Discharge actuator base for sterile testing

Abstract

An exemplary embodiment relates to an ejection actuator for a cassette used in sterility testing. The sterile cassette may have a spring-loaded ejection port that allows fluid to flow through a porous membrane. To activate the ejection port, upward pressure is applied to the spring via an actuator base during kit preparation. The actuator base can automatically activate the ejection port when the cassette is inserted into the actuator base and may be separate from or integrated with a thermoformed ejection tray. When the sterile cassette is removed from the tray, the base automatically closes the ejection port. The actuator base has the functions of maintaining rotational alignment between the tray and the cassette, activating the ejection port at the bottom of the cassette, minimizing outflow from the ejection port, minimizing fluid stagnation, providing rigid support across the entire surface of the ejection tray, and maintaining a locked state in the ejection tray when the cassette is removed.

Description

[[Technical Field]]

[0001] Cross-Reference to Related Applications This application claims the priority and benefit of U.S. Patent Application No. 18 / 464,066 filed on September 8, 2023, the entire content of which is incorporated herein by reference. [[Background Art]]

[0002] Sterility testing is an important process used to determine whether viable microorganisms are present in a product or sample. It is generally performed on pharmaceuticals, medical devices, and other sterile products to ensure their safety and efficacy.

[0003] Generally speaking, sterility testing may proceed as follows. First, a representative sample of the product or material to be tested may be obtained. Then a test method may be selected. Membrane filtration is typically the test method applied, as it offers advantages in terms of sensitivity, versatility, quantification, compatibility, sample recovery, validation, potential for automation, and time efficiency.

[0004] In membrane filtration, a sample is filtered through a membrane filter having a predefined pore size (typically 0.45 µm). This filter retains any microorganisms present in the sample, allowing them to be subsequently detected. The membrane filter may be provided in a suitable analysis container such as a sterile cassette provided by Rapid Micro Biosystems, Inc. of Lowell, Massachusetts. As the sample is filtered through the membrane filter, residual sample fluid that has passed through the membrane filter may be discharged from the drain port at the base of the cassette.

[0005] After filtration, the membrane filter is aseptically transferred to a suitable culture medium that promotes the growth of a wide range of microorganisms. The medium may be broth-based or agar-based, depending on the test method used. The inoculated medium is then incubated under suitable conditions, usually at a temperature of 20–40°C, for a specified period, often ranging from 2 to 14 days. This allows viable microorganisms to grow and form visible colonies.

[0006] After the incubation period, the culture medium is tested for the presence or absence of microbial growth. If visible colonies are present, it indicates a positive result, suggesting the presence of viable microorganisms and therefore a failure of the sterility test. On the other hand, if no visible growth is observed, it indicates a negative result, suggesting the absence of viable microorganisms and a successful sterility test. In the case of a positive result, additional tests such as Gram staining, biochemical tests, or molecular biological methods such as polymerase chain reaction (PCR) can be performed to identify the present microorganisms.

[0007] The results of the sterility test, including the test method, sample details, incubation conditions, and results, will be documented as part of the test record. [Overview of the Initiative]

[0008] An exemplary embodiment provides a sterile cassette having a spring-loaded outlet that allows fluid flow through a porous membrane. To activate the outlet, upward pressure is applied to the spring via an actuator base during kit preparation. The actuator base may be a plastic component that automatically activates the outlet when the cassette is inserted into the actuator base, and may be separate from or integrated with a thermoformed outlet tray. When the sterile cassette is removed from the tray, the spring action causes the base to automatically close the outlet. The actuator base may be injection-molded from a rigid thermoplastic resin (e.g., polycarbonate) that can withstand ethylene oxide (ETO) sterilization.

[0009] The actuator base is designed to interface the discharge tray with the discharge port in the sterile cassette. The actuator base has the functions of maintaining rotational alignment between the tray and the cassette, activating the discharge port at the bottom of the cassette, minimizing outflow from the discharge port, minimizing fluid stagnation, providing rigid support across the entire surface of the discharge tray, and maintaining a locked state in the discharge tray when the cassette is removed.

