Device for sterile transfer of goods between a container and an isolator

DE502020011200D1Active Publication Date: 2025-06-26ATEC PHARMATECHN
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Patent Information

Application Number
DE502020011200
Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
Priority Date
2019-05-10
Filing Date
2020-04-09
Publication Date
2025-06-26
Estimated Expiration
2040-04-09

AI Technical Summary

Technical Problem

Existing rapid transfer ports face challenges in maintaining sterility during the transfer of goods between containers and isolators due to the risk of contamination through safety devices, which often require through-holes that can compromise the sterile barrier.

Method used

The implementation of safety devices with two magnetic elements that are movable relative to each other, with a closed wall without a through opening between them, allowing for contactless activation and preventing germ penetration by using attractive or repulsive forces to block or release the safety device positions.

Benefits of technology

This solution effectively reduces the risk of contamination by preventing germ penetration through the sterile barrier, while allowing for reliable and contactless operation of the safety devices, thus ensuring the sterility of the transfer process.

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Description

[0001] The invention relates to a device for the sterile transfer of goods between a container and an isolator according to the preamble of claim 1.

[0002] Devices of this type are also referred to as rapid transfer ports. Rapid transfer ports comprise an alpha part in the wall of the isolator, consisting essentially of the port flange and the port door, and a beta part, consisting essentially of the container flange and the container lid, which is docked onto the alpha part before the material is transferred. Such a rapid transfer port is known, for example, from US Pat. No. 9,704,607 B2 and WO 2013 / 053844 A1.This known device has a total of five safety devices in the form of bolts which prevent accidental contamination of the goods through unwanted contact with the environment when transferring goods from the container to the isolator or when transferring goods from the isolator to the container, or conversely, toxic substances from the container and / or isolator from escaping into the environment, for example as a result of incorrect operation of the device, which the safety devices are intended to prevent.

[0003] Similar devices of this type with a smaller number of safety devices are known from FR 2 695 343 A1 or from WO 2015 / 032713 A1.

[0004] The first safety device prevents the port door from opening if the container is not fitted with a container lid. When the port door is closed and resting against the container lid, the bolt is in its release position, allowing the actuating mechanism to be moved into the open position. When the closed port door is not resting against a container lid, the bolt is in its blocking position, preventing the actuating mechanism from being moved into the open position.

[0005] The second safety device prevents the port door from opening unless the container flange is properly connected to the port flange, i.e., not properly docked to the port flange. In this case, the bolt, in its locking position, blocks the actuating mechanism in the closed position, so that it can only leave the closed position toward the open position once the container and isolator flanges are properly connected. A bayonet connection is usually used to connect the two flanges. This connection is confirmed when a cam on the container flange strikes a shoulder on the port flange.

[0006] The third safety device prevents the two flanges from being separated while the port door is open, i.e., while the actuating mechanism is in its open position or between its closed and open positions. In this case, the bolt, in its locking position, prevents rotation of the two flanges, which could lead to loosening of the bayonet connection. When the actuating mechanism is in its closed position, the bolt is in its release position, allowing rotation of the two flanges and loosening of the bayonet connection.

[0007] The fourth safety device serves to prevent the container flange from becoming detached from the port flange after the actuating mechanism has been moved to the open position and the port door and the container lid connected to the port door have been opened. In this case, the bolt in the locking position prevents the actuating mechanism from returning to its closed position when it is in its open position or between its closed and open positions. When the actuating mechanism is in its closed position, the bolt is in its release position.

[0008] The fifth safety device, described in detail in US 9 704 607 B2 and WO 2013 / 053844 A1, is only required very rarely, namely only in the case of deliberate misoperation or complete ignorance of the device's functionality by the operator. Here, the bolt blocks the actuating mechanism if the container flange is not properly connected to the port flange between the release of the actuating mechanism by the second safety device and the blocking of the container flange by the third safety device.

[0009] In the device described in US Pat. No. 9,704,607 B2 and WO 2013 / 053844 A1, the bolt of the first safety device is axially movably inserted into a through-hole in the port door, while the bolt of the third safety device and parts of the bolts of the second and fifth safety devices are axially movably inserted into a through-hole in the port flange. The bolts have a diameter of a few millimeters.

