Ultrasonic and cleaning efficacy indicator

Abstract

An ultrasonic cleaning efficacy indicator (100), comprising: a first container (104); a metallic foil (102) disposed within the first container; and a cleaning indicator (108a / b) disposed on a surface of the first container (104) or attached to the first container (104), the cleaning indicator configured to monitor at least one of temperature of an ultrasonic bath solution, a chemistry of the ultrasonic bath solution, or time the cleaning indicator is immersed in the ultrasonic bath solution, Cooperating container (104) and holder (140).

Description

Ultrasonic and Cleaning Efficacy IndicatorCross-Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 540,471, filed September 26, 2023, entitled “ULTRASONIC AND CLEANING EFFICACY INDICATOR,” which is incorporated by reference herein its entirety.Field of Invention

[0002] The present invention relates to ultrasonic cleaning and, more particularly, to a device and method for determining the cleaning efficacy of an ultrasonic cleaning process.Background of the Invention

[0003] Ultrasonic cleaning devices are commonly employed in the cleaning of medical instruments. In the use of an ultrasonic cleaning device, the contaminated instruments are placed in a basin of water which is then exposed to ultrasonic energy that generates ultrasonic waves in the water. The waves produce cavitation in the water, resulting in the creation of cavitation bubbles, which ultimately collapse. As the bubbles collapse, they become convoluted on one side due to a jet of fluid that shoots through the bubble at high speed as it collapses. The jet of fluid then hits on the opposite side of the bubble, often at speeds of up to 500 m / s. The cleaning effect of the device results from the jets of fluid, which hit the contaminated instruments at these high speeds, and thereby remove impurities from the instrument surfaces.

[0004] Due to the non-homogeneous distribution of ultrasonic waves in the basin, regions of both low cavitation density and high cavitation density are created (nodes and antinodes, respectively). Naturally, the regions having a high cavitation density will yield a higher cleaning efficiency than the regions having a lower cavitation density. Unfortunately, because the movement of the ultrasonic waves is not visible and the cavitation bubbles are very difficult to see, it is not possible to identify the regions having a high cavitation density, and therefore it is not possible to identify high cleaning efficiency solely by observing the water in the cleaning basin.

[0005] It is therefore desirable to provide a device and method that enables reliable and reproducible testing of the cleaning efficiency of an ultrasonic cleaning device. As described in detail herein, the present invention provides such a device and method.Summary of the Invention

[0006] A cleaning efficacy device and method in accordance with the present invention provide a complete ultrasonic cleaning indicator for monitoring multiple cycle parameters, including ultrasonic action, temperature, chemistry and time of an ultrasonic washer cycle. The cleaning efficacy device in accordance with the invention includes multiple types of indicators, each providing information concerning a cleaning cycle efficacy. The cleaning efficacy device and method have multiple applications, including, but not limited to: routine monitoring of an ultrasonic cleaning cycle, whereby at least once a day a cycle would be run with a cleaning efficacy device inside the otherwise empty ultrasonic cleaner bath to check cycle efficacy before use; as a tool to aid the validation of the cleaning cycle of a newly installed or repaired ultrasonic cleaner, whereby the function of the transducer(s) could be checked and / or the cleaning profile of the bath mapped out by running cycles with simultaneous placement of multiple cleaning efficacy devices in different locations and depths within the otherwise empty bath; and for routine monitoring of an ultrasonic cleaning cycle, whereby each cycle would be run with a cleaning efficacy device placed amongst instruments to be cleaned inside the ultrasonic cleaner bath to check cycle efficacy.These applications allow the detection of nodes / antinodes, loss of power density, nonfunctioning transducers, and the most / least efficacious cleaning zones in the bath.

[0007] According to one aspect of the invention, an ultrasonic cleaning efficacy indicator includes: a first container; a metallic foil disposed within the first container; and a cleaning indicator disposed on a surface of the first container or attached to the first container, the cleaning indicator configured to monitor at least one of temperature of an ultrasonic bath solution, a chemistry of the ultrasonic bath solution, or time the cleaning indicator is immersed in the ultrasonic bath solution.

[0008] In one embodiment, the first container includes at least one of a liquid-tight flexible container, a liquid-tight rigid container, or a mesh container.

[0009] In one embodiment, the first container comprises a transparent portion for viewing the foil.

[0010] In one embodiment, the device includes a liquid disposed within the first container.

[0011] In one embodiment, the foil is freely suspended in the liquid.

[0012] In one embodiment, the liquid includes at least one of tap water, distilled water, sanitized water, sterile water, deionized water, mineral water.

[0013] In one embodiment, the liquid comprises at least one additive configured to inhibit corrosion or tarnishing of the foil, or prevent bacterial growth or biofilms within the first container.

[0014] In one embodiment, the liquid includes a buffer configured to at least one of inhibit corrosion of the cleaning indicator, provide chemical stability to the foil or provide chemical stability to the liquid.

[0015] In one embodiment, the buffer includes at least one of a phosphate or an acetate.

[0016] In one embodiment, the device includes a thermochromic indicator disposed on the surface of the first container or attached to the first container.

[0017] In one embodiment, the metallic foil is in the form of single foil leaf, a plurality of foil leafs, or a plurality of elongated foil leaf pieces.

[0018] In one embodiment, the first container comprises at least one securing member.

[0019] In one embodiment, the first container comprises a flap formed along an end of the first container, and the at least one securing member comprises a hole formed in the flap.

[0020] In one embodiment, the foil forms at least part of a sealed second container disposed within the first container, the second container including a water-soluble agent.

[0021] In one embodiment, the agent is at least one of coated on at least part of an inside surface of the second container or disposed between surfaces of the second container.

[0022] In one embodiment, the agent comprises a compound that changes at least one of a color of the liquid or a pH of the liquid.

[0023] In one embodiment, the second container comprises a plurality of water-soluble agents.

[0024] In one embodiment, the device includes a plurality of the second containers disposed within the first container, wherein at least some of the plurality of second containers have different performance characteristics than others of the plurality of second containers.

[0025] In one embodiment, the different performance characteristics comprise at least one of a different foil thickness of the second container, or a different agent disposed within the second container.

[0026] In one embodiment, the device includes at least one water-soluble agent encapsulated by the foil.

[0027] In one embodiment, the device includes a wax film disposed over the foil.

[0028] In one embodiment, the device includes a plurality of foil-encapsulated water soluble agents, wherein at least some of the plurality of foil-encapsulated agents have different performance characteristics than others of the plurality of foil-encapsulated agents.

[0029] In one embodiment, the device includes a blister pack container disposed with the first container, wherein the water-soluble agent encapsulated by the foil is disposed within the blister pack container.

[0030] In one embodiment, the foil comprises a metallic coupon with at least one water- soluble agent deposited on the coupon, and a first coating formed over the at least one water- soluble agent and at least part of the coupon.

[0031] In one embodiment, the device includes a second coating formed over the first coating.

[0032] In one embodiment, the first container includes a base having an open end and a cap removably couplable to the open end, and the foil is arranged on one of the open end or within the cap, the foil forming a liquid-tight seal between a portion of the cap and the base, further comprising at least one water-soluble agent disposed between the cap and the foil, and a liquid disposed within at least a portion of an inner volume of the base.

[0033] In one embodiment, the foil spans across the first container to define a first liquid- tight chamber and a second liquid-tight chamber, a first liquid is disposed in the first liquid- tight chamber and a second liquid is disposed in the second liquid-tight chamber, the second liquid having at least one property different from that of the first liquid.

[0034] In one embodiment, the device includes a support frame disposed within the first container and having a first end and a second end, wherein the foil is a ribbon foil having a first ribbon foil end attached to the first end of the support frame, and a second ribbon foil end attached to the second end of the support frame.

[0035] In one embodiment, the ribbon foil comprises a plurality of ribbon foils each attached to the support frame.

[0036] In one embodiment, the first container includes a rigid container having a first open end and a second open end, a first cap removably couplable to the first open end and a second cap removably couplable to the second open end, and the foil is attached to the first and second caps or held in place by the first and second caps.

[0037] In one embodiment, the container comprises a flexible container, and the foil comprises an elongated shape spanning from one end of the flexible container to another end of the flexible container, each end of the foil secured to the flexible container via respective sealing members at the respective ends of the flexible container.

[0038] In one embodiment, the foil includes a pre-weakened region configured to serve as a location at which degradation of the foil due to ultrasonic action is initiated.

[0039] In one embodiment, the pre-weakened region comprises at least one of a serrated edge, a hole within a body of the foil, or a cut along an edge of the foil.

[0040] In one embodiment, the pre-weakened region comprises a plurality of holes within the body of the foil.

[0041] In one embodiment, at least one surface of the foil is colored.

[0042] According to another aspect of the invention, a cleaning efficacy system includes an ultrasonic and cleaning efficacy indicator as described herein, and a holder for securing the ultrasonic cleaning efficacy device within an ultrasonic cleaning device.

[0043] In one embodiment, the holder comprises at least one of a bespoke holder or a mesh container.

[0044] In one embodiment, the holder comprises at least one extendable / retractable hook or clip.

[0045] In one embodiment, the holder comprises a first plate and a second plate disposed adjacent to the first plate, the first and second plates having corresponding openings that define a through-hole, and a mesh material covering the through-hole.

[0046] In one embodiment, the system includes a notch formed in the first and second plates adjacent to the mesh material.

[0047] In one embodiment, the mesh structure is disposed in a plane different from a plane defined by the first and second plates.

[0048] According to another aspect of the invention, a cleaning indicator device for holding a cleaning indicator element includes: a container formed from a mesh material and having a first open end, the mesh material having a mesh size that enables ingress of liquid inside the container; a first cap removably couplable to the first open end; and a mount attached to the second end, the mount adapted to be inserted into a holder for supporting the container.

[0049] In one embodiment, the container has a second open end, further comprising a second cap removably coupled to the second open end.

[0050] In one embodiment, at least one of the first cap or the second cap comprises a mesh cap that enables ingress of liquid inside the container.

[0051] In one embodiment, the second cap includes a solid cap that is impervious to liquid.

[0052] In one embodiment, the system includes a cleaning indicator element disposed within the container.

[0053] In one embodiment, the system includes a structural support ring disposed at the first end or the second end.

[0054] In one embodiment, the system includes a holder removably coupled to the support member.

[0055] According to another aspect of the invention, a holding device for securing an ultrasonic cleaning efficacy device within an ultrasonic cleaning device includes: a first member; a second member attached to the first member, wherein at least a portion of one of the first member or the second member is resiliently movable relative to at least a portion of the other of the first member or the second member; and a first aperture disposed in the first member and a second aperture disposed in the second member, the first and second apertures being concentric.

[0056] In one embodiment, the holding device includes a mesh structure covering the first aperture and the second aperture.

[0057] In one embodiment, at least a portion of the mesh structure is disposed in a plane different from a plane defined by the first and second members.

[0058] In one embodiment, the holding device includes a slot formed in the mesh structure.

[0059] In one embodiment, the first member comprises a first planar surface and a second planar surface, the second planar surface arranged perpendicular to the first planar surface.

[0060] In one embodiment, the second member comprises a first planar surface, a second planar surface, and a third planar surface, the second planar surface arranged perpendicular to the first planar surface, and the third planar surface arranged parallel to the first planar surface and non-parallel to the second planar surface.

[0061] In one embodiment, the first planar surface of the first member and the first planar surface of the second member are immediately adjacent to one another, and a slot is formed between the respective surfaces.

[0062] In one embodiment, the first planar surface of the first member includes a plurality of first apertures, and the first planar surface of the second member includes a plurality of second apertures, respective ones of the plurality of first apertures being aligned with respective ones of the plurality of second apertures.

[0063] In one embodiment, the holding device includes at least one protrusion extending from a side of at least one of the first member or the second member, the at least one protrusion configured to secure and prevent migration of the holding device within the ultrasonic cleaning device.

[0064] In one embodiment, the holding device includes a notch formed in the first and second plates adjacent to the mesh material.

[0065] In one embodiment, the at least one protrusion includes a plurality of elongated members extending from a common side of at least one of the first member or the second member, the plurality of elongated members configured to secure the holding device to a support structure.

[0066] In one embodiment, the first member and the second member define a clamp region, the holding device including a biasing member operatively coupled to the first member and the second member, the biasing member configured to urge the first member and the second member to close the clamp region.

[0067] In one embodiment, the holding device includes a through-hole operative to enable air bubbles to pass from a first side of the holding device to a second, opposite side of the holding device.

[0068] In one embodiment, the at least one through-hole is formed in at least one of the biasing member, the first member or the second member.

[0069] To the accomplishment of the foregoing and related ends, the invention, then, comprises the features hereinafter fully described and particularly pointed out in the claims. The following description and the annexed drawings set forth in detail certain illustrative embodiments of the invention. These embodiments are indicative, however, of but a few of the various ways in which the principles of the invention may be employed. Other objects, advantages and novel features of the invention will become apparent from the following detailed description of the invention when considered in conjunction with the drawings.Brief Description of the Drawings

[0070] The invention may take physical form in certain parts and arrangement of parts, a preferred embodiment of which will be described in detail in the specification and illustrated in the accompanying drawings which form a part hereof.

[0071] Fig. 1 is a top view of a cleaning efficacy device in accordance with an embodiment of the invention.

[0072] Fig. 2A is a top view of a cleaning efficacy device in accordance with another embodiment of the invention.

[0073] Fig. 2B is a top view of a cleaning efficacy device in accordance with yet another embodiment of the invention.

[0074] Fig. 3A is a top view of a cleaning efficacy device in accordance with another embodiment of the invention.

[0075] Fig. 3B illustrates the cleaning efficacy device of Fig. 3A after processing through a cleaning cycle.

[0076] Fig. 4A is a top view of a cleaning efficacy device in accordance with another embodiment of the invention.

[0077] Fig. 4B illustrates the cleaning efficacy device of Fig. 4A after processing through a cleaning cycle.

[0078] Fig. 5 A is a side view of a cleaning efficacy device in accordance with another embodiment of the invention.

[0079] Fig. 5B is a perspective view of the cleaning efficacy device of Fig. 5 A.

[0080] Figs. 6 A and 6B are top views of an exemplary holder in accordance with an embodiment of the invention that can be used to hold the cleaning efficacy device in an ultrasonic bath.

[0081] Figs. 6C, 6D and 6E are top, side and rear views, respectively, of another exemplary holder in accordance with an embodiment of the invention that can be used to hold the cleaning efficacy device in an ultrasonic bath.

[0082] Fig. 7 illustrates another holder for holding the cleaning efficacy device in accordance with the invention.

[0083] Fig. 8A illustrates another holder for holding the cleaning efficacy device in accordance with the invention.

[0084] Fig. 8B illustrates the cleaning efficacy device and holder of Fig. 8A attached to a basket of an ultrasonic cleaning device.

[0085] Fig. 9 illustrates yet another holder for holding the cleaning efficacy device in accordance with the invention.

[0086] Fig. 10A illustrates yet another holder for holding the cleaning efficacy device in accordance with the invention.

[0087] Fig. 10B and 10C are each top views of a cleaning efficacy device in accordance with another embodiment of the invention. The device in Fig. 10B is shown after processing in an ultrasonic cleaning cycle and opened to show the foil fragments therein. The device in Fig. 10C is shown unprocessed.

[0088] .

[0089] Fig. 11A is a top view of a cleaning efficacy device in accordance with another embodiment of the invention.

[0090] Fig. 11B illustrates the cleaning efficacy device of Fig. 11A after processing through a cleaning cycle.

[0091] Fig. 12A is a top view of a cleaning efficacy device in accordance with another embodiment of the invention.

[0092] Fig. 12B is a top view of a single-layer coated agent in accordance with an embodiment of the invention.

[0093] Fig. 12C illustrates the cleaning efficacy device of Fig. 12A after processing through a cleaning cycle.

[0094] Fig. 12D is a top view of a multi-layer coated agent in accordance with an embodiment of the invention.

[0095] Fig. 12E is a top view of a cleaning efficacy device in accordance with yet another embodiment of the invention.

[0096] Fig.13 A is a top view of a metal coupon having an agent deposited thereon for use in the cleaning efficacy device in accordance with the invention.

[0097] Fig. 13B illustrates the metal coupon of Fig. 13A with a coating over the agent.

[0098] Fig.13C is a top view of a metal coupon having multiple agents deposited thereon for use in the cleaning efficacy device in accordance with the invention.

[0099] Fig. 14A is a side view of a cleaning efficacy device in accordance with another embodiment of the invention.

[0100] Fig. 14B is a side view of a cleaning efficacy device in accordance with yet another embodiment of the invention.

[0101] Fig. 15A is a side view of a cleaning efficacy device in accordance with another embodiment of the invention.

[0102] Fig. 15B is a side view of a mounting means for a foil ribbon in accordance with an embodiment of the invention.

[0103] Fig. 15C is a side view of a cleaning efficacy device in accordance with yet another embodiment of the invention.

