Splash shield and cartridge assembly for sterility testing

Abstract

Membrane filtration is a technique for performing a sterility test on a product in which a sample is introduced through an inlet port to a sterile environment, such as a cartridge, and then through one or more filters. The sample may be pumped into the cartridge at a relatively high pressure, which may cause the sample to spray, fog, or blister. When the sample is sprayed in this manner, it will result in inconsistent results and will obscure the field of view through the cassette, which makes it difficult to analyze the incubated media. Exemplary embodiments provide a unique splash shield sized and shaped to transition incoming sample fluid from a high pressure state to a low pressure flow. Thus, the fluid flows more smoothly into the cartridge, which results in more consistent and accurate results.

Description

[0001] Related Applications

[0002] This application claims the priority and benefit of U.S. Patent Application No. 18 / 065,247, filed on December 13, 2022, the entire content of which is incorporated herein by reference in its entirety. Background Art

[0003] In some cases, especially when developing products for human consumption, it may be necessary or desirable to test the products to determine the presence of contaminating microorganisms. One technique for testing such products involves membrane filtration. In membrane filtration, a sterile environment (such as a specially designed cartridge) is prepared. A sample is introduced into the environment and filtered through one or more membrane filters. Filters with appropriate pore sizes can be selected such that the microorganisms of interest are retained on the filters. An appropriate growth medium is transferred to the filters, and the microorganisms are incubated on the growth medium for a suitable period of time (e.g., 14 days). After this period of time has passed, the growth medium is analyzed to determine the presence of the microorganisms of interest. Summary of the Invention

[0004] In one aspect, a device includes a cartridge assembly that includes: one or more inlets configured to receive one or more fluids at a first pressure; a membrane filter; and an outlet configured to release the one or more fluids from the cartridge assembly after the one or more fluids have passed through the membrane filter; and a splashguard configured to block the fluid flow between the inlet and the membrane filter.

[0005] The splashguard may be configured to reduce the pressure of the one or more fluids from the first pressure to a second pressure that is lower than the first pressure. For example, the splashguard may redirect the one or more fluids entering the inlet in the radial direction of the cartridge to the circumferential direction of the cartridge. The splashguard may include grooves configured to change the flow direction of the one or more fluids. The splashguard may include a cover extending between the inlet and the lid.

[0006] The splashguard may be provided between the lid and the middle body assembly. In some embodiments, the splashguard may be provided on a foil cutter configured to be disposed between the lid and the middle body assembly.

[0007] The cartridge assembly may include a lid, a middle body assembly including the inlet, and a base assembly including the outlet.

[0008] The splashguard may include through-holes configured to receive fasteners to attach the splashguard to the cartridge assembly. The fasteners may be built into the cartridge assembly. The splashguard and the cartridge assembly may include mating alignment elements.

[0009] A method for deploying a cartridge assembly and a splash shield may include assembling the cartridge assembly and the splash shield, inserting a fluid delivery device into an inlet, and delivering fluid to the inlet, wherein the fluid is redirected by the splash shield.

[0010] For example, the inlet may include a septum, and inserting the fluid delivery device into the inlet may include piercing a rubber septum with a needle. Delivering fluid to the inlet may include delivering fluid through the needle.

[0011] Assembling the cartridge assembly and the splash shield may include inserting one or more fasteners attached to the cartridge assembly into one or more through-holes of the splash shield.

[0012] Assembling the cartridge assembly and the splash shield may include aligning the splash shield with the cartridge assembly using one or more mating alignment elements provided on the cartridge assembly and the splash shield.

[0013] The method may further include using the splash shield to reduce the pressure of the fluid between the inlet and a membrane.

[0014] The cartridge assembly may include a lid, a middle body assembly including an inlet, and a base assembly including an outlet. Assembling the cartridge assembly may include: placing the middle body assembly on the base assembly, attaching the splash shield above the middle body assembly, and placing the lid on the splash shield and the middle body assembly. Other embodiments may have an inlet and an outlet in the middle body assembly, may have an inlet and an outlet in the base, or may have separate inlets and outlets for the middle body assembly and the base.