[0010] When such devices are used in the pharmaceutical or medical field, where complete sterility of the goods inside the isolator and container is required, the alpha part of the Rapid Transfer Port forms a sterile barrier that must not be penetrated by particles or germs. However, since the through-holes penetrate the sterile barrier, seals must be inserted into the through-hole to prevent germs from passing through the through-holes. However, since the bolts move back and forth in the through-holes and protrude from the holes with their free ends in one end position, particles or germs can still pass through the through-holes despite the seals. In addition, the seals are subjected to dynamic stress by the moving bolts and can therefore fail more quickly.Furthermore, the integrity of the seals is difficult to monitor, resulting in an even greater risk of contamination in the event of a seal failure. Sterilizing the device is also difficult, as germs that have penetrated the through-holes cannot be killed or are only partially killed, thus also leading to contamination.

[0011] Furthermore, DE 693 07 433 T2, US 2016 / 201382 as well as US 5 425 400 A and US 9704607B2 disclose port systems with mechanical safety devices.

[0012] Based on this, the invention is based on the object of improving a device of the type mentioned at the outset in such a way that the risk of possible contamination of the isolator or the container in the area of ​​the safety devices can be reduced and, if possible, prevented.

[0013] This object is achieved according to the invention in that at least one and preferably several of the safety devices each comprise two magnetic elements which are movable relative to one another, in that at least one closed wall without a through opening is arranged between the two magnetic elements and in that the magnetic elements attract or repel one another through the closed wall either in a blocking position or in a release position of the safety device.

[0014] Since the at least one closed wall without a through opening between the two magnetic elements is impermeable to germs, penetration of the sterile barrier can be reliably prevented, unlike with known safety devices. The safety devices according to the invention can be activated contactlessly through the at least one closed wall between the two magnetic elements, i.e. moved from their blocking position to their release position and vice versa. In this case, one of the two magnetic elements is brought so close to the other magnetic element that the magnetic attraction or repulsion forces acting between the two magnetic elements cause the other magnetic element to move through the wall, causing the safety device to assume the blocking position or the release position.

[0015] In principle, it is sufficient if a single closed wall is arranged between the two magnetic elements. However, since the two magnetic elements are always arranged in different components of the device that are movable relative to one another, e.g., one in the port flange and the other in the actuating mechanism, or one in the port door or a component that is movable together with the port door and the other in the port flange, two closed walls can preferably be arranged between the magnetic elements, which tightly seal each of the two components from the interior of the insulator.

[0016] In principle, it is possible to equip the device with only one of the five safety devices, such as the third safety device, which prevents the container from detaching from the isolator as long as the port door is open. In this case, this safety device is equipped with two magnetic elements.

[0017] Furthermore, it is also possible to equip the device with two, three, or four safety devices, such as the device described in FR 2 695 343 A1. In this case, one or more of the safety devices can be equipped with two magnetic elements. Preferably, those safety devices that would otherwise require a through hole in one of the components are always equipped with two magnetic elements.

[0018] Safety devices according to the invention can be used regardless of the design of the device or the rapid transfer port: For example, there are rapid transfer ports where the actuating mechanism or a rotatable lock part of a lock thereof is mounted on the inside of the port flange, as described, for example, in US Pat. No. 9,704,607 B2. Alternatively, there are rapid transfer ports where the actuating mechanism or a rotatable lock part of a lock thereof is movable together with the port door, as described below.

[0019] Safety devices according to the invention can also be used not only in rapid transfer ports where the opening and closing of the port door and the operation of the actuating mechanism are carried out manually, e.g. by means of a glove extending into the interior of the isolator, but also in rapid transfer ports where the opening and closing of the port door and the operation of the actuating mechanism are carried out with the aid of motor drives, e.g. from the outside of the isolator.

[0020] An advantageous embodiment of the invention provides that each of the two magnetic elements of a safety device comprises a permanent magnetic body. This embodiment has the advantage that either attractive or repulsive forces can be used between the two magnetic elements. If only attractive forces between the two magnetic elements are to be used, it is alternatively possible to provide one of the two magnetic elements with a ferromagnetic body and the other with a permanent magnetic body. In principle, it would also be conceivable for at least one of the magnetic elements to be designed as an electromagnet, although this would require a power supply.

