Methods for Integrity Testing of Disposable Systems

Abstract

A method for integrity testing of a disposable system (116) for processing at least one flowable material (112), particularly for use in pharmaceutical processing, is disclosed. The method includes the steps of: i.) providing at least one disposable system (116) for processing at least one flowable material (112), the disposable system (116) having at least one plastic component; ii.) applying at least one test gas (124) to at least one lumen of the disposable system (116), particularly via at least one connector (122) of the disposable system (116), the test gas (124) having one or more spectral absorption or spectral emission characteristics in the infrared spectral range that are distinguishable from ambient air; and iii.) monitoring at least a portion of the disposable system (116) using an infrared camera (126). Further disclosed is a method for processing at least one flowable material (112) by using at least one disposable system (116), a testing system (114) for integrity testing of the at least one disposable system (116) for processing the at least one flowable material (112), and a processing system (110) for processing the at least one flowable material (112).

Description

Technical Field

[0001] The present invention refers to a method for integrity testing of a disposable system for treating at least one fluid material and a test system for integrity testing of at least one disposable system for treating at least one fluid material. The present invention further relates to a method and a treatment system for treating at least one fluid material. The method and system according to the present invention can be used, in particular, for the treatment of pharmaceutical materials, such as the preparation of pharmaceutical materials and / or the packaging of pharmaceuticals, including the packaging of vaccines and other biological or pharmaceutical materials. However, other applications may also be possible.

Background Art

[0002] In various technical fields, there is a strong need for separation of processes, materials, or thermal energy. As an example, in the field of civil engineering or construction engineering, the quality of insulation is typically inspected by using a thermal imaging camera to detect leaks or failures during insulation. Similarly, in the field of chemical engineering, leak tests are used to detect leaks in pipelines or chemical reactors, and various tests are generally known, including thermal cameras for detecting emerging chemical products such as gaseous hydrocarbons.

[0003] In the processing of pharmaceuticals such as vaccines, single-use systems (SUS), also known as disposable systems, are commonly used for the manufacture, transport, storage, or packaging of pharmaceutical materials. For this purpose, single-use manufacturing technologies, including appropriate standards for these single-use systems, have been developed in recent years. An overview of single-use technologies can be found in "Design, controlling and monitoring of single-use systems for integrity assurance," Bio-Process Systems Alliance, 2017, available at https: / / bpsalliance.org / technical-guides. A single-use system may typically comprise multiple plastic components made from one or more plastic materials, such as tubes, connectors, bags, containers, and other components.

[0004] In disposable systems, there is a need for integrity assurance, including testing of barrier properties and leaks. Specifically, disposable systems containing plastic materials are increasingly being used for the manufacture of sterile pharmaceuticals such as vaccines. However, processing components made of plastic materials are more sensitive to mechanical loads and strains and are more susceptible to potential damage and leaks compared to components made of metal materials such as stainless steel.

[0005] Various methods for testing the integrity of disposable systems for pharmaceutical manufacturing are generally known to those skilled in the art. These tests can be found in the aforementioned publication by the Bio-Process Systems Alliance, particularly pages 14-22. Specifically, for leak detection in disposable systems, a pressure decay test is known in which pressure is applied to the system and the pressure drop due to the leak is monitored over time. Other tests are also known that measure the gas flow rate required to maintain the system pressure during the test. Furthermore, a helium integrity test is known in which the container to be tested is filled with helium and placed in a vacuum chamber connected to a helium mass spectrometer.

[0006] The article "Best Practices in Qualification of Single-Use Systems - Bioprocess Development Forum" by Weibing Ding on September 10, 2015, at http: / / www.processdevelopmentforum.com / articles / best-practices-in-qualificationof-single-use-systems / describes best practices for the technical certification of single-use systems for bio-manufacturing processes, including those involving fluids. The article, in particular, lists aspects of validation guidelines for common polymers and single-use systems used in most disposable components.

[0007] European Patent Application Publication No. 0632259 discloses a device for detecting leaks in a component, comprising a device for passing a gas through a component to be inspected, a camera having narrowband filter characteristics essentially matching the spectral absorption of the gas, and a device connected to the camera for processing and displaying recorded images of the component to be inspected.

[0008] However, known tests for disposable systems involve several technical challenges in everyday use. Thus, as outlined above, disposable systems are highly sensitive to mechanical loads and strains. Consequently, with respect to pressure testing, the applicable pressure to the system's components depends heavily on the size of the component being tested. Typically, the larger the component under test, the lower the applicable pressure, resulting in lower test sensitivity. For example, with respect to a highly sensitive component, leaks in the 100 μm size range may be detected, while for sterilization purposes, acceptable leaks are typically well below 30 μm. Further technical challenges arise from the fact that components in typical disposable systems are made of deformable materials such as plastics. As a result, changes in the volume or lumen of the component may occur during testing, which can negatively impact the accuracy and reproducibility of leak measurements. Typically, larger components must be inserted into the measurement chamber. Nevertheless, more complex systems, including tubes and bags or containers, typically cannot be inserted into these chambers, and therefore, testing these more complex systems is strongly desired. Furthermore, typical leak tests cannot test the system or system components in the state they are in when inserted into the processing setup.

[0009] Similarly, helium integrity testing typically requires the use of a vacuum chamber. While these tests are generally known to offer higher reliability and resolution, they generally require considerable technical effort. Furthermore, the possible shapes of the test components are limited by the size of the vacuum chamber. Also, regarding pressure testing, testing while inserted into a processing setup is generally not possible with helium testing.

[0010] Furthermore, with respect to both pressure and helium tests, the tests are typically only suitable for detecting the total amount of leaks. Thus, the pressure or helium released from all leaks is integrated by the measurement setup without distinguishing between one large opening or multiple smaller leaks. However, for the purpose of integrity, multiple small leaks, such as several leaks with an effective size significantly smaller than 30 μm, may still provide a sufficient sterile barrier and still prevent the entry of microorganisms such as bacteria, whereas large leaks do not.

[0011] As a result, despite the advantages and advancements achieved in disposable systems in recent years, several significant technical challenges remain related to integrity testing. Therefore, testing should generally be conducted without the need to use large test chambers, including vacuum chambers. Furthermore, larger disposable systems, including larger components or assemblies of components, should be tested. Moreover, it is desirable to test components or even complete systems in an integrated state, such as when integrated into processing setups, including manufacturing and / or packaging setups. Furthermore, it is necessary to distinguish between small and large leaks, in contrast to known integration methods. In addition, the potential errors in leak measurements mentioned above, due to the elastic or deformable properties of components, should be avoided by the measurements. Finally, the sensitivity of leak testing must be increased, as decomposition of leaks down to 10 μm is typically required to ensure the entry of microbial contamination. [Overview of the project] [Problems that the invention aims to solve]

[0012] Therefore, it is desirable to provide methods, devices, and systems that address the aforementioned technical challenges of disposable systems for processing via materials such as gaseous and / or fluid materials, specifically in the field of pharmaceutical manufacturing or packaging. Specifically, methods and systems that enable high-throughput, low-risk, low-cost integrity testing of disposable systems with high sensitivity to leaks are desirable. [Means for solving the problem]

[0013] This problem is addressed by a method for testing the integrity of a disposable system for processing at least one fluid material, and a test system for testing the integrity of at least one disposable system for processing at least one fluid material, as well as by a method and processing system for processing at least one fluid material having the features of the independent claims. Advantageous embodiments that can be achieved by a single method or any arbitrary combination are enumerated in the dependent claims.

[0014] As used below, the terms “have,” “comprise,” or “include,” or any grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms can refer to both situations in which the entity described in relation to it has no further features other than those introduced by these terms, and situations in which one or more additional features exist. For example, the expressions “A has B,” “A has B,” and “A includes B” can refer to situations in which, other than B, no other elements exist in A (i.e., A consists solely and exclusively of B), and situations in which, in addition to B, one or more elements exist in entity A, such as elements C, elements C and D, or further elements.

[0015] Furthermore, it should be noted that terms indicating that a feature or element may exist once or more times, such as "at least one," "one or more," or similar expressions, are typically used only once when introducing each feature or element. In most cases below, when referring to each feature or element, the expressions "at least one" or "one or more" will not be repeated, despite the fact that each feature or element may exist once or more times.

[0016] Furthermore, as used below, the terms “preferably,” “more preferably,” “particularly,” “more especially,” “specifically,” “more specifically,” or similar terms are used in conjunction with optional features without limiting the possibility of alternatives. Thus, features introduced by these terms are optional features and are not intended to limit the scope of the claims. The present invention may be implemented by using alternative features, as those skilled in the art will recognize. Similarly, features introduced by “in embodiments of the present invention” or similar expressions are intended to be optional features, without limiting the scope of the present invention, without limiting the possibility of combining the features thus introduced with other optional or non-optional features of the present invention.

[0017] In a first aspect of the present invention, a method for testing the integrity of a disposable system is disclosed, which is configured to process at least one fluid material, specifically for use in pharmaceutical processing. The method comprises the following steps: The steps of the method may be carried out in a given order, specifically; however, different orders are also possible. Two or more steps of the method may be carried out simultaneously or in overlapping time. Thus, it is further possible to repeat one, two, or all of the steps of the method. The method may include additional steps of the method that are not enumerated.

[0018] This method is i.) A step of providing at least one disposable system for processing at least one fluid material, wherein the disposable system has at least one plastic component, ii.) Specifically, a step of applying at least one test gas to at least one lumen of a disposable system via at least one connector of the disposable system, wherein the test gas has one or more spectral absorption or spectral emission properties in the infrared spectral range that are distinguishable from ambient air, iii) The step of monitoring at least a portion of the disposable system by using an infrared camera.

