Device inspection navigation device with position lock and fall protection and method of use thereof

Abstract

The disclosed technology greatly improves the safety, accuracy, and efficiency of the cleaning verification process. Swab sampling can be performed in a fully automated manner. The cost and safety risks of accessing a restricted space are avoided. An apparatus inspection navigation device is disclosed, comprising: an apparatus mounting base configured to attach to an apparatus access port; an extension pole control device connected to the apparatus mounting base; modular extension poles connected to the extension pole control device; a test tool connected to the modular extension poles; a test tool position compensation subsystem connected to the modular extension poles; and a surface contact sensing subsystem connected to the test tool position compensation subsystem. The invention solves various problems encountered so far during the swab sampling process and is effective even for challenging surfaces such as a stir shaft. Use cases include: surface swab sampling for cleaning verification and apparatus monitoring; cleaning verification bacteria touch plate sampling; and measurement of surface thickness and surface roughness.

Description

Priority data

[0001] This patent application is an international patent application claiming priority to U.S. Provisional Patent Application No. 63 / 546,314, filed October 30, 2023, and U.S. Patent Application No. 18 / 926,041, filed October 24, 2024, each of which is hereby incorporated herein by reference. Invention Field

[0002] This invention generally relates to automated swab sampling, cleaning validation, and internal inspection of equipment in the biotechnology, pharmaceutical, medical device, and related industries. Background of the Invention

[0003] In the life sciences, food, cosmetics, and other related industries, ensuring that equipment used in the production of customer products is properly maintained and cleaned is a critical issue involving the safety of consumers and employees. Due to the size and complexity of some manufacturing equipment, performing the required cleanliness and maintenance tests may expose employees to unsafe conditions and / or negatively impact their ability to perform the tests correctly. The following tests are routinely performed on manufacturing equipment: (1) cleanliness validation surface swab sampling, (2) cleanliness validation bacterial contact plate testing, (3) environmental monitoring surface swab sampling, (4) environmental monitoring bacterial contact plate testing, (5) pressure vessel wall thickness testing, and (6) surface roughness testing.

[0004] Clean validation and environmental monitoring are critical quality assurance and control procedures used by companies in the life sciences, food, and cosmetics industries. Regulatory agencies (such as the FDA or EMA) mandate that companies manufacturing and selling consumer products must implement scientifically developed clean validation and environmental monitoring procedures in order to be licensed to sell their products. When implemented properly, these procedures provide a high degree of assurance that a company's products are not subject to cross-contamination from other products it manufactures or other foreign substances. Clean validation and environmental monitoring procedures consist of (1) predefined testing methods and protocols, (2) training and certification, and (3) testing equipment and consumables.

[0005] Companies in the life sciences, food, and cosmetics industries develop maintenance procedures to ensure equipment functions as expected throughout its lifespan. These procedures include testing methods designed to measure specific variables that can indicate outstanding equipment problems. Regulatory bodies, such as the Occupational Health and Safety Administration (OHSA), require routine testing (such as pressure vessel wall thickness testing) to ensure employee safety. A company's cleaning validation procedures may require routine surface roughness or rouging tests, as variations in product contact surfaces can adversely affect the performance of the cleaning process.

[0006] Significant challenges businesses face when performing tests required for cleaning validation, environmental monitoring, and maintenance procedures are human error and test variability. Human error refers to any deviation from a predefined test method caused by the individual performing the test. Test variability is inherent to the test method itself, such as the accuracy and precision of the testing equipment used. Testing in hard-to-reach or inaccessible locations increases variability and the likelihood of inaccurate results, as the individual performing the test is not in a sufficiently good position to make the test difficult. Businesses invest significant time and money in training and certifying the individuals performing these tests. Even with extensive training, there remains a high risk of false pass or false fail results, both of which are problematic.

[0007] In some cases, testing must be performed in confined spaces, which is dangerous, costly, and time-consuming. To minimize the risk of injury or death, companies have established strict confined space entry procedures that clearly define the safety protocols, required protective equipment, and necessary monitoring during confined space entry. Each confined space entry requires: (1) a pre-approved work permit signed by multiple stakeholders; (2) preparatory work before entering the confined space; (3) dedicated equipment for entry, monitoring, and retrieval; and (4) multiple support personnel in place during the test execution. Even with safety protocols and additional safety measures in place, many injuries and fatalities still unfortunately occur during confined space entry.

[0008] One solution businesses use to eliminate the risks of entering confined spaces is to perform clean validation surface swab sampling using a telescopic pole. While this solution eliminates the risk of this type of test entering confined spaces, it significantly reduces recovery rates and increases test variability. Consequently, the risk of false positive or false negative results is higher, increasing costs and exposing businesses and users of their products to risk. If a telescopic pole is used instead of entering the container to perform swab sampling, the risk of inadequate sampling increases with existing methods and systems due to the distance between the person controlling the swab and the swab's location.

[0009] Given the problems of the current prior art outlined above, there is a strong commercial expectation for improvements in the consistency, accuracy, recyclability, cost, and safety of cleaning validation, environmental monitoring, and maintenance testing for equipment used in the manufacture of consumer products in the life sciences, food, cosmetics, and related industries. Summary of the Invention

[0010] Some variations of the present invention provide a device inspection navigation device, the device inspection navigation device comprising:

[0011] Equipment mounting base, configured to attach to the access port of a selected inspectable device;

[0012] An extension rod control device, which is connected to the equipment mounting base;

[0013] One or more modular extension rods, which are connected to an extension rod control device;

[0014] A testing tool that is connected to at least one of the modular extension bars;

[0015] A test tool position compensation subsystem, which is connected to a modular extension bar; and

[0016] A surface contact sensing subsystem, which is connected to a test tool position compensation subsystem.

[0017] In some embodiments, the device mounting base is configured to rotate around the access port of a selected inspectable device.

[0018] In some embodiments, the extension rod control provides three degrees of freedom to move the test tool within a selected inspectable device.

[0019] In some embodiments, the extension bar control includes an automatically locking independent crank handle.

[0020] In some embodiments, the modular extension bar utilizes interlocking barbs.

[0021] In some embodiments, the test tool position compensation subsystem provides the test tool with two degrees of freedom relative to the modular extension bar.

[0022] In some embodiments, the surface contact sensing subsystem includes a sensor that provides feedback on the initial contact between the test tool and the internal surface of a selected inspectable device.

[0023] In some embodiments, the surface contact sensing subsystem includes a sensor that provides feedback on the distance of the test tool from the internal surface of a selected inspectable device.

[0024] In a typical embodiment of the device inspection navigation device, the testing tool includes a swab.

[0025] In some embodiments, the testing tool is configured to measure or detect bacteria.

[0026] In some embodiments, the testing tool is configured to measure surface thickness and / or surface roughness.

[0027] In some embodiments, the testing tool is configured to record photographic data, including photographic images and / or videos. For example, the photographic data can be used to plot multiple internal surfaces of a selected inspectable device.

[0028] In some embodiments, the testing tool includes a swab configured to contact the internal surface of a selected inspectable device, wherein the testing tool is configured to use photographic data as input to assist in guiding the placement of the swab as output.

[0029] In some embodiments, the control subsystem is configured to drive an electric motor to move the test tool to a desired location.

[0030] In some embodiments, the device inspection navigation device is configured to have six degrees of freedom.

[0031] In some embodiments, the device inspection navigation device is automated.

