Fastening element for attachment to a connection element of a process vessel

Description

[0001] The invention relates to a fastening element for arrangement on a connection element of a process container according to claim 1. Furthermore, the invention relates to a process container according to claim 10.

[0002] Process vessels are used, for example, in chemical, biotechnological, and pharmaceutical plants. Within these plants, process vessels are used to carry out chemical, biological, or pharmaceutical processes. The process vessel is thus a process engineering device, whereby state variables such as temperature, pressure, or even the concentration of the medium within the process vessel must be changed to carry out the processes.

[0003] An example of a process vessel from the biotechnology field is a bioreactor. These bioreactors are typically used to cultivate microorganisms for the cultivation of animal, human, or plant cells.

[0004] The raw materials obtained through bioreactors can be used to produce pharmaceuticals. Pharmaceuticals require a high level of product purity. Therefore, high process reliability is essential in the production of pharmaceuticals and their basic building blocks to minimize waste.

[0005] In order to ensure this process reliability, the process is typically controlled or regulated using a control unit.

[0006] This requires information about the process status, known as process parameters. These process parameters are typically determined by taking samples and analyzing them. However, this sampling carries the risk of contamination of the medium in the process vessel, which can lead to a defective production batch. To avoid having to immediately take a sample of the medium within the process vessel to determine the process status, it is common practice to integrate connection elements into process vessels, particularly in bioreactors.

[0007] These connection elements are used to perform measurements inside the container from outside the container. For this purpose, a fastening element is attached to the container's connection element. A sensor can be placed over the attached fastening element, which has a measuring window. The sensor emits measuring radiation, such as infrared rays, through the measuring window to measure, for example, the turbidity of the medium.

[0008] Such a fastening element is known from DE102019115147B4: The fastening element is connected to the connection element of the process vessel via a screw connection. For this purpose, the fastening element is divided into a nozzle and a retaining element. To prevent contamination of the medium, the fastening element is connected to the connection element of the vessel in a fluid-tight manner via the retaining element.

[0009] US2013 / 145818 A1 discloses a sensor unit that can be attached to a container. The sensor unit comprises a flange unit with a sensor holding area in which a measuring unit with at least one measuring element is placed. A clamping device is used to attach the measuring unit to the sensor holding area.

[0010] To reduce the production costs of process vessels, especially the cleaning costs during use, so-called disposable process vessels are used. Disposable bioreactors are particularly common in bioreactors. These disposable reactors typically have connectors to which fastening elements are attached. Due to the single-use nature of disposable reactors, disposable fastening elements are also common. With the disposable version of the fastening element, the material from which the fastening element is made does not necessarily have to be autoclavable. This allows costs, especially material costs, to be saved during the production of the fastening element.

[0011] The present invention is based on the object of developing a fastening element of the type mentioned in such a way that a renewed loosening of the fastening element after it has been fixed to a connection element of a process container is prevented.

[0012] A risk associated with the use of disposable fasteners on single-use bioreactors is that potential reuse of a fastener designed for single-use only on another vessel may result in contamination of the medium within the other vessel.

[0013] In addition, when the fastening element is removed, contaminants can enter the process container and medium can escape from the container.

[0014] The risk of reusing the fastening element is avoided by an additional securing element. The securing element secures the fixed fastening element.

[0015] According to the invention, the fastening element for mounting on a connection element of a process container, in particular a reactor, preferably a bioreactor, particularly preferably a disposable bioreactor, comprises a nozzle and a securing element. The nozzle has a sensor opening for inserting a sensor into the nozzle and a measuring window formed on a side opposite the sensor opening. The securing element is designed to mount the nozzle on the connection element of the process container.

[0016] It is essential that the fixing element has at least one locking arm with a movable locking region to form a locking connection with the connection element of the process container. Furthermore, the fixing element has at least one securing element movably arranged on the fixing element, wherein the securing element and the fixing element are configured to cooperate in such a way that, in an insertion position of the securing element, the locking region of the at least one locking arm is movable, and, in a securing position of the securing element, movement of the locking region of the at least one locking arm is prevented by the securing element.