[0019] Specifically, as outlined in more detail below, the method may be configured for leak testing on a micrometer scale, such as detecting single leaks with a diameter of less than 100 μm or equivalent, specifically less than 50 μm in diameter, including leaks from 5 μm to 10 μm.

[0020] As used herein, the term “integrity testing” is a broad term, and its usual customary meaning should be given to those skilled in the art, and not limited to any special or customized meaning. Specifically, the term may refer, without limitation, to the process of obtaining information on at least one item relating to the integrity of a subject. Within this, the term “integrity” is also a broad term, and its usual customary meaning should be given to those skilled in the art, and not limited to any special or customized meaning. Specifically, the term may refer, without limitation, to the properties of a subject that satisfy one or more integrity criteria. Specifically, integrity and integrity testing may refer to the leak-tightness of a subject, specifically, a subject having at least one lumen enclosed by one or more walls. For further possible definitions and examples of integrity, refer to the aforementioned publications by the Bio-Process Systems Alliance.

[0021] As used herein, the term “disposable system” is a broad term, and its ordinary, customary meaning should be given to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may mean, without limitation, a system comprising one or more interacting system components, which is configured as a single-use and / or disposable system.

[0022] A disposable system includes at least one plastic component, i.e., at least one component made entirely or partially from at least one plastic material. For example, the at least one plastic material may include at least one plastic material selected from the group consisting of polyethylene such as low-density polyethylene and / or high-density polyethylene, polypropylene, substituted polyethylene, fluorinated polymer, silicone material, polycarbonate, ethylene vinyl acetate polymer, polyester, composite material, multilayer film, polytetrafluoroethylene, fluorinated polyvinylidene, difluorinated polyvinylidene, ethylene vinyl acetate, and poly(ethersulfone).

[0023] For example, at least one plastic component of a disposable system may include at least one plastic component selected from the group consisting of at least one connector element made at least partially of plastic, at least one tube element made at least partially of plastic, at least one bag element made at least partially of plastic, at least one container element made at least partially of plastic, at least one valve element made at least partially of plastic, at least one filter capsule, at least one sampling system such as at least one sampling system including at least one bag and / or at least one capsule, and at least one syringe. Further options and / or embodiments of disposable systems may be referenced from the aforementioned publications by the Bio-Process Systems Alliance. However, other options are also feasible. Integrity testing methods may refer to integrity testing of one or more disposable systems. Furthermore, integrity testing methods may refer to integrity testing of the entire disposable system or at least a part of a disposable system. In addition to at least one plastic component, a disposable system may also include at least one component made of at least one non-plastic component, such as at least one component made of at least one metallic material. Therefore, for example, a disposable system may be made of at least 50% by weight of plastic components, and additionally and optionally, one or more further components made of other materials such as metal. Therefore, for example, a disposable system may include one or more plastic components, such as one or more plastic tubes, and in addition, one or more metal components, such as one or more of at least one metal connector element and at least one metal valve.

[0024] The disposable system is configured to process at least one fluidic material. As used herein, the term "fluidic material" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or customized meaning. Specifically, the term can refer to at least one bulk material, such as, without limitation, at least one of a liquid material, a gaseous material, and a powder. Mixing of two or three or more materials is also possible.

[0025] For the purpose of processing at least one fluidic material, the disposable system, as outlined above, may comprise at least one plastic component having at least one lumen surrounded by at least one component, specifically at least one wall, preferably at least one wall made entirely or in part of at least one plastic material. Thus, the disposable system may comprise at least one hollow and / or tubular component through which at least one fluidic material, such as at least one gaseous material and / or at least one fluid material, may flow. Additionally or alternatively, the disposable system may comprise at least one storage section for a container component that may be temporarily or permanently filled with at least one fluidic material, such as at least one gaseous material and / or at least one fluid material, for other purposes, such as storage purposes and / or for the transfer, reaction, phase change, mixing, splitting, separation, or other processes or process steps typically carried out with fluidic materials. Again, additionally or alternatively, the disposable system may comprise one or more connectors, such as one or more ports, through which one or more materials enter and / or exit the disposable system. As will be appreciated by those skilled in the art, other components, such as one or more valves, one or more regulators, one or more sensors, etc., may be present in the disposable system.

[0026] As outlined above, in step i.), at least one disposable system is provided. To provide a disposable system, various options are feasible. Thus, by way of example, the disposable system may comprise one or more components. In relation to step i.), the disposable system may be provided in a pre-assembled state, such as by being assembled or purchased. The disposable system may be provided at a stage where it is ready to be used to process at least one fluidic material, and / or may be provided in a partially assembled state, such as by providing some of the disposable system, and further assembly steps may be required, such as by connecting some of the disposable system components before processing the fluidic material.

[0027] In step ii.), the method includes the step of applying at least one test gas to at least one lumen of the disposable system. As outlined above, the term "lumen" as used herein is a broad term and should be given its ordinary customary meaning to those skilled in the art and should not be limited to a special or customized meaning. Specifically, the term may refer, without limitation, to the internal space of the disposable system that is completely or partially surrounded by at least one wall of the disposable system. The lumen may have a tubular shape and / or may have another shape, such as is typical for, for example, the bag element and / or container element of the disposable system. By way of example, the wall may specifically be made of at least one plastic material.

[0028] The application of at least one test gas may be carried out specifically via at least one test gas supply unit, such as one or more test gas supply units selected from the group consisting of test gas bottles, test gas containers, test gas generators, test gas pipelines, test gas tubes, and pumps for pushing or carrying the test gas into a lumen. The test gas supply unit may preferably provide the test gas outside at least one lumen of the disposable system. However, additionally or alternatively, one or more test gases that are at least partially generated within the disposable system may be applied, such as by applying one or more process gases as test gases, such as one or more gases used or generated during processing, for example, gases generated during fermentation and / or one or more inert gases. The application of the test gas may be carried out specifically via at least one connector of the disposable system. Thus, as an example, the disposable system may comprise at least one of the following: a screw connector, or a plug-in connector, a Luer lock connector, a bayonet connector, etc. At least one connector may be dedicated to the application of the test gas. However, alternatively, at least one connector may also be dual-purpose and used later for processing fluid materials, such as supplying one or more fluid materials to a disposable system. Therefore, for example, at least one connector may alternatively be connectable to a test gas supply unit or a supply unit for at least one fluid material. To switch between these options, at least one connector may also include at least one switchable valve, such as a three-way valve. The test gas supply unit may include at least one sterile filter. The sterility and / or purity of the test gas may be checked periodically.

[0029] As used herein, the term “test gas” is a broad term, and its usual customary meaning should be given to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer, without limitation, to gaseous materials specifically used for integrity testing of disposable systems. Among these, pure materials or mixtures of materials may be used as test gases. As further outlined above, at least one test gas is selected so that the test gas is configured to emit and / or absorb electromagnetic radiation in the infrared spectral range, thereby allowing the spectral absorption and / or spectral emission properties of the test gas in the infrared spectral range to be distinguished from ambient air. As commonly used herein, the term “infrared spectral range” is a broad term, and its usual customary meaning should be given to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer, without limitation, to a range having one or more wavelengths or wavelength components in the range of 780 nm to 1 mm, or frequencies of frequency components in the range of 300 GHz to 400 THz, or 10 cm -1 From 12800cm -1 This can refer to the spectral range of electromagnetic radiation having wavenumbers within that range.

[0030] For example, the molar decay coefficient of a test gas may differ from that of ambient air by at least 1.1 times, more specifically at least 1.5 times, at least 2.0 times, or more. For example, the molar decay coefficient of a test gas may generally be greater than 1. Additionally or alternatively, the test gas may emit electromagnetic radiation in the infrared spectral range, with emission characteristics different from ambient air. For example, the test gas may or may contain at least one molecule having at least one bond or group that can vibrate at frequencies in the infrared spectral range. For example, it is generally known to those skilled in the art that carbon dioxide emits electromagnetic radiation in the infrared spectral range, which is thought to be due to the specific molecular structure of this molecule. Therefore, although we do not wish to be bound by this theory, carbon dioxide has a double bond in which a carbon atom is inserted between two oxygen atoms, and each of the carbon and oxygen atoms is connected by a double bond, and the carbon atom is approximately 2349 cm⁻¹ -1 Corresponding to the wavenumber and wavelength of approximately 4.26 μm, it can oscillate at a frequency of approximately 70 THz. As a result, for example, the test gas may contain and / or consist of carbon dioxide. However, it should be noted that other test gases with infrared spectral properties may also be used additionally or as substitutes.

[0031] Disposable systems can, specifically, be sterile and / or be completely or partially sterilized during and / or before processing. For example, disposable systems can be completely or partially sterilized by using gamma sterilization and / or other sterilization methods known to those skilled in the art. As a result, the application of at least one test gas can be carried out in a sterilization manner, specifically by using at least one sterile filter, such as two or three or more sterile filters into which the test gas is induced before, during, or after entering one or more further components of the disposable system.

