OVERPRESSURE PROTECTION MEANS

Abstract

The invention relates to an apparatus 10 for storing and/or processing at least one medium 11, in particular a bioprocessing device, comprising at least one disposable container 1, which is designed to accommodate at least some of the at least one medium 11, and at least one overpressure protection means 5, which is fluid-connected to the at least one disposable container 1. The at least one overpressure protection means is designed, when triggered, to conduct at least some of the at least one medium 11 into an apparatus region 3a′ in front of the overpressure protection means 5 in relation to a flow direction F, in particular into the at least one disposable container 1 and/or into at least one further, second container 1a.

Claims

1. A bioprocess device for storing and/or processing at least one medium, the device comprising: at least one disposable container which is configured to at least partially receive at least one medium; and at least one overpressure protection means which is connected to the at least one disposable container in fluid terms, wherein the at least one overpressure protection means is configured, in the event of an activation, to guide the at least one medium at least partially into a device region which is arranged upstream of the overpressure protection means with respect to a flow direction, and/or into the at least one disposable container; and/or into at least one additional second container.

2. The bioprocess device as claimed in claim 1, wherein the at least one overpressure protection means is integrated directly in container walls of the at least one disposable container.

3. The bioprocess device as claimed in claim 1, wherein the at least one overpressure protection means comprises a disposable overpressure protection means, in particular a mechanical overpressure protection means, which is preferably at least partially formed from a high-grade steel and/or a plastics material.

4. The bioprocess device as claimed in claim 1, wherein the at least one overpressure protection means comprises at least one of the following: a bursting disk, an overflow valve, a safety valve, a membrane and in particular an electrical and/or mechanical force limiter of a pump.

5. The bioprocess device as claimed in claim 1, further comprising at least one discharge which is configured, when the at least one overpressure protection means is activated, 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.

6. A system comprising: a bioprocess device comprising: at least one disposable container which is configured to at least partially receive at least one medium; and at least one overpressure protection means which is connected to the at least one disposable container in fluid terms, wherein the at least one overpressure protection means is configured, in the event of an activation, to guide the at least one medium at least partially into a device region which is arranged upstream of the overpressure protection means with respect to a flow direction, and/or into the at least one disposable container; and/or into at least one additional second container; a main line for fluid connection of the at least one disposable container to a target container; at least one discharge which is configured, when the at least one overpressure protection means is activated, to direct the at least one medium at least partially into at least one additional container; and/or a bypass line which is configured, when the at least one overpressure protection means is activated, to direct the at least one medium at least partially back into the device region which is arranged upstream of the overpressure protection means with respect to a flow direction, in particular into a portion of the main line and/or into the at least one disposable container, wherein the at least one overpressure protection means is arranged on the discharge and/or the bypass line and, when the at least one overpressure protection means is activated, the discharge and/or the bypass line is/are connected in fluid terms to the main line.

7. System as claimed in claim 6, further comprising the target container which is configured to at least partially receive the at least one medium and which is preferably a disposable container.

8. The system as claimed in claim 6, further comprising at least one pressure-producing means, in particular a pump, wherein the at least one pressure-producing means is configured to pump at least a portion of the at least one medium from the at least one disposable container into the third container in the flow direction.

9. The system as claimed in claim 8, wherein the at least one pressure-producing means is arranged on the main line and is configured to produce a pressure drop along the main line.

10. The system as claimed in claim 8, wherein the at least one pressure-producing means is arranged on the disposable container and is configured to produce a pressure drop within the disposable container and/or along the main line.

11. The system as claimed in claim 6, wherein the discharge and/or the bypass line is/are integrated at least partially in the pressure-producing means.

12. The system as claimed in claim 10, further comprising a feedback, in particular an electrical feedback, between the overpressure protection means and pressure-producing means, wherein the feedback is configured to switch off the pressure-producing means when the at least one overpressure protection means is activated.

13. A method for at least partially collecting at least one medium in a device, comprising the steps of: providing at least one disposable container which is configured to at least partially receive the at least one medium; providing at least one overpressure protection means which is connected to the at least one disposable container in fluid terms; and, in the event that the overpressure protection means is activated: discharging the at least one medium at least partially into an additional second container by means of a discharge; and/or returning the at least one medium at least partially into a device region which is arranged upstream of the overpressure protection means with respect to a flow direction, in particular into the at least one disposable container, by means of a bypass line.

