SEALING ARRANGEMENT FOR A STERILE ENVIRONMENT

Abstract

A sealing arrangement (12; 70; 80; 100) for arrangement on a shaft (28; 82; 126), comprising: a sealing body (14; 114) with a gap (16, 124) formed therein for the passage of the shaft (28; 82; 126), a seal carrier (22; 86; 102) held in the gap (16; 124), the seal carrier being selectively positionable between a sealing position and a rotational position by displacement along a displacement path, at least one seal (24; 88A, 88B, 88C, 88D; 106, 110) carried by the seal carrier, and a hermetic seal (26) held in the gap (16; 124) outside the displacement path of the seal carrier, wherein the hermetic seal is configured to be abraded by a shaft (28; 82; 126) against which the hermetic seal presses,characterized in that at least two seals (24; 88A, 88B, 88C, 88D;106, 110), wherein the one, first seal (24; 88D; 106) is arranged in a sealing groove (42) which is formed in an outer edge of the seal carrier, in order to seal against a wall (52) of the seal body (14; 114), and the other, second seal (24; 88A, 88B, 88C; 110) is arranged in a sealing groove (42) which is formed in an inner edge of the seal carrier, in order to seal against the shaft (28; 82; 126);

Description

Background of the invention 1. Field of the invention

[0001] The present invention relates to seals and in particular seals for maintaining a sterile environment. 2. Description of the state of the art

[0002] Certain products, particularly those in the pharmaceutical and food industries, require a high degree of sterility during the manufacturing process to guarantee safe consumption. The production of such products typically takes place in dedicated cleanrooms, where the environment and equipment are strictly controlled to prevent the introduction of foreign organisms and substances into the products during the manufacturing process. Maintaining sterility in cleanrooms can be achieved through a combination of industry and government guidelines for Good Manufacturing Practice (GMP), along with facility controls, to minimize the risk of product contamination.

[0003] Since maintaining sterility in an entire room, which many employees may enter and exit during a production process, is often impractical, sterile products are typically manufactured in specially designed devices called bioreactors, which are sealed from the external environment. The introduction of material into the bioreactor is limited to a few inlets, thus minimizing the risk of introducing foreign organisms and substances. Each inlet is sealed unless material is being deliberately introduced to prevent contamination of the product inside the bioreactor.

[0004] A particular challenge in bioreactor production lies in the difficulty of mixing or otherwise stirring the sterile contents within the bioreactor. Typically, the contents are stirred using a paddle or other instrument driven by a motor located outside the sterile environment. This stirring instrument does not typically remain inside the bioreactor for the entire production process, which can last for months, as the bioreactor contents could react with the instrument's material, rendering the contents unusable. Therefore, the stirring instrument is usually only inserted into the bioreactor to agitate the contents at predetermined intervals during the production process.

[0005] To maintain a sterile environment while the stirring instrument is used to stir the contents of the bioreactor, a feedthrough can be used that seals tightly against the moving surface of the stirring instrument. Known feedthroughs are effective in maintaining sterility during stirring of the bioreactor contents, but they must be replaced after stirring. This is impractical for manufacturing, as the feedthroughs must be replaced after each stirring operation, and also introduces another potential source of contamination, since contamination may occur during the replacement process or the new feedthrough may not have been properly disinfected.Furthermore, it is possible to contain the contents of the bioreactor within the bioreactor in sterile containers, for example, in polymer bags, and later, after stirring, transfer them to another bioreactor. With known solutions, it is not possible to stir the contents of the sterile bag, transfer them to another bioreactor, and then stir them again while maintaining the sterile environment within the bag, without at least once changing the setup.

[0006] In this field, a sealing arrangement is needed to maintain a sterile environment, which can overcome some of the disadvantages of known sealing arrangements described above. Summary of the invention

[0007] The present invention provides a sealing arrangement comprising at least one seal held by a sealing carrier between a sealing position and a rotational position, and a hermetic seal configured to be rubbed by a rotating element against which the hermetic seal presses.