[0032] As further outlined above, in step iii), at least a portion of the disposable system is monitored by using at least one infrared camera. Among these, one or more infrared cameras may be used. The term “infrared camera” as used herein is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer, without limitation, to a spatially resolved optical detector capable of detecting at least one spectral characteristic of at least one object or environment in a spatially resolved manner, where the spectral characteristic is a spectral characteristic in the infrared spectral range. Infrared cameras are sometimes also called thermographic cameras or thermal imaging cameras, without limitation of the spectral range. As an example, at least one infrared camera may comprise at least one infrared camera chip having multiple pixels highly sensitive in the infrared spectral range, such as a CCD and / or CMOS chip. Among these, many sensors suitable for infrared detection, such as photodiodes or photoconductors highly sensitive in the infrared spectral range, are generally known to those skilled in the art. As an example, narrow-bandgap semiconductors such as indium antimonide, indium arsenide, cadmium mercury telluride, lead sulfide, lead selenide, or one or more of these in combination may be used. Additionally or alternatively, materials or photosensitive elements suitable for changing one or more resistances, voltages, or currents when heated by infrared radiation may be used. At least one infrared camera chip may be actively cooled, for example, by using at least one cooling element such as a Stirling refrigerator, a Peltier element, liquid nitrogen, or liquid helium. In addition to at least one infrared camera chip, at least one infrared camera may comprise one or more optical elements such as one or more lenses, prisms, reflectors, concentrators, diaphragms, or combinations thereof. At least one optional optical element may be made of one or more materials suitable for transmitting electromagnetic radiation in the infrared spectral range.Therefore, as an example, one or more materials selected from the group consisting of germanium, calcium fluoride, or crystalline silicon may be used. Other materials are also feasible. At least one optical element may also have an anti-reflective coating. As an example, a thermal detection camera and / or gas detection camera may be used, such as a commercially available thermal detection camera and / or gas detection camera. As an example, a commercially available infrared camera may be used, such as a GF series camera such as the GF343, available from FLIR Systems, Inc., Wilsonville, Oregon, USA. Other infrared cameras may be used. These thermal detection cameras are typically used in engineering, housing, or large industrial facilities to detect leaks in insulation products or large pipelines, for example. Surprisingly, as will be shown later, these infrared cameras may also be used in relation to the present invention, specifically at the micron scale, to detect leaks down to a few micrometers or less, when a temperature gradient is established between the test gas and the background, such as ambient air and / or background elements, to increase sensitivity.

[0033] As used herein, the term “monitor” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may mean, without limitation, one or more of detecting at least one property of an object and detecting changes in at least one property of the object over time. For example, the at least one property may be selected from the group consisting of physical properties, chemical properties, or biological properties. In the present invention, monitor may specifically refer to at least one optical property and / or at least one mechanical or fluid property of at least a part of a disposable system, such as a leak and / or release of a test gas from the disposable system.

[0034] The monitor may specifically include taking one or more images of at least a portion of a disposable system. These images may be a single image, a series of images, or a video. The monitor may also specifically include deriving information of at least one item from at least one image, such as integrity information of at least one item, as outlined in further detail below. The integrity information of at least one item may specifically include leak information of at least one item. For this purpose, the monitor may be fully or partially computer-based, or supported by at least one computer. Specifically, the monitor may include using one or more image recognition algorithms.

[0035] The method may, specifically, return integrity information for at least one item relating to the integrity of a disposable system. Therefore, the information for at least one item relating to the integrity of a disposable system may include at least one item that qualitatively and / or quantitatively assesses the integrity of the disposable system, such as whether the disposable system meets one or more integrity criteria, such as a criterion for leak characteristics. For example, the integrity information for at least one item may include information for at least one item indicating whether the disposable system contains one or more leaks with a diameter exceeding or equivalent to at least one predetermined threshold, such as a threshold of 30 μm, 20 μm, or 10 μm. The integrity information for at least one item may be, or include, binary item integrity information, such as single-item integrity information indicating whether one or more integrity criteria are met. Additionally or alternatively, the integrity information for at least one item may also include additional information, such as information quantifying the degree of conformity to one or more integrity criteria.

[0036] As outlined above, the test gas can specifically contain carbon dioxide. The method can specifically be carried out in ambient air under normal conditions, or at a normal pressure of 1013 mbar and a room temperature of 25 °C. Specifically, the disposable system and / or the test gas can have the same temperature as the ambient air.

[0037] As an example, the ambient air can have a flow velocity u when carrying out the method. The flow velocity of the ambient air can occur randomly, such as by chance. Additionally or alternatively, the flow velocity of the ambient air can be controlled and thus can occur due to specifically adjusted ambient conditions, such as in a cleanroom environment. Thus, generally, the method can include a step of using at least one flow regulator, which is configured to control at least one of the flow velocity of the ambient air, the mass flow rate of the ambient air, and the volume flow rate of the ambient air. As an example, the flow regulator can comprise at least one ventilation device. Further, additionally or alternatively, the flow regulator may comprise at least one filter device for filtering the ambient air, such as a HEPA filter. As an example, the ambient air, such as the air surrounding the disposable system when carrying out the method, can move at a speed between 0 and 0.5 meters per second (m / s). Thus, the flow velocity u of the ambient air can specifically be 0 m / s < u ≤ 0.5 m / s, more specifically 0.05 m / s ≤ u ≤ 0.3 m / s. Measuring the flow velocity can be an optional element of the method.

[0038] A disposable system can be made entirely of one or more plastic components. Alternatively, hybrid systems are also feasible, such as a system containing one or more plastic components and one or more components made of other materials, such as metal. In the case of leak testing as part of integrity testing, leak testing may be performed on at least one plastic component and / or on at least one interface between at least two plastic components and / or between at least one plastic component and at least one non-plastic component. In this process, the integrity of the entire system, or the integrity of one or more components of the system, may be tested.

[0039] As outlined above, the method may be fully or partially computer-controlled or performed by a computer. Specifically, one or more of steps ii) and iii) may be computer-controlled or performed by a computer. For example, the method may utilize at least one computerized valve for applying and / or controlling the test gas, such as the flow and / or pressure of the test gas. Additionally or alternatively, monitoring of at least part of the disposable system by using at least one infrared camera may be computer-controlled or performed by a computer. For example, at least one infrared camera may be connected to at least one computer having at least one processor, the at least one computer being configured to control the infrared camera and / or process data such as image data provided by the infrared camera, by software programming or the like. The computer may be part of an evaluation system or evaluation apparatus. The computer may also be configured for image processing, such as evaluating one or more images provided by an infrared camera, and / or deriving information about one or more items from one or more images provided by an infrared camera, such as integrity information for one or more items.

[0040] The method may further include a step of optically improving the contrast of one or more images provided by at least one infrared camera. Specifically, in the infrared spectral range, the quality and / or contrast of an image may depend heavily on the control of environmental conditions such as ambient temperature or background temperature. Therefore, the method may be carried out entirely or partially in a temperature-controlled environment. Additionally or alternatively, step iii) may include providing at least one background element, wherein at least a portion of a disposable system monitored by using an infrared camera is positioned at least partially between the background element and the infrared camera. Specifically, the at least one background element may be positioned entirely or partially within the field of view of the infrared camera such that the background element can be seen as a background in at least one image captured by the infrared camera. As a result, the term “monitor” as used herein is a broad term and should be given its usual customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer, without limitation, to an element that forms a visible background in at least one image of an infrared camera. The background element may be, or include, a flat or curved surface, such as a screen or screen surface. For example, the background element may include at least one visually uniform background screen, where the visual uniformity may specifically result in non-uniformity of the infrared spectral range used by the infrared camera, preferably 10% or less, preferably 5% or less, 2% or less, or even 1% or less, with respect to the intensity variation across the image of the background element captured by the infrared camera.

[0041] For at least some monitors of the disposable system in step iii.) of the process, at least a part of the disposable system can be placed within the field of view of an infrared camera, and specifically, the disposable system can be positioned at a distance d from the infrared camera. As an example, the distance d between the disposable system and the infrared camera can enable sufficient and safe monitoring of the disposable system. In particular, the disposable system can be positioned at a distance of up to 2 meters (m) from the infrared camera such that the distance d can be 0m < d ≤ 2m. Specifically, the distance d between the disposable system and the infrared camera can be 0.05m ≤ d ≤ 1.5m. More specifically, the distance d between the disposable system and the infrared camera can be 0.1m ≤ d ≤ 1.2m. Preferably, the distance d between the disposable system and the infrared camera can be 0.25m ≤ d ≤ 1m. More preferably, the distance d between the disposable system and the infrared camera can be 0.5m.

[0042] The disposable system can be further positioned at a distance L from at least one background element provided, for example, in step iii.) of the method. In particular, the disposable system can be positioned at a distance of up to 0.5 meters from the background element such that the distance L can be 0m ≤ L ≤ 0.5m. Specifically, the distance L between the disposable system and the background element can be 0.05m ≤ L ≤ 0.25m. More specifically, the distance L between the disposable system and the background element can be 0.08m ≤ L ≤ 0.15m. Preferably, the distance L between the disposable system and the background element can be 0.1m.

[0043] At least one background element may be mechanically disconnected from the infrared camera. Alternatively, the background element may also be mechanically connected to the infrared camera. Thus, as an example, the method may utilize a frame, mount, or rack connecting at least one infrared camera to at least one background element to provide defined, reproducible spatial positioning between these elements. Between them, the mount, rack, or frame may leave sufficient space for at least one disposable system and / or at least a part thereof.

[0044] At least one background element may be temperature-controlled, specifically, all or partially. For example, at least one background element may include at least one temperature controller. Additionally or alternatively, at least one background element may include at least one temperature sensor in addition to at least one heating element and / or at least one cooling element. Generally, at least one background element may be actively heated or actively cooled, or actively heated and actively cooled, specifically by at least one of a fluid control element and an electrical control element, more specifically by at least one Peltier element. However, passive heating and / or passive cooling are also possible, additionally or alternatively. Other means of heating and / or cooling may be used, alternatively or additionally.