[0017] The advantage is that the movable locking arm allows for a simple locking connection, allowing the securing element to be easily slid over the connection element of the process container. Because the locking arm is movable, a slight bending back of the locking arm causes the locking area to form the actual locking connection with the connection element. Another advantage is that the locking element does not restrict the locking arm's mobility in the insertion position.

[0018] Furthermore, it is advantageous that a simple movement of the securing element from the insertion position to the securing position results in a reduction in the mobility of the locking area of ​​the locking arm.

[0019] Another advantage is that no securing means such as screw locking adhesive or seals need to be used to secure the fixing element of the fastening element to the connecting element.

[0020] In an advantageous embodiment of the fastening element, the fixing element has a cylindrical base body which is divided into at least two locking arms by preferably axially extending slots. The advantage of this embodiment is that the slot provides a simple means of providing mobility to the locking areas of the locking arms. Thus, when the fixing element is positioned on the connecting element of the process container, the locking arms can move outward from the center, so that the fixing element engages behind a region of the connecting element. It is particularly advantageous if multiple slots result in a plurality of locking arms being formed.

[0021] Due to the greater freedom of movement of the locking arms, the more locking arms are designed, the easier it is to position the fixing element on the connecting element.

[0022] In a further advantageous embodiment, the securing element is ring-shaped and encloses the fastening element, at least in the locking area, in the locking position. The ring-shaped securing element prevents the movable locking arms and their locking areas of the fastening element from moving. It is advantageous that only one securing element is used to secure all fastening arms.

[0023] In a further preferred embodiment, the securing element is ring-shaped and encloses the fixing element in an insertion position. The advantage of this embodiment is that the securing element already encloses the fixing element in the insertion position, so that the securing element does not need to be additionally positioned.

[0024] It is particularly advantageous if the securing element encloses the fixing element in the insertion position, and the fastening element has a stop for the securing element to prevent the securing element from being displaced from the insertion position in the opposite direction to the locking region of the fixing element. Advantageously, the stop for the securing element is therefore arranged and designed such that the securing element, in the insertion position, rests against the stop on the side facing away from the securing position.

[0025] The advantage of this embodiment is that the fixing element and the securing element can be arranged next to each other before being fixed to the connection element of the process container and yet a loss of the securing element is avoided, which in particular facilitates the assembly process.

[0026] In a further advantageous embodiment of the fastening element, the securing element and the fixing element are designed to interact in such a way that the securing element and the fixing element form a positively engaging snap-in connection in the securing position. An advantage of this embodiment is that the positive snap-in connection enables simple and quick assembly of the fastening element on the connection element of the process container. A further advantage of the snap-in connection is that the snap-in connections can be brought together in a simple manner to create a connection, but releasing the snap-in connection is made difficult by the geometry of the snap-in elements (in particular snap-in lugs). It is also advantageous that the snap-in connection can only be released again by destroying the securing element. It is therefore advantageous that at least one snap-in lug is formed on the fixing element.

[0027] In a further advantageous embodiment, the measuring window is arranged hermetically sealed on the nozzle, in particular via a socket located inside the nozzle, preferably a step-shaped socket.

[0028] A hermetically sealed arrangement of the measuring window on the nozzle is advantageous due to the required freedom from contamination of the medium in the process vessel. Furthermore, the stepped design of the socket, in particular, prevents the measuring window from being pushed out into the interior of the process vessel when a sensor is inserted into the nozzle.

[0029] Another advantage of the stepped mount is that the forces generated by inserting the sensor into the nozzle are evenly distributed across the surface areas of the individual steps. This prevents excessive stress on the measuring window.

[0030] In a further advantageous embodiment, the measuring window is arranged fluid-tight on the nozzle.

[0031] Fluid tightness is a prerequisite for ensuring that a fluid medium remains within the process vessel and does not escape from the process vessel via the fastening element.

[0032] In a further advantageous embodiment of the fastening element, the material of the nozzle is biocompatible, in particular made of polyethylene (PE), preferably of polyaryletherketone (PAEK), preferably of polyethylene terephthalate (PET) or of polypropylene (PP) or of polyamide (PA), in particular of polyetheretherketone (PEEK), preferably of polyphenylenesulfone (PPSU).