[0008] According to one embodiment, the invention relates to a sealing arrangement comprising: a sealing body with a space formed therein, a sealing carrier which is held in the space, wherein the sealing carrier can be selectively positioned between a sealing position and a rotational position by displacement along a displacement path, at least one seal which is supported by the sealing carrier, and a hermetic seal which is held outside the displacement path of the sealing carrier in the space, wherein the hermetic seal is configured to be rubbed by a rotating element against which the hermetic seal presses.

[0009] According to a further embodiment, the invention relates to a stirring arrangement comprising a shaft and a sealing arrangement mounted on the shaft. The sealing arrangement comprises a sealing body with a cavity formed therein, the shaft occupying a portion of the cavity; a sealing carrier held in the cavity, wherein the sealing carrier can be selectively positioned between a sealing position and a rotational position by displacement along a displacement path; at least one seal supported by the sealing carrier; and a hermetic seal held in the cavity outside the displacement path of the sealing carrier and sealing against the shaft, the hermetic seal being configured to be worn during rotation of the shaft.

[0010] According to yet another embodiment, the invention relates to a method for maintaining a sterile environment, comprising the following steps: providing a sealing arrangement with a cavity formed therein, a sealing carrier within the cavity having a sealing position and a rotational position and defining a displacement path, at least one seal supported by the sealing carrier, and a hermetic seal held within the cavity outside the displacement path; establishing a seal against a rotatable element by means of the at least one seal in the sealing position and the hermetic seal; moving the sealing carrier from the sealing position to the rotational position; rotating the rotatable element, whereby the hermetic seal is worn away during the rotation;and moving the sealing carrier from the rotational position into the sealing position.;

[0011] An advantage of the present invention is that the seal carried by the sealing carrier allows sterility to be maintained after the hermetic seal has been worn away, thus enabling sterility to be maintained during several stirring cycles with the device.

[0012] Another advantage is that by using more than one seal supported by one or more seal carriers, a high number of stirring cycles can be made possible before the sealing arrangement can no longer maintain sterility.

[0013] Another advantage is that purge gas can be introduced into the gap to maintain overpressure within the gap, thus keeping contaminants out of the gap while the rotating element rotates. Brief description of the drawings

[0014] The aforementioned and further features and advantages of the present invention and the manner in which they are to be achieved will become clearer and the invention will become more understandable with reference to the following description of embodiments of the invention in conjunction with the accompanying drawings.

[0015] This shows:

[0016] Fig. 1 a cross-sectional view of a part of an embodiment of a stirring arrangement designed according to the present invention, wherein a sealing carrier is in a sealing position,

[0017] Fig. 2 a cross-sectional view of the in Fig. 1 stirring arrangement shown, wherein the sealing carrier is in a rotational position,

[0018] Fig. 3 a cross-sectional view of a part of a further embodiment of a stirring arrangement designed according to the present invention,

[0019] Fig. 4 a cross-sectional view of an embodiment of a sealing arrangement designed according to the present invention, comprising several seals which are supported by a sealing carrier, and

[0020] Fig. 5 a cross-sectional view of a further embodiment of a sealing arrangement designed according to the present invention, which has several seals which are supported by several sealing carriers.

[0021] In the various views, corresponding components are designated by corresponding reference numerals. The present exemplary embodiments are intended to illustrate embodiments of the invention, and it is in no way intended to limit the scope of protection of the invention with these exemplary embodiments. Detailed description of the invention