[0104] Fig. 15D illustrates a holder for a cleaning efficacy device in accordance with the invention.

[0105] Fig. 15E is a side view of two cleaning efficacy devices utilizing different mounting means for a foil ribbon in accordance with an embodiment of the invention.

[0106] Fig. 15F illustrates the cleaning efficacy device of Fig.l5E after processing through a cleaning cycle.

[0107] Fig. 16 is a side view of a cleaning efficacy device in accordance with another embodiment of the invention.

[0108] Figs. 17A-17C illustrate exemplary holders for the cleaning efficacy device in accordance with the invention.

[0109] Fig. 18A illustrates a cleaning efficacy device in accordance with another embodiment of the invention.

[0110] Fig. 18B illustrates a holder for the cleaning efficacy device of Fig. 18A.

[0111] Fig. 18C illustrates the cleaning efficacy device of Fig. 18A in the holder of Fig. 18B.

[0112] Fig. 18D illustrates the cleaning efficacy device of Fig. 18A after processing through different cleaning cycles.

[0113] Figs. 19A-19C are front, back and side views of another holder for the cleaning efficacy device (present in the holder) in accordance with the invention.

[0114] Figs. 19D-19G illustrate further exemplary holders for the cleaning efficacy device of Fig. 18A in accordance with the invention.

[0115] Fig. 20 illustrates a cleaning indicator device for housing a cleaning indicator in accordance with an embodiment of the invention.Detailed Description of the Invention

[0116] Aspects of the present invention will now be described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. Such aspects may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey its scope to those skilled in the art. Further, it will be understood that the figures are not necessarily to scale.

[0117] The word “about” when immediately preceding a numerical value means a range of plus or minus 10% of that value, e.g., “about 50” means 45 to 55, “about 25,000” means 22,500 to 27,500, etc., unless the context of the disclosure indicates otherwise, or is inconsistent with such an interpretation. For example, in a list of numerical values such as “about 49, about 50, about 55, “about 50” means a range extending to less than half the interval(s) between the preceding and subsequent values, e.g., more than 49.5 to less than 52.5. Furthermore, the phrases “less than about” a value or “greater than about” a value should be understood in view of the definition of the term “about” provided herein.

[0118] The present invention is directed to a cleaning efficacy device / method for monitoring ultrasonic cleaning cycles to check the cycle efficacy and / or to validate the cleaning cycle. The cleaning efficacy device and method in accordance with the inventionprovide a complete ultrasonic cleaning indicator for monitoring all four cycle parameters, namely, ultrasonic action, temperature, chemistry and time, of an ultrasonic washer cycle. The cleaning efficacy device monitors the ultrasound region of the sonic spectrum (20 kHz to 10 MHz), more specifically the low frequency high power ultrasound region (20-100 kHz, preferred range), and the high frequency medium power ultrasound region (100 kHz - 1 MHz).). In a preferred embodiment, the cleaning efficacy device includes a foil leaf that monitors ultrasonic action, where perforation of the foil leaf is visible through a transparent pouch material that houses the foil leaf and is also filled with a pouch liquid. A key feature of the invention is the retention of any aluminium particles generated within the device during sonication, obviating the need for the bath to be cleaned after the cycle. Further, a cleaning indicator monitors temperature / chemistry / time, where the result provided by the cleaning indicator is visible through presence / absence of indicator ink on the pouch surface. An optional thermochromic indicator monitors thermal disinfection stage with the result visible through irreversible indicator ink color change (e.g., Thermax Irreversible Thermochromic Label Level A [40 - 71 °C]). An optional holder maintains the pouch in a desired orientation within the bath.

[0119] A typical ultrasonic cleaning cycle starts with a degassing cycle whereby gases dissolved in the liquid medium (e.g., water, detergent solution) are removed by a mild sonication process (e.g., pulsed ultrasound) not intended to have any cleaning action. The cleaning efficacy device may be used alone for monitoring the complete ultrasonic and cleaning action over time during a cycle, with or without instruments. As discussed in further detail below, the ultrasonication indicator part of each inventive concept has been designed to show negligible discernible response to the degassing cycle.First Embodiment

[0120] Referring initially to Fig. 1, a cleaning efficacy device 100 in accordance with a first embodiment of the invention includes a piece of metallic foil leaf 102, such as a square of aluminium foil, encased in a clear plastic pouch 104 filled with a pouch liquid 106 (e.g., water or aqueous solution); the contents of the pouch are clearly visible. An outer surface of the pouch 104 includes a cleaning indicator ink composition 108a printed thereon, such as STERIS Verify® All Clean Test, Washer Indicator, which includes a dried test soil formula containing proteins, lipids and polysaccharides of avian origin. Optionally, the cleaning indicator ink composition may further comprise a thermochromic indicator ink composition

[0121] The volume of pouch liquid 106 inside the pouch 104 preferably is sufficient to allow the foil leaf 102 to float inside the pouch 104, minimizing contact between the foil leaf 102 and internal surfaces of the pouch 104, thereby maximizing exposure to ultrasonication energy and allowing the required degree of pitting (perforation) for a PASS result to be achieved within, e.g., less than 5 minutes. The volume of pouch liquid 106 in the filled pouch 104 is partly dependent on the material used to construct the pouch 104, and the volume of pouch liquid 106 should be sufficient to allow contact of the pouch liquid 106 with both sides of the foil leaf 102 therein, enabling cavitation at the surface and edges of the foil leaf 102 to occur. Also, the volume of pouch liquid 106 inside the pouch 104 preferably is sufficient to minimize the headspace, i.e., volume of air or other gas, within the pouch 104.

[0122] Pouches 104 with smaller volumes take considerably longer for cavitation to occur at the surface of the foil leaf 102. Preferably, the volume of pouch liquid 106 is 60-100 mL, and more preferably 65-75 mL. However, larger or smaller volumes are possible (in correspondingly larger or smaller pouches). For example, in one variant the volume of pouch liquid 106 within the pouch 104 is approximately 1900-2100 mL, and in another variant, the minimum volume of pouch liquid 106 in the pouch 104 is 45 mL. In some embodiments, the minimum volume may be 2 mL, with the most preferred volume being 8-18 mL.

[0123] The pouch liquid 106 may be tap water, distilled, deionized, sterile, sanitized, mineral water, or reverse-osmosis grade and may additionally be degassed prior to filling the pouch 104. Additives may be included in the pouch liquid 106 to inhibit corrosion / tamishing of the foil leaf 102, prevent bacterial growth or biofilms and otherwise to preserve the shelf life of the cleaning efficacy device 100. Examples of such additives include detergents (surfactants), biocides (e.g., benzalkonium chlorides, quaternary ammonium salts, sodium azide, aryl alcohols, sodium benzoate, parabens, phenoxyethanol, disinfecting agents), anti- tarnishing agents (e.g., Carboshield 1000, metal ion sequestering agents, chelants, corrosion inhibitors), antifoaming agents, buffers (e.g., acetate, phosphate or like buffers that inhibit corrosion of the foil leaf 102 and / or provide long-term chemical stability to the pouch liquid), preservatives, pH active compounds (e.g., acids, alkalis) and antioxidants. The pouch liquid 106 may be tinted with a water-soluble dye so that the cleaning efficacy device 100 is visually easier to distinguish once immersed in the ultrasonication washer bath. The degree of pouch solution coloration, however, should not impede the visualization of the pitting or perforation of the foil leaf 102.

[0124] Preferably, the size of the foil leaf 102 within the pouch 104 is no more than 210 x 300 mm (area 63,000 mm2, approximately A4 sheet size). More preferably, the foil leaf 12has a square shape with a size of 100 x 100 mm (area 10,000 mm2) and even more preferably the size of the foil leaf 102 is in the range 40 x 40 mm (area 1600 mm2) to 60 x 60 mm (3600 mm2). Further, while an aluminium foil leaf is preferred, other types of metal foils may be used including, for example, copper, silver, gold, or other malleable metals or alloys. Further, in addition to the foil leaf 102, beads may be used inside the pouch 104 as a cavitation promoter or nucleation site.

[0125] The dimensions, thickness, grade, purity, pre-treatment, construction and shape of the foil leaf 102 within the pouch 104 may be tailored to match the characteristics of the ultrasonic action of an ultrasonic cleaning cycle. Briefly referring to Figs. 2A and 2B, cleaning efficacy devices 100a, 100b are shown that include a plurality of elongated leaf pieces in the pouch 104. For example, the foil leaf 102 may be in the form of multiple ribbons 110 and / or strips 112. Foil leaves that are colored (e.g., by anodizing, printing etc.) on one side or both sides of the foil may also be used. Use of colored foils may improve the ease of result interpretation, improve the aesthetics of the product and extend the life of the product with respect to tarnishing of the foil leaf.

[0126] In one variant of the cleaning efficacy device 100c, as illustrated in Figs. 3A and 3B, the foil leaf 102 may have at least one region that is pre-weakened 120, e.g., a short nick, cut on one edge, serrated edge, or at least one punched hole within the body of the foil leaf 102. The weakened region 120 serves as points to initiate degradation of the foil leaf 102 and promote the disintegration 122 of the foil leaf 102, as seen in Fig. 3B.

[0127] In another variant of a cleaning efficacy device lOOd as shown in Figs. 4A and 4B, the foil leaf 102 may have holes 124 or a pattem / matrix 126 punched out of the leaf 102 to make visualization of the sonication result easier to see than looking for a cut or nick in the foil leaf 102. As an example, a foil leaf 102 with a 4 x 4 arrangement of holes 124 punched in it is sonicated in a water bath while inside a sealed clear plastic pouch 104 filled with pouch liquid 106. A distance between each hole 124 and the arrangement of holes (and their size) can be optimized so that ultrasonic action degrades and break one or more of the narrow foil bridges 128 between the holes 124 as seen in Fig. 4B, thereby allowing the result to be interpreted more easily as a pass result (destruction - at least in part - of the pattem / matrix) than checking an otherwise intact / complete foil (i.e., having no punched holes) for perforation.

[0128] The pouch 104 for each embodiment / variant of the cleaning efficacy device 100- lOOd should be sized to accommodate one or more foil leaves 102, allowing a limited degree of movement of the foil leaves within the filled pouch 104, e.g., a diagonal length of the foilleaf 102 restricts rotation of the leaf 102 within the same plane as the pouch 104. Preferably, maximum pouch dimensions (without seams) are 235 x 325 mm (area 76,375 mm2), more preferably the pouch dimensions are 125 x 125 mm (area 15,625 mm2) and even more preferably the pouch dimensions are in the range 65 x 65 mm (area 4,225 mm2) to 95 x 95 mm (area 9,025 mm2). In one embodiment the pouch dimensions are 140 x 40 mm (area 5,600 mm2), which is preferred when using a single foil leaf in the form of a rectangle. Typically, seams around each side of the pouch 104 (minimum 3 sides) would be 10 ± 5 mm and may vary in width, depending on the material and sealing equipment (e.g., heat sealing, sonic welding). Additional to the pouch size, the dimensions of one or more of the sides of the pouch material may be extended beyond a seam to incorporate additional features, e.g., holes for positioning or securing the cleaning efficacy device 100-lOOd, printing the cleaning indicator ink 108a and / or a thermochromic indicator ink composition 108b thereon, or securing a weight so that the pouch 104 has a vertical orientation if suspended in the liquid inside the ultrasonic bath. For example, the pouch material for each embodiment of the cleaning efficacy device 100-lOOd may be extended at each end of the cleaning efficacy device and hole punched at each comer to allow the cleaning efficacy device to be suspended in the bath by means of hook(s), spring(s) or other fixed or elastic means, allowing the monitoring of the cycle at a specified depth of the bath solution between the bottom and the surface.

[0129] The pouch 104 for each embodiment of the cleaning efficacy device 100-lOOd is preferably formed from water and detergent-resistant polymers such as polyethylene, low- density polyethylene, high-density polyethylene, polypropylene, biaxially oriented polypropylene, polyethylene terephthalate, polycarbonate, biaxially oriented polyethylene terephthalate, cellophane, polyvinyl chloride, polystyrene, poly methyl methacrylate, polyamide, ABS, SAN, TPU, spun-bonded polyolefin, PTFE and other flexible transparent or translucent, spun or cast material. Transparent polymers are preferred and at least one side of the pouch 104 must be at least partially transparent. The pouch material may be a single polymer, a polymer blend, a copolymer, or a composite material consisting of different laminates bonded together.

[0130] The dimensions, thickness, flexibility, grade, pre-treatment, chemical composition, puncture / shear resistance and shape of the pouch material may be tailored to match the characteristics of the ultrasonic action of an ultrasonic cleaning cycle. More than one pouch material may be used to construct the pouch part of the cleaning efficacy device 100-lOOd.The surface of one or both sides of pouch material may be colored or metallized, e.g., white,as an opaque background to improve the visual evaluation of the test result, i.e., perforation of the foil leaf 102. If both sides are opaque, the user may open the pouch after a cycle to evaluate the state of the foil leaf 102 inside and record the result.

[0131] The cleaning efficacy device lOO-lOOd may be manufactured so that the cleaning efficacy device (an unsealed / sealable pouch 104 containing a foil leaf 102 and bearing an external cleaning indicator 108a and / or a thermochromic indicator ink composition 108b) is empty and needs to be filled with liquid and sealed prior to use. In such unsealed variant, the unfilled device (devoid of liquid) occupies substantially less volume and is substantially lower in weight, thereby allowing a greater number of devices 100-lOOd to be provided in the marketed product of a given container size. Any suitable sealing system or method may be used that ensures there is no leakage of the pouch contents, non-exhaustive examples of which include capping (screw or twist caps), zip-type sealing, sonic sealing and heat sealing.

[0132] In another variant of a cleaning efficacy device lOOe in accordance with the invention, the pouch may be replaced with a hard transparent container 104a, e.g., a glass or plastic bottle, sealed with a liquid-tight (i.e., leakproof) cap 104b, as shown in Figs. 5 A and 5B. The material forming the container 104a may be glass or a transparent polymer as described above with respect to the pouch 104 and may be a single polymer, a polymer blend, a copolymer, or a composite material consisting of different laminates bonded together. The materials forming the cap 104b may similarly be a polymer from those listed for the pouch material and may be a single polymer, a polymer blend, a copolymer, or a composite material consisting of different laminates bonded together. The material forming the cap 104b may be different form that of the bottle 104a and does not need to be transparent.

[0133] For each embodiment of the cleaning efficacy device 100-lOOe, the external cleaning indicator ink composition 108a (e.g., VERIFY® All Clean Test, Washer Indicator, LCC012, STERIS Corporation) may be printed as an ink on the pouch 104, container 104a or cap 104b, or attached to a piece of substrate extending from the pouch 104 (e.g., a flap), container 104a or cap 104b. Alternatively, and as discussed in more detail with respect to Fig. 20, a separate cleaning indicator device may be attached to the pouch 104, container 104a or cap 104b by various means, e.g., stapling, ties between holes present at the end of the pouch 104 or on the cap 104b.

[0134] The external cleaning indicator 108a may optionally include a thermochromic indicator 108b (e.g., Thermax Irreversible Thermochromic Label Level A [40 - 71 °C]), printed as an ink on the pouch 104, container 104a or cap 104b, or attached to a piece of substrate extending from the pouch 104 (e.g., a flap), container 104a or cap 104b.Alternatively, a separate thermochromic indicator 108b may be attached to the pouch 104, container 104a or cap 104b by various means, e.g., stapling, ties between holes present at the end of the pouch 104 or cap 104b and in the separate cleaning indicator 108a.

[0135] Briefly referring to Figs. 6A and 6B, the cleaning efficacy device 100-lOOe may be used with a bespoke holder 140 to allow the positioning of the cleaning efficacy device 100- lOOe in different locations and orientations within the ultrasonication bath. Additionally, the holder 140 prevents or minimizes the migration of the cleaning efficacy device 100-lOOe during an ultrasonication cycle, e.g., by means of attached clips, lugs or hooks. The holder 140 may be made of stainless steel, aluminium, other metal(s) or alloys, or a water- and detergent-resistant polymer. Preferably, the holder 140 has sufficient mass and density and / or is designed to remain anchored to the base of the bath so as to prevent the escape of the cleaning efficacy device 100-lOOe during a cycle. An example of such a holder is the Browne STF Load Check Holder (2316, Albert Browne Ltd), an L-shaped clip used to house a double-sided cleaning indicator (Browne STF Load Check Indicator, 2315, Albert Browne Ltd). A distal (perpendicular) end of the 2316 holder may be shortened in length to clasp the seam of a pouch. With the base of the holder contacting the base of the bath, the distal ends are vertical, allowing a clasped pouch to reach a vertical orientation when fully submerged in the cleaning solution.