Description

[0101] The invention is explained in greater detail below with reference to embodiments which are shown in Figures. Individual features which are shown in the Figures can be combined with other embodiments as long as they are not mutually exclusive. The same reference numerals refer in this instance to components of the embodiments which are identical or similar. In the drawings:

[0102] FIG. 1 is a schematic side view of a cross-section of a device comprising a disposable container, an overpressure protection means and a discharge according to an embodiment;

[0103] FIG. 2 is a schematic side view of a cross-section of a device comprising a disposable container, an overpressure protection means and a discharge according to another embodiment;

[0104] FIG. 3 is a schematic side view of a system having a device comprising a disposable container, a pump, an overpressure protection means and a bypass line according to an embodiment;

[0105] FIG. 4 is a schematic side view of a system having a device comprising a disposable container, a pump, an overpressure protection means and a bypass line according to another embodiment;

[0106] FIG. 5 is a schematic side view of a system having a device comprising a disposable container, a pressure-producing means, an overpressure protection means and a bypass line according to another embodiment;

[0107] FIG. 6 is a schematic side view of a system having a device comprising a disposable container, a pump, an overpressure protection means and a discharge according to another embodiment;

[0108] FIG. 7 is a schematic side view of a system having a device comprising a disposable container, a pump, an overpressure protection means which is integrated in the pump and a bypass line which is integrated in the pump according to an embodiment;

[0109] FIG. 8 is a schematic side view of a system having a device comprising a disposable container, a pump, an overpressure protection means which is integrated in the pump and a bypass line according to an embodiment;

[0110] FIG. 9 shows a bursting disk in an open state after it has been activated and a bursting disk in a closed state prior to being activated according to an embodiment;

[0111] FIG. 10 shows a non-return valve according to an embodiment.

[0112] FIG. 1 shows a device 10 according to an embodiment comprising at least one disposable container 1 having a volume V and at least one overpressure protection means 5. The overpressure protection means 5 is arranged on the container wall 12 of the disposable container 1 and in particular 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 which is 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 (at least partially) emptied via them. In this instance, the medium may be or comprise a fluid (in particular a liquid and/or gas) and/or a solid material.

[0113] In the disposable container 1 there is in particular at least one fluid medium 11 and a gas which is located above. In the disposable container 1 there is applied a mean pressure P which may comprise partial pressures but which preferably substantially do not differ from each other substantially powerfully (for example, by no more than approximately 10%, preferably no more than approximately 1%). The disposable container 1 forms with the overpressure protection means 5 a system 9 which is substantially closed or hermetically closed or separated from an environment as long as the overpressure protection means 5 has not been activated. The overpressure protection means 5 may in particular comprise a bursting disk and/or a membrane and/or a membrane filter. Alternatively or additionally, the overpressure protection means 5 may represent a portion of the container wall 12 which has a structuring, in particular a desired breaking location.

[0114] As soon as the pressure P in the closed system exceeds a specific (predetermined or predeterminable) activation pressure of the overpressure protection means 5, the overpressure protection means 5 opens and/or bursts or breaks so that the closed system becomes an open system, in particular with a connection relating to the pressure with respect to the outer side. At least a portion of the at least one medium can pass through the overpressure protection means 5 and be introduced along a line 3, which in this instance corresponds to a discharge 3c and which comprises a pipe, into at least one target volume ZV of another second container 1a, in particular a collection container. In the embodiment shown, the path which the at least one portion of the medium 11 takes through the discharge 3c to the collection container 1a is not a closed system. Since the level of the medium within the disposable container 1 extends below the height of the lower of the two inlets and/or outlets 2, a gas can also escape.

[0115] A disposable container 1 is a container which is configured for single use. After the disposable container 1 has been used once, it has generally performed its function and can be disposed of. For example, a disposable container 1 is produced from plastics material which may comprise polyamide, polycarbonate, polyethylene, polystyrene, polyethersulfone, polypropylene, polytetrafluoroethylene, polyvinyl chloride, cellulose acetate and/or ethyl vinyl acetate, but is not limited thereto. In an example, the disposable container 1 may be substantially rigid, that is to say, its form cannot be modified. In another example, the disposable container 1 may have (at least partially) flexible walls or flexible container walls 12, that is to say, the disposable container 1 can change its shape without breaking.

[0116] Disposable containers 1 may be used, for example, for critical applications in particular in the biopharmaceutical and bioproduction industry. The use of one of the disposable containers 1 may include the following, but without being limited thereto: storing a medium (for example, product), mixing and/or cell cultivation. The disposable container 1 is in particular a sterilizable disposable container 1 which is made of plastics material and which is configured to receive or hold at least one fluid. It may be or comprise a bioreactor bag, a mixing container a 2D and/or a 3D bioprocess bag.

[0117] For example, a disposable container 1 may comprise a housing or container walls 12 with a multi-layer film structure, that is to say, a superimposition of thin sheets of plastics materials which provides a secure barrier between the contents of the disposable container 1 (for example, biohazardous material) and the external environment. Furthermore, a disposable container 1 may, for example, be provided in a pre-sterilized state (for example, by means of gamma irradiation and/or autoclaving). A disposable container 1 may consequently represent an advantageous alternative to conventional glass and/or high-grade steel systems.

[0118] The disposable container 1 may at least partially comprise at least one medium 11 which contains a fluid, for example a gas, a liquid and/or a mixture thereof, wherein the phases may be present separately and/or in a substantially “mixed” state. The pressure P in the disposable container 1 acts substantially on the walls of the housing or the container walls 12 of the disposable container 1. In one example, the housing 100 may be a Biostat® Cultibag® STR-Bioreactor bag or a Flexsafe/Flexel mixing/storage flexboy, etcetera.