[0045] Generally, a cold-controlled background is also achievable, but sometimes called a warm background and / or controlled ground. The background element may be, or comprise, at least one of a cooling plate, a hot plate, and / or a heating or cooling panel. In particular, the background element may be, or comprise, one or more of a hot plate, a cooling plate, a cooling panel, and / or a heating panel that are cooled and / or heated by using one or more electrical conditioning elements, such as an electrical heating element including at least one electric heating wire. For example, the electrical conditioning elements of the background element may be arranged in a meandering manner within the plate and / or panel.

[0046] Additionally or alternatively, the background element may be, or comprise, at least one plate and / or panel regulated by one or more fluids, for example, at least one flow-regulating element. Thus, for example, at least one fluid, for example, water, may be transported through the plate and / or panel to regulate it. For example, the flow-regulating element may be arranged in a meandering manner within the plate and / or panel. Specifically, the fluid may be guided through the background element in a meandering manner.

[0047] For example, background elements may be made of one or more of the following materials, at least in part: plastic, ceramic, and metallic. Specifically, the plastic material may be one or more of the following: acrylic materials such as acrylic glass, e.g., polymethyl methacrylate (PMMA), and / or polyvinyl chloride (PVC) materials such as PVC foil, or may include them. Additionally or alternatively, background elements may be made of metallic materials such as aluminum. In particular, background elements may include at least one anodized aluminum as, for example, a surface material. Additionally or alternatively, the anodized aluminum of the background element may be coated on its outer surface with a plastic material, for example, a colored plastic material. For example, a black, optically matte PVC material, such as foil, may be used to coat the outer surface of the background element. The anodized aluminum as the surface material of the background element and, additionally or alternatively, the plastic coating may specifically reduce reflections, such as reflections caused by the use of an infrared camera. In particular, the emission value of the background element may be improved by using a plastic coating, such as a black, matte PVC foil.

[0048] The integrity test may be performed, for example, at ambient temperature, i.e., the ambient temperature of the surrounding air, such as 25°C. The background element may be maintained at a background temperature that differs from the ambient temperature by, for example, at least 1K or at least 2K, in order to provide sufficient temperature contrast, and therefore sufficient contrast in one or more images of the infrared camera. For example, the background temperature may differ from the ambient temperature by at least 2K, specifically 2 to 40K, more specifically 4 to 30K, preferably 10 to 20K. Thus, the test gas may be assumed to be in temperature equilibrium with the disposable system so that when the test gas is released from the disposable system, such as from one or more leaks, the temperature of the test gas may differ by the same amount. In general, the background temperature may be higher or lower than the ambient temperature. For example, the ambient temperature may be room temperature or 25°C, and the background temperature may be 26°C to 60°C, specifically 30°C to 50°C, more specifically 45°C.

[0049] As outlined above, the monitor may also include a complete or partial assessment of the integrity of the disposable system. Thus, step iii) may specifically include detecting one or more leaks in the disposable system. As outlined in more detail below, the monitor may include detecting test gases emitting from the disposable system by evaluating one or more images provided by an infrared camera. Thus, as an example, image recognition may be used to detect and / or quantify leaks by detecting and / or quantifying the flow or jet of test gas in one or more images.

[0050] The method may specifically include a step of returning, i.e., providing and / or transmitting, at least one integrity result. For example, the integrity result may include information on at least one item that quantifies and / or qualitatively assesses the integrity of a disposable system. For example, the integrity result may be provided wirelessly and / or via a wired connection by a test system implementing the method to a user or operator, and / or to another device such as a computer or computer system. The integrity result may, for example, be visually and / or audibly displayed to the user. Specifically, the return of at least one integrity result may be performed automatically by at least one evaluation device in the test system implementing the method, and / or by a computer, for example.

[0051] As outlined above, the monitoring may also include fully or partially evaluating the integrity of the disposable system. Specifically, step iii) may include visually detecting the release of a test gas from the disposable system. Thus, as outlined above, the test gas typically has a temperature different from the ambient air temperature, thereby providing contrast between the test gas and the ambient air and / or between the test gas and background elements in at least one image captured by the infrared camera.

[0052] Specifically, visual detection of the release of the test gas may involve detecting at least one of the following in at least one image captured by an infrared camera: a jet, flow, cloud, or mist of the test gas. Thus, one or more jets, gas flows, gas clouds, or gaseous mist may be detected as linear or curved co-pending coloration in at least one image. Hereafter, whenever the term "at least one jet" of the test gas is used, this expression shall also include the option of at least one flow, cloud, or mist of the test gas instead of a jet.

[0053] Visual detection may be performed by using image recognition, such as computerized image recognition, which is performed on an evaluation device such as an infrared camera and / or a computer in the evaluation device. Thus, generally speaking, the method may include a step of using automated image recognition, specifically computer-based image recognition, to detect the release of a test gas from a disposable system.

[0054] The method may further include a step of automatically quantifying the leak in a disposable system by visually evaluating the jet of the test gas, specifically by using image recognition to evaluate the jet profile of the test gas. Thus, one or more parameters of the detected jet profile, such as the length and / or width of the test gas jet profile, may be specifically automatically evaluated. Furthermore, the image recognition may include using one or more artificial neural networks for image evaluation, thereby qualitatively and / or quantitatively determining the leak in the disposable system. Thus, for example, at least one artificial neural network may be trained by using multiple images of a training component and / or training system that has a well-defined leak and is being tested under well-defined conditions, such as under a known test gas pressure.

[0055] In general, well-defined test conditions may be required to obtain reproducible and reliable test results. Specifically, the pressure of the test gas may be a parameter that is controlled, defined, or at least known in a precise manner. Therefore, one or more pressure monitors or pressure sensors may be used to monitor the pressure of the test gas in a disposable system. Additionally or alternatively, one or more flow monitors or flow sensors may be used to monitor the flow of the test gas into and / or out of the disposable system.

[0056] One advantage of the method of the present invention is that, generally, low pressures of the test gas may be sufficient for the test, thereby avoiding or at least reducing the falsification of measurements by mechanical stress on the disposable system and / or elastic or inelastic expansion or contraction of one or more components of the disposable system, as will be discussed in more detail below. Generally, in step ii), the test gas may be applied to the lumen of the disposable system at pressures from 5 mbar to 300 mbar, specifically from 10 mbar to 200 mbar, more specifically from 20 mbar to 100 mbar, specifically from 50 mbar. These pressures yield satisfactory results in the visual detection of leaks due to low mechanical stress at the same time, although other pressures of the test gas are generally feasible. As used in this context, the term “pressure” may specifically refer to overpressure, i.e., the positive pressure difference between the lumen of the disposable system and the ambient environment. Thus, the pressure may specifically be overpressure exceeding the normal pressure of, for example, 10¹³ mbar.

[0057] As outlined above, step iii) may include capturing multiple images of the disposable system or at least a part thereof, such as a series of images and / or video clips, by using an infrared camera. Specifically, step iii) may include capturing at least one image stream, specifically video, of the disposable system by using an infrared camera.

[0058] Step iii) may include capturing an image of at least one of the entire disposable system, a single component or group of components of the disposable system, or a part of the disposable system. Additionally or alternatively, step iii) may include scanning the disposable system or a part thereof by sequentially monitoring different parts of the disposable system. For scanning purposes, at least one infrared camera, and optionally at least one background element, may be moved relative to the disposable system, or vice versa. For example, a movable stage may be used to move the infrared camera and / or move the disposable system so that images of different parts of the disposable system can be captured sequentially. The movable stage may be computer-controlled, for example.

[0059] Infrared cameras can be sensitive in a subspectral range, specifically in the range of 2 μm to 10 μm, more specifically in the range of 3 μm to 6 μm, and more specifically in the range of 4 μm to 5 μm. As outlined above, carbon dioxide is known to emit infrared radiation at approximately 4.26 μm. Generally, carbon dioxide is a suitable test gas with various advantages. Therefore, at least at low concentrations, carbon dioxide is generally non-toxic and broadly inert to reactions with materials typically used in disposable systems. Furthermore, carbon dioxide is also inert to reactions that may occur with fluid materials that are typically sequentially filled into disposable systems. In addition, the use of carbon dioxide provides a cost-effective means of pressurizing disposable systems.

[0060] An infrared camera may comprise at least one camera chip, as outlined above. The at least one camera chip may be made of one or more of the materials described above, for example. Specifically, the at least one camera chip may be actively cooled by using at least one cooling element, such as at least one Stirling refrigerator. Additionally or alternatively, cooling may be performed by using at least one cooling medium, such as liquid nitrogen and / or liquid helium. The infrared camera may further comprise one or more optical components and / or one or more housings, which may be thermally insulated, as outlined above.

[0061] In a further embodiment, a method for processing at least one fluid material by using at least one disposable system is disclosed. For definitions and examples of processing, refer to the description of the test method above. Specifically, processing may include one or more of the following processes: storage, reaction, phase change, mixing, splitting, separation, or other processes commonly known to those skilled in the art. Specifically, processing may include processing one or more pharmaceutical and / or biological materials, such as one or more pharmaceuticals, such as vaccines. The method includes the following steps: The steps may be carried out specifically in a given order. However, it should be noted that different orders are also possible. Thus, it is possible to carry out step II at least once before carrying out step I. The steps of the method may be carried out specifically independently and at different times, for example, successively but in a way that overlaps in time, or at least partially simultaneously. Furthermore, it is also possible to repeat one or both steps. The method may include additional steps of the method that are not enumerated.

[0062] This method is I. A step of testing the integrity of a disposable system by using a method of integrity testing according to the present invention, such as according to any one of the embodiments disclosed above and / or any one of the embodiments disclosed in further detail below, II. The process includes connecting the disposable system to at least one supply unit of at least one fluid material and at least partially filling the disposable system with the fluid material.