[0010] In one embodiment, the discharge actuator for a sterile cassette includes a discharge actuator base having a defined discharge outlet, and a discharge actuator provided at the discharge outlet and configured to interact with a discharge plunger base of a discharge plunger provided in the sterile cassette, wherein the discharge actuator is sized and shaped such that when the discharge plunger base interacts with the discharge actuator, it applies pressure to open the discharge plunger.

[0011] The discharge actuator may be substantially triangular in shape. In another embodiment, the discharge actuator has a flat surface for interacting with the discharge plunger base, and the flat surface is located between the rounded sides.

[0012] The discharge actuator may also include one or more alignment mechanisms of a size and shape that engage with a corresponding mechanism in the discharge tray to maintain rotational alignment between the discharge tray and the sterile cassette.

[0013] The discharge actuator base may include one or more ridges extending radially across the surface of the discharge actuator base. The discharge actuator may include an inner ridge around the discharge outlet. The discharge actuator may include an outer ridge provided on the outer circumference of the discharge actuator base.

[0014] The discharge actuator may also include one or more fasteners configured to secure the discharge actuator to the discharge tray.

[0015] Discharge actuators may be formed from thermoplastic resins, such as rigid thermoplastic resins. The thermoplastic resin can be selected from a group of thermoplastic resins capable of withstanding sterilization processes applied to sterile cassettes, such as ethylene oxide (ETO) sterilization.

[0016] In another embodiment, the sterility test kit includes a sterile cassette containing a discharge assembly and the discharge actuator described in claim 1. The discharge assembly may include a spring, a discharge plunger, and / or a sealing element. The kit may further include a discharge tray.

[0017] In another embodiment, a method for assembling a sterile kit includes inserting a sterile cassette into an actuator base, the insertion of which automatically opens the outlet of the sterile cassette; injecting a sample into the sterile cassette, the sample being filtered through a membrane; and removing the sterile cassette from the actuator base, the removal of which automatically closes the outlet of the sterile cassette.

[0018] This method may also include sterilization of the discharge actuator using methods such as ethylene oxide sterilization, hydrogen peroxide gas (VHP) sterilization, chlorine dioxide (ClO2) sterilization, nitrogen dioxide (NO2) sterilization, X-ray sterilization, and gamma ray sterilization.

[0019] This method may also include assembling the discharge port into the base assembly of the sterile cassette.

[0020] The actuator base may be integral with the discharge tray, or may be attached to the discharge tray. By removing the sterile cassette from the actuator base, the actuator base may remain attached to the discharge tray.

[0021] Other technical features will be readily apparent to those skilled in the art from the following drawings, the description, and the claims.

[0022] To facilitate easy identification of a discussion of any particular element or operation, the most significant digit or digits in a reference number refer to the figure number in which the element is first introduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] [Figure 1] FIG. 1 is a diagram illustrating an exemplary cassette assembly according to one embodiment. [Figure 2] FIG. 2 is an enlarged view of a portion of a cross-section of a cassette assembly according to one embodiment. [Figure 3] FIG. 3 is a diagram illustrating an exemplary base assembly for a sterile cassette including a discharge assembly according to one embodiment. [Figure 4] FIG. 4 is an enlarged view of a portion of a cross-section of a base assembly according to one embodiment. [Figure 5A] FIG. 5 is a cross-sectional view of an actuator base interfacing with a base assembly and a discharge outlet, when in an open position, according to one embodiment. [Figure 5B] FIG. 6 is a perspective view of a base assembly according to one embodiment. [Figure 5C] FIG. 7 is a cross-sectional view of an actuator base interfacing with a base assembly and a discharge outlet, when in a closed position, according to one embodiment. [Figure 6] FIG. 8 is a perspective view of an alternative base assembly design according to one embodiment. [Figure 7] FIG. 9 is a diagram illustrating an exemplary base assembly fixed to a discharge tray according to one embodiment. [Figure 8]FIG. 7 is a diagram showing an assembled cassette attached to the base assembly and discharge tray according to one embodiment. [Figure 9] FIG. is a flowchart illustrating an exemplary procedure for using a discharge actuator with a sterility test kit according to one embodiment. MODE FOR CARRYING OUT THE INVENTION

[0024] As described above, during the filtration process, residual sample fluid may be discharged through the discharge port at the base of the cassette. Conventional systems often employ manual discharge ports such as plug-type or flip-out type discharge ports. Since such discharge outlets require manual actuation, they increase the labor required to perform a sterility test, reduce the possibility of automation, and increase the time required to perform the analysis.

