Overpressure protection

Abstract

Device (10) for storing and / or processing at least one medium (11), in particular a bioprocessing device, comprising - at least one disposable container (1) designed to at least partially accommodate the at least one medium (11); and - at least one overpressure safety device (5) which is fluidically connected to the at least one disposable container (1), wherein the at least one overpressure safety device (5) is designed, when triggered, to at least partially - to lead into a device area (3a') upstream of the overpressure protection device (5) with respect to a flow direction (F), and / or - into at least one disposable container (1); and / or - into at least one further second container (1a), characterized in that the overpressure protection device (5) is designed to be triggered by an electrical signal, wherein the electrical signal is sent from at least one sensor to the overpressure protection device (5) and / or wherein the electrical signal is sent from a first triggered overpressure protection device (5) to a second overpressure protection device (5).

Description

[0001] The application relates to a method, a device comprising a disposable container and an overpressure protection device, as well as a system equipped with the device for storing and / or processing and / or processing and / or conditioning at least one medium, as well as for at least partially collecting the at least one medium when the overpressure protection device is triggered.

[0002] A disposable container can, in particular, be a single-use bag. A disposable container is essentially a container that is generally disposed of after its use, in particular after a single use. In special cases, a disposable container can also be designed for multiple use, in particular two, three, or four times, but it is not designed for permanent use. A disposable container can, for example, be made of a plastic, in particular a deformable synthetic material. In particular, the aforementioned disposable containers are designed or suitable for use as components of bioprocess plants. The use of such disposable containers in bioprocess engineering is particularly advantageous over conventional stainless steel containers in terms of cost and flexibility.

[0003] Furthermore, a disposable container, and a disposable system in general, is preferably essentially easy to sterilize. In particular, a disposable container is already sterilized prior to use, so the user does not need to take any steps in this regard. This allows the user to reduce the risk of contamination with hazardous substances, particularly due to single use and subsequent disposal, as cleaning and / or reprocessing of the disposable container, which carries a risk of contamination, can be avoided.

[0004] However, a decisive factor when weighing up the use of a disposable container versus a steel container is the safety of the processes. In the event of overpressure, a disposable container can comparatively easily break and / or crack and / or leak in the container, particularly in its container wall. This can lead to leakage from the container, a loss of medium, and contamination of the environment by the medium and / or of the medium by the environment. Contamination can therefore refer, on the one hand, to the environment, which can be contaminated with the leaked and / or escaped medium. In particular, the medium can be and / or contain a biologically hazardous substance, the uncontrolled release of which into the environment could expose users to hazardous substances.On the other hand, contamination can also refer to the leaked and / or escaped medium, which can be contaminated by substances in the environment.

[0005] When a medium, in particular a fluid medium such as a gas and / or a liquid and / or a granulate and / or a powder, is fed into and / or filled into a system and / or container, increasing pressure can arise, particularly if the filling is not properly regulated and / or the system and / or container is not appropriately vented. The pressure of the medium can cause the container to exceed the maximum pressure or burst pressure of the device and / or container and / or system. The maximum pressure or burst pressure is the pressure above which a section of the system and / or device and / or container, for example, develops a leak and at least part of the medium can escape from the system and / or device and / or container.

[0006] So-called overpressurization and / or an uncontrolled exceeding of a maximum or maximum permissible pressure and / or a burst pressure can, for example, be causally preceded by malfunctions of a primary vent filter. Overpressurization can be triggered, for example, by a blockage with condensate, by the primary vent filter becoming jammed or closed, by an incorrectly entered value and / or a faulty regulator and / or by a closed valve and / or hose clamp or otherwise blocked hose line. Furthermore, a pump speed may be set too high and / or some other inputs relating to proper regulation, monitoring and / or venting may be incorrectly set, resulting in an uncontrolled increase in pressure.Uncontrolled overpressure can cause leaks in the hose material used, in connectors, and / or in or on components of the device, or even cause them to burst. Sensors built into the device can also be compromised and, in particular, destroyed.

[0007] Typically, in single-use systems (SU systems) and / or single-use containers, the pressure is monitored and / or controlled using pressure sensors and control units. The pressure is therefore indirectly controlled. A malfunction of a control unit and / or incorrect installation and / or malfunction of the pressure sensor designed to measure and monitor the operating pressure can result in malfunctions. Furthermore, an incorrect signal can be transmitted to the control system, which can also lead to an uncontrolled exceedance of the maximum permissible operating pressure.

[0008] The maximum permissible pressure of a device and / or a container and / or a system, which in the scope of this application is also called bursting pressure, corresponds to the value of the pressure which a device can withstand without overpressure protection and above which the device bursts and / or bursts and / or breaks at least partially or at least in one section and / or a leak develops.

[0009] The trigger pressure of an overpressure protection device is the maximum pressure that the overpressure protection device can withstand, and above which the overpressure protection device is triggered or triggered. The trigger pressure is preferably substantially lower than the maximum permissible pressure at the location where the overpressure protection device is located and / or installed and / or integrated into the device. However, the trigger pressure should not be significantly lower than the maximum permissible pressure.

[0010] US 2016 / 0298810 A1 discloses a disposable container for preventing overpressure. The disposable container has a housing for a fluid and an overpressure relief device fluidly connected to the housing. The overpressure relief device is configured to relieve pressure from the enclosure when the pressure of the fluid in the enclosure exceeds a specified relief pressure. The specified relief pressure is set to be lower than the burst pressure of the housing. The overpressure relief device is connectable to a controlled path for controlled release of the fluid from the housing.

[0011] CN 201 306 795 Y discloses a voltage regulation and expansion water refill device that is part of the auxiliary equipment of a district heating system, in particular the hydraulic pressure adjustment device of the heating system. The device comprises a voltage-regulating water tank.

[0012] The present invention is accordingly based on the object of providing a device with a disposable container for at least partial storage and / or processing of at least one medium with improved safety.

[0013] This object is achieved by the independent claims. The subject matter of the dependent claims represents preferred embodiments.

[0014] The invention relates to a device for storing and / or processing and / or processing and / or conditioning at least one medium, in particular a bioprocessing device, comprising - at least one disposable container, in particular a disposable bag of a bioreactor, which is designed to at least partially accommodate the at least one medium and whose volume is preferably designed to at least partially store and / or process the at least one medium; and - at least one overpressure protection device, which is fluidically connected to the at least one disposable container, wherein the at least one overpressure protection device is designed, upon triggering, to at least partially or at least a part of at least one of the at least one medium - into a device area upstream of the overpressure protection device with respect to a flow direction, in particular into the at least one disposable container; and / or - into at least one other second container, wherein the overpressure protection device is designed to be triggered by an electrical signal, wherein the electrical signal is sent from at least one sensor to the overpressure protection device and / or wherein the electrical signal is sent from a first triggered overpressure protection device to a second overpressure protection device.

[0015] The flow direction refers in particular to a flow and / or material flow of at least a part of the at least one medium and can preferably be generated by a pressure-generating means.

[0016] In other words, a device comprises one or more disposable containers and one or more overpressure protection devices. The at least one disposable container is fluidically connected to the at least one overpressure protection device. For example, the disposable container and the overpressure protection device can be components of a single closed, in particular hermetically sealed (or fluidically separated from an environment) system. The two spatial areas in which both components are located can then communicate with each other in terms of pressure and / or fluidly. For example, a pressure between the two spatial areas can be equalized. The overpressure protection device can be triggered, in particular, by exceeding a specific (predetermined or predeterminable) trigger pressure.This means that the pressure in the device and in particular directly at the overpressure protection device exceeds a pressure which is greater than the specific trigger pressure, namely the maximum possible pressure which an overpressure protection device can withstand. After the overpressure protection device has been triggered, at least a portion of the at least one medium, in particular the portion of the at least one medium which passes through the triggered overpressure protection device, is drained away and / or returned to a collecting container and / or to a device region upstream of the overpressure protection device with respect to a flow direction, in particular to the at least one disposable container. A device region upstream of the overpressure protection device with respect to a flow direction can, for example, be part of a line through which the at least one medium passes or can pass before it passes through the triggered overpressure protection device.In particular, the triggered overpressure relief device forms one or more openings and / or the triggered overpressure relief device becomes permeable to at least a portion of the at least one medium. In other words, a rupture disc, also known as a disposable membrane, can burst and form an opening and / or a membrane can become permeable if a trigger pressure is exceeded.

[0017] However, the disposable container and the overpressure protection device do not necessarily have to form a closed system. They can also form an essentially open system that is at least partially open to the environment. Furthermore, a permanent and continuous open connection between two spatial areas, each containing the disposable container and the overpressure protection device and capable of communicating with each other regarding pressure, is not absolutely necessary under all circumstances. The spatial areas can also be temporarily shielded or separated from each other by a barrier, such as a clogged filter and / or a pump.