[0015] Alternatively or additionally, a foil cutter may be provided on the middle body assembly, wherein the splash shield is attached to the foil cutter.

[0016] The method may further include providing a seal (e.g., an O-ring, ultrasonic welding, heat fusion, an adhesive, bonding, etc.) between the middle body assembly and the base assembly, and / or providing an O-ring between the middle body assembly and the lid.

[0017] Other technical features will be readily apparent to those skilled in the art from the following drawings, description, and claims. Description of the Drawings

[0018] To easily identify the discussion of any particular element or action, the most significant digit or digits in the reference numerals refer to the figure number in which the element was first introduced.

[0019] Figure 1 An exemplary cartridge assembly according to one embodiment is shown.

[0020] Figure 2 is a close-up of a portion of a cross-sectional view of a cartridge assembly according to one embodiment.

[0021] Figure 3A Depicts an exemplary splash guard attached to a cartridge assembly according to one embodiment.

[0022] Figure 3B Is a bottom view of an exemplary splash guard according to one embodiment.

[0023] Figure 4 Is a top cross-sectional view showing fluid delivery through the splash guard according to one embodiment.

[0024] Figure 5 Is a flow chart depicting an exemplary method for deploying a cartridge assembly with a splash guard according to one embodiment. Detailed Description

[0025] In membrane filtration technology, a sample can be introduced into a cartridge through an inlet port. The inlet port can include a rubber septum that can be penetrated by a needle. The sample can be pumped into the cartridge through the needle. This results in a relatively high-pressure stream being supplied to the cartridge, which can cause the sample to splash, fog, or foam. When the sample splashes in this manner, it can cause inconsistent results and can obscure the view through the cartridge lid, making it difficult to analyze the incubated media.

[0026] The exemplary embodiments described herein provide a unique splash guard that is customized in size and shape to transition the incoming sample fluid from a high-pressure state to a low-pressure stream. As a result, the fluid flows more smoothly into the cartridge, which produces more consistent and accurate results.

[0027] Figure 1 Shows an example of a cartridge assembly 100, and Figure 2 Shows a cross-sectional side view. The cartridge assembly 100 can provide a sterile environment for testing. Depending on the application, the cartridge assembly 100 can provide an anaerobic or aerobic environment. Note that, for ease of discussion, the splash guard described in more detail below is omitted in Figure 1 and Figure 2 but can be deployed in the positions (or other suitable positions, such as attached to a middle body assembly or a base) mentioned in connection with the subsequent figures.

[0028] In Figure 1 from top to bottom, the exemplary cartridge assembly 100 includes a lid 102, an O-ring 104, an optional foil cutter 106, a purge tray assembly 108, a middle body assembly 110, a membrane filter 120, a second seal 112, and a base assembly 114.

[0029] The base assembly 114 forms the bottommost component of the cartridge assembly 100 and serves as a support structure to which the other components can be mounted. The base assembly 114 can be customized in size and shape to be accommodated in a suitable testing or analysis device.

[0030] The membrane filter 120 may be provided between the base assembly 114 and the middle body assembly 110. The membrane filter 120 may be part of a media pad that is custom-sized and shaped to be received by a corresponding recess in the base assembly 114. The membrane filter 120 may be any suitable filter and may have properties (such as a desired porosity) selected based on the specific application (e.g., the size of the microorganisms of interest expected to be captured by the membrane filter 120). In some embodiments, more than one membrane filter 120 may be provided, which may include multiple different types of membrane filters 120.