[0022] Let us now turn to the drawings, and in particular to… Fig. 1, this is an embodiment of a stirring arrangement 10 shown, which is designed according to the present invention and which includes a sealing arrangement 12 for a sterile environment, which generally has a sealing body 14 with a gap 16 includes the sealing body 14 from one end 18 of the sealing body 14 to an opposite end 20of the sealing body 14 is trained to be a sealing carrier 22 , which is in the space 16 of the sealing body 14 is held and can be optionally positioned in a sealing position and in a rotational position and defines a displacement path, at least one seal 24 , which are from the sealing carrier 22 is worn, as well as a hermetic seal. 26 , which are in the space 16 of the sealing body 14 outside the displacement path of the sealing carrier 22 is held. The sealing arrangement 12 , which can be described as a “passage”, can be on a wave 28 be arranged in such a way that the wave 28 through the space 16 of the sealing body 14 is inserted through it, whereby the seal(s) 24 and the hermetic seal 26sealing around the shaft 28 around it, as will be described in more detail later. The sealing body 14 can at one end 18 a mounting flange 30 feature, which can be attached to a sterile environment such as a sterile bag of a bioreactor or a food mixer to secure the sealing arrangement 12 on the wave 28 to hold, which is introduced into the sterile environment to rotate. The sealing body 14 It can also include one or more storage areas. 32 exhibit, which in the space 16 are held to the wave 28 to stabilize when these are in the space 16 It has been introduced. As shown, the sealing body can 14 a generally cylindrical shape with different diameters D1, D2, D3 along this to accommodate the various components of the sealing arrangement 12to be included. In the sealing body 14 can a gas connection 34 be trained to deal with an area of ​​the interstitial space 16 is connected, which is between the sealing carrier 22 and the hermetic seal 26 lies, as will be described in more detail later, and in the gas connection 34 can a filter membrane 36 be arranged. The gas connection 34 can be in the sealing body 14 They can be formed in different places, as shown in the various figures. Furthermore, they can be found in the space between. 16 of the sealing body 14 additional seals 38 be arranged in a way that is not aligned with the dynamic surface of the wave 28 come into contact to help maintain sterility. Since the sealing body 14 Typically used to maintain a sterile environment, the sealing body14 be trained using materials and procedures that comply with Good Manufacturing Practice (GMP) guidelines and sterilize the sealing assembly 12 enable this through one or more common methods such as irradiation, sterilization with ethylene trioxide (EtO), hot air sterilization and autoclaving.

[0023] The sealing carrier 22 will be in the space 16 of the sealing body 14 held and can optionally be in a sealing position (in Fig. 1 shown) and in a rotational position (in Fig. (2 shown) can be positioned, with a displacement path defined between the two positions. The meaning of the sealing position and the rotation position will be described in more detail later. As can be seen, the sealing carrier can be 22 a carrier body 40with a ring-shaped form, which has sealing grooves 42 features in which the seals 24 to be held. For the targeted positioning of the sealing carrier. 22 can the sealing carrier 22 a magnetic core 44 include, for example, a material containing iron, such that a magnetized actuator is located outside the sealing body. 14 with the magnetic core 44 can interact and cause the sealing carrier to 22 in the space 16 of the sealing body 14 is moved without a mechanical actuator in the sealing body 14 The displacement path is therefore defined as the area in which the sealing carrier needs to be positioned. 22 in the space 16 of the sealing body 14It can be moved between the sealing position and the rotation position. The sealing carrier 22 can have a tapered section 46 adjacent to the sealing grooves, where a width of the sealing carrier 22 to a section 48 with reduced diameter, whereby the sealing grooves 42 between the section 48 with reduced diameter and a section 50 are designed with a full diameter. The sealing carrier 22 can be made from a similar material to the sealing body 14 be trained in a way that allows for sterilization.

[0024] As shown, the sealing carrier 22 two seals 24 The seals 24 These can be, for example, dynamic seals. One type of dynamic seal is... 24 can be in a sealing groove 42be arranged in an outer edge of the sealing carrier 22 is designed to move against a wall 52 of the sealing body 14 to seal, and the other dynamic seal 24 can be in a sealing groove 42 be arranged in an inner edge of the sealing carrier 22 is trained to ride the wave 28 to seal it. It should be noted that the sealing carrier 22 even just one or more than two seals 24 can carry. The seals 24 They can be designed in any way that allows them to seal against the wall. 52 of the sealing body 14 and on the wave 28 to prevent fluid located in the sterile environment 54 escapes from the sterile environment or becomes contaminated by non-sterile impurities. The seals 24They can be made, for example, of rubber, polytetrafluoroethylene (PTFE) or other materials that can create a seal and be kept sterile.