[0063] Therefore, for the purpose of testing integrity, the disposable system may be temporarily connected to at least one test gas supply unit configured to supply at least one test gas to the disposable system. The test gas supply unit may specifically include at least one pressure monitor and / or at least one flow rate monitor, as outlined above. For processing purposes, the test gas supply unit may be separated or disconnected from the disposable system, but instead, the disposable system may be connected to at least one supply unit of one or more fluid materials. Alternatively, the test of step I may be performed after step II. At least one valve, such as at least one three-way valve, may be provided to switch from the test gas supply unit to at least one fluid material supply unit, or vice versa. However, alternatively, switching between supply units may be done manually, such as by unplugging the disposable system from the test gas supply unit or otherwise disconnecting it, and then connecting the disposable system to at least one fluid material supply unit, or vice versa. The supply unit of at least one fluid material may, as an example, include at least one connector, for example, supplying at least one fluid material for processing from a storage container or pipeline to the connector.

[0064] For example, connecting the disposable system to at least one supply of at least one fluid material in step II may be carried out by switching from the test gas supply to at least one fluid material supply, for example, automatically, by using at least one switch, such as a valve. Thus, the connection may be carried out specifically, for example, by manually disconnecting the disposable system from the test gas supply and then controlling at least one switch, such as a valve, without reconnecting the disposable system to at least one supply of one or more fluid materials. Thus, as an example, a method for processing at least one fluid material may specifically include a step of providing at least one switch for switching from at least one test gas supply to at least one supply of one or more fluid materials, or vice versa. This specifically makes it possible to directly test the integrity of the disposable system in a hygienic room where the processing of fluid materials may also be carried out, for example, under the same conditions in which it is used for processing. Thus, the switching may enable, for example, on-site testing of the integrity of the disposable system.

[0065] In a further aspect of the present invention, a test system for integrity testing of at least one disposable system for processing at least one fluid material is disclosed. The disposable system comprises at least one plastic component. The test system is a.) At least one test gas supply unit for applying at least one test gas to at least one lumen of a disposable system, specifically, at least one test gas supply unit connectable to at least one connector of the disposable system, wherein the test gas has one or more spectral absorption or spectral emission properties in the infrared spectral range distinguishable from ambient air, b.) comprising at least one infrared camera for monitoring at least a portion of the disposable system.

[0066] For definitions of the test system and possible embodiments, refer to the description of the integrity test method above.

[0067] The testing system further, c.) At least one evaluation device for evaluating the integrity of a disposable system, the evaluation device being configured to derive integrity information of at least one item from at least one image provided by an infrared camera.

[0068] As used herein, the term “evaluation apparatus” is a broad term, and its usual customary meaning should be given to those skilled in the art, and not limited to any special or customized meaning. Specifically, the term may mean, without limitation, an apparatus capable of performing one or more evaluation operations. Specifically, an evaluation apparatus may comprise at least one programmable processor, with appropriate software, for performing one or more evaluation operations. Specifically, as outlined above, an evaluation may include producing at least one integrity result, such as an integrity result containing information on at least one item relating to integrity, specifically leak rate, leak dimensions, etc. As used herein, the term “processor” is a broad term, and its usual customary meaning should be given to those skilled in the art, and not limited to any special or customized meaning. Specifically, the term may mean, without limitation, an arbitrary logic circuit configured to perform basic operations of a computer or system, and / or generally, an apparatus configured to perform calculations or logic operations. In particular, a processor may be configured to process basic instructions that drive a computer or system. For example, a processor may comprise at least one arithmetic logic unit (ALU), at least one floating-point unit (FPU), such as a numerical arithmetic coprocessor or numerical coprocessor, a number of registers, specifically registers configured to supply operators to the ALU and store the results of operations, and memory such as L1 and L2 cache memories. In particular, a processor may be a multicore processor. Specifically, a processor may be or comprise a central processing unit (CPU). Additionally or alternatively, a processor may be or comprise a microprocessor, and therefore, specifically, the elements of a processor may be contained in a single integrated circuit (IC) chip. Additionally or alternatively, a processor may be or comprise one or more application-specific integrated circuits (ASICs) and / or one or more field-programmable gate arrays (FPGAs), etc.Specifically, the processor may be configured to perform one or more evaluation operations through software programming or other means. For example, the processor may be programmed to perform image recognition, as discussed above.

[0069] At least one evaluation device may be completely or partially isolated from at least one infrared camera. Additionally or alternatively, at least one evaluation device may also be fully or partially integrated with at least one infrared camera. Specifically, at least one evaluation device may be connected to at least one infrared camera by a wired connection or a wireless connection, etc. Specifically, the evaluation device may comprise at least one image processing system. The image processing system may be entirely or partially hardware-based and / or entirely or partially software-based.

[0070] The testing system further, d.) The test system may comprise at least one background element, wherein at least a portion of the disposable system can be positioned at least partially between the background element and the infrared camera.

[0071] For possible embodiments and definitions of at least one background element, refer to the description of the integrity test method above. Specifically, as outlined above, at least one background element may be connected to at least one infrared camera by at least one mechanical connection. Alternatively, however, at least one background element may also be independently arranged and / or positioned.

[0072] The test system may be configured to carry out a method of integrity testing according to the present invention, specifically, by any one of the embodiments disclosed above and / or any one of the embodiments disclosed in more detail below.

[0073] In a further aspect of the present invention, a processing system for processing at least one fluid material is disclosed. The processing system may be configured to carry out a method for processing at least one fluid material according to the present invention, such as by any one of the embodiments disclosed above and / or any one of the embodiments disclosed in further detail below. The processing system A. At least one disposable system for processing at least one fluid material, wherein the disposable system comprises at least one plastic component, B. At least one test system as described in any one of the preceding claims relating to a test system, C. comprising at least one supply unit for fluid material.

[0074] In this context, the disposable system can be selectively connected to the test gas supply unit and the fluid material supply unit of the test system in a switchable manner.

[0075] As used herein, the term “processing system” is a broad term and should be given its usual and customary meaning to those skilled in the art, and should not be limited to any special or customized meaning. Specifically, the term may refer, without limitation, to an apparatus or combination of apparatus configured to carry out at least one method of processing one or more materials, such as flowable materials. Possible definitions and embodiments can be found in the description of the processing method above.

[0076] As outlined above, the methods according to the present invention may be carried out and / or controlled by a computer, in whole or in part. Therefore, in further embodiments, computer programs and computer-readable storage media are disclosed that, when executed on a computer or computer network, fully or partially control, support, or carry out one or more of the methods according to the present invention. Specifically, as outlined above, step ii) may be controlled by a computer. Additionally or alternatively, step iii) may be fully or partially controlled or carried out by a computer. As used herein, the term “computer-readable storage media” may specifically refer to non-temporary data storage means such as a hardware storage medium storing computer-executable instructions thereon. Computer-readable data carriers or storage media may specifically be, or comprise, storage media such as random access memory (RAM) and / or read-only memory (ROM). Computer programs may also be embodied as computer program products. As used herein, computer program products may refer to a program as a tradable product. Products may generally exist in arbitrary formats, such as written documents, or on computer-readable data carriers and / or computer-readable storage media. Specifically, computer program products may be distributed via data networks.

[0077] The methods and systems according to the present invention offer many advantages over known systems and methods of a similar type.

[0078] Therefore, specifically, by using the method and apparatus according to the present invention, integrity testing using one or more infrared cameras, such as one or more thermal detection cameras and / or one or more test gas-specific cameras, can be performed even in complex disposable or disposable systems. Testing of disposable systems before or after use is possible. Specifically, the method and apparatus can be used to create processing steps for pharmaceuticals.

[0079] The method and apparatus may be applied specifically to one or more environments in which the actual processing takes place. For example, the integrity testing method may be performed in a hygienic and / or sterile environment in which the fluid material is processed. In other words, the present invention may be applied at a point of use, such as a hygienic manufacturing site or facility. The present invention may be applied to both unused and used disposable systems, for example, when the disposable system is contaminated with the fluid material. For example, the integrity testing of a disposable system may be performed before use, such as before use. Additionally or alternatively, the integrity testing of a disposable system may be performed after use, such as after use.

[0080] Integrity testing may be performed, for example, by applying a mixture of gaseous carbon dioxide and / or a test gas containing carbon dioxide to a disposable system. The test gas may be applied at an overpressure of 20–100 mbar, for example. The overpressure may also be adapted to the specific requirements of the disposable system and / or part thereof. Thus, for example, lower overpressures may be used for bags, while higher overpressures may be used for tubes. The setup of the disposable system or part thereof may be monitored by using an infrared camera configured to detect carbon dioxide. Static monitoring or scanning is possible. Leaks may be immediately visible on a display, such as the camera and / or the display of the evaluation device, and the location of the leak may be directly visible by the respective opening and, for example, by the gas jet released at the leak.

[0081] The resolution of this method and test system can significantly exceed that of common methods and systems. Therefore, it may be possible to detect leaks smaller than 10 μm, thereby reliably identifying leaks that could lead to microbial contamination. In addition to the sensitivity and resolution of this method, its reliability can be further improved by adjusting the temperature and by inducing temperature gradients in the test environment and / or disposable systems, for example, by using the background elements described above.

[0082] Therefore, generally speaking, the methods and apparatus of the present invention can provide a safe, simple, yet reliable integrity test, specifically relating to leaks. The test can be performed directly in a sanitary room, such as a cleanroom, a sterile room, or one or more of other clean facilities, where further processing of the fluid material is also carried out. Thus, the test and processing can be performed in the same room or facility, for example, under the same sanitary conditions.