[0032] Another variation of the present invention provides a device inspection navigation device, the device inspection navigation device comprising:

[0033] An extension rod configured for insertion into an inspection device, the extension rod having a first end portion and a second end portion;

[0034] A pole mounting system, which is coupled to a first end portion of an extension pole, wherein the pole mounting system is configured to attach to an accessible area of ​​an inspectable device, the accessible area being accessible from space outside the inspectable device; and

[0035] An automated swab device is attached to the second end portion of an extension rod, wherein the automated swab device is configured to perform a swab sampling process on the internal surface of an inspectable device.

[0036] The automated swab device is connected to the extension rod via a locking connector and a spring unit.

[0037] The locking connector is adjustable and configured to allow the automated swab device to be oriented at multiple different angles relative to the extension rod.

[0038] The spring unit is flexible and configured to allow the automated swab device to be positioned at multiple different locations relative to the internal surface of the inspectable device.

[0039] In some embodiments, the pole mounting system includes a mounting base and an extension pole control device coupled to the mounting base, wherein the pole mounting system is configured to be attached to an accessible area via the mounting base, and wherein the pole mounting system is coupled to a first end portion of the extension pole via the extension pole control device.

[0040] Another variation of the present invention provides a device inspection navigation device, the device inspection navigation device comprising:

[0041] A pole mounting system configured to attach to an accessible area of ​​an inspectable device that is accessible from space outside the inspectable device;

[0042] An extension rod configured for insertion into an inspectable device, wherein the extension rod comprises multiple rod segments; and

[0043] A set of barbs, which are attached to the extension bar.

[0044] The multiple rod segments are detachably connected to each other via a set of barbs, each barb within the set of barbs being equipped with an independent locking mechanism.

[0045] The pole installation system includes a telescopic pole control device that is detachably connected to at least one of the plurality of pole segments.

[0046] In some embodiments, at least one of the plurality of rod segments may extend from a first segment length to a second segment length, wherein the set of barbs is configured to prevent the plurality of rod segments from extending beyond the stop length associated with the extension rod.

[0047] Another variation of the present invention provides a method for inspecting a device, the method comprising:

[0048] (a) Select the inspectable equipment to be inspected;

[0049] (b) Providing a device inspection navigation device, wherein the device inspection navigation device includes: a device mounting base configured to attach to an access port of a selected inspectable device; an extension rod control device connected to the device mounting base; one or more modular extension rods connected to the extension rod control device; a test tool connected to at least one of the modular extension rods; a test tool position compensation subsystem connected to the modular extension rods; and a surface contact sensing subsystem connected to the test tool position compensation subsystem.

[0050] (c) Attach the device mounting base to the access port of the inspectable device;

[0051] (d) Use the extension bar control device and modular extension bar to navigate the test tool to the desired internal surface of the equipment to be inspected;

[0052] (e) Using the test tool position compensation subsystem and the surface contact sensing subsystem, the test tool is positioned against the desired internal surface; and

[0053] (f) Perform checks using testing tools.

[0054] The inspection may optionally be selected from the group consisting of: surface swab sampling for cleanliness validation, surface swab sampling for equipment monitoring, bacterial contact plate sampling for cleanliness validation, bacterial contact plate sampling for equipment monitoring, surface thickness measurement, surface roughness measurement, and combinations thereof.

[0055] Optionally, steps (d), (e), and (f) are automated. Attached Figure Description

[0056] Figure 1 A system is described in some embodiments of the invention, including an inspectable device (shown as a tank) and a device inspection navigation device.

[0057] Figure 2 A system is described in some embodiments of the invention, including an inspectable device (shown as a tank, with emphasis on the tank manhole) and a device inspection navigation device.

[0058] Figure 3A This is a detailed schematic diagram of a device mounting base in some embodiments of the present invention. The device mounting base includes a device base extension arm, a device base distal clamp support, a main load-bearing rotating bushing, and a device base clamp.

[0059] Figure 3B In some embodiments of the present invention Figure 3A Another detailed schematic diagram of the equipment mounting base shown includes an equipment base extension arm, a equipment base distal clamp support, an extension rod control device quick-release guide rail, and an angle adjustment slot.

[0060] Figure 4A This is a detailed schematic diagram of an extension rod control device in some embodiments of the present invention. The extension rod control device includes a dual-bar feed foldable handle, a bar feed braking mechanism, a pitch control handle, a quick-release locking handle, a quick-release sliding tab, and a pressure adjusting spring shaft.

[0061] Figure 4B In some embodiments of the present invention Figure 4A Another detailed schematic diagram of the extension rod control device shown includes a rod feed foldable handle, a pitch control handle, a drive roller, a passive roller, a pitch control screw housing, and a pitch control linkage.

[0062] Figure 5A This is a schematic diagram of an extension bar control device locking an independent handle in some embodiments of the present invention. The extension bar control device locking an independent handle includes a movable handle, a lockable handle, and a pawl.

[0063] Figure 5BIn some embodiments of the present invention Figure 5A Another schematic diagram of the extension bar control device locking the independent handle is shown, in which the dual-bar feed foldable handle allows for convenient operation from both sides.

[0064] Figure 6 This is a schematic diagram of an interlocking system for a modular extension rod at different positions on the extension rod in some embodiments of the present invention.

[0065] Figure 7A This is a schematic diagram of a system for through-pass protection of an extension rod control device in some embodiments of the present invention.

[0066] Figure 7B In some embodiments of the present invention Figure 7A Another schematic diagram of a system for through-pass protection of the extension rod control device.

[0067] Figure 7C In some embodiments of the present invention Figure 7A Another schematic diagram of a system for through-pass protection of the extension rod control device.

[0068] Figure 8A This is a schematic diagram of a test tool position compensation subsystem in some embodiments of the present invention, which includes a mounting base, a sewn cover, a spring, and a button.

[0069] Figure 8B This is a schematic diagram of a system including a testing tool and a button that allows the connector to rotate ±90°, as described in some embodiments of the invention.

[0070] Figure 9A This is a schematic diagram of a surface contact sensing subsystem in some embodiments of the present invention, which includes a replaceable high-friction, non-marking plunger end for gripping the can wall and a spring for providing plunger extension force.

[0071] Figure 9B In some embodiments of the present invention Figure 9A Another schematic diagram of the surface contact sensing subsystem shown shows that the plunger end contacts the tank wall with various patterns or geometries (such as vertical surface contact plane, positive surface contact plane and negative surface contact plane).

[0072] Figure 10A This is a schematic diagram of a surface contact sensing subsystem with three contact points in some embodiments of the invention, which is expected to confirm surface detection and swab sampling distance converted into swab sampling pressure.

[0073] Figure 10B Describing the use of Figure 10AThe surface contact sensing subsystem implements the surface contact placement geometry.

[0074] Figure 11A This is a schematic diagram of a surface contact sensing subsystem utilizing a horizontal centering boss and a vertical centering boss in some embodiments of the present invention.

[0075] Figure 11B In some embodiments of the present invention Figure 11A Another schematic diagram of the surface contact sensing subsystem shown includes a large centering boss.

[0076] Figure 12A The invention describes the use of testing tools to inspect the couplings connecting the various sections of the stirring shaft in some embodiments of the invention.

[0077] Figure 12B The inspection of the stirring shaft using a test tool in a vertical configuration is described in some embodiments of the invention.

