Systems and methods for electrostatic integrity testing

Abstract

The present invention relates to a system for testing integrity of a test specimen, comprising: a housing having a compartment; and a test assembly disposed within the compartment of the housing, the test assembly including, a test platform including a first electrode and an electrode pair, wherein the electrode pair includes a second electrode and a third electrode, the second electrode being coupled to a top end of the test platform; a guard lid configured to cover the top end of the test platform, and the third electrode being coupled to a bottom end of the guard lid; and a detector assembly in electrical communication with the first electrode and the electrode pair, the detector assembly being configured to check the integrity of the test specimen by monitoring an electrical circuit between the first electrode and the electrode pair.

Description

1 Docket No. TP387661WO1SYSTEMS AND METHODS FOR ELECTROSTATIC INTEGRITY TESTINGCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of the U. S. Provisional Patent Application Ser. No. 63 / 722,760 filed November 20, 2024, titled “ELECTROSTATIC LEAK TESTING SYSTEMS AND METHODS,” and U. S. Provisional Patent Application Ser. No. 63 / 722,743, filed November 20, 2024, titled “SYSTEMS AND METHODS FOR ELECTROSTATIC INTEGRITY TESTING, which are incorporated herein by specific reference.FIELD

[0002] The present disclosure relates to electrostatic integrity testing systems and methods. More specifically, the present disclosure is directed to automated integrity testing systems and methods configured for detecting defects or flaws in films, flexible bags or containers, and fill and finish assemblies having seals, port seals, face port seals, edge port seals, tubing assemblies, by using a high-voltage electric current.BACKGROUND OF THE INVENTION

[0003] As technology and innovation advance within the bioprocessing industry, single-use technologies, including flexible bioprocessing equipment, have also made considerable progress in the drag and vaccine manufacturing space. Some of the well-known advantages of single-use systems are lowered costs, reduced contamination risks, decreased facility footprint, increased flexibility, and production throughput efficiency with less cleanup, all resulting in quicker turnaround and increased production capabilities. Typical examples of single-use bioprocessing equipment include flexible two or three-dimensional (2D or 3D) chambers or containers used as bioreactors, fermentors, mixers or fluid storage containers having perimeter seals, edge port seals, or face port seals, tubing assemblies, and fill and finish assemblies having surge bags, beta bags, tubing assemblies, and filling needles. To achieve the above advantages with such flexible bioprocessing equipment, it is crucial to qualify the integrity of the flexible bioprocessing equipment prior to use. Moreover, compliance with international standards and customer requirements to ensure 100% leakproof or integrity -tested products is mandatory for commercialization. Qualification of integrity is based on precise inspection techniques for accurate detection of defects or flaws including pores, holes, pinholes, thinned regions, or imperfections previously present or created in the films or materials during the manufacturing2 Docket No. TP387661WO1 of flexible bioprocessing equipment. Conventionally defect detection in flexible chambers is performed by a leak hold test or tracer gas leak test. While major limitations associated with the leak hold test are the inability to detect small holes or thinned regions of films and contamination of chambers during testing, the tracer gas leak test has challenges related to the permeation of the gas through the film and the requirement of large machines for large chambers. Additional limitations associated with these methods include high costs, unavoidable accidents like the destruction of the chamber during the tests, obtaining false positive results, and longer test time periods.

[0004] Accordingly, what is needed in the art are time-efficient and cost-effective systems and methods for the accurate detection of defects in flexible bioprocessing equipment that solve all or some of the above-identified shortcomings or other deficiencies known in the art.SUMMARY OF THE DISCLOSURE

[0005] It is understood that each independent aspect recited herein may include any of the features, options, and possibilities recited in association with the other independent aspects set forth above or as recited elsewhere within this document.

[0006] A first independent aspect of the disclosure provides an apparatus for detecting a defect in a test area of a test specimen. The apparatus includes a first electrode positioned external to the test area and a second electrode having at least a portion disposed within the specimen. A detector assembly is in electrical communication with the electrodes and includes a voltage generator configured to produce and deliver a voltage to the first electrode and a measuring tool configured to detect a defect by monitoring an electrical circuit between the electrodes.

[0007] In some embodiments, the first electrode includes both an upper and a bottom electrode. The measuring tool may generate a first signal when a continuous circuit is detected and a second signal when a discontinuity is detected, thereby indicating the presence or absence of a defect. The test specimen may be a flexible bioprocess container, a tubing assembly, or another non-conductive or electrically insulative component. The defect may be a hole or a thin film region relative to surrounding material, including seals between film layers or port seals between a port and multiple film layers. The first or second electrode may serve as a charged electrode or a ground electrode. The apparatus may further include a control unit in electronic communication with the detector assembly to coordinate testing operations and record results.

[0008] A second independent aspect of the disclosure provides a system for testing the integrity of a test specimen. The system includes a housing with a compartment containing a3 Docket No. TP387661WO1 test assembly. The test assembly features a test platform having a first electrode and an electrode pair comprising second and third electrodes. The second electrode is coupled to a top end of the platform, while the third electrode is coupled to a bottom end of a guard lid that covers the top of the platform.

[0009] A detector assembly is in electrical communication with the first electrode and the electrode pair and is configured to check specimen integrity by monitoring an electrical circuit between these electrodes. The detector assembly may include a voltage generator that supplies a voltage to one or both of the second and third electrodes, and a measuring tool configured to generate first and second signals corresponding respectively to circuit continuity or discontinuity. Additional embodiments include a lid movement control unit that locks the guard lid during testing, a sensor coupled to the lid to detect specimen presence, and a voltage sensor coupled to the test platform to monitor generation of a set voltage.

[0010] A third independent aspect of the disclosure provides an automated system for testing specimen integrity. The system includes a controller having a processor and memory for storing operational instructions and controlling system components. The system further includes the test assembly described above, comprising the test platform, the electrode pair, the guard lid, and the detector assembly.

[0011] The detector assembly monitors the electrical circuit between the electrodes to determine the integrity of the specimen and provides a pass or fail result. The automated system may include a specimen marking unit in communication with the controller, positioned for example at the bottom end of the guard lid. The marking unit may be a printer, cutter, scriber, or hole-punch device configured to mark, cut, scribe, or perforate a specimen according to the controller’s instructions, enabling automatic differentiation between passed and failed specimens.

[0012] A fourth independent aspect of the disclosure provides a method for qualifying the integrity of a test specimen. The method includes selecting a stored testing recipe, placing the specimen on a testing platform, and securing a lid to position a first electrode external to and a second electrode within the specimen. A test run is initiated by applying a voltage generated by a voltage generator to one of the electrodes, and the resulting electrical circuit is monitored to determine whether the specimen passes or fails the integrity test.

[0013] A fifth independent aspect of the disclosure provides a method for integrity testing of a fill-and-finish assembly. The method includes checking the integrity of perimeter seals, edge ports, and / or face port seals of one or more chambers using an electrostatic integrity tester, as well as checking the integrity of tubing assemblies and manifolds using a flexible electrode4 Docket No. TP387661WO1 integrated within the tester. This allows comprehensive non-destructive integrity verification of multi-chamber bioprocess assemblies.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Various embodiments of the present invention will now be discussed with reference to the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope.

[0015] FIG. 1A illustrates a high-level circuit diagram of an exemplary configuration of a system for integrity testing in accordance with example embodiments.

[0016] FIG. IB illustrates a high-level circuit diagram of an exemplary configuration of a system for integrity testing in accordance with example embodiments.

[0017] FIG. 1C illustrates an exemplary test specimen system for integrity testing in accordance with example embodiments.

[0018] FIG. ID illustrates an exemplary test specimen system for integrity testing in accordance with example embodiments.

[0019] FIG. 2A illustrates an exemplary integrity testing system in accordance with example embodiments.

[0020] FIG. 2B illustrates an exemplary integrity testing system in accordance with example embodiments.

[0021] FIG. 3A illustrates an expanded view of the exemplary integrity testing system in accordance with example embodiments.

[0022] FIG. 3B illustrates an expanded view of the exemplary integrity testing system in accordance with example embodiments.

[0023] FIG. 4A illustrates an expanded view of the exemplary integrity testing system in accordance with example embodiments.

[0024] FIG. 4B illustrates an expanded view of the exemplary integrity testing system in accordance with example embodiments.

[0025] FIG. 4C illustrates an exemplary component of the integrity testing system in accordance with example embodiments.

[0026] FIG. 4D illustrates an exemplary component of the integrity testing system in accordance with example embodiments.

[0027] FIG. 4E illustrates an exemplary component of the integrity testing system in accordance with example embodiments.5 Docket No. TP387661WO1

[0028] FIG. 4F illustrates an exemplary component of the integrity testing system in accordance with example embodiments.

[0029] FIG. 4G illustrates an exemplary component of the integrity testing system in accordance with example embodiments.

[0030] FIG. 5 illustrates an exemplary integrity testing system in accordance with example embodiments.

[0031] FIG. 6 is a block diagram of an automated integrity testing system in accordance with example embodiments.

[0032] FIG. 7 is a user interface displayed on a client computing device in accordance with example embodiments.

[0033] FIG. 8 is a user interface displayed on a client computing device in accordance with example embodiments.

[0034] FIG. 9 is a user interface displayed on a client computing device in accordance with example embodiments.

[0035] FIG. 10 is a user interface displayed on a client computing device in accordance with example embodiments.

[0036] FIG. 1 1 is a user interface displayed on a client computing device in accordance with example embodiments.

[0037] FIG. 12 is a block diagram of an automated integrity testing system in accordance with example embodiments.

[0038] FIG. 13 illustrates an exemplary handheld integrity testing system in accordance with example embodiments.

[0039] FIG. 14 is a flow diagram of a method for operating an integrity testing system in accordance with example embodiments.

[0040] FIG. 15 is a block diagram of an example computing device that can automate all operations of an example integrity testing system, including a fluid mixing assembly.DETAILED DESCRIPTION

[0041] Before describing the present disclosure in detail, it is to be understood that this disclosure is not limited to particularly exemplified apparatus, systems, methods, or process parameters that may, of course, vary. It is also to be understood that the terminology used herein is only for the purpose of describing particular embodiments of the present disclosure and is not intended to limit the scope of the disclosure in any manner.6 Docket No. TP387661WO1

[0042] All publications, patents, and patent applications cited herein, whether supra or infra, are hereby incorporated by reference in their entirety to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

[0043] The term “comprising” which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.

[0044] It will be noted that, as used in this specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the content clearly dictates otherwise. Thus, for example, a reference to a “partition” includes one, two, or more partitions.

[0045] As used in the specification and appended claims, directional terms, such as “top,” “bottom,” “left,” “right,” “up,” “down,” “upper,” “lower,” “proximal,” “distal” and the like are used herein solely to indicate relative directions and are not otherwise intended to limit the scope of the disclosure or claims.

[0046] Where possible, like numbering of elements has been used in various figures. Furthermore, multiple instances of an element and or sub-elements of a parent element may each include separate letters appended to the element number. For example, two instances of a particular element “10” or two alternative embodiments of a particular element may be labeled as “10a” and “10b”. In that case, the element label may be used without an appended letter (e.g., “10”) to generally refer to all instances of the element or any one of the elements. Element labels, including an appended letter (e.g., “10a”) can be used to refer to a specific instance of the element or to distinguish or draw attention to multiple uses of the element. Furthermore, an element label with an appended letter can be used to designate an alternative design, structure, function, implementation, and / or embodiment of an element or feature without an appended letter. Likewise, an element label with an appended letter can be used to indicate a sub-element of a parent element. For instance, an element “12” can comprise subelements or surfaces “12a” and “12b.”

[0047] Various aspects of the present devices and systems may be illustrated by describing components that are coupled, attached, and / or joined together. As used herein, the terms “coupled”, “attached”, and / or “joined” are used to indicate either a direct connection between two components or, where appropriate, an indirect connection to one another through intervening or intermediate components. In contrast, when a component is referred to as being “directly coupled”, “directly attached”, and / or “directly joined” to another component, there are no intervening elements present. Furthermore, as used herein, the terms “connection,”7 Docket No. TP387661WO1“connected,” and the like do not necessarily imply direct contact between the two or more elements.

[0048] Various aspects of the present devices, systems, and methods may be illustrated with reference to one or more example embodiments. As used herein, the term “embodiment” means “serving as an example, instance, or illustration,” and should not necessarily be construed as preferred or advantageous over other embodiments disclosed herein.

[0049] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure pertains. Although one or more methods and materials similar or equivalent to those described herein can be used in the practice of the present disclosure, the preferred systems, materials and methods are described herein.