[0083] Furthermore, the disposable system may also be tested after processing, for example, if it is contaminated with at least one fluid material. The test may be performed without cleaning the disposable system. However, it is necessary to note that a wet tube may alter or affect the test results.

[0084] Furthermore, the method and apparatus enable the integrity testing of a single leak, rather than merely aggregating leak tests. Therefore, in contrast to testing methods that add leaks to a total value, a single leak, such as a hole, perforation, unwanted opening, crack, or other leak, can be directly detected and analyzed in an isolated manner. As a result, false positive tests for leaks can be avoided, for example, by distinguishing between multiple small leaks and a single large leak.

[0085] The small overpressure required for the test can also avoid the aforementioned mechanical problems. Thus, firstly, mechanical damage to the disposable system can be avoided. Furthermore, tampering with the test due to the formation of undesirable elastic or inelastic formations in the test system can also be reduced compared to known methods of integrity testing.

[0086] Furthermore, as outlined above, the test method can be carried out in ambient air without the need to use a test chamber. Therefore, compared to, for example, known pressure tests or helium leak tests, a pressurized or vacuum chamber is not required, which also allows for integrity testing at the actual point of application of the disposable system. Moreover, large disposable systems can be tested for integrity without the need to disassemble them to the size of a test chamber. Specifically, actual disposable systems used to handle fluid materials can be tested.

[0087] In general, the methods and apparatus according to the present invention enable the processing of at least one fluid material by using a reliable disposable system. The disposable system can be tested by using a low-cost, reliable test that clearly indicates the location and size of possible leaks under realistic conditions. Process efficiency and yield can be increased compared to known processing of fluid materials, as processing using defective equipment can be largely avoided.

[0088] To summarize without excluding further possible embodiments, the following embodiments may be envisioned.

[0089] Embodiment 1: A method for testing the integrity of a disposable system for processing at least one fluid material, specifically for use in pharmaceutical processing, wherein the method is i.) A step of providing at least one disposable system for processing at least one fluid material, wherein the disposable system has at least one plastic component, ii.) Specifically, a step of applying at least one test gas to at least one lumen of a disposable system via at least one connector of the disposable system, wherein the test gas has one or more spectral absorption or spectral emission properties in the infrared spectral range that are distinguishable from ambient air, iii) A method comprising the step of monitoring at least a portion of a disposable system by using an infrared camera.

[0090] Embodiment 2: The method according to Embodiment 1, wherein the test gas contains carbon dioxide.

[0091] Embodiment 3: The method according to Embodiment 1 or 2, wherein the method is carried out in ambient air, specifically at atmospheric pressure and room temperature.

[0092] Embodiment 4: The method according to Embodiment 3, wherein the ambient air has a flow velocity u, specifically 0 m / s < u ≤ 0.5 m / s, more specifically 0.05 m / s ≤ u ≤ 0.3 m / s.

[0093] Embodiment 5: The method according to any one of Embodiments 1 to 4, wherein the method includes a step of using at least one flow regulator, and the flow regulator is configured to control at least one of the flow velocity of the ambient air, the mass flow rate of the ambient air, and the volume flow rate of the ambient air.

[0094] Embodiment 6: At least one plastic component of the disposable system includes at least one sampling system selected from the group consisting of at least one connector element at least partially made of plastic, at least one tube element at least partially made of plastic, at least one bag element at least partially made of plastic, at least one container element at least partially made of plastic, at least one valve element at least partially made of plastic, at least one filter capsule, at least one bag and / or at least one capsule, etc., and at least one plastic component selected from the group consisting of at least one syringe, the method according to any one of Embodiments 1 to 5.

[0095] Embodiment 7: The method according to any one of Embodiments 1 to 6, wherein one or more of the methods, specifically steps ii.) and iii.), are fully or partially computer-controlled.

[0096] Embodiment 8: Step iii.) includes providing at least one background element, and at least a part of the disposable system monitored by using an infrared camera is positioned at least partially between the background element and the infrared camera, the method according to any one of Embodiments 1 to 7.

[0097] Embodiment 9: The disposable system (116) is positioned at a distance d from the infrared camera (126), where 0 m < d ≤ 2 m, specifically 0.05 m ≤ d ≤ 1.5 m, more specifically 0.1 m ≤ d ≤ 1.2 m, preferably 0.25 m ≤ d ≤ 1 m, and more preferably d = 0.5 m, according to the method described in any one of Embodiments 1 - 8.

[0098] Embodiment 10: The disposable system (116) is positioned at a distance L from at least one background element (132), where 0 m ≤ L ≤ 0.5 m, specifically 0.05 m ≤ L ≤ 0.25 m, more specifically 0.08 m ≤ L ≤ 0.15 m, and preferably L = 0.1 m, according to the method described in Embodiment 8 or 9.

[0099] Embodiment 11: The background element comprises at least one visually uniform background screen, according to the method described in any one of Embodiments 8 - 10.

[0100] Embodiment 12: The background element is mechanically connected to the infrared camera, according to the method described in any one of Embodiments 8 - 11.

[0101] Embodiment 13: The background element is temperature - controlled, according to the method described in any one of Embodiments 8 - 12.

[0102] Embodiment 14: The background element is actively heated or actively cooled, or both actively heated and actively cooled, specifically by at least one of a flow - regulating element and an electrical - regulating element, and more specifically by at least one Peltier element, according to the method described in any one of Embodiments 8 - 13.

[0103] Embodiment 15: Either one of the flow - regulating element and / or the electrical - regulating element is arranged to meander within the background element, according to the method described in Embodiment 14.

[0104] Embodiment 16: The method according to any one of Embodiments 8 to 15, wherein the background element (132) is made at least partially of one or more plastic materials, specifically acrylic materials such as acrylic glass and / or polyvinyl chloride (PVC) materials such as polymethyl methacrylate (PMMA) and / or PVC foil, ceramic materials, and metallic materials such as aluminum.

[0105] Embodiment 17: The method according to any one of Embodiments 8 to 16, wherein the integrity test is performed at ambient temperature and the background element is maintained at a background temperature different from the ambient temperature.

[0106] Embodiment 18: The method according to Embodiment 17, wherein the background temperature differs from the ambient temperature by at least 2K, specifically 2-40K, more specifically 4-30K, preferably 10-20K.

[0107] Embodiment 19: The method according to Embodiment 17 or 18, wherein the background temperature is higher than the ambient temperature.

[0108] Embodiment 20: The method according to any one of Embodiments 17 to 19, wherein the ambient temperature is room temperature and the background temperature is 26°C to 60°C, specifically 30°C to 50°C, and more specifically 45°C.

[0109] Embodiment 21: The method according to any one of Embodiments 1 to 20, wherein step iii) includes detecting one or more leaks in a disposable system.

[0110] Embodiment 22: The method according to any one of Embodiments 1 to 21, wherein the method comprises the step of returning at least one integrity result, the integrity result quantifying or qualitatively determining the integrity of a disposable system.

[0111] Embodiment 23: The method according to any one of Embodiments 1 to 22, wherein step iii) includes visually detecting the release of a test gas from a disposable system.

[0112] Embodiment 24: The method according to Embodiment 23, wherein visual detection of the emission includes detecting at least one of a jet, flow, cloud, or mist of the test gas.

[0113] Embodiment 25: The method according to Embodiment 24, wherein the method includes a step of automatically quantifying a leak in a disposable system by visually evaluating a jet, flow, cloud, or mist of the test gas, specifically by using image recognition to evaluate the jet profile of the test gas.

[0114] Embodiment 26: The method according to any one of Embodiments 1 to 25, wherein the method includes a step of using automated image recognition, specifically computer-based image recognition, to detect the release of a test gas from a disposable system.

[0115] Embodiment 27: The method according to any one of Embodiments 1 to 26, wherein in step ii, the test gas is applied to the lumen of a disposable system at a pressure of 5 mbar to 300 mbar, specifically at a pressure of 10 mbar to 200 mbar, more specifically at a pressure of 20 mbar to 100 mbar, specifically at a pressure of 50 mbar, specifically under pressure.

[0116] Embodiment 28: The method according to any one of Embodiments 1 to 27, wherein step iii) includes capturing multiple images of the disposable system by using an infrared camera.

[0117] Embodiment 29: The method according to any one of Embodiments 1 to 28, wherein step iii) includes capturing an image stream, specifically video, of a disposable system by using an infrared camera.

[0118] Embodiment 30: The method according to any one of Embodiments 1 to 29, wherein step iii) includes scanning a disposable system by sequentially monitoring different parts of the disposable system.

[0119] Embodiment 31: The method according to any one of Embodiments 1 to 30, wherein the infrared camera has sensitivity in a subspectral range of at least 2 μm to 10 μm, specifically 3 μm to 6 μm, and more specifically 4 μm to 5 μm.

[0120] Embodiment 32: The method according to any one of Embodiments 1 to 31, wherein the infrared camera comprises at least one camera chip, and at least one camera chip is actively cooled by using at least one cooling element.

[0121] Embodiment 33: A method for processing at least one fluid material by using at least one disposable system, I. A step of testing the integrity of a disposable system by using the method described in any one of Embodiments 1 to 32, II. A method comprising the steps of connecting a disposable system to at least one supply of at least one fluid material and at least partially filling the disposable system with the fluid material.

[0122] Embodiment 34: A test system for integrity testing of at least one disposable system for processing at least one fluid material, wherein the disposable system has at least one plastic component, and the test system a.) At least one test gas supply unit for applying at least one test gas to at least one lumen of a disposable system, specifically, at least one test gas supply unit connectable to at least one connector of the disposable system, wherein the test gas has one or more spectral absorption or spectral emission properties in the infrared spectral range distinguishable from ambient air, b.) A test system comprising at least one infrared camera for monitoring at least a portion of a disposable system.