[0078] Figure 12C The inspection of the stirring shaft using a test tool in a horizontal configuration is described in some embodiments of the invention.

[0079] Figure 12D The inspection of couplings using test tools in a vertical configuration is described in some embodiments of the invention.

[0080] Figure 12E The inspection of couplings using test tools in a vertical configuration is described in some embodiments of the invention.

[0081] Figure 13 This is a schematic diagram of a surface contact sensing subsystem in some embodiments of the present invention, in which a cylinder is being inspected / tested.

[0082] Figure 14 This is a schematic diagram of a test tool subsystem with a flexible protective cover and a swab protector in some embodiments of the present invention, wherein the test tool is configured with a stretchable membrane, a swab protector and a membrane support. Detailed Implementation

[0083] The systems (synonymous, devices) and methods of the present invention will be described in detail with reference to various non-limiting embodiments.

[0084] This description will enable those skilled in the art to make and use the invention, and describes several embodiments, modifications, variations, alternatives, and uses of the invention. These and other embodiments, features, and advantages of the invention will become more apparent to those skilled in the art when taken in conjunction with the following detailed description of the invention in conjunction with the accompanying drawings.

[0085] As used in this specification and the appended claims, unless the context clearly indicates otherwise, the singular forms “a / an” and “the” include plural indicators. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0086] Unless otherwise specified, all numerical values ​​representing conditions, concentrations, dimensions, etc., used in this specification and claims should be understood to be modified by the term "about" in all cases. Accordingly, unless otherwise specified, the numerical parameters set forth in the following specification and appended claims are approximations, which may vary at least depending on the specific analytical technique.

[0087] The term "comprising," synonymous with "including," "containing," or "characterized in," is inclusive or open-ended and does not exclude additional, unlisted elements or method steps. "Comprising" is a specialized term used in claims language, meaning that the specified claim element is essential, but other claim elements may be added and still constitute a concept within the scope of the claims.

[0088] As used herein, the phrase “consisting of” excludes any element, step, or component not specified in the claims. When the phrase “consisting of” (or variations thereof) appears in a clause of the body of a claim, rather than immediately following the preamble, the phrase limits only the element set forth in that clause; other elements are not excluded from the claims as a whole. As used herein, the phrase “substantially constitutes” limits the scope of the claims to the specified elements or method steps, plus those that do not substantially affect the basis of the claimed subject matter and one or more novel features.

[0089] Regarding the terms “comprising / including,” “consisting of,” and “substantially consisting of,” when one of these three terms is used herein, the currently disclosed and claimed subject matter may include the use of any of the other two terms, except when used with Markush groups. Therefore, in some embodiments not otherwise explicitly enumerated, any instance of “comprising / including” may be replaced by “consisting of” or alternatively, “substantially consisting of.”

[0090] In this specification, reference will be made to Swabbot™, an automated swab sampling device (testing tool) for performing a swab sampling process, in certain embodiments. Swabbot is a trademark of Swabbot Solutions, LLC, the same assignee as the assignee of this patent application. This invention is by no means limited to the Swabbot device.

[0091] In this specification, “equipment” is a singular noun and is synonymous with “container,” “tank,” and “reactor.” In this specification, “container” is synonymous with “tank” when no reaction occurs and with “reactor” when a reaction occurs within the container. “Equipment wall” (or “container wall”) refers to an internal surface, such as the inner wall or other internal component within the equipment boundary. A container wall can be an inner wall, a stirrer surface, a stirrer shaft surface, a coupling surface, a sensor surface, a container window, a top surface, a bottom surface, the surface of an internal component (e.g., a temperature sensor or dissolved oxygen probe), or any other surface that can be inspected.

[0092] This invention allows users to navigate, position, and hold the testing device at a desired location within a selected inspectable device, enabling the appropriate execution of specified testing methods to determine the acceptability of the device under test. In various embodiments, this invention addresses various problems encountered to date during the swab sampling process.

[0093] The disclosed testing apparatus and methods include, but are not limited to, surface swab sampling for cleanliness validation and equipment monitoring; cleanliness validation bacterial contact plate sampling for cleanliness validation and equipment monitoring; surface thickness measurement; and surface roughness measurement. These tests are routinely performed and are designed to ensure that selected equipment remains within its design specifications. For example, automated or manual surface swab sampling for cleanliness validation is used as a direct test validation method for surface cleanliness. The amount of residual product from the final manufacturing process and other potential contaminants remaining on the product contact surfaces of the equipment must be below scientifically developed acceptable levels before subsequent products can be manufactured in that equipment. Swab samples taken from surfaces after cleaning the equipment will determine whether the surfaces have been cleaned to a specified acceptable level, thereby reducing the risk of subsequent product contamination that could lead to product loss, product recall, or injury or death to individuals using the product.

[0094] Some variations of the present invention provide a device inspection navigation device, the device inspection navigation device comprising:

[0095] Equipment mounting base, configured to attach to the access port of a selected inspectable device;

[0096] An extension rod control device, which is connected to the equipment mounting base;

[0097] One or more modular extension rods, which are connected to an extension rod control device;

[0098] A testing tool that is connected to at least one of the modular extension bars;

[0099] A test tool position compensation subsystem, which is connected to a modular extension bar; and

[0100] A surface contact sensing subsystem, which is connected to a test tool position compensation subsystem.

[0101] The main functional components of the equipment inspection navigation device are the equipment mounting base, extension rod control device, modular extension rod, test tool, test tool position compensation subsystem, and surface contact sensing subsystem. Each of these main functional components contributes to the navigation and positioning of the test tool and / or reduces the risk of damage to the test tool due to component failure or operator error. These will be discussed in more detail later. Figure 1 The main functional components of the equipment inspection navigation device are described.

[0102] The equipment inspection navigation device is preferably equipped with safety features to ensure that parts of the device do not fall into the equipment.

[0103] In some embodiments, the device inspection navigation device is configured to have six degrees of freedom, which provides significant advantages for both the precision and accuracy of the test.

[0104] The equipment mounting base provides a stable platform for the extension rod control unit, modular extension rod, test tool position compensation subsystem, surface contact sensing subsystem, and the test tool itself. The mounting base is securely attached directly to the equipment or other structures near the equipment's entry port. The mounting base allows the equipment inspection navigation device to rotate around the entry port, thus providing the system with a degree of freedom to access different areas within the equipment. This will be discussed in more detail later. Figure 2 A device mounting base is depicted that is directly attached to a container with an extension rod control device and a modular extension rod.

[0105] In some embodiments, the device mounting base is configured to rotate about the access port of a selected inspectable device. The device mounting base preferably has adjustable attachment points to connect the device inspection navigation device to different sized access ports and types of fastening devices. The portion of the device mounting base that contacts the device is preferably covered with a material that will not leave marks or any residue on the device surface. The device mounting base is preferably equipped with a quick-connect device that allows the extension rod control device to be easily connected and disconnected from the device mounting base (see detailed discussion below). Figure 4A).

[0106] Depending on the application, different device mounting bases can be configured to mount the device inspection navigation device directly onto various types of equipment or structures near device inlet ports. The modular design of the device inspection navigation device allows for the interchangeability of customized or device-specific mounting bases with the device inspection navigation device and various testing tools.

[0107] In this specification, the “extension rod control device” is a structural and functional device that allows adjustment of (a) the angle of the modular extension rod relative to the tank opening, and (b) the extension rod’s insertion into or extension from the tank. Although the extension rod control device is connected to the equipment mounting base, it is preferably a device physically separate from the equipment mounting base due to weight, rather than a single device comprising the equipment mounting base and the extension rod control device.