[0021] There are basically four alternatives for the functioning of the magnetic elements of a particular safety device: 1) The magnetic elements attract each other in the blocking position, but not in the release position, 2) The magnetic elements repel each other in the blocking position, but not in the release position, 3) The magnetic elements attract each other in the release position, but not in the blocking position, 4) The magnetic elements repel each other in the release position, but not in the blocking position.

[0022] A further advantageous embodiment of the invention provides that at least one of the two magnetic elements is movable within the component in which it is mounted, e.g., the port flange, the port door, or the actuating mechanism, between two end positions corresponding to the blocking position or release position of the respective safety device. In some cases, it is sufficient if only one of the two magnetic elements is movable between two end positions, while in other cases, it is advantageous if both magnetic elements are movable between two end positions.

[0023] Since the two magnetic elements are movable relative to one another according to the invention, one magnetic element can be moved closer to or away from the other magnetic element. This relative movement of one magnetic element with respect to the other magnetic element can be triggered by a movement of a component of the device, for example, by a movement of the actuating mechanism between its open and closed positions, by a movement of the port door when opening or closing it, or by a relative movement of the container flange and the port flange when connecting them.

[0024] When one magnetic element approaches the other, the mutual forces of attraction or repulsion cause the other magnetic element to move to its one end position, in which the associated safety device is in the release or blocking position. Moving away from the other magnetic element cancels out or at least decreases the forces of attraction or repulsion.

[0025] In order for the other magnetic element to move into its other end position in this case as well, so that the associated safety device is then in the blocking position or the release position, the other magnetic element is preferably movable against the force of a return spring, which moves the magnetic element back into the other end position after the mutual attractive or repulsive forces have been eliminated or reduced.

[0026] In a number of known rapid transfer ports, the actuating mechanism comprises a lock with a lock part that can be rotated about a rotation axis from the closed position to the open position and is generally mounted inside the isolator either on the port flange or on a bracket projecting radially beyond the port door. When the actuating mechanism is operated manually, the lock part has an actuating handle that serves to rotate the lock part and can be grasped and actuated by an operator wearing a glove that extends into the isolator. In this case, it is advantageous if at least one of the two magnetic elements is movable parallel to the rotation axis of the lock part. This makes it easier, when several safety devices according to the invention are present, to mount their magnetic elements next to one another in the rotatable lock part and to actuate them separately.The movable magnetic element advantageously serves to block rotation of the lock part in the blocking position of a safety device and to allow rotation of the lock part in the release position.

[0027] Advantageously, in at least one safety device, one of the two magnetic elements is arranged in the port flange. This can be, for example, the fourth safety device, which comprises a first magnetic element arranged in the port flange and a second magnetic element that is movable together with the port door. The second magnetic element releases the actuating mechanism or the rotatable lock part in the release position of the safety device when the port door rests against the port flange and the two magnetic elements attract or repel each other. Conversely, the second magnetic element blocks the actuating mechanism orthe rotatable lock part when the port door is opened and the opening movement moves the two magnetic elements so far apart that they no longer attract or repel each other or no longer sufficiently strongly and consequently the return spring moves the second magnetic element into the end position in which the safety device is in the blocking position.

[0028] However, it can also be the second safety device, which also comprises a first magnetic element arranged in the port flange and a second magnetic element acting on the actuating device. In this case, the latter releases the actuating mechanism or its rotatable lock part when the container flange and the port flange are correctly and completely connected to one another. In this state, a pawl arranged in the port flange is fully depressed by a cam of the container flange. The pawl, in turn, acts on the movable first magnetic element and presses it into the end position in which it attracts or repels the second magnetic element through the at least one wall.

[0029] A further advantageous embodiment of the invention provides that, in at least one of the safety devices, one of the two magnetic elements is rotatable together with the rotatable lock part about its axis of rotation. This is advantageously the third safety device, which comprises a first magnetic element in the port flange and a second magnetic element in the rotatable lock part, wherein the second magnetic element moves away from the first magnetic element when the lock part is rotated into the open position. The second magnetic element then moves into its other end position under the force of a return spring, in which it blocks the container flange connected to the port flange from rotating back.

