Sealed nutrient cartridge for imaging

Abstract

One among various embodiments discloses a sealed nutrient cartridge for bioburden or sterility testing, comprising a transparent cover, a flexible side panel assembly coupled to the transparent cover, a transparent film assembly coupled to the flexible side panel providing a transparent film on an opposing side of the transparent cover, wherein the transparent cover, the flexible side panel assembly, and the transparent film assembly form an interior vessel for receiving a growth medium and a sample of a product.

Description

SEALED NUTRIENT CARTRIDGE FOR IMAGINGCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims the benefit of U.S. Provisional Application titled, “SYSTEM AND METHODS FOR IMPROVED BIOBURDEN AND / OR STERILITY TESTING,” filed on May 6, 2024, and having Serial No. 63 / 643,126. The present application claims the benefit of U.S. Provisional Application titled, “SYSTEM AND METHODS FOR IMPROVED TIMING FOR BIOBURDEN AND / OR STERILITY TESTING,” filed on May 6, 2024, and having Serial No. 63 / 643,140. The present application claims the benefit of U.S. Provisional Application titled, “SYSTEM AND METHODS FOR IMPROVED FILTRATION FOR BIOBURDEN AND / OR STERILITY TESTING,” filed on May 6, 2024, and having Serial No. 63 / 643,142. The present application claims the benefit of U.S. Provisional Application titled, “IMPROVED CARTRIDGES / CONSUMABLES FOR BIOBURDEN AND / OR STERILITY TESTING,” filed on May 6, 2024, and having Serial No. 63 / 643,132. The present application claims the benefit of U.S. Provisional Application titled, “SYSTEM AND METHODS FOR IMPROVED CONTACT AND IMAGING IN BIOBURDEN AND / OR STERILITY TESTING,” filed on May 6, 2024, and having Serial No. 63 / 643,135. The subject matter of these related applications is hereby incorporated herein by reference.BACKGROUNDField of the Various Embodiments

[0002] The various embodiments relate generally to generating high resolution images of microorganisms in a growth medium, and, more specifically, a sealed nutrient cartridge for performing bioburden and sterility testing.Description of the Related Art

[0003] A petri dish or cell-culture dish is a transparent dish that is employed to hold a growth medium in which cells are cultured. Petri dishes have been utilized for many years to grow bacterial and fungal cultures. Petri dishes are generally made of glass, plastics, or other transparent or semi-transparent materials. Petri dishes are often utilized in bioburden testing or microbial testing to detect and / or quantify microbial or fungal contamination of a product, such as a pharmaceutical product. Bioburden testing is performed to ensure safety, quality, and regulatory compliance of products such as medical devices, food and beverage products, pharmaceutical products, cosmetic products, and other products. Membrane filtration is a common method for bioburden testing in which a sample is passed through a membrane filterhaving a specified pore size, such as less than 1 pm. In some cases, a vacuum pump is utilized to draw the sample through the filter. The filter is transferred into a culture medium in a petri dish for a period of time, during which the level of microbial or fungal contamination is monitored. During and / or following an incubation period, the sample on the filter is analyzed to determine the degree of microbial contamination in the sample.

[0004] One drawback associated with conventional petri dishes is they are typically unsealed or closed with a layer that is air permeable or water permeable. As a result, desiccation of the growth medium or the sample itself can occur, which makes analyzing a sample in the petri dish during or after an incubation period more difficult. Additionally, desiccation also makes microscopy, imaging, and / or automated analysis of a sample in the petri dish difficult. Because traditional methods of bioburden and sterility testing often rely on manual analysis of a sample in a petri dish, desiccation is tolerable in a traditional bioburden analysis workflow.

[0005] As the foregoing illustrates, what is needed in the art are more effective ways to contain and analyze a sample for bioburden and / or sterility testing where high-resolution imaging or computer-aided analysis of the sample is conducted.SUMMARY

[0006] In an example embodiment, sealed nutrient cartridge for bioburden or sterility testing, comprising, a transparent cover, a flexible seal assembly coupled to the transparent cover, a transparent film assembly coupled to the flexible seal assembly providing a transparent film on an opposing side of the transparent cover, wherein the transparent cover, the flexible seal assembly, and the transparent film assembly form an interior vessel for receiving a growth medium and a sample of a product.

[0007] At least one technical advantage of the disclosed techniques herein relative to the prior art is that, with the disclosed techniques, desiccation or settling of a sample contained within a sealed cartridge is reduced or eliminated in either anaerobic or aerobic test environments. Another technical advantage of the disclosed techniques is that the disclosed cartridge maintains improved contact with an image sensor that is positioned beneath the cartridge. Another technical advantage of the disclosed techniques is that a sample within the cartridge can be imaged through a film that is positioned beneath the cartridge through a transparent film.

[0008] These technical advantages provide one or more technological improvements over prior art approaches.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] So that the manner in which the above recited features of the various embodiments can be understood in detail, a more particular description of the inventive concepts, briefly summarized above, can be had by reference to various embodiments, some of which are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate only typical embodiments of the inventive concepts and are therefore not to be considered limiting of scope in any way, and that there are other equally effective embodiments.

[0010] FIG. 1 shows an example evaluation system that includes a specimen evaluation unit according to various embodiments.

[0011] FIG. 2 illustrates an example sample module that can be a part of the specimen evaluation unit shown in FIG. 2.

[0012] FIGS. 3-7 illustrates a sample collection system depositing a sample on a sealed nutrient cartridge according to various embodiments.

[0013] FIG. 8 illustrates an example of a sealed nutrient cartridge according to various embodiments.

[0014] FIG. 9 illustrates an exploded perspective view of a sealed nutrient cartridge according to various embodiments.

[0015] FIGS. 10-15 illustrate cross-sectional views of various implementations of a sealed nutrient cartridge according to various embodiments.

[0016] FIG. 16 illustrates an example of a fluid growth medium nutrient cartridge according to various embodiments.DETAILED DESCRIPTION

[0017] In the following description, numerous specific details are set forth to provide a more thorough understanding of the various embodiments. However, it will be apparent to one skilled in the art that the inventive concepts can be practiced without one or more of these specific details. For explanatory purposes, multiple instances of like objects are symbolized with reference numbers identifying the object and parenthetical numbers identifying the instance where needed. While the invention may be described within the context of a use caseassociated with a specific imaging system, the inventive concepts described herein are broader than that particular use case and can be applied in any appropriate context / use case. In certain instances, this application may reference directly or indirectly to ePetri technology which, in some instances, refers to certain technology described in U.S