[0033] It is important that the nozzle material does not decompose, preventing degradation products from entering the medium and contaminating it. It is also advantageous to use plastics. Manufacturing costs are lower compared to metal-based nozzles. Furthermore, simple plastic part manufacturing processes can be used.

[0034] In an advantageous embodiment of the fastening element, a coupling, preferably a coupling plug, particularly preferably a quick-release coupling plug, for arranging a sensor is formed in a region of the sensor opening of the nozzle. This is advantageous in that the arranged coupling allows the sensor to be easily arranged on the fastening element. In particular, the embodiment with a quick-release coupling offers the advantage of also allowing quick attachment and detachment of the sensor, especially when multiple measurements are performed with the sensor in different process vessels or in different fastening elements of the same process vessel within a short period of time.

[0035] In a further advantageous embodiment, the material of the measuring window is transparent, preferably made of glass, in particular of glass ceramic, particularly preferably of sapphire glass.

[0036] The advantage of this embodiment is that, through a transparent measuring window, measuring beams emitted by a sensor in the direction of the measuring window are not absorbed or are only slightly absorbed by the material of the measuring window. The same applies to incoming radiation reflected or generated in the medium. Therefore, the measuring window preferably has a transparency in a wavelength range that corresponds to the measuring range of the sensor, preferably in a wavelength range from 100 nm to 2000 nm. The particular advantage of using sapphire glass or glass ceramic is the particularly scratch-resistant surface of the glass and the low-attenuation transmission of electromagnetic waves through the materials.

[0037] In a further advantageous embodiment of the fastening element, the locking element has several outwardly opening locking arms. The locking arms preferably form a truncated cone that is open on the side with the larger diameter.

[0038] The advantage of this embodiment is that the distance between the securing element and the connecting element is greater in the area of ​​the locking arms than in the embodiment with locking arms that do not open outwards. This greater distance makes it easier to move the securing element from the insertion position to the securing position. Another advantage is that when the locking arms open outwards, a spring force acts on the securing element due to the spring action of the locking arms when the securing element is positioned in the securing position. The spring force helps maintain the securing position and makes it more difficult to release the securing element in the securing position.

[0039] In a further advantageous embodiment of the fastening element, the securing element can be releasably locked in the insertion position. This is advantageous because the securing element is prevented from accidentally entering the locking position.

[0040] In a further advantageous embodiment of the fastening element, the securing element is ring-shaped and has an internal thread, and the fixing element has a portion with an external thread. The securing element is initially arranged in the insertion position so that the portion with the external thread of the guide element and the internal thread of the securing element engage. The securing element is guided from the insertion position to the securing position by a rotational movement. When the securing element reaches the securing position, movement of the locking arm is prevented by the securing element.An advantage of this embodiment is that the restoring force that occurs with a fastening element with curved locking arms, which causes the securing element to be pushed toward the insertion position in the opposite direction to the locking position, is counteracted by the longitudinal screw force that opposes the restoring force. This is advantageous because it allows for easy fastening of the fastening element to the fastening element.

[0041] In the process container according to the invention, in particular for cultivating cell cultures or microorganisms in a medium with at least one connecting element with an arranged fastening element according to the invention, it is essential that the connecting element of the process container is fluid-tight due to the arrangement of the fastening element on the connecting element, in particular such that the measuring window adjoins an interior of the process container.

[0042] An advantage of this process container according to the invention is that the fluid-tight connection of the fastening element to the connection element of the process container prevents fluid media from escaping from the process container to the environment via the fastening element. Furthermore, it is advantageous that the measuring window is also directed into the interior of the process container to allow measurements to be performed inside the measuring container.

[0043] In an advantageous embodiment of the process container, the connection element is formed by a flange with a molded-on adapter, preferably a molded-on hose adapter, particularly preferably with a molded-on tubular adapter, particularly preferably with a molded-on tubular adapter which has a circular-cylindrical inner side and a frustoconical region on the outside, particularly particularly preferably with a molded-on tubular adapter which has a circular-cylindrical inner side and has a plurality of axial regions with differing outer diameters on the outside.