[0050] For example, the flexible bioprocessing equipment, including the 2D or 3D chambers herein disclosed, are configured for biological reactions, including but not limited to growing cells or other biological components. In example embodiments, flexible bioproccssing equipment can also comprise or be substituted with one or more bioreactors, fermenters, mixers, storage vessels, fluid management systems (flexible tubing assemblies, flexible hose assemblies, flexible fluid manifolds), cell culture equipment, centrifuges, centrifugal separators, chromatography units, mixers, homogenizers, magnetic processing units, blood separating devices, biocomponent filtering devices, biocomponent agitators or any other device designed for growing, mixing or processing cells and / or other biological components. It is also appreciated that flexible bioprocessing equipment can comprise any conventional bioreactor, fermenter, or cell culture device, such as a stirred-tank reactor, rocker-type reactor, paddle mixer reactor, or the like.

[0051] In general, flexible bioprocessing equipment is configured for containing fluids or bioprocess fluids in the above-mentioned various flexible bioprocessing equipment. By way of example and not by limitation, the fluid can include one or more biocomponents, including fluids, solids, mixtures, solutions, and suspensions including, but not limited to, bacteria, fungi, algae, plant cells, animal cells, white blood cells, T-cells, cell media, protozoans, nematodes, plasmids, viral vectors, blood, plasma, organelles, proteins, nucleic acids, lipids, plasmids, carbohydrates, and / or other biological components, and the like. Some common biological components grown in fluid include E. coli, yeast, bacillus, and CHO cells. Fluid can also comprise cell-therapy cultures, cells, and microorganisms that are aerobic, anaerobic, adherent, or non-adherent. Different media compositions known in the art can be used to accommodate the specific cells or microorganisms grown and the desired end product. In some uses, flexible8 Docket No. TP387661WO1 bioprocessing equipment is primarily used to grow and recover cells for subsequent use (e.g., preparing vaccine materials from the cells themselves). But in many uses, the ultimate purpose of growing cells in flexible bioprocessing equipment is to produce and later recover biological products (such as recombinant proteins, viral vectors, etc..) that are exported from the cells into the growth medium. It is common to use flexible bioprocessing equipment to grow cells in a master batch to prepare a specific volume, density, concentration, CFU, and / or aliquot of cells for subsequent use as an inoculant for multiple subsequent batches of cells grown to recover biological products.

[0052] FIGs. 1A and IB are schematic representations of circuits 100A and 100B, respectively, for an exemplary electrostatic integrity testing system 100 in accordance with an embodiment. The circuits 100 A and 100B include defect detection circuits 110A and 110B for test specimens S 1 , and S2, respectively, and are shown in the context of a practical application, namely, detecting a defect, which is shown in FIG. IB as a defect DI in test specimen S2.

[0053] In various embodiments the defect detection circuits 110A and HOB include a detector assembly 120 in electrical communication with a first electrode, E-l, and a pair of second electrodes, F-2A and F-2B. The detector assembly comprises a voltage generator 122, and a measuring tool 124. The voltage generator is configured to generate a voltage for defect detection circuits 110A and HOB based on the specifications of test specimens SI and S2, including material, conductivity type, size, thickness, width, and other test specimen-related parameters. While at least a portion of the first electrode E- 1 is placed inside the test specimens S 1 and S2, the pair of second electrodes E-2A and E-2B is placed proximate to the upper sides 126 A, 126B and the lower sides 128 A, 128B of the test specimens SI, S2, respectively. In example embodiments the defect detection circuits 110A and HOB can include the detector assembly 120 in electrical communication with the first electrode, E-l, and the second electrode, E-2A or E-2BA. A standard Earth Protection 129 connected to the detector assembly 120 also ensures the safety and proper functionality of defect detection circuits 1 10 A and 110B.

[0054] In various embodiments the defect detection circuits 110A and HOB are shown and described in connection with FIG. 1 A and FIG. IB and is configured to operate using a currentvoltage V generated by the voltage generator 122. The voltage generator can be an alternating current or a direct current AC or DC voltage source. Optionally, the voltage generator can include a high-voltage transformer to boost the voltage. In an example, the voltage can be in a range of 5-100 kV, such as a range of 10-85 kV or a range of 12-67 kV. For example, the voltage generated by the voltage generator 122 can be in the range of 15-35 kV and can provide a switched DC input or AC input voltage to the second electrode E-2. In other examples, the9 Docket No. TP387661WO1 voltage generated by the voltage generator 122 can be in the range of 30-60 kV and can provide a switched DC input or AC input voltage to the second electrode E-2. For example, the voltage generated by the voltage generator 122 can be as high as up to 50kV and can provide a switched DC input or AC input voltage signal to the pair of second electrodes E-2 A and E-2B.

[0055] In various embodiments, the first electrode, E-l, and second electrodes, E-2A, E- 2B, can include a conductive surface that is disposed proximate to the test specimens S I and S2 during integrity testing. For example, the first electrode E-l, and second electrodes E-2A, E-2B can be a single wire, a single metallic strip, a multifilament brash, flexible strip electrodes, flexible wire electrodes, foldable electrodes as well as any other type of electrode that would allow conductivity to be established between the second electrodes E-2A, E-2B and the first electrode E-l through a portion of the test specimen S 1 or S2. In various embodiments, the first electrode, E-l, and second electrodes, E-2A, E-2B, can have a shape to complement the shape of the test specimen at the testing region. For example, if the testing region of the test specimen has a flat shape, the first electrode, E-l, and the second electrodes, E-2A, E-2B, can also have a flat shape to provide uniform voltage to the test specimen. In other examples, if the test specimen has a cylindrical shape, the first electrode, E-l, can have a flat shape, but the second electrodes, E-2A, E-2B can be shaped to encompass or envelop the cylindrical shape of the test specimen. In various embodiments, the first electrode, E-l, can be a ground electrode, and the second electrodes, E-2A, E-2B can be charged electrodes. In this case, the charged electrodes E-2A, E-2B can be configured to receive voltages in the range of 15-35kV. In various other embodiments, the first electrode, E- 1 , can be a charged electrode, and the second electrodes, E-2A, E-2B, can be ground electrodes. In this case, the charged electrode E-l can be configured to receive voltages in the range of 15-35kV. In general, the size and shape of the electrodes are directly dependent on the shape and size of the test specimen in the testing region and also on the detection accuracy and sensitivity required for the integrity testing.

[0056] In various embodiments, the measuring tool 124 is configured to measure one or more properties of the electrical signal through the first electrode E-l, which is a function of the input voltage signal and the electrical properties of the surface inspected using the second electrodes E-2A, E-2B. For instance, the measuring tool 124 can be any instrument suitable for measuring the current flow through the first electrode E-l, and / or voltage and can be configured to detect defects in the test specimen SI, S2 as a function of the measured transient voltage and / or current flow. For example, as the electric current or voltage moves from the charged electrodes E-2A, E-2B to ground electrode E-l through a portion of test specimen S2 having the defect DI, the electric current arcs or jumps across the defect. The arcing of the10 Docket No. TP387661WO1 electric current serves as an indicator of the presence of the defect in the specimen S2. In the case when test specimen S2 includes one or more defects, upon moving the electrodes E-2A, E-2B over the test specimen S2, the electric current arcs through defects, indicating the number of defects in the test specimen S2. In some embodiments, measuring tool 124 is configured to generate a first signal upon detecting a complete circuit or a continuity in the electrical circuit 100A / 100B. In other embodiments, the measuring tool 124 is configured to generate a second signal upon detecting an incomplete circuit or a discontinuity in the electrical circuit 100A / 100B.

[0057] More specifically, in the exemplary configuration shown in FIG. 1A, and FIG. IB, the defect detection circuits 110A and HOB are configured to operate on the principle that the test specimen SI and S2 act as a capacitor, essentially, a large charge accumulator. As a voltage is applied to the second electrodes E-2A, E-2B and the voltage reaches the first electrode after passing through a portion of the test specimen, the rate of increase and decrease of the signal through the first electrode E- 1 can be measured by a high-speed voltage measuring tool 124 (e.g. an Analog to Digital Converter) and that measured signal response analyzed to detect defects.

[0058] In addition, or alternatively, to using a voltmeter as the measuring tool 124, a current sensor could be used in series with test specimens for measuring current flow. In such a configuration, the current sensor measurements would show relatively more current flowing when defects are reached (and over a longer period of time) thereby allowing for detection of defects as a function of the measured current as shown in FIG. IB. In other words, as shown in FIG. 1 A, Current II measured in circuit 110A is lower than current 12 measured in circuit HOB, as the presence of a defect lowers the value of resistance R2. It should be understood that the defect-detecting circuits 110A and 110B are shown in FIG. 1 A in a simplified form. The defect-detecting circuits 110A and 110B can include additional components that enhance the integrity testing of various test specimens. For instance, circuit circuits 110A and 110B can be communicatively coupled to a processor. This processor is configured by executing encoded instructions to analyze the measured signal response, record the measured information in a computer-readable storage medium, and generate audible and / or visual alerts for the operator. These alerts are delivered via a suitable display or audio-output device, as detailed later in this disclosure.

[0059] In various embodiments, the sensitivity of the integrity testing can be attributed to one or more variables, including the voltage applied to the second electrodes E-2A and E-2B, the distance between the first electrode E-l and the defect DI in the test specimen, the distance11 Docket No. TP387661WO1 between the second electrode E-2A, E-2B and the defect DI in the test specimen, the size of the defect DI and the time period of application of voltage to the second electrodes E-2A, E- 2B. The higher the sensitivity of the integrity testing, the smaller the size of the defect that can be detected, and vice versa. The sensitivity of the integrity testing can be affected by the amount of voltage applied to the electrodes, amount of current supplied to the electrodes, size of electrodes, voltage application time or current supplied time.

[0060] Depicted in FIG. IC is one embodiment of a container system 130. Container system 130 is an example of a test specimen SI , S2 described above. Container system 130 comprises a container 132 having one or more ports 133 which will be described in more detail below. In the embodiment depicted container 132 comprises a flexible bag-like body 136 having an interior surface 138 that bounds a chamber 140 suitable for holding a fluid or biological material. More specifically, body 136 comprises a side wall 142 that, when body 136 is unfolded, has a substantially circular or polygonal transverse cross-section that extends between a first end 144 and an opposing second end 146. The first end, 144, terminates at a top-end wall 148, while the second end, 146, terminates at a bottom-end wall 150.

[0061] Body 136 is comprised of a flexible, water-impermeable material such as low- density polyethylene or other polymeric sheets or films having a thickness in a range between about 0.1 mm to about 5 mm, with about 0.2 mm to about 2 mm being more common. Other thicknesses can also be used. The material can be comprised of a single ply material or can comprise two or more layers which are either sealed together or separated to form a double wall container. Where the layers are sealed together, the material can comprise a laminated or extruded material. The laminated material comprises two or more separately formed layers that are subsequently secured together by an adhesive. In some embodiments, the body 136 of the container 132 can be built using non-conductive or insulative material.

[0062] The extruded material comprises a single integral sheet that comprises two or more layers of different material that are each separated by a contact layer. All of the layers are simultaneously co-extruded. One example of an extruded material that can be used in the present invention is the HyQ CX3-9 film available from HyClone Laboratories, Inc. out of Logan, Utah. The HyQ 0X3-9 film is a three-layer, 9 mil cast film produced in a cGMP facility. The outer layer is a polyester elastomer coextruded with an ultra-low density polyethylene product contact layer. Another example of an extruded material that can be used in the present invention is the HyQ 0X5-14 cast film also available from HyClone Laboratories, Inc. The HyQ 0X5-14 cast film comprises a polyester elastomer outer layer, an ultra-low density12 Docket No. TP387661WO1 polyethylene contact layer, and an EVOH barrier layer disposed therebetween. In still another example, a multi-web film produced from three independent webs of blown film can be used. The two inner webs are each a 4 mil monolayer polyethylene film (which is referred to by HyClone as the HyQ BM1 film) while the outer barrier web is a 5.5 mil thick 6-layer coextrusion film (which is referred to by HyClone as the HyQ BX6 film).

[0063] The material is approved for direct contact with living cells and is capable of maintaining a solution sterile. In such an embodiment, the material can also be sterilizable such as by ionizing radiation. Examples of materials that can be used in different situations are disclosed in U.S. Pat. No. 6,083,587 which issued on Jul. 4, 2000 and United States Patent Publication No. US 2003-0077466 Al, published Apr. 24, 2003 which are each hereby incorporated by specific reference.

[0064] In one embodiment, body 136 comprises a two-dimensional pillow-style bag wherein two sheets of material are placed in overlapping relation, and the two sheets are bound together at their peripheries by perimeter seals 152 to form an internal chamber 140. Alternatively, a single sheet of material can be folded over and seamed around the periphery to form an internal chamber 140. In another embodiment, body 136 can be formed from a continuous tubular extrusion of polymeric material that is cut to length and the ends seamed closed.