[0119] The overpressure protection means 5 is connected in terms of flow medium or in fluid terms to the disposable container 1 and in particular the container walls 12 thereof by a fluid flow or a material flow from the container wall 12 to the overpressure protection means 5 being enabled. In other words, there is substantially no obstacle which cannot be overcome under normal circumstances and which impedes the medium from flowing from the container wall 12 to the overpressure protection means 5. In one example, the overpressure protection means 5 may be integrated directly in the container walls 12, for example, the container walls 12 may be fitted and/or arranged integrally in the container wall 12 without a mechanical connection piece.

[0120] The overpressure protection means 5 may, for example, be positioned and/or arranged at least partially inside a multi-layer structure of the container walls 12 (for example, a flange may be embedded and/or soldered in one or more layers of the multi-layer structure).

[0121] In another example, the overpressure protection means 5 may be connected to the container walls “externally”, in particular by means of a connection piece. The overpressure protection means 5 may, for example, be arranged on an external additional container 1b and/or on a line which in each case can be connected to the container walls 12 by means of a connection, such as a hose connection.

[0122] Connection pieces and/or connections, such as lines, may preferably comprise aseptic connections, such as, for example, aseptic connectors, in particular OPTA® connectors. In an example, the overpressure protection means 5 is configured to be sterilized prior to being assembled on the disposable container 1, for example, using gamma irradiation, chemical sterilization means (such as evaporated hydrogen peroxide, ethylene oxide, etcetera), vapor sterilization and/or autoclaving. In another example, the overpressure protection means 5 can be sterilized together with the disposable container 1, in particular the container walls 12 thereof.

[0123] FIG. 2 shows a device 10 according to an embodiment comprising a disposable container 1 having a volume V and a line which corresponds to a discharge 3c on which an overpressure protection means 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 the disposable container 1 is at least one fluid medium 11 and a gas above it, which can be considered to be another medium. The disposable container 1 can be considered to be a first part-system 10a, which may be open or closed, depending on whether one or both of the inlets and/or outlets 2 is/are open or closed in each case. The line may be considered to be a second part-system 10b which may be open or closed, depending on whether the inlet and/or outlet 2 on which the line is arranged is/are open or closed in each case.

[0124] As long as the inlet and/or outlet 2 on which the line is arranged is/are open, the line forms with the disposable container 1 a closed system in which there is a mean overall pressure P and which is indicated with a dashed line. In the first open or closed system 10a, comprising the disposable container 1, there may be a pressure, in particular a partial pressure P.sub.1. In the second open or closed system 10b comprising the line, there may be a pressure, in particular a partial pressure P.sub.2. Normally, a fluid medium 11 during filling, for example, through the upper inlet and/or outlet 2, may flow into the line, where it is prevented by the overpressure protection means 5 from escaping from the line as long as the pressure P in the device, in particular the pressure Pi in the line, does not exceed the activation pressure.

[0125] In the disposable container 1 there is a mean pressure P which may include partial pressures P.sub.1 and P.sub.2 which differ from each other, as long as the systems are connected to each other, but preferably not substantially powerfully (for example, by no more than approximately 10%, preferably no more than approximately 1%). The disposable container 1 forms with the overpressure protection means 5 a substantially closed or hermetically closed system 9 as long as the overpressure protection means 5 has not been activated.

[0126] As soon as the pressure P, in particular the partial pressure P.sub.2 in the closed system exceeds the specific activation pressure of the overpressure protection means 5, the overpressure protection means 5 opens and/or bursts or breaks so that the closed system comprising the two part-systems 10a and 10b becomes an open system, in particular having a connection with respect to the pressure toward the outer side. At least a portion of the at least one medium can pass through the overpressure protection means 5 and be introduced along the line into a target volume ZV of a second container 1a. Also in this embodiment set out, the path which at least a portion of the medium 11 takes through the discharge 3c to the collection container 1a is not a closed system.

[0127] The medium 11 which is discharged can in this manner be directed in a controlled, defined and/or guided manner through the line into a collection container 1a. Consequently, it is possible to prevent the discharged medium from being lost. Furthermore, it is possible to prevent the medium from reaching and potentially contaminating the environment.

[0128] Downstream of the overpressure protection means 5 there is a pressure P.sub.3 which, as long as the system is an open one, may be a local pressure of the environment. Alternatively, the system may also downstream of the overpressure protection means 5 constitute a closed system at a controlled and/or predetermined pressure. This is particularly advantageous when the discharged medium 11 contains substances which are volatile, that is to say, readily change from a fluid state into a gaseous state and/or media and/or substances which should not come into contact with the environment. The same applies to a medium 11 which comprises a gas.

[0129] FIG. 3 shows a system 100 according to an embodiment which comprises a device 10. The device 10 comprises a disposable container 1 having a volume V which is configured to at least partially receive at least one medium 11. The disposable container 1 has two inlets and/or outlets 2 which can be opened and/or closed separately by hand and/or automatically (for example, by means of a control or regulation device which is not shown). In alternative embodiments, disposable containers comprise more than two or less than two inlets and/or outlets. At the lower inlet and/or outlet 2, there is arranged a main line 3a which is configured to guide a material flow or a stream comprising at least a portion of the at least one medium 11 in a local flow or stream direction F.