[0025] Conventional discharge outlets also have the problem of back pressure. In the context of a filtration process, back pressure often occurs when fluid passes through a filter medium. As the fluid flows through the filter, resistance to the flow is created by the presence of the filter medium, particularly when the filter medium is fine or dense. This resistance generates a pressure opposing the flow.

[0026] High back pressure in a filtration system can lead to several undesirable effects. It can reduce the flow rate of fluid through the filter, affecting the overall filtration efficiency and throughput. Furthermore, high back pressure increases the pressure loss of the entire system, which can affect the integrity or service life of the filter medium itself. Therefore, managing back pressure is extremely important in a fluid system to ensure optimal operation and prevent adverse effects.

[0027] Furthermore, conventional discharge ports may experience fluid retention problems. If fluid remains in the cassette after filtration, it may lead to inaccurate measurement results. Due to the shape and configuration of conventional discharge ports, it can be extremely difficult to completely remove all fluid that has passed through the membrane during filtration from the bottom of the cassette.

[0028] Therefore, an improved discharge system for cassettes is beneficial to improve processing capacity and accuracy in sterility testing.

[0029] Figure 1 shows an example of a cassette assembly 100, and Figure 2 shows a side cross-sectional view thereof. The cassette assembly 100 can provide a sterile environment for testing. Depending on the application, the cassette assembly 100 can provide an anaerobic or aerobic environment.

[0030] From top to bottom in Figure 1, the exemplary cassette assembly 100 includes a lid 102, an O-ring 104, an optional foil cutter 108, a scavenging tray assembly 110, an intermediate assembly 112, a membrane filter 122, a second O-ring 114, and a base assembly 116.

[0031] The base assembly 116 forms the bottom of the cassette assembly 100 and serves as a support structure to which other components can be attached. The base assembly 116 can be sized and shaped to fit into a suitable test or analyzer.

[0032] The membrane filter 122 can be provided on the base assembly, between the base assembly 116 and the intermediate assembly 112. The membrane filter 122 may also be part of a media pad, sized and shaped to fit into a corresponding recess in the base assembly 116. The membrane filter 122 can be any suitable filter and may have properties (such as desired porosity) selected based on a specific application (e.g., the size of the target microorganisms intended to be captured by the membrane filter 122). In some embodiments, two or more membrane filters 122 may be provided, which may include several different types of membrane filters 122.

[0033] The target fluid to be analyzed can pass through the membrane filter 122 and flow into the base assembly 116. The base assembly 116 may include a discharge port 120 that allows the fluid to be removed from the cassette assembly 100 after filtration. The discharge port 120 may include an opening in a portion of the base assembly 116 located inside the cassette assembly 100, which connects to a specially shaped outlet on the outside of the cassette assembly 100. This outlet may be sized and shaped to fit with a discharge manifold that receives the removed fluid and sends it to a suitable disposal site.

[0034] An O-ring 114 can be provided between the base assembly 116 and the intermediate assembly 112 to prevent fluid from leaking around the membrane filter 122 and thereby bypassing it. The intermediate assembly 112 includes an intermediate inlet 118 that allows the target fluid being analyzed to be introduced into the cassette assembly 100. The intermediate inlet 118 includes an opening provided in a portion of the intermediate assembly 112 located inside the cassette assembly 100, which connects to an opening on the outside of the cassette assembly 100. Inside the intermediate inlet 118, there may be a structure such as a rubber partition that seals the cassette assembly 100. To introduce the target fluid into the cassette assembly 100, a needle can be used to puncture the structure of the intermediate inlet 118 and supply the fluid at a relatively high pressure.

[0035] In some embodiments, the intermediate assembly 112 may include two or more intermediate inlets 118. For example, an intermediate inlet 118 may be provided to introduce a first sample (target fluid to be analyzed) into the cassette assembly 100, and a second intermediate inlet 118 may be provided to introduce a second different sample. In other embodiments, a first intermediate inlet 118 may be provided to introduce a sample, and a second intermediate inlet 118 may be provided to introduce a culture medium.