[0044] An advantage of this embodiment is that the securing element of the fastening element, for example, encloses the frustoconical region, so that the locking arms can engage the base region of the frustoconical region. Due to the frustoconical shape, an escape region is formed into which the movable locking region of the at least one locking arm can escape until the securing position of the securing element is reached. Furthermore, it is advantageous to design the inner side of the connecting element as a circular cylinder, so that the connecting piece can be easily guided through the connecting piece and a simple fit with a connecting piece with a circular cylindrical outer surface can be achieved.

[0045] The socket of the fastening element therefore preferably has a circular-cylindrical outer side, in particular the socket is preferably circular-cylindrical.

[0046] The advantage is that the flange of the connection element allows for easy attachment to the process vessel. However, since a flange only forms one opening, it is essential that the flange also has an adapter. This adapter serves to position the fastening element.

[0047] In a further advantageous embodiment of the process container, the material of the connection element is biocompatible, in particular made of polyethylene (PE), preferably of polyaryletherketone (PAEK), preferably of polyethylene terephthalate (PET), or of polypropylene (PP) or of polyamide (PA), in particular of polyetheretherketone (PEEK), preferably of polyphenylenesulfone (PPSU).

[0048] A benefit of designing the connection element as a biocompatible connection element is that contact between the connection element and the fluid in the process container does not produce any decomposition products that migrate into the medium of the process container. A further advantage of using materials from the plastics group is that they can be manufactured simply and cost-effectively using known manufacturing processes.

[0049] In a further advantageous embodiment of the process container, the fixing element and the at least one connection element of the process container are arranged concentrically; in particular, the fixing element, the securing element, and the connection element are preferably arranged concentrically. This enables simple arrangement of the individual elements, such that first the nozzle is inserted into the connection element and subsequently the fixing element is arranged concentrically on the connection element, such that the nozzle is arranged on the connection element via the fixing element, and the securing element is arranged concentrically to the fixing element in the connection element in a simple manner. A further advantage of the concentric arrangement of the components is the small space requirement.

[0050] In a further advantageous embodiment of the process container, an escape area is formed between the fixing element and the connecting element, into which the movable locking area of ​​the at least one locking arm can escape until the securing position of the securing element is reached, in particular by bending the locking arm.

[0051] The advantage of this design is that the securing function of the securing element can be implemented in a simple manner by forming the deflection zone. The deflection movement of the locking arms into the deflection zone makes it possible to easily move the ring-shaped securing element into the securing position. Upon reaching the securing position, the bending of the locking arms and thus the deflection into the deflection zone are reversed.

[0052] In a further advantageous embodiment, a sensor is arranged in the nozzle of the fastening element of the process container. The sensor is designed as an optoelectronic sensor, in particular as a turbidity sensor. The advantage of attaching the sensor to the fastening element is that the sensor, guided or held by the fastening element, enables a measurement into the interior of the container through the measuring window. Another advantage is that an optoelectronic sensor performs the most interference-free measurement possible within the medium. By measuring with the sensor via the fastening element, no samples need to be taken to perform a measurement in the medium.

[0053] In an advantageous development of the aforementioned embodiment of the process container with a sensor, a coupling, preferably a coupling plug, in particular a quick-release coupling plug, is formed in a region of the sensor opening of the nozzle of the fastening element for arranging the sensor. It is particularly advantageous for the sensor to be arranged on the fastening element by means of the coupling of the nozzle, in particular via a coupling socket of the sensor, preferably a quick-release coupling socket of the sensor.

[0054] An advantage of this embodiment is that the sensor can be easily positioned on the fastening element. Another advantage is that, particularly when using the quick-release coupling, the sensor can be positioned within the fastening element with one hand.

[0055] Further advantageous features and embodiments are described below using exemplary embodiments and the Figures 1 to 4 shown. The following shows: Figure 1: Partial illustrations of various embodiments of fastening elements on a connection element of a process container; Figure 2: another embodiment of a fastening element with a nozzle, securing element and connection element according to Figure 1a Figure 3: Embodiments of securing elements of the fastening element in a view from below, as well as an embodiment with outwardly extending locking arms; Figure 4: Embodiment of a fastening element shown in section on a connection element of a process container with and without an attached sensor.