[0130] The main line 3a substantially connects the disposable container 1 to another container 1b which is also referred to as a third container 1b if it is assumed that a first container 1 corresponds to the disposable container 1 and a second container 1a corresponds to a collection container. However, the system 100 does not necessarily have to comprise a collection container 1a. At least a portion of the at least one medium 11 in the disposable container 1 can accordingly reach the third container 1b along the main line and in the flow direction F by means of a pressure-producing 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 portion of the main line 3a. As a result of an inlet and/or outlet 2 of the additional or third container 1b, the at least one medium 11 at least partially reaches the inner space of the additional or third container 1b. The additional or third container 1b may in particular also be another disposable container. Alternatively, the additional or third container 16 may also be or comprise a reusable container.

[0131] In the disposable container 1 there is substantially applied a mean pressure P.sub.1, which is in particular homogeneous or spatially constant. In the portion of the main line 3a between the inlet and/or outlet 2 of the disposable container 1 and the pump 4 there is a pressure P.sub.2. As long as the mentioned inlet and/or outlet 2 of the disposable container 1 is open, the two pressures P.sub.1, P.sub.2 may be substantially identical or only slightly different.

[0132] During operation of the pressure-producing means 4, in particular a pressure drop along the main line 3a is produced so that in the portion of the main line 3a between the inlet and/or outlet 2 of the disposable container 1 and the pressure-producing means 4 there is a lower pressure P.sub.2 than in the portion “behind” the pressure-producing means 4 in the direction of the third container 1b. The pressure P.sub.3 between the pressure-producing means 4 and the filter 7 is accordingly greater than the pressure P.sub.2 which is applied with respect to the flow direction F upstream of the pressure-producing means 4. The pressure drop along the main line 3a may in particular extend in a substantially continuous manner or increase abruptly, in particular in the direct vicinity of the pressure-producing means 4. With a substantially continuous increase, the mean pressure P.sub.3 would, for example, comprise different partial pressures, whereas with an abrupt increase the pressure P.sub.3 in the region between the pressure-producing means 4 and filter 7 is distributed in a substantiality locally homogeneous manner.

[0133] A filter 7 substantially represents a resistance for a material stream or flow, for which reason with respect to the flow direction F “behind” the filter 7 there is applied a different pressure P.sub.4 from previously. It may accordingly be the case that P.sub.4 has a smaller value than P.sub.3. As long as there are substantially 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 P.sub.4 can be distributed in a substantially locally homogeneous manner in the third region 1b and in the corresponding portion of the main line 3a.

[0134] In the above-mentioned configuration, at least a portion of the at least one medium 11, driven by a pressure-producing means 4, flows from the disposable container 1 into the third container 1b. The corresponding portion of the at least one medium 11 is in this manner filtered in the flow direction F so that potentially suspended particles from the corresponding portion of the at least one medium 11 can be filtered. Furthermore, it may the case that in the disposable container 1 at least one chemical and/or biological and/or biochemical and/or physical process takes place and a portion of the at least one medium, for example, a sediment and/or a supernatant of the sediment which have formed during the at least one process, is/are intended to be transferred into the additional container 1b. In the additional or 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 which has been transferred into the third container 1b can be further processed and/or discarded and/or stored.

[0135] The above-described case corresponds in particular to normal operation of the system 100. In rare cases, there may be malfunctions, in particular when the pressure at a location or position in the system 100 exceeds a bursting pressure of the system 100. There may occur at the corresponding location cracks and/or fractures and/or leakages, through which at least a portion of the medium 11 can be discharged. At a particularly fragile and/or critical position where there is the likelihood of a pressure exceeding a bursting pressure of the system 100 and/or the device 10, an overpressure protection means 5 may be installed to assist. FIG. 3 shows such a critical location between the pressure producing element 4 or the pump and the filter 7. In one scenario, an excessively high pump power may be adjusted at the pump 4 so that a larger volume of the medium 11 is pumped than can flow away through the main line 3a. This state results in the pressure P.sub.3 between the pump 4 and filter 7 constantly rising. In another scenario, it may be the case that the filter is clogged and consequently forms a high level of resistance, as a result of which the pressure P.sub.3 upstream of the filter 7 also constantly increases. Also in this instance, the pump power at the pump 4, even if it was correctly adjusted at the beginning, is so high that a larger volume of the medium 11 is pumped than can flow away or pass through the main line 3a and in particular the filter 7. If no suitable overpressure protection means 5 is installed at the corresponding location, it may be the case that the system 100 breaks or bursts at this location. Accordingly, in the system 100 of FIG. 3 an overpressure protection means 5 is arranged on the main line 3a, in particular on a side arm of the main line 3a between the pump 4 and filter 7.