[0108] In some embodiments, the extension bar control provides three degrees of freedom to move the test tool within a selected inspectable device. The test tool utilizes these three degrees of freedom to achieve greater precision and accuracy for the desired test. The extension bar control may be designed to perform one or more of the following functions: (1) changing the angle of the modular extension bar relative to the device; (2) increasing or decreasing the length of the modular extension bar within the device; (3) allowing the modular extension bar to rotate to properly align the test tool relative to the surface being tested; (4) applying the necessary force to the modular extension bar during test procedure execution to hold the test tool in place; and (5) providing drop protection to ensure that the modular extension bar and the test tool do not fall into the device, thereby damaging the test tool and / or the device.

[0109] In some embodiments, the extension bar control device has an anti-drop feature. For example, the extension bar control device may include self-locking individual crank handles designed to stop movement of the modular extension bar if the operator loses control of the handles. The equipment mounting base may include connection points and safety straps that can be secured to an external structure of the equipment to prevent damage to the equipment in the event of an accidental drop of the equipment mounting base or failure of the mounting points during operation. To improve usability and mitigate operator error, the crank handles are operated independently via a gear system in the bar drive rollers. This feature is crucial for the safe operation of the extension bar control device, as device orientation may limit the operator's ability to effectively feed the modular extension bar.

[0110] The number of individual modular extension rods constituting the overall extension rod (“extension rod system”) can vary, such as one, two, three, four, five, or more. The number of modular extension rods used will typically be determined by the equipment geometry, such as the distance to be traversed from the equipment inlet port to the wall, and the length of each modular extension rod. Modular extension rods of different lengths can be used, for example, from kits containing various lengths required for a given application. In one embodiment (e.g., a small tank), a single extension rod is used.

[0111] In some embodiments, modular extension bars utilize interlocking barbs. Modular extension bars allow equipment inspection navigation devices to extend their range within selected equipment without limiting their use cases due to limited space around the equipment under test. Since many modular bars are typically used to reach distant locations within equipment, modular extension bars are designed to interlock together for rapid deployment of the extension bar system. Using many bars introduces the following risks to test tools and equipment: (1) the bars may break apart due to improper assembly; (2) the bars may break apart due to a failure of the locking mechanism; and (3) the bars may lose connection to the drive wheel due to the operator continuously extending the bar into the equipment beyond its end or due to a failure of the drive wheel and locking handle. In this invention, modular extension bars are designed to mitigate these risks through a redundant interlocking barb system (see [link to invention]). Figure 7A and Figure 7B These barbs act as individual locks to ensure the rod remains connected, provide visual indication that the rod is fully connected during assembly, and provide limiting stops to prevent the rod from passing through the extension rod control (see...). Figure 7C ).

[0112] In some embodiments, the test tool position compensation subsystem provides two degrees of freedom for the test tool relative to the modular extension rod. This relative degree of freedom allows the test tool to sit properly on the surface being tested. Without the test tool position compensation subsystem, the movement of the test tool may be restricted, thus limiting the positions that can be tested within the device. The test tool position compensation subsystem may include a tethered spring unit and an adjustable locking joint. The adjustable locking joint allows the operator to orient the test tool before inserting it into the device. This angle is determined by the operator based on the target position. The tethered spring unit is flexible and allows for fine movement in the test tool orientation, thereby compensating for holding the test tool on the surface and providing protection against drops caused by device malfunction.

[0113] In some embodiments, the surface contact sensing subsystem includes a sensor that provides feedback on the initial contact between the test tool and the internal surface of a selected inspectable device. In some embodiments, the surface contact sensing subsystem includes a sensor that provides feedback on the distance of the test tool from the internal surface of the selected inspectable device. The surface contact sensing subsystem can provide the operator with desired feedback to ensure adequate contact between the test tool and the surface being tested. In some embodiments, the surface contact sensing subsystem includes multiple sensors that provide two types of feedback to the operator: (1) upon initial contact with the surface; and (2) when the test tool is at an appropriate distance from the surface.

[0114] Sensors allow for the efficient navigation of a device inspection device to a surface using non-marking contact pads. These non-marking contact pads and the robotic arm of the sensor provide the force required to properly position the test tool against the surface. In some embodiments, the test tool is equipped with a sensor that accurately determines the distance from the test tool to the device surface. In some embodiments, the test tool is also equipped with a sensor designed to ensure proper positioning of the test tool relative to the device surface. This ensures that testing is performed with high accuracy and precision.

[0115] In a typical embodiment of the device inspection navigation device, the testing tool includes a swab. The use of the swab in the testing can utilize the technology disclosed in U.S. Patent No. 10,576,511, issued to Mineo on March 3, 2020, which is hereby incorporated by reference.

[0116] In some embodiments, the testing tool is configured to measure or detect bacteria. The testing tool can also be configured to measure or detect a wide variety of materials other than bacteria, including, for example, living organisms (e.g., bacteria or yeast), viruses, enzymes, proteins, antibiotics, or chemical contaminants (e.g., corrosion byproducts). The testing tool can be configured to measure or detect the chemical composition at the inner wall of a container, which may indicate a layer of material disposed on the wall or may indicate the health condition of the wall material itself (e.g., the presence or absence of corrosion, erosion, pitting, cracking, porosity, micro-defects, or leaks). These potential measurements of chemical composition at surfaces are the type of equipment testing as contemplated herein.

[0117] In some embodiments, the testing tool is configured to measure surface thickness and / or surface roughness. Surface thickness and surface roughness can be important parameters for equipment integrity and safety. A decrease in surface thickness over time can indicate a loss of wall material, which may occur if the wall material is not inert relative to the equipment contents. An increase in surface roughness can also indicate a loss of wall material, such as due to corrosion or reaction of the wall material itself, or the deposition of other materials on the surface. High surface roughness can be problematic for many reasons, such as making it easier for bacteria to survive sterilization procedures.

[0118] In some embodiments, the testing tool is configured to record photographic data, including photographic images and / or videos. For example, the photographic data can be used to plot multiple internal surfaces of a selected inspectable device.

[0119] In some embodiments, the testing tool includes a swab configured to contact the internal surface of a selected inspectable device, wherein the testing tool is configured to use photographic data as input to assist in guiding the placement of the swab as output.

[0120] In some embodiments, the device inspection navigation device is used to provide a stable base to allow manipulation of testing tools (e.g., automated swab sampling devices such as Swabbot, cameras, or other measuring devices) inside the container or device.

[0121] In some embodiments, the device inspection navigation device is used to apply force to a testing tool used for device inspection (e.g., an automated swab sampling device (such as a Swabbot), a camera, or another measuring device) to ensure that the testing tool is correctly positioned and remains in that position for the duration of the test.

[0122] In some embodiments, after testing has been performed, a device inspection navigation device is used to navigate the testing tools (e.g., an automated swab sampling device (such as a Swabbot), a camera, or another measuring device) back from the device to the external environment.

[0123] In some embodiments, the device inspection navigation device is equipped with a laser and / or a camera to guide the testing tool (e.g., an automated swab sampling device (such as a Swabbot), a camera, or another measuring device) into place.