[0030] Instead of a lock with a rotatable lock part, the actuating mechanism could also comprise a lock with a linearly movable lock part. Advantageously, the second magnetic element of the third safety device would then be movable together with the linearly movable lock part to bring it closer to the first magnetic element in the port flange, while the second magnetic elements of the first and second safety devices would block or release the linearly movable lock part.

[0031] In the following, the invention is explained in more detail using an embodiment shown schematically in the drawing. Fig. 1 shows a perspective view of a port flange and a port door of a device according to the invention before docking a container, of which only the container flange and the container lid are shown; Fig. 2 shows a perspective view according to Fig. 1 however, after docking the container; Fig. 3 shows a plan view of the opposite side of the port flange and port door before opening a lock of the operating mechanism; Fig. 4 shows a view according to Fig. 3 , but after opening the lock; Fig. 5 shows a sectional view along the line AA of the Fig. 3 before docking the container and when the lock is closed; Fig. 6 shows an enlarged view of detail B of the Fig. 5 ; Fig. 7 shows a sectional view along the line AA of the Fig. 3 after docking the container and in the closed state of the lock; Fig. 8 shows an enlarged view of detail C of the Fig. 7 ; Fig. 9 shows another sectional view along the line AA of the Fig. 3 after docking the container and in the closed state of the lock; Fig. 10 shows an enlarged view of detail D of the Fig. 9 ; Fig. 11 shows a sectional view along the line EE of the Fig. 4 after docking the container, in the open state of the lock and before opening the port door; Fig. 12 shows an enlarged view of detail F of the Fig. 11 ; Fig. 13 shows an enlarged view of detail G of the Fig. 1 in a state prior to docking of the container; Fig. 14 shows an enlarged view of detail G of the Fig. 1 in a state after the container has been docked (in Fig. 10 not shown); Fig. 15 shows a sectional view along the line EE of the Fig. 4 after docking the container, in the open state of the lock and before opening the port door; Fig. 16 shows an enlarged view of detail H of the Fig. 15 ; Fig. 17 shows a perspective sectional view along the line EE of the Fig. 4 after docking the container, with the lock open and the port door slightly open; Fig. 18 shows an enlarged view of detail I of the Fig. 17 ; Fig. 19 shows a partially sectioned side view of the port flange and the port door after the lock has been opened and with the port door slightly open; Fig. 20 shows an enlarged view of detail K of the Fig. 15 .

[0032] The device 10, only partially shown in the drawing and also known in the art as a Rapid Transfer Port, is used for the sterile transfer of goods between a container (not shown) and an isolator (not shown). The goods can be, for example, rubber or plastic stoppers for infusion bottles or vials, syringe parts, or even liquids. For an explanation of the transfer process, reference is made to the Fig. 1 US 9 704 607 B2 and the associated description.

[0033] For sterile material transfer, the device 10 comprises a so-called alpha part 12 or alpha port on the isolator side, while it comprises a so-called beta part 14 or beta port on the container side. The alpha part 12 has a port opening surrounded by a port flange 16, also referred to as an alpha flange, a port door 18 for closing the port opening, and an actuating mechanism 20 for opening and closing the port door 18. The beta part has a container opening surrounded by a container flange 22, also referred to as a beta flange, and a container lid 24, which normally closes the container opening and can be removed from the container flange 22. For material transfer, the beta part 14 of the container is docked to the alpha part 12 of the isolator.This is achieved with two bayonet connections that tightly connect the container flange 22 to the port flange 16 and the container lid 24 to the port door 18, while simultaneously the container lid 24 detaches from the container flange 22. One bayonet connection has cams 26 projecting radially beyond the container flange 22, which, upon docking, engage with a corresponding receiving groove 28 of the port flange 16. To fully dock the beta part 14 to the alpha part 12, the inner part of the port flange 16 is rotated by means of a lever 30 about an axis perpendicular to the plane of the port opening until the cams 26 abut against corresponding cam stops in the groove 28.

[0034] For other Rapid Transfer Ports, the Beta Part 14 can also be docked to the Alpha Part 12 by rotating the Beta Part 14 relative to the Alpha Part 12.