[0025] Let us now turn to the Fig. 1 and Fig. 2. Reference, it can be seen that the sealing carrier 22 , which carries the seals, magnetically or otherwise between the in Fig. 1 shown sealing position and the one in Fig. The shaft can be moved to the rotation position shown in point 2. As shown, the shaft can be moved to the position shown in point 2. 28 , which are through the inner edge seal 24 is sealed, a wave taper 56 exhibiting where the shaft transitions from a first width W1 to a second width W2, the second width W2 being larger than the first width W1 and closer to the mounting flange 30 lies. If the sealing carrier 22 and the seals it carries 24The seals are in the sealing position. 24 close to the second width W2 of the wave 28 pressed and prevent rotation of the shaft 28 If the sealing carrier 22 However, when it is moved into the rotation position, the supported seals 24 no longer firmly against the wave 28 pressed, since the first width W1 is smaller than the second width W2, thus the shaft 28 It can rotate freely, but without additional sealing, contaminants may also enter the sterile environment.

[0026] To provide an additional seal to prevent the ingress of contaminants into the sterile environment when the sealing carrier 22 and the seals it carries 24 When in the rotation position, a hermetic seal is formed. 26 in the space 16 of the sealing body14 held, which provides a static, hermetic seal to prevent the ingress of contaminants into the gap 16 of the sealing body 14 and to prevent entry into the sterile environment. The hermetic seal 26 It can be a static seal that is not intended to rotate, i.e., a hermetic seal. 26 It wears down and no longer provides a seal when the shaft 28 rotates. The hermetic seal 26 can be designed as any type of hermetic seal that seals around the shaft 28 around it and the ingress of air and other contaminants into the space 16 of the sealing body 14 prevented. Because of the hermetic seal 26 is intended to be static against the wave 28 To seal it, the hermetic seal should be used. 26 within the space 16are held outside the displacement path, so that the displacement of the sealing carrier 22 and the seals it carries 24 the function of the hermetic seal 26 not affected. Analogous to the sealing body. 14 and the worn seals 24 can the hermetic seal 26 be made of a material that allows for the production of a hermetic seal 26 in accordance with good manufacturing practice (GMP) and that it can be sterilized.

[0027] To the sealing arrangement 12 To maintain sterility, the sealing arrangement is used. 12 first attached to the sterile environment, whereby the sealing carrier 22 in the sealing position, for example by attaching the mounting flange 30 on a sterile bag with sterile contents inside. The sealing arrangement 12can be attached if the shaft 28 already through the sealing arrangement 12 is carried out, or the wave 28 can be achieved through the sealing arrangement 12 be carried out after the sealing arrangement 12 has been attached. If the shaft 28 The sealing carrier is to rotate. 22 magnetically or otherwise set into the rotational position. At this point, the supported seals are sealed. 24 the sterile environment is no longer sealed off, the sterile environment is within the space between 16 of the sealing body 14 However, this is due to the hermetic seal. 26 maintained so that no external contaminants enter the sterile environment. The sterile environment can be further maintained by supplying sterile purge gas from a purge gas supply. 58 through the gas connection 34 and one in the gas connection 34held membrane 36 is initiated to create overpressure in the space between 16 of the sealing body 14 to maintain and prevent the ingress of foreign bodies into the space 16 to prevent the wave 28 It can then begin to rotate to remove the fluid held in the sterile environment. 54 to mix or otherwise move. While the wave 28 When rotating, it can happen that the statically tight against the shaft 28 maintained hermetic seal 26 begins to wear away and a crack appears 60 between the remaining material of the hermetic seal 26 and the wave 28 forms. This between the hermetic seal 26 and the wave 28 The resulting gap provides an outlet for the gas from the supply to escape. 58 originating gas, so that no harmful high gas pressure in the space 16This occurs when the wave rotates. 28 Once finished, the sealing carrier can be used. 22 and the seals 24 through a spring 62 be returned to the sealing position and the purge gas is introduced into the gas connection. 34 can be switched off. The purge gas supply 58 can be configured in such a way that the gas introduction 58 into the gas connection 34 It stops automatically when the sealing carrier... 22 is in the sealing position, or the gas inlet 58 into the gas connection 34 can be manually switched off after the sealing carrier 22 has returned to the sealing position.