[0036] The upper part of the intermediate assembly 112 may be shaped to accommodate a scavenging tray assembly 110, which may contain scavenging material that absorbs oxygen within the cassette assembly 100 (for example). The scavenging tray assembly 110 may be covered on top with foil, which holds the scavenging material in place and protects it from the outside air until the scavenging tray assembly 110 is placed inside the cassette assembly 100. To release the scavenging material, the cassette assembly 100 may be provided with a foil cutter 108, which is designed to penetrate the foil and allow the scavenging material to scavenge the environment inside the sealed cassette assembly 100.

[0037] To seal the cassette assembly 100, an O-ring 104 can be placed on top of the intermediate assembly 112, and then the entire assembly can be covered with a lid 102. As shown in Figure 2, the O-ring 104 forms a seal between the intermediate assembly 112 and the lid 102, preventing fluid from leaking from the top of the cassette assembly 100 (and also sealing the inside of the cassette assembly 100, allowing the scavenging material to scavenge an oxygen-containing environment).

[0038] As further shown in Figure 2, the intermediate assembly 112 may include an intermediate assembly floor 202 that extends radially from the inner circumferential wall 204 of the intermediate assembly 112 toward the interior of the cassette assembly 100. The intermediate assembly floor 202 may be inclined toward the membrane filter 122 to facilitate the flow of fluid toward the membrane filter 122.

[0039] While the exemplary embodiments are described with reference to the illustrated cassette assembly configurations for illustrative purposes, those skilled in the art will understand that other types of cassette assemblies (with more, fewer, or different configurations of parts) or other sterile environments may also be used. Furthermore, while the exemplary embodiments describe sterility testing using membrane filtration (the structures in Figures 1 and 2 are configured accordingly), other applications of the splash guard described below will also become readily apparent.

[0040] Note that Figures 1 and 2 show the discharge port 120 located on the side of the base assembly 116. While this configuration can be used in the embodiments described herein, in the embodiments described below, the discharge port 120 is instead moved to the bottom center of the base assembly 116, which may allow for better discharge.

[0041] For example, Figure 3 shows an exemplary base assembly 116 on which a discharge assembly is mounted. This discharge assembly includes a discharge plunger 302, a spring 306, a sealing element 308, a discharge support 310, and one or more fasteners 312. These elements are shown in cross-sectional view in Figure 4.

[0042] Note that directions such as “upward” and “downward” are mentioned in the descriptions of these and subsequent drawings. Generally, “downward” corresponds to the direction of gravity, as fluid is usually discharged in this direction. However, in some situations, fluid may flow out of the discharge port in a direction different from the direction of gravity, in which case the direction from which the fluid is discharged may be considered “downward,” and the opposite direction may be considered “upward.” Further directions include the longitudinal direction, which refers to the direction extending along the axis that passes through the center of the base assembly 116 in the direction in which the sterile cassette is assembled. The radial direction is the direction extending outward from this central axis, radially from the center point.

[0043] The discharge plunger 302 is a component configured to fit over and / or extend into the discharge port 314 of the base assembly, preventing fluid from flowing through the discharge port 314 of the base assembly when the discharge plunger 302 is in the closed position. The bottom surface of the discharge plunger 302 forms a discharge plunger base 402 configured to interact with the discharge actuator 504, as will be described in more detail in relation to Figure 5A.

[0044] The discharge plunger 302 includes a circumferential discharge plunger flange 404. The discharge plunger flange 404 is configured and positioned on the discharge plunger 302 to interact with the sealing element 308. When in the closed position, the discharge plunger flange 404 is pressed against the sealing element 308, thereby sealing the base assembly 116 and preventing fluid from flowing out of the discharge port 314 of the base assembly.