[0136] Optionally, the design of the holder 140 allows it to be placed in different orientations with respect to the base of the bath, providing additional testing modes for the ultrasonication washer. For example, the design of the holder 140 can include one or more hooks or protrusions (not shown in Figs. 6A and 6B) for attachment to the side of an instrument basket inside the ultrasonic bath. These hooks or clips may also be extendable or retractable to allow the depth of the holder (and ultimately the cleaning efficacy device 100- lOOe) to be adjusted to the desired depth in the bath.

[0137] With continued reference to Figs. 6A and 6B, the holder 140 includes a back member 140a and a front member 140b, the two members secured to one another by a biasing member 140c, such as a spring hinge or the like. A right end each of the front and back members (to the right of the biasing member in Fig. 6A) form a clamp 140d, while a left end of each of the front and back members 140a, 140b (to the left of the spring clamp in Fig. 6A) form a lever 140e, whereby compression of the lever 140e pivots the front member relative to the back member and moves the clamp 140d to the open position. The biasing member 140c biases the front and back members 140a, 140b such that upon release of the lever 140e the front and back members pivot relative to each other and the clamp 140d returns to the closedposition. In use, the lever 140e is compressed to open the clamp 140d, and a portion of the cleaning efficacy device is inserted into the clamp 140d. Upon the lever 140e being released, the clamp 140d closes to secure the cleaning efficacy device therein. Optionally, a portion of the clamp 140d includes a screen mesh 140f in each member that permits fluid flow therethrough, e.g., as seen in Fig. 6C; the holder illustrated in Figs. 6A and 6B is not shown with a screen mesh 140f.

[0138] Referring briefly to Figs. 6C, 6D and 6E, illustrated is another embodiment of a holder 140’ in accordance with the invention. The holder 140’ of Figs. 6C, 6D and 6E is similar to the holder 140 of Figs. 6A and 6B and hence only the differences between the holders will be discussed here. It is noted that features and characteristics discussed above with respect to holder 140 are also applicable to the holder 140’.

[0139] The holder 140’ includes several elongated members 141a, 141b, 141c extending from one end or side of the holder 140’. In the illustrated embodiment of Figs. 6C, 6D and 6E, three elongated members 141a, 141b, 141c are shown, although it will be appreciated that more or fewer elongated members may be utilized depending on the specific application for the holder 140’. While the elongated members are illustrated as having a rectangular shape, other shapes are contemplated, e.g., triangular, tubular, conical, etc. The elongated members 141a, 141b, 141c provide a support means for the holder 140’ and are operative to reduce or eliminate migration and / or toppling of the holder 140’ during an ultrasonic cycle. For example, the elongated members 141a, 141b, 141c can prevent movement / toppling of the holder 140’ due to a water jet directly or indirectly interacting with the holder 140’. The elongated members 141a, 141b, 141c are configured to cooperate with securing members disposed in a basket base of an ultrasonic cleaner so as to inhibit displacement of the holder 140’ relative to the basket. In this regard, the basket base may include slots, gaps or the like, and the elongated members 141a, 141b, 141c engage these slots, gaps or the like to secure the holder 140’ against lateral movement relative to the basket base.

[0140] Additionally, and in contrast to the holder of Figs. 6A, 6B, which has no screen mesh sections in the clamp 140d, the holder 140’ of Figs. 6C and 6D has a mesh section 140f in each member in the clamp 140d.

[0141] The holder 140’ may optionally include one or more through-holes 141 d formed in the holder 140’. For example, in the illustrated embodiment a through-hole is formed adjacent to the mesh 140f in each of the front and back members 140a, 140b, as best seen in Figs. 6C and 6E. It is noted, however, that through-holes may be formed elsewhere, such as in the biasing member, 140c. The one or more through-holes 14 Id facilitate removal of airbubbles that otherwise may become trapped by the holder. In the illustrated embodiment of Fig. 6C the through-hole 141d has a rectangular slot-like shape, although other shapes are contemplated, e.g., circular, oval, etc. The dimensions of the one or more through -holes 14 Id should be sufficient to enable air bubbles to readily pass therethrough during an ultrasonic cleaning cycle.

[0142] The holder may also be designed to span two opposite sides of a basket 142 used in the ultrasonic washer bath, as illustrated in Fig. 7. In this variant, the pouch 104 of the cleaning efficacy device lOO-lOOd is attached to the holder 144 such that it is suspended (e.g., vertically) from the holder 144 to allow the cleaning efficacy device lOO-lOOd to test for ultrasonic action at a location above the base of the basket 142. This holder may have one or more telescopic or elastic arms 144a so that it spans baskets of different dimensions, and the end of each arm may have a hook or other attachment mechanism (not shown) to secure or fix the position of the holder 144 above the basket 142.

[0143] With reference to Figs. 8A and 8B, holes 105 at one end of a pouch 104 may be used for attachment of the cleaning efficacy device 100-lOOd to the holder 144 with the holes at the other end of the pouch 104 used for the attachment to sides of the basket 142 and / or to one or more weights (not shown) to ensure that the pouch 104 is held vertically in the water bath, i.e., to minimize the buoyancy of the pouch 104 in the aqueous media, thereby preventing the cleaning efficacy device 100-lOOd from floating on the surface of the aqueous media in the ultrasonic bath. The holder 144 may also be in the form of a basket, open or sealed container whose structure is wholly or partially open such that it that allows the cleaning efficacy device 100-lOOd therein to contact the aqueous media, e.g., detergent solution, in the ultrasonic bath.

[0144] Fig. 9 illustrates another embodiment of a holder 150 in the form of caged mesh holder. The caged mesh holder 150 can be hinged to enable a front part of the holder to move relative to a back part of the holder, thereby enabling the cleaning efficacy device 100-lOOe to be placed on one part of the mesh (e.g., the back part) and secured therein by positioning the front and back parts over and adjacent to each other. Alternatively, the mesh holder 150 may be pouch-like, where the front part and the back part are attached to each other on three sides, thereby leaving one side open for insertion / removal of the cleaning efficacy device 100-lOOe into the holder 150.

[0145] The cleaning efficacy device 100-lOOe may be held (e.g., anchored or suspended) horizontally, vertically, or at any angle between in one plane and may be placed at any angle in an orthogonal plane. The pouch 104 may be anchored by means of the holder 150 suchthat it is positioned vertically when fully immersed in the cleaning solution. The actual angle will be dependent on the depth of cleaning solution in the bath and the buoyancy of the pouch 104.

[0146] Advantages of the First Embodiment include:• Device aligns with testing to the HTM 01-05 standard through use of foil leaf as part of the design• Ease of use - direct placement in the bath• Complete test - result of each test on the cleaning efficacy device is clearly visible with each indicator having its own mode of response - Foil perforation / breakage [sonication], ink removal [washing], ink color change [thermal disinfection]• Sonication indicating element (foil leaf) is self-contained - no direct contact with ultrasonic bath liquid but able to detect ultrasonic action via pouch liquid• Contained - the aluminium particulates are contained within the pouch - no careful rinsing of the bath after processing is required• No metallic or chemical components / particles left in the washer• No harmful chemicals• Optional holder to anchor device to a particular location in the bath and reduce migration during an ultrasonication cycle• Sonication [foil leaf], cleaning efficacy [printed washer indicator] and optional thermochromic [ink or label] results are irreversibleSecond Embodiment

[0147] According to a second embodiment of a cleaning efficacy device 200 in accordance with the invention, a foil leaf 102 is encased in a wire mesh tabular box / envelope container 104c as shown in Fig. 10A. The device 200 contents are easily visible. A cleaning indicator element 108a could be used in conjunction with mesh tabular container 104c, comprising e.g., two separate containers 104c, one containing a foil leaf 102 and the other containing a cleaning element 108a; these containers, with their contents could be conjoined to form a single cleaning efficacy device. Figs. 10B-10C show a variant of the cleaning efficacy device 200a where a stainless steel mesh envelope 104d is formed by folding the sides of the mesh over each other, and the foil leaf 102 is sandwiched between front and back sides of the envelope. Adhesive may optionally be used to secure the sides and prevent the envelope from opening during use. The mesh spacing of the container / envelope 104c / 104d is selectedsuch that ingress of water / detergent solution in the ultrasonic washer bath is permitted into the container / envelope 104c / 104d and egress of aluminium particles formed from the pitting or perforation of the foil leaf 102 is prevented. For example, the mesh size may be 300 Mesh or 500 Mesh. The container / pouch 104c / 104d includes an external cleaning indicator 108a and optional thermochromic indicator 108b attached to the mesh. An advantage of the wire mesh is that it is reusable, whereby as the foil leaf 102 breaks / perforates during testing the particulates are trapped by the mesh. Optionally, the mesh may be attached to or formed integral with the cleaning basket that is immersed in the ultrasonic bath such that as the basket is closed the interior space of the basket is surrounded by the mesh.

[0148] The mesh material may be made of stainless steel, other suitable metals or alloys, water- and detergent-resistant polymers (e.g., those listed for the First Embodiment described above), nylon, materials used to construct, for example, tea bags and other flexible materials that fulfil the requirements above. Optionally, the container / envelope material may be extended at each end of the cleaning efficacy device 200, 200a and hole punched at each comer to allow the cleaning efficacy device 200, 200a to be suspended in the bath by means of hook(s), spring(s) or other fixed or elastic means as discussed above with respect to the First Embodiment.

[0149] The dimensions, thickness, grade, pre-treatment and shape of the foil leaf 102 within the mesh container / envelope 104c / 104d may be tailored to match the characteristics of the ultrasonic action of an ultrasonic cleaning cycle. More than one foil leaf 102 may be in a mesh container / envelope 104c / 104d.

[0150] Advantages of the Second Embodiment include:• Device aligns with testing to the HTM 01-05 standard through use of foil leaf as part of the design• Ease of use - direct placement in the bath• Complete test - result of each test on the cleaning efficacy device is clearly visible with each indicator having its own mode of response - foil perforation / breakage [sonication], ink removal [washing], ink color change [thermal disinfection]• Contained - the aluminium particulates are contained within the mesh container / envelope - no careful rinsing of the bath after processing is required• No harmful chemicals• Optional holder to anchor device to a particular location in the bath and reduce migration during an ultrasonication cycle• Sonication [foil leaf], cleaning efficacy [printed washer indicator] and optional thermochromic [ink or label] results are irreversible• The wire mesh container / envelope 104c / 104d is reusable, with fresh foil leaf 102 inserted within, and cleaning efficacy [printed washer indicator] and optional thermochromic [ink or label] added to, the device before each ultrasonication cycleThird Embodiment

[0151] According to a third embodiment of the invention, a cleaning efficacy device 300 includes a sealed foil leaf mini pouch 302 (e.g., a sachet or individual blister from a blister pack, at least part of which is made of a foil leaf) containing a water-soluble agent, as shown in Figs. 11A and 11B. The device 300 contents are easily visible. The agent may be coated on at least part of one or more inside surfaces of the foil leaf mini pouch 302, or may be simply sandwiched between front and back surfaces of the foil leaf mini pouch 302, i.e., the agent is not coated on any surface. The foil leaf mini pouch 302 is disposed within the pouch 104 or container 104a according to the First Embodiment described above and subjected to an ultrasonic cleaning cycle. Upon the mini pouch 302 being subjected to sufficient ultrasonic action, the foil leaf portion of the foil leaf mini pouch 302 ruptures and the agent within the mini pouch 302 is released. The released agent rapidly dissolves in the pouch liquid 106 admitted into the mini pouch 302, and on egress of the solution from the mini pouch 202 forms a colored solution 304 inside the pouch 104 as an indication of sufficient ultrasonic action, as shown in Fig. 11B. Such coloration of the pouch liquid 106 can provide a clearer and more-stark visual indication of ultrasonic action than the pitting / perforation of a foil leaf alone.

[0152] The contents (‘agent’ unless stated otherwise) of the foil leaf mini pouch 302 itself includes at least one of the following:• Water-soluble dye as powder or crystalline solid alone• Water-soluble dye as powder or crystalline solid within an inert solid matrix in the form of a tablet, pellet or capsule; the matrix is suitably porous to allow egress of the dye and / or ingress of the pouch liquid 106 to allow the rapid dissolution and release of the dye on contact, once the integrity of the foil leaf mini pouch 302 has been breached by pitting / perforation during ultrasonication• Solution of a dye, using water or water-miscible solvent• Water-soluble dye within a paste or gel such as a hydrogel, where contact with the outer pouch liquid 106 causes rapid dissolution and release of the dye on contact, once the integrity of the foil leaf mini pouch 302 has been breached by pitting / perforation during ultrasonication• Water-soluble dye in a coating on the inside surface of the foil leaf mini pouch 302. Any conventional coating or printing method may be used; the coating matrix is suitably porous to allow egress of the dye and / or ingress of the pouch liquid 106 to allow the rapid dissolution and release of the dye on contact, once the integrity of the foil leaf mini pouch 302 has been breached by pitting / perforation during ultrasonication• Solid water-soluble dye within a saturated bibulous pad, where contact with the outer pouch liquid 106 allows for the rapid dissolution and release of the dye once the integrity of the foil leaf mini pouch 302 has been breached by pitting / perforation during ultrasonication• Solid water-soluble dye in the form of a powder, pellet, tablet or bibulous pad, with additives such as fillers, binders, buffers, pH stabilizers and materials susceptible to ultrasonic degradation. One or more carbonate or bicarbonate salts in combination with one or more organic acids may also be present to generate carbon dioxide during sonication on initial contact with the pouch liquid 106. The effervescence from this acid / base reaction would accelerate the test result (e.g., color change) with the rapid gas evolution helping to rupture the coating and hastening the dispersion of the foil leaf mini pouch contents (i.e., the agent) into the pouch liquid 106.• Water-soluble dye with carbonate or bicarbonate salts and organic acids (as hydrates) containing carboxylate groups with additives such as fillers, binders, buffers, pH stabilizers. The hydrated acid provides an internal latent source of water ready to react with the carbonate or bicarbonate salt(s) present; ultrasonic action would release the water of crystallization from the acid and initiate the reaction of acid with the base.• Organic acids, e.g., containing carboxylate or sulfonate groups, and optionally with additives such as fillers, binders, buffers, pH stabilizers and materials susceptible to ultrasonic degradation, that would change the pH of the liquid in the pouch containing a pH-sensitive dye on release from the foil leaf mini pouch 302, generating a color change.• Alkaline compounds such as carbonate or bicarbonate salts or amines, and optionally with additives such as fillers, binders, buffers, pH stabilizers and materials susceptible to ultrasonic degradation, that would change the pH of the liquid in the pouch containing a pH-sensitive dye on release from the foil leaf mini pouch 302, generating a color change.

[0153] Non-exhaustive examples of appropriate solid acids that can be used in an agent formulation inside the foil leaf mini pouch 302 include mono- and poly-carboxylic acids such as citric acid, salicylic acid, acetylsalicylic acid, malic acid, tartaric acid, lactic acid, EDTA (ethylenendiaminetetraacetic acid), succinic acid, maleic acid, fumaric acid and tartronic acid. An example of a suitable sulfonic acid is p-toluenesulfonic acid. More than one acid may be used in an agent formulation.

[0154] Non-exhaustive examples of alkaline compounds that can be used in an agent formulation inside the foil leaf mini pouch 302 include alkali metal, alkaline earth, or ammonium carbonate and / or bicarbonate salts such as sodium carbonate, sodium bicarbonate, ammonium carbonate, ammonium bicarbonate, potassium carbonate, potassium bicarbonate. Other alkaline compounds include amines such as triethanolamine, DABCO (1,4- diazabicyclo[2.2.2]octane); more than one alkaline compound, or a combination of these, may be used in an agent formulation.

[0155] More than one water-soluble dye may be used in the cleaning efficacy device 300. For example, more than one dye may be used within the foil leaf mini pouch 302 or at least one dye may be disposed within the foil leaf mini pouch 302 and another dye may be disposed in the pouch liquid 106, e.g., release of a blue dye from the foil leaf mini pouch 302 after exposure to ultrasonic action mixing with yellow-dyed pouch liquid 106 to form a green pouch solution. The user would observe a yellow (unprocessed) to green (processed) color change. The water-soluble dye may also be pH sensitive so that its release into the bulk pouch liquid of one color (dyed or colorless) causes a color change to a different color as a result of the pH of the pouch liquid 106.

[0156] More than one foil leaf mini pouch 302 may be disposed in the cleaning efficacy device 300 and the additional foil leaf mini pouches may have different performance characteristics (e.g., foil thickness) to enable the cleaning efficacy device 300 to become a semi-quantitative ultrasonication indicator, e.g., by the release of a different colored dye from each mini pouch 302, thereby different aspects or levels of the ultrasonication exposure (e.g., frequency, power, exposure time) can be monitored.

[0157] With the exception of the discussion of the foil leaf 102, features discussed with respect to the various embodiments of the First Embodiment are also applicable to the embodiments discussed in the Third Embodiment.