[0065] In still other embodiments, body 136 can comprise a three-dimensional bag that not only has an annular side wall but also a two-dimensional top-end wall 148 and a two- dimensional bottom-end wall 150. Three-dimensional body 136 comprises a plurality of discrete panels, typically three or more, and more commonly four or six. Each panel is substantially identical and comprises a portion of the side wall, top end wall, and bottom end wall of body 136. The corresponding perimeter edges of each panel are seamed. The seams are typically formed using methods known in the art such as heat energies, RF energies, sonics, or other sealing energies. The seamed perimeter edges are also known as perimeter seals. In the case of two-dimensional or three-dimensional bags, during manufacturing, due to the thinning of sheets or films of materials, pores, small holes, pin holes, and imperfections related to regions with variable thicknesses of sheets or films are common. In general, these pores, holes, pinholes, and imperfections can be termed defects or flaws in the test specimen. To qualify a test specimen as 100% leakproof, it is necessary to inspect a perimeter seal around the bag, and also region by region of the bag for defects. A portion of the perimeter seal, when inspected for defects, can also be termed as a testing region 152A in accordance with the disclosure of this invention.13 Docket No. TP387661WO1

[0066] In alternative embodiments, the panels can be formed in a variety of different patterns. Further disclosure with regard to one method of manufacturing three-dimensional bags is disclosed in United States Patent Publication No. US 2002-0131654 Al that was published Sep. 19, 2002, of which the drawings and Detailed Description are hereby incorporated by reference.

[0067] It is appreciated that body 136 can be manufactured to have virtually any desired size, shape, and configuration. For example, body 36 can be formed having chamber 40 sized to 10 liters, 30 liters, 100 liters, 250 liters, 500 liters, 750 liters, 1,000 liters, 1 ,500 liters, 3,000 liters, 5,000 liters, 10,000 liters or other desired volumes. Although body 136 can be any shape, in one embodiment body 136 is specifically configured to be complementary or substantially complementary to a compartment of a support housing configured to support the container system.

[0068] Although in the above-discussed embodiment, container, 132 has a flexible, baglike configuration, in alternative embodiments, it is appreciated that container 132 can comprise any form of a collapsible container or semi-rigid container. Furthermore, in contrast to having a closed top-end wall 148, container 132 can comprise an open top liner. Container 132 can also be transparent or opaque and can have ultraviolet light inhibitors incorporated therein.

[0069] Mounted on side walls 142 and top end wall 148 are a plurality of ports 133 which are in fluid communication with chamber 140. Although four ports 133 are shown, it is appreciated that one, two, three, or more ports 33 can be present depending on the intended use of container 132. Each port 133 is an edge port, alternatively the port 133 can be a face port. As such, each port 133 can serve a different purpose depending on the type of processing to be undertaken. For example, port 133 can be coupled with a tube, such as a fluid line, for dispensing fluid or other components into chamber 140 or withdrawing fluid from chamber 140. In addition, when container 132 is used as a bioreactor for growing cells or microorganisms, tube port 133 can be used to provide various probes, such as temperature probes, pH probes, dissolved oxygen probes, sparger probes, and the like, access to chamber 140. Each of the ports 133 is coupled to container 132 by port seals based on various known techniques of sealing including heat sealing or sealing with radio frequencies. The region of attachment of ports 133 to container 132 has the potential to have defects leading to leakage of fluids from chamber 140 to the outside and a pathway for introducing external contaminants to the inside. To qualify a test specimen as 100% leakproof, it is necessary to inspect each of the port seals around the bag for defects. A portion of the port seal, when14 Docket No. TP387661WO1 inspected for defects, can also be termed as a testing region or inspection region 152A in accordance with the disclosure of this invention.

[0070] Referring back to Fig. 1 A and FIG. IB, defect detection circuits 110A and 110B can be used to detect defects in both the perimeter seal and port seal of container 132. For example, the first electrode, E-l, can be placed on the inside of container 132, and a pair of second electrodes, E-2A and E-2B, can be placed proximate to perimeter seal testing region 152A or port seal testing region 154A and the voltage can be run through the circuit to qualify integrity of container 132. Even though the defect detection circuits 1 10A and 110B are described for detecting defects in localized regions, namely perimeter seal testing region 152A or port seal testing region 154A, the first and second electrodes can be configured or customized to detect around an entire perimeter of a test specimen or one or more ports and the perimeter at a single test run.

[0071] Depicted in FIG. ID is one embodiment of a fill and finish system 160 incorporating examples of test specimens SI, and S2. Fill and Finish system 160 comprises a surge bag 162, beta bag 164, tubing assemblies 166, fluid manifold 168, and filling needles 170. Each of the various components of the fill and finish system, including surge bag 162, beta bag 164, tubing assemblies 166, and filling manifold 168, form an example of test specimens SI and S2.

[0072] In various embodiments, surge bag 162 and beta bag 164 are similar to container 132 described above, and defect detection circuits 110A and 110B can be used to detect defects in both the perimeter seal and port seal of surge bag 162 and beta bag 164. For example, the first electrode, E-l, can be placed on the inside of surge bag 162, and beta bag 164, and a pair of second electrodes, E-2A and E-2B, can be placed proximate to perimeter seal testing region 152A or port seal testing region 154A of surge bag 162, and beta bag 164 and the voltage can be run through the circuit to qualify integrity of container 132. In various other embodiments, defect detection circuits 110A and HOB can be used to detect defects in tubing assemblies 166 and filling manifolds 168. For example, the first electrode E-l can be a flexible electrode configured to pass through the tubing assembly, and a pair of second electrodes, E-2A and E- 2B, can be placed proximate to a length of the tubing assembly, and the voltage can be run through the circuit to qualify integrity of tubing assemblies 166, and filling manifold 168.

[0073] Depicted in FIG. 2A and FIG. 2B is an exemplary embodiment of an automated integrity testing system 200 incorporating features of the present disclosure. The automated integrity testing system 200 is an example of an integrity testing system 100 described above. As will be discussed below in further detail, system 200 is configured for detecting defects, flaws, pores, pinholes, or holes in the test specimens, including films, flexible bags or15 Docket No. TP387661WO1 containers, seals, edge port seals, face port seals, tubing assemblies, and fill and finish assemblies by using a high-voltage electric current. The automated integrity testing system 200 can be used in the biopharmaceutical industry for use in inspecting and qualifying flexible bioprocess equipment. However, automated integrity testing system 200 can also be used in other industries for inspecting and qualifying flexible products, including bags and tubing, such as in the production, distribution, and / or use of chemicals, food products, beverage products, or other desired products in various industrial applications. In particular, system 200 is configured for integrity testing of port seals of flexible bags, containers, or chambers, and is depicted in an open configuration 200A in FIG. 2A and FIG.2B. In example embodiments, the system 200 is configured to detect holes as small as 1.0 microns and film material having a different thickness in a first region compared to a second region of the film. The holes can have a diameter ranging between 0.9 - 1.1 microns.

[0074] The automated integrity testing system 200 includes an integrity testing unit 201, including a testing assembly 202 housed in an open compartment 204 of a housing 206, and an integrated control unit 208 having a control panel 210, display 211 with user interface 212, in electronic communication with the integrity testing unit 201. In the depicted embodiment the housing 206 is disposed on top of a pedestal structure 214 supported on a footing plate 216. In other embodiments, the housing 206 can be placed on any stationary or portable structure. Although housing 206 can have a variety of different configurations, in the depicted embodiment, housing 206 has a generally open box-shaped configuration that includes a floor 218 extending longitudinally along a floor length LI, between a pair of opposing side walls 220 A and 220B and orthogonal to the pedestal structure 214 to operationally function as a tabletop structure. Floor 218 can have a front end 218A, aback end 218B, a top end 218C, and a bottom end 218D, respectively. In the depicted embodiment, a perimeter rail wall 219 runs on a front end 218A and extends upward from the top end 218C of floor 218. The side walls 220 A and 220B are disposed orthogonal to floor 218 and extend between an upper-end 222 and an opposing lower-end 224. In the depicted embodiment, the side walls 220A and 220B extend longitudinally along a portion of the floor- length LI, providing easy user access to the compartment 204. However, in other embodiments, the side walls can extend all along the floor length LI .

[0075] In various embodiments, test assembly 202 housed in housing 206 includes a detector assembly 226 disposed on floor 218 of housing 206, a test platform 230, extending between and coupled to the side walls 220A, and 220B, and a guard lid 234 coupled between the sidewalls 220A, 220B configured to securely cover the test platform 230 while integrity16 Docket No. TP387661WO1 testing of a test specimen is in progress. The detector assembly 226 is an example of detector assembly 120 shown in Fig.lA and FIG. IB. Additionally, the test assembly 202 includes a guard lid control assembly 238 disposed at the back end 218B of floor 218 (proximately behind the side walls 220B, 220B). The guard lid control assembly 238 includes one or more components configured to maintain the guard lid 234 in a closed position during, and after the integrity testing of a test specimen until the user permits unlocking of the guard lid 234. In the depicted embodiment, the guard lid control assembly 238 includes a top wall 238A, side walls 238B, 238C, front wall 238D, and back wall 238E for protecting the guard lid control assembly from the outside environment. The top wall 238 A and front wall 238D are made of clear transparent material, while side walls 238B, 238C, and back wall 238D are made of opaque material. The user performing the integrity testing can view one or more components in the guard lid control assembly 238 by viewing through the top and front walls 238A, 238D. In other embodiments, a different combination of transparent and opaque features for the top wall 238A, side walls 238B, 238C, front wall 238D, and back wall 238E can be employed.

[0076] In various embodiments, the integrated control unit 208 can be supported by a support 242 and the support 242 can be affixed to the housing 206. The support 242 can have locations for screws or welds that enable physical connections to the integrated control unit 208 and the housing 206. In alternate embodiments, the integrated control unit 208 can be located remotely and configured to communicate electronically with the test assembly 202. Additionally, integrated control unit 208 can be coupled to an electrical disconnect lockout 240. The electrical disconnect lockout can be used during emergencies to cut down power supply to the system 200.

[0077] In various embodiments, the control panel 210 can include an emergency stop button 244 for quick and easy access by the user to stop the integrity testing of a test specimen in case of an emergency. The emergency situation can be due to varied reasons owing to application of voltage other than required, improper closing of the guard lid 234 on the test platform 230, or improper placement of the test specimen on the test platform 230. Additionally, a barcode scanner 246 can be mounted on the control panel 210. In the depicted embodiment, scanner 246 is securely fixed to control panel 210. In other embodiments, the barcode scanner 246 can be removable and mounted to control panel 210 or can be a hand-held scanner that can be manually manipulated. Upon scanning a test specimen with the barcode scanner by the user, the user interface 212 displays information related to the test specimen ID, material type, type and number of ports, or testing region description for integrity testing, voltage to be applied for17 Docket No. TP387661WO1 integrity testing, recipe for testing, and the user has the option to revise the information as needed.

[0078] In various embodiments, the integrated control unit 208 can be configured to sense different parameters, and changes occurring in the different parameters during integrity testing of a test specimen in the automated integrity testing system 200. The integrated control unit 208 is unique in the field of integrity testing of flexible products because it consolidates each controlled component to a single user interface 212.

[0079] In various embodiments, the integrated control unit 208 can be in electrical and electronic communication with the detector assembly 226 which can then initiate and measure one or more parameters to perform the integrity testing of a test specimen placed within the interior of test assembly 202.

[0080] In various embodiments, a user can access the functions of the integrated control unit 208 through the user interface or Human Machine Interface (HMI) 212 by touching the touch-sensitive display or interactive display 212. For example, the user can control the status of the test assembly prior to initiating integrity testing of a test specimen and also control the voltage and timing of application of the voltage to the test specimen during integrity testing of a test specimen.

[0081] In various embodiments, the pedestal structure 214 includes a top portion 214 A and a bottom portion 214B. The top portion of the pedestal structure 214A is coupled to the bottom of housing 206 through an ergo lift structure 248 (shown in FIG.2B) and the ergo lift structure 248 is configured for displacement along an axis orthogonal to the longitudinal length LI of the floor 218. In an example embodiment, the ergo lift structure 248 is operated through an electrical motor (not shown in FIG 2A or FIG. 2B), but other mechanisms, including hydraulic, pneumatic mechanisms, scissor lifts, and screw scissor lifts, fall under the scope of this disclosure. In any case, the electrical, hydraulic, pneumatic, scissor lift, and screw scissor lifts mechanisms, provide for adjusting the test assembly 202 to a convenient height for the user). In an example embodiment, the vertical displacement of the test assembly 202 by manipulating the ergo lift structure 248 can be controlled by an ergo lift control panel 250 mounted to the front portion 218 A of the floor 218, and the power for the ergo lift structure 248 can be provided by an ergo lift power supply box 252 mounted to the integrated control unit 208.