[0045] Optionally, the discharge plunger 302 may include a tapered side 406 near the discharge plunger base 402. In this region, the side of the discharge plunger 302 is tapered and therefore narrower than the rest of the body of the discharge plunger 302. Thus, when the discharge plunger 302 is lifted upward by a certain distance d (which may substantially correspond to the length of the tapered side 406), the tapered side 406 creates a gap between the wall of the base assembly 116 and the discharge plunger 302. This allows the discharged fluid to pass between the discharge plunger flange 404 and the sealing element 308 and from there over the tapered side 406 and out through the base assembly discharge port 314. Alternatively or in addition, the tapered side 406 can serve to guide the discharge plunger 302 back into the base assembly discharge port 314 when it closes.

[0046] The spring 306 biases the discharge plunger 302 to the closed position. To open the discharge port, upward pressure can be applied to the discharge plunger base 402 to press the discharge plunger 302 against the spring 306, causing the plunger to be pulled out through the opening in the base assembly 116 that forms the base assembly discharge port 314.

[0047] The sealing element 308 may be any element capable of sealing the base assembly discharge port 314 against fluid ingress. For example, the sealing element 308 may be an O-ring.

[0048] The discharge support section 310 is a component configured to support the discharge plunger 302 and to hold the discharge plunger 302 and spring 306 to the base assembly 116. The discharge support section 310 is provided with a discharge opening 304 through which a fluid, such as a filtered sample, may pass. The discharge support section 310 may further include an opening for a fastener 312, which allows the discharge support section 310 to be fixed to the base assembly 116.

[0049] Referring to Figures 5A to 5C, the base assembly 116 can be positioned on the actuator base 502. In practice, the actuator base 502 may be part of the discharge tray or attached to the discharge tray (the discharge tray will be described in more detail in relation to Figure 7). The discharge tray and / or the actuator base 502 may include an interlock mechanism that allows the discharge tray and the actuator base 502 to be temporarily locked together when the actuator base 502 is positioned on the discharge tray. When the base assembly 116 is connected to the actuator base 502, the discharge actuator 504 on the actuator base 502 presses against the discharge plunger base 402 of the discharge plunger 302, thereby causing the discharge plunger 302 to press against the spring 306 and open. This occurs automatically when the base assembly 116 is pressed against the actuator base 502.

[0050] In this example, the discharge actuator 504 is substantially triangular in shape. The sides of the discharge actuator 504 may have one or more inclinations, and in this example, the discharge actuator 504 is inclined to a flat top surface 516 that contacts the discharge plunger base 402. Because the sides are inclined, only the top surface 516 contacts the discharge plunger base 402, and there is sufficient space between the discharge plunger base 402 and the inclined side of the discharge actuator 504 to allow the fluid to flow out of the outlet without obstruction. The discharge actuator 504 can also take on different shapes, for example, it may have a tapered tip or a rounded top surface 516. For example, Figure 6 shows an example where the discharge actuator 504 is a crossbar with a flat top surface and rounded sides. The flat top surface engages with the discharge plunger base 402 and pushes it upward, while the rounded sides provide a setback from the base assembly 116, thereby allowing the fluid to flow out of the outlet.

[0051] Returning to Figure 5A, the base assembly 116 rests on the inner ridge 506 of the actuator base 502. Inside the inner ridge 506 is an outlet 508 that penetrates the actuator base 502, allowing fluid to flow from the base assembly 116 through the actuator base 502 to the discharge tray.

[0052] The shape of the discharge actuator 504 in Figures 5A and 6 minimizes contact between the actuator base 502 and the base assembly 116, allowing the discharge port to be operated. As a result, the fluid flow is less obstructed than usual, improving discharge (and thus reducing back pressure and fluid stagnation within the base assembly 116).

[0053] In addition to acting as a actuator for the discharge plunger 302, the discharge actuator 504 also acts as a rigid support, which is particularly useful when the actuator base 502 is relatively thin and flexible (or when the actuator base 502 is part of a discharge tray, which is conventionally a fragile structure). This provides the additional benefit of adding rigidity to the actuator base 502 (and / or discharge tray), preventing the base assembly 116 from buckling when pressed against the discharge actuator 504.