[0035] The port door 18 is pivotally mounted on the port flange 16 so that, after the container has been docked, it can be pivoted into the interior of the isolator together with its lid 24. For this purpose, the port door 18 is provided with a bracket 32 ​​rigidly mounted on the port door 18, which extends diametrically across the inside of the port door 18. A first end of the bracket 32, which projects radially beyond the circumference of the port door 18, is pivotally connected to the inside of the port flange 16 by means of a pivot joint 34.

[0036] The port door 18 can be locked in its closed position by means of the actuating mechanism 20, which for this purpose comprises a lock 36. The lock 36 comprises a first lock part 38, which is rotatably mounted on a second projecting end of the bracket 32, by means of an actuating handle 40 between a closed position ( Fig. 3 ) and an open position ( Fig. 4 ) and has a radially projecting locking lug 42. The lock 36 further comprises a second lock part 44, which is rigidly mounted on the inside of the port flange 16 opposite the first lock part 38 and has a bolt receptacle 46 ( Fig. 20 ) into which the locking lug 42 engages in the closed position to keep the port door 18 closed. In the open position, the locking lug 42 is disengaged from the latch receptacle 46.

[0037] The rotatable lock part 38 has a disc-shaped configuration and is penetrated by a rigid axle (not visible) that projects vertically above the shackle 32. A disc-shaped cover 48 is snapped onto the lock part 38 and rotates together with the lock part 38.

[0038] The device 10 comprises four safety devices 50, 52, 54 arranged in the alpha part 12, which are intended to prevent incorrect operation of the Rapid Transfer Port, which could cause contamination of the goods through unwanted contact with the environment or contamination of the isolator through unwanted entry of germs during the transfer of goods.

[0039] The first safety device prevents the port door 18 from opening if the container is not provided with a container lid 24 and therefore the interior of the container is not sterile. The second safety device 50 prevents the rotatable locking part 38 from moving into the open position and thus the port door 18 from opening as long as the container flange 14 is not properly docked to the port flange 12. The third safety device 52 blocks the container flange 14, which is properly connected to the port flange 12, and prevents the associated bayonet connection from being released as soon as the rotatable locking part 38 leaves the closed position toward the open position. The fourth safety device 54 prevents the locking part 38 from turning back to the closed position when the port door 18 is open, thus also preventing the second and third safety devices 50, 52 from being released.

[0040] In order to prevent the safety devices 50, 52, 54 from impairing the sterility of the Rapid Transfer Port and the sterile barrier of the Alpha part 12 from being penetrated by germs, the three safety devices 50, 52, 54 each comprise two magnetic elements 56, 58; 60, 62; 64, 66 which are movable relative to one another, wherein two closed walls 68, 70 without a through opening are arranged between the two magnetic elements 56, 58; 60, 62; 64, 66 and wherein the magnetic elements 56, 58; 60, 62; 64, 66 attract or repel one another through the closed walls 68, 70 either in a blocking position or in a release position of the respective safety device 50, 52, 54.

[0041] In all three safety devices 50, 52, 54, one 56; 60; 64 of the two magnetic elements 56, 58; 60, 62; 64, 66, hereinafter referred to as the first magnetic element, is housed in the port flange 16, while the other 58; 62; 66 of the two magnetic elements, hereinafter referred to as the second magnetic element, is housed in the bracket 32 ​​of the port door 18. Both magnetic elements 56, 58; 60, 62; 64, 66 each comprise a cylindrical or annular magnetic body made of a permanent magnetic material, for example, a neodymium-iron-boron alloy or another rare earth alloy. The two magnetic bodies are each mounted such that two flat end faces of the magnetic bodies face each other.

[0042] The first safety device used to check for the presence of the container lid 24 in the Rapid Transfer Port described here, unlike the Rapid Transfer Port from US Pat. No. 9,704,607 B2, only requires a statically loaded seal in the port door 18. Therefore, and to avoid having to equip each container lid with a magnetic element, it is designed here without magnetic elements and will not be described in detail. The above-mentioned second, third, and fourth safety devices 50, 52, 54, in contrast, each comprise two magnetic elements 56, 58; 60, 62; 64, 66.