[0082] In various embodiments, an internet radio 254 is mounted on the pedestal structure 214, as seen in FIG. 2B. The internet radio 254 for connection with the network and to data log results of integrity testing. Optionally a protective guard 256 can be mounted around the internet radio 254 so that it avoids any damage to the internet radio 254 while the user18 Docket No. TP387661WO1 performing the integrity testing. Additionally, a remote I / O 258 (See FIG. 2A and FIG. 2B), including one or more sensors and a storage shelf 260 (See FIG. 2B), are mounted on the bottom end 218D of the back portion 218B of the floor 218. While one or more sensors of the remote I / O 258 are in electronic communication with the integrated control unit 208 for feedback control of different parameters in integrity testing, the storage shelf 260 is used for storing tooling or die accessories required for integrity testing of test specimens.

[0083] In various embodiments, the footing plate 216 includes a top surface 216A, a step structure 216B, and a bottom surface 216C. The advantages of having a step structure 216B on the top surface 216A of the footing plate 216 include providing provision for receiving a forklift below the footing plate 216 proximate to the bottom surface 216C and for increasing the height of the combination of the testing assembly 202 and housing 206. For mobility purposes, disposed at a bottom surface 216C of the footing plate are a plurality of castor wheels 262. In the depicted embodiment, four castor wheels 262 are used. In other embodiments, integrity testing system 200 can be supported with two, three, or five or more castor wheels 262. Castor wheels 262 can be used to enable easy and selective movement of the automated integrity testing system 200. In one embodiment, castor wheels 262 can include a locking feature 264 so that the user can park the automated integrity testing system 200 at a desired location. In alternative embodiments, castor wheels 262 can be eliminated or replaced with stationary footing supports for the footing plate 216.

[0084] FIG. 3A and FIG. 3B illustrates a close-up view of the front and back perspective view of the testing assembly 202 in FIG. 2A, FIG. 2B, respectively, in an open configuration 202A. In both FIG. 3A and FIG. 3B, it can be seen that top wall 238A, side walls 238B, 238C, front wall 238D, and back wall 238E of the guard lid control assembly 238 are removed to get insight into the interiors of the test assembly 202. As mentioned before, test assembly 202 includes the test platform 230, which is coupled to the opposing side walls 220A and 220B by fastening elements Fl. The test platform 230 comprises a front-end 230A, a back end 230B, a top-end 230C, and a bottom end 230D. The test platform 230 is supported by a support wall 302 extending orthogonally from floor 218 and mounted to the bottom end 230D of the test platform 230. The support wall 302 is also coupled to the opposing sidewalls 220A and 220B by fastening elements F2. The coupling of the testing platform 230 and support wall 302 to side wall 220B can be seen in FIG.3A, and FIG. 3B, but it can be appreciated that a similar set of fastening elements can be employed to couple the testing platform 230 and support wall 302 to side wall 220A. Mounted on opposing sides of the top end 230C and at the back end 230B are a first-side mount 304 and a second-side mount 306. Additionally, mounted to the bottom-19 Docket No. TP387661WO1 end 230D is a voltage sensor 307 for sensing the application of voltage by the detector assembly 226 when the integrity testing of a test specimen is in progress. In other embodiments, the voltage sensor 307 can be integrated inside the detector assembly 226.

[0085] In various embodiments, the guard lid 234 comprises a frame structure 308, and the frame structure 308 is pivotably and slidingly coupled between the opposing side walls 220A and 220B. The guard lid 234 is configured to completely cover the test platform 230 when the integrity testing of the test specimen is in progress. The frame structure 308 includes a first lever arm 310 and an opposing second lever arm 312. The first lever arm 310 has a first end 310A, a second end 310B (shown in FIG. 3B), an inner surface 310C, and an outer surface 310D (shown in FIG. 3B). Similarly, the second lever arm 312 includes a first end 312A, a second end 312B (shown in FIG. 3B), an inner surface 312C, and an outer surface 312D (shown in FIG. 3B). The first end 310A, 312A of the first lever arm 310 and the second lever arm 312, respectively, are bridged by a lid handle 314 including a start button 315, whereas the second ends 310A, 312A of the first lever arm 310, and the second lever arm 312, respectively, arc bridged by a counterweight bar 316 (shown in FIG. 3B). The start button 315 on the lid handle 314 can be in electronic communication with the integrated control unit 208 and configured to initiate a test run and be selectively lighted (for example different colors like red, green, amber etc..) based on the status of the integrity testing or the result of the integrity testing. The counterweight bar 316 facilitates the test assembly 202 to remain in an open configuration 202 A unless the user uses the lid handle 314 to move the test assembly 202 to a closed configuration 202B, described later. Coupled between the inner side 312C of the second lever arm 312 and the second side mount 306 is a lock assembly 317, including a lock actuator portion 317A, lock receiver portion 317B, and a lock sensor portion 317C. The lock actuator portion 317 A is coupled to the inner side 312C of the lever ami 312 and the lock receiver portion 317B is coupled to the side mount 306. In an example the lock assembly 317 can be a magnetic auto lock assembly configured lock under magnetic interactions. Additionally, the lock assembly 317 can be in electronic communication with the integrated control unit 208 to provide a signal regarding the lock status of the test assembly 202 as locked or unlocked. In an example embodiment, the magnetic lock assembly 317 can be a safety door interlock by Keyence, GS-ML 1P. Each of the inner surfaces 310C and 312C of the first and second lever anus 310 and 312 include a linear track 318A, 318B proximate to their respective first ends 306A and 308A (shown in FIG. 3A). The outer surfaces 310D and 312D of the first and second lever arms 310 and 312 are mounted with rollers 320 A, 320B proximate to their respective second ends 310B, 312B. The first and second lever arms 310, 312 are coupled to their20 Docket No. TP387661WO1 respective side walls, 220A, and 220B, by the disposition of the rollers 320A and 320B in V- shaped tracks VT-1 and VT-2 carved out in the side walls 220A, 220B, respectively. Each of the V-shaped tracks includes a curved vertical leg 319A, 319B and linear horizontal leg 321A, 321 B (shown in FIG. 3B).

[0086] In various embodiments, the frame structure 308 houses a test cover 322, and a clear plate 324. The test cover 322 has a front-end 322A and a back end 322B, a top-end 322C, and a bottom-end 322D. The back end 322B of the test cover 322 is pivotably coupled between the first-side mount 304 and a second-side mount 306. The clear plate 324 is mounted onto of the top end 322C of the test cover 322 with one or more fastening elements, and the clear plate 324 extends beyond a length L2 of the test cover 322 and terminates in a visor structure 325. The visor structure 325 facilitates protecting the test assembly 202 when the guard lid 234 is closed over the test assembly 202 during the integrity testing process. The top end 322C of the test cover 322 includes one or more channels C for routing cables or wires extending from a cable carrier or voltage carrier device 326. For example, the cables or wires can be employed for electrical communication between the detector assembly 226 and the electrodes described later in this disclosure. Additionally, a bag presence sensor 327 is mounted at the top end 322C of the test cover 322 for detecting the presence of a bag or test specimen prior to initiating an integrity test cycle. The bag presence sensor 327 can be in electronic communication with the integrated control unit 208 to provide a signal to the integrated control unit 208 for the presence or absence of a bag or test specimen prior to integrity testing.

[0087] In various embodiments, a pair of cam followers 328A and 328B is mounted onto the bottom end 322D, proximate to opposing sides of the front end 322A of the test cover 322. Further, each of the cam follower 328A, 328B is coupled to a roller 330A, 330B, which is disposed inside of their respective proximate linear track 318A, 318B in the first and second lever arms 310, 312. Each of the rollers 330A, and 330B facilitates the forward / backward movement of the frame structure 308 or first and second lever arms 310, 312 for closing / opening of the guard lid 234 onto the test platform 230 during the integrity testing process.

[0088] In various embodiments, in order to cover the test platform 230 with the guard lid 234, the user holds the lid handle 314 and pulls the guard lid 234 downward in direction DI, the front ends 310A, 312A of the lever arms 310, 312 move downward, while simultaneously, the back ends 310B, 312B of the lever arm 310, 312 move upward in direction D2. The upward movement of the back ends 310B, 312B of the lever arms 310, 312 is facilitated by the movement of the rollers 320 A, 320B along the curved vertical leg 319A, 319B of the V-shaped21 Docket No. TP387661WO1 tracks VT- 1, VT-2. At this point both the lever arms 310 and 312 are resting on the test platform 230. Further when the user holds the lid handle 314 and pulls the guard lid 234 forward in a direction D3, the roller 320A, 320B move along the linear horizontal leg 321 A, 321B of the V- shaped tracks VT-1, VT-2, and the guard lid 234 is positioned to cover the test platform 230. Similarly, in order to open up the test platform 230, the user holds the lid handle 314 and pushes the guard lid 234 backward in a direction opposite to D3, the roller 320A, 320B move back along the linear horizontal leg 321A, 321B of the V-shaped tracks VT-1, VT-2. Further, the user holds the lid handle 314 and pulls the guard lid 234 upward in a direction opposite to DI , the front ends 310A, 312A of the lever arms 310, 312 move upward, while simultaneously, the back ends 310B, 312B of the lever arm 310, 312 move downward in a direction opposite to D2. The downward movement of the back ends 310B, 312B of the lever arms 310, 312 is facilitated by the movement of the rollers 320A, 320B along the curved vertical leg 319A, 319B of the V-shaped tracks VT-1, VT-2.

[0089] In various embodiments, the test assembly 202 comprises one or more electrode components mounted on the top end 230C of the test platform in a lower electrode area 340 and one or more electrode components mounted on the bottom end 322C of the test cover in an upper electrode area 350. The detector assembly is configured to generate a voltage and provide the voltage to the electrodes in the lower and upper electrodes 340 and 350 for performing integrity testing of a test specimen placed in the test assembly.

[0090] In various embodiments, an expanded form of test platform or lower electrode area 340 in FIG. 3A, is shown in FIG. 4A. It can be seen that a lower electrode 342A, a lower port alignment tool 354A, and a ground electrode assembly 362 are removably mounted on the top end 230C of the test platform 230. The lower electrode 342A can be a charged electrode and can be mounted onto the test platform 230 by fastening elements F3 and F4. The lower electrode 342A has a body 344 having a raised step structure 346A between a pair of lowered step structures 348 A and 348B. The lower step structures 348 A and 348B are mounted onto the test platform by the fastening elements F3 and F4. The raised step structure 346A has a pair of U-shaped receptacles 350A and 350B for receiving the sealed port region of a test specimen, including two ports for integrity testing. In an embodiment, apertures 352A, and 352B on the lower step structures can be used for receiving wires or cables for electrical communication with the detector assembly 226. Additionally, the test platform 230 can have one or more apertures Al extending from the top end 230C to the bottom end 230D for routing cables of wires from the detector assembly 226 to the lower electrode 342A.22 Docket No. TP387661WO1

[0091] The lower port alignment tool 354A, having a body 356A, is placed proximately behind the lower electrode 342A, such that a pair of U-shaped receptacles 358A, 358B for receiving the ports of the test specimen for integrity testing is aligned with the U-shaped receptacles 350A, 350B of the lower electrode 342A. In an embodiment, the lower port alignment tool 354A can be embedded with magnets, for example neodymium magnets, for coupling with the test platform 230. In other embodiments, lower port alignment tool 354A can be coupled with the test platform 230 by fastening elements known in the art.

[0092] The ground electrode assembly 362 is placed proximately behind the lower port alignment tool 354A such that one or more ground pins 364 originating from the ground electrode assembly 362 can be received beyond the lower port alignment tool 354A and the lower electrode 342A when the guard lid is closed on the test platform 230. The ground electrode assembly 362 comprises a ground base plate sub-assembly 366 and a ground insert plate sub-assembly 368. Further, the ground base plate sub-assembly 366 comprises a ground base plate 370 and a ground guide base plate 372 connected across a pair of guide rods 374. The ground guide base plate 372 is fixedly mounted on the test platform, whereas the ground base plate 370 is movably mounted on the guide rod 374 so as to position the ground pins 364 beyond the lower electrode 342A. The ground base plate 370 extends orthogonally between the first and second lever arms 310, and 312 and is mounted to the inner sides 310C, 312C, of the first and second lever arms 310, and 312, respectively, by pivot pins (not seen in FIG. 4A). The first and second lever arms 310 and 312 can be pivoted around a first pivot axis Pl extending through the ground base plate 370 and the pivot pins. Each of the ground base plate 370 and a ground guide base plate 372 includes a pair of shoulder bolts 376 for receiving the ground insert plate sub-assembly 368. Additionally, the ground guide base plate 372 includes a thumb screw 378 for securing the ground insert plate sub-assembly 368 onto the ground plate sub-assembly 366.

