second annular gasket (28) of the hatch (1) between the first frame (26) and the first wall (23) to create a seal between the first frame (26) and the first wall (23) and a third annular gasket (29) of the hatch (1) between the second frame (2) and the second wall (24) to create a seal between the second frame (2) and the second wall (24).