[0124] In some embodiments, the control subsystem is configured to drive an electric motor to move the test tool to a desired location. Control subsystems are well known in the art and are typically implemented by a computing device. The control subsystem may be connected to the Internet and may be remotely controlled. In this way, the device inspection navigation device can be fully automated if needed.

[0125] Another variation of the present invention provides a device inspection navigation device, the device inspection navigation device comprising:

[0126] An extension rod configured for insertion into an inspection device, the extension rod having a first end portion and a second end portion;

[0127] A pole mounting system, which is coupled to a first end portion of an extension pole, wherein the pole mounting system is configured to attach to an accessible area of ​​an inspectable device, the accessible area being accessible from space outside the inspectable device; and

[0128] An automated swab device is attached to the second end portion of an extension rod, wherein the automated swab device is configured to perform a swab sampling process on the internal surface of an inspectable device.

[0129] The automated swab device is connected to the extension rod via a locking connector and a spring unit.

[0130] The locking connector is adjustable and configured to allow the automated swab device to be oriented at multiple different angles relative to the extension rod.

[0131] The spring unit is flexible and configured to allow the automated swab device to be positioned at multiple different locations relative to the internal surface of the inspectable device.

[0132] In some embodiments, the pole mounting system includes a mounting base and an extension pole control device coupled to the mounting base, wherein the pole mounting system is configured to be attached to an accessible area via the mounting base, and wherein the pole mounting system is coupled to a first end portion of the extension pole via the extension pole control device.

[0133] Another variation of the present invention provides a device inspection navigation device, the device inspection navigation device comprising:

[0134] A pole mounting system configured to attach to an accessible area of ​​an inspectable device that is accessible from space outside the inspectable device;

[0135] An extension rod configured for insertion into an inspectable device, wherein the extension rod comprises multiple rod segments; and

[0136] A set of barbs, which are attached to the extension bar.

[0137] The multiple rod segments are detachably connected to each other via a set of barbs, each barb within the set of barbs being equipped with an independent locking mechanism.

[0138] The pole installation system includes a telescopic pole control device that is detachably connected to at least one of the plurality of pole segments.

[0139] In some embodiments, at least one of the plurality of rod segments may extend from a first segment length to a second segment length, wherein the set of barbs is configured to prevent the plurality of rod segments from extending beyond the stop length associated with the extension rod.

[0140] Another variation of the present invention provides a method for inspecting a device, the method comprising:

[0141] (a) Select the inspectable equipment to be inspected;

[0142] (b) Providing a device inspection navigation device, wherein the device inspection navigation device includes: a device mounting base configured to attach to an access port of a selected inspectable device; an extension rod control device connected to the device mounting base; one or more modular extension rods connected to the extension rod control device; a test tool connected to at least one of the modular extension rods; a test tool position compensation subsystem connected to the modular extension rods; and a surface contact sensing subsystem connected to the test tool position compensation subsystem.

[0143] (c) Attach the device mounting base to the access port of the inspectable device;

[0144] (d) Use the extension bar control device and modular extension bar to navigate the test tool to the desired internal surface of the equipment to be inspected;

[0145] (e) Using the test tool position compensation subsystem and the surface contact sensing subsystem, the test tool is positioned against the desired internal surface; and

[0146] (f) Perform checks using testing tools.

[0147] The inspection may optionally be selected from the group consisting of: surface swab sampling for cleanliness validation, surface swab sampling for equipment monitoring, bacterial contact plate sampling for cleanliness validation, bacterial contact plate sampling for equipment monitoring, surface thickness measurement, surface roughness measurement, and combinations thereof.

[0148] Optionally, steps (d), (e), and (f) are automated.

[0149] In a preferred method, steps (d), (e), and (f) are automated via a computing device. The computing device can be programmed with executable code to send electronic signals to a control system that drives electric motors for moving the test tool to and from desired locations. The computing device can be programmed with executable code to control a vision system (e.g., a visible light camera or one or more lasers) to map at least a portion of the container's internal surface. The computing device can be programmed with executable code to run a software application that collects and analyzes test data. The computing device can be programmed with executable code to automatically load consumables (e.g., swabs) used by the equipment inspection navigation device.

[0150] In methods using bacterial contact plate sampling for cleaning validation and / or equipment monitoring, bacterial growth can be manual or automated. In some embodiments, the testing tool collects genetically sequenced bacterial samples as an additional step. In the future, if DNA sequencers become sufficiently miniaturized, the testing tool could directly incorporate a small DNA sequencer.

[0151] Some method variations are designed for non-contact inspection of the inner walls of equipment. In these methods, visual inspection (such as with a camera) or laser inspection can be performed using testing tools, and because samples are not necessarily collected, the testing tools do not necessarily come into contact with the equipment walls.

[0152] Another variation provides a method for inspecting a device, the method comprising:

[0153] (a) Select the inspectable equipment to be inspected;

[0154] (b) Providing an equipment inspection navigation device, wherein the equipment inspection navigation device includes: an equipment mounting base configured to attach to an access port of a selected inspectable equipment; an extension rod control device connected to the equipment mounting base; one or more modular extension rods connected to the extension rod control device; and a testing tool connected to at least one of the modular extension rods, wherein the testing tool is configured to perform at least one non-contact measurement with a wall of the inspectable equipment;

[0155] (c) Attach the device mounting base to the access port of the inspectable device;

[0156] (d) Using the extension bar control device and modular extension bar, navigate the test tool to the desired internal surface of the equipment to be inspected; and

[0157] (e) Perform checks using testing tools.

[0158] The examination may optionally be selected from the group consisting of: optical radiography, optical video imaging, laser-based imaging, X-ray imaging, ultrasound imaging, and combinations thereof.

[0159] Optionally, steps (d) and (e) are automated.

[0160] In non-contact testing methods, the testing tool can be configured with one or more inspection methods. The testing tool can be configured with an optical camera for taking photographs, videos, or both. The testing tool can be configured with laser sources of various laser frequencies for laser-based evaluation of the wall, such as measuring surface roughness or thickness. For example, laser scanning (profilometry) is an effective inspection method for measuring variations in the device wall. Deviations from normal geometry, such as those caused by corrosion or mechanical damage, are measured using laser scan data. Various laser frequencies can be utilized. In some embodiments, the testing tool is configured to generate X-rays that can be used to analyze the device wall. X-ray data can be used in various ways, such as X-ray diffraction or X-ray computed tomography. In some embodiments, the testing tool is configured to generate high-frequency ultrasonic waves through a transducer to the device wall under test. The reflected waves can be analyzed to identify potential defects in the wall structure. When sufficiently miniaturized, the testing tool can be equipped with an optical microscope, a scanning electron microscope, or other types of imaging utilizing the scattering of photons, electrons, or neutrons.

[0161] Various embodiments of the present technology will now be discussed further with reference to the accompanying drawings, which will be understood as exemplary rather than restrictive.

[0162] Figure 1 A system 100 is depicted, comprising an inspectable device (shown as a can) and a device inspection navigation device. The device inspection navigation device includes a device mounting base 110, an extension rod control device 120, a modular extension rod 130, and a test tool 140. The test tool 140 includes a test tool position compensation subsystem 150 and a surface contact sensing subsystem 160 connected to the test tool position compensation subsystem 150.