[0018] In particular, the device can comprise one, two, three, four, five, or more disposable containers. The device can further comprise one, two, three, four, five, six, or more overpressure safety devices. A device can further have or comprise one, two, three, four, five, six, or more discharge lines and / or one, two, three, four, five, six, or more bypass lines and / or be or become connected to the respective discharge lines and / or bypass lines. The discharge lines and / or bypass lines can each be or become fluidically connected to one or more other regions of the device by means of one and the same or by means of several overpressure safety devices. The flow direction orThe essential flow direction of at least a portion of the at least one medium in at least one part and / or section of the device can be brought about, for example, by a pressure-generating means, in particular a pump and / or a heat source, and / or a mechanical press and / or a gradient, as well as a weight force of at least a portion of the medium. The term "pressure-generating means" also explicitly refers to the inherent weight force of at least a portion of the at least one medium. Accordingly, one pressure-generating means can comprise multiple pressure-generating means.

[0019] The described device can prevent the uncontrolled escape of material in single-use process solutions and / or devices with at least one disposable container, for example, when an excess pressure is generated by a pressure-generating medium, which in extreme cases causes or could cause leaks and / or ruptures. Thus, a loss of at least part of the medium can be prevented.

[0020] It is also possible to prevent a pressure within at least one section of the device from increasing any further when a specific (predetermined or predeterminable) trigger pressure and / or a maximum permissible pressure is exceeded, since at least a portion of the at least one medium is essentially led away and / or back into a collecting container and / or the disposable container in a controlled manner. Furthermore, in particular a gas can be provided with an increased volume after the triggering of an overpressure protection device, which allows the gas to expand in order to thus reduce the pressure or at least limit it to a predetermined value. The aforementioned process, in particular the triggering and opening of the overpressure protection device, preferably takes place directly, in particular mechanically, i.e. essentially without control by signals and / or transmission of signals, for example electrical signals.The overpressure protection device accordingly represents at least one predetermined breaking point which, starting at a trigger pressure or when a trigger pressure is exceeded, forms an opening for the controlled escape of at least part of the medium. The overpressure protection device can, for example, be selected according to a specific trigger pressure. Additionally or alternatively, the overpressure protection device can be set to a desired trigger pressure or selected according to a desired trigger pressure. The desired trigger pressure corresponds to the pressure in the device above which, in particular the pressure in the disposable container should at least no longer increase and the overpressure protection device should be triggered. For example, the specific trigger pressure of the overpressure protection device and / or the maximum permissible pressure of the device can be adjustable and can preferably be adjusted by the user as required.

[0021] Furthermore, contamination of the medium by substances in the environment and / or contamination of the environment by substances in the medium can be prevented by means of the described device. For example, it is possible to prevent a substance of the at least one medium, for example a cell culture medium, from escaping from the device in an uncontrolled manner and consequently becoming contaminated by substances in the environment. This is particularly the case if the device forms a sterile and closed system and at least a portion of the at least one medium is essentially returned within the closed system, for example, to the disposable container and / or directed into a collecting container.

[0022] Furthermore, the device described is particularly advantageous when the application risk is increased, for example when toxic, infectious and / or aggressive substances and / or hazardous substances are contained in the at least one medium and are to be processed.

[0023] Furthermore, the described device can advantageously prevent the loss of high-quality and / or rare and / or valuable substances that may be contained in the at least one medium within the device in the event of excess pressure and the imminent risk of a component of the device potentially bursting and / or breaking and / or rupturing. In particular, the pharmaceutical industry has a strong interest in risk minimization during processing, as active pharmaceutical ingredients can often be of considerable value.

[0024] In general, an escaping liquid can be fed under pressure into a container, in particular into a storage vessel, so that a process fluid used does not have to be discarded but can be further processed.

[0025] The device can therefore achieve greater process reliability. In addition to conventional control technology, such as process monitoring and process assurance, e.g., including disposable pressure sensors, the device can further optimize or at least improve safety during the processing and / or storage of hazardous and / or harmful and / or sensitive and / or valuable materials.

[0026] A further advantage may be that, in some cases, the installation of pressure sensors can be dispensed with entirely, thus providing a simplified and / or cost-reduced device. Furthermore, the potentially complex maintenance of such pressure sensors can be eliminated, which can lead to further simplification and cost reduction. In particular, the operation of the device by the user can prove to be uncomplicated and simplified.

[0027] According to one aspect, the at least one overpressure protection device is integrated directly into a container wall of the at least one disposable container, in particular the overpressure protection device essentially closes with a form fit with the container wall.

[0028] A particularly simple and advantageous handling is achieved when the overpressure protection device is integrated into a section of the wall of the disposable container that is as flat as possible, so that, for example, no substantially protruding parts can interfere with or be damaged during transport and / or use.

[0029] It can also prevent users from having to assemble the components of the overpressure relief device and the disposable container prior to use if these components are already connected during production by the manufacturer. This can be particularly the case if a rupture disc is integrated, particularly in a form-fitting manner, into the container wall.

[0030] According to one aspect, the at least one overpressure protection device comprises a one-way overpressure protection device, in particular a mechanical one-way overpressure protection device, which is preferably formed at least partially from a stainless steel and / or a plastic.

[0031] All the advantages of using disposable components apply when a disposable pressure relief device is used for single use. The term "single use" in the case of a disposable pressure relief device refers to one-time activation. After one-time activation, the disposable pressure relief device can be disposed of. If the disposable pressure relief device is essentially permanently installed with and / or integrated into a disposable device and / or a disposable container, the term "single use" can also refer to the one-time use of the disposable device and / or the disposable container without the need to activate the disposable pressure relief device. For example, if all parts are designed for single use, the entire device can be disposed of as a whole after its single use.In this case, contamination during complete or partial reprocessing and / or cleaning of the device can be avoided. Furthermore, the use of disposable components proves particularly convenient. If the device is primarily made of relatively inexpensive materials, disposal after a single use can also prove to be more cost-effective than multiple uses with reprocessing and cleaning.

[0032] According to one aspect, the at least one overpressure protection device comprises at least one of the following, but is not limited to: a rupture disc, an overflow valve, a safety valve, a diaphragm, and in particular an electrical and / or mechanical force limiter of a pump.

[0033] The above-mentioned overpressure protection devices, in particular a rupture disc, an overflow valve, a safety valve, a pinch valve and / or a diaphragm, have proven to be particularly simple, easily sterilizable and relatively inexpensive components. The use and / or provision of these overpressure protection devices requires no action and / or no essential knowledge on the part of the user. The respective technology on which the implementation of a rupture disc, an overflow valve, a safety valve, a diaphragm and a pinch valve is based is simple and reliable. In particular, a pressure in at least one section of the device can be directly limited to a predetermined value by the above-mentioned overpressure protection devices. The triggering of the respective overpressure protection devices occurs essentially mechanically and in particular completely mechanically. “Mechanical” means in particular that only the pressure which reaches a maximum value orexceeds a specific (predetermined or predeterminable) trigger pressure, it is sufficient to trigger the overpressure protection device. Accordingly, a signal, such as an electrical and / or optical or similar signal, does not necessarily have to be sent from a sensor to the overpressure protection device in order to trigger it. This embodiment therefore advantageously represents a further device with increased safety.

[0034] According to one aspect, the device further comprises at least one discharge line designed to direct the at least one medium at least partially into the at least one disposable container and / or into at least one second container upon triggering of the at least one overpressure protection device. Preferably, the discharge line is integrated and / or attached in or on the overpressure protection device, particularly when the overpressure protection device is already integrated and / or attached in or on the container wall. Optionally, the discharge line can be formed integrally with the overpressure protection device. The discharge line can also be formed integrally with the overpressure protection device and the container wall of the disposable container.

[0035] The drain allows the user to drain, in a defined manner, any medium that overflows or escapes due to a triggered overpressure protection device. For example, the affected component of the at least one medium can be drained and / or diverted into another container. In the case where the aforementioned components are formed integrally with one another, a particular advantage is that contact points between the components can be avoided. Such contact points could be leaky or become leaky, which could lead to contamination from the outside or inside of the device. Therefore, this embodiment represents a further device with increased safety.

[0036] Furthermore, it's particularly easy and convenient for the user, as they may require no or fewer assembly steps. Furthermore, assembly can be eliminated during production, making manufacturing more efficient and therefore more cost-effective.

[0037] According to one aspect, the at least one overpressure safety device is triggered by an electrical signal from at least one sensor. In one embodiment, one overpressure safety device can be triggered purely mechanically, whereas another overpressure safety device can be triggered by an electrical signal. In addition, an overpressure safety device that can be triggered mechanically can also be triggered electrically.

[0038] In other words, an overpressure protection device can be triggered directly by exceeding a trigger pressure or by an electrical signal, for example from a pressure and / or temperature sensor. A pressure and / or temperature sensor can send an electrical signal to the overpressure protection device and trigger its triggering. Additionally or alternatively, a second overpressure protection device can be triggered by an electrical signal from a first overpressure protection device when the first overpressure protection device is triggered. Or the second overpressure protection device is triggered entirely by an electrical signal, while the first overpressure protection device is triggered mechanically and / or electrically. In addition to a first and a second overpressure protection device, further overpressure protection devices can be provided, which can be triggered in all conceivable variations.