[0043] How best to Figuren 5 bis 8 , 13 und 14 As shown, in the second safety device 50, the first magnetic element 56 mounted in the port flange 16 consists of an annular magnetic body and a holder 72, which are movable in a blind hole of the port flange 16 against the force of a return spring 74. The holder 72 comprises a plate and a pin that penetrates the annular magnetic body. A pawl 76 pivotally mounted in the port flange 16 near the blind hole acts on the plate. The pawl 76 projects into the receiving groove 28 of the port flange 16 before the container is docked, as shown in Fig. 13 where it is fully depressed by one of the cams 26 of the container flange 22, as in Fig. 14 shown when the two flanges 22, 16 are properly connected to each other when the cams 26 strike against a stop of the port flange 16. After undocking the container, the latch 76 is moved back into the receiving groove 28 by the return spring 74, as shown in Fig. 13 Depending on the pivoting position of the pawl 76, the first magnetic element 56 is moved back and forth between two end positions, as shown in Fig. 6 and 8 shown. When the pawl 76 projects into the receiving groove 28, the first magnetic element 56 is in the first end position ( Fig. 6 ), while when the latch 76 is depressed, it is in the second end position at the bottom of the blind hole ( Fig. 8 ). The blind hole is closed towards the bracket 32 ​​by the wall 68, which consists of thin non-rusting and non-magnetic steel sheet.

[0044] The second magnetic element 58 is located opposite the first magnetic element 56 inside the bracket 32. In addition to a cylindrical magnetic body, the second magnetic element 58 includes a pin 78 that projects beyond the side of the magnetic body facing away from the port flange 16. The magnetic body and the pin 78 are movable in a blind hole in the bracket 32, which is closed off from the port flange by the wall 70. The wall 70 is also made of thin, stainless and non-magnetic sheet steel.

[0045] How best in Fig. 6 and 8As shown, the pin 78 rests with its end facing away from the magnet body against another pin 80, which is mounted axially displaceably in a bore of the rotatable lock part 38 against the force of a return spring 82. The return spring 82 presses the second magnet element 58 against the wall 70 via the pins 80, 78 when the first magnet element 56 is in its first end position with the latch 76 unloaded.

[0046] The two magnetic bodies are aligned so that they repel each other. When the pawl 76 is pressed down, thereby moving the first magnetic element 56 into the second end position and bringing it closer to the second magnetic element 58, the second magnetic element 58 is lifted from the bottom of the blind hole against the force of the spring 82. The repulsive forces of the two magnetic elements 56, 58 are matched to the spring force of the return spring 82 in such a way that the mutually abutting flat end surfaces of the two pins 78, 80 are aligned with a flat contact surface of the rotatable lock part 38 on the shackle 32 when the pawl 76 is fully pressed down. This Fig. 8 The position shown is the release position of the second safety device 50, in which the rotatable lock part 38 can be rotated from the closed position of the lock 36 into its open position.

[0047] If the latch 76 returns to the position shown in Fig. 6 and 13 shown position, the second safety device 50 assumes the blocking position in which the rotatable lock part 38 cannot be moved out of the closed position.

[0048] How best to Figuren 9 bis 12 As shown, in the third safety device 52, the first magnetic element 60 mounted in the port flange 16 has a corresponding design to that of the second safety device 50 and consists of an annular magnetic body and a holder 84, which are movable in a blind hole in the port flange 16 against the force of a return spring 86. The holder 84 consists of a plate and two pins, one of which penetrates the annular magnetic body. The other pin projects beyond the opposite side of the plate. The magnetic body and the two pins are axially movable in the blind hole, which is closed off from the bracket 32 ​​by the wall 68.

[0049] The second magnetic element 62 consists of a long cylindrical magnetic body which is connected in a rotationally fixed manner to the rotatable lock part 38, projects beyond the side of the lock part 38 facing the port flange 16 and projects into a curved slot 90 of the bracket 32, which is closed at its base towards the port flange 16 by the wall 70. When the rotatable lock part 38 is in its closed position, as in Fig. 3 and 10 As shown, the second magnetic element 62 is arranged exactly opposite the first magnetic element 60. When the rotatable lock part 38 is in its open position, as shown in Fig. 4 and 12 As shown, the second magnetic element 62 is laterally offset with respect to the first magnetic element 60.