[0031] The target fluid for analysis may pass through the membrane filter 120 and into the base assembly 114. The base assembly 114 may include a discharge port 118 that allows the fluid to be removed from the cartridge assembly 100 after filtration. The discharge port 118 may include an opening provided in the portion of the base assembly 114 that is inside the cartridge assembly 100, which is connected to a specially shaped outlet on the outside of the cartridge assembly 100. The outlet may be custom-sized and shaped to mate with a discharge manifold that receives the removed fluid and conveys it to an appropriate processing location.

[0032] A seal 112 may be provided between the base assembly 114 and the middle body assembly 110 to prevent fluid from leaking around and thus bypassing the membrane filter 120. The middle body assembly 110 includes a middle body inlet 116 that allows the target fluid (or fluids) to be analyzed to be introduced into the cartridge assembly 100. The middle body inlet 116 may include an opening provided in the portion of the middle body assembly 110 that is inside the cartridge assembly 100, which is connected to an opening on the outside of the cartridge assembly 100. Inside the middle body inlet 116 may be a structure, such as a rubber diaphragm, that seals the cartridge assembly 100. To introduce the target fluid into the cartridge assembly 100, a needle may be used to pierce the structure in the middle body inlet 116 and convey the fluid at a relatively high pressure (but the exemplary embodiments are also compatible with low-pressure fluid flow).

[0033] In some embodiments, more than one middle body inlet 116 may be included in the middle body assembly 110. For example, one middle body inlet 116 may be provided for introducing a first sample (the target fluid of interest for analysis) into the cartridge assembly 100, while a second middle body inlet 116 may be provided for introducing a different second sample. In other embodiments, a first middle body inlet 116 may be provided for introducing a sample, while a second middle body inlet 116 may be provided for introducing a growth medium.

[0034] The top of the central body assembly 110 may be customized in shape to accommodate the environmental conditioning tray 108, which may include, for example, scavenging materials (such as O2 scavengers, desiccants, moisture beads, etc.) that absorb oxygen in the cassette assembly 100. The scavenging tray assembly 108 may be capped with a foil that holds the scavenging materials in place and protects them from external air until the scavenging tray assembly 108 is deployed in the cassette assembly 100. To release the scavenging materials, the cassette assembly 100 may be provided with a foil cutter 106, which is designed to penetrate the foil and allow the scavenging materials to condition the environment within the sealed cassette assembly 100.

[0035] To seal the cassette assembly 100, an O-ring 104 may be placed on top of the central body assembly 110, and then the entire assembly may be covered with a lid 102. As Figure 2 shown, the O-ring 104 forms a seal between the central body assembly 110 and the lid 102 and prevents fluid from leaking from the top of the cassette assembly 100 (and seals the interior of the cassette assembly 100 to allow the scavenging materials to scavenge oxygen from the environment).

[0036] As Figure 2 further shown, the central body assembly 110 may include a central body assembly base plate 202 that extends radially inward from the inner circumferential wall 204 of the central body assembly 110 toward the interior of the cassette assembly 100. The central body assembly base plate 202 may be inclined toward the membrane filter 120 to facilitate fluid flow toward the membrane filter 120.

[0037] Although, for illustrative purposes, the exemplary embodiments have been described with reference to the depicted cassette assembly configurations, those skilled in the art will recognize that other types of cassette assemblies (with more, fewer, or different component configurations) or other sterile environments may also be used. Additionally, although the exemplary embodiments have been described in the context of testing microbial samples using membrane filtration (and Figure 1 and Figure 2 the structures in

[0038] In Figure 3A and Figure 3B are constructed accordingly), other applications of the splash guard described below will be readily apparent.

[0039] The splash guard 304 has a length that extends circumferentially about the central body assembly 110, a height that extends axially of the cartridge assembly 100, and a width that extends radially of the cartridge assembly 100. The length and / or width of the splash guard 304 can depend on the length and configuration of the fluid conduit or recess 310 that is used to divert fluid from the central body inlet 116 into the interior of the cartridge assembly 100 (see Figure 3B ). For example, if fluid is introduced into the cartridge assembly 100 at a first high pressure, a first length of recess 310 can be used, where the first length is calculated to reduce the high pressure to a suitable low target pressure. On the other hand, if fluid is introduced into the cartridge assembly 100 at a second high pressure that is higher than the first high pressure, a longer, wider, or differently configured recess 310 may be required to reduce the fluid to the low target pressure. This may require a longer and / or wider splash guard 304. Some embodiments also or alternatively can utilize the internal geometry of the central body assembly as part or all of the fluid path.