[0093] In various embodiments, the ground insert plate sub-assembly 368 comprises a ground pin insert plate 380 and a ground pin guide insert plate 382. Both the ground pin insert plate 380 and a ground pin guide insert plate 382 have inverted U-shaped structures (not shown in FIG. 4A) configured to be placed on the shoulder bolts 376 of the ground base plate 370 and the ground guide base plate 372. When the ground insert plate sub-assembly 368 is placed on the ground base plate sub-assembly 366, the ground pins 364 originating from the ground pin insert plate 380 are guided through the ground pin guide insert plate 382 by ground pin guides 384. Additionally, cables of wires routed through apertures Al of the test platform 230 can be23 Docket No. TP387661WO1 connected to the ground electrode assembly for electrical and electronic communication with the detector assembly 226.

[0094] In various embodiments, an expanded form of test cover or upper electrode area 350 is shown in FIG. 4B. An upper electrode 342B and an upper port alignment tool 354B are removably mounted on the bottom end 322D of the test cover 322. The upper electrode 342B can be a charged electrode and can be mounted onto the test cover 322 by fastening elements F5. The upper electrode 342B has a body 344B having a raised step structure 346B between a pair of lowered step structures 348C and 348D. The lower step structures 348C and 348D are mounted onto the test cover by the fastening elements F5. The raised step structure 346B has a pair of U-shaped receptacles 350C, 35OD for encompassing the sealed port region of a test specimen, including two ports for integrity testing. Apertures 352C, 352D on the lower step structures 348C and 348D can be used for receiving wires or cables for electrical communication with the detector assembly 226. Additionally, the test cover 322 can have one or more apertures A2 extending from the top end 322C to the bottom end 322D for routing of cables of wires from the detector assembly 226 to the upper electrode 342B.

[0095] fhe upper port alignment tool 354B, having a body 356B, is placed proximately behind the upper electrode 342B. The upper port alignment tool differs from the lower port alignment tool 354A by not having the U-shaped receptacles but having a raised step-like structure 358C. In an embodiment, the upper port alignment tool 354B can be embedded with magnets, for example, neodymium magnets, for coupling with the test cover 322. In other embodiments, upper port alignment tool 354B can be coupled with the test cover 322 by fastening elements known in the art.

[0096] In various embodiments, FIGs 4C-4G illustrate isolated components of the test assembly 202, namely, the upper electrode 342B, lower electrode 342A, upper port alignment tool 354B, lower port alignment tool 354A, and ground insert plate sub assembly 368. Each of the above components illustrated in FIGs. 4C-4G is configured for integrity testing of an edge port seal of a flexible chamber having two tubular ports. Each of the above components can be configured for integrity testing of flexible chambers having less or more than two ports of different sizes and shapes. As mentioned before, each of the lower electrode 342A, lower port alignment tool 354A, and ground insert plate assembly 368 is removably mounted on the top end 230C of the test platform 230, while each of the upper electrode 342B, and upper port alignment tool 354B is mounted removably mounted on the bottom end 322D of the test cover 322. The relative spacing between each of these components on the test platform 230 or below the test cover 322 can be configured based on the dimensions of test specimens 130 and 16024 Docket No. TP387661WO1 for integrity testing. Different components and their dimensions are shown in Table- 1, below, but other sizes and shapes fall under the scope of this disclosure.Table- 1

[0097] Referring back to FIG. 3A, in various embodiments, the detector assembly 226 is in electrical and electronic communication with the lower and upper electrodes 342A, 342B, and the ground electrode 364, and is configured to check the integrity of the test specimen by detecting an electrical circuit between the lower and upper electrodes 342A, 342B and the ground electrode 364. The detector assembly 226 is also in electronic communication with the integrated control unit 210 for sending and receiving instructions for the integrity testing of a test specimen. In an example embodiment, the detector assembly is POROTEST 7 by ElektroPhysik.

[0098] In various embodiments, the detector assembly obtains power from an external source through power inlet 227A. In alternative embodiments, the detector assembly can operate on an inbuilt battery-powered power supply. Additionally, the detector assembly includes an in-built voltage generator, a detection circuit, and a measuring tool (not shown in FIG. 3A) for generating the voltage required for integrity testing and detecting the voltage or current received after routing through the test specimen. The voltage generated by the voltage generator in the detector assembly is boosted by a voltage transfer device 228 before routing the voltage to the lower electrode and the upper electrode. The voltage carrier cables can be routed through the cable carrier or voltage carrier device 326. In particular, the voltage-carrying wires can be routed through apertures Al to provide voltage to the lower electrode 342A. Similarly, the voltage-carrying wires can be routed through apertures A2 to provide voltage to the upper electrode 342B.

[0099] Depicted in FIG. 5 is a closed configuration 200B of the automated integrity testing system 200 incorporating features of the present disclosure for integrity testing of the container system 130. It can be seen in the closed configuration 200B that, (i) the guard lid 234 is configured to completely cover the test platform 230, in other words, the test cover 322 is positioned over the test platform 230, and (ii) the ground pins 364 are received inside of the25 Docket No. TP387661WO1 container system 130 beyond the combination of lower and upper electrodes 342A, 342B. The container system 130, placed in the closed configuration 200B of the automated integrity testing system 200, is all set for integrity testing.

[0100] Referring back to FIG. 1C, FIG. 4A, FIG.4B, and FIG. 5, in various embodiments, the following steps can be followed by the user to achieve the closed configuration 200B for the system 200. Firstly, container system 130, having two edge ports, is placed in the lest assembly 202 for the integrity testing of the edge ports. In particular, ports 133 of container system 130 are aligned in the U-shaped receptacles 358A of the lower port alignment tool 354A (See FIG. 4B). The sealed port region or test region 154A of the container system is placed over the raised region 346A of the lower electrode 344A such that the port region of the container system is received in the U-shaped receptacles 350A and 350B of the lower electrode 342A (See FIG. 4B). Secondly, the user holds the handle 314 to pull the guard lid 234 downward to place the guard lid 234 overlappingly over the test platform 230. To facilitate the downward movement of the guard lid 234 the first and second lever arms 310, 312 of the frame structure 308, pivot across the curved leg 319A, 319B of the V-shaped tracks VT-1, VT-2 in the side walls 220a, 220B, and along the pivot axis Pl of the ground base plate. Lastly, the user holds the handle 314 to pull the guard lid 234 forward to insert the ground pins 364 inside the container system 130 and prepare the test assembly for integrity testing of the container system 130. To facilitate the forward movement of the guard lid 234 the first and second lever arms 310, 312 of the frame structure 308, move laterally across the horizontal leg 321 A, 321B of the V-shaped tracks VT-1, VT-2 in the side walls 220a, 220B, and the ground base plate 370 is moved along the guide rods 374 so that the ground pins 364 attached to the ground insert plate 380 are moved into the ground pin guides 384 and received inside the container system 130 beyond the lower and upper electrode combination pair 342A, 342B. As the ground pins 364 are received inside container system 130 and the lower electrodes 342A are aligned with the upper electrodes 342B, sandwiching the edge port test region 154A there between. The magnetic lock assembly 317 locks the test assembly 202 and sends a signal to the integrated control unit 208 that the test assembly 202 is locked and the container system 130 is ready for integrity testing.

[0101] FIG. 6 is a block diagram of an automated integrity testing system 600, consistent with implementations of the current subject matter. System 600 is an example of automated integrity testing system 200 described above. The integrity testing system 600 is designed for detecting defects, flaws, pores, pinholes, or holes in the test specimens, including films, flexible bags or containers, seals, edge port seals, face port seals, tubing assemblies, and fill and finish26 Docket No. TP387661WO1 assemblies by using a high-voltage electric current . In example embodiments, the system 600 is configured to detect holes as small as 1.0 microns and film material thinned or thickened in a first region compared to a second region of the film. The holes can have a diameter ranging between 0.9 - 1.1 microns.

[0102] In various embodiments, automated integrity testing system 600 can include an integrity testing unit 601 comprising test assembly 602, associated sensors 604, and other electrical and electronic peripherals, in electronic communication with an integrated control unit 630, and a user workstation 650 operated by a user. The test assembly 602 is an example of the test assembly 202 described above. A communication switch 670, for example, an ethemet IP switch, functions as a router to facilitate and balance communications and data transmission between integrity testing unit 601 and / or sensor 604 and sensor transmitter (not shown) associated with the integrated control unit 630, and user workstation 650. The communication switch 670 is an example of the internet radio 254 mounted to the pedestal 214 of system 200. The user workstation 650 is an example of the control panel 210 having the display 211 and the user interface 212 of system 200. Other communication links, routers, or switches can also facilitate and balance communications and data transmission between integrity testing unit 601, sensors 604, integrated control unit 630, and user workstation 650.

[0103] Integrity testing unit 601 can include a test assembly 602, a plurality of sensors 604, test specimen 606, charged electrode 608, ground electrode 610, a detector assembly 614 and a vertical translation motor 618, and / or other peripherals, instruments, and electrical equipment. For the purposes of this example, the test specimen 606 is a flexible chamber or container 130, but can be a tubing assembly, and fill and finish assembly or other flexible bioprocessing equipment used to process biological fluids. In an example embodiment, the test specimen 606 in automated integrity testing system 600 can be a Thermo Scientific™ 2D Labtainer™ BioProcess Container (BPC) or any similar flexible bioprocessing container or equipment 130, 160 described above. Charged electrode 608, and ground electrode 610 are examples of lower and upper electrodes 342A, 342B, and ground pins 360, respectively. The detector assembly 614 is an example of the detector assembly 226 (POROTEST-7) described above. The vertical translation motor 618 is an example of the ergo lift 248 described above.

[0104] Operations of the integrity testing system 600, including the running of an integrity test of test specimen 606 in test assembly 602, can be controlled by the integrated control unit 630. Operation of sensors 604, detector assembly 614, vertical translation motor 618 can be controlled by analog or digital input modules, transmitters, communication hubs, communication channels, and / or other signal and data communication and / or processing27 Docket No. TP387661WO1 devices for processing and exchanging data with the controller (e.g., Ethernet / IP codesys, DI / DO modules).

[0105] Integrated Control Unit 630 includes at least one processor 632 and at least one associated primary memory 634 for storing instructions, which, when executed by at least one processor 632, are configured to perform one or more operations, including process control operations for automating control of bioprocessing equipment. Further, a communication link 635 facilitates electronic communication between test assembly 602, sensors 604, charged electrodes 608, ground electrodes 610, detector assembly 614, vertical translation motor 618, integrated control unit 630, and user workstation 650, via communication switch 670. Communication link 635 can include any wired and / or wireless network, including, for example, a wide area network (WAN), a local area network (LAN), a virtual local area network (VLAN), a public land mobile network (PLMN), the Internet, and / or the like. All data interactions, including sending, receiving, writing, overwriting, and copying instructions, signals, and data between the above components, integrity testing unit 601, integrated control unit 630, and user workstation 650, can be stored in memory 634.

[0106] In some implementations, memory 634 can be a centralized repository designed to store, process, and secure large amounts of structured, semi -structured, and unstructured data. In general, memory 634 can store and / or process the data received from integrity testing unit 601 and serve as a source of data for user workstation 650 and vice-versa. In various embodiments, portions of data stored in memory 634 can be configured to be transferred to other similar instruments. For example, data stored in memory 934 can be used for data analytics, predictive protocols, and process optimization. In various embodiments, data can be collected from the various components within the integrated control unit 630 and sent to a desktop computer for further processing. In some embodiments, data can be transferred to a USB drive from the integrated control unit 630 for ease of transfer.

[0107] Further, integrated control unit 630, includes an equipment interface module 636 and a sensor interface module 638, configured to generally interface with, receive, and transmit signals and data to and from one or more operational components, peripherals, or equipment (charged and ground electrodes, detector assembly, detection circuits) and sensors 604 (or associated transmitters) of the integrity testing unit 601. In various embodiments, the integrated control unit 630 can be a single unit or a distributed control system with a client-side control component for client inputs and outputs and a production- side control component closer in proximity to the bioprocessing plant.28 Docket No. TP387661WO1

[0108] A user can control operations of integrity testing unit 601 via user interface 652 displayed on user workstation 650. In particular, user interface 652, includes user inputs and readable instrument and process parameter outputs for controlling and monitoring integrity testing unit 601. For example, user workstation 650 can be configured to remotely control and monitor one or more operations of integrity testing unit 601 by receiving inputs / outputs from sensors 604, charged electrodes 608, ground electrodes 610, detector assembly 614, and other equipment, or associated transmitters.

[0109] In various embodiments, when the sensor 604 of the integrity testing system (a sensor or voltage or current reader) begins communication with the integrated control unit 630 or a new sensor gets plugged into the system, processor 632 can detect a signal which can then be compared with a library of signals stored on the memory 634 in order to determine what kind of sensor is being accessed. The memory can further include instructions for autocalibration of the sensor 604. For example, if the sensor is a voltage sensor 604 it may be calibrated in order to take accurate voltage measurements at a desired location. In some embodiments, after the sensor 604 is recognized an integrity testing module can be activated and automatically arranged within display 212 of the control panel 210 based on a set of processes or tasks selected by the user or predetermined by the system.