[0050] The two magnetic bodies are aligned such that they attract each other when, in the closed position of the lock 36, the second magnetic element 62 is located opposite the first magnetic element 60. The attractive forces of the two magnetic elements 60, 62 are matched to the spring force of the return spring 86 such that, in this release position of the third safety device 52, the first magnetic element 60 assumes a first end position in which the pin 88 is completely retracted from the receiving groove 28 against the force of the return spring 86 ( Fig. 13 ). When the second magnetic element 62 is moved away from the first magnetic element 60 in the direction of rotation within the elongated hole 90 when the lock part 38 is rotated into the open position, the magnetic attraction forces between the magnetic elements 60, 62 decrease to such an extent that the first magnetic element 60 is pressed by the return spring 86 back into the second end position, in which the pin 88 again projects into the receiving groove 28 ( Fig. 14 ) and the third safety device 52 is in its blocking position. The position of the pin 88 in the groove 28 is selected such that it projects into the groove 28 directly behind one of the cams 26 of the container flange 22 and prevents the cam 26 or the container flange 22 from turning back.

[0051] How best to Figuren 15 bis 20 As shown, in the fourth safety device 54, the first magnetic element 64 consists merely of a stationary magnetic body mounted in the port flange 16, which is separated from the interior of the insulator by the wall 68 on the inside of the port flange 16. The second magnetic element 66 is located directly opposite the first magnetic element 64 inside the bracket 32, so that when the port door 18 is opened, it moves away from the first magnetic element 64 and, when the port door 18 is closed, it moves closer to the first magnetic element 64. In addition to the magnetic body, the second magnetic element 66 comprises a pin 92 that projects beyond the side of the magnetic body facing away from the port flange 16. The magnetic body and the pin 92 are axially movable in a blind hole in the bracket 32, which is closed off from the port flange 16 by the wall 70. As best shown in Fig. 16 and 18As shown, the pin 92 rests with its flat end facing away from the magnet body against the flat end of a further pin 94 which is mounted so as to be axially displaceable in a blind hole of the rotatable lock part 38 against the force of a return spring 96.

[0052] The two magnetic bodies are aligned such that they repel each other when the port door 18 is closed, thus bringing the second magnetic element 66 closer to the first magnetic element 64. The repulsive forces of the two magnetic elements 64, 66 are matched to the spring force of the return spring 96 such that the mutually abutting flat end faces of the two pins 92, 94 are aligned with the flat contact surface of the rotatable lock part 38 on the shackle 32 when the shackle 32 rests against the port flange 16 with the port door 18 closed. This position is the release position of the fourth safety device 54, in which the rotatable lock part 38 can be rotated from the open position of the lock 36 back into the closed position.

[0053] When the port door 18 is opened slightly with the lock 36 in the open position, the repulsive forces between the two magnetic elements 64, 66 decrease. This results in the force of the return spring 96 moving the second magnetic element 66 within the bore in the direction of the wall 70, whereby the mutually abutting flat end surfaces of the two pins 92, 94 move out of the plane of the contact surface of the rotatable lock part 38 on the bracket 32, as best shown in Fig. 18 shown. In this blocking position of the fourth safety device 54, the rotatable lock part 38 cannot be rotated from the open position of the lock 36 into its closed position.

[0054] How best to Figuren 6 , 8 , 10 , 12 , 16 and 18As shown, the rotatable lock part 38 is sealed to the shackle 32 and to the cover 48 by an O-ring 98, 100 which extends along the outer circumference of the rotatable lock part 38 and the cover 48, respectively.