[0028] If the hermetic seal 26 is so worn that it no longer seals hermetically against the wave 28 If sealed, the gap can 16 from the side of hermetic sealing 26from up to the worn seals 24 considered contaminated, the space in between 64 behind the worn seals 24 However, where the sterile environment is located, it can still be considered sterile. In this sense, the worn seals constitute 24 a boundary between sterile and contaminated environments when the hermetic seal is broken 26 has been abrasioned. Such a case can occur during transport of the sterile environment and its contents to a separate processing plant or processing room. After transport or for other reasons, the shaft must be cleaned. 28 It may be rotated again to move or mix the contents in the sterile environment. For this purpose, purge gas can be introduced into the gas connection again. 34 to be initiated to create overpressure in the space 16 of the sealing body 14to maintain. The sealing carrier 22 and the worn seals 24 They can then be moved again, magnetically or otherwise, from the sealing position to the rotational position, so that the shaft 28 it can rotate freely again. After the rotation of the shaft 28 once the second time has ended, the sealing carrier can 22 and the worn seals 24 It is returned to the sealing position and the purge gas can be shut off. At this point, the environment within the gap is 16 of the sealing body 14 no longer to be considered sterile and the sealing arrangement 12 can be disposed of or replaced.

[0029] It should be noted that there are some different variations of the one in the Fig. 1 and Fig. 2 shown sealing arrangement 12 to consider. For example, the sealing carrier22 in a manner other than magnetically, between the sealing position and the rotational position, for example by using the pressure generated by the purge gas to simultaneously move the sealing carrier 22 to shift between the positions and create overpressure in the space between. Furthermore, the gas connection can 34 become superfluous when the space in between 16 within the sealing body 14 is pressurized with sterile purge gas, which is sufficient to create overpressure in the sealing body. 14 to maintain after the hermetic seal 26 through the rotating wave 28 was worn away and for one or more additional shaft rotation cycles after the abrasion of the hermetic seal 26 It is also possible that the gas pressure in the space 16 of the sealing body 14through the purge gas introduction into the gas connection 34 The pressure that builds up is sufficient to create overpressure within the space. 16 during transport and one or more additional shaft rotation processes after the abrasion of the hermetic seal 26 to maintain. It is also possible that the sealing carrier 22 not the entire volume of the seals 24 between the sealing position and the rotation position, but only one sealing section of the seals. 24 For example, the sealing carrier 22 a magnetically actuated element that attaches to (not shown) sealing lips of the seals 24 which can be specifically positioned between a sealing position in which the sealing carrier 22 the sealing lips against the shaft 28 and the wall 52 of the sealing body 14presses, and a rotational position in which the sealing carrier 22 the sealing lips no longer against the shaft 28 and the wall 52 of the sealing body 14 presses.

[0030] While the in the Fig. 1 and Fig. 2 shown sealing arrangement 12 While primarily intended for use above a fluid level maintained in a sterile environment, it is also considered that there may be cases where a sterile seal is desired in a location where there is concern that fluid pressure could force fluid into the sealing assembly. With reference to Fig. 3 now describes a further embodiment of a sealing arrangement. 70 to maintain such a sterile environment. The in Fig. 3 shown sealing arrangement 70 is analogous to the one in the Fig. 1 and Fig. 2 shown sealing arrangement12 constructed, additionally based on the sealing carrier in relation to 22 the hermetic seal 26 opposite side fluid seals 72 in a section 74 with an increased diameter of the sealing body 14 be held. The fluid seals 72 white lips 76 up, against the wave 28 and the inner wall 78 of the section 74 with an increased diameter of the sealing body 14 Press to expel fluid from the space 16 in the sealing body 14 to stay out of it. Those who oppose the wave 28 pressed lips 76 can be flexible and dynamic, so that the fluid seals 72 These are low-resistance seals. The ones in Fig. 3 shown sealing arrangement 70 can be essentially analogous to the one in the Fig. 1 and Fig. 2 shown sealing arrangement 12 can be used, the main difference being that purge gas is introduced into the gas connection. 34 a gas pressure can also be generated, which seals the fluid sealing lips. 76 sufficient from the wave 28 be "lifted off" so that the wave 28 can rotate. Once the purge gas pressure is released, the fluid sealing lips can rotate. 76 spontaneously reset and fight against the wave 28 press and create a fluid-tight seal against the shaft 28 produce.