[0136] As soon as the pressure P.sub.3 exceeds an activation pressure of the overpressure protection means 5, the overpressure protection means 5 is activated and directs at least a portion of the at least one medium 11 into a bypass line 3b. The bypass line 3b is configured to return the corresponding medium 11 into a portion 3a′ of the system 100 which is located upstream of the overpressure protection means 5—with respect to the stream or flow direction F in the main line 3a—and thus of the main line 3a. This is possible when the pressure P.sub.2 in front of the pump 4 has a lower value than the pressure P.sub.3 between the pump 4 and filter 7. In this manner, the pressure P.sub.3 in a portion 3a″ of the system 100 located downstream of the overpressure protection means 5—with respect to the flow direction F in the main line 3a and of the main line 3a, can be reduced or at least limited.

[0137] In a particularly advantageous manner, there is a feedback 8 between the overpressure protection means 5 and the pump 4 since the feedback 8 may be a signal which is configured to switch off the pump 4, and consequently brings about no further pressure build-up by means of the pump 4 between the pump 4 and filter 7. The feedback 8 may, for example, be an emergency switch or an emergency signal which in the event of an emergency switches off the pump 4 and/or the entire system 100, in particular all the processes which are being carried out therein. The feedback 8 may further also be and/or comprise another signal which can activate an alarm.

[0138] Furthermore, a barometer 6 which is arranged on the main line 3a between the pump 4 and the filter 7 can measure a local pressure P.sub.3. This barometer 6 can be used to improve the reliability of the system 100 since a user can control the pressure P.sub.3 during operation of the system 100.

[0139] FIG. 4 also shows a system 100 according to another embodiment which comprises a device 10. In this embodiment shown, if the pressure P.sub.3 exceeds an activation pressure of the overpressure protection means 5, the overpressure protection means 5 is activated and at least a portion of the at least one medium 11 is discharged into the bypass line 3b. In this case, the bypass line 3b is configured to return the corresponding medium 11 into a portion 3a′ of the system 100 located upstream of the overpressure protection means 5—with respect to the stream or flow direction F in the main line 3a—into the disposable container 1. This is possible when the pressure P.sub.1 in the disposable container 1 has a lower value than the pressure P.sub.3 between the pump 4 and filter 7. In this manner, the pressure P.sub.3 in a portion 3a″ of the system 100 located downstream of the overpressure protection means 5—with respect to the flow direction F in the main line 3a—and thus of the main line 3a, can be reduced or at least limited.

[0140] If a feedback, as illustrated in FIG. 3, were integrated in the system 100, this could transmit a signal to the inlets and/or outlets 2, in particular the lower inlet and/or outlet 2, in order to close it/them so that no further medium 11 can be conveyed from the disposable container 1. Such a feedback may be integrated in 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 by means of the signal. Furthermore, a ventilation valve in the system 100 could also be caused by means of the signal to ventilate the system 100 and to equalize at least a partial pressure of the pressure P in the system 100 with respect to the ambient pressure in order to prevent another potentially uncontrolled increase of the pressure P in the system 100. Generally, the pressure P may correspond to a mean overall pressure and/or one of the partial pressures P.sub.1, P.sub.2, P.sub.3, P.sub.4.

[0141] As a result of the redirection or return of a portion of the at least one medium 11 into the disposable container 1, this portion can be saved from an uncontrolled discharge. In particular, it can be supplied again to the portion of the medium 11 which has remained in the disposable container 1.

[0142] FIG. 5 also shows a system 100 according to another embodiment which comprises a device 10. In this embodiment shown, at least one pressure-producing means 4 is arranged at a location of the system 100 at which a medium 11 can be pumped and/or conveyed and/or introduced into the disposable container 1. The disposable container 1 may accordingly be considered to be a “pressurized” container. The pressure-producing means 4 may also in this instance comprise and/or constitute a pump. It may be assumed that the disposable container 1 is connected via the main line 3a in fluid terms to the third container or the additional container 1b.

[0143] The pressure-producing means 4 conveys the at least one medium 11 which is intended to be introduced into the disposable container 1 at a pressure P.sub.6 into the disposable container 1 so that a pressure P.sub.1 is produced and/or increases in the disposable container 1.

[0144] If the pressure P.sub.2 in the main line exceeds an activation pressure of the overpressure protection means 5, the overpressure protection means 5 is activated and at least a portion of the at least one medium 11 is discharged into the bypass line 3b. In this case, the bypass line 3b is configured to return the corresponding medium 11 into a portion 3a′ of the system 100 which is located upstream of the overpressure protection means 5—with respect to the stream or flow direction F in the main line 3a—a line which is arranged upstream of the disposable container 1. This is possible when the pressure P.sub.5 in the line which is arranged upstream of the disposable container 1 has a lower value than the pressure P.sub.2 between the disposable container 1 and filter 7. In this manner, the pressure P.sub.2 in the main line 3a and/or the disposable container 1 can be reduced or at least limited. In this instance, the pressure P.sub.1 in the disposable container 1 substantially corresponds to the pressure P.sub.2 in the main line 3a as long as there is no significant resistance between the disposable container 1 and the main line 3a.

[0145] Also in this embodiment there may be a feedback, as shown in FIG. 3, between the overpressure protection means 5 and the pressure-producing means 4, wherein the pressure-producing means 4 can be switched off by means of a signal of the feedback. Such a feedback may optionally be integrated in the system 100 shown, but this does not necessarily have to be the case. The feedback is not shown in this illustration.