[0110] In various embodiments, an example of a feedback loop can include measuring the voltage applied to the charged electrodes 608 by either the detector assembly 614 or voltage sensor 604A. An example of a voltage sensor 604A is the voltage sensor 307 coupled to the bottom end 230D of the test platform (See FIG. 3A and FIG. 3B). The voltage sensor 604A can then relay information by wireless or wired communication to the voltage transmitter and the processor 632. The processor 632 can then access the memory 634 which can identify the type of information being received and from which device. The memory can also include instructions for actions to be taken depending on what information is being received. For example, if the voltage is too low, the memory may include instructions to increase, change, or modify the voltage applied to the charged electrodes. The processor 632 can then firstly abort the run because of the application of improper voltage and then secondly activate the voltage generator in the detector assembly to generate the proper voltage for the charged electrodes 608. Once the voltage sensor 604 registers a value within a defined range, the voltage generator in the detector assembly 614 can be deactivated until the next cycle or run. Alternatively, upon detection of the improper voltage, the user can access the electrical disconnect lockout 240 coupled to the integrated control unit 208 or the emergency button 244 on the control panel to29 Docket No. TP387661WO1 manually switch off the system 600, rather than waiting for the processor 632 to handle the aborting of the run electronically.

[0111] In various embodiments, an example of a feedback loop can include detecting the presence of a test specimen in the test assembly 602 before the initiation of the integrity testing by a test specimen presence sensor 604B. An example of a test specimen presence sensor 604B is the bag presence sensor 327 coupled to the top end 322D of the test cover (See FIG. 3A and FIG. 3B). The test specimen presence sensor 604B can then relay information by wireless or wired communication to the test specimen presence transmitter and the processor 632. The processor 632 can then access the memory 634 which can identify the type of information being received and from which device. The memory can also include instructions for actions to be taken depending on what information is being received. For example, if the test specimen is absent, the memory may include instructions to provide a message to the user on the user workstation 650 about the missing test specimen and provide the option to place the test specimen and rerun the test specimen presence check to ensure proper placing of the test specimen in the test assembly 602.

[0112] In various embodiments, an example of a feedback loop can include detecting the locking configuration of the test assembly 602 before the initiation of the integrity testing by a lock sensor 604C. An example of a lock sensor 604C is the lock sensor component 317C of lock assembly 317 coupled to the second lever arm 312 (See FIG. 3A and FIG. 3B). The lock sensor 604C can then relay information by wireless or wired communication to the lock sensor transmitter and the processor 632. The processor 632 can then access the memory 634 which can identify the type of information being received and from which device. The memory can also include instructions for actions to be taken depending on what information is being received. For example, if the test assembly 602 remains unlocked, the memory can include instructions to provide a message to the user on the user workstation 650 about the unlocked status of the test assembly 602 and to provide prompts to the user to check for potential faults including, improper alignment of port alignment tools, charged, or ground electrodes.

[0113] In various embodiments, an example of a control loop can include the controlling operation of the vertical translation motor 618 by the integrated control unit 630. In example embodiments, the equipment interface module routes electronic communication between the processor 632 and the vertical translation motor 618. The processor instructs the user workstation 650 to display options for adjusting the height of the test assembly 602. The user can select a height option and the processor 632 sends instructions to the equipment interface30 Docket No. TP387661WO1 module 636 to control the operation of the vertical translation motor for upward or downward vertical translation.

[0114] In various embodiments, the user scans a barcode of a chamber with a barcode scanner 639. The bar code scanner sends a signal to the equipment interface module 636 and the processor 632 to scan the memory 634 for all information related to the test specimen. The memory pulls out all the related information about the test specimen and sends it back to the processor 632. Further, processor 632 sends instructions to display 652 to show all the test specimen-related information to the user with an additional selection of recipes for integrity testing. The user views the available selection of recipes and picks a recipe for performing the integrity testing of the test specimen. Each recipe for integrity testing comprises a plurality of parameters, including test specimen information (ID, dimension, brand name, number of ports, size of ports, type of port, etc..), amount of voltage to be applied to the electrodes for integrity testing, time for cycle ran, and other relevant parameters.

[0115] The user then places the test specimen or chamber 606 in the test assembly by aligning the ports in their respective port alignment receptacles and sealed port region on the lower charged electrodes 608. The relative distance between the port alignment tool and the lower charged electrode 608 is configurable based on the chamber size. Next, the user pulls the guard lid downward and forward to (i) align the upper charged electrode on the lower charged electrode, (ii) align upper port alignment tool onto the lower port alignment tool, and (iii) insert the ground electrodes 610 inside the chamber 606. Upon inserting the ground electrodes 610 inside the chamber the bag presence sensor 604B sends a signal to the integrated control unit 630 indicating the presence of the bag and the lock sensor 604C sends a signal to the integrated control unit 630 that the test assembly is in locked configuration and is ready for integrity testing of the chamber 606. The processor 632 processes these signals from the bag presence sensor 604B and lock sensor 604C and sends a signal to the detector assembly to apply the predefined voltage based on the recipe selected by the user to the charged electrodes 608 sandwiching the sealed port region of the test specimen. Alternatively, upon obtaining confirmation of the lock status of the test assembly on the user workstation, the user can manually press the start button 315 on the lid handle 314 (See FIG. 3A, FIG. 3B) to initiate the application of the predefined voltage to the charged electrodes.

[0116] Based on the instructions by the processor 632 or the manual initiation by the start button on the lid handle, the detector assembly 614 applies the predefined voltage to the charged electrodes 608, and the detector assembly 614 is configured to measure the current or voltage arcing through the sealed port region of the chamber 606 and the voltage or current31 Docket No. TP387661WO1 received at the ground electrode 610. Based on the voltage or current received at the ground electrode 610 the detector assembly 614 qualifies the chamber 606 as passed or failed. If the voltag e / current received at the ground electrode 610 is higher than applied, then the chamber 606 failed the integrity testing, and if the voltage / current received at the ground electrode is the same as applied, then the chamber passed the integrity testing without any defects.

[0117] The detector assembly 614 sends the signal with test results to the processor 632, which provides instructions to the user's workstation 650 to display the results. The test assembly 602 continues to remain in the locked configuration to ensure user safety during and after the integrity testing due to the usage of charges. In particular, for a failed chamber, the user must acknowledge the result, and then the test assembly 602 is transitioned to the open configuration when the user can push the guard lid backward to remove the ground electrodes 610 outside the chamber 606 and then lift the guard lid upwards to open up the test assembly 202 for removing the chamber 606.

[0118] FIG. 7 illustrates a home screen 702 that may be shown on an integrity testing workspace 700 that can be displayed on a touch-sensitive display or interactive display 212 on an automated integrity testing system 200 described above, while running integrity testing of test specimens according to various embodiments. The integrity testing workspace 700 can comprise one or more integrity testing modules 704, including a top banner 706, a bottom banner 708, a recipe status 710, a door lock status module 712, a test results module 714, an operator ID module 716, and a fault reset module 718. Additionally, operator messages 720 and fault messages 721 can be displayed on the home screen 702 to facilitate the user in running the integrity testing of test specimens.

[0119] In various embodiments, an integrity testing workspace 700 may include one or more integrity testing modules 704. A user may interact with the integrity testing modules 704 through the touch- sensitive display or interactive display 212. Each integrity testing module 704 may represent a single process or many processes. Alternatively, integrity testing module 704 may represent a single process making use of several peripheral devices. In FIG. 7 The individual modules 704 depicted are specific to running recipes, checking door lock status, inputting operator ID, viewing test results, and resetting fault settings, which are shown under the top banner 706 labeled as ‘Main.’

[0120] In various embodiments, the integrity testing modules 704 can display the recipe status 710, door lock status 712, test results 714, operator ID 716, fault settings 718, operator message 720, and a fault message 721. Some or all of the components of each integrity testing module 704 may be interactive and may depend on the type of process or action represented32 Docket No. TP387661WO1 by the integrity testing module 704. For example, the operator ID module 716 may allow a user to directly interact with the display to enter the required information about the user ID. Another example may include a reset fault settings module 718 that provides for adjusting or resetting faults by the user as part of a recipe.

[0121] In various embodiments, the bottom banner 708 of integrity testing workspace 700 can have one or more buttons to provide user access to various functions. For example, a back button 722 allows the user to return to the previous screen. For example, upon accessing the back button, the user can be navigated to the start-up screen. A wrench and screwdriver button 724 allows the user to go to a ‘Maintenance screen’ described below in FIG. 8. The maintenance screen provides access to the user to one or more maintenance functions. A house button 726 navigates the user to the Start-Up screen and has a similar function as the back button 722. A red / green lock button 728 provides for the user to ‘log In or log Out screen’ for access to engineering and maintenance functions. A red exclamation triangle button 730 and a spoon and fork button 732 allow the user to navigate to the ‘Fault History screen’ and a ‘Recipe Select screen’, respectively, described below.

[0122] FIG. 8 illustrates a maintenance screen 802 that may be shown on a maintenance workspace 800 that can be displayed on a touch-sensitive display or interactive display 212 according to various embodiments. The maintenance screen 802 can be obtained when the user accesses the wrench and screwdriver button 724 in FIG. 7. The maintenance screen 802 can comprise one or more maintenance modules 804, including a top banner 806, a bottom banner 808, an instrument status module 810, a door status module 812, a test status module 814, a total cycle module 816, and a resettable cycle module 818.

[0123] In various embodiments, the maintenance workspace 800 may include one or more maintenance modules 804. A user may interact with the maintenance modules 804 through the touch-sensitive display or interactive display 212. In FIG. 8 the individual modules 804 depicted are specific to integrity testing instrument status, door lock status, test module status, total cycle status, and resettable cycles status, which are shown under the top banner 806 labeled as ‘Menu.’ The bottom banner 808 of maintenance workspace 800, can have a back button 822, a wrench and screwdriver button 824, a house button 826, a red / green lock button 828, a red exclamation triangle button 830, and a spoon and fork button 832 similar to bottom banner 708 described above. The door status module 812 and the test status module 814 provide the user with the option to test door locks and manually activates the voltage applications. These options help in ensuring that the doors are necessarily locked prior to activation of the voltage application.33 Docket No. TP387661WO1

[0124] FIG. 9 illustrates a Log-In-Log-Out screen 902 that may be shown on a Log-In-Log- Out workspace 900 that can be displayed on a touch- sensitive display or interactive display 212 according to various embodiments. The Log-In-Log-Out screen 902 can be obtained when the user accesses the red / green lock button 728 in FIG. 7. This Log-In-Log-Out screen 902 ensures users with appropriate authentication / permissions get access to edit, modify, revise, or rewrite engineering and maintenance functions.

[0125] FIG. 10 illustrates a default history screen 1002 that may be shown on a default history workspace 1000 that can be displayed on a touch-sensitive display or interactive display 212 according to various embodiments. The default history screen 1002 can be obtained when the user accesses the red exclamation triangle button 730 in FIG. 7. The default history screen 1002 can comprise, a top banner 1006, a bottom banner 1008, and a list of fault history 1010. In particular, the default history screen 1002 provides users with a list of faults, accurate time of fault occurrence, accurate time of the beeping of the alarm upon the occurrence of a fault, notification if the fault was acknowledged by the user, an accurate time of acknowledgment of the fault notification, and description or details of the fault. Also, the default history screen 1002 provides users with options to acknowledge one alarm at a time or acknowledge multiple alarms at a time, and to reset all faults. The bottom banner 1008 of history screen 1002, can have a back button 1022, a wrench and screwdriver button 1024, a house button 1026, a red / green lock button 1028, a red exclamation triangle button 1030, and a spoon and fork button 1032 similar to bottom banner 706 described above.

[0126] FIG. 1 1 illustrates a recipe select screen 1102 that may be shown on a recipe select workspace 1100 that can be displayed on a touch-sensitive display or interactive display 212 according to various embodiments. The recipe select screen 1102 can be obtained when the user accesses the spoon and fork button 732 in FIG. 7. The recipe select screen 1102 can comprise, a top banner 1106, a bottom banner 1108, and a list of recipes 1110. The recipe select screen 1102 provides users with a list of recipes for selection by the user for running the integrity testing of test specimens. Each recipe is provided with its corresponding test duration, time period, voltage applied in KV, and sensitivity of the integrity testing. The bottom banner 1108 of recipe select screen 1102 can have a back button 1122, a wrench and screwdriver button 1124, a house button 1126, a red / green lock button 1128, a red exclamation triangle button 1130, and a spoon and fork button 1132 similar to bottom banner 706 described above.