[0054] As shown in Figures 5B and 6, the actuator base 502 includes one or more ridges 510, which also contribute to the stability and rigidity of the actuator base 502. The base assembly 116 may also rest on the outer peripheral ridges 512, which provides an additional contact point between the actuator base 502 and the base assembly 116 away from the outlet area, thereby preventing obstruction of the flow through the outlet. The outer peripheral ridges 512 also serve to reinforce the actuator base 502, providing it with further stability and rigidity.

[0055] Furthermore, the actuator base 502 may be provided with one or more alignment mechanisms 514. These notches formed on the outer circumference of the actuator base 502 are sized and configured to engage with corresponding mechanisms in the discharge tray (see, for example, Figure 7). In this way, it is possible to prevent the actuator base 502 (and therefore the base assembly 116) from rotating when pressure is applied to the discharge plunger 302. This allows for rotational alignment between the sterile cassette and the discharge tray, which can be important when attempting to align the injection port of the sterile cassette so that a sample can be introduced into the cassette.

[0056] Figure 5A shows the discharge plunger 302 in the closed position with the base assembly 116 positioned on the actuator base 502. As shown in Figure 5C, when the base assembly 116 is removed from the actuator base 502, the spring 306 pushes the discharge plunger 302, closing the discharge outlet 508.

[0057] Figures 7 and 8 show an exemplary discharge tray 702 with an alternative actuator design fixed in place.

[0058] In sterility testing, the discharge tray 702 refers to a specially designed tray or container used to collect and contain excess sterilizer or culture medium during the testing process. Since sterility testing is performed to determine whether or not viable microorganisms are present in a sample or product, the discharge tray 702 helps prevent cross-contamination and facilitates the safe disposal of the sterilizer or culture medium after the test is complete.

[0059] During sterility testing, test samples are often placed in containers such as vials, ampoules, syringes, or the sterile cassettes mentioned above. These containers may be filled with sterilizing agents or culture media to support microbial growth if microorganisms are present in the sample. Any excess sterilizing agent or culture media not absorbed by the test sample must be drained to prevent dilution or interference with the test results.

[0060] The discharge tray 702 is typically placed beneath the test sample to collect excess liquid, ensuring that it does not come into contact with other samples or contaminate the test area. The discharge tray 702 may have an inclined or perforated surface to facilitate drainage and prevent liquid accumulation. This tray is often made of a material compatible with the sterilizer or culture medium used in the test process.

[0061] Once the test is complete, the discharge tray 702 can be easily removed, and the sterilizer or culture medium can be disposed of according to the established plan and safety guidelines. The use of the discharge tray 702 helps maintain the integrity and accuracy of the test results while ensuring proper containment and disposal of potentially contaminating materials.

[0062] In this example, the actuator is represented by a relatively simple design comprising a discharge actuator 504 in the shape of a post with a tapered top, and two actuator support arms 704 connected thereto. The discharge actuator 504 engages with the discharge plunger 302 as described above. The actuator support arms 704 serve as rigid supports for the discharge actuator 504 and are connected to the actuator support arms 704 via actuator fasteners 706. Examples of actuator fasteners 706 include screws, mating tabs, adhesives, and the like. Alternatively or in addition, the actuator base 502, including the discharge actuator 504 and the actuator support arms 704, may simply be integrated with 704.

[0063] In this example, the discharge tray opening 708 allows the fluid to pass through the discharge tray 702 and potentially flow into a secondary recovery area. The discharge tray opening 708 is optional; instead, the fluid may flow into the discharge tray 702 itself, allowing the fluid to be discarded or reused from the discharge tray 702 and the discharge tray 702 to be cleaned.

[0064] As described above, the discharge tray 702 includes a tray alignment mechanism 710 that corresponds to the size, shape, and position of the alignment mechanism 514 on the actuator base 502. These fitting mechanisms can fix the actuator base 502 and / or base assembly 116 so as not to rotate while the discharge actuator 504 is engaged with the discharge plunger 302.

[0065] Figure 7 is shown as a specific actuator design, but some features of Figure 7 are generalizable to other actuator designs. For example, the actuator fastener 706 may be provided on the actuator base 502 shown in Figure 5B, allowing the actuator base 502 to be fixed to the discharge tray 702. The actuator fastener 706 may be provided on the top of the actuator base 502 (so that the actuator base 502 is fixed to the discharge tray 702 from below) or on the bottom of the actuator base 502 (so that the actuator base 502 is fixed to the discharge tray 702 from above).