[0146] The inlets and/or outlets 2 shown may be present in an open and/or in a closed state. Each inlet and/or outlet 2 may thus be either open or closed. In particular, an inlet and/or outlet 2 can be opened in order to equalize a pressure P, for example, a pressure P.sub.1, in the disposable container 1 with respect to the ambient pressure and/or in order to reduce this pressure P.sub.1.

[0147] FIG. 6 also shows a system 100 according to another embodiment, which comprises a device 10. The system comprises a disposable container 1, a second container 1a which can be understood to be a collection container and a third container 1b into which at least a portion of the at least one medium 11 is intended to be conveyed during normal operation, that is to say, without exceeding the activation pressure of the overpressure protection means 5.

[0148] As soon as the specific (predetermined or predeterminable) activation pressure of the overpressure protection means 5 has been exceeded in the immediate environment thereof, the overpressure protection means 5 is activated and at least a portion of the at least one medium 11 is thus supplied via the discharge 3c to the volume V′ of the second container 1a as long as the pressure P.sub.7 in the discharge and the second container 1a does not exceed the activation pressure which in this instance when the overpressure protection means 5 is activated corresponds to the pressure P.sub.3.

[0149] FIG. 7 also shows a system 100 according to another embodiment, which comprises a device 10. On a main line 3a, there is arranged a pressure-producing means 4 which comprises an internal or integrated overpressure protection means 5. Furthermore, the system 100 comprises a bypass line 3b. As soon as the pressure P.sub.3 exceeds a specific (predetermined or predeterminable) activation pressure of the overpressure protection means 5, the overpressure protection means 5 is activated and discharges at least a portion of the at least one medium 11 into the bypass line 3b. The bypass line 3b is in this instance configured to return the corresponding medium 11 into a portion 3a′ of the system 100 which is arranged upstream of the overpressure protection means 5—with respect to the stream or flow direction F in the main line 3a—and thus of the main line 3a. This is possible when the pressure P.sub.2 in front of the pump 4 has a lower value than the pressure P.sub.3 between the pump 4 and filter 7. In this manner, the pump P.sub.3 in a portion 3a″ of the system 100 located downstream of the overpressure protection means 5—with respect to the flow direction F in the main line 3a—and thus of the main line 3a, can be reduced or at least limited.

[0150] The bypass line 3b may alternatively also be completely or at least partially integrated in the pressure-producing means 4 or in the pump 4, At least the pump 4 may have a connection for a bypass line 36.

[0151] FIG. 8 also shows a system 100 according to another embodiment which comprises a device 10. On a main line 3a there is arranged a pressure-producing means 4 or a pump 4 which comprise(s) an internal or integrated overpressure protection means 5. Furthermore, the system 100 also comprises a bypass line 3b. As soon as the pressure P.sub.3 has exceeded a specific (predetermined or predeterminable) activation pressure of the overpressure protection means 5, the overpressure protection means 5 is activated and directs at least a portion of the at least one medium 11 into the bypass line 3b. The bypass line 3b is in this instance configured to return the corresponding medium 11 into a portion 3a′ of the system 100 which is located upstream of the overpressure protection means 5—with respect to the stream or flow direction F in the main line 3a—and thus into the disposable container 1.

[0152] In this case, the bypass line 3b may also be at least partially integrated in the pressure-producing means 4 or in the pump 4. The pump 4 may at least have a connection for a bypass line 36.

[0153] FIG. 9 shows another embodiment of an overpressure protection means 5, that is, a bursting disk 13 which is present in an intact closed state G and in a burst or activated or open state O. The overpressure protection means 5 is formed at least partially from metal, in particular an aluminum and/or high-grade steel. Alternatively, the bursting disk 13 may also be formed from a plastics material, particularly when corrosion of the material is intended to be prevented.

[0154] In the closed state G, one or more desired breaking locations 15 or seams can be seen on the closed face of the bursting disk. The convex-curved face 17 is subdivided into six triangular part-portions 18 of the convex-curved face 17 of the bursting disk 13, which are separated from each other by means of a desired breaking location 16. The desired breaking locations 16 are in this instance arranged symmetrically within an annular frame 19.

[0155] In the open state O, which corresponds to the state when the bursting disk 13 has been activated, the triangular part-portions 18 of the convex-curved face 17 of the bursting disk 13 are released or detached from each other along the desired breaking locations 16 so that they are retained only by an annular frame 19 and substantially form an opening 14.

[0156] During activation (particularly when the specific (predetermined or predeterminable) activation pressure is reached), the bursting disk 13 bursts or breaks or opens along the desired breaking locations 16 in a fragment-free manner so that no particles and/or element of the bursting disk 13 is introduced into the system 100 and/or the medium 11. Generally, a bursting disk 13 has an activation pressure. The bursting disk 13 is accordingly configured in such a manner that it bursts when this activation pressure is exceeded. This may, for example, be predetermined or defined by the selection of the material and/or the stability of the desired breaking locations 16 and/or the curvature of the bursting disk 13.