[0039] If an overpressure protection device has been faultily manufactured and, for example, cannot be triggered by the predetermined trigger pressure, or if a "false" overpressure protection device is mistakenly provided which is triggered at a trigger pressure higher than the maximum permissible pressure, the overpressure protection device can also be triggered by an electrical signal, for example sent from a pressure sensor, in order to achieve a further level of safety. Additionally or optionally, the signal can also be sent to the overpressure protection device from a temperature and / or a gas and / or an optical sensor. For example, if a predetermined orpredeterminable maximum temperature of at least part of the medium, an electrical signal is sent to trigger the overpressure protection, so that a medium with an excessively high temperature is discharged and thereby essentially prevents this part of the medium with an excessively high temperature from damaging and / or impairing possibly temperature-sensitive elements of the device and / or other media therein.

[0040] If a plurality of (two, three or more) overpressure protection devices are provided, it may be advantageous that, when one overpressure protection device is triggered mechanically by exceeding a trigger pressure, the other overpressure protection devices, where the local (partial) pressure may not yet have reached and in particular exceeded the respective maximum value or pressure, are triggered electrically. In this way, further openings can be created through which at least a portion of the at least one medium, for example a fluid (in particular a gas), can expand and escape in a controlled manner and / or be discharged and / or collected in a controlled manner. In this case, it can be prevented in advance that pressure increases in various sections of a device after the respective overpressure protection devices have been triggered. In this way, the safety of the device can be further improved.This embodiment therefore represents a further device with increased safety.

[0041] According to one aspect, an overpressure protection device can send a signal to another component of the device when triggered. In particular, an overpressure protection device can send an electrical signal to a pump when triggered, causing the pump to shut down. Alternatively or additionally, an overpressure protection device can send a signal to at least one other safety unit when triggered, causing it to shut down or trigger a function. For example, the main fuse of a power supply can receive a signal from an overpressure protection device when triggered, causing the main fuse to shut down the power supply.

[0042] Feedback between an overpressure protection device and another element, for example, another safety device and / or a motor and / or a pump, has the advantage that at least parts of the system can be completely shut down in a hazardous situation once an overpressure protection device has been triggered. This can prevent further portions of the at least one medium from being discharged and / or escaping through the opened overpressure protection device, possibly causing a collecting container to overflow. In particular, it can prevent a further increase in pressure in other sections of the device. This embodiment therefore also represents a further device with increased safety.

[0043] The invention further relates to a system comprising: - at least one disposable container designed to at least partially contain the at least one medium; - at least one overpressure protection device which is fluidly connected to the at least one disposable container; - a main line for fluidically connecting the at least one disposable container to a target container; and - at least one discharge line designed to direct the at least one medium at least partially into at least one further container when the at least one overpressure protection device is triggered; and / or - a bypass line which is designed, when the at least one overpressure protection device is triggered, to guide the at least one medium at least partially back into the device region upstream of the overpressure protection device with respect to a flow direction, in particular a section of the main line and / or into the at least one disposable container, wherein the at least one overpressure protection device is arranged on the discharge line and / or the bypass line and, when the at least one overpressure protection device is triggered, the discharge line and / or the bypass line is fluidically connected to the main line.

[0044] In other words, it is a system comprising one of the aforementioned devices, in particular according to a preferred embodiment, wherein the system further comprises: - a main line for fluidically connecting the at least one disposable container with an additional third container, which corresponds to a target container or which is a target container; and - at least one discharge line designed to direct the at least one medium at least partially into the at least one additional second container when the at least one overpressure protection device is triggered; and / or - a bypass line which is designed, when the at least one overpressure protection device is triggered, to guide the at least one medium at least partially back into the device region upstream of the overpressure protection device with respect to a flow direction, in particular a section of the main line and / or into the at least one disposable container, wherein the at least one overpressure protection device is arranged on the discharge line and / or the bypass line and, when the at least one overpressure protection device is triggered, the discharge line and / or the bypass line is fluidically connected to the main line.

[0045] In particular, parts of the system or volumes of the system, in particular containers and / or lines and / or discharge lines and / or bypass lines, form physical communicating tubes after the triggering of an overpressure protection device, which can exchange a fluid and a pressure, provided that a fluidic connection exists between the corresponding parts or sections.

[0046] In addition to the advantages of the embodiments of a device, the described system has further advantages, both as a whole and in its individual components. The provision of a main line allows the user to spatially separate a portion of the medium that has undergone a process and / or operation from the portion of the medium that is yet to undergo this process and / or operation.

[0047] Providing a discharge line and / or a bypass line has the advantage that a medium that passes through an overpressure protection device after it has been triggered can be discharged in a defined and controlled manner and / or returned to an area upstream of the overpressure protection device in terms of flow direction. A defined and / or controlled discharge or return of at least a portion of the medium consists in the path the medium takes between the overpressure protection device and the target volume. For example, the medium can be conducted at least partially through a hose and / or a pipe. Furthermore, it can be defined and / or controlled whether the subsystem into and / or through which at least a portion of the medium is conducted should represent a substantially closed or substantially open system. Furthermore, all physical parameters, such as volume, pressure, temperature, etc., can be defined and / or controlled.

[0048] Providing a drain and / or a bypass line can have the advantage that a suitable target volume can be selected as needed. For example, the target volume for a portion of the medium drained via a drain can be in a collecting container. The target volume for a portion of the medium returned via a bypass line can be in the area upstream of the overpressure protection device with respect to a flow direction, in particular in the disposable container.

[0049] According to one aspect, the system comprises the further third container, which is designed to at least partially accommodate the at least one medium and which is preferably a disposable container.

[0050] One advantage of providing an additional container in addition to the disposable container and, if applicable, a collection container is that a medium that is at least partially located in the disposable container can be transferred to the additional container if, for example, a chemical and / or biological process has taken place in the disposable container. For example, the medium can pass through a filter on its way to the additional container, where it is at least partially purified and / or filtered before it reaches the additional container. In this way, a portion of the medium that has undergone a process and / or operation can be spatially separated from the portion of the medium that is still to undergo this process and / or operation.

[0051] Providing an additional disposable container has the advantage of allowing another component of the system to be disposed of after a single use. The advantages of providing disposable containers have already been discussed.

[0052] According to one aspect, the system comprises at least one pressure-generating means, in particular a pump, wherein the at least one pressure-generating means is designed to pump at least a portion of the at least one medium from the at least one disposable container into the third container along the flow direction.

[0053] Providing a pressure-generating means allows the user to transport at least a portion of the at least one medium to another area of ​​the system and / or device, for example, into another container, via a main line. In particular, the pressure-generating means can generate a material flow or a stream of a portion of the at least one medium and / or a pressure gradient.

[0054] A pressure-generating means can, in particular, be at least one pump. The at least one pump can, in particular, comprise a hose pump, diaphragm pump, centrifugal pump, and / or a peristaltic pump. Any other known pump for generating a pressure gradient and / or a material flow or stream is also conceivable. Preferably, a pressure-generating means comprises at least one of: a single-use or one-way safety valve, optionally with a spring, a single-use check valve or one-way non-return valve, a rupture disc with an "internal loop" or at least partially integrated bypass and / or discharge, a rupture disc with an "external loop" or non-integrated external bypass and / or discharge.

[0055] A similar pressure-generating means may also be a mechanical press or piston and / or other means which compress a flexible disposable container, for example by mechanical contact pressure by actuation and / or by weight.

[0056] A pressure-generating means can also comprise a gradient or an arrangement with a gradient and / or a support or technical equipment and / or device that generates a gradient with respect to the direction of gravity. For example, the disposable container at least partially filled with a medium can be fluidly connected to another container and positioned slightly elevated relative to it, so that the weight of the medium itself ensures that a pressure is created that generates a material flow or a stream of at least a portion of the medium from the disposable container to the other container.

[0057] A pressure-generating means can also comprise a heat source, which, by acting on at least a portion of the at least one medium, causes it to expand or even change its state of aggregation, for example, from a liquid to a gas. This expansion, provided the container essentially maintains its volume, generates a pressure that can also be capable of generating a material flow or a stream of at least a portion of the medium from the disposable container to the other container.

[0058] According to one aspect, the at least one pressure-generating means, in particular a pump, is arranged on the main line and designed to generate a pressure gradient along the main line.

[0059] Providing a pump on the main line has the advantage that, for example, a portion of the at least one medium can be drawn into the main line from a section of the system upstream of the pump in terms of flow direction. The portion of the at least one medium that passes through the pump can then be transported and / or pumped into a section of the system downstream of the pump, for example, through a filter into another container.

[0060] According to one aspect, the at least one pressure-generating means is arranged on the disposable container and is designed to generate a pressure gradient within the disposable container and / or along the main line.

[0061] The above-mentioned embodiment has the advantage that a disposable container can be filled under pressure and therefore the filling process can be accelerated.

[0062] According to one aspect, the discharge line and / or the bypass line, and in particular the overpressure protection device, is / are arranged downstream of the pressure-generating means and / or on a main line with respect to the flow direction. Alternatively or additionally, the at least one overpressure protection device can be arranged on a component of the device and / or system other than the disposable container and / or the main line, for example, on a third container.

[0063] The aforementioned arrangement of the discharge line and / or bypass line immediately downstream of the pressure-generating means with respect to a current or flow direction has the advantage that at least a portion of the medium can be discharged and / or returned if the overpressure protection device is triggered. This can be triggered, for example, by excessive pumping power or a blockage in a filter and / or the main line. In particular, an overpressure protection device is arranged on the discharge line and / or the bypass line.