[0040] As Figure 3B shown, the recess 310 begins at an inlet 306 of the splash guard 304, which is configured to receive fluid from the central body inlet 116 (and is thus configured to be aligned with the central body inlet 116). After the recess 310 diverts the fluid flow around a bend (about 90 degrees in this embodiment, but other angles can be used depending on the typical fluid pressure at the central body inlet 116 and the desired target pressure at the outlet 308), the recess 310 extends to an outlet 308 of the splash guard 304.

[0041] The recess 310 can initially be configured to convey fluid in a radially inward direction into the cartridge assembly 100. The recess 310 can then turn through an angle to divert the fluid flow. In the depicted example, the recess 310 turns about 90 degrees to divert the flow from the radial direction to the circumferential direction (see Figure 4 ). Thus, the rear portion of the recess 310 after the bend may not necessarily be completely straight, but can be slightly curved according to, for example, the curvature of the inner circumferential wall 204 of the central body assembly 110.

[0042] The recess 310 can be sized and shaped to reduce the pressure of the fluid received at the central body inlet 116. The width of the recess 310 can remain constant from the inlet 306 to the outlet 308. Alternatively, the width can vary (e.g., become wider as the recess 310 approaches the outlet 308). The outlet 308 can be positioned and shaped to cause the fluid to leave the splash guard 304 in a particular pattern or in a particular direction. For example, the outlet 308 can be positioned to direct the fluid towards the central body assembly bottom plate 202.

[0043] The splash guard 304 may be open at the bottom or may be enclosed.

[0044] The height of the splash guard may depend on the amount of available space (in the axial direction) within the cartridge assembly 100 between the membrane filter 120 (and / or the bottom plate of the middle body assembly 110) and the lid 102.

[0045] The splash guard 304 may be integrally formed with the middle body assembly 110 or the foil cutter 106, or may be mounted to either or both of these elements. For example, the foil cutter 106 may include a cutout designed to receive the flange 314 of the splash guard 304 (see Figure 3B ). The flange 314 may be an extension of the splash guard 304 that extends radially away from the point where the splash guard 304 is configured to intersect the inner circumferential wall of the middle body assembly 110.

[0046] The middle body assembly 110 (or the foil cutter 106) may include one or more protrusions that serve as fasteners 316 that can pass through corresponding through-holes 312 in the flange 314 of the splash guard. To facilitate the installation of the fasteners 316 into the through-holes 312, the middle body assembly 110 may also include one or more alignment protrusions 318 that are configured to mate with corresponding alignment recesses 320 on the splash guard 304 (or vice versa, with protrusions provided on the splash guard 304 and recesses provided on the middle body assembly 110 and / or the foil cutter 106). The alignment protrusions 318 and the fasteners 316 may be positioned such that when the splash guard 304 is installed onto the cartridge assembly 100, the inlet 306 of the splash guard 304 is aligned with the middle body inlet 116 of the middle body assembly 110.

[0047] Figure 5 is a flow chart depicting an exemplary method for deploying a splash guard in a cartridge assembly.

[0048] In block 502, the base assembly, the membrane, and the middle body assembly may be deployed. For example, the base assembly may be placed on a suitable surface in the test area, and the membrane (and / or the media pad) may be placed on the base assembly. A seal (such as an O-ring) may be placed in position around the perimeter of an appropriate portion of the base assembly. Then, the middle body assembly may be lowered onto the base assembly such that the O-ring creates a seal and / or locks the middle body assembly to the base assembly.