[0123] Embodiment 35: The test system further, c.) The test system according to Embodiment 34, comprising at least one evaluation device for evaluating the integrity of a disposable system, the evaluation device being configured to derive integrity information of at least one item from at least one image provided by an infrared camera.

[0124] Embodiment 36: The test system according to Embodiment 35, wherein the evaluation device comprises at least one processor.

[0125] Embodiment 37: The test system according to Embodiment 35 or 36, wherein the evaluation device comprises at least one image processing system.

[0126] Embodiment 38: The test system further, d.) A test system according to any one of embodiments 34 to 37, comprising at least one background element, wherein the test system is configured such that at least a portion of the disposable system can be positioned at least partially between the background element and the infrared camera.

[0127] Embodiment 39: The test system according to any one of Embodiments 34 to 38, wherein the test system is configured to perform the integrity test method described in any one of Embodiments 1 to 32, which refers to the integrity test method.

[0128] Embodiment 40: A processing system for processing at least one fluid material, wherein the processing system is A. At least one disposable system for processing at least one fluid material, wherein the disposable system comprises at least one plastic component, B. At least one test system as described in any one of embodiments 34 to 39 that refer to a test system, C. comprising at least one supply unit for fluid material, A processing system in which a disposable system can be selectively connected, specifically in a switchable manner, to the test gas supply section and the fluid material supply section of the test system. [Brief explanation of the drawing]

[0129] Further optional features and embodiments are disclosed in more detail in subsequent descriptions of embodiments, preferably in conjunction with dependent claims. Therein, each optional feature can be implemented in any feasible combination, as will be understood by those skilled in the art, in addition to separate methods. The scope of the present invention is not limited by preferred embodiments. Embodiments are schematically shown in the drawings, where the same reference numerals in these drawings refer to identical or functionally comparable elements.

[0130] [Figure 1] Embodiments of a processing system, a testing system, and a disposable system are shown. [Figure 2] A flowchart shows an embodiment of a method for processing at least one fluid material by using at least one disposable system, and an embodiment of a method for integrity testing. [Figure 3A] This image shows some images of a disposable system that does not use temperature-controlled background elements. [Figure 3B] Figure 3A shows a partial image of the disposable system using a temperature-controlled background element. [Figure 4] An example image for leak testing of components in a disposable system is shown. [Modes for carrying out the invention]

[0131] Figure 1 illustrates an embodiment of a processing system 110 for processing at least one fluid material 112. Furthermore, Figure 1 shows an embodiment of a test system 114 for integrity testing of at least one disposable system 116 for processing at least one fluid material 112. The processing system 110 comprises a disposable system 116 for processing the fluid material 112 and at least one supply unit 118 for the fluid material 112. Furthermore, the processing system 110 comprises a test system 114. Specifically, the processing system 110 may be configured to carry out a method 117 for processing at least one fluid material 112 by using at least one disposable system 116. Method 117 will be described with reference to an exemplary embodiment shown in the flowchart illustrated in Figure 2.

[0132] The test system 114 comprises at least one test gas supply unit 120, specifically at least one test gas supply unit 120 connectable to at least one connector 122 of the disposable system 116. The test gas supply unit 120 is configured to apply at least one test gas 124 to at least one lumen of the disposable system 116, for example, to a certain volume. Specifically, the test gas 124 has one or more spectral absorption or spectral emission properties in an infrared spectral range distinguishable from ambient air. Furthermore, the test system 114 comprises at least one infrared camera 126 for monitoring at least a portion of the disposable system 116. Commercially available infrared cameras, such as portable or stationary infrared cameras, such as those available from FLIR Systems, Inc., Wilsonville, Oregon, USA, as outlined above, may be used. As an example, a camera of type GF343 was used in the experiment to capture the images in Figures 3A, 3B, and 4, which are discussed in more detail below.

[0133] In the processing system 110, the disposable system may be selectively connected to the test gas supply unit 120 and the fluid material 112 supply unit 118 of the test system 114 by a switchable method, for example by a connector 122, for example by a three-way valve.

[0134] Furthermore, the test system 114 may include at least one evaluation device 128 for evaluating the integrity of the disposable system 116. In particular, the evaluation device 128 may be configured to derive integrity information of at least one item from at least one image provided by the infrared camera 126. Thus, the evaluation device 128 and the infrared camera 126 may be configured to transmit information, such as transmitting at least one image and / or at least one set of information, as illustrated in Figure 1 by arrows pointing from the evaluation device 128 to the infrared camera 126 and vice versa. Furthermore, the evaluation device 128 may be used to control the connector 122, for example, a three-way valve, as illustrated in Figure 1 by arrows pointing from the evaluation device 128 to the connector 122 and vice versa. The evaluation device 128 may further include at least one processor 130.

[0135] The test system 114 may further comprise at least one background element 132. The background element 132 may be temperature-controlled, for example, by using at least one temperature sensor 133 and / or at least one temperature controller. For example, the background element 132 may be temperature-controlled by using at least one heating element and / or at least one cooling element and / or at least one temperature controller. Thus, for example, the background element 132 may be kept at a temperature different from the ambient temperature and / or the temperature of the disposable system 116. For example, as outlined above, a temperature difference of 2 to 10 K between the background element and the ambient temperature and / or the temperature of the disposable system 116 may be maintained, such as a temperature difference of 3 to 5 K.

[0136] Specifically, the test system 114 may be configured such that at least a portion of the disposable system 116 is positionable at least partially between the background element 132 and the infrared camera 126. The background element 132 and / or the camera 126 may be connected, for example, by at least one connecting element 135, or they may be positionable independently. In particular, mechanically connecting the infrared camera 126 and the background element 132 via the connecting element 135, as illustrated in Figure 1, may be an optional feature. The background element 132 and / or the camera 126 may also be positionable by one or more stages for automated testing, such as an automated stage, as indicated by arrows in elements 126 and 132 in Figure 1.

[0137] The test system 114 may be configured to perform a method 134 for testing the integrity of a disposable system 116 for processing at least one fluid material 112. Method 134 will be described with reference to an exemplary embodiment shown in the flowchart illustrated in Figure 2.

[0138] Method 134 for testing the integrity of a disposable system 116 for processing at least one fluid material 112 comprises the following steps, which can be performed in a given order. However, different orders are also possible. Two or more steps of the method may be performed entirely or partially simultaneously. Furthermore, one, two or more, or even all, steps of the method may be performed once or repeatedly. Method 134 may include additional steps of the method that are not listed. The steps of the method are as follows: i.) A step of providing at least one disposable system 116 for processing at least one fluid material 112 (as shown in reference no. 136), wherein the at least one disposable system 116 has at least one plastic component, ii.) Specifically, a step of applying at least one test gas 124 to at least one lumen of a disposable system 116 via at least one connector 122 of the disposable system 116, wherein the test gas 124 has one or more spectral absorption or spectral emission properties in the infrared spectral range distinguishable from ambient air, iii) A step of monitoring at least a portion of the disposable system 116 by using an infrared camera 126 (referred to as reference no. 140).

[0139] The application of one or more test gases in step 138 may be carried out at low pressures of 20 to 100 mbar, such as 50 mbar.

[0140] Method 134 may be controlled entirely or partially by computer. Specifically, one or more of steps ii)138 and iii)140 of Method 134 may be controlled by computer.

[0141] The background element 132 may specifically comprise at least one visually uniform background screen 142, as illustrated in Figure 1. Furthermore, the background element 132 may be temperature-controlled. Specifically, the temperature of the background element 132 may be controlled using the evaluation device 128, as illustrated in Figure 1 by arrows pointing from the evaluation device 128 to the background element 132 or vice versa. For example, the background element may be actively heated or actively cooled, or both. However, it should be noted that passive heating and / or passive cooling may also be possible.

[0142] Step iii) 140 may further include detecting one or more leaks 144 in the disposable system 116. For example, leak detection in step iii) may include detecting the release of test gas 124 from the disposable system 116, specifically, at least one jet 146, at least one flow, at least one cloud, or at least one mist of the test gas 124 may be detected.

[0143] Method 134 may include a further step of returning at least one integrity result (as shown in reference no. 148). Specifically, the integrity result may quantify or qualitatively determine the integrity of the disposable system. To return at least one integrity result, for example, the method may further include a step of automatically quantifying leaks 144 in the disposable system by, for example, visually evaluating the jet 146 of the test gas 124. In particular, image recognition may be used to evaluate the jet profile of the test gas 124.

[0144] In step ii) 138, the test gas 124 may be applied to the lumen, for example, the volume, of the disposable system 116, at pressure, specifically overpressure. The pressure of the test gas 124 in the disposable system 116 may be a parameter that should be controlled, defined, or at least known in an accurate manner. Thus, the test system 114 may comprise one or more of the pressure regulator 150, valve 152, mass flow meter 154, pressure gauge 156, clamp 158, sterile filter, or any further elements suitable for controlling and / or monitoring the pressure or flow of the test gas 124. In particular, information regarding the pressure and / or flow of the test gas 124 may be transmitted and processed by using the evaluation device 128, as illustrated by the arrows pointing from the evaluation device 128 to any one of the pressure regulator 150, valve 152, mass flow meter 154, and pressure gauge 156, and vice versa.