[0163] Figure 2 System 200 is depicted, which includes inspectable equipment (shown as a tank, with emphasis on the tank manhole) and an equipment inspection navigation device. The equipment inspection navigation device includes an equipment mounting base 210, an extension rod control device 220, a modular extension rod 230, an adjustable equipment base arm 211, an equipment base interlock 212, an extension control handle 221, an angle (pitch) control handle 222, an extension rod control device release device 223, a communication and power supply reel 224, an extension rod interlock 231, and a test tool digital interface 270.

[0164] Figure 3AThis is a detailed schematic diagram of the equipment mounting base 310. The equipment mounting base 310 includes an equipment base extension arm 311, an equipment base distal clamp support 312, a main load-bearing rotating bushing 313, and an equipment base clamp 314. The equipment base extension arm 311 allows the navigation device to traverse manholes of various sizes with minimal dimensions and avoids the need for multiple covers when inspecting different tanks. The equipment base distal clamp support 312 is clamped by a standard clamp used to secure the manhole cover during tank operation. The top surface design and height variations accommodate various types of manhole clamps. Access to the tank at various angles is achieved by simply setting the three rigid clamps onto the manhole surface once using the main load-bearing rotating bushing 313. The equipment base clamp 314 is held proximally to the tank manhole.

[0165] Figure 3B yes Figure 3A Another detailed schematic diagram of the equipment mounting base 310 is shown. The equipment mounting base 310 includes an equipment base extension arm 311, a distal clamp support 312, a quick-release guide rail 315 for the extension rod control device, and an angle adjustment groove 316. The angle adjustment groove 316 connects to the main load-bearing rotating bushing 313 (e.g., ...). Figure 3A (As shown) With the collaboration of three hard clamps, it is possible to enter the tank at various angles by simply setting the three hard clamps onto the manhole surface at once.

[0166] Figure 4A This is a detailed schematic diagram of the extension rod control device 420. The extension rod control device 420 includes a dual-bar feed foldable handle 421, a rod feed braking mechanism 421B, a pitch control handle 422, a quick-release locking handle 424, a quick-release sliding tab 425, and a pressure adjusting spring shaft 426. The dual-bar feed foldable handle 421 allows for easy operation from either side of the can, which is advantageous because entering the can can be challenging when the environment around the can opening changes. The rod feed braking mechanism 421B automatically stops rod feed if the user does not pull out the handle to release the ratchet. Rotation of the pitch control handle 422 allows for increasing and decreasing the pitch angle of the extension rod when it is in the appropriate position between the rollers. The quick-release locking handle 424 allows the entire extension rod control device 420 to be slid forward by pressing the quick-release locking handle 424, thus removing the extension rod control device 420 from the equipment mounting base.

[0167] Figure 4B yes Figure 4AAnother detailed schematic diagram of the extension rod control device 420 is shown. The extension rod control device 420 includes a rod feed foldable handle 421, a pitch control handle 422, a drive roller 427, a driven roller 428, a pitch control screw housing 429, and a pitch control linkage 430. The drive roller 427 is equipped with an integrated 2:1 differential to allow for less force application during operation. The driven roller 428 provides pressure to the drive roller 427 to allow appropriate friction to be generated on the extension rod. The pitch control screw housing 429 holds the screw nut for final deceleration. The pitch control linkage 430 allows for reduced input force and achieves up to approximately 90% of the can surface contact within the desired angular travel range.

[0168] Figure 5A This is a schematic diagram 500 of the extension bar control device locking the independent handle. It includes a movable handle 531, a lockable handle 532, and a pawl 533. The dual-bar feed foldable handle 521 allows for convenient operation from both sides. A differential gear mechanism (such as...) is located within the drive roller. Figure 4B (As shown) This allows for lever operation from both sides—one hand to activate and the other to lock. The 2:1 differential gearing provides the user with a mechanical advantage by feeding the extension lever via the extension lever control mechanism.

[0169] Figure 5B yes Figure 5A Another schematic diagram 500 shows the extension lever control locking the independent handle. The dual-lever feed foldable handle 521 allows for convenient operation from both sides. An internal differential 534 is utilized in the drive roller. The four-lever spring-loaded handle linkage 535 requires user input, with one hand on the handle to release the brake, ensuring that the lever cannot move if the user cannot control the drive roller using one or both handles. To release the lock on the roller, the user needs to pull one or the other handle (arrow 536A or arrow 536B) or both handles (arrows 536A and 536B). The handles then rotate freely. In this configuration, if the user pulls out both handles (one hand on each side), they will lose the advantage of the 2:1 gear ratio applied by the differential to the lever, but the lever will move twice as fast.

[0170] Figure 6 This is a schematic diagram of an interlocking system for a modular extension rod at different positions. The rod connection mechanism incorporates offset hooks 632 and 633 to prevent the rod from falling into the tank through the rod holder even if adjacent rods are not properly connected. The hook opening limiting surface 634 ensures that hook 632 does not over-rotate when resistance to system tension is required. Similarly, the hook opening limiting surface 635 ensures that hook 633 does not over-rotate when resistance to system tension is required.

[0171] Figure 7AThis is a schematic diagram of a system for through-hole protection of the extension rod control device. Figure 7A The diagram depicts barbs 732 and 733, collar 736, and collar alignment tube 737. Barb 732 serves as the primary barb, while barb 733 serves as an auxiliary attachment barb to catch the bar and prevent it from falling if the primary barb fails. Collar 736 is the primary mechanical connection between the two bars. Collar alignment tube 737 ensures alignment of the barb and the groove.

[0172] Figure 7B yes Figure 7A Another schematic diagram of a system for through-pass protection of the extension rod control device. Figure 7B The barbs 732 and 733, and the barb spring 738 are depicted. The barb spring 738 pushes the barbs 732 / 733 into place to ensure automatic locking with the mating rod.

[0173] Figure 7C yes Figure 7A Another schematic diagram of a system for through-pass protection of the extension bar control device is shown together with the extension bar control device 720. Figure 7C The barbs 732 and 733, the lever-feeding foldable handle 721, and the barb retaining surface 739 are depicted.

[0174] Figure 8A This is a schematic diagram of a test tool position compensation subsystem 800, which includes a mounting base 851, a sewn cap 852, a spring 853, and a button 854. The mounting base 851 is a simple screw-in type for connecting other components of the test tool (e.g., a surface contact sensing subsystem). The spring 853 allows conformability to various surfaces. In particular, a spring-based extension rod control using a pivot point allows the test tool to better conform to container walls. The sewn cap 852 prevents clamping points on the spring 853 and is robust enough to hold the test tool in place so that the spring can be retrieved in the event of breakage. The button 854 allows the connector to rotate ±90° (total span 180°).

[0175] Figure 8B This is a schematic diagram of a system including test tool 840. Button 854 allows the connector to rotate ±90° (total span 180°). Figure 8B In the middle, the mounting base, sewn cover, and spring are hidden from view (see...). Figure 8A ).

[0176] Figure 9AThis is a schematic diagram of a surface contact sensing subsystem 900. The surface contact sensing subsystem 900 includes a plunger end 941 and a spring 942. The plunger end 941 is a replaceable, high-friction, non-marking plunger end for gripping the can wall. The spring 942 provides plunger extension force. Each mounting device has two sensing contact points 943. The first contact point emits a surface contact signal, while the second contact point ensures the test tool plane is in the correct position.