[0049] In some embodiments, the splash guard may be integral with the middle body assembly or an optional foil cutter. If not, then in block 504, the splash guard may be aligned. For example, the splash guard may be placed between suitable alignment protrusions provided on the middle body assembly and / or the foil cutter. Alternatively or additionally, protrusions may be provided on the splash guard that may be aligned with recesses on the middle body assembly and / or the foil cutter. The protrusions and recesses may be customized in shape and configured to mate with each other.

[0050] In block 506, the splash guard may be attached to the middle body assembly and / or the foil cutter. For example, one or more fasteners attached to the cartridge assembly (e.g., the middle body assembly and / or the foil cutter) may be inserted into one or more through-holes of the splash guard. Alternatively or additionally, one or more fasteners on the splash guard may be placed into one or more holes in the cartridge assembly (which may extend partially or fully through the middle body assembly and / or the foil cutter).

[0051] In block 508, the lid may be deployed onto the cartridge assembly. This may involve providing an O-ring at a suitable location on the middle body assembly and then securing the lid at the inner or outer periphery of the O-ring.

[0052] In block 510, the fluid delivery device may be inserted into the inlet of the middle body assembly. For example, the inlet may include a rubber diaphragm. The rubber diaphragm may be pierced with a needle, and the fluid may be delivered to the inlet through the needle (at block 512). The fluid may be delivered through one or more tubes attached to the needle or through another suitable delivery device.

[0053] In block 514, the fluid may be redirected using the splash guard. For example, the fluid may be made to enter the inlet of the splash guard and then may be redirected around a groove in the splash guard. This may be used to reduce the pressure of the fluid between the inlet and the membrane.

[0054] In block 516, the fluid may pass through the membrane. Then, in block 518, the fluid may be released through an outlet in the base assembly. After the fluid is released, the growth medium may be provided near the membrane (e.g., through the middle body inlet or another suitable inlet), and the cartridge assembly may be left to incubate for a predetermined period of time. Then, any growth of microorganisms on the growth medium may be measured (e.g., by imaging the growth medium through a lid that may be optically transparent).

[0055] Figure 5Depict exemplary actions taken in a certain order. However, the embodiments are not limited to the depicted order. For example, another possible arrangement is to first align the splash guard (block 504), and then attach the splash guard to the middle body assembly (block 506). Subsequently, the membrane and the middle body assembly (with the attached splash guard) can be deployed, and then the middle body assembly / splash guard / membrane can be deployed on the base assembly (block 502). Then, the cover can be deployed on top of the rest of the assembly.

[0056] Some embodiments may use the phrases "one embodiment" or "an embodiment" and their derivatives to describe. These terms indicate that the specific features, structures, or characteristics described in connection with that embodiment are included in at least one embodiment. The phrase "in one embodiment" that appears throughout the specification does not necessarily refer to the same embodiment. Additionally, unless otherwise stated, the features described above are considered to be used in any combination together. Thus, any individually discussed feature can be used in combination with each other, unless it is mentioned that these features are incompatible with each other.

[0057] Generally referring to the symbols and nomenclature used herein, the detailed description herein can be presented in program procedures executed on a computer or a computer network. Those skilled in the art use these procedures, descriptions, and representations to most effectively convey the essence of their work to other technicians in the field.

[0058] Some embodiments may use the phrases "coupled" and "connected" and their derivatives to describe. These terms are not necessarily synonyms for each other. For example, some embodiments may use the terms "connected" and / or "coupled" to describe to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" can also mean that two or more elements are not in direct contact with each other, but still cooperate or interact with each other.