[0145] Method 134 for testing the integrity of a disposable system 116 may be included in Method 117 for processing at least one fluid material 112 by using at least one disposable system 116. In particular, Method 117 for processing at least one fluid material 112 by using at least one disposable system 116 includes the following steps, which may be performed specifically in a given order. Nevertheless, different orders may also be possible. It may also be possible to perform two or more steps of the Method completely or partially simultaneously. Furthermore, it may also be possible to perform one, two or more, or even all, steps of the Method once or repeatedly. Method 117 may include additional steps of the Method that are not listed. The steps of the Method are as follows: I. A step of testing the integrity of the disposable system 116 by using method 134 (referred to as reference number 160) for testing the integrity of the disposable system 116, II. Connecting the disposable system 116 (referred to as reference no. 162) to at least one supply unit 118 of at least one fluid material 112, and at least partially filling the disposable system 116 with the fluid material 112.

[0146] Furthermore, as illustrated in Figure 2, method 117 may include a branch point 164. The branch point 164 may represent a conditional query, such as one that determines between a first branch 166 and a second branch 168. For example, the conditional query may leverage the integrity result. Specifically, the integrity result may include information on at least one item that quantifies and / or qualitatively assesses the integrity of the disposable system 116. As an example, the first branch 166 may indicate the integrity of the disposable system 116, such as indicating that the disposable system 116 is sufficiently intact. Thus, the first branch 166 leads to process II.162, where the disposable system 116 can be connected to a supply unit 118 for the fluid material 112 and subsequently filled with the fluid material 112.

[0147] A second branch 168 may indicate that the disposable system 116 is not sufficiently intact, for example, that it contains at least one leak such that it does not meet the integrity criteria that must be met for use in method 117 to process at least one fluid material 112 by using at least one disposable system 116. Thus, the second branch 168 leads to a step of discontinuing method 117, which is shown in reference no. 170.

[0148] Figures 3A, 3B, and 4 show examples of images captured using the method in Figure 2. The images were taken using the FLIR Systems, Inc. GF343 infrared camera mentioned above.

[0149] Therefore, first, in Figures 3A and 3B, a significant improvement in image recognition is demonstrated by using background element 132. Both images were taken at room temperature of 22°C. Figure 3A shows some images of a disposable system without using a background element. It can be clearly seen that the contrast of the image is considerably low. Specifically, neither the tube walls nor the surface details of the element are visible. Conversely, Figure 3B shows images of the same setup captured with a background element, where the background element was kept at a different temperature than room temperature. In this case, a fluid-heated background element with a temperature of 28°C was used. It can be clearly seen that this policy significantly improved the contrast. Thus, the tube walls can be clearly seen and structural details can be detected.

[0150] Figure 4 shows an image of a leak test using a heated background element, as shown in Figure 3B. In this test, a 50 μm diameter cannula was inserted into a plastic tube. The plastic tube was pressurized with carbon dioxide at a pressure of 50 mbar. Five leaks, intentionally inserted into the tube wall for this purpose, can be clearly seen by detecting the gas jets of the test gas in the image. Image analysis, such as automated image recognition software, can be used to analyze the gas jets. This allows for the derivation of the leak location and size using the pressure and data knowledge derived from the image analysis. [Explanation of Symbols]

[0151] 110 Processing System 112 Flowable materials 114 Test Systems 116 Disposable Systems 117 A method for processing at least one fluid material. 118 Supply unit for fluid materials 120 Test Gas Supply Unit 122 connector 124 Test gas 126 Infrared Camera 128 Evaluation device 130 processors 132 background elements 133 Temperature Sensor 134 Method for testing the integrity of disposable systems 135 connection elements 136 Process i.) 138 Process ii.) 140 process iii.) 142 background screens 144 Leak 146 Test gas jet 148 Return of at least one completeness result 150 Pressure Regulator 152 valves 154 Mass Flowmeter 156 Pressure gauge 158 Clamp 160 Process I. 162 Process II. 164 Branching Point 166 The First Branch 168 The second branch 170 Discontinuation of method

Claims

1. 1. A method for integrity testing of a disposable system (116) for processing at least one flowable material (112), said method comprising: i.) providing at least one disposable system (116) for processing at least one flowable material (112), said at least one disposable system (116) having at least one plastic component; ii.) applying at least one test gas (124) to at least one lumen of said disposable system (116), said test gas (124) having one or more spectral absorption or spectral emission characteristics in the infrared spectral range that are distinguishable from ambient air; iii.) monitoring at least a portion of said disposable system (116) by using an infrared camera (126).

2. The method of claim 1 , wherein the test gas (124) comprises carbon dioxide.

3. 3. The method according to claim 1, wherein the method is carried out in ambient air, the ambient air having a flow velocity u, where 0 m / s<u≦0.5 m / s, in particular 0.05 m / s≦u≦0.3 m / s.

4. 4. The method of claim 1, wherein the method includes using at least one flow regulator, the flow regulator configured to control at least one of a flow velocity of the ambient air, a mass flow rate of the ambient air, and a volumetric flow rate of the ambient air.

5. 5. The method of claim 1, wherein the at least one plastic component of the disposable system (116) comprises at least one plastic component selected from the group consisting of at least one connector element made at least partially of plastic, at least one tubing element made at least partially of plastic, at least one bag element made at least partially of plastic, at least one container element made at least partially of plastic, at least one valve element made at least partially of plastic, at least one filter capsule, at least one sampling system such as at least one sampling system including at least one bag and / or at least one capsule, and at least one syringe.

6. The method of any one of claims 1 to 5, wherein step iii.) comprises providing at least one background element (132), and at least a portion of the disposable system (116) monitored by using the infrared camera (126) is positioned at least partially between the background element (132) and the infrared camera (126).

7. The method of any one of claims 1 to 6, wherein the disposable system (116) is positioned at a distance d from the infrared camera (126), where 0 m<d≦2 m.

8. The method of claim 6 or 7, wherein the disposable system (116) is positioned at a distance L from the at least one background element (132), where 0 m≦L≦0.5 m.

9. The method of any one of claims 6 to 8, wherein the background element (132) comprises at least one visually uniform background screen (142).

10. The method of any one of claims 6 to 9, wherein the background element (132) is mechanically connected to the infrared camera (126).

11. The method of any one of claims 6 to 10, wherein the background element (132) is temperature controlled.

12. The method of any one of claims 6 to 11, wherein the background element (132) is at least one of actively heated and actively cooled.

13. The method of claim 12 , wherein the background element (132) is at least one of actively heated and actively cooled by at least one of a fluidic and an electrical regulating element.

14. The method of claim 13 , wherein any one of the flow regulating element and / or the electrical regulating element is arranged in a serpentine manner within the background element.

15. The method of any one of claims 6 to 14, wherein the background element (132) is made at least in part from one or more of a plastic material, a ceramic material, and a metallic material.

16. 16. The method of claim 6, wherein the integrity test is performed at ambient temperature, and the background element (132) is maintained at a background temperature different from the ambient temperature, the background temperature differing from the ambient temperature by at least 2 K.

17. The method of claim 16 , wherein the background temperature is greater than the ambient temperature.

18. 18. The method of claim 16 or 17, wherein the ambient temperature is room temperature and the background temperature is between 26°C and 60°C.

19. 19. The method of any one of claims 1 to 18, wherein the method includes returning at least one integrity result, the integrity result quantifying, qualifying, or quantifying and qualifying the integrity of the disposable system (116).

20. The method of any one of claims 1 to 19, wherein step iii.) comprises visually detecting the release of a test gas (124) from the disposable system (116).

21. 21. The method of claim 20, wherein visually detecting the release comprises detecting at least one of a jet, a flow, a cloud, or a mist of the test gas, and the method includes automatically quantifying a leak in the disposable system by visually assessing the jet, the flow, the cloud, or the mist, respectively, of the test gas.

22. The method of any one of claims 1 to 21, wherein the method comprises using automatic image recognition.

23. The method of any one of claims 1 to 22, wherein in step ii.) the test gas (124) is applied to the lumen of the disposable system (116) at a pressure of between 5 mbar and 300 mbar.

24. The method of any one of claims 1 to 23, wherein step iii.) comprises scanning the disposable system (116) by sequentially monitoring different portions of the disposable system (116).

25. A method for processing at least one flowable material (112) by using at least one disposable system (116), comprising: I. Testing the integrity of the disposable system (116) by using the method of any one of claims 1 to 24; II. connecting said disposable system (116) to at least one supply of at least one flowable material (112) and at least partially filling said disposable system (116) with said flowable material (112).

26. 1. A test system (114) for testing the integrity of at least one disposable system (116) for processing at least one flowable material (112), said disposable system (116) having at least one plastic component, said test system (114) comprising: a.) at least one test gas supply (120) for applying at least one test gas (124) to at least one lumen of said disposable system (116), said test gas (124) having one or more spectral absorption or spectral emission characteristics in the infrared spectral range that are distinguishable from ambient air; b.) at least one infrared camera (126) for monitoring at least a portion of said disposable system (116).

27. The test system (114) c.) The testing system (114) of claim 26, further comprising at least one evaluation device (128) for evaluating the integrity of the disposable system (116), the evaluation device (128) configured to derive integrity information of at least one item from at least one image provided by the infrared camera (126).

28. The test system (114) d.) The test system (114) of claim 26 or 27, further comprising at least one background element (132), wherein the test system (114) is configured such that at least a portion of the disposable system (116) is at least partially positionable between the background element (132) and the infrared camera (126).

29. A processing system (110) for processing at least one flowable material (112), said processing system (110) comprising: A. at least one disposable system (116) for processing at least one flowable material (112), said disposable system (116) having at least one plastic component; B. At least one test system (114) according to any one of claims 26 to 28; C. at least one supply (118) of said flowable material (112); A processing system (110) wherein the disposable system (116) is selectively connectable to a test gas supply of the test system (114) and a supply (118) of the flowable material (112).

Images