[0157] FIG. 10 shows another embodiment of an overpressure protection means 5, that is, a non-return valve 15 according to an embodiment. A non-return valve 15 or a check valve is a component which ensures the flow of a fluid in only one direction. FIG. 10 shows a resiliently loaded non-return valve 15 in which a closure element 20 is closed in one direction by means of a restoring spring 21 and in the other direction is in contrast released by the pressure of a flowing fluid. In this instance, in particular a ball is used as a closure element 20. Alternatively, a cone, a flap or a membrane can be pressed into the respective seat. If there is a pressure in the passage direction which can overcome the force of the restoring spring 21, the closure element 20 is separated or raised from its seat and the throughflow is ensured. Other embodiments also have no spring, wherein the closure element 20 can only open as a result of the flowing fluid and in particular can close as a result of the weight force of the closure element 20.

[0158] It is self-evident that the overpressure protection means 5 shown in FIGS. 9 and 10 may be integrated in 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 be included thereby or connected thereto.

[0159] The above-described embodiments of the device 10, the system 100 and the method can be used in different sectors. In particular, the sector of biotechnology is involved, but other application areas may also be considered, such as, for example: food technology, drinks technology, chemical industry, chemical research, laboratory requirements, medical technology (for example, accessories for blood reserves and/or dialysis and/or infusions), process chemistry, technical chemistry.

[0160] The following process(es) can inter alia take place within a container: chemical and/or biological and/or biochemical and/or physical processes, in particular fermentation, digestion, distillation, cleaning, decomposition, aerobic processes, anaerobic processes. In particular, the device 10, system 100 and method can be used together with FlexAct systems, Sartoflow Crossflow installations, chromatography installations and installations for cell harvesting and single-use or disposable bioreactors.

[0161] The device 10 and the embodiments thereof may, for example, also be used in the storage and/or processing of hazardous 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, may comprise an overpressure protection means which is configured to direct at least a portion of the medium in the event of an overpressure into another vessel or another container. Another case could relate to a waste canister for solvents in which often hazardous and/or reactive solvent mixtures may be located. Such a waste canister or a bottle, as mentioned above, may be considered to be, for example, a disposable container and part of the device according to the invention. This would have the advantage that uncontrolled discharge of at least one of the media mentioned and/or the substances mentioned or even bursting of the canister and/or bottle can be prevented.

[0162] 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 state and after use and contamination with the content does not have to be cleaned or autoclaved again, but instead can be disposed of. By using cost-effective materials to produce disposable bioreactors, processes can be carried out or implemented in a particularly cost-effective manner. All the components of a device, a system and a container, in particular a bioreactor, and all the accessories can be constructed as disposable elements. Alternatively, only individual components of a device, a system and a container, in particular of a bioreactor, may be constructed as disposable elements, whereas other components constitute reusable elements.

[0163] A medium 11 or media in the context of the present invention is/are considered to be in particular liquids, gases, suspensions, dispersions, buffers and/or cell culture broths. Media may further also include solids, such as, for example, powders, pressed pellets, particles, grains and mixtures thereof. A medium may accordingly comprise different components with the same or different aggregation states, for example, an emulsion or a dispersion.

[0164] Containers in the context of the present invention are intended to be understood in particular to be disposable containers 1. Preferably, they are disposable or single-use bags of a soft plastics material. Containers may comprise one or more of the following: containers for mixing, storing and/or transporting and bioreactors or containers as a component of bioreactors and fermenters, but also vessels, canisters and containers for storing media and/or buffer solutions. A bioreactor or fermenter may comprise or constitute a container. The container may further also be, for example, a mixing tank or container, a storage container, a bottle, a canister or a food tank or vessel. The container may also be containers in which chemical material is stored, transported and/or processed, a container may also be a chemical laboratory device, for example, a column vessel for column chromatography, a vessel or an element, for example, of a distillery. A container may in particular be at least partially formed from plastics material. Alternatively, a container may also be at least partially formed from a metal, in particular from steel. Furthermore, a container may at least partially be formed from glass. It should be expressly mentioned that the containers mentioned may also be reusable containers. For example, a collection container may also be a canister which can be configured for multiple use.

[0165] Containers, such as bioreactors, mixing systems and pellet tanks, serve substantially to receive, store and/or mix biological media, such as, for example, fluids and/or solids and/or gases. Biological media may be provided in containers, such as, for example, bags, in particular in plastics bags which may include a volume of several hundred or even several thousand liters. The biological media may preferably be introduced inside such a bag into the bioreactor in which they can be stored, temperature-controlled and/or mixed.

[0166] Disposable containers 1 may in particular be integrated in filtration/fermentation and reconditioning installations, such as, for example, virus filtration/chromatography or crossflow installations.