[0066] Figure 9 shows an example of how the actuator base 502 is used with a sterile cassette as part of a sterile kit. This example shows a specific sequence of operations, but the order can be changed without departing from the scope of this disclosure. For example, some of the operations shown may be performed in parallel or in a different order that does not substantially affect the functionality of the routine. In other examples, different components of an example device or system implementing this routine may perform functions substantially simultaneously or in a specific order.

[0067] Some or all of the steps described below may be performed automatically by a suitable sterile kit assembly device, such as a robotic system capable of manipulating the sterile cassette and automatically introducing the sample fluid into the sterile cassette.

[0068] This method can be initiated in block 902 when the sterility testing process is started. In block 904, the sterile cassette including the base assembly 116 can be accessed, and the discharge port can be assembled to the base assembly 116. In some embodiments, the discharge assembly may already be attached to the base assembly 116 before the sterility process is started (for example, it may be attached by the manufacturer or a third party, or it may be integrated with the base assembly 116). As one example, the user can place the sealing element 308 into the base assembly discharge port 314, and then place the spring 306 and discharge plunger 302 into the central opening of the sealing element 308. The discharge support 310 can be lowered over the spring 306 and discharge plunger 302, and the discharge support 310 can be fixed to the base assembly 116 by applying the fastener 312.

[0069] In block 906, the remaining parts of the sterile cassette can be assembled. This may include (depending on the specific structure of the particular cassette used) placing the membrane support 106 on the base assembly 116, adding a suitable membrane filter 122 on top of the membrane support 106, fitting the intermediate assembly 112 onto the base assembly 116 over the membrane filter 122 and the membrane support 106, optionally placing the scavenging tray assembly 110 and / or foil cutter 108 in a suitable recess of the intermediate assembly 112, adding an O-ring 104 to the intermediate assembly 112, and covering the top of the assembly with a lid 102.

[0070] In block 908, the assembled cassette can be inserted into the discharge tray 702. The discharge tray may include an integrated actuator base 502, or optionally, the actuator base 502 may be placed on or attached to the discharge tray 702 before the assembled cassette is inserted. When the cassette is inserted into the discharge tray, the discharge actuator 504 contacts the discharge plunger base 402, pressing the spring 306 to cause the discharge plunger 302 to open automatically.

[0071] In block 910, with the discharge plunger open, a sample can be injected (for example, through the intermediate inlet 118). The sample can be filtered through the membrane filter 122, and any residual fluid not retained by the membrane filter 122 can flow to the bottom of the base assembly 116, pass through the discharge opening 304, around the discharge plunger 302, and flow out through the discharge opening 304 and the discharge outlet 508 to the discharge tray (or secondary recovery area).

[0072] In block 912, the culture medium can be injected into the lower chamber of the base assembly 116 (for example, below the membrane filter 122). Excess culture medium can be removed through the outlet 508 in the same manner as the sample solution.

[0073] After the sample has been filtered through the membrane and any other desired fluid (e.g., rinse solution) has been filtered and discharged, the cassette can be removed from the discharge tray 702 (and accordingly from the actuator base 502) in block 914. Once the cassette is removed, the discharge plunger base 402 is pulled away from the discharge actuator 504 until the discharge actuator 504 is no longer in contact with the discharge plunger base 402. Due to the action of the spring 306, the discharge plunger 302 automatically closes, sealing the inside of the sterile cassette.

[0074] Subsequently, in block 916, a sterility test can be performed on the sealed cassette, and then the method is completed in block 918.

[0075] In some embodiments, the expression "one embodiment" or its derivatives may be used to describe them. These terms mean that a particular feature, structure, or characteristic described in relation to that embodiment is included in at least one embodiment. The expression "in one embodiment" appearing in various parts of this specification does not necessarily refer to the same embodiment. Furthermore, unless otherwise stated, the features described above are understood to be usable together in any combination. Thus, features considered individually can be used together in combination unless explicitly stated to be contradictory.