[0031] While the in the Fig. 1– Fig. 3 shown embodiments of the sealing arrangements 12 , 70 While a single resealing step can be used, it is also intended that more than one resealing step may be desirable for various reasons. With reference to Fig. Section 4 now describes an embodiment of part of a sealing arrangement. 80 to maintain a sterile environment, which may involve several resealing steps. The in Fig. 4 shown sealing arrangement 80 can be essentially analogous to those in the Fig. 1– Fig. The sealing arrangements shown in the 3 examples are designed, with the difference that a shaft 82 , which are caused by the sealing arrangement 80 It is sealed, several tapered sections 84A , 84B , 84C features and the sealing arrangement 80 a sealing carrier 86 features multiple seals 88A , 88B , 88C carries, which depends on the position of the sealing carrier 86 along the displacement path against the wave 82 can press. As can be seen, every worn seal 88A , 88B , 88C, which against the wave 82 is held in a shaft seal groove 90A , 90B , 90C worn, which are located at different diameters SD1, SD2, SD3 of the sealing carrier 86 are trained. The sealing carrier 86 It also features a wall seal. 88D for sealing against a wall 92 of the sealing body, since the wall 92 If the path runs in a straight line, without relative changes in radius, only one of the sealing carriers will be used. 86 supported wall seal 88D for sealing against the wall 92 required, but more than one seal can also be used for sealing against the wall if desired. 92 the sealing body is used. The in Fig. 4 shown sealing arrangement 80 can be analogous to those in the Fig. 1– Fig. 3 shown sealing arrangements 12 , 70are used, with each step of resealing involving a displacement of the sealing carrier. 86 between the rotation position and the sealing position, and an overpressure is maintained in the space by purging gas until the sealing carrier 86 is again in its sealing position after the hermetic seal has been rubbed off. If three resealing steps are desired, as in Fig. As shown in section 4, the sealing carrier can 86 After the hermetic seal has worn away, it is moved into the rotational position, and purge gas can be introduced into the space between the sealing body and the seal. Once the rotation process is complete, the seal carrier can be removed. 86 to be returned to the sealing position. After the first resealing step, the leftmost seal is... 88C , which against the wave 82 is pressed, be contaminated, whereby the second seal88B from the left against the wave 82 presses and represents a boundary between contaminated and sterile environments, and the third seal 88A from the left, against the wave 82 The pressure is applied while the device is still in a sterile environment. After another resealing step, the second seal is then applied. 88B from the left, against the wave 82 presses, be contaminated, and the third seal 88A from the left, against the wave 82 Pressing it down, it is still to be considered sterile. Finally, after the third resealing step, the sealing arrangement is... 80 It can no longer be considered sterile and can be disposed of or replaced. Therefore, it is important to note the number of seals. 88A , 88B , 88C , which against the wave 82 be pressed, which can correspond to the number of resealing steps during which the sealing arrangement 80Can maintain sterility. For controlled movement of the sealing carrier. 86 During the resealing steps, magnetic or other types of actuation can be used to actuate the seal carrier. 86 along the wave 82 to move and stop at suitable points to achieve the desired number of resealing steps. For example, stops (not shown) can be placed along the movement path at desired points to stop the seal carrier. 86 during each resealing step at the correct location in relation to the shaft 82 to maintain, or the amount by which the sealing carrier 86 The displacement can be controlled during each resealing step by controlling the actuator that moves the sealing carrier. 86 moved.