[0127] FIG. 12 is a block diagram of an automated integrity testing system 1200, consistent with implementations of the current subject matter. The automated integrity testing system 1200 is similar to the automated integrity testing system 200 and 600 described earlier but34 Docket No. TP387661WO1 includes a product marking assembly 1210 coupled to the test assembly 202. When integrity testing of one or more test specimen samples 130 and 160 is carried out, it is advantageous to mark the test specimen with a ‘pass’ or ‘fail’ of the integrity testing to avoid ambiguity regarding the integrity of the test specimens. The product marking assembly 1210 facilitates marking of the test specimen with a marking or destroys a failed sample to avoid reuse.

[0128] In various embodiments, the product marking assembly 1210 can be placed proximate or spaced away from the test assembly 202, 602, but a product marking element 1212 of the product marking assembly 1210 can be in near proximity or at least coupled to the test platform 230 or the test cover 322 to be accessible for marking a test specimen immediately after the integrity testing process is completed. The product marking assembly can be in electronic communication with the integrated control units 208 and 630 to receive signals from the integrated control unit 208, 630 through the equipment interface module 636 regarding instractions for handling the marking of test specimens 130 and 160. The integrated control unit 208 receives a signal from the detector assembly 226, 614 regarding the testing as ‘pass’ or ‘fail’ and provides the instructions to the product marking assembly 1210 to mark the test specimen accordingly.

[0129] In various embodiments, the product marking assembly 1210 can be a printer, including a printing element 1212A configured to print the text ‘pass’ or ‘fail’ on the test specimen 130, 160 based on the testing results. In other embodiments, the product marking assembly 1210 can be a sticker applicator, including an applicator element 1212B configured to apply a sticker including the text ‘pass’ or ‘fail’ on test specimens 130 and 160 based on the testing results. In other embodiments, the product marking assembly 1210 can be a cutter assembly, including a cutting element 1212C configured to make a cut marking on the test specimen 130, 160 based on the testing results. In other embodiments, the product marking assembly 1210 can be a scribing assembly, including a scribing element 1212D configured to scribe a line on the test specimen 130, 160 based on the testing results. In other embodiments, the product marking assembly 1210 can be a hole punch assembly, including a punching element 1212E configured to make a cut marking on the test specimen 130, 160 based on the testing results.

[0130] FIG. 13 illustrates a cross-sectional view of a handheld integrity testing system 1300, consistent with implementations of the current subject matter. The handheld integrity testing system can be employed in the integrity testing of face ports 1302 sealed onto film 1304, prior to the perimeter sealing of film 1304 for forming chambers or bags used in bioprocessing. The face port 1302 can be sealed onto film 1304 by well-known sealing techniques, including heat35 Docket No. TP387661WO1 sealing, adhesive sealing, and ultrasonic sealing. During the sealing of the face port 1302 to film 1304, following one of the above-mentioned sealing techniques can potentially cause defects or flaws at the face port seals due to improper sealing for various reasons. The handheld integrity testing device 1300 can be positioned proximate to the face port seal 1302 and film 1304 to inspect or test the integrity of the face port sealing.

[0131] In various embodiments, the handheld integrity testing device 1300 comprises a body 1310 coupled to a handle 1312. Body 1310 comprises a top portion of 1314 and a bottom portion of 1316. The top portion 1314 includes a ring-like charged electrode portion 1318 housed in an insulation cover 1320. The bottom portion, 1316, includes a ring-like ground electrode portion, 1322. The handle 1312 comprises a front portion 1324 and a back portion 1326. The front portion 1324 of the handle 1312 is configured for attachment to a conductor 1328 to connect to the charged electrode portion 1318. A battery-powered voltage or current source can be embedded in the handle 1312 to provide the necessary voltage or current for integrity testing. Additionally, a voltage or current sensor can be embedded in body 1310 to detect the voltage or current received at the ground electrode portion 1322 after passing through the face port seal. While integrity testing of the face port 1302, the user places the film with the face port 1302 over the ground electrode portion 1322, and then the charged electrode portion 1318 is placed so as to encircle the face port 1302 and sandwich the film 1304 between the charged and the ground electrode portions 1318, 1322. Based on the voltage or current detected at the voltage or current sensor the integrity of the face port seal is evaluated as ‘pass’ or ‘fail’.

[0132] FIG. 14 is a flow diagram of method 1400 for operating an automated integrity testing system 200, 600 in accordance with an integrity testing recipe. Aspects of the example integrity testing systems 200 and 600 are depicted in FIG. 2A, FIG. 2B and FIG. 6 can be utilized in the method steps described below. The example method 1400 may not recite the complete process or all steps of the method. Also, the steps need not necessarily all be performed, and in some cases, can be performed by the user simultaneously or in a different order than the order shown.

[0133] At step 1410, the user scans a barcode of a chamber or container 132 or specimen SI or S2 at a barcode scanner. All the information related to the chamber is populated on the display screen of the control panel. Typical information gathered could include the brand name of the chamber, material properties of the chamber, catalog, lot, and batch numbers of the chamber to provide the history of manufacturing details, size, capacity, and dimensions of the36 Docket No. TP387661WO1 chamber, number of ports, type of ports (For example: Labtainer™ Pro BioProcess Container with BioTitan Retention, Aegis™ 5-14, 2 ports, end-ported with insert and body luer lock)

[0134] At step 1420, a recipe for integrity testing of the chamber is selected or modified by the user. Based on the chamber information gathered by scanning the barcode, the processor in the integrated control unit provides a list of recipes for integrity testing. The user selects a recipe or modifies the recipe accordingly to meet the needs of the integrity testing of the chamber. Parameters defined in a recipe could at least include the voltage to be applied and pre-defined sensitivity for the integrity testing.

[0135] At step 1430, the chamber is placed in an integrity-testing assembly. The ports of the chamber are placed in the lower port alignment tool, the sealed port region of the chamber is placed over the lower electrodes, and the rest of the chamber is allowed to rest on the test platform.

[0136] At step 1440, a guard lid is pulled downward and forward by the user, to lock the integrity test assembly. Upon pulling the guard lid downward, the upper port alignment tool is positioned over the lower port alignment tool such that the lower and upper port alignment tools encompass the port. Also, by pulling the guard lid downward, the upper electrode is positioned over the lower electrode such that the sealed port region is sandwiched between the upper and lower ports. Further, by pulling the guard lid forward the ground pins are inserted inside the chamber through the ports. As the ground pins are inserted inside the chamber, the integrity test assembly is locked by a magnetic lock assembly to ensure the safety of the user during the integrity testing process due to the usage of voltage.

[0137] At step 1450, a voltage is applied, and the chamber is tested for integrity. The voltage generated by the detector assembly is applied to the lower and upper electrodes and the voltage received at the ground electrode after passing through the sealed port region is read by a voltage sensor. The readings of the voltage sensor qualify the integrity of the chamber as ‘pass’ or ‘fail.’

[0138] At step 1460, if the integrity testing of the chamber resulted in a ‘pass’ the method proceeds to step 1080 below.

[0139] At step 1470, if the chamber's integrity testing results in a ‘fail,’ the method proceeds to step 1490 below.

[0140] At step 1480, upon obtaining a ‘pass’ result, the integrity test assembly is unlocked, and the chamber is retrieved for further use.

[0141] At step 1490, upon obtaining a ‘fail’ result, the user acknowledges the failed result, the integrity test assembly is unlocked, and the chamber is discarded. Optionally, the chamber37 Docket No. TP387661WO1 can be marked up (for example, print the text TAILED,' scribe a line, punch a hole, apply a sticker, etc.) to avoid inadvertent usage of chambers that failed the integrity testing.

[0142] FIG. 15 depicts a block diagram of an example computing device 1500 that can perform some or all operations of an automated bioprocessing system, including a fluid mixing system, user computing device(s), processing unit(s) and / or controller(s) in accordance with the example embodiments. The example automated bioprocessing system, including a fluid processing system, and system controller, including controllers, modules, libraries, and data repositories, disclosed herein can include or be implemented by one or more computing devices. In some embodiments, the example user computing device or workstation 650, and integrated control unit 630 include a single computing device 1500 or multiple computing devices 1500. Further, as discussed below, in reference to FIG. 6, a computing device 1500 (or multiple computing devices 1500) that implements the example automated bioprocessing system, including a fluid processing system, modules, data repositories, and libraries, can be part of one or more integrity testing assemblies 202, user or client computing devices 650 with user interfaces 652, processors 632 and integrated control unit 630, a user’s local computing device, a service provider’s local computing device, or a remote computing device. Client computing devices or user workstations 650, processing units 632, and integrated control unit 630, can also be contained in a unitary computing system or server with a user interface or distributed over servers and systems.

[0143] The computing device 1500 of FIG. 15 is illustrated as having a number of components, but any one or more of these components may be omitted or duplicated, as suitable for the application and setting. In some embodiments, some or all of the components included in the computing device 1500 can be attached to one or more motherboards and enclosed in a housing (e.g., including plastic, metal, and / or other materials). In some embodiments, some of these components may be fabricated onto a single system-on-a-chip (SoC) (e.g., an SoC may include one or more processing devices 1502 and one or more storage devices 1504). Additionally, in various embodiments, the computing device 1500 may not include one or more of the components illustrated in FIG. 15, but may include interface circuitry (not shown) for coupling to one or more components using any suitable interface (e.g., a Universal Serial Bus (USB) interface, a High-Definition Multimedia Interface (HDMI) interface, a Controller Area Network (CAN) interface, a Serial Peripheral Interface (SPI) interface, an Ethernet interface, a wireless interface, or any other appropriate interface). For example, the computing device 1500 may not include a display device 1510, but may include display device interface circuitry (e.g., a connector and driver circuitry) to which a display device 1510 may be coupled.38 Docket No. TP387661WO1

[0144] The computing device 1500 can include a processing medium or device 1502 (e.g., one or more processing devices). As used herein, the term "processing device" refer to any device or portion of a device that processes electronic data from registers and / or memory to transform that electronic data into other electronic data that may be stored in registers and / or memory. The processing device 1502 can include one or more digital signal processors (DSPs), application-specific integrated circuits (ASICs), central processing units (CPUs), graphics processing units (GPUs), crypto processors (specialized processors that execute cryptographic algorithms within hardware), server processors, or any other suitable processing devices.

[0145] The computing device 1500 can also include a storage device 1504 (e.g., one or more storage devices). The storage device 1504 can include one or more memory devices such as random-access memory (RAM) (e.g., static RAM (SRAM) devices, magnetic RAM (MRAM) devices, dynamic RAM (DRAM) devices, resistive RAM (RRAM) devices, or conductive- bridging RAM (CBRAM) devices), hard drive -based memory devices, solid-state memory devices, networked drives, cloud drives, or any combination of memory devices. In some embodiments, the storage device 1504 can include memory that shares a die with a processing device 1502. In such an embodiment, the memory can be used as cache memory and can include embedded dynamic random-access memory (eDRAM) or spin transfer torque magnetic random-access memory (STT-MRAM), for example. In some embodiments, the storage device 1504 can include non-transitory computer- readable media having instructions thereon that, when executed by one or more processing devices (e.g., the processing device 1502), cause the computing device 1500 to perform any appropriate ones of or portions of the methods and operations disclosed herein.

[0146] The computing device 1500 can include an interface device 1506 (e.g., one or more interface devices 1506). The interface device 1506 can include one or more communication chips, connectors, and / or other hardware and software to govern communications between the computing device 1500 and other computing devices. For example, the interface device 1506 can include circuitry for managing wireless communications for the transfer of data to and from the computing device 1500. The term "wireless" and its derivatives are used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that can communicate data through the use of modulated electromagnetic radiation through a nonsolid medium. The term does not imply that the associated devices do not contain any wires, although in some embodiments they might not. Circuitry included in the interface device 1506 for managing wireless communications can implement any of a number of wireless standards39 Docket No. TP387661WO1 or protocols, including but not limited to Institute for Electrical and Electronic Engineers (IEEE) standards including Wi-Fi (IEEE 802.11 family), IEEE 802.16 standards (e.g., IEEE 802.16-2005 Amendment), Long-Term Evolution (LTE) project along with any amendments, updates, and / or revisions (e.g., advanced LTE project, ultra-mobile broadband (UMB) project (also referred to as "3GPP2"), etc.). In some embodiments, circuitry included in the interface device 1006 for managing wireless communications may operate in accordance with a Global System for Mobile Communication (GSM), General Packet Radio Service (GPRS), Universal Mobile Telecommunications System (UMTS), High Speed Packet Access (HSPA), Evolved HSPA (E-HSPA), or LTE network. In some embodiments, circuitry included in the interface device 1506 for managing wireless communications can operate in accordance with Enhanced Data for GSM Evolution (EDGE), GSM EDGE Radio Access Network (GERAN), Universal Terrestrial Radio Access Network (UTRAN), or Evolved UTRAN (E-UTRAN). In some embodiments, circuitry included in the interface device 1506 for managing wireless communications can operate in accordance with Code Division Multiple Access (CDMA), Time Division Multiple Access (TDMA), Digital Enhanced Cordless Telecommunications (DECT), Evolution-Data Optimized (EV-DO), and derivatives thereof, as well as any other wireless protocols that are designated as 3G, 4G, 5G, and beyond. In some embodiments, the interface device 1006 can include one or more antennas (e.g., one or more antenna arrays) to receipt and / or transmission of wireless communications.