[0177] Figure 9B yes Figure 9A Another schematic diagram of the surface contact sensing subsystem 900 is shown. An internal sliding surface 944, together with an external sliding surface 945, allows for smooth operation at various surface contact angles. A replaceable, high-friction, non-marking plunger tip 921 is used to grip the device wall. During operation, the plunger tip 921 contacts the device wall in various patterns or geometries, such as perpendicular to the surface contact plane, a positive surface contact plane, and a negative surface contact plane 944.

[0178] Figure 10A This is a schematic diagram of a surface contact sensing subsystem 1000. There are three contact points 1041, which are desired for confirming surface detection and, for example, translating into swab sampling distance and sampling pressure. The contact points 1041 are generated by different plungers.

[0179] Figure 10B Describing the use of Figure 10A The surface contact sensing subsystem 1000 implements the surface contact placement geometry. Three contact points 1041 (see...) Figure 10A Triangular positions are formed, which are mathematically determined to ensure minimal variation in scrubbing pressure between tanks of varying curvatures. Geometrically, tank curvature angular offset and tank curvature distance offset are considered. Note that... Figure 10B The triangle in the image can point upwards or downwards.

[0180] Figure 11A This is a schematic diagram of the surface contact sensing subsystem 1100. Three contact points 1141 form a triangular position, which is mathematically determined to ensure minimal variation in swab sampling pressure between cans with different curvatures. A horizontal centering boss and a vertical centering boss 1147 are utilized. Figure 11A Two horizontal centering bosses and two vertical centering bosses are depicted. The convex swab sampling panel 1146 is mounted to the plunger.

[0181] Figure 11B yes Figure 11AAnother schematic diagram of the surface contact sensing subsystem 1100 shown. Three contact points 1141 form a triangular location, which is mathematically determined to ensure minimal variation in swab sampling pressure between canisters of different curvatures. The surface contact sensing subsystem 1100 includes a shaft-connected panel 1148 and a large centering boss 1149 (with...). Figure 11A (The centering boss 1147 is different).

[0182] Figure 12A The figure depicts the inspection of the coupling 1280 connecting the various sections of the stirring shaft 1270 using a test tool 1240. The modular extension rod 1230 and the extension rod control device 1220 are also shown in the figure.

[0183] Figure 12B The image depicts the inspection of the agitator shaft 1270 using a test tool 1240 in a vertical configuration. A centering boss 1247 is used to assist in the inspection of the agitator shaft 1270. The coupling 1280 is not inspected in this figure.

[0184] Figure 12C The image depicts the inspection of the agitator shaft 1270 using a test tool 1240 in a horizontal configuration. A centering boss 1247 is used to assist in the inspection of the agitator shaft 1270. The coupling 1280 is not inspected in this figure.

[0185] Figure 12D The figure depicts the inspection of coupling 1280 using test tool 1240 in a vertical configuration. A large centering boss 1249 is used to assist in the inspection of coupling 1280. The agitator shaft 1270 is not inspected in this figure.

[0186] Figure 12E The figure depicts the inspection of coupling 1280 using test tool 1240 in a vertical configuration. A large centering boss 1249 is used to assist in the inspection of coupling 1280. The agitator shaft 1270 is not inspected in this figure.

[0187] Figure 13 This is a schematic diagram of a surface contact sensing subsystem 1300, where a cylinder 1390 is being inspected / tested. The surface contact sensing subsystem 1300 includes a quick-release clip 1350 and a V-block 1351. The quick-release clip 1350 allows for easy removal and installation around a removable plunger end while leaving the plunger end in place. The V-block 1351 correctly aligns with the cylindrical surface to ensure precise pressure is applied and the appropriate area is covered by a predefined scanning pattern. The V-block 1351 allows for alignment of small-diameter and large-diameter cylinders within a given range.

[0188] Figure 14This is a schematic diagram of a test tool subsystem 1400 with a flexible protective cover and an optional swab protector. The test tool 1440 is configured with a stretchable membrane 1452, an optional swab protector 1453, and a membrane holder 1454. The stretchable membrane 1452 is a low-force membrane that allows a low-cost, low-force stepper motor to move throughout its full x–y stroke without being limited by force constraints caused by the membrane's linear length limitation. The swab protector 1453 is attached to the low-force membrane and snaps around the swab holder. The swab protector 1453 provides protection against contact between the swab head and the membrane when the swab is in the retracted position. The optional swab protector 1453 also connects the stretchable membrane 1452 to the test tool. The stretchable membrane 1452 snaps onto the membrane holder 1454 and is then secured to the front housing of the test tool to clamp the stretchable membrane 1452 and ensure it remains in place during operation. This configuration also makes it easy to replace the stretchable membrane 1452 as needed (e.g., due to mechanical damage or contamination).

[0189] Equipment inspection navigation devices can be manual, automatic, or a combination of both. A fully automated equipment inspection navigation device may include: (1) a vision system that maps the internal surfaces of the equipment; (2) a control system that drives electric motors for moving (multiple) test tools to and from desired locations identified by the vision system; (3) a software application that collects and analyzes test data; and (4) an automated tool that automatically loads consumables.

[0190] As previously described, the equipment inspection navigation device can be configured to have six degrees of freedom. The first degree of freedom is provided by the equipment mounting base, which can be positioned around the entry port and pivot once attached to the equipment. This degree of freedom is important because it allows the operator to access all parts of the equipment. The second and third degrees of freedom are provided by an extension rod control device, which can change the angle of the modular extension rod relative to the entry port and increase or decrease the length of the modular extension rod positioned within the equipment. These two degrees of freedom work together to allow the operator to guide the test tool to the desired position within the selected equipment. The fourth degree of freedom is also provided by the extension rod control device, which allows the modular extension rod to rotate to ensure the test tool is properly oriented relative to the surface to be tested. The fifth and sixth degrees of freedom are provided by a test tool position compensation subsystem, which allows the test tool to change its angle relative to the modular extension rod in all directions. These two degrees of freedom are important for allowing the test tool to be effectively positioned against virtually any surface within the selected equipment.

[0191] Being able to test hard-to-reach surfaces within a container can be important. Depending on the application, the selection of specific areas to be tested can be based on, for example, known contamination points (e.g., agitators, agitator shafts, input / output ports, etc.), mathematical optimization algorithms, prescribed testing protocols, computational fluid dynamics simulations to reveal areas not easily exposed to clean fluids, or even random selection. In some cases, only one equipment surface needs to be tested at a given time. The same surface can be tested at a later time (e.g., in different production batches) to allow for comparison with previous results. In other cases, it may be desirable to test many internal surfaces within selected equipment. In extreme cases, testing virtually all internal surfaces within selected equipment can be useful, such as for corrosion or mechanical fatigue testing.

[0192] In some embodiments, the device inspection navigation device is capable of accessing at least 50% of the surface area defined by all internal surfaces within a selected device. In a preferred embodiment employing six degrees of freedom as described in the preceding paragraph, the device inspection navigation device is capable of accessing at least 75%, more preferably at least 90%, even more preferably at least 95%, and most preferably at least 99% (and potentially 100%) of the surface area defined by all internal surfaces within a selected device.

[0193] When selected equipment has been substantially emptied of its normal chemical contents, an equipment inspection navigation device is typically employed. For example, when the vessel is a bioreactor that uses bacteria to ferment sugars to produce pharmaceutical compounds, it may be necessary to remove bacteria from the bioreactor after production activities so that a different product can be produced in the next batch. In this case, the bioreactor will typically be emptied and may undergo steam cleaning and potentially sterilization with a sterilizing agent (such as sodium hypochlorite). After this cleaning, an equipment inspection navigation device can be used to test one or more internal surfaces to ensure there is no bacterial contamination.