[0064] According to one aspect, the system further comprises a feedback loop, in particular an electrical feedback loop, preferably between the overpressure safety device and the pressure-generating means, wherein the feedback loop is designed to deactivate the pressure-generating means upon triggering of the at least one overpressure safety device. In other words, said overpressure safety device preferably has a feedback loop that can send a signal, preferably an electrical signal, to the pump after triggering, wherein the signal causes the pump to deactivate and adjust the pumping power. This embodiment has the advantage of providing a particularly safe system.

[0065] According to one aspect, the discharge line and / or the bypass line and in particular the overpressure protection device is / are at least partially integrated into the pressure-generating means.

[0066] The aforementioned design has the advantage that components can be processed or integrated into one another, which can make use particularly simple. Furthermore, subsequent assembly by the user can be avoided, thus allowing for particularly convenient use.

[0067] According to one aspect, at least the disposable container and / or the overpressure safety device is / are sterilizable, in particular at least partially made of a plastic and / or stainless steel. In other words, the disposable container and / or the overpressure safety device and / or the entire device and / or the system is / are at least partially designed to be sterilized using a validated method, preferably using at least one of gamma irradiation, autoclaving, steam sterilization, and chemical sterilizing agents.

[0068] A sterilizable element has the advantage that it can come into contact with media, such as cell cultures, that should not be contaminated by biological substances. It is also advantageous if components or elements of a device, especially disposable components, are already sterilized upon sale or at the factory, so that the user does not have to take any sterilization measures before putting the device and / or system into operation.

[0069] According to one aspect, the overpressure protection device further comprises a valve for equalizing pressure conditions or for releasing or reducing pressure through material flow in a predetermined or predeterminable direction. Furthermore, the overpressure protection device can comprise a backflow prevention device for preventing backflow of a medium that has already escaped through the overpressure protection device.

[0070] According to one aspect, the overpressure protection device has a trigger pressure corresponding to a maximum pressure value that the overpressure protection device can tolerate or withstand, or the maximum pressure that the overpressure protection device can withstand, and above which the overpressure protection device is triggered. The trigger pressure is preferably set and / or selected such that it is substantially lower than the maximum permissible pressure or the burst pressure of the container and / or the device and / or the system, in particular at the location where the overpressure protection device is arranged on the device.

[0071] If the trigger pressure is lower than the maximum permissible pressure or the bursting pressure of the container, bursting, breaking, tearing, and / or damage to the container and / or device and / or system can normally be prevented. This can also prevent a portion of the medium from escaping uncontrollably from the container and / or device and / or system, allowing it to be discharged in a controlled manner.

[0072] According to one aspect, the overpressure protection device comprises at least one layer and / or one material and / or one film or layer layer, preferably with predetermined breaking points, wherein the layer and / or the material and / or the film or layer layer is / are configured such that it / they break when it / they are subjected to a pressure that exceeds the trigger pressure.

[0073] According to one aspect, the overpressure protection device consists of a section of the container wall of the disposable container, wherein the container wall at least partially comprises a film and the overpressure protection device is part of this film and has a film structure of the film layer that is weakened in at least one position or has a predetermined breaking point in order to adjust the trigger pressure or to be triggered when the trigger pressure is exceeded. Preferably, the film structure and in particular the predetermined breaking point are produced by stretching, perforation, chemical processing and / or physical processing. In particular, the overpressure protection device according to this embodiment is formed integrally with the disposable container.

[0074] There is an advantage in incorporating the overpressure protection device as part of the film, as this saves material and / or effort and / or costs. The aforementioned design enables a particularly simple and / or cost-effective solution with increased safety.

[0075] According to one aspect, the at least one overpressure protection device, in particular the rupture disc and / or the foil layer with a predetermined breaking point, is designed to break without fragmentation when it is or are triggered.

[0076] Fragment-free bursting of a pressure relief device can prevent splinters and / or fragments and / or small particles and components of the pressure relief device from entering the medium and / or the device and / or the system and / or the pump. This can avoid and / or prevent the need for subsequent processing and / or cleaning and / or removal of fragments, which can be very costly.

[0077] According to one aspect, the device further comprises at least one sensor which is designed to indicate when the overpressure protection device has been triggered and in particular the predetermined breaking point has been broken after the trigger pressure has been exceeded.

[0078] A sensor that can indicate whether the overpressure protection device has been triggered can, for example, also be designed to send a signal to another element of the device and / or system to shut down an element, such as a pump and / or a process. Therefore, this particular embodiment provides increased safety for the user.

[0079] According to one aspect, the overpressure protection device, in particular the rupture disc and / or the film layer with a predetermined breaking point, comprises at least one membrane and / or a membrane filter, wherein the membrane and / or the membrane filter is / are designed to have a trigger pressure that essentially corresponds to the maximum permissible or bursting pressure. Thus, for example, only one component of the at least one medium can escape through the overpressure protection device, while other components of the medium remain in the system and / or the device. For example, a medium can comprise a solid and a liquid, for example suspended solid particles present in a liquid. If the trigger pressure of the membrane and / or the membrane filter is exceeded, the liquid can escape and be discharged while the solid or solids remain in the system and / or the device.This is particularly advantageous if the substance that is to remain in the system and / or device is particularly sensitive, for example, to fluctuations (e.g. temperature, pressure, atmosphere, etc.).

[0080] According to one aspect, a rupture disc can be incorporated and / or arranged and / or attached to the disposable container and / or the device and / or the system by means of a Tri-Clamp connection. According to another aspect, at least one discharge line and / or at least one bypass line and / or at least one main line can comprise and / or represent a "plastic pipe" device.

[0081] Tri-Clamp connections are universally applicable and can be provided as essentially cost-effective connections.

[0082] The invention further relates to a method for at least partially collecting at least one medium in a device comprising the steps: - Providing at least one disposable container designed to at least partially contain the at least one medium; - Providing at least one overpressure protection device which is fluidically connected to the at least one disposable container and which can be triggered by an electrical signal which is sent from at least one sensor to the overpressure protection device and / or which is sent from a first overpressure protection device to a second overpressure protection device; and In case the overpressure protection is triggered: - draining the at least one medium at least partially into a further second container by means of a drain; and / or - Returning the at least one medium at least partially into a device area upstream of the overpressure protection device with respect to a flow direction, in particular into the at least one disposable container, by means of a bypass line.

[0083] Particular embodiments of the method may further comprise features of the aforementioned embodiments of a device and / or system. A method may accordingly have the aforementioned advantages of the individual features.

[0084] The invention is explained in more detail below with reference to exemplary embodiments shown in the figures. Individual features shown in the figures can be combined with other exemplary embodiments, provided they are not mutually exclusive. The same reference numerals designate the same or similar components of the embodiments. They show: Fig. 1 is a schematic side view of a cross-section of a device comprising a disposable container, an overpressure protection device and a drain according to one embodiment; Fig. 2 a schematic side view of a cross section of a device comprising a disposable container, an overpressure protection device and a drain according to another embodiment; Fig. 3 is a schematic side view of a system with a device comprising a disposable container, a pump, an overpressure protection device and a bypass line according to one embodiment; Fig. 4 a schematic side view of a system with a device comprising a disposable container, a pump, an overpressure protection device and a bypass line according to another embodiment; Fig. 5 is a schematic side view of a system with a device comprising a disposable container, a pressure-generating means, an overpressure safety device and a bypass line according to another embodiment; Fig. 6 is a schematic side view of a system with a device comprising a disposable container, a pump, an overpressure protection device and a drain according to one embodiment; Fig. 7 is a schematic side view of a system with a device comprising a disposable container, a pump, an overpressure protection device integrated into the pump, and a bypass line integrated into the pump according to one embodiment; Fig. 8 is a schematic side view of a system with a device comprising a disposable container, a pump, an overpressure protection device integrated into the pump, and a bypass line according to one embodiment; Fig. 9 a rupture disc in an open state after its activation and a rupture disc in a closed state before its activation according to an embodiment; Fig. 10 a check valve according to an embodiment.

[0085] The Fig. 1 shows a device 10 according to an embodiment comprising at least one disposable container 1 with a volume V and at least one overpressure safety device 5. The overpressure safety device 5 is arranged on the container wall 12 of the disposable container 1 and in particular is integrated therein. Furthermore, the disposable container 1 comprises two inlets and / or outlets 2 through which a medium can be introduced into and / or discharged from the disposable container 1. In an embodiment not shown here, a disposable container 1 comprises more than two inlets and / or outlets 2 or only one inlet and / or outlet. In other words, the disposable container 1 can be filled with the medium via the inlets and / or outlets 2 and / or can be (at least partially) emptied from them. In this case, the medium can be or comprise a fluid (in particular a liquid and / or gas) and / or a solid.

[0086] The disposable container 1 contains, in particular, at least one liquid medium 11 and a gas above it. A mean pressure P prevails in the disposable container 1, which may include partial pressures which, however, preferably do not differ greatly from one another (e.g., by no more than approximately 10%, preferably no more than approximately 1%). The disposable container 1, together with the overpressure protection device 5, forms a system 9 which is essentially closed or hermetically sealed or separated from an environment, provided the overpressure protection device 5 has not been triggered. The overpressure protection device 5 can, in particular, comprise a rupture disc and / or a membrane and / or a membrane filter. Alternatively or additionally, the overpressure protection device 5 can represent a section of the container wall 12 which has a structure, in particular a predetermined breaking point.