[0158] Advantages of the Third Embodiment include:• Device aligns with testing to the HTM 01-05 standard through use of foil leaf as part of the design• Ease of use - direct placement in the bath• Complete test - result of each test on the cleaning efficacy device is clearly visible with each indicator having its own mode of response - pouch liquid color change [sonication], ink removal [washing], ink color change [thermal disinfection]• Sonication indicating element (agent in foil leaf mini pouch) is self-contained - no direct contact with ultrasonic bath liquid but able to detect ultrasonic action via pouch liquid• Contained - the aluminium particulates are contained within the pouch - no careful rinsing of the bath after processing is required• Optional holder to anchor device to a particular location in the bath and reduce migration during an ultrasonication cycle• Sonication [pouch liquid], cleaning efficacy [printed washer indicator] and optional thermochromic [ink or label] results are irreversible• Potential to generate a semi-quantitative ultrasonication indicatorFourth Embodiment

[0159] Embodiments of a cleaning efficacy device 400 according to the Fourth Embodiment (and its sub-variants) are identical to those discussed in the First Embodiment, but the encased foil leaf 102 is replaced with a coated agent 402. Referring to Figs. 12A and 12B, the coated agent 402 may be in the form of a pellet, tablet, capsule or bibulous pad containing a water-soluble agent 402a that is encapsulated by a coating 402b. The agent 402a is released on rupture of the coating 402b due to exposure to ultrasonic action. While the coated agent 402 is shown as having a circular shape, any shape may be utilized so long as the water soluble agent 402a is completely covered by the coating 402b.

[0160] As best seen in Fig. 12C, upon rupture of the coating 402b the released agent 402a rapidly dissolves in the pouch liquid 106 and forms a colored solution 404 inside the pouch104 as an indication of sufficient ultrasonic action. The processed device 400 result is easily visible. The coloration of the pouch liquid 106 can provide a clearer and more-stark visual indication of ultrasonic action than pitting of a foil leaf alone. The pouch 104 includes an external cleaning indicator 108a and optional thermochromic indicator 108b printed on a surface of the pouch 104 or attached thereto. The cleaning efficacy device 400 may be used with an optional holder as discussed with respect to the First Embodiment. The contents of the coated agent 402 can include one or more of the following:• Solid water-soluble dye• Solid water-soluble dye with additives such as fillers, binders, buffers, pH stabilizers• Solid water-soluble dye with additives such as fillers, binders, buffers, pH stabilizers and materials susceptible to ultrasonic degradation• Solid water-soluble dye with additives such as fillers, binders, buffers, pH stabilizers and materials susceptible to ultrasonic degradation. One or more carbonate or bicarbonate salts in combination with one or more organic acids may also be present to generate carbon dioxide on initial contact with the pouch liquid during sonication which would help to rupture the coating (by promoting the break-up of the pellet material and release of gas) thereby releasing the dye into the pouch liquid 106. Such effervescence would also accelerate the dispersion of the pellet contents into the pouch liquid, leading to a faster color change• Water-soluble dye with carbonate or bicarbonate salts and organic acids (as hydrates) containing carboxylate groups with additives such as fillers, binders, buffers, pH stabilizers. The hydrated acid provides an internal latent source of water ready to react with the carbonate or bicarbonate salt(s) present; ultrasonic action would release the water of crystallization from the acid and initiate the reaction of acid with the base• Organic acids containing carboxylate or sulfonate groups with optional additives such as fillers, binders, buffers, pH stabilizers - the released excess acid would change the pH of the liquid 106 in the pouch 104 containing a pH-sensitive dye, generating a color change• Alkaline compounds such as carbonate or bicarbonate salts or amines, and optionally with additives such as fillers, binders, buffers, pH stabilizers and materials susceptible to ultrasonic degradation. The released excess alkali would change the pHof the liquid 106 in the pouch 104 containing a pH-sensitive dye, generating a color change.

[0161] Non-exhaustive examples of suitable solid acids to be used in a pellet formulation include mono- and poly-carboxylic acids such as citric acid, salicylic acid, acetylsalicylic acid, malic acid, tartaric acid, lactic acid, EDTA (ethylenendiaminetetraacetic acid), succinic acid, maleic acid, fumaric acid and tartronic acid. An example of a suitable sulfonic acid is p- toluenesulfonic acid. More than one acid may be used in a pellet formulation.

[0162] Non-exhaustive examples of alkaline compounds to be used in a pellet formulation include alkali metal, alkaline earth, or ammonium carbonate and / or bicarbonate salts such as sodium carbonate, sodium bicarbonate, ammonium carbonate, ammonium bicarbonate, potassium carbonate, potassium bicarbonate. Other alkaline compounds include amines such as triethanolamine, DABCO (l,4-diazabicyclo[2.2.2]octane). More than one alkaline compound, or a combination of these, may be used in a pellet formulation.

[0163] In one variant, the agent 402a, especially in the form of pellet, tablet, capsule or bibulous pad, may be covered in metal foil 402b by means of spray painting, painting, dipping, printing, wrapping, sealing or other means. The metallic coating precludes the requirement for a foil leaf and preserves the link with the use of an aluminium leaf for testing stated in HTM 01-05. Ultrasonic action causes the degradation of this coating, thereby allowing ingress of the pouch liquid 106 and concomitant release of the dye / active agents as the pellet ruptures.

[0164] For this embodiment, it is critical for the outermost film in the coating to be insoluble in water and / or pouch liquid 106 or otherwise unaffected by continuous contact with water or pouch liquid 106 over time, to prevent premature spoiling of the cleaning efficacy device 400.

[0165] The coating 402b can include at least one layer of the following films or filmforming materials; combinations of these in a single layer or multiple layers may be used:• Aluminium (flake or non-flake)• Paint containing aluminium flake or powder / particles• Lacquers, varnishes, pastes, acrylic paint and media, polymer dispersions - both aqueous and non-aqueous, containing aluminium flake or powder / particles• Lacquers, varnishes, pastes, acrylic paint and media, polymer dispersions - both aqueous and non-aqueous• Enteric coatings such as fatty acids, waxes, shellac, polymers• Cellulose derivatives, e.g., ethyl cellulose, hydroxypropyl methyl cellulose, nitrocellulose• Starches, e.g., modified starches.• Waxes, e.g., artificial, natural, water soluble and water insoluble varieties

[0166] Referring to Fig. 12D, in one variant an outermost layer 402c of the coating 402’ comprises a wax film (e.g., hexadecanol, melting point 49.3 °C) which melts during an ultrasonic cleaning cycle as the temperature of the pouch liquid 106 in the heated bath solution exceeds the wax melting point, to reveal the next layer 402b which is ruptured by ultrasonic action, thereby exposing the agent 402a to the pouch liquid 106, leading to a color change in the pouch liquid 106.

[0167] More than one water-soluble dye may be used in the pellet, or the pellet may include at least one dye and the pouch liquid 106 includes another dye, e.g. release of a blue dye from the pellet after exposure to ultrasonic action mixes with yellow-dyed pouch solution to form a green pouch solution. The user would observe a yellow (unprocessed) to green (processed) pouch color change. The water-soluble dye may also be pH sensitive so that its release into the bulk pouch liquid of one color (dyed or colorless) causes a color change to a different color as a result of the pH of the pouch liquid.

[0168] More than one coated agent 402 may be in a pouch 14, and the additional coated agents may have different performance characteristics (e.g., coating thickness, coating material(s)) to enable the cleaning efficacy device 400 to become a semi-quantitative ultrasonication indicator, e.g., by the release of a different colored dye from each coated agent, thereby allowing aspects or levels of the ultrasonication exposure (e.g., frequency, power, exposure time, the efficacy of the cleaning process can be more precisely identified) can be monitored.

[0169] With reference to Fig. 12E, in one variant of a cleaning efficacy device 400a the coated agent 402 may be encapsulated within a foil sachet or individual blister pack 410 that is disposed within the pouch 104 and pouch liquid 106. A user would activate the cleaning efficacy device 400a by releasing the coated agent 402 from the sachet / blister pack 410 immediately before use by manually breaking the sachet / blister pack 410. Subsequent destruction of the released coated agent 400 during an ultrasonication cycle releases the dye or active agent. The physical separation of the coated agent 402 from the pouch liquid 106 by means of encapsulation within a foil sachet or blister system 410 prevents degradation of the coated agent 402 by pouch liquid 106 over time, thereby improving the stability and shelf life of the cleaning efficacy device 400a.

[0170] In another variant, an ink containing a dye (e.g., pararosaniline acetate) is applied to a substrate (e.g., aluminium foil) and dried. The dried film is removed from the substrate and dipped multiple times in a molten hydrophobic wax to form a coated agent having a water- impermeable coating. The coated agent and a liquid (e.g., pouch liquid 106) are disposed within a sealable container 104a, e.g., a bottle such as a plastic bottle to form a cleaning efficacy device. Sufficient sonication of the cleaning efficacy device breaches the coating and releases the dye in the pouch liquid 106, which changes from a colorless liquid to a red liquid.

[0171] Advantages of the Fourth Embodiment include:• Device aligns with testing to the HTM 01-05 standard through use of aluminium as part of the design• Ease of use - direct placement in the bath• Complete test - result of each test on the cleaning efficacy device is clearly visible with each indicator having its own mode of response - pouch liquid color change [sonication], ink removal [washing], ink color change [thermal disinfection]• Sonication indicating element (pellet) is self-contained - no direct contact with ultrasonic bath liquid but able to detect ultrasonic action via pouch liquid• Contained - the aluminium particulates are contained within the pouch - no careful rinsing of the bath after processing is required• Optional holder to anchor device to a particular location in the bath and reduce migration during an ultrasonication cycle• Sonication [pouch liquid], cleaning efficacy [printed washer indicator] and optional thermochromic [ink or label] results are irreversibleFifth Embodiment

[0172] Embodiments of a cleaning efficacy device 500 according to Fifth Embodiment are identical to those discussed in the First Embodiment, but the foil leaf is replaced by a metal coupon. Referring to Fig. 13A, a metal coupon 502 has a film 504 (primary film) containing a water-soluble agent deposited thereon. The primary film 504 optionally is coated with one or more secondary films 506, such as an aluminium-containing film, as seen in Fig. 13B. The secondary film 506 completely encapsulates and protects the water-soluble agent of the primary film 504 from contact with the pouch liquid 106. Exposure to ultrasonic actiondegrades the multiple-film coating, thereby releasing the agent from the primary film 504, and the agent rapidly dissolves in the pouch liquid 106 to form a colored solution inside the pouch 104 or container 104a as an indication of sufficient ultrasonic action. The coloration of the pouch liquid 106 inside the pouch 104 or container 104a can provide a clearer and more-stark visual indication of ultrasonic action than pitting / perforation of a foil leaf alone. The pouch 104 or container 104a includes an external cleaning indicator 108a and optional thermochromic indicator 108b printed thereon or attached thereto. The cleaning efficacy device 500 may be used with an optional holder as discussed with respect to the First Embodiment.

[0173] The primary film 504 deposited on the metal coupon 502 and optional secondary films(s) 506 may be in the form of an ink, lacquer, varnish, paint or other coating medium and shall contain one of the following water-soluble agents:• Water-soluble dye• Water-soluble dye with additives such as fillers, binders, buffers, pH stabilizers• Water-soluble dye with additives such as fillers, binders, buffers, pH stabilizers and materials susceptible to ultrasonic degradation• Water-soluble dye with additives such as fillers, binders, buffers, pH stabilizers and materials susceptible to ultrasonic degradation. One or more carbonate or bicarbonate salts in combination with one or more organic acids may also be present to generate carbon dioxide on initial contact with the pouch liquid during sonication which would help to rupture the coating (by promoting the break-up of the film / coating material and release of gas) thereby releasing the dye into the pouch liquid 106. Such effervescence would also accelerate the dispersion of the film / coating contents into the pouch liquid 106, leading to a faster color change• Water-soluble dye with carbonate or bicarbonate salts and organic acids (as hydrates) containing carboxylate groups with additives such as fillers, binders, buffers, pH stabilizers. The hydrated acid provides an internal latent source of water ready to react with the carbonate or bicarbonate salt(s) present; ultrasonic action would release the water of crystallization from the acid and initiate the reaction of acid with the base• Organic acids containing carboxylate or sulfonate groups with optional additives such as fillers, binders, buffers, pH stabilizers - the released excess acidwould change the pH of the liquid in the pouch containing a pH-sensitive dye, generating a color change• Alkaline compounds such as carbonate or bicarbonate salts or amines, and optionally with additives such as fillers, binders, buffers, pH stabilizers and materials susceptible to ultrasonic degradation - the released alkaline compound would change the pH of the pouch liquid 106 containing a pH-sensitive dye, generating a color change.

[0174] Non-exhaustive examples of appropriate solid acids that can be used in the primary or secondary film formulation(s) include mono- and poly-carboxylic acids such as citric acid, salicylic acid, acetylsalicylic acid, malic acid, tartaric acid, lactic acid, EDTA (ethylenendiaminetetraacetic acid), succinic acid, maleic acid, fumaric acid and tartronic acid; an example of a suitable sulfonic acid is p-toluenesulfonic acid. More than one acid may be used in a film formulation.

[0175] Non-exhaustive examples of alkaline compounds to be used in the primary or secondary film formulation(s) include alkali metal, alkaline earth, or ammonium carbonate and / or bicarbonate salts such as sodium carbonate, sodium bicarbonate, ammonium carbonate, ammonium bicarbonate, potassium carbonate, potassium bicarbonate. Other alkaline compounds include amines such as triethanolamine, DABCO (1,4- diazabicyclo[2.2.2]octane); more than one alkaline compound, or a combination of these, may be used in a film formulation.

[0176] In order to physically separate the acid component from the alkaline / basic component in films, methods such as microencapsulation of one or more of these reactants in a single film or separate films in mutual contact may be used. One reactant, e.g., acid (free or encapsulated) may in the primary film 504 and the other reactant, e.g., alkali / base (free or encapsulated) may be in the first secondary film 506, applied directly over the primary film 504.

[0177] The primary film 504 deposited on the coupon 502 may be applied as an ink, lacquer, varnish, gel, paint or other coating medium by means of spray painting, painting, dipping, pipetting, dispensing, printing, wire rod drawdowns or other means. The primary film 504 is allowed to dry completely before application of the secondary film(s) 506.

[0178] The secondary film 506 is deposited over the primary film 504 on the coupon 502. The secondary film 506 may be applied as an ink, lacquer, varnish, gel, paint or other coating medium by means of spray painting, painting, dipping, pipetting, dispensing, printing, wire rod drawdowns or other means.

[0179] Each secondary film 506 deposited on the coupon 502 preferably completely covers the primary film 504 and any previously applied secondary film 506. Optionally the coupon 504 itself (i.e., reverse side and edges), and may be applied as an ink, lacquer, varnish, paint, wire rod drawdowns or other coating medium by means of spray painting, painting, dipping, printing or other means. Each secondary film 506 is allowed to dry completely before application of next the secondary film(s).

[0180] In one variant, the primary film 504 (and any secondary film 506 applied over the primary film 504) may be covered in aluminium (or other metal), by means of spray painting, painting, dipping, printing, wire rod drawdowns or other means as the final secondary film (topmost layer of the coating). The aluminium coating preserves the link with the use of aluminium for testing stated in HTM 01-05 - ultrasonic action causes the degradation of this coating, allowing release of the dye or other active agents listed above into the pouch liquid 106.

[0181] A benefit of this variant of the cleaning efficacy device 500 is that use of a stainless steel coupon 502 serves as a surrogate surgical instrument, so ultrasonic destruction of the coating 504 on the coupon 502 is an exact representation of cleaning a stainless steel surgical instrument.

[0182] The coupon material can be a treated or untreated malleable or non-malleable metal or alloy that is stable in water, preferably stainless steel or aluminium. The coupon size preferably is at least 6 x 30 mm (180 mm2) and at most 100 x 100 mm (10000 mm2). More preferably, the coupon size is in the range 6 x 30 mm (180 mm2) to 60 x 60 mm (3600 mm2).

[0183] The dimensions, thickness, grade, purity, pre-treatment, construction and shape of the coupon 502 within the pouch 104 or container 104a may be tailored to match the characteristics of the ultrasonic action of an ultrasonic cleaning cycle. More than one coupon 502 may be in the pouch 104 or container 104a of the cleaning efficacy device 500.

[0184] For the Fifth Embodiment, it is critical for the dried outermost film(s) in the coating to be insoluble in water and / or pouch liquid 106, impermeable to moisture ingress, or otherwise unaffected by continuous contact with water, water vapour or pouch liquid 106 over time, to prevent premature spoiling of the cleaning efficacy device 500.