[0032] While at the in Fig. 4 shown sealing arrangement 80a single sealing carrier 86 Since it is used to achieve multiple resealing steps, it is also intended that multiple sealing carriers can be used to achieve multiple resealing steps. With reference to Fig. Section 5 will now describe an embodiment of a sealing arrangement. 100 will be shown which provide a first sealing carrier 102 and a second sealing carrier 104 includes, each of which has a wall seal 106 , 108 and a shaft seal 110 , 112 carry. As can be seen, each seal carrier 102 , 104 designed analogously to the single sealing carrier shown in the embodiments of sealing arrangements described in the Fig. 1– Fig. As shown in section 3, each resealing step can be analogous to the single resealing step of the section shown in the Fig. 1– Fig. The sealing arrangements shown in the three diagrams can be implemented. A sealing body 114 can have different diameters, with a first spring 116 in a section 118 with reduced diameter against the first sealing carrier 102 is pressed and a second spring 120 in a section 122 with an increased diameter against the second sealing carrier 104 is pressed. The different diameters and the springs 116 , 120 act as natural limits to the displacement path of the respective sealing carrier, whereby they determine the amount of movement by which each sealing carrier can move. 102 , 104 in an intermediate space 124 of the sealing body 114 can be shifted, limited. A wave 126 , against which the shaft seals 110 , 112 Furthermore, two tapered sections can be pressed. 128 , 130exhibit, analogous to the single tapered section that is in the Fig. 1– Fig. Figure 3 shows which enable the supported shaft seals to 110 , 112 during the resealing steps, either sealing against the shaft 126 are attached to or detached from it. Each sealing carrier 102 , 104 can therefore be used independently of the other sealing carrier(s). 104 , 102 are moved in steps, whereby sterility on one side opposite the worn hermetic seal is maintained by the non-moved sealing carrier(s). 102 , 104 is maintained, whereby the hermetic seal is not in Fig. 4 is shown, but at analogous locations relative to the sealing carriers 102 , 104It can be arranged like the hermetic seals described and illustrated above. It can therefore be seen that the number of desired resealing steps can be regulated by changing the number of seal carriers and the seals mounted on them that are included in the sealing arrangement, as well as by how the seal carriers are repositioned during the resealing steps.

[0033] Although the present invention has been described with respect to at least one embodiment, it can be further modified within the scope of the inventive idea and the scope of protection of the present disclosure. The present application is therefore intended to cover all variations, uses, or adaptations of the invention based on its fundamental principles. Furthermore, the present application is intended to cover such deviations from the present disclosure as fall within the scope of what is customary in the field to which the present invention relates and which are within the limits of the appended claims.