[0087] As soon as the pressure P in the closed system exceeds a specific (predetermined or predeterminable) trigger pressure of the overpressure relief device 5, the overpressure relief device 5 opens and / or bursts or breaks, transforming the closed system into an open system, in particular with a pressure connection to the outside. At least a portion of the at least one medium can pass through the overpressure relief device 5 and, along a line 3, which here corresponds to a discharge line 3c and comprises a pipe, into at least one target volume ZV of a further, second container 1a, in particular a collecting container. In the embodiment shown, the path taken by at least a portion of the medium 11 through the discharge line 3c to the collecting container 1a is not a closed system. Once the level of the medium within the disposable container 1 falls below the height of the lower of the two inlets and / or outlets 2, gas can also escape.

[0088] A disposable container 1 is a container configured for single use. After the disposable container 1 has been used once, it has typically fulfilled its function and can be disposed of. By way of example, a disposable container 1 is made of plastic, which may include, but is not limited to, polyamide, polycarbonate, polyethylene, polystyrene, polyethersulfone, polypropylene, polytetrafluoroethylene, polyvinyl chloride, cellulose acetate, and / or ethylvinyl acetate. In one example, the disposable container 1 may be substantially rigid, i.e., its shape cannot be modified. In another example, the disposable container 1 may have (at least partially) flexible walls or a flexible container wall 12, i.e., the disposable container 1 can change its shape without breaking.

[0089] Disposable containers 1 can be used, for example, for critical applications, particularly in the biopharmaceutical and biomanufacturing industries. The use of one of the disposable containers 1 can include, but is not limited to, the following: storage of a medium (e.g., product), mixing, and / or cell cultivation. The disposable container 1 is, in particular, a sterilizable plastic container 1 designed to receive or hold at least one liquid. It can be or comprise a bioreactor bag, a mixing container, a 2D and / or a 3D bioprocess bag.

[0090] For example, a disposable container 1 can comprise a housing or a container wall 12 with a multilayer film structure, i.e., a superposition of thin layers of plastic materials that provides a secure barrier between the contents of the disposable container 1 (e.g., biohazardous material) and the external environment. Furthermore, a disposable container 1 can, for example, be provided pre-sterilized (e.g., by gamma irradiation and / or autoclaving). A disposable container 1 can thus represent an advantageous alternative to conventional glass and / or stainless steel systems.

[0091] The disposable container 1 can at least partially comprise at least one medium 11 containing a fluid, for example, a gas, a liquid, and / or a mixture thereof, wherein the phases can be separate and / or substantially "mixed." The pressure P in the disposable container 1 acts substantially on the walls of the housing or the container wall 12 of the disposable container 1. In one example, the housing 100 can be a Biostat® Cultibag® STR bioreactor bag or a Flexsafe / Flexel mixing / storage flexboy, etc.

[0092] The overpressure protection device 5 is fluidically connected to the disposable container 1 and in particular to its container wall 12, by enabling a fluid flow or a material flow from the container wall 12 to the overpressure protection device 5. In other words, there is essentially no obstacle that is insurmountable under normal circumstances and prevents the medium from flowing from the container wall 12 to the overpressure protection device 5. In one example, the overpressure protection device 5 can be integrated directly into the container wall 12, e.g., the container wall 12 can be integrally attached and / or arranged on the container wall 12 without a mechanical connecting piece.

[0093] The overpressure protection device 5 can, for example, be positioned and / or arranged at least partially within a multi-layer structure of the container wall 12 (e.g., a flange can be embedded and / or soldered into one or more layers of the multi-layer structure).

[0094] In another example, the overpressure relief device 5 can be connected "externally," in particular by means of a connecting piece to the container wall 12. The overpressure relief device 5 can, for example, be arranged on an external additional container 1b and / or on a line, each of which can be connected to the container wall 12 by means of a connection, such as a hose connection.

[0095] Connectors and / or connections, such as lines, can preferably comprise aseptic connections, such as aseptic connectors, in particular OPTA® connectors. In one example, the overpressure protection device 5 is designed to be sterilized prior to its assembly to the disposable container 1, e.g., by means of gamma irradiation, chemical sterilization (such as vaporized hydrogen peroxide, ethylene oxide, etc.), steam sterilization, and / or autoclaving. In another example, the overpressure protection device 5 can be sterilized together with the disposable container 1, in particular its container wall 12.

[0096] The Fig. 2 shows a device 10 according to an embodiment comprising a disposable container 1 with a volume V and a line corresponding to a discharge line 3c, on which an overpressure protection device 5 is arranged. Furthermore, the disposable container 1 comprises in particular two inlets and / or outlets 2, wherein the line is arranged or can be arranged on one of the two inlets and / or outlets 2. In particular, the disposable container 1 contains at least one liquid medium 11 and a gas above it, which can be regarded as a further medium. The disposable container 1 can be regarded as a first subsystem 10a, which can be open or closed, depending on whether one or both of the inlets and / or outlets 2 is / are open or closed.The line can be considered as a second subsystem 10b, which can be open or closed, depending on whether the inlet and / or outlet 2 at which the line is arranged is open or closed.

[0097] If the inlet and / or outlet 2, at which the line is arranged, is open, the line forms a closed system with the disposable container 1, in which an average total pressure P prevails and which is indicated by a dashed line. A pressure, in particular a partial pressure P1, can prevail in the first open or closed system 10a comprising the disposable container 1. A pressure, in particular a partial pressure P2, can prevail in the second open or closed system 10b comprising the line. Normally, a fluid medium 11 can flow into the line during filling, for example through the upper inlet and / or outlet 2, where it is prevented from escaping the line by the overpressure protection device 5, provided that the pressure P in the device, in particular the pressure P1 in the line, does not exceed the trigger pressure.

[0098] A mean pressure P prevails in the disposable container 1, which may include partial pressures P1 and P2, which, provided the systems are connected to one another, preferably do not differ significantly from one another (e.g., by no more than about 10%, preferably no more than about 1%). The disposable container 1 forms a substantially closed or hermetically sealed system 9 with the overpressure protection device 5, provided the overpressure protection device 5 has not been triggered.

[0099] As soon as the pressure P, in particular the partial pressure P2 in the closed system, exceeds the specific trigger pressure of the overpressure relief device 5, the overpressure relief device 5 opens and / or bursts or breaks, so that the closed system consisting of the two subsystems 10a and 10b becomes an open system, in particular with a pressure connection to the outside. At least a portion of the at least one medium can pass through the overpressure relief device 5 and, along the line, reach a target volume ZV of a second container 1a. In this embodiment shown, the path that at least a portion of the medium 11 takes through the discharge line 3c to the collecting container 1a is also not a closed system.

[0100] The escaping medium 11 can be guided through the line into a collecting container 1a in a controlled, defined, and / or guided manner. This prevents the escaping medium 11 from being lost. Furthermore, it can be prevented that the medium enters the environment and potentially contaminates it.

[0101] A pressure P3 prevails behind the overpressure protection device 5, which, if the system is open, can be a local ambient pressure. Alternatively, the system behind the overpressure protection device 5 can also be a closed system with a controlled and / or predetermined pressure. This is particularly advantageous when the escaping medium 11 contains substances that are volatile, i.e., easily convert from a liquid to a gaseous state, and / or media and / or substances that should not come into contact with the environment. The same applies to a medium 11 that comprises a gas.

[0102] The Fig. 3 shows a system 100 according to an embodiment, which comprises a device 10. The device 10 comprises a disposable container 1 with a volume V, which is designed to at least partially accommodate at least one medium 11. The disposable container 1 has two inlets and / or outlets 2, which can each be opened and / or closed separately manually and / or automatically (e.g. by a control or regulating device not shown). In alternative embodiments, disposable containers comprise more than two or fewer than two inlets and / or outlets. Arranged at the lower inlet and / or outlet 2 is a main line 3a, which is designed to guide a material flow or a stream comprising at least part of the at least one medium 11 along a local stream or flow direction F.

[0103] The main line 3a essentially connects the disposable container 1 to a further container 1b, which is also referred to as a third container 1b if one assumes that a first container 1 corresponds to the disposable container 1 and a second container 1a corresponds to a collecting container. However, the system 100 does not necessarily have to comprise a collecting container 1a. At least a portion of the at least one medium 11 in the disposable container 1 can reach the third container 1b along the main line and the flow direction F via a pressure-generating means 4, in particular a pump. Furthermore, the at least one medium 11 at least partially passes through a filter 7, which is arranged on the main line 3a and / or forms a section of the main line 3a. The at least one medium 11 at least partially reaches the interior of the further or third container 1b through an inlet and / or outlet 2 of the further or third container 1b.The third container 1b can, in particular, also be another disposable container. Alternatively, the further or third container 1b can also be or include a reusable container.