Claims

1. Apparatus (10) for sterile transfer of material between a container and an isolator, wherein the container has a container opening surrounded by a container flange (22) and a container lid (24) removable from the container flange (22) for closing the container opening, wherein the isolator has a port opening surrounded by a port flange (16), a port door (18) for closing the port opening and an actuating mechanism (20) movable between a closed position and an open position for opening and closing the port door (18), wherein the container flange (22) is detachably connectable to the port flange (16) and the container lid (24) is detachably connectable to the port door (18), and to one or more of the following safety devices (50, 52, 54): - a first safety device that blocks the actuating mechanism (20) in the closed position and releases it when the port door (18) rests against the container lid (24), - a second safety device (50) that blocks the actuating mechanism (20) in the closed position and releases it when the container flange (22) is correctly connected to the port flange (16), - a third safety device (52) that blocks the container flange (22) connected to the port flange (16) when the actuating mechanism (20) leaves the closed position, and that prevents the two flanges (16, 22) from being released from each other as long as the port door (18) is open, - a fourth safety device that blocks return of the actuating mechanism (20) from the open position to the closed position when the port door (18) is open, and - a fifth safety device, which blocks the actuating mechanism (20) if the container flange (22) is not correctly connected to the port flange (16) between the release of the actuating mechanism (20) by the second safety device (50) and the blocking of the container flange (22) by the third safety device (52), characterised in that at least one of the safety devices (50; 52; 54) comprises two magnetic fields (56, 58; 60, 62; 64, 66), which are movable relative to one another, in that at least one closed wall (68, 70) without a through-opening is arranged between the two magnetic elements (56, 58; 60, 62; 64, 66) and in that the magnetic elements (56, 58; 60, 62; 64, 66) attract or repel one another through the closed wall (68, 70) either in a blocking position or in a release position of the safety device (50; 52; 54).

2. Apparatus according to claim 1, characterised in that< / b> the two magnetic elements (56, 58; 60, 62; 64, 66) are arranged in two components (32; 16) of the apparatus, which components are separated by the at least one wall (68, 70) and can move in relation to one another.

3. Apparatus according to claim 1 or 2, characterised in that each of the two magnetic elements (56, 58; 60, 62; 64, 66) comprises at least one permanent magnetic body.

4. Apparatus according to claim 1 or 2, characterised in that one of the two magnetic elements comprises at least one ferromagnetic body and the other of the two magnetic elements comprises at least one permanent magnetic body.

5. Apparatus according to any one of the preceding claims, characterised in that at least one of the two magnetic elements (56, 58; 60, 62; 64, 66) is movable between two end positions.

6. Apparatus according to claim 5, characterised in that the at least one moveable magnetic element (56, 58; 60; 66) can be moved against the spring force of a return spring (74, 82; 86; 96).

7. Apparatus according to any one of the preceding claims, characterised in that the actuating mechanism (20) comprises a lock (36) with a lock part (38) rotatable about an axis of rotation between the closed position and the open position, and in that at least one of the two magnetic elements (56, 58; 60; 66) is movable parallel to the axis of rotation of the lock part (36).

8. Apparatus according to claim 7, characterised in that the movable magnetic element (58; 66) blocks rotation of the lock part (38) in the blocking position of the lock (36) and permits rotation of the lock part (38) in the release position.

9. Apparatus according to any one of the preceding claims, characterised in that the actuating mechanism (20) comprises a lock (36) with a lock part (38) rotatable about an axis of rotation between the closed position and the open position, and in that one of the two magnetic elements (62) is rotatable together with the lock part (38) about the axis of rotation.

10. Apparatus according to any one of the preceding claims, characterised in that< / b> the two magnetic elements (56, 58; 60, 62; 64, 66) each comprise a first magnetic element (56; 60; 64) arranged in the port flange (16).

11. Apparatus according to claim 10, characterised in that the first magnetic element (56; 60) is movable in the port flange (16).

12. Apparatus according to claim 10 or 11, characterised in that the two magnetic elements (56, 58) of the second safety device (50) comprise a second magnetic element (58), which releases the actuating mechanism (20) in the closed position when the first magnetic element (56) is brought closer to the second magnetic element (58) when the container flange (22) is connected to the port flange (16).

13. Apparatus according to claim 10 or 11, characterised in that the two magnetic elements (60; 62) of the third safety device (52) comprise a second magnetic element (62), which moves away from the first magnetic element (60) when the actuating mechanism (20) is moved to the open position, whereupon the first magnetic element (60) blocks the container flange (22) connected to the port flange (16).

14. Apparatus according to claim 10 or 11, characterised in that< / b> the two magnetic elements (64; 66) of the fourth safety device (54) comprise a second magnetic element (66), which is movable together with the port door (18) and which blocks the actuating mechanism (20) in the open position when the second magnetic element (66) moves away from the first magnetic element (64) when the port door (18) is opened.