[0185] The complete coating is formed from the primary film 504 and optionally at least one secondary film 506. Each of the following films or film-forming materials may be used individually or as combinations in a single or in multiple films:• Aluminium (flake or non-flake)• Paint containing aluminium flake or powder / particles• Lacquers, varnishes, pastes, polymer dispersions - both aqueous and nonaqueous, containing aluminium flake or powder / particles• Lacquers, varnishes, pastes, acrylic paint and media, polymer dispersions - both aqueous and non-aqueous• Enteric coatings such as fatty acids, waxes, shellac, polymers• Cellulose derivatives, e.g., ethyl cellulose, hydroxypropyl methyl cellulose• Starches, e.g., modified starches• Waxes, e.g., artificial, natural, water soluble and water insoluble varieties

[0186] The whole coupon 502 and primary film 504 having the water-soluble agent may be encapsulated in one or more films that comprise the coating. The device 500 contents are easily visible. In one variant, the outermost layer of the coating comprises a wax film (e.g., hexadecanol, melting point 49.3 °C) which melts during an ultrasonic cleaning cycle as the temperature of the pouch liquid 106 in the heated bath solution exceeds the wax melting point, to reveal the next layer which is ruptured by ultrasonic action, thereby exposing the contents of the primary film 504 (at a minimum) to the pouch liquid 106, leading to a color change in the pouch liquid.

[0187] More than one water-soluble dye may be used in the primary film 504 or coating (multiple film layer). For example, more than one dye may be disposed with the primary film 504 or at least one dye may be disposed within the primary film 504 and another dye in the pouch liquid 106, e.g., release of a blue dye from the primary film 504 after exposure to ultrasonic action mixing with the yellow-dyed pouch liquid 106 to form a green pouch solution. A user would observe a yellow (unprocessed) to green (processed) pouch color change. The water-soluble dye may also be pH sensitive so that its release into the bulk pouch liquid 106 of one color (dyed or colorless) causes a color change to a different color as a result of the pH of the pouch liquid 106.

[0188] Additionally, more than one coated coupon 502 may be in the cleaning efficacy device 500, and the additional coated coupons 502 may have different performance characteristics (e.g., coating thickness, coating material(s)) to enable the cleaning efficacy device 500 to become a semi-quantitative ultrasonication indicator. For example, different levels of ultrasonication exposure (e.g., frequency, power, exposure time) can be determined by the release of a different colored dye from each coated coupon 502. Similarly, more than one primary film 504 may be applied to a coupon 502. For example and with reference to Fig. 13C, a cleaning efficacy device 500a includes a metal coupon 502 having a first primary film 504a, a second primary film 504b, and a third primary film 504c, each film havingdifferent characteristics from the other, e.g., different film area, formulation, composition, etc.. The cleaning efficacy device 500a may also include one or more secondary films as discussed above with respect to the cleaning efficacy device 500 of Fig. 13B

[0189] The performance of the coated coupon of the cleaning efficacy device 500, 500a may be modulated to meet the performance parameters of a particular ultrasonic cycle. Non- exhaustive examples of factors that may be adjusted include the following:• Primary film thickness, area, distance(s) of film edge from the coupon edge, shape, formulation, method of application, number of applications on a single coupon• Secondary film thickness, area, distance(s) of film edge from the coupon edge, shape, formulation, method of application, number of applications on a single coupon, extent of coverage over primary film (e.g., extent of secondary film beyond the edge of the primary film), extent of coverage over secondary film, extent of coverage of coupon.

[0190] In one variant of a semi-quantitative ultrasonication indicator, a coupon 502 may have a primary coating 504 deposited thereon, where the primary coating 504 comprises a primary film having a dark water-soluble dye (e.g., black), and a number of secondary films 506 deposited over the primary film 504. Some of the secondary films 506 contain water- soluble dyes of gradually lighter color with each film application. An example of such a coating may be expressed as AxByCz, where primary film A contains a black dye, secondary film B contains a blue dye, and secondary film C contains a yellow dye. Secondary films x, y and z are colorless and operate to buffer secondary films from each other, with film z, as the outermost film and containing aluminium. Ultrasonic action would, in order of exposure time, i) first rupture the aluminium in film z allowing the pouch liquid 106 to attack or dissolves film C, turning the colorless pouch liquid 106 to yellow. Further ultrasonic action (combined with any erosion and dissolution by the pouch liquid 106) degrades the films y and B, releasing the blue dye and turning the pouch liquid 106 green. Yet further ultrasonic action (combined with any erosion and dissolution by the pouch liquid 106) degrades the films x and A, releasing the black dye and turning the pouch liquid 106 black.

[0191] Advantages of the Fifth Embodiment include:• Device aligns with testing to the HTM 01-05 standard through use of aluminium as part of the design• Ease of use - direct placement in the bath• Use of a stainless steel coupon serves as a surrogate surgical instrument so ultrasonic destruction of the coating on the coupon is an exact representation of cleaning a stainless steel surgical instrument.• Complete test - result of each test on the cleaning efficacy device is clearly visible with each indicator having its own mode of response - pouch liquid color change [sonication], ink removal [washing], ink color change [thermal disinfection]• Sonication indicating element (coupon) is self-contained - no direct contact with ultrasonic bath liquid but able to detect ultrasonic action via pouch liquid• Contained - the aluminium / coating particulates are contained within the pouch - no careful rinsing of the bath after processing is required• Optional holder to anchor device to a particular location in the bath and reduce migration during an ultrasonication cycle• Sonication [pouch liquid], cleaning efficacy [printed washer indicator] and optional thermochromic [ink or label] results are irreversible• Potential to generate a semi-quantitative ultrasonication indicatorSixth Embodiment

[0192] Embodiments of a cleaning efficacy device 600 according to the Sixth Embodiment are identical to those discussed in the First Embodiment, but with the following differences:• The pouch 104 is replaced by a sealed transparent bottle, jar, vial, flask or other such vessel (‘bottle’) (similar to the variant shown in Figs. 5 A and 5B of the First Embodiment) - the contents are clearly visible• The bottle has an external cleaning indicator 108a and optional thermochromic indicator 108b printed thereon or attached thereto (similar to the variant shown in Figs. 5 A and 5B of the First Embodiment)• The foil leaf is present as a watertight foil seal over the whole top rim of the bottle• Inside the bottle is the pouch liquid, whose escape is prevented by the foil seal• The bottle has a cap, inside which is deposited a film (primary film) containing a water-soluble agent which may itself be subsequently coated with one or more secondary films• The cleaning efficacy device may be used with an optional bottle holder.

[0193] Exposure to ultrasonic action degrades the aluminium seal thereby releasing the pouch liquid into the cap, which rapidly dissolves the agent from the primary film to form a colored solution inside the bottle as an indication of sufficient ultrasonic action. The coloration of the liquid inside the bottle can provide a clearer and more-stark visual indication of ultrasonic action than pitting of an aluminium foil alone.

[0194] Referring to Fig. 14A, illustrated is a cleaning efficacy device 600 according to theSixth Embodiment. The cleaning efficacy device 600 includes a container 602 in the form of a bottle, jar or the like, and a sealing cap 604 threadedly couplable to the container 602. A pouch liquid 106 occupies at least a portion of the inner volume of the container 602, and an external cleaning indicator 108a and optional thermochromic indicator 108b are printed on or attached to the container 602. Inside the cap 604 is deposited a film 608 (primary film) containing a water-soluble agent, which may itself be subsequently coated with one or more secondary films. A seal 610 in the form of metal foil, e.g., aluminium foil, is attached to the top of the container 602 to isolate the cap 604 (and thus the film 608) from the pouch liquid 106. Alternatively, the seal 610 may be attached to the cap 604 with the film 608 disposed between the seal 610 and the cap 604, and / or the primary film 608 may be disposed on the outward facing (cap-facing) side of the seal 610 (as opposed to being disposed on the cap). Exposure to ultrasonic action degrades the metal foil seal 610 thereby releasing the pouch liquid 106 into the cap 604, which rapidly dissolves the agent from the primary film 608 to form a colored solution inside the container 602. The coloration of the liquid inside the container can provide a clearer and more-stark visual indication of ultrasonic action than pitting of a metal foil alone.

[0195] The primary film 608 and any secondary films deposited on the cap 604 or foil seal610 may be in the form of an ink, lacquer, varnish, paint or other coating medium and shall contain one of the following water-soluble agents:Water-soluble dyeWater-soluble dye with additives such as fillers, binders, buffers, pH stabilizersWater-soluble dye with additives such as fillers, binders, buffers, pH stabilizers and materials susceptible to ultrasonic degradationWater-soluble dye with additives such as fillers, binders, buffers, pH stabilizers and materials susceptible to ultrasonic degradation. One or more carbonate or bicarbonate salt in combination with one or more organic acid may also be present to generate carbon dioxide on initial contact with the pouch liquid 106 duringsonication which would help to rupture the coating (by promoting the break-up of the film material and release of gas) thereby releasing the dye into the pouch liquid. Such effervescence would also accelerate the dispersion of the film / coating contents into the pouch liquid, leading to a faster color change• Organic acids containing carboxylate or sulfonate groups with additives such as fillers, binders, buffers, pH stabilizers - the released acid would change the pH of the pouch liquid in the bottle containing a pH-sensitive dye, generating a color change• Alkaline compounds such as carbonate or bicarbonate salts or amines, with additives such as fillers, binders, buffers, pH stabilizers - the released alkaline compound would change the pH of the pouch liquid in the bottle containing a pH- sensitive dye, generating a color change.

[0196] Non-exhaustive examples of appropriate acids to be used in the primary or secondary film formulation(s) include mono- and poly-carboxylic acids such as citric acid, salicylic acid, acetylsalicylic acid, malic acid, tartaric acid, lactic acid, EDTA (ethylenendiaminetetraacetic acid), succinic acid, maleic acid, fumaric acid and tartronic acid. An example of a suitable sulfonic acid is p-toluenesulfonic acid. More than one acid may be used in a film formulation.

[0197] Non-exhaustive examples of alkaline compounds to be used in the primary or secondary film formulation(s) include alkali metal, alkaline earth, or ammonium carbonate and / or bicarbonate salts such as sodium carbonate, sodium bicarbonate, ammonium carbonate, ammonium bicarbonate, potassium carbonate, potassium bicarbonate. Other alkaline compounds include amines such as triethanolamine, DABCO (1,4- diazabicyclo[2.2.2]octane). More than one alkaline compound, or a combination of these, may be used in a film formulation.

[0198] In order to separate physically the acid component from the alkaline / basic component in films, methods such as microencapsulation of one or more of these reactants in a single film or separate films in mutual contact may be used. One reactant, e.g., acid (free or encapsulated) may in the primary film and the other reactant, e.g., alkali / base (free or encapsulated) may be in the first secondary film, applied directly over the primary film.

[0199] The primary film 608 deposited inside the cap 604 may be applied as an ink, lacquer, varnish, gel, paint or other coating medium by means of spray painting, painting, dipping, pipetting, dispensing, printing or other means. The primary film 608 is allowed to dry completely before application of the secondary film(s). If the coating consists only of the primary film 608, this film may be deposited over the entire inner surface of the cap 604.

[0200] The secondary film deposited over the primary film 608 as an ink, lacquer, varnish, gel, paint or other coating medium by means of spray painting, painting, dipping, pipetting, dispensing, printing or other means.

[0201] Each secondary film deposited on the cap preferably completely covers the primary film 608 and any previously applied secondary film and, optionally, the entire inner cap surface itself. The secondary film may be applied as an ink, lacquer, varnish, paint or other coating medium by means of spray painting, painting, dipping, printing or other means. Each secondary film is allowed to dry completely before application of next the secondary film(s).

[0202] The use of an aluminium seal 610 within the cleaning efficacy device 600 preserves the link with the use of aluminium for testing stated in HTM 01-05 - ultrasonic action causes the degradation of this seal, allowing release of the dye or other active agents listed above into the pouch liquid 106.

[0203] The complete coating preferably comprises the primary film 608 and at least one secondary film. Each of the following films or film-forming materials may be used individually or as combinations in a single or in multiple films:• Aluminium (flake or non-flake)• Paint containing aluminium flake or powder / particles• Lacquers, varnishes, pastes, acrylic paint and media, polymer dispersions - both aqueous and non-aqueous, containing aluminium flake or powder / particles• Lacquers, varnishes, pastes, acrylic paint and media, polymer dispersions - both aqueous and non-aqueous• Enteric coatings such as fatty acids, waxes, shellac, polymers• Cellulose derivatives, e.g., ethyl cellulose, hydroxypropyl methyl cellulose• Starches, e.g., modified starches• Waxes, e.g., artificial, natural, water soluble and water insoluble varieties

[0204] The dimensions, thickness, grade, purity, pre-treatment, construction and shape of the seal 610 within the container 602 may be tailored to match the characteristics of the ultrasonic action of an ultrasonic cleaning cycle. More than one seal 610 may be in a container 602. Seals that are colored (e.g., by anodizing, printing, etc.) on one side or both sides of the seal 610 may also be used.

[0205] More than one water-soluble dye may be used in the primary film 608 or coating (multiple film layer). Alternatively, at least one dye may be used within the primary film 608 (e.g., blue) and another dye may be used in the pouch liquid 106 (e.g., yellow). Release of the dye from the primary film 608 after exposure to ultrasonic action causes the dye of theprimary film to mix with the dye of the pouch liquid 106 to form a different color, e.g., blue + yellow produces a green pouchliquid. A user would observe a yellow (unprocessed) to green (processed) color change. The water-soluble dye may also be pH sensitive so that its release into the bulk pouch liquid of one color (dyed or colorless) causes a color change to a different color as a result of the pH of the pouch liquid.

[0206] The performance of the coated cap in a bottle device may be modulated to meet the performance parameters of a particular ultrasonic cycle. Non-exhaustive examples of factors that may be adjusted include the following:• Primary film thickness, area, distance(s) of film edge from the cap edge, shape, formulation, method of application, number of applications on the cap• Secondary film thickness, area, distance(s) of film edge from the cap edge, shape, formulation, method of application, number of applications on the cap, extent of coverage over primary film (e.g., extent of secondary film beyond the edge of the primary film), extent of coverage over secondary film, extent of coverage on the cap inside surface.

[0207] The container 602 may be formed from glass or a transparent polymer such as those used to form the pouch or container of the First Embodiment, including a single polymer, a polymer blend, a copolymer, or a composite material consisting of different laminates bonded together. The cap 604 may be formed from materials similar to that of the pouch 104 or cap described in the First Embodiment, including a single polymer, a polymer blend, a copolymer, or a composite material consisting of different laminates bonded together. The cap material may be different from that of the container and does not have to be transparent.

[0208] In one variant of a semi-quantitative ultrasonication indicator 600, a cap 604 with a coating deposited thereon may be used, where the coating includes primary film 608 having a dark water-soluble dye (e.g., black), with a number of secondary films formed over the primary film, some of the secondary films including water-soluble dyes of gradually lighter color with each film application. An example of such a coating may be expressed as AxByCz, where primary film A contains a black dye, secondary B contains a blue dye, secondary C contains a yellow dye, and x, y and z are colorless buffering secondary films. Ultrasonic action would, in order of exposure time, first rupture the foil seal 610, ingress of the pouch liquid 106 into the cap 604 then attacks or dissolves film z then film C, turning the colorless pouch liquid 106 to yellow. Further ultrasonic action (combined with any erosion and dissolution by the pouch liquid 106) degrades the films y and B, releasing the blue dye and turning the pouch liquid 106 green, and yet further ultrasonic action (combined with anyerosion and dissolution by the pouch liquid 106) degrades the films x and A, releasing the black dye and turning the pouch liquid 106 black,

[0209] Fig. 14B illustrates another variant of a cleaning efficacy device 600a in which a container 620 includes a seal 622 that splits the container 620 into a first chamber 624 and a second chamber 626, the container 620 and seal 622 being formed from the same materials as the cleaning efficacy device 600 of Fig. 14A discussed above. The first chamber 624 may include a pouch liquid 106 without any dye (e.g., a clear liquid) and the second chamber 626 may include a pouch liquid 106a with a dye (e.g., a colored liquid). Upon the seal 622 being perforated due to sonication, the colored pouch liquid 106a of the second chamber 626 migrates to first chamber 624 and changes the color of the pouch liquid 106 in the first chamber, thereby indicating perforation of foil. Alternatively, instead of using a clear liquid, colored liquids may be used in each chamber, and upon perforation of the seal the two colored liquids mix to give a third color.

[0210] Advantages of the Sixth Embodiment include:• Device aligns with testing to the HTM 01-05 standard through the use of aluminium foil in the design• Ease of use - direct placement in the bath• Complete test - result of each test on the cleaning efficacy device is clearly visible with each indicator having its own mode of response - pouch liquid color change [sonication], ink removal [washing], ink color change [thermal disinfection]• Sonication indicating element (foil seal) is self-contained - no direct contact with ultrasonic bath liquid but able to detect ultrasonic action via pouch liquid• Contained - the aluminium / coating particulates are contained within the bottle - no careful rinsing of the bath after processing is required• Optional holder to anchor device to a particular location in the bath and reduce migration during an ultrasonication cycle• Sonication [pouch liquid], cleaning efficacy [printed washer indicator] and optional thermochromic [ink or label] results are irreversibleSeventh Embodiment

[0211] Embodiments of a cleaning efficacy device 700 according to the Seventh Embodiment are identical to those discussed in the First Embodiment, but with the following differences:• The pouch is replaced by a sealed transparent tube, test tube, vial, flask or other such tube-shaped vessel (‘tube’) - the tube contents are clearly visible• The tube sealing mechanism is by means of a cap, septum, bung or plug (‘cap’)• The tube has an external cleaning indicator and optional thermochromic indicator printed thereon or attached thereto, on the tube itself or the cap• The foil leaf is present as a ribbon shape (‘foil ribbon’), whose maximum width is less than the inner diameter of the tube and whose length is less than or equal to double the length of the tube• Inside the tube is a liquid, which is retained in the tube by the cap• The cleaning efficacy device may be used with an optional tube holder.