[0194] However, there are other use cases. It is possible to use equipment inspection navigation devices within equipment still containing reaction contents. For example, when the vessel is a bioreactor using yeast to ferment sugar to produce pharmaceutical compounds (where bacteria are contaminants), production can be stopped for a relatively short period for testing. The bioreactor manhole can be opened, and equipment inspection navigation devices can be used to test for the presence of contaminating bacteria in the bioreactor walls. Alternatively, samples of the liquid broth can be collected using conventional methods; however, it should be noted that bacteria can sometimes hide more effectively in the walls than in the liquid bulk—especially for walls with high surface roughness.

[0195] In this detailed description, reference has been made to various embodiments and accompanying drawings, wherein specific exemplary embodiments of the invention are illustrated by way of example. These embodiments have been described in sufficient detail to enable those skilled in the art to practice the invention, and it should be understood that modifications can be made to the various disclosed embodiments by those skilled in the art.

[0196] Where the above methods and steps specify that certain events occur in a certain order, those skilled in the art will recognize that the order of certain steps can be modified, and such modifications are made according to variations of the invention. Furthermore, certain steps can be performed simultaneously in parallel processes where possible, or they can be performed sequentially.

[0197] All publications, patents, and patent applications cited in this specification are incorporated herein by reference in their entirety, as if each publication, patent, or patent application had been expressly and individually set forth herein. This specification incorporates by reference U.S. Patent No. 10,576,511, issued March 3, 2020.

[0198] The above embodiments, variations, and drawings are intended to indicate the practicality and versatility of the invention. Other embodiments not providing all the features and advantages set forth herein may be used without departing from the spirit and scope of the invention. Such modifications and variations are considered to fall within the scope of the invention as defined by the claims.

Claims

1. A device inspection navigation device, comprising: A device mounting base configured to attach to the access port of a selected inspectable device; An extension rod control device, the extension rod control device being connected to the equipment mounting base; One or more modular extension rods, the one or more modular extension rods being connected to the extension rod control device; Test tool, the test tool being connected to at least one of the modular extension rods; A test tool position compensation subsystem, which is connected to the modular extension rod; as well as A surface contact sensing subsystem, which is connected to the test tool position compensation subsystem.

2. The device inspection navigation device as described in claim 1, wherein, The device mounting base is configured to rotate around the access port of the selected inspectable device.

3. The device inspection navigation device as described in claim 1, wherein, The extension rod control device provides three degrees of freedom to move the test tool within the selected inspectable equipment.

4. The device inspection navigation device as described in claim 1, wherein, The extension bar control device includes an automatically locking independent crank handle.

5. The device inspection navigation device as described in claim 1, wherein, The modular extension rod utilizes interlocking barbs.

6. The device inspection navigation device as described in claim 1, wherein, The test tool position compensation subsystem provides the test tool with two degrees of freedom relative to the modular extension rod.

7. The device inspection navigation device as described in claim 1, wherein, The surface contact sensing subsystem includes a sensor that provides feedback on the initial contact between the test tool and the internal surface of the selected inspectable device.

8. The device inspection navigation device as described in claim 1, wherein, The surface contact sensing subsystem includes a sensor that provides feedback on the distance of the test tool from the internal surface of the selected inspectable device.

9. The device inspection navigation device as described in claim 1, wherein, The testing tool includes a swab.

10. The device inspection navigation device as claimed in claim 1, wherein, The testing tool is configured to measure or detect bacteria.

11. The device inspection navigation device as claimed in claim 1, wherein, The testing tool is configured to measure surface thickness and / or surface roughness.

12. The device inspection navigation device as claimed in claim 1, wherein, The testing tool is configured to record photographic data, including photographic images and / or videos.

13. The device inspection navigation device as claimed in claim 12, wherein, The testing tool includes a swab configured to contact the internal surface of the selected inspectable device, and wherein the testing tool is configured to use the photographic data as input to assist in guiding the placement of the swab as output.

14. The device inspection navigation device as claimed in claim 1, wherein, The control subsystem is configured to drive an electric motor to move the test tool to the desired location.

15. The device inspection navigation device as claimed in claim 1, wherein, The device inspection navigation unit is configured to have six degrees of freedom.

16. A device for inspecting navigation devices, comprising: An extension rod configured for insertion into an inspection device, the extension rod having a first end portion and a second end portion; A pole mounting system, the pole mounting system being coupled to the first end portion of the extension pole, wherein the pole mounting system is configured to attach to an accessible area of ​​the inspectable device, the accessible area being accessible from space outside the inspectable device; and An automated swab device is coupled to the second end portion of the extension rod, wherein the automated swab device is configured to perform a swab sampling process on the internal surface of the inspectable device. The automated swab device is connected to the extension rod via a locking connector and a spring unit. The locking connector is adjustable and configured to allow the automated swab device to be oriented at multiple different angles relative to the extension rod. The spring unit is flexible and configured to allow the automated swab device to be in multiple different positions relative to the internal surface of the inspectable device.

17. The device inspection navigation device as claimed in claim 16, wherein, The pole mounting system includes a mounting base and an extension pole control device coupled to the mounting base, wherein the pole mounting system is configured to be attached to the accessible area via the mounting base, and wherein the pole mounting system is coupled to the first end portion of the extension pole via the extension pole control device.

18. A device for inspecting navigation devices, comprising: A pole mounting system configured to attach to an accessible area of ​​the inspectable device, the accessible area being accessible from space outside the inspectable device; An extension rod configured for insertion into the inspectable device, wherein the extension rod comprises a plurality of rod segments; and A set of barbs, the set of barbs being connected to the extension rod, The plurality of rod segments are detachably connected to each other via the set of barbs, wherein each barb in the set of barbs is equipped with an independent locking mechanism, and The pole installation system includes a telescopic pole control device, which is detachably connected to at least one of the plurality of pole segments.

19. The device inspection navigation device as claimed in claim 18, wherein, At least one of the plurality of pole segments is capable of extending from a first segment length to a second segment length, and wherein the set of barbs is configured to prevent the plurality of pole segments from extending beyond a stop length associated with the extension bar.

20. A method for inspecting equipment, the method comprising: (a) Select the inspectable equipment to be inspected; (b) Providing a device inspection navigation device, wherein the device inspection navigation device includes: a device mounting base configured to attach to an access port of a selected inspectable device; an extension rod control device connected to the device mounting base; one or more modular extension rods connected to the extension rod control device; a test tool connected to at least one of the modular extension rods; a test tool position compensation subsystem connected to the modular extension rods; and a surface contact sensing subsystem connected to the test tool position compensation subsystem. (c) Attach the device mounting base to the access port of the inspectable device; (d) Using the extension rod control device and the modular extension rod, navigate the test tool to the desired internal surface of the inspectable device; (e) Using the test tool position compensation subsystem and the surface contact sensing subsystem, the test tool is positioned against the desired internal surface; and (f) Perform the check using the aforementioned testing tool. The inspection may optionally be selected from the group consisting of: surface swab sampling for cleanliness verification, surface swab sampling for equipment monitoring, bacterial contact plate sampling for cleanliness verification, bacterial contact plate sampling for equipment monitoring, surface thickness measurement, surface roughness measurement, and combinations thereof. Optionally, steps (d), (e), and (f) are automated.

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