[0056] All figures are schematic representations, not to scale. Identical reference symbols in the figures indicate identical or equivalent elements.

[0057] The figures each show exemplary embodiments of fastening elements according to the invention. Figure 1 , 2 and 4 Furthermore, connection elements of embodiments of process containers according to the invention are shown.

[0058] The exemplary embodiment of a fastening element 14 shown in partial figure 1a shows the individual elements of the fastening element 14: the nozzle 1, the fixing element 2 and the securing element 3. The figure shows the fixed state of the fastening element 14 on the connection element 6 of a process container. The connection element 6 of the process container is designed as a flange with a molded-on adapter 4. This molded-on adapter 4 is tubular and has a cylindrical interior and a frustoconical exterior. All elements are shown in cross-section. The nozzle 1 of the fastening element 14 has a measuring window 5 in a lower area. The measuring window 5 is made of glass in this exemplary embodiment. The nozzle 1 of the fastening element 14 is made of PEEK in this example.In this exemplary embodiment, the base body of the nozzle 1, the base body of the fixing element 2, the securing element 3, and the connecting element are rotationally symmetrical. The nozzle 1 is tubular and has a sensor opening for inserting a sensor into the nozzle 1. This sensor opening is located as shown in . Figure 1 at the upper end of the nozzle 1. Furthermore, a web is formed along the circumference of the nozzle 1 in an upper area of ​​the nozzle 1. This web is ring-shaped and serves to attach the nozzle 1 to the upper side of the frustoconical area 4 of the connection element of the process vessel via the fixing element 2 of the fastening element. The length of the tubular adapter 4 is shorter than that of the nozzle 1, so that the nozzle 1 extends partially into the interior of the process vessel.

[0059] To fix the nozzle 1 to the connection element 6 of the process container, the fixing element 2 has locking arms separated by two slots, according to the design of the Figure 3a . The securing element 3 is slidably arranged on the fixing element 2 and is held by the Figure 1aabove the securing position, lying insertion position, displaced downwards in the direction of the securing position, so that the securing element 3 presses the locking arms inwards in the direction of an escape area of ​​the connecting element 6 during the displacement process until the securing position on the fixing element 2 is reached. The aforementioned escape area represents the area which arises between the outer surface of the connecting element - in this case the outer surface of the frustoconical base body of the connecting element 6 - and the inner surface of the locking arms of the fixing element 2. In this example, the escape area is larger in the upper area than the escape area running towards the bottom of the frustoconical area due to the frustoconical design of the upper area of ​​the molded-on area.After reaching the securing position, the securing element 3 engages with an inner, circumferential ring into the locking area of ​​the fixing element 2, which is designed as an outer, circumferential groove. The locking mechanism prevents the securing element 3 from leaving the securing position 3. The securing element prevents the locking arms from moving outward and thus prevents the fastening element from detaching from the connecting element 6.

[0060] In this embodiment, the nozzle 1 of the fastening element does not have a molded coupling option. However, it is possible to insert a sensor into the tubular interior of the nozzle 1. The sensor is held to the inner wall of the nozzle 1 by a retaining lip of the sensor. The measuring window, made of glass in this case, is glued into an opening in the nozzle base, which is opposite the sensor opening.

[0061] The Figure 1b The embodiment shown differs from the embodiment shown in Figure 1a is shown by the fastening of the glass of the measuring window 5 in the nozzle base of the fastening element. Here, the receptacle of the glass is designed in a stepped manner, so that the glass extends through the base of the nozzle 1 into the interior of the nozzle 1 and has a smaller diameter within the nozzle base than in the area of ​​the interior of the nozzle 1. To fix the nozzle 1 to the connection element 6 of the process container, the fixing element 2 is designed according to the Figure 3a and has two locking arms separated by slots.

[0062] The stepped design of the glass mount has the advantage that it prevents the glass of the measuring window 5 from being pushed out when the sensor is inserted into the opening of the nozzle. Furthermore, the larger surface area created by positioning a stepped shape between the nozzle and the glass allows for better bonding and sealing. Another advantage of the exemplary embodiment is that during processes in the process vessel that are carried out at lower pressure, such as the external pressure of the ambient air, the glass of the measuring window 5 is pressed against the bottom of the nozzle 1. This allows the resulting force to be better transmitted to the stepped mount.

[0063] The embodiment shown in Figure 1c shown differs from that shown in Figure 1ashown embodiment by the possibility of coupling a sensor in the region of the sensor opening of the nozzle 1. In this embodiment, a coupling plug is formed in the region of the sensor opening of the nozzle 1. This coupling plug has a recess running in the circumferential direction. This recess makes it possible to place a socket on the plug, which engages in this recess to enable a connection between the fastening element 14 and the sensor fastened to the socket. To fix the nozzle 1 to the connection element 6 of the process container, the fixing element 2 is designed according to the Figure 3c and has five locking arms separated by slots.

[0064] The Figure 1d The embodiment shown differs from the one in Figure 1ashown embodiment by the design of the connection element of the process container. In contrast to the truncated cone-shaped design of the upper region 4 of the tubular piece of the connection element 6 designed as a flange, the embodiment in Figure 1d a cylindrical area with a groove-shaped recess along its circumference. This groove-shaped recess allows for a consistent deflection area within the groove.

[0065] The Figure 2a The embodiment of a fastening element shown differs from the ones shown in Figure 1 shown embodiments of the fastening element by the design of the fixing element 2. In Figure 2aThe securing element 3 is shown in the insertion position E. In this embodiment, the securing element 3, which is ring-shaped, is movably arranged on the fixing element 2. However, the securing element 3 is prevented from being separated from the fixing element 2 by a bulge in the fixing element 2. The bulge thus forms a stop for the securing element 3 in order to prevent displacement of the securing element 3 according to Figure 2 to prevent upwards.

[0066] The fixing element 2 forms a bearing for the securing element 3 in the securing position S. Furthermore, the securing element 3 is prevented in the insertion position E from independently reaching the securing position S, since the fixing element 2 has a truncated cone-shaped area that inhibits independent movement of the securing element 3 in the direction of the securing position 3.

[0067] In this embodiment, the fixing element 2 has five grid arms separated by slots. Figure 2a The fixing element 2 is fixed to the connecting element 6 of the process vessel, but not yet in a secured state. In order to fix and secure the fastening element 14 via the fixing element 2 and the annular securing element 3 to the end element 6 of the process vessel, the securing element 3 is displaced toward the nozzle base. The movable locking arms are bent into the deflection area between the fixing element 3 and the connecting element 6. The material of the fixing element 2 thus displaced in the frustoconical area enables the securing element 3 to reach the securing position S.

[0068] In Figure 2bthe securing element 3 is shown in the securing position S of the fastening element. When the securing position S is reached, the flexible locking arms spring out and are secured by the positive locking area between the fixing element 2 and the securing element 3. Furthermore, the spring force generated by the locking arms improves the positive locking connection to the securing element 3 and the fixing element 2. The fixing element 2 has a further bulge on the side opposite the insertion position E. This further bulge comes into play when the fixing element 2 is not yet placed on the nozzle 1 or the connection element 6 of the process container and is intended to prevent the securing element 3 from being separated from the fixing element 2 due to the flexible locking arms.

[0069] The partial images of the Figure 3 the Figures 3a to 3cshow different embodiments of the fixing element 2, these differ in the arrangement or the division and number of the locking arms 7 of the fixing element 2. The Figure 3a The fastening element 2 shown has a circular opening which is smaller on the top side than on the bottom. Furthermore, the fastening element 2 has an area between the top and bottom sides which has a larger inner diameter than the opening size of the openings on the top and bottom sides. The fastening element 2 is divided by two axially running slots. These slots run from the bottom side of the fastening element 2 to the top side of the fastening element 2, whereby the slots are not continuous but end at a distance from the top side of the fastening element 2. In this exemplary embodiment, the locking arms 7 of the fastening element 2 are formed. In this exemplary embodiment, two locking arms 7a / 7b are formed by the two slots.

[0070] In part 3b a fixing element 2 is shown, which is connected to the Figure 3a shown fixing element 2 in that this fixing element 2 has three slots and thus has three formed locking arms 7a / 7b / 7c.

[0071] Partial Figure 3c shows an embodiment of a fixing element 2 which forms five locking arms 7a-7e via five slots.

[0072] Partial Figure 3d shows an embodiment of a securing element 2 having locking arms 7a / 7b separated by two slots. In this embodiment, the locking arms 7a / 7b are curved. The curved locking arms extend outward, so that the locking arms 7a / 7b are spread apart. The locking arms thus form a slotted, truncated cone-shaped body, with the side of the truncated cone with the larger radius facing the bottom of the socket 1.

[0073] In Figure 4a an embodiment of a fastening element is shown which is arranged on a connection element 6 of an embodiment of a process container 8 according to the invention. In this embodiment, the process container 8 is a disposable bioreactor. In this disposable bioreactor, cell cultures for the pharmaceutical industry are produced. The fastening element 14, in particular the nozzle 1 of the fastening element 14 and the measuring window 5 of the nozzle 1 protrude into the disposable bioreactor. In this case, the bioreactor 8 is filled with a cell culture medium 9. The measuring window 5 is in direct contact with this cell culture medium 9. In this embodiment, the nozzle 1 has a coupling plug. The fastening element 14 is secured by the securing element 3 and fixed to the connection element 6 of the bioreactor 8 by the fixing element 2.

[0074] In Figure 4Bis the fastening element 14 which is in Figure 4a The sensor 10 is shown coupled to the sensor via a coupling socket, which is arranged on the sensor 10. In this exemplary embodiment, the sensor 10 is rod-shaped and has a measuring window 11 on its underside. The rod-shaped sensor 10 is arranged within the cylindrical interior of the nozzle 1, so that the measuring window 11 of the sensor and the measuring window 5 of the nozzle 1 are in contact. The coupling socket attached to the sensor 10 is coupled to the coupling plug of the fixing element 2, in particular the coupling plug of the nozzle 1, via a ball lock.

[0075] In this embodiment, the sensor 10 is designed to perform a turbidity measurement in the cell culture medium 9 located in the disposable bioreactor 8. For this purpose, the sensor 10 has a light source 12 that emits a signal in the infrared wavelength range (schematically represented by an arrow). This signal passes through the interior of the sensor 10 and penetrates the measuring window 11 of the sensor as well as the measuring window 5 of the nozzle 1, radiating into the interior of the bioreactor 8. Part of the emitted infrared light signal is reflected by the cells located in the cell culture medium 9 and returned toward the measuring window 5 of the nozzle 1. The returned signal passes through the measuring window 5 of the nozzle 1 and the measuring window 11 of the sensor, and through an interior of the sensor, to the receiver 13 of the sensor 10.The turbidity of the cell culture medium 9 located in the bioreactor can be used to determine the concentration of cells in the medium 9. The detachable connection of the coupling socket with the coupling plug allows the sensor to be easily removed from the fastening element 14 after the measurement.

Claims

1. Fastening element for arrangement on a connecting element (6) of a process container (8), in particular a reactor, preferably a bioreactor, most preferably a single-use bioreactor, wherein the fastening element has a nozzle (1) and a fixing element (2), wherein the nozzle (1) has a sensor opening for inserting a sensor into the nozzle (1) and a measuring window (5) on a side opposite the sensor opening, and wherein the fixing element (2) is designed to arrange the nozzle (1) on the connecting element (6) of the process container (8), characterized in that the fixing element (2) has at least one latching arm (7) with a movable latching region in order to form a latching connection with the connecting element (6) of the process container (8), and the fixing element (2) has at least one securing element (3) arranged displaceably on the fixing element (2), wherein the securing element (3) and the fixing element (2) are designed to interact in such a way that, when the securing element (3) is in an insertion position (E), the latching region of the at least one latching arm (7) is movable and, when the securing element (3) is in a securing position (S), a movement of the latching region of the at least one latching arm (7) is prevented by the securing element (3).

2. Fastening element according to claim 1, characterized in that the fastening element (2) has a preferably cylindrical base body which is divided into at least two latching arms (7) by preferably axially extending slots.

3. Fastening element (14) according to claim 1 and 2, characterized in that the securing element (3) is annular in shape and in the securing position encloses the fixing element at least in the latching region.

4. Fastening element (14) according to claim 1, claim 2 and claim 3, characterized in that the securing element (3) and the fixing element (2) are designed to interact in such a way that the securing element (3) and the fixing element (2) form a positively engaging latching connection in the securing position (S).

5. Fastening element (14) according to claim 1, characterized in that the measuring window (5) is arranged hermetically sealed against the nozzle (1), in particular via a socket located inside the nozzle (1), preferably a stepped socket.

6. Fastening element (14) according to claim 1, characterized in that the material of the nozzle (1) is biocompatible, in particular made of polyethylene (PE), preferably of polyaryletherketone (PAEK), particularly preferably of polyethylene terephthalate (PET) or of polypropylene (PP), of polyamide (PA), in particular of polyetheretherketone (PEEK), preferably of polyphenylene sulfone (PPSU).

7. Fastening element (14) according to claim 1, characterized in that a coupling, preferably a coupling plug, in particular a quick-release coupling plug for arranging a sensor (10), is designed in a region of the sensor opening of the nozzle (1).

8. Fastening element (14) according to claim 1, characterized in that the material of the measuring window (5) is transparent, preferably made of glass, in particular of glass-ceramic, most preferably of sapphire glass.

9. Fastening element (14) according to claim 1, characterized in that the securing element (2) can be releasably locked in the insertion position (E), in particular can be releasably locked and is axially mounted on one side in the insertion position (E).

10. Process container (8), in particular for cultivating cell cultures or microorganisms in a medium (9), with at least one connecting element (6) with an arranged fastening element (14) according to any one of the preceding claims, wherein the connecting element (6) of the process container (8) is sealed in a fluid-tight manner by the arrangement of the fastening element (14) on the connecting element (8), in particular in such a way that the measuring window (5) adjoins an interior space of the process container (8).

11. Process container (8) according to claim 10, characterized in that the connecting element (6) is formed by a flange with a moulded-on adapter (4), preferably with a moulded-on hose adapter (4), in particular with a moulded-on tubular adapter (4), particularly preferably with a moulded-on tubular adapter (4) which has a circular cylindrical inner side and has a frustoconical region on the outside, most preferably with a moulded-on tubular adapter (4) which has a circular cylindrical inner side and has multiple axial regions with differing outer diameters on the outside.

12. Process container (8) according to any one of claims 10 to 11, characterized in that the material of the connecting element (6) is biocompatible, in particular made of polyethylene (PE), preferably of polyaryletherketone (PAEK), particularly preferably of polyethylene terephthalate (PET) or of polypropylene (PP), of polyamide (PA), in particular of polyetheretherketone (PEEK), preferably of polyphenylene sulfone (PPSU).

13. Process container (8) according to any one of claims 10 to 12, characterized in that the fixing element (2) and the at least one connecting element (6) of the bioreactor are arranged concentrically, in particular in that the fixing element (2), securing element (3) and connecting element (6) are arranged concentrically.

14. Process container (8) according to any one of claims 10 to 13, characterized in that between the fixing element (2) and the connecting element (6), a deviation region is designed into which the movable latching region of the at least one latching arm (7) can deviate until the securing position (S) of the securing element (3) is reached, in particular by bending the latching arm (7).

15. Process container (8) according to any one of claims 10 to 14, characterized in that a sensor (10) is arranged in the nozzle (1) of the fastening element (14) and the sensor (10) is designed as an optoelectronic sensor (10), in particular designed as a turbidity sensor.

16. Process container according to claim 15, characterized in that the fastening element (14) is designed according to claim 2 and the sensor (10) is arranged on the fastening element (14) by means of the coupling of the nozzle (1), in particular via a coupling socket of the sensor (10), preferably a quick-release coupling socket of the sensor (10).