[0212] Referring to Fig. 15A, illustrated is an exemplary cleaning efficacy device 700 in accordance with a Seventh Embodiment of the invention. The cleaning efficacy device 700 includes a container 702 in the form of a tube, such as a centrifuge tube, with a ribbon-shaped foil leaf 102 and liquid 106 disposed in the container 702. The liquid inside the tube is exactly as described for the First Embodiment. A cap 704 is threadedly coupled to an open end of the container 702 to form a liquid-tight seal. A ballast device 706 may be placed inside the container 702 to prevent the container from floating in the bath. The ballast device may be any device that increases the mass of the cleaning efficacy device such that the device will not float in the bath.

[0213] Moving to Figs. 15B and 15C, illustrated is a variant of a cleaning efficacy device 700a that is similar to the device 700 of Fig. 15A, but utilizes a plastic frame 710 to hold the foil ribbon 102 taut. The plastic frame 710 along with the foil ribbon 102 are placed within the container 702 along with a pouch liquid 106, and the cap 704 is coupled to the container 702 to provide a liquid-tight seal. In use, the cleaning efficacy device 700a is held by a holder so as to be submerged in the bath, where prior to processing the foil ribbon 102 is intact. After processing the foil ribbon 102 'snaps' or is destroyed in a manner similar to an electrical fuse.

[0214] The dimensions, thickness, grade, purity, pre-treatment, construction and shape of the foil ribbon 102 within the tube 702 may be tailored to match the characteristics of the ultrasonic action of an ultrasonic cleaning cycle. The size of the aluminium foil ribbonwithin the cleaning efficacy device should be no more than the maximum area available within a tube, and may be formed from aluminium, copper, silver, gold, or other such malleable metals or alloys. More than one foil ribbon 102 may be in a cleaning efficacy device 700. Foil ribbons 102 that are colored (e.g., by anodizing, printing, etc.) on one side or both sides of the foil ribbon may also be used. Use of colored foil ribbons may improve the ease of result interpretation, improve the aesthetics of the product and extend the life of the product with respect to tarnishing of the foil ribbon 102.

[0215] The foil ribbon 102 may have at least one short nick on one edge or at least one punched hole within the body of the foil ribbon 102 to serve as points to initiate degradation of the foil and promote the disintegration of the foil. The foil ribbon 102 may be scored or bent along its axis to maintain an extended shape in the cleaning efficacy device. Alternative presentations of the foil ribbon 102 include spiral, twisted, curved, tapered, rectangular or triangular shapes.

[0216] The volume of liquid 106 inside the container 702 is sufficient to allow the foil ribbon 102 to float inside the container 702, minimizing contact between the foil ribbon 102 and the internal surfaces of the container, and thereby maximizing exposure to the ultrasonication energy and allowing the required degree of pitting (perforation) for a PASS result to be achieved within less than 5 minutes. The volume of liquid in the filled container should be sufficient to allow contact of the liquid 106 with both sides of the ribbon leaf 102, allowing cavitation at the surface and edges of the ribbon leaf 102 to occur. Also, the volume of liquid inside the container 702 should also be sufficient to minimize the headspace, i.e., volume of air or other gas, within the container 702.

[0217] The container 702 is sized to accommodate one or more foil ribbons 102, allowing a limited degree of movement of the ribbon within the filled container 702, i.e., the diagonal length of the ribbon leaf 102 shall restrict the rotation of the ribbon leaf within the same axis as the container.

[0218] The container 702 may be formed from glass or water- and detergent-resistant polymers such as polyethylene, low-density polyethylene, high-density polyethylene, polypropylene, biaxially oriented polypropylene, polyethylene terephthalate, polycarbonate, biaxially oriented polyethylene terephthalate, cellophane, polyvinyl chloride, polystyrene, poly methyl methacrylate, polyamide, ABS, SAN, TPU, spun-bonded polyolefin, PTFE and other transparent or translucent, spun or cast materials that fulfil the requirements above. Transparent polymers / materials are preferred. The container material may be a singlepolymer, a polymer blend, a copolymer, or a composite material consisting of different laminates bonded together.

[0219] The cap 704 may seal the container 702 by means of a screw thread, a push fitting system (e.g., bladed cap), crimping, etc. It is critical that the seal between the cap 704 and the container 702 is watertight and robust. Additional elements such as internal O-rings, external tape, shrink sleeve fitting may be employed to achieve the watertight seal.

[0220] The dimensions of the end and / or the side of the cap 704 may be extended width ways (side) or lengthwise (end) to incorporate additional features, e.g., holes for positioning or securing the cleaning efficacy device, printing the cleaning indicator ink 108a, 108b thereon, or securing a weight or attachment to a holder so that the container 702 has a vertical orientation if suspended or anchored in the water inside the ultrasonic bath. The cap 704 may have a flat end at its base so that the cleaning efficacy device 700 can stand vertically on the cap 704, unaided by any other support device. The cap end may be designed to allow attachment and / or securing to a holder. Such means of attachment include a screw thread, bayonet fitting, Luer lock male or female fitting, blades for a push fitting.

[0221] In one embodiment, and with reference to Fig. 15D, an exemplary holder 720 is shown formed as a squat aluminium cylinder having a thick wall 722. The bottom end of the cylinder may or may not be closed. A securing means is arranged close to the bottom of the cylinder and across its diameter, two small holes 724a, 724b having a screw thread drilled through the wall circumference. In each hole 724a, 724b is screwed a single long screw 726a, 726b that is of sufficient length for the two screws to meet at an angle of 180° within the cavity of the cylinder. Other types of securing means include a push fitting system (e.g., bladed end of cap), female Luer lock fitting (on the base of the holder) for a cap-end male Luer lock fitting, grooves in the inner wall to accommodate a cap-end having a bayonet fitting.

[0222] In one embodiment of the invention, the cleaning efficacy device 700 may be used alone for monitoring the complete ultrasonic and cleaning action over time during a cycle, with or without instruments. In another, specific, embodiment, the cleaning efficacy device 700 comprises:• a clear polystyrene container, such as a test tube (length without cap 100 mm, inner diameter 14 mm, outer diameter 15-16 mm), containing: o deionized water (12 ± 2 mL) o blue anodized aluminium foil ribbon (85 x 2 mm)• plastic cap (push fitting, flat end), extending 10 mm from the end of the tube• washing indicator 108a as an adhesive label applied to the exterior surface of the tube• thermochromic indicator 108b as an adhesive label applied to the exterior surface of the tubeThis device is fitted and secured within the tube holder.

[0223] In another embodiment, the cleaning efficacy device 700 may be used with a bespoke holder to allow the positioning of the device 700 in different locations and orientations within the ultrasonication bath. Additionally, the holder prevents or minimizes the migration of the cleaning efficacy device 700 during an ultrasonication cycle.

[0224] The holder 720 may be made of stainless steel, aluminium, other metal(s) or alloys, or a water- and detergent-resistant polymer. The holder 720 should have a design and sufficient mass and density to remain anchored to the base of the bath and to prevent the escape of the indicating device during a cleaning cycle.

[0225] Optionally, the design of the holder shall allow the holder to be placed in different orientations with respect to the base of the bath, providing additional testing modes for the ultrasonication washer. Optionally, the design of the holder shall have one or more hooks for attachment to the side of the instrument basket inside the ultrasonic bath. Such hooks or clips may also be extendable or retractable, to allow the depth of the holder (and ultimately the monitoring device) to be adjusted to the desired depth in the bath.

[0226] The holder may also be designed to span two opposite sides of a basket used in the ultrasonic washer bath. In this embodiment, the cleaning efficacy device 700 is attached to the holder such that it is suspended (e.g., vertically) from the holder to allow the cleaning efficacy device to test for ultrasonic action at a location above the base of the basket. This holder may have one or more telescopic arms so that it spans baskets of different dimensions. The end of each arm may have a hook or other attachment mechanism to secure or fix the position of the holder above the basket. Loops, hooks or other attachment means at one end of a cleaning efficacy device 700 may be used for attachment of the cleaning efficacy device to the holder with the loops, hooks or other attachment means at the other end of the tube used for the attachment of one or more weights to ensure that the tube is held vertically in the water bath, i.e., to minimise the buoyancy of the tube in the aqueous media, thereby preventing the cleaning efficacy device from floating on the surface of the aqueous media in the ultrasonic bath.

[0227] The holder may also be in the form of a basket, open or sealed container whose structure is wholly or partially open such that it that allows the cleaning efficacy device 700 therein to contact the aqueous media, e.g. detergent solution, in the ultrasonic bath.

[0228] With reference to Figs. 15E and 15F, in another specific variant of the seventh embodiment, the cleaning efficacy device includes:• a clear extruded polycarbonate hollow cylinder 730 (e.g., length without cap 85 mm, inner diameter 7 mm, outer diameter 10 mm), containing: o water (3-6 mL) o blue anodized aluminium foil ribbon 102 that is 15 pm thick (85 ± 5 x 3 ± 1 mm) within plastic frame 710 either 1) attached to each end of the cylinder 730 by means of the caps 732a, 732b (e.g., the ribbon foil is pinched between the caps and the cylinder), or 2) attached to a discrete open rectangular polypropylene substrate730a; the ribbon is allowed to float freely within the sealed cylinder.• two plastic caps 732a, 732b (push fitting, flat end), sealing the cylinder at each end and trapping each end of the ribbon 102 to hold it in a fixed position within the cylinder 730• an optional cleaning indicator 108a as an adhesive label applied to the exterior surface of the cylinder• an optional thermochromic indicator 108b as an adhesive label applied to the exterior surface of the cylinder

[0229] The left image of the cleaning efficacy device 700b in Fig. 15E shows the foil ribbon 102 attached to a discrete open rectangular polypropylene substrate, 710. In the illustrated embodiment the foil ribbon 102 is held within the cylinder by the frame 710. In other embodiments the foil ribbon 102 may be bonded to bottom surfaces of the caps 732a, 732b (i.e., the surfaces of the caps that face each other) or pinched between sidewalls of the caps and the cylinder 730. The right image of the cleaning efficacy device 700c in Fig. 15E shows the foil ribbon 102 held in place by each cap 732a, 732b (e.g., the foil ribbon is pinched between the cap and the cylinder).

[0230] The cleaning efficacy device 700b was fitted and secured within holder 720 described above, with the single screw 726a in the holder 720 to secure the cleaning efficacy device 700b in a vertical position. The cleaning efficacy device 700b in the holder was placed inside an ultrasonic bath (on the base of the bath) and the ultrasonic cleaning cycle (using sonication, water and temperature) initiated. The ultrasonic cycle was performed using aMedisafe Innowave Eco Ultrasonic Cleaner at 38 kHz in 10 L water at 50±5 °C for 2 to 5 minutes. The destruction of the ribbon (‘blown’ fuse) occurred between 2 to 5 minutes, typically between 3 and 4 minutes (PASS result). Fig. 15F shows a 3 minute cleaning cycle result, the foil ribbon 102 (within 710) is split along the center 734, thereby demonstrating a PASS result.

[0231] The variants illustrated in Figs. 15E and 15F differ from other variants of the seventh embodiment, as those embodiments utilize a closed tube sealed with a single cap and therefore cannot trap a foil ribbon at both ends via the tube.Eighth Embodiment

[0232] Embodiments of a cleaning efficacy device 800 according to the Eighth Embodiment are identical to those discussed in the Seventh Embodiment, but with the following differences:• The tube 730 is replaced by a sealed, transparent, flexible rectangular pouch 104 - pouch contents are easily visible• The pouch 104 has an external cleaning indicator 108a and optional thermochromic indicator 108b each printed thereon or attached thereto, e.g. as a tag or label; monitors ultrasonic action / temperature / chemistry / time - result visible through presence / absence of indicator ink on pouch surface or tag extending from, or attached to, the pouch• The foil 102 inside the pouch is present either as 1) a ribbon shape [‘ribbon’]; the ribbon is fully extended within the pouch by means of attachment to both short ends of the pouch ([‘bridge’] design), or 2) the fuse or window designs described for the Seventh Embodiment; complete breakage of the ribbon allows easy visualisation of a successful cycle• Inside the pouch is the pouch liquid 106, whose escape is prevented by sealing all sides of the pouch• The cleaning efficacy device may be used with an optional holder.

[0233] Referring to Fig. 16, illustrated is a cleaning efficacy device 800 in accordance with the Eighth Embodiment. The cleaning efficacy device 800 includes a foil ribbon 102 arranged within a sealed pouch 104 with a pouch fluid 106 disposed inside the pouch 104. In the embodiment illustrated in Fig. 16, the foil ribbon 102 is secured to ends of the pouch 104 via the pouch seals 802a, 802b. For example, the pouch 104 may be formed as a sleeve having open ends 804a, 804b, where the foil ribbon 102 is inserted into the sleeve such thatends 102a, 102b of the ribbon 102 are disposed at respective ends 804a, 804b of the sleeve. The open ends 804a, 804b of the sleeve then are sealed, for example, using heat sealing, sonic welding, adhesive, or the like, such that the ends 102a, 102b of the foil ribbon 102 are secured within the seals 802a, 802b, respectively. In one variant, instead of the foil ribbon ends being secured within the seals, tabs may be formed within the pouch 104 and the ends 102a, 102b of the foil ribbon 102 may be secured to the tabs, for example, using an adhesive. The pouch 104 includes an external cleaning indicator 108a and optional thermochromic indicator 108b printed thereon or attached thereto. If the external cleaning indicator 108a and thermochromic indicator 108b are attached to the pouch 104, they may be attached using the same means used to seal the sleeve ends.

[0234] The volume of liquid 106 inside the pouch 104 should be sufficient to allow the foil ribbon 102 to flex inside the pouch 102, minimizing contact between the foil ribbon 102 and the internal surfaces of the pouch 104, and thereby maximize exposure to the ultrasonic action and allowing the required degree of degradation (e.g., splitting) for a PASS result to be achieved within a prescribed time period, e.g., less than 5 minutes for an ultrasonic bath operating at a frequency of 20-150 kHz (excluding the degassing phase).

[0235] The volume of liquid 106 in the filled pouch should be sufficient to allow contact of the liquid with both sides of the foil ribbon 102 therein, allowing cavitation at the surface and edges of the ribbon 102 to occur. Also, the volume of liquid inside the pouch should also be sufficient to minimize the headspace, i.e., volume of air or other gases, within the pouch 104. The pouch liquid 106 and the materials used to form the pouch 104 and its other construction details are as described for Embodiment One. Transparent polymers are preferred and at least one side of the pouch 104 must be transparent to enable viewing of the foil ribbon 102.

[0236] Additional to the pouch size, the dimensions of one or more of the sides / ends of the pouch material may be extended beyond a seam to incorporate additional features, e.g., holes for positioning or securing the cleaning efficacy device 800, printing the cleaning indicator ink thereon, or securing a weight so that the pouch 104 has a vertical orientation if suspended or when placed in the ultrasonic bath.

[0237] The cleaning efficacy device 800 may be used with a bespoke holder to allow the positioning of the device 800 in a preferred, e.g., vertical, orientation within the ultrasonic bath. Additionally, the holder prevents or minimizes the migration of the monitoring device during an ultrasonic cycle. The holder may be made of stainless steel, aluminium, other metal(s) or alloys, or a water- and detergent-resistant polymer. The holder should have a design and sufficient mass and density to remain anchored to the bath and to preventmigration and the escape of the cleaning efficacy device 800 during a cycle. The holder may also include mesh material, details of which are described with respect to the First Embodiment.

[0238] An example of such holder is in the form of a matchbox-shaped rectangular cuboid of dimensions of width 45 mm, height 58 mm and depth 20 mm. As will be appreciated, alternative dimensions, mesh sizes and construction methods may be used. The sides and bottom surface include 70 Mesh stainless steel, with the top made of two stainless steel coupons with a gap covering the width of the cuboid to serve as a slot into which the cleaning indicator part of the device is inserted. The holder may have some attachment mechanism to allow it to be secured to the base of the ultrasonic bath.

[0239] The holder described with respect to the first embodiment may have its slot modified to a cross (+) shape, with the additional vertical part of the cross (the actual modification) wide enough to accommodate the part of the pouch 104 that is attached to the cleaning indicator (e.g., seam). In this embodiment of the holder, not all the pouch 104 is intended to be inserted into the slot. The holder may also be modified to enable it to be clipped to the side of a basket.