[0104] In the disposable container 1, there is essentially an average pressure P1, which is particularly homogeneous or spatially constant. A pressure P2 prevails in the section of the main line 3a between the inlet and / or outlet 2 of the disposable container 1 and the pump 4. If the said inlet and / or outlet 2 of the disposable container 1 is open, the two pressures P1 and P2 can be essentially the same or only slightly different.

[0105] During operation of the pressure-generating means 4, in particular a pressure gradient is generated along the main line 3a, so that in the section of the main line 3a between the inlet and / or outlet 2 of the disposable container 1 and the pressure-generating means 4, a lower pressure P2 prevails than in the section “behind” the pressure-generating means 4 in the direction of the third container 1b. The pressure P3 between the pressure-generating means 4 and the filter 7 is correspondingly greater than the pressure P2 prevailing upstream of the pressure-generating means 4 with respect to the flow direction F. The pressure gradient along the main line 3a can, in particular, be essentially continuous or increase abruptly, in particular in the immediate vicinity of the pressure-generating means 4.In the case of a substantially continuous increase, the averaged pressure P3 would, for example, comprise various partial pressures, whereas in the case of a sudden increase, the pressure P3 is distributed substantially homogeneously in the region between the pressure-generating means 4 and the filter 7.

[0106] Essentially, a filter 7 represents a resistance to a material flow or stream, which is why, with respect to the flow direction F, a different pressure P4 prevails "behind" the filter 7 than in front of it. Accordingly, P4 may have a lower value than P3. Provided there are essentially no resistances between the filter 7 and the third container 1b and the inlet and / or outlet 2 of the third container 1b is open, the pressure P4 can be distributed essentially homogeneously locally in the third container 1b and in the corresponding section of the main line 3a.

[0107] In the aforementioned configuration, at least a portion of the at least one medium 11 flows, driven by a pressure-generating means 4, from the disposable container 1 into the third container 1b. The corresponding portion of the at least one medium 11 is filtered along the flow direction F in this way, so that suspended particles can possibly be filtered out of the corresponding portion of the at least one medium 11. Furthermore, it can be the case that at least one chemical and / or biological and / or biochemical and / or physical process takes place in the disposable container 1 and a portion of the at least one medium, for example a sediment and / or a supernatant of the sediment, which has formed during the at least one process, is or should be transferred to the further container 1b. In the further orIn the third container 1b, the transferred portion of the at least one medium 11 can be spatially separated from the other portion of the at least one medium 11 remaining in the disposable container 1. Furthermore, the portion of the at least one medium 11 transferred into the third container 1b can be further processed and / or discarded and / or stored.

[0108] The previously described case corresponds in particular to normal operation of the system 100. In rare cases, malfunctions may occur, particularly when the pressure at a point or position in the system 100 exceeds a bursting pressure of the system 100. As a result, cracks and / or breaks and / or leaks may occur at the corresponding point, through which at least a portion of the medium 11 may escape. In a particularly fragile and / or critical position, where there is a probability that a pressure will exceed a bursting pressure of the system 100 and / or the device 10, an overpressure protection device 5 may be installed as a remedy. Fig. 3, such a critical point can be found between the pressure-generating element 4 or the pump and the filter 7. In one scenario, the pump power set on the pump 4 may be too high, so that a larger volume of the medium 11 is pumped than can flow out through the main line 3a. This condition results in the pressure P3 between pump 4 and filter 7 constantly increasing. In another scenario, the filter may be clogged and thus create a high resistance, due to which the pressure P3 upstream of the filter 7 also constantly increases. In this case, too, the pump power at the pump 4, even if it was set correctly at the beginning, is so high that a larger volume of the medium 11 is pumped than can flow out or pass through the main line 3a and in particular the filter 7.If a suitable overpressure relief device 5 is not installed at the corresponding location, the system 100 may break or burst at that location. Accordingly, the system 100 is provided with the . Fig. 3 an overpressure protection device 5 is arranged on the main line 3a, in particular on a side arm of the main line 3a between pump 4 and filter 7.

[0109] As soon as the pressure P3 exceeds a trigger pressure of the overpressure protection device 5, the overpressure protection device 5 is triggered and diverts at least a portion of the at least one medium 11 into a bypass line 3b. The bypass line 3b is designed to return the corresponding medium 11 to a section 3a' of the system 100, namely the main line 3a, which is located upstream of the overpressure protection device 5 with respect to the flow or current direction F in the main line 3a. This is possible if the pressure P2 upstream of the pump 4 has a lower value than the pressure P3 between the pump 4 and the filter 7. In this way, the pressure P3 can be reduced or at least limited in a section 3a'' of the system 100, namely the main line 3a, which is located downstream of the overpressure protection device 5 with respect to the flow direction F in the main line 3a.

[0110] A feedback loop 8 between the overpressure protection device 5 and the pump 4 is particularly advantageous, since the feedback loop 8 can be a signal designed to shut off the pump 4 and thus prevent any further pressure buildup by the pump 4 between the pump 4 and the filter 7. The feedback loop 8 can, for example, be an emergency switch or an emergency signal that shuts off the pump 4 and / or the entire system 100, in particular all processes occurring therein, in an emergency. Furthermore, the feedback loop 8 can also be and / or include another signal that can trigger an alarm.

[0111] Furthermore, a barometer 6, arranged on the main line 3a between the pump 4 and the filter 7, can measure a local pressure P3. This barometer 6 can serve to improve the safety of the system 100, since a user can monitor the pressure P3 during operation of the system 100.

[0112] The Fig. 4 also shows a system 100 according to a further embodiment, which comprises a device 10. In this embodiment shown, if the pressure P3 exceeds a trigger pressure of the overpressure protection device 5, the overpressure protection device 5 is triggered and at least a portion of the at least one medium 11 is discharged into the bypass line 3b. The bypass line 3b is designed to return the corresponding medium 11 to a section 3a' of the system 100, namely the disposable container 1, which is located upstream of the overpressure protection device 5 with respect to the flow or current direction F in the main line 3a. This is possible if the pressure P1 in the disposable container 1 has a lower value than the pressure P3 between the pump 4 and the filter 7.In this way, the pressure P3 in a section 3a'' of the system 100 downstream of the overpressure protection device 5, namely the main line 3a, can be reduced or at least limited.

[0113] If feedback, as in Fig. 3, were integrated into the system 100, this could send a signal to the inlets and / or outlets 2, in particular the lower inlet and / or outlet 2, in order to close them so that no further medium 11 can be conveyed from the disposable container 1. Such feedback can be integrated into the system 100, but this does not necessarily have to be the case. The feedback is not shown in this illustration. Furthermore, the pump 4 could optionally be switched off using the signal. In addition, a vent valve in the system 100 could also be caused by the signal to vent the system 100 and to equalize at least a partial pressure of the pressure P in the system 100 to the external pressure in order to prevent a further, possibly uncontrolled, increase in the pressure P in the system 100. In general, the pressure P can correspond to an average total pressure and / or one of the partial pressures P1, P2, P3, P4.

[0114] By diverting or returning a portion of the at least one medium 11 into the disposable container 1, this portion can be prevented from uncontrolled leakage. In particular, it can be returned to the portion of the medium 11 that remains in the disposable container 1.

[0115] The Fig. 5 also shows a system 100 according to a further embodiment, which comprises a device 10. In this embodiment shown, at least one pressure-generating means 4 is arranged at a location in the system 100 at which a medium 11 can be pumped and / or conveyed and / or filled into the disposable container 1. The disposable container 1 can accordingly be considered a "pressurized" container. In this case, the pressure-generating means 4 can also comprise and / or represent a pump. It can be assumed that the disposable container 1 is fluidly connected to the third container or the further container 1b via the main line 3a.

[0116] The pressure-generating means 4 conveys the at least one medium 11 to be filled into the disposable container 1 at pressure P6 into the disposable container 1, so that a pressure P1 is created and / or increases in the disposable container 1.

[0117] If the pressure P2 in the main line exceeds a trigger pressure of the overpressure protection device 5, the overpressure protection device 5 is triggered and at least a portion of the at least one medium 11 is discharged into the bypass line 3b. The bypass line 3b is designed to return the corresponding medium 11 to a section 3a' of the system 100 upstream of the overpressure protection device 5—with respect to the flow or current direction F in the main line 3a—namely a line upstream of the disposable container 1. This is possible if the pressure P5 in the line upstream of the disposable container 1 has a lower value than the pressure P2 between the disposable container 1 and the filter 7. In this way, the pressure P2 in the main line 3a and / or the disposable container 1 can be reduced or at least limited.The pressure P1 in the disposable container 1 essentially corresponds to the pressure P2 in the main line 3a, provided there is no significant resistance between the disposable container 1 and the main line 3a.

[0118] Also in this embodiment there may be a feedback as in Fig. 3, between the overpressure protection device 5 and the pressure-generating means 4, wherein the pressure-generating means 4 can be deactivated by means of a feedback signal. Such feedback can optionally be integrated into the system 100 shown, but this is not mandatory. The feedback is not shown in this illustration.

[0119] The inlets and / or outlets 2 shown can be open and / or closed. Each inlet and / or outlet 2 can therefore be either open or closed. In particular, an inlet and / or outlet 2 can be opened to adjust a pressure P, for example, a pressure P1 in the disposable container 1 to the external pressure and / or to reduce this pressure P1.