[0167] The disposable container 1 may be a disposable bioreactor bag having flexible walls, such as, for example, a Biostat® Cultibag® agitation reactor, bioreactor bag, a Cultibag® RM-Rocking bioreactor bag of the Wave® type, an agitation bag of the Agitation-ORB® type or other flexible bioreactor bags. The disposable container 1 may further be a disposable 3D bioprocess bag, for example, a Palletank® storage or mixing bag, a LevMix® or MagMix® mixing bag, other flexible 3D bioprocess bags or 3D bag covers. The disposable container 1 may also be a disposable bioprocess bag with 2 dimensions, for example, a FlexBoy®, Celsius® or other 2D-bioprocess bag. The disposable container 1 may also be a disposable bioreactor container with rigid container walls 12, such as, for example, the Biostat® SU, the TAP Biosystems ambr15, the ambr250 and other rigidly covered bioreactor containers. The disposable container 1 may also be a rigid-walled CellSTACK® container for single use which is a multi-chamber plastics material container with rigid walls. For example, for tissue culture of growing adherent cells inter alia fixed wall CellSTACK® containers are used.

[0168] The term “activating an overpressure protection means 5” is in particular intended to be understood to mean that the overpressure protection means 5 performs its function at the time at which it is activated. In particular, an activation may involve a pressure exceeding a maximum value and thus an activation pressure, whereby an overpressure protection means 5 is activated in such a manner that it forms an opening and consequently can at least prevent the pressure P within the device 10 or a portion of the device 10 from rising further. Through the opening, after the activation of the overpressure protection means 5, at least a portion of the medium 11 located in the device 10 can escape and/or be discharged in a controlled manner and/or be discharged and/or returned. In specific cases, after an overpressure protection means 5 has been activated, the pressure P in the device 10 or in at least a portion of the device may even be reduced compared with the value prior to the activation.

[0169] An overpressure protection means 5 may also be connected in fluid terms to at least one filter. Such a filter may, without being limited thereto, be or comprise a hydrophobic ventilation filter, a hydrophilic liquid filter, a sterilizing filter, a virus retention filter, a combined hydrophilic/hydrophobic filter, a blocking filter, a filter series with a plurality of filters. Filters may prevent toxic and/or hazardous substances, in particular aerosols which are discharged from the system 100 and/or the device 10, from impairing a user and/or escaping into the environment.

[0170] A line 3, a bypass line 3b, a discharge 3c and/or an overpressure protection means 5 may comprise at least one filter, in particular a membrane filter. The filter may, without being limited thereto, be a hydrophobic ventilation filter, a hydrophilic liquid filter, a sterilizing filter, a virus retention filter, a combined hydrophilic/hydrophobic filter, a blocking filter and/or a filter line with a plurality of filters. A branch or a combination of filters may also be provided and can include separate hydrophilic and hydrophobic filters.

[0171] A device 10 comprises at least the features of the device 10 which are included by the first main claim. The embodiments of the device 10 illustrated by way of example in the drawings or Figures also include additional features which are intended to be understood to be optional.

[0172] A target container comprises all known containers which are considered to be disposable containers. Furthermore, a target container comprises an open or closed vessel, a (pipe) line, a container, a (bio) reactor and other containers for preparing or processing fluids.

LIST OF REFERENCE NUMERALS

[0173] 1 Disposable container

[0174] 1a Additional second container

[0175] 1b Additional third container also called target container

[0176] 2 Inlet and/or outlet

[0177] 3 Line

[0178] 3a Main line

[0179] 3a′ Portion arranged upstream of the overpressure protection means with respect to a flow direction in the main line

[0180] 3a″ Portion arranged downstream of the overpressure protection means with respect to a flow direction in the main line

[0181] 3b Bypass line

[0182] 3c Discharge

[0183] 4 Pressure-producing means, for example, a pump

[0184] 5 Overpressure protection means

[0185] 6 Pressure measuring device, for example, manometer

[0186] 7 Resistance, for example, filter (installation)

[0187] 8 Feedback between the overpressure protection means and pump

[0188] 9 System which may be open or closed

[0189] 10 Device

[0190] 10a First part-system which is closed or open

[0191] 10b Second part-system which is closed or open

[0192] 11 Medium

[0193] 12 Container walls

[0194] 13 Bursting disk

[0195] 14 Opening in the bursting disk

[0196] 15 Non-return valve

[0197] 16 Desired breaking locations or seam

[0198] 17 Convex-curved face of a bursting disk

[0199] 18 Triangular part-portions of the convex-curved face of a bursting disk

[0200] 19 Annular frame

[0201] 20 Closure element of a non-return valve

[0202] 21 Restoring spring of a non-return valve

[0203] 100 System

[0204] F Flow direction

[0205] G Closed state of the overpressure protection means

[0206] O Open state of the overpressure protection means

[0207] P Pressure in front of the overpressure protection means

[0208] P.sub.1 Pressure in the container

[0209] P.sub.2 Pressure in the main line in front of the pump

[0210] P.sub.3 Pressure in the main line after the pump

[0211] P.sub.4 Pressure in the main line and where applicable in the second container after the resistance

[0212] P.sub.5 Pressure in front of the pressurized disposable container

[0213] P.sub.6 Pressure in the discharge and where applicable in the third container

[0214] V Container volume of the disposable container

[0215] ZV Target volume