[0240] Figs. 17A-17C illustrate another exemplary holder 810, 810a that has been raised by means of legs attached the holder. In Fig. 17A the legs are in the form of elongated members 812 extending out from a bottom surface of the holder 810, while in Figs. 17B and 17C the legs are in the form of stands 814 attached to a side surfaces of the holder 810a. The holder 810a may optionally include a weight 816 to further secure the holder within the bath.

[0241] In one specific embodiment of the invention and method of use, the cleaning efficacy device 800 comprises:• a sealed pouch 104 (length 95 mm, width 40 mm) comprising laminated aluminium as the lower surface and a clear transparent polymer as the upper surface, containing: o water (5-10 mL) o blue anodized aluminium foil ribbon 15 pm thickness (length 95 mm, width 3 ± 1 mm) attached to each end of the pouch by means of heat sealing; the ribbon is allowed to flex freely within the sealed pouch• one end of the pouch having a 5-10 mm extension for attachment by heat sealing: o a double-sided cleaning indicator (half a Browne STF Load Check Indicator, REF 2315, Albert Browne Ltd, or VERIFY® All-Clean Test, REF LCC012, STERIS Corporation)• an optional thermochromic indicator as an adhesive label applied to the exterior surface of the pouch• an optional holder for the pouch to ensure the cleaning indicator remains in place and to anchor the pouch during the cycle.Use Example

[0242] A cleaning efficacy device 800 (without thermochromic indicator) was inserted into a holder 820, securing the cleaning efficacy device 800 in a vertical position, as shown in Figs. 18A-18C. The cleaning efficacy device 800 in the holder 820 was placed inside an ultrasonic bath (on the base of the bath) and the ultrasonic cleaning cycle (using sonication, water and temperature) initiated. The ultrasonic cycle was run using a Medisafe Innowave Eco Ultrasonic Cleaner at 38 kHz in 10 L water at 50±5 °C for 5 minutes.

[0243] Fig. 18D illustrates three cleaning efficacy devices 800 after being subjected to a five minute cleaning cycle. In each case the foil ribbons 102 broke after 2-3 minutes of processing, thereby demonstrating PASS results for sonication. The use of water in these cycles gave FAIL results for the cleaning indicator, as can be seen by the remnants 822 of the cleaning indicator.

[0244] Briefly referring to Figs. 19A-19C, yet another example of a holder 830 is a modified Browne STF Load Check Holder (REF 2316, Albert Browne Ltd), an L-shaped clip used to house a double-sided cleaning efficacy device 800. The distal (perpendicular) end 832 of the 2316 holder may be adapted such that the two grid designs are replaced with mesh. With the base 834 of the holder 830 contacting the base of the bath, the distal ends 832 are vertical, allowing the distal end 832 to clasp a portion of the cleaning efficacy device’s pouch 104, resulting in the pouch of the cleaning efficacy device 800 being in a vertical orientation when fully submerged in the ultrasonic bath. Figs. 19D-19G are further adaptions based on the examples described for Figs. 19A-19C of a holder 830. Fig. 19D shows the base 834 of the holder 830a having a notch or gap 836 cut out of both the base 834 and the upper plate 838 in a region adjacent to the wire mesh 839. Fig. 19E shows the holder 830b where the wire mesh 839 is raised from the plane of the upper plate 838 of the holder 830b so that direct contact between the mesh 839 and the cleaning indicator is minimized or reduced to zero. The wire mesh 839 is so raised by sides 840 including further wire mesh, metal, or other suitable materials in appropriate designs to support the wire mesh away from and parallel to the plane of the base 834 of the holder 830. Fig. 19F shows a holder 830c similar to the holder 830b as for Fig. 19E, but with one or more sides 840 having one or more holes 842.Fig. 19G shows a holder 830d having i) affixed two loops 844, used as a means of anchoring the holder 830d to a basket or otherwise preventing migration during a cycle, and ii) a slot 846 cut out of the wire mesh 839; this slot may be of any shape and size and is a means of reducing the wire mesh coverage of the window area from 100%.

[0245] As can be seen in Fig. 19G, the holder 830d includes a first member 850 and a second member 852 attached to the first member 850, at least a portion of the second member 852 resiliently movable relative to the first member 850. The first member 850 includes a first planar portion 850a and a second planar portion 850b attached to one end of the first planar portion 850a, the second planar portion 850b being generally perpendicular to the first planar portion 850a. The second member 852 includes a first planar portion 852a that is parallel to the first planar portion 850a of the base 850, and a second planar portion 852b attached to one end of the first planar portion 852a and generally perpendicular to the first planar portion 852a. A third planar portion 852c of the second member 852 is attached to another end (i.e., an end of the first planar portion 852a opposite the end attached to the second planar portion 852b) of the first planar portion 852a via biasing member 854. The third planar portion 852c lies in a plane that is non-parallel to planes in which the first planar portion 852a and the second planar portion 852b lie. Thus, surfaces of the first planar portion 850a of the first member 850 and the first planar portion 852a of the second member 852 are parallel to each other. Further, the third planar portion 852c is movable relative to the first and second planar portions 852a, 852b by means of the biasing member 854.

[0246] An additional feature of the Seventh and Eighth Embodiments is that the fuse, if of appropriate length, may capture the nodes and antinodes of sonication; this also applies for the First Embodiment, where the aluminium foil has the appropriate dimensions.Ninth Embodiment

[0247] Ultrasonic action will have a significant cleaning effect on the cleaning indicator element 108a of the cleaning efficacy device as described herein. There is a need to tailor the performance of the cleaning indicator element 108a, i.e., toughness, so the cleaning indicator element survives sonication (i.e., shows a FAIL result) in the test cycle in a cold, detergent free cycle. A cleaning indicator device in accordance with an embodiment of the invention addresses the issue of monitoring the cleaning efficacy of the ultrasonic cleaning cycle without the cleaning indicator element 108a itself being completely cleaned by the ultrasonic action (including degassing) in that the cleaning is primarily effected by detergent, temperature, time and any mechanical action e.g., circulation or impingement. The cleaningindicator device 900 in accordance with an embodiment of the invention dampens, minimizes or controls (limits) the effect of the ultrasonic action on the cleaning indicator element 108a.

[0248] In accordance with an embodiment of the invention, and with reference to Fig. 20, a cleaning indicator device 900 includes a cylinder 902 of mesh material within which a cleaning indicator element 108a (e.g., a test soil on a substrate) is placed. The mesh is coarse enough to allow ingress of water / detergent solution of the ultrasonic bath into the cylinder. The mesh size preferably is 10 Mesh to 500 Mesh, and may be made of stainless steel or copper. The mesh size (or count) is defined as the number of openings / apertures per linear inch of wire mesh. Thus, a wire mesh which has 10 openings per inch (width and length) would be designated as 10 x 10 Mesh or 10 Mesh. An increase in mesh size is associated with a decrease in rigidity of the mesh, a decrease in hole size, a variation in the percent open area, and a decrease in the wire thickness.

[0249] A top portion 904 of the cylinder 902 includes a first cap 906, e.g., a mesh cap, and a bottom portion 908 of the cylinder 902 includes a second cap 910, e.g., a solid or mesh cap. The cylinder 902, first cap 906 and second cap 910 define a volume of the cylinder and prevent escape of the cleaning indicator 108a during an ultrasonic cleaning cycle. An optional support ring 912 may be disposed in the bottom portion of cylinder 902 to provide additional structural support to the cleaning indicator device 900. The cleaning indicator device 900 may further include a mount 914, which in the illustrated embodiment is in the form of a solid or hollow metal cylinder or rod. The mount 914 may be attached to the 902 at one of the top portion 904 or the bottom portion 908, and is configured to be inserted or attached to a holder, such as holder 720 described with respect to the Seventh Embodiment. A cylinder platform 916, which may be formed, for example, from a rubber, metal or plastic ring, may be disposed within the mount 914 to support the cylinder 902 within the mount 914 and limit an insertion depth of the cylinder 902 within the mount 914.

[0250] In use, on completion of the ultrasonic cleaning cycle and following removal of the cleaning indicator device 900 from the ultrasonic bath, the first or second cap 906, 910 is removed, and the cleaning indicator element 108a is taken out for evaluation. For the next ultrasonic cleaning cycle, a fresh cleaning indicator element 108a is inserted into the cylinder 902, which is then sealed using the first and / or second cap 906, 910.

[0251] The cleaning indicator device 900 may be single use device or may be used more than once. The tubular design of the mesh part of the cleaning indicator device 900 is preferably cylindrical but may be square (box-shape) or otherwise polygonal (with any number of sides until cylindrical). In the illustrated embodiment the mount 914 of thecleaning indicator device 900 is cylindrical and matches the geometry of the mesh part, but may have a different geometry from the mesh part. The geometry (in the same plane) of the remaining components of the cleaning indicator device (e.g. rings, supports, and cap) would be appropriate to fit the cleaning indicator device.

[0252] An exemplary configuration of the cleaning indicator device 900 may include:• The mount 914 is formed from an aluminum cylinder of dimensions 40 mm length, 16 mm outer diameter and 13 mm inner diameter; inserted at one end of the cylinder is a cylinder platform 916 formed as a 5 mm length of rubber tubing having an outer diameter that provides a snug fit inside the mount 914; on top of this tubing is affixed the first cap 906 (e.g., mesh cap), which serves as the base of the cylinder cavity.• Wrapped (with a 10 mm overlap) around the top 8 mm of the aluminum mount 914 (where the platform is located) and extending 60 mm beyond the mount 914, is the mesh cylinder 902 (e.g., stainless steel, 24 mesh); the mesh cylinder 902 may be attached to the mount 914 by means of an adhesive, which is also used to secure the support ring 912, formed as a 4 mm long section of aluminum cylinder placed at the distal end of the mesh cylinder 902 to strengthen the construction.• A second cap 910 in the form of a 5 mm length of the same rubber tubing is used for the cylinder platform 916.• The mesh grade used for the first cap 906 may be different from the mesh grade used for the cylinder 902.

[0253] The mesh and / or base material used in the cylinder 902 and / or first cap 906 may be made of stainless steel, water- and detergent-resistant polymers (e.g., those listed for the First Embodiment), coated and uncoated metals, synthetic rubbers, and other rigid or flexible materials that fulfil the requirements above. The material used for the mount 914 may be different from that used for the mesh.

[0254] Attachment of the mesh cylinder 902 to the mount 914 may be achieved by various means, e.g. adhesive, spot weld, crimping, clamping etc. The material, nature (e.g., woven, welded, galvanized), dimensions, wire thickness, hole size, open area, rigidity, weave pattern, purity, grade, pre-treatment and shape of the mesh used in the cylinder 902 and first cap 906 may be tailored to match the characteristics of the cleaning action of an ultrasonic cleaning cycle, while dampening or otherwise minimizing the effect of the ultrasonic action. The diameter of the cylinder 902 and first cap 906 and length of cylinder 902 may also be tailored for this purpose.

[0255] The material used in the platform 916 (if used) and / or support ring 912 may be made of stainless steel, water- and detergent-resistant polymers (e.g. those listed for the First Embodiment), coated and uncoated metals, synthetic rubbers, and other rigid or flexible materials that fulfil the requirements above. The material used in the platform 916 (if used) and / or support ring 912 may be different; the material used for these may be different from that used for the mount 914.

[0256] The removable and replaceable second cap 910 may seal the cylinder 902 and be attached to the cylinder, for example, via a screw thread, a bayonet fitting, a Luer lock fitting, a magnetic fitting, a hook and loop system, a clasp system, a friction fitting, an internal Ciring, a short tubing length, a lock and key system. Each fitting system would secure the second cap 910 via its complementary fitting on or in the cylinder 902, where applicable. The second cap 910 may be made of stainless steel, water- and detergent-resistant polymers (e.g., those listed for the First Embodiment), coated or uncoated metals, rubber, synthetic rubbers, and other rigid or flexible materials that fulfil the requirements above. The second cap 910 may be in the form (shape) of a flexible or rigid covering, mesh, tube, cylinder, septum, bung or plug. The second cap 910 may be reusable or single use.

[0257] The dimensions of the end and / or the side of the second cap 910 may be extended width ways (side) or lengthwise (end) to incorporate additional features, e.g., holes for positioning or securing the cleaning indicator device 900, printing an optional thermochromic indicator ink thereon, or securing an attachment to an alternative holder so that the cylinder 902 has a vertical orientation (preferred) if suspended or anchored in the water inside the ultrasonic bath.

[0258] The first and / or second cap 906, 910 may have a flat end so that the cleaning indicator device can stand vertically unaided. The cleaning indicator element 108a may be a single-use cleaning indicator having approximate dimensions of 10 x 30 mm and including a soil formulation printed on to a plastic substrate (e.g., Browne STF Load Check Indicators, REF 2315, Albert Browne Ltd, Leicester, UK, cut to size). More than one cleaning indicator element 108a may be placed in the cleaning indicator device 900. Alternatively, a cleaning indicator 108a printed on one side (instead of two) may be used.

[0259] In another method of use of the cleaning indicator device 900, the cleaning indicator device 900 (with included indicator 108a) may be used alone for monitoring the cleaning action only over time during an ultrasonic cleaning cycle, with or without surgical instruments. In another method of use, the cleaning indicator device 900 (with includedindicator 108a) may be affixed to a holder for monitoring the cleaning action only over time during an ultrasonic cleaning cycle, with or without surgical instruments.

[0260] In a variant of the Ninth Embodiment, the cleaning indicator device 900 may be a component of an apparatus and method used to monitor all four cycle parameters - ultrasonic action / temperature / chemistry / time - of an ultrasonic bath cycle. Such an apparatus would include the following:• a cleaning efficacy device having a metallic (e.g., aluminium) foil ribbon (e.g., fuse) in a sealed transparent tube (Seventh Embodiment) for monitoring ultrasonic action; result visible through breakage of the foil ribbon inside tube;• a separate cleaning indicator 108a encased in a cleaning indicator device 900 that monitors ultrasonic action (in part) / temperature / chemistry / time; result visible through presence / absence of indicator ink on indicator;• a separate thermochromic indicator (attached to the tube, cylinder or holder) that monitors the cycle temperature; result visible through irreversible indicator ink color change;• Holder(s) for the tube and cylinder; may be separate holders or a double aperture holder as described in the Seventh Embodiment.

[0261] Appropriate holders for this variant are described under the Seventh Embodiment. A double holder (e.g., two holders 720 illustrated in of Fig. 15D attached to each other) provides a heavier base to minimize any migration of the held devices during the ultrasonic cleaning cycle and simplifies placement of the cleaning efficacy device (e.g., tubular embodiments) adjacent to the cleaning indicator device 900 at a single location in the ultrasonic bath. The apertures in the holder may be of different designs (e.g., size, shape, securing mechanism) that are specific to the indicator type.

[0262] In another variant, the cleaning indicator device 900 may be a component of an apparatus and method used to monitor all four cycle parameters - ultrasonic action / temperature / chemistry / time - of an ultrasonic bath cycle. In this case the temperature monitoring may be addressed by the cleaning indicator, i.e., a FAIL result observed after processing in a cycle with the required detergent dose but operating at the incorrect temperature for that detergent to be fully effective. Such apparatus may include the following:• a cleaning efficacy device having a metallic (e.g., aluminium) foil ribbon (e.g., fuse) in a sealed tube (Seventh Embodiment) that monitors ultrasonic action; the result is visible through breakage of the foil ribbon inside tube;• a separate cleaning indicator device 900 that monitors ultrasonic action (in part) / temperature / chemistry / time; the result is visible through presence / absence of indicator ink on the cleaning indicator;• Holder(s) for the cleaning efficacy device and the cleaning indicator device 900; may be separate holders or a double aperture holder.

[0263] Descriptions of appropriate holders for this variant are detailed in the Seventh Embodiment. A double holder (e.g., two holders 720 illustrated in of Fig. 15D attached to each other) provides a heavier base to minimize any migration during the ultrasonic cleaning cycle and simplifies placement of the ultrasonic indicator (tubular embodiments) adjacent to the cleaning indicator device 900 at a single location in the ultrasonic bath. The apertures in the holder may be of different designs (e.g. size, shape, securing mechanism) that are specific to the indicator type. Additionally, in each variant more than one apparatus may be placed in an ultrasonic bath for processing in a cycle.

[0264] To illustrate the effects different mesh size has on the cleaning indicator device 900, two cleaning indicator devices 900 each device having cylinders 902 of different stainless steel mesh sizes (50 Mesh and 100 Mesh) were placed in a holder. The cleaning indicator devices 900 each utilized individual cleaning indicators cut from Browne STF Load Check Indicators, REF 2315 and inserted into each test cleaning indicator device 900. This combination was processed in a Medisafe ECO Innowave ultrasonic bath with the following cycle parameters: fill volume = 10 litres, temperature = 50±2 °C, detergent = STERIS Prolystica Multi enzyme at 0 (water only) or 7.5 mL / L (the maximum dose), time = 2, 3 and 5 minutes, no basket.