[0147] In some embodiments, the interface device 1506 can include circuitry for managing wired communications, such as electrical, optical, or any other suitable communication protocols. For example, the interface device 1506 can include circuitry to support communications in accordance with Ethernet technologies. In some embodiments, the interface device 1506 can support both wireless and wired communication, and / or may support multiple wired communication protocols and / or multiple wireless communication protocols. For example, a first set of circuitries of the interface device 1506 can be dedicated to shorter- range wireless communications such as Wi-Fi or Bluetooth, and a second set of circuitries of the interface device 1506 can be dedicated to longer-range wireless communications such as global positioning system (GPS), EDGE, GPRS, CDMA, WiMAX, LTE, EV-DO, or others. In some embodiments, a first set of circuitries of the interface device 1006 can be dedicated to wireless communications, and a second set of circuitries of the interface device 1506 can be dedicated to wired communications.

[0148] The computing device 1500 can include battery / power circuitry 1508. The battery / power circuitry 1508 can include one or more energy storage devices (e.g., batteries or40 Docket No. TP387661WO1 capacitors) and / or circuitry for coupling components of the computing device 1500 to an energy source separate from the computing device 1500 (e.g., AC line power).

[0149] The computing device 1500 can include a display device 1510 (e.g., multiple display devices). The display device 1510 can include any visual indicators, such as a heads-up display, a computer monitor, a projector, a touchscreen display, a liquid crystal display (LCD), a light-emitting diode display, or a flat panel display.

[0150] The computing device 1500 can include other input / output (I / O) devices 1512. The other I / O devices 1512 can include one or more audio output devices (e.g., speakers, headsets, earbuds, alarms, etc.), one or more audio input devices (e.g., microphones or microphone arrays), location devices (e.g., GPS devices in communication with a satellite-based system to receive a location of the computing device 1500, as known in the art), audio codecs, video codecs, printers, sensors (e.g., thermocouples or other temperature sensors, humidity sensors, pressure sensors, vibration sensors, accelerometers, gyroscopes, etc.), image capture devices such as cameras, keyboards, cursor control devices such as a mouse, a stylus, a trackball, or a touchpad, bar code readers, Quick Response (QR) code readers, or radio frequency identification (RFID) readers, for example.

[0151] The computing device 1500 can have any suitable form factor for its application and setting, such as a handheld or mobile computing device (e.g., a cell phone, a smartphone, a mobile internet device, a tablet computer, a laptop computer, a netbook computer, an Ultrabook computer, a personal digital assistant (PDA), an ultra-mobile personal computer, etc.), a desktop computing device, or a server computing device or other networked computing components.

[0152] The different embodiments and examples of the systems and methods for electrostatic integrity testing described herein provide several advantages over known solutions for integrity testing of flexible products. For example, illustrative embodiments and examples described herein allow for the detection of flaws in nonconductive materials and joints like film, tubing, seals, port seals, perimeter seals, edge port seals, face port seals, two-dimensional and three-dimensional bags or chambers.

[0153] Additionally, and among other benefits, illustrative embodiments and examples described herein allow for the reliable detection of holes as small as 1.0 microns and films thinned in a first region compared to a second region of the flexible bioprocess equipment.

[0154] Additionally, and among other benefits, illustrative embodiments and examples described herein prevent the destruction or compromise of the test specimen during the test process.41 Docket No. TP387661WO1

[0155] Additionally, and among other benefits, illustrative embodiments and examples described herein are configured to provide reliable, safe, cost-effective, simple, and quicker integrity tests for flexible bioprocessing equipment compared to conventional leak hold tests or tracer gas leak tests.

[0156] Additionally, and among other benefits, illustrative embodiments and examples described herein allow for a localized test in a testing region and expandable to a broader range of testing areas by modifying the testing components accordingly.

[0157] Additionally, and among other benefits, illustrative embodiments and examples described herein prevent the formation of any visible marks or signs during testing.

[0158] Additionally, and among other benefits, illustrative embodiments and examples described herein allow for specific marking of failed test specimens after the completion of the integrity testing.

[0159] Additionally, and among other benefits, illustrative embodiments and examples described herein allow for simultaneous integrity testing of flexible bags or chambers while manufacturing of the flexible bags or chambers are in progress.

[0160] Various alterations and / or modifications of the inventive features illustrated herein, and additional applications of the principles illustrated herein, which would occur to one skilled in the relevant art and having possession of this disclosure, can be made to the illustrated embodiments without departing from the spirit and scope of the invention as defined by the claims, and are to be considered within the scope of this disclosure. Thus, while various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. While a number of methods and components similar or equivalent to those described herein can be used to practice embodiments of the present disclosure, only certain components and methods are described herein.

[0161] It will also be appreciated that systems, processes, and / or products according to certain embodiments of the present disclosure may include, incorporate, or otherwise comprise properties features (e.g., components, members, elements, parts, and / or portions) described in other embodiments disclosed and / or described herein. Accordingly, the various features of certain embodiments can be compatible with, combined with, included in, and / or incorporated into other embodiments of the present disclosure. Thus, disclosure of certain features relative to a specific embodiment of the present disclosure should not be construed as limiting the application or inclusion of said features to the specific embodiment. Rather, it will be appreciated that other embodiments can also include said features without necessarily departing from the scope of the present disclosure.42 Docket No. TP387661WO1

[0162] The present disclosure may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. While certain embodiments and details have been included herein and in the attached disclosure for purposes of illustrating embodiments of the present disclosure, it will be apparent to those skilled in the art that various changes in the methods, products, devices, and apparatus disclosed herein may be made without departing from the scope of the disclosure or of the invention, which is defined in the appended claims. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

43 Docket No. TP387661WO1CLAIMS1. An apparatus for detecting a defect in a test area of a test specimen, comprising: a first electrode disposed external to the test area of the test specimen; a second electrode having at least a portion thereof disposed within the test specimen; and a detector assembly in electrical communication with each of the first and second electrodes, the detector assembly including, a voltage generator configured (a) to generate a voltage and (b) to supply the voltage to the first electrode; and a measuring tool configured to detect the defect in the test area of the test specimen by detecting an electrical circuit between the first and second electrodes.

2. The apparatus according to claim 1, wherein the first electrode comprises an upper electrode and a bottom electrode.

3. The apparatus according to claim 1 or 2, wherein the measuring tool is configured to generate a first signal upon detecting a complete circuit or a continuity in the electrical circuit.

4. The apparatus according to any of claims 1 to 3, wherein the measuring tool is configured to generate a second signal upon detecting an incomplete circuit or a discontinuity in the electrical circuit.

5. The apparatus according to any of claims 1 to 4, wherein the test specimen comprises a flexible bioprocess container.

6. The apparatus according to claim 5, wherein the defect comprises a first film region of the bioprocess container, the first film region having a different thickness compared to a second film region of the flexible bioprocess container.

7. The apparatus according to any of claims 1 to 6, wherein the test area comprises a seal between two or more film layers.44 Docket No. TP387661WO18. The apparatus according to any of claims 1 to 7, wherein the test area comprises a port seal between a port and at least two film layers.

9. The apparatus according to any of claims 1 to 8, wherein the test specimen comprises a tubing assembly.

10. The apparatus according to any of claims 1 to 9, wherein the defect is a hole having a diameter of at least 1 .0 microns.

11. The apparatus according to any of claims 1 to 10, wherein the test specimen comprises a nonconductive material or an electrically insulative material.

12. The apparatus according to any of claims 1 to 11, wherein the first electrode comprises an electrode configured to receive the voltage.

13. The apparatus according to any of claims 1 to 12, wherein the second electrode comprises a ground electrode.

14. The apparatus according to any of claims 1 to 13, wherein the first electrode comprises a ground electrode.

15. The apparatus according to any of claims 1 to 14, wherein the second electrode comprises an electrode configured to receive the voltage.

16. The apparatus according to any of claims 1 to 15, further comprising a control unit in electrical and electronic communication with the detector assembly.

17. A system for testing integrity of a test specimen, comprising: a housing having a compartment; and a test assembly disposed within the compartment of the housing, the test assembly including, a test platform including a first electrode and an electrode pair, wherein the electrode pair includes a second electrode and a third electrode, the second electrode being coupled to a top end of the test platform;45 Docket No. TP387661WO1 a guard lid configured to cover the top end of the test platform, and the third electrode being coupled to a bottom end of the guard lid; and a detector assembly in electrical communication with the first electrode and the electrode pair, the detector assembly being configured to check the integrity of the test specimen by monitoring an electrical circuit between the first electrode and the electrode pair.

18. The system according to claim 17, wherein the detector assembly comprises a voltage generator configured to generate a voltage and supply the voltage to the second electrode and / or the third electrode.

19. The system according to claim 17 or 18, wherein the detector assembly comprises a measuring tool configured to detect a defect in the test specimen.

20. The system according to claim 1 , wherein the measuring tool is configured to generate a first signal upon detecting a complete circuit or a continuity in the electrical circuit.

21. The system according to claim 19 or 20, wherein the measuring tool is configured to generate a second signal upon detecting an incomplete circuit or a discontinuity in the electrical circuit.

22. The system according to any of claims 17 to 21, further comprising a lid movement control unit in electrical communication with the guard lid.

23. The system according to claim 22, wherein the lid movement control unit is configured to maintain the guard lid in a locked configuration when the integrity testing is in process.

24. The system according to any of claim 17 to 23, further comprising a first sensor coupled to the guard lid.

25. The system according to claim 24, wherein the first sensor is configured to detect presence or absence of the test specimen on the test platform.46 Docket No. TP387661WO126. The system according to any of claim 18 to 25, further comprising a voltage sensor coupled to a bottom end of the test platform.

27. The system according to claim 26, wherein the voltage sensor is configured to detect a generation of a set voltage by the voltage generator.

28. An automated system for testing integrity of a test specimen comprising: a controller comprising a processor and memory for storing operational instructions and controlling system components; and a test assembly including a test platform including a first electrode and an electrode pair, wherein the electrode pair includes a second electrode and a third electrode, the second electrode being coupled to a top end of the test platform; a guard lid configured to cover the top end of the test platform, and the third electrode being coupled to a bottom end of the guard lid; and a detector assembly in electrical communication with the first electrode and the electrode pair, the detector assembly being configured to check the integrity of the test specimen by monitoring an electrical circuit between the first electrode and the electrode pair.

29. The automated system according to claim 28, wherein the detector assembly provides a pass result or a fail result of the test specimen.

30. The automated system according to claim 28 or 29, further comprising a specimen marking unit in electrical communication with the controller.

31. The automated system according to claim 30, wherein the specimen marking unit is coupled to the bottom end of the guard lid.

32. The automated system according to any of claims 30 to 31, wherein the specimen marking unit includes a printer configured to print a pass or fail text on the specimen upon instractions provided by the controller.47 Docket No. TP387661WO133. The automated system according to any of claims 30 to 32, wherein the specimen marking unit includes a device configured to cut the test specimen upon instructions provided by the controller for a failed test specimen.

34. The automated system according to any of claims 30 to 33, wherein the specimen marking unit includes a scribing element configured to scribe a line on the test specimen upon instructions provided by the controller for a failed test specimen.

35. The automated system according to any of claims 30 to 34, wherein the specimen marking unit includes a hole punch element configured to punch a hole in the specimen upon instructions provided by the controller for a failed test specimen.

36. A method for qualifying integrity of a test specimen, comprising: selecting a recipe for testing a test specimen; providing the test specimen on a testing platform of a test machine; securing a lid on the testing platform to (a) place a first electrode proximate and external to the test specimen and (b) to place a second electrode within the test specimen; initiating a test run by providing a voltage generated by a voltage generator to the first or second electrodes; and monitoring an electrical circuit between the first and second electrodes to determine if the test specimen is a passed specimen or a failed specimen.

37. A method for integrity testing of a fill and finish assembly, comprising: checking an integrity of a perimeter seal, edge port and / or face port seal of one or more chambers of the fill and finish assembly by using an electrostatic integrity tester; and checking an integrity of one or more tubing assemblies, and tubing manifolds by using a flexible electrode in the electrostatic integrity tester.

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