[0059] It is emphasized that the abstract of the present disclosure is provided to allow the reader to quickly ascertain the nature of the technical disclosure. The abstract is submitted on the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Further, in the foregoing detailed description, it can be seen that, for the purposes of simplifying the present disclosure, various features are combined in a single embodiment. This method of disclosure should not be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the appended claims reflect, the inventive subject matter lies in less than all of the features of a single disclosed embodiment. Thus, the appended claims are hereby incorporated into the detailed description, with each claim standing on its own as a separate embodiment. In the appended claims, the terms "comprising" and "wherein" each serve as the plain-language equivalents of the respective terms "including" and "in which". Further, the terms "first", "second", "third", etc. are used merely as labels and are not intended to impose numerical requirements on their objects.

[0060] The foregoing description includes examples of the disclosed architecture. Of course, it is not possible to describe every conceivable combination of components and / or methods, but one of ordinary skill in the art will recognize that many additional combinations and permutations are possible. Accordingly, this novel architecture is intended to cover all such alterations, modifications, and variations that fall within the spirit and scope of the appended claims.

Claims

1. An apparatus, comprising: A cartridge assembly, the cartridge assembly comprising: an inlet configured to receive one or more fluids at a first pressure; a membrane filter; and an outlet configured to release the one or more fluids from the cartridge assembly after the one or more fluids have passed through the membrane filter; and A splash guard configured to block fluid flow between the inlet and the membrane filter.

2. The device according to claim 1, wherein, The splash guard is configured to reduce the pressure of the one or more fluids from the first pressure to a second pressure that is lower than the first pressure.

3. The device according to claim 1, wherein, The cartridge assembly includes a lid, a middle body assembly including the inlet, and a base assembly including the outlet.

4. The apparatus according to claim 3, wherein, The splash guard is provided between the lid and the middle body assembly.

5. The device according to claim 2, wherein The splash guard includes a cover extending between the inlet and the lid.

6. The device according to claim 3, wherein, The splash guard is provided on the middle body assembly or on a foil cutter configured to be disposed between the lid and the middle body assembly.

7. The apparatus according to claim 1, wherein The splash guard includes through holes configured to receive fasteners to attach the splash guard to the cartridge assembly.

8. The device according to claim 1, wherein, The fasteners are built into the cartridge assembly.

9. The device according to claim 1, wherein, The splash guard redirects the one or more fluids entering the inlet in a radial direction of the cartridge to a circumferential direction of the cartridge.

10. The device according to claim 1, wherein, The splash guard includes grooves configured to change the flow direction of the one or more fluids.

11. The apparatus according to claim 1, wherein, The splash guard and the cartridge assembly include mating alignment elements.

12. A method, comprising: Assembling the cartridge assembly and the splash guard according to claim 1; Inserting a fluid delivery device into the inlet; And Delivering fluid to the inlet, wherein the fluid is redirected by the splash guard.

13. The method according to claim 12, wherein: The inlet includes a rubber diaphragm, Inserting the fluid delivery device into the inlet includes piercing the rubber diaphragm with a needle, and Delivering the fluid to the inlet includes delivering the fluid through the needle.

14. The method according to claim 12, wherein, Assembling the cartridge assembly and the splash guard includes inserting one or more fasteners attached to the cartridge assembly into one or more through holes of the splash guard.

15. The method according to claim 12, wherein, Assembling the cartridge assembly and the splash guard includes aligning the splash guard with the cartridge assembly using one or more mating alignment elements provided on the cartridge assembly and the splash guard.

16. The method according to claim 12, further comprising using the splash guard to reduce the pressure of the fluid between the inlet and the membrane.

17. The method according to claim 12, wherein The cartridge assembly includes a lid, a middle body assembly including the inlet, and a base assembly including the outlet, and assembling the cartridge assembly includes: Attaching the splash guard above the middle body assembly; Placing the middle body assembly on the base assembly; and Placing the lid on the splash guard and the middle body assembly.

18. The method according to claim 17, further comprising providing a foil cutter on the central body assembly, wherein, The splash guard is attached to the foil cutter.

19. The method according to claim 17, further comprising providing a seal between the middle body assembly and the base assembly.

20. The method according to claim 17, further comprising providing a seal between the middle body assembly and the lid.

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