[0265] Each ultrasonic cycle was performed once for each bath liquid (water or detergent solution) and duration (2, 3 and 5 minutes) using three test apparatuses having the same mesh size. Cycles were also run using detergent solution but with no ultrasonic action. The results of the test are summarized in Table 1.Table 1

[0266] For the cleaning indicator device 900 utilizing a 50 Mesh cylinder 902, residual soil was present on all indicators (FAIL results = Not Clean in the Table) after each type of processing (i.e., in water, in the presence of detergent, and without ultrasonic action). For ultrasonication in both bath liquids, the quantity of residual soil was reduced with exposure time and for each exposure time, more soil was removed by the detergent solution than the water.

[0267] For the cleaning indicator device 900 utilizing a 100 Mesh cylinder 902, residual soil was present on all indicators tested (FAIL results) after processing separately in water and without ultrasonic action. However, in a detergent solution the soil was completely removed at all three exposure times (PASS results = Clean in the Table). For ultrasonication in water, the quantity of residual soil was reduced with exposure time.

[0268] These results show that the cleaning indicator device mesh size affects the soil removal from the enclosed indicator during an ultrasonic cycle using detergent. The 100 Mesh allows complete removal of the soil whereas the coarser 50 Mesh affects the ultrasonic cleaning to the extent that detergent solution (chemical action) alone is insufficient to remove all the soil. The results of the cycles run in water show that in this system, ultrasonic cleaning (mechanical action) alone is insufficient to remove all the soil. The results of the cycles run in detergent solution without ultrasonic action demonstrate that in this system, detergent alone is insufficient to remove all the soil.

[0269] In this system, a combination of detergent, ultrasonic action and appropriate mesh size (100 Mesh) is required to achieve a PASS result for a cleaning indicator 108a processed inside the cleaning indicator device 900 in cycles of 2-5 minutes’ duration. During this timeframe, the cleaning indicator 108a processed inside a 100 Mesh cleaning indicator device 900 indicates the presence of detergent and ultrasonic action.

[0270] In another test case, cleaning indicator devices 900 each having cylinders of different stainless steel mesh sizes, ranging from 40 Mesh to 100 Mesh, were tested inside holder 720. To investigate the effect of time and mesh size on cleaning, individual cleaning indicators 108a (double sided indicators, cut from Browne STF Load Check Indicators, REF 2315) inserted into each cleaning indicator device 900 and were processed in a Medisafe ECO Innowave ultrasonic bath with the following cycle parameters: fill volume = 10 litres, temperature = 50±2 °C, detergent = Medisafe 8E-Zyme at 7.5 mL / L (the maximum dose), time = 1 to 5 minutes, no basket. Each ultrasonic cycle was performed once for each duration (1, 2, 3, 4 and 5 minutes) using three cleaning indicator devices 900 having the same meshsize. These results of the test may be summarized in the Table 2 and are presented as the number of clean indicators (PASS results) vs number tested:Table 2*No ultrasonication.

[0271] Looking at the ultrasonication cycle results from the 40 Mesh device at 1 minute (top left) to the 100 Mesh device at 5 minutes (bottom right), the point at which the indicators are consistently cleaned (3 / 3 clean) is the 60 Mesh device at 4 minutes. These data imply that the optimum cylinder mesh size for monitoring cleaning with the 2315 cleaning indicator lies between Mesh 60 and Mesh 80. A lower mesh size is too ‘tough’ (too many FAIL results) and a higher mesh size is too ‘soft’ (too many PASS [clean] results).

[0272] These results show that the device mesh size affects the soil removal from the enclosed cleaning indicator device 900 during an ultrasonic cycle using detergent. The higher mesh sizes (80 and 100 Mesh) allow complete removal of the soil whereas the coarser, lower mesh sizes (40 and 50 Mesh) almost completely inhibit the ultrasonic cleaning to the extent that in this system, detergent solution alone is insufficient to remove all the soil.

[0273] The effect of ultrasonication is shown by comparison of the test results for the 100 Mesh samples. Cycles with ultrasonication give 100% clean results but cycles without ultrasonication give 0% clean results, demonstrating that for 100 Mesh in this system, the detergent alone is insufficient to remove all the soil. In this test apparatus and in the timescale of 1-5 min, it is the lower mesh size that is the primary cause of the FAIL [unclean] results whereas at the highest mesh size tested, it is the absence of ultrasonic action that is the primary cause of the FAIL results. Testing using other ultrasonication equipment, detergents and / or with other cleaning indicator soil formulations may result in different optimal mesh sizes.

[0274] The cleaning indicator device 900 for monitoring ultrasonic cleaning cycles may be used in conjunction with a cleaning efficacy device as described in Embodiments 1-8. Suchapparatuses may also comprise an optional thermochromic indicator and be used with an optional holder.

[0275] Although the invention has been shown and described with respect to a certain embodiment or embodiments, equivalent alterations and modifications may occur to others skilled in the art upon the reading and understanding of this specification and the annexed drawings. In particular regard to the various functions performed by the above described elements (components, assemblies, devices, compositions, etc.), the terms (including a reference to a "means") used to describe such elements are intended to correspond, unless otherwise indicated, to any element which performs the specified function of the described element (i.e., that is functionally equivalent), even though not structurally equivalent to the disclosed structure which performs the function in the herein exemplary embodiment or embodiments of the invention. In addition, while a particular feature of the invention may have been described above with respect to only one or more of several embodiments, such feature may be combined with one or more other features of the other embodiments, as may be desired and advantageous for any given particular application.

Claims

What is claimed is:

1. An ultrasonic cleaning efficacy indicator, comprising: a first container; a metallic foil disposed within the first container; and a cleaning indicator disposed on a surface of the first container or attached to the first container, the cleaning indicator configured to monitor at least one of temperature of an ultrasonic bath solution, a chemistry of the ultrasonic bath solution, or time the cleaning indicator is immersed in the ultrasonic bath solution.

2. The ultrasonic cleaning efficacy indicator according to claim 1, wherein the first container comprises at least one of a liquid-tight flexible container, a liquid-tight rigid container, or a mesh container.

3. The ultrasonic cleaning efficacy indicator according to any one of claims 1-2, wherein the first container comprises a transparent portion for viewing the foil.

4. The ultrasonic cleaning efficacy indicator according to any one of claims 1-3, further comprising a liquid disposed within the first container.

5. The ultrasonic cleaning efficacy device according to claim 4, wherein the foil is freely suspended in the liquid.

6. The ultrasonic cleaning efficacy indicator according to any one of claims 3-5, wherein the liquid comprises at least one of tap water, distilled water, sanitized water, sterile water, deionized water, mineral water.

7. The ultrasonic cleaning efficacy indicator according to any one of claims 4-6, wherein the liquid comprises at least one additive configured to inhibit corrosion or tarnishing of the foil, or prevent bacterial growth or biofilms within the first container.

8. The ultrasonic cleaning efficacy device according to any one of claims 4-7, wherein the liquid comprises a buffer configured to at least one of: inhibit corrosion of the ultrasonicindicator, provide chemical stability to the aluminium foil or provide chemical stability to the liquid.

9. The ultrasonic cleaning efficacy device according to claim 8, wherein the buffer comprises at least one of a phosphate or an acetate.

10. The ultrasonic cleaning efficacy indicator according to any one of claims 1-9, further comprising a thermochromic indicator disposed on the surface of the first container or attached to the first container.

11. The ultrasonic cleaning efficacy indicator according to any one of claims 1-10, wherein the metallic foil is in the form of single foil leaf, a plurality of foil leafs, or a plurality of elongated foil leaf pieces.

12. The ultrasonic cleaning efficacy indicator according to any one of claims 1-11, wherein the first container comprises at least one securing member.

13. The ultrasonic cleaning efficacy indicator according to claim 12, wherein the first container comprises a flap formed along an end of the first container, and the at least one securing member comprises a hole formed in the flap.

14. The ultrasonic cleaning efficacy indicator according to any one of claims 1-13, wherein the foil forms at least part of a sealed second container disposed within the first container, the second container including a water-soluble agent.

15. The ultrasonic cleaning efficacy indicator according to claim 14, wherein the agent is at least one of coated on at least part of an inside surface of the second container or disposed between surfaces of the second container.

16. The ultrasonic cleaning efficacy indicator according to any one of claims 14-15, wherein the agent comprises a compound that changes at least one of a color of the liquid or a pH of the liquid.

17. The ultrasonic cleaning efficacy indicator according to any one of claims 14-16, wherein the second container comprises a plurality of water-soluble agents.

18. The ultrasonic cleaning efficacy indicator according to any one of claims 14-17, comprising a plurality of the second containers disposed within the first container, wherein at least some of the plurality of second containers have different performance characteristics than others of the plurality of second containers.

19. The ultrasonic cleaning efficacy indicator according to claim 18, wherein the different performance characteristics comprise at least one of a different foil thickness of the second container, or a different agent disposed within the second container.

20. The ultrasonic cleaning efficacy indicator according to any one of claims 1-19, further comprising at least one water-soluble agent encapsulated by the foil.

21. The ultrasonic cleaning efficacy indicator according to claim 20, further comprising a wax film disposed over the foil.

22. The ultrasonic cleaning efficacy indicator according to any one of claims 20-21, comprising a plurality of foil-encapsulated water-soluble agents, wherein at least some of the plurality of foil-encapsulated agents have different performance characteristics than others of the plurality of foil-encapsulated agents.

23. The ultrasonic cleaning efficacy indicator according to claim 20-22, further comprising a blister pack container disposed with the first container, wherein the water- soluble agent encapsulated by the foil is disposed within the blister pack container.

24. The ultrasonic cleaning efficacy indicator according to any one of claims 1-23, wherein the foil comprises a metallic coupon with at least one water-soluble agent deposited on the coupon, and a first coating formed over the at least one water-soluble agent and at least part of the coupon.

25. The ultrasonic cleaning efficacy indicator according to claim 24, further comprising a second coating formed over the first coating.

26. The ultrasonic cleaning efficacy indicator according to any one of claims 1-25, wherein the first container comprises a base having an open end and a cap removably couplable to the open end, and the foil is arranged on one of the open end or within the cap, the foil forming a liquid-tight seal between a portion of the cap and the base, further comprising at least one water-soluble agent disposed between the cap and the foil, and a liquid disposed within at least a portion of an inner volume of the base.

27. The ultrasonic cleaning efficacy indicator according to any one of claims 1-26, wherein the foil spans across the first container to define a first liquid-tight chamber and a second liquid-tight chamber, a first liquid is disposed in the first liquid-tight chamber and a second liquid is disposed in the second liquid-tight chamber, the second liquid having at least one property different from that of the first liquid.

28. The ultrasonic cleaning efficacy indicator according to any one of claims 1-27, further comprising a support frame disposed within the first container and having a first end and a second end, wherein the foil is a ribbon foil having a first ribbon foil end attached to the first end of the support frame, and a second ribbon foil end attached to the second end of the support frame.

29. The ultrasonic cleaning efficacy device according to claim 28, wherein the ribbon foil comprises a plurality of ribbon foils each attached to the support frame.

30. The ultrasonic cleaning efficacy device according to any one of claims 1-29, wherein the first container comprises a rigid container having a first open end and a second open end, a first cap removably couplable to the first open end and a second cap removably couplable to the second open end, and the foil is attached to the first and second caps or held in place by the first and second caps.

31. The ultrasonic cleaning efficacy indicator according to any one of claims 1-30, wherein the first container comprises a flexible container, and the foil comprises an elongated shape spanning from one end of the flexible container to another end of the flexible container, each end of the foil secured to the flexible container via respective sealing members at the respective ends of the flexible container.

32. The ultrasonic cleaning efficacy indicator according to any one of claims 1-31, wherein the foil includes a pre-weakened region configured to serve as a location at which degradation of the foil due to ultrasonic action is initiated.

33. The ultrasonic cleaning efficacy indicator according to claim 32, wherein the preweakened region comprises at least one of a serrated edge, a hole within a body of the foil, or a cut along an edge of the foil.

34. The ultrasonic cleaning efficacy indicator according to any one of claims 32-33, wherein the pre-weakened region comprises a plurality of holes within the body of the foil.

35. The ultrasonic cleaning efficacy indicator according to any one of claims 1-34, wherein at least one surface of the foil is colored.

36. An ultrasonic cleaning efficacy system, comprising, the ultrasonic and cleaning efficacy indicator according to any one of claims 1-35; and a holder for securing the ultrasonic cleaning efficacy device within an ultrasonic cleaning device.

37. The ultrasonic cleaning efficacy system according to claim 36, wherein the holder comprises at least one of a bespoke holder or a mesh container.

38. The ultrasonic cleaning efficacy system according to claim 37, wherein the holder comprises at least one extendable / retractable hook or clip.

39. The ultrasonic cleaning efficacy system according to any one of claims 36-38, wherein the holder comprises a first plate and a second plate disposed adjacent to the first plate, the first and second plates having corresponding openings that define a through-hole, and a mesh material covering the through-hole.

40. The ultrasonic cleaning efficacy system according to claim 39, further comprising a notch formed in the first and second plates adjacent to the mesh material.

41. The ultrasonic cleaning efficacy system according to any one of claims 39-40, wherein the mesh structure is disposed in a plane different from a plane defined by the first and second plates.

42. A cleaning indicator device for holding a cleaning indicator element, comprising: a container formed from a mesh material and having a first open end, the mesh material having a mesh size that enables ingress of liquid inside the container; a first cap removably couplable to the first open end; and a mount attached to the second end, the mount adapted to be inserted into a holder for supporting the container.

43. The cleaning indicator device according to claim 42, wherein the container has a second open end, further comprising a second cap removably coupled to the second open end.

44. The cleaning indicator device according to claim 43, wherein at least one of the first cap or the second cap comprises a mesh cap that enables ingress of liquid inside the container.

45. The cleaning indicator device according to claim 44, wherein the second cap comprises a solid cap that is impervious to liquid.

46. The cleaning indicator device according to any one of claims 42-45, further comprising a cleaning indicator element disposed within the container.

47. The cleaning indicator device according to any one of claims 42-46, further comprising a structural support ring disposed at the first end or the second end.

48. The cleaning indicator device according to any one of claims 42-47, further comprising a holder removably coupled to the support member.

49. A holding device for securing an ultrasonic cleaning efficacy device within an ultrasonic cleaning device, the holding device comprising: a first member;a second member atached to the first member, wherein at least a portion of one of the first member or the second member is resiliently movable relative to at least a portion of the other of the first member or the second member; and a first aperture disposed in the first member and a second aperture disposed in the second member, the first and second apertures being concentric.

50. The holding device according to claim 49, further comprising a mesh structure covering the first aperture and the second aperture.

51. The holding device according to claim 50, wherein at least a portion of the mesh structure is disposed in a plane different from a plane defined by the first and second members.

52. The holding device according to any one of claims 50-51, further comprising a slot formed in the mesh structure.

53. The holding device according to any one of claims 49042, wherein the first member comprises a first planar surface and a second planar surface, the second planar surface arranged perpendicular to the first planar surface.

54. The holding device according to any one of claims 49-53, wherein the second member comprises a first planar surface, a second planar surface, and a third planar surface, the second planar surface arranged perpendicular to the first planar surface, and the third planar surface arranged parallel to the first planar surface and non-parallel to the second planar surface.

55. The holding device according to claim 54, wherein the first planar surface of the first member and the first planar surface of the second member are immediately adjacent to one another, and a slot is formed between the respective surfaces.

56. The holding device according to claim 55, wherein the first planar surface of the first member includes a plurality of first apertures, and the first planar surface of the second member includes a plurality of second apertures, respective ones of the plurality of first apertures being aligned with respective ones of the plurality of second apertures.

57. The holding device according to any one of claims 49-56, further comprising at least one protrusion extending from a side of at least one of the first member or the second member, the at least one protrusion configured to secure and prevent migration of the holding device within the ultrasonic cleaning device.

58. The holding device according to claim 57, wherein the at least one protrusion comprises a plurality of elongated members extending from a common side of at least one of the first member or the second member, the plurality of elongated members configured to secure the holding device to a support structure.

59. The holding device according to any one of claims 49-58, further comprising a notch formed in the first and second plates adjacent to the mesh material.

60. The holding device according to any one of claims 49-59, wherein the first member and the second member define a clamp region, further comprising a biasing member operatively coupled to the first member and the second member, the biasing member configured to urge the first member and the second member to close the clamp region.

61. The holding device according to any one of claims 49-60, further comprising a through-hole operative to enable air bubbles to pass from a first side of the holding device to a second, opposite side of the holding device.

62. The holding device according to claim 61, wherein the at least one through-hole is formed in at least one of the biasing member, the first member or the second member.

Images