[0120] The Fig. 6 also shows a system 100 according to a further embodiment, which comprises a device 10. The system comprises a disposable container 1, a second container 1a, which can be understood as a collecting container, and a third container 1b, into which at least a portion of the at least one medium 11 is to be conveyed during normal operation, i.e., without exceeding the trigger pressure of the overpressure protection device 5.

[0121] As soon as the special (predetermined or predeterminable) triggering pressure of the overpressure protection device 5 is exceeded in its immediate vicinity, the overpressure protection device 5 is triggered and thus at least a part of the at least one medium 11 is supplied through the discharge line 3c to the volume V' of the second container 1a, provided that the pressure P7 in the discharge line and the second container 1a does not exceed the triggering pressure, which here corresponds to the pressure P3 when the overpressure protection device 5 is triggered.

[0122] The Fig. 7 also shows a system 100 according to a further embodiment, which comprises a device 10. A pressure-generating means 4, which comprises an internal or integrated overpressure relief device 5, is arranged on a main line 3a. Furthermore, the system 100 comprises a bypass line 3b. As soon as the pressure P3 exceeds a specific (predetermined or predeterminable) trigger pressure of the overpressure relief device 5, the overpressure relief device 5 is triggered and diverts at least a portion of the at least one medium 11 into the bypass line 3b. The bypass line 3b is designed to return the corresponding medium 11 to a section 3a' of the system 100, namely the main line 3a, which is located upstream of the overpressure relief device 5 with respect to the flow or current direction F in the main line 3a. This is possible when the pressure P2 upstream of the pump 4 has a lower value than the pressure P3 between the pump 4 and the filter 7.In this way, the pressure P3 in a section 3a'' of the system 100 downstream of the overpressure protection device 5, namely the main line 3a, can be reduced or at least limited.

[0123] Alternatively, the bypass line 3b can also be fully or at least partially integrated into the pressure-generating means 4 or into the pump 4. At least the pump 4 can have a connection for a bypass line 3b.

[0124] The Fig. 8 also shows a system 100 according to a further embodiment, which comprises a device 10. A pressure-generating means 4 or a pump 4, which comprises an internal or integrated overpressure protection device 5, is arranged on a main line 3a. Furthermore, the system 100 also comprises a bypass line 3b. As soon as the pressure P3 exceeds a specific (predetermined or predeterminable) trigger pressure of the overpressure protection device 5, the overpressure protection device 5 is triggered and diverts at least a portion of the at least one medium 11 into the bypass line 3b. The bypass line 3b is designed to return the corresponding medium 11 to a section 3a' of the system 100 located upstream of the overpressure protection device 5 with respect to the flow or current direction F in the main line 3a, specifically into the disposable container 1.

[0125] In this case, the bypass line 3b can also be at least partially integrated into the pressure-generating means 4 or the pump 4. At least the pump 4 can have a connection for a bypass line 3b.

[0126] The Fig. Figure 9 shows a further embodiment of an overpressure relief device 5, namely a rupture disc 13, which is present in an intact, closed state G and in a burst or triggered or open state O. The overpressure relief device 5 is formed at least partially from a metal, in particular aluminum and / or stainless steel. Alternatively, the rupture disc 13 can also be formed from a plastic, particularly if corrosion of the material is to be prevented.

[0127] In the closed state G, one or more predetermined breaking points 16 or seams can be seen on the closed surface of the rupture disc. The convexly curved surface 17 is divided into six triangular sections 18 of the convexly curved surface 17 of the rupture disc 13, each of which is separated from the other by a predetermined breaking point 16. The predetermined breaking points 16 are arranged symmetrically within an annular frame 19.

[0128] In the open state O, which corresponds to the state when the rupture disc 13 has been triggered, the triangular sections 18 of the convexly curved surface 17 of the rupture disc 13 are released or detached from one another along the predetermined breaking points 16, so that they are only held by an annular frame 19 and essentially form an opening 14.

[0129] Upon triggering (particularly upon reaching the specific (predetermined or predeterminable) trigger pressure), the rupture disc 13 bursts or breaks or opens along the predetermined breaking points 16 without fragmentation, so that no particle and / or element of the rupture disc 13 enters the system 100 and / or the medium 11. Typically, a rupture disc 13 has a trigger pressure. The rupture disc 13 is accordingly designed such that it bursts when this trigger pressure is exceeded. This can be predetermined or defined, for example, by the choice of material and / or the stability of the predetermined breaking points 16 and / or the curvature of the rupture disc 13.

[0130] The Fig. Figure 10 shows another embodiment of an overpressure protection device 5, namely a check valve 15 according to one embodiment. A check valve 15 or a check valve is a component that allows the flow of a fluid in only one direction. Fig. 10 shows a spring-loaded check valve 15 in which a closing element 20 is closed in one direction by a return spring 21 and released in the other direction by the pressure of a flowing fluid. In particular, a ball is used as the closing element 20. Alternatively, a cone, a flap, or a diaphragm can be pressed into the respective seat. If a pressure is present in the flow direction that can overcome the force of the return spring 21, the closing element 20 is separated or lifted from its seat, and flow is permitted. Other embodiments also manage without a spring, wherein the closing element 20 can only open due to the flowing fluid and, in particular, can close due to the weight of the closing element 20.

[0131] It goes without saying that the Fig. 9 and Fig.10 shown overpressure safety devices 5 can be integrated into one of the devices 100 and / or one of the systems 10 and / or one of the disposable containers 1 and / or containers 1a, 1b or can be comprised thereby or connected thereto.

[0132] The previously described embodiments of the device 10, the system 100, and the method can be applied in various fields. The field of biotechnology is particularly concerned, but other fields of application may also be considered, such as: food technology, beverage technology, the chemical industry, chemical research, laboratory supplies, medical technology (e.g., accessories for blood banks and / or dialysis and / or infusions), process chemistry, and technical chemistry.

[0133] The following processes, among others, can take place within a container: chemical and / or biological and / or biochemical and / or physical processes, in particular fermentation, digestion, distillation, purification, decomposition, aerobic processes, and anaerobic processes. In particular, device 10, system 100, and method can be used in conjunction with FlexAct systems, Sartoflow crossflow systems, chromatography systems, and cell harvesting systems, as well as single-use or disposable bioreactors.

[0134] The device 10, as well as its embodiments, can also be used, for example, in the storage and / or processing of dangerous and / or toxic and / or explosive chemicals. For example, a bottle in which an explosive and / or toxic substance of a medium is stored and / or transported can comprise an overpressure protection device designed to direct at least part of the medium into another vessel or container in the event of overpressure. Another case could concern a waste canister for solvents, which can often contain dangerous and / or reactive solvent mixtures. Such a waste canister or bottle, as mentioned above, can be considered, for example, a disposable container and be part of the device according to the invention.This would have the advantage of preventing an uncontrolled leakage of at least one of the media and / or substances mentioned, or even the bursting of the canister and / or bottle.

[0135] In other words, a disposable element such as a disposable container 1, in particular a disposable bioreactor, has the advantage that it can be provided in a sterile condition and, after use and contamination with contents, does not need to be cleaned or autoclaved again, but can be disposed of. By using inexpensive materials to manufacture disposable bioreactors, processes can be carried out or implemented particularly cost-effectively. All components of a device, a system, and a container, in particular a bioreactor, as well as all accessories, can be designed as disposable elements. Alternatively, only individual components of a device, a system, and a container, in particular a bioreactor, can be designed as disposable elements, whereas other components represent reusable elements.

[0136] Within the scope of the present invention, medium 11 or media are considered to include, in particular, liquids, gases, suspensions, dispersions, buffers, and / or cell culture broths. Media may also include solids, such as powders, pressed pellets, particles, granules, and mixtures thereof. A medium may accordingly comprise different components with the same or different aggregate states, for example, an emulsion or a dispersion.

[0137] In the context of the present invention, containers are understood to mean, in particular, disposable containers 1. These are preferably disposable or single-use bags made of a soft plastic. Containers can comprise one or more of the following: containers for mixing, storage and / or transport, as well as bioreactors or containers as components of bioreactors and fermenters, but also vessels, canisters and containers for storing media and / or buffer solutions. A bioreactor or fermenter can comprise or represent a container. Furthermore, the container can also be, for example, a mixing tank or container, a storage container, a bottle, a canister or a food tank or barrel.The container can also be a container in which chemical material is stored, transported, and / or processed; it can also represent a piece of chemical laboratory equipment, for example, a column vessel for column chromatography, a vessel, or an element, for example, of a still. A container can, in particular, be made at least partially of plastic. Alternatively, a container can also be made at least partially of a metal, in particular of steel.

[0138] Furthermore, a container can be made at least partially of glass. It should be expressly noted that these containers can also be reusable containers. For example, a collection container can also be a canister designed for multiple use.

[0139] Containers such as bioreactors, mixing systems, and pellet tanks are essentially used for receiving, storing, and / or mixing biological media, such as fluids and / or solids and / or gases. Biological media can be provided in containers such as bags, particularly plastic bags, which can have a volume of several hundred or even several thousand liters. The biological media can preferably be introduced into the bioreactor within such a bag, where they can be stored, tempered, and / or mixed.