[0076] In some embodiments, the terms “joined” and “connected,” and their derivatives, may be used to describe the configuration. These terms may indicate that two or more elements are in direct physical or electrical contact with one another. However, they may also mean that two or more elements are not in direct contact with one another but still cooperate or interact with one another.

[0077] It is emphasized that this summary of the disclosure is provided to enable readers to quickly grasp the nature of the technical disclosure. This summary is submitted on the premise that it will not be used to interpret or limit the scope or meaning of the claims. In addition, as can be seen in the detailed description above, various features have been grouped into a single embodiment for the purpose of brevity of the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed embodiment requires features beyond those explicitly stated in each claim. Rather, as reflected in the following claims, the subject matter of the invention lies in some, but not all, of the features of the single embodiment disclosed. Thus, the following claims are incorporated into “Modes for Carrying Out the Invention,” and each claim stands alone as a separate embodiment. In the attached claims, the terms “including” and “in which” are used as plain English synonyms for “comprising” and “wherein,” respectively. Furthermore, terms such as "first," "second," and "third" are used merely as labels and are not intended to impose numerical requirements on those items.

[0078] The foregoing includes examples of disclosed architectures. Naturally, it is impossible to describe all possible combinations of components and / or methods, but those skilled in the art will recognize that many further combinations and substitutions are possible. Therefore, novel architectures are intended to encompass all such modifications, changes, and variations that fall within the spirit and scope of the attached claims.

Claims

1. An ejection actuator for sterile cassettes, An exhaust actuator base with a defined exhaust outlet, A discharge actuator provided at the discharge outlet and configured to interact with the discharge plunger base of a discharge plunger provided in the sterile cassette, wherein the discharge actuator has a size and shape such that when the discharge plunger base interacts with the discharge actuator, it applies pressure to the discharge plunger to open. An ejection actuator for sterile cassettes, equipped with the above features.

2. The discharge actuator according to claim 1, wherein the discharge actuator has a substantially triangular shape.

3. The discharge actuator according to claim 1, wherein the discharge actuator has a flat surface for interacting with the discharge plunger base, and the flat surface is provided between rounded sides.

4. The discharge actuator according to claim 1, further comprising one or more alignment mechanisms having a size and shape that engage with a corresponding mechanism of the discharge tray to maintain rotational alignment between the discharge tray and the sterile cassette.

5. The discharge actuator according to claim 1, wherein the discharge actuator base comprises one or more ridges extending radially across the surface of the discharge actuator base.

6. The discharge actuator according to claim 1, further comprising an inner circumferential ridge around the discharge outlet.

7. The discharge actuator according to claim 1, further comprising an outer peripheral ridge provided on the outer circumference of the discharge actuator base.

8. The discharge actuator according to claim 1, further comprising one or more fasteners configured to fix the discharge actuator to a discharge tray.

9. The discharge actuator according to claim 1, wherein the discharge actuator is formed from a thermoplastic resin.

10. A sterile cassette equipped with an ejection assembly, The discharge actuator according to claim 1 and A sterile testing kit equipped with the necessary components.

11. The kit according to claim 10, wherein the discharge assembly comprises a spring.

12. The kit according to claim 10, wherein the discharge assembly comprises the discharge plunger.

13. The kit according to claim 10, further comprising a sealing element in the discharge assembly.

14. The kit according to claim 10, further comprising an discharge tray.

15. This is a method for assembling a sterile kit. Inserting a sterile cassette into an actuator base, wherein the outlet of the sterile cassette automatically opens upon insertion. The process involves injecting the sample into the sterile cassette, wherein the sample is filtered through a membrane. The removal of the sterile cassette from the actuator base, wherein the discharge port of the sterile cassette automatically closes upon removal. How to assemble a sterile kit, including [specific components / features].

16. The method according to claim 15, further comprising sterilizing the discharge actuator.

17. The method according to claim 15, further comprising assembling the discharge port to the base assembly of the sterile cassette.

18. The method according to claim 15, wherein the actuator base is integrated with the discharge tray.

19. The method according to claim 15, further comprising attaching the actuator base to the discharge tray.

20. The method according to claim 19, wherein the actuator base remains attached to the discharge tray by removing the sterile cassette from the actuator base.

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