Claims

[1] Sealing arrangement ( 12 ; 70 ; 80 ; 100 ), comprehensive: a sealing body ( 14 ; 114 ) with a space formed therein ( 16 , 124 ), a sealing carrier ( 22 ; 86 ; 102 ), which is in the space ( 16 ; 124 ) is held, wherein the sealing carrier can be selectively positioned between a sealing position and a rotational position by displacement along a displacement path, at least one seal ( 24 ; 88A , 88B , 88C , 88D ; 106 , 110 ), which is supported by the sealing carrier, and a hermetic seal ( 26 ), which is held in the space outside the displacement path of the sealing carrier, wherein the hermetic seal is configured to be rotated by a rotating element ( 28 ;82 ; 126 ) to be rubbed off, against which the hermetic seal presses. [2] Sealing arrangement according to claim 1, characterized by that the sealing body ( 14 ) a gas connection ( 34 ) exhibits, which is connected to an area of ​​the gap located between the sealing carrier and the hermetic seal. [3] Sealing arrangement according to claim 1, further characterized by a spring ( 62 ; 116 ), which pre-tensions the sealing carrier in the direction of the sealing position. [4] Sealing arrangement according to claim 1, characterized by that the sealing carrier is a magnetic material ( 44 ) contains. [5] Sealing arrangement according to claim 1, characterized by that the at least one seal supported by the sealing carrier is a plurality of seals ( 88A , 88B , 88C , 88D ; 106 , 110 ) includes those from the sealing carrier (86 ; 102 are worn. [6] Sealing arrangement according to claim 1, further characterized by a second sealing carrier ( 104 ), which is within the space ( 124 ) is held and can be selectively positioned between a second sealing position and a second rotational position by sliding along a second sliding path, and by a second seal ( 108 , 112 ), which is from the second sealing carrier ( 104 ) is worn. [7] Sealing arrangement according to claim 1, further characterized by a fluid seal ( 72 ), which are in a section ( 74 ) with an increased diameter of the sealing body ( 14 ) is arranged. [8] Stirring arrangement ( 10 ), with a wave ( 28 ; 82 ; 126 ); and one on the wave ( 28 ; 82 ; 126) arranged sealing arrangement ( 12 ; 70 ; 80 ; 100 ), characterized by that the sealing arrangement includes: a sealing body ( 14 ; 114 ) with a space formed therein ( 16 ; 124 ), where the wave ( 28 ; 82 ; 126 ) part of the space ( 16 ; 124 ) occupies; a sealing carrier ( 22 ; 86 ; 102 ), which is held in the space, wherein the sealing carrier can be selectively positioned between a sealing position and a rotational position by displacement along a displacement path, at least one seal ( 24 ; 88A , 88B , 88C , 88D ; 106 , 110 ), which is supported by the sealing carrier, and a hermetic seal ( 26), which is held in the space outside the displacement path of the sealing carrier and against the shaft ( 28 ; 82 ; 126 ) seals, whereby the hermetic seal ( 26 ) is configured for this during the rotation of the shaft ( 28 ; 82 ; 126 ) to be rubbed off. [9] Stirring arrangement according to claim 8, characterized by that at least one seal prevents rotation of the shaft ( 28 ; 82 ; 126 ) prevents when the sealing carrier is in the sealing position, and allows rotation of the shaft when the sealing carrier is in the rotation position. [10] Stirring arrangement according to claim 9, characterized by that the wave ( 28) has a first diameter (W1) and a second diameter (W2) which is larger than the first diameter, wherein the at least one seal touches the second diameter when the seal carrier is in the sealing position. [11] Stirring arrangement according to claim 8, further characterized by a purge gas supply ( 58 ), which is connected to a sealing body ( 14 ) trained gas connection ( 34 ) is connected, wherein the gas connection is connected to an area of ​​the space between the sealing carrier and the hermetic seal. [12] Stirring arrangement according to claim 11, characterized by that the purge gas supply ( 58 ) is configured to supply purge gas to the gas connection ( 34 ) to be output when the sealing carrier is in the rotation position. [13] Stirring arrangement according to claim 8, characterized by that the sealing carrier is a magnetic material ( 44) contains. [14] Methods for maintaining a sterile environment, comprising the following steps: Providing a sealing arrangement ( 12 ; 70 ; 80 ; 100 ) with a space formed therein ( 16 ; 124 ), a sealing carrier ( 22 ; 86 ; 102 ) within the space ( 16 ; 124 ), which has a sealing position and a rotational position and defines a displacement path, at least one seal supported by the sealing carrier ( 24 ; 88A , 88B , 88C , 88D ; 106 , 110 ) as well as a hermetic seal ( 26 ), which is held within the space outside the displacement path; Creating a seal against a rotating element ( 28 ; 82 ; 126 ) by means of at least one seal ( 24 ;88A , 88B , 88C , 88D ; 106 , 110 ) in the sealing position and the hermetic seal ( 26 ); Repositioning the sealing carrier ( 22 ; 86 ; 102 ) from the sealing position to the rotation position; Rotating the rotatable element ( 28 ; 82 ; 126 ), whereby the hermetic seal ( 26 ) is worn away during rotation; and Repositioning the sealing carrier ( 22 ; 86 ; 102 ) from the rotation position to the sealing position, [15] Method according to claim 14, further characterized by the step of introducing purge gas into the space during the rotation of the rotatable element. [16] Method according to claim 15, further characterized by the step of stopping the purge gas flow into the space when the sealing carrier is moved into the sealing position. [17] Method according to claim 14, further characterized by the following steps: for the second time moving the sealing carrier from the sealing position to the rotation position; and Rotate the rotatable element for the second time. [18] The method of claim 17, further characterized by the following steps: Introducing purge gas into the gap during the rotation of the rotating element; and Stopping the flow of purge gas into the gap when the sealing carrier is moved into the sealing position. [19] Method according to claim 17, further characterized by the step of disposing of the sealing arrangement after the rotatable element has been rotated a second time.

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