[0140] Disposable containers 1 can be integrated in particular into filtration / fermentation and processing systems, such as virus filtration / chromatography or crossflow systems.

[0141] The disposable container 1 can be a disposable bioreactor bag with a flexible wall, such as a Biostat® Cultibag® stirred reactor, bioreactor bag, a Cultibag® RM rocking bioreactor bag of the Wave® type, a shaking ORB® type, or other flexible bioreactor bags. The disposable container 1 can also be a disposable 3D bioprocessing bag, such as a Palletank® storage or mixing bag, a LevMix® or MagMix® mixing bag, other flexible 3D bioprocessing bags, or 3D bag wraps. The disposable container 1 can also be a disposable 2D bioprocessing bag, such as a FlexBoy®, Celsius®, or other 2D bioprocessing bag. The disposable container 1 may also be a disposable bioreactor container with a rigid container wall 12, such as the Biostat® SU, the TAP Biosystems ambr15, the ambr250 and other rigid jacketed bioreactor containers.The disposable container 1 can also be a single-use, rigid-walled CellSTACK® container, which is a multi-chamber plastic container with rigid walls. For example, rigid-walled CellSTACK® containers are used, among other things, for tissue culture of growing adherent cells.

[0142] The term "triggering of an overpressure protection device 5" means, in particular, that the overpressure protection device 5 fulfills its function at the moment of triggering. In particular, triggering can consist in a pressure exceeding a maximum value, namely a trigger pressure, whereby an overpressure protection device 5 is triggered in such a way that it forms an opening and thus at least a further increase in the pressure P within the device 10 or a section of the device 10 can be prevented. After the overpressure protection device 5 is triggered, at least part of the medium 11 located in the device 10 can escape through the opening and / or exit in a controlled manner and / or be removed and / or returned. In special cases, after an overpressure protection device 5 is triggered, the pressure P in the device 10 or in at least a section of the device can even be reduced compared to the value before triggering.

[0143] An overpressure protection device 5 can also be fluidically connected to at least one filter. Such a filter can be or include, but is not limited to, a hydrophobic vent filter, a hydrophilic liquid filter, a sterilizing filter, a virus retention filter, a combined hydrophilic / hydrophobic filter, a barrier filter, or a filter train with multiple filters. Filters can prevent toxic and / or hazardous substances, particularly aerosols, that escape from the system 100 and / or device 10 from affecting a user and / or escaping into the environment.

[0144] A line 3, a bypass line 3b, a discharge line 3c, and / or an overpressure protection device 5 may comprise at least one filter, in particular a membrane filter. The filter may be, but is not limited to, a hydrophobic vent filter, a hydrophilic liquid filter, a sterilizing filter, a virus retention filter, a combination hydrophilic / hydrophobic filter, a barrier filter, and / or a filter string with multiple filters. A branch or a combination of filters may also be present, which may include separate hydrophilic and hydrophobic filters.

[0145] A device 10 comprises at least the features of the device 10 covered by the first main claim. The embodiments of the device 10 shown as examples in the drawings or figures also comprise additional features which are to be understood as optional.

[0146] A target container includes all of the containers mentioned that qualify as disposable containers. In addition, a target container includes an open or closed vessel, a pipe, a container, a (bio)reactor, and other containers for the treatment or processing of fluids. Reference symbol 1 disposable container 1a Additional second container 1b Another third container also called target container 2 Inlet and / or outlet 3 Line 3a Main line 3a' Section upstream of the overpressure protection device with respect to a flow direction in the main line 3a'' With respect to a flow direction in the main line downstream of the overpressure protection section 3b Bypass line 3c Derivation 4 Pressure-generating means, e.g. pump 5 Overpressure protection 6 Pressure measuring device, e.g. manometer 7 Resistance, for example filter (system) 8 Feedback between overpressure protection and pump 9 System that can be open or closed 10 Device 10a First subsystem that is closed or open 10b Second subsystem, which is closed or open 11 Medium 12 Container wall 13 Rupture disc 14 Opening in the rupture disc 15 Check valve 16 predetermined breaking points or seam 17 Convex curved surface of a rupture disc 18 Triangular sections of the convex surface of a rupture disc 19 Ring-shaped frame 20 Closing element of a check valve 21 Return spring of a check valve 100 systems F Flow direction G Closed state of the overpressure protection O Open state of the overpressure protection P Pressure before overpressure protection P1 pressure in the vessel P2 pressure in main line before pump P3 Pressure in main line after pump P4 Pressure in main line and if necessary in second container after resistance P5 Pressure in front of pressurized disposable container P6 Pressure in the downstream line and, if applicable, in the third container V Container volume of the disposable container ZV target volume

Claims

[1] Device (10) for storing and / or processing at least one medium (11), in particular a bioprocessing device, comprising - at least one disposable container (1) designed to at least partially accommodate the at least one medium (11); and - at least one overpressure safety device (5) which is fluidically connected to the at least one disposable container (1), wherein the at least one overpressure safety device (5) is designed, when triggered, to at least partially - to lead into a device area (3a') upstream of the overpressure protection device (5) with respect to a flow direction (F), and / or - into at least one disposable container (1); and / or - into at least one further second container (1a), characterized by , that the overpressure protection device (5) is designed to be triggered by an electrical signal, wherein the electrical signal is sent from at least one sensor to the overpressure protection device (5) and / or wherein the electrical signal is sent from a first triggered overpressure protection device (5) to a second overpressure protection device (5). [2] Device (10) according to claim 1, wherein the at least one overpressure safety device (5) is integrated directly into a container wall (12) of the at least one disposable container (1). [3] Device (10) according to one of the preceding claims, wherein the at least one overpressure safety device (5) comprises a one-way overpressure safety device, in particular a mechanical one-way overpressure safety device, which is preferably formed at least partially from a stainless steel and / or a plastic. [4] Device (10) according to one of the preceding claims, wherein the at least one overpressure protection device (5) comprises at least one of the following: a rupture disc, an overflow valve, a safety valve, a membrane and in particular an electrical and / or a mechanical force limiter of a pump. [5] Device (10) according to one of the preceding claims, further comprising at least one discharge line (3c) which is designed to direct the at least one medium (11) at least partially into the at least one disposable container (1) and / or into at least one second container (1a) upon triggering of the at least one overpressure protection device (5). [6] System (100) comprising the device (10) according to any one of the preceding claims, the system further comprising: - a main line (3a) for fluidically connecting the at least one disposable container (1) to a target container (1b); - at least one discharge line (3c) which is designed to direct the at least one medium (11) at least partially into at least one further container (1a) upon triggering of the at least one overpressure protection device (5); and / or - a bypass line (3b) which is designed, when the at least one overpressure protection device (5) is triggered, to guide the at least one medium (11) at least partially back into the device region (3a') upstream of the overpressure protection device (5) with respect to a flow direction (F), in particular a section of the main line and / or into the at least one disposable container (1), wherein the at least one overpressure protection device (5) is arranged on the outlet line (3c) and / or the bypass line (3b) and, when the at least one overpressure protection device (5) is triggered, the outlet line (3c) and / or the bypass line (3b) is fluidically connected to the main line (3a). [7] System (100) according to claim 6, further comprising the target container (1b) which is designed to at least partially accommodate the at least one medium (11) and which is preferably a disposable container. [8] System (100) according to one of claims 6 or 7, further comprising at least one pressure-generating means (4), in particular a pump, wherein the at least one pressure-generating means (4) is designed to pump at least a portion of the at least one medium from the at least one disposable container (1) into the third container (1b) along the flow direction (F). [9] System (100) according to claim 8, wherein the at least one pressure generating means (4) is arranged on the main line (3a) and is designed to generate a pressure gradient along the main line (3a). [10] System (100) according to claim 8 or 9, wherein the at least one pressure generating means (4) is arranged on the disposable container (1) and is designed to generate a pressure gradient within the disposable container (1) and / or along the main line (3a). [11] System (100) according to one of claims 6 to 10, wherein the discharge line (3c) and / or the bypass line (3b) is / are at least partially integrated in the pressure generating means (4). [12] System (100) according to claim 10 or 11, further comprising a feedback (8), in particular an electrical feedback, between the overpressure safety device (5) and the pressure-generating means (4), wherein the feedback (8) is designed to switch off the pressure-generating means (4) when the at least one overpressure safety device (5) is triggered. [13] Method for at least partially collecting at least one medium (11) in a device comprising the steps: - Providing at least one disposable container (1) which is designed to at least partially accommodate the at least one medium (11); - Providing at least one overpressure safety device (5) which is fluidically connected to the at least one disposable container (1) and which can be triggered by an electrical signal which is sent from at least one sensor to the overpressure safety device (5) and / or which is sent from a first triggered overpressure safety device (5) to a second overpressure safety device (5); and in the event that the overpressure safety device (5) is triggered: - discharging the at least one medium (11) at least partially into a further second container (1a) by means of a discharge line (3c); and / or - Returning the at least one medium (11) at least partially into a device region (3a') upstream of the overpressure protection device (5) with respect to a flow direction (F), in particular into the at least one disposable container (1), by means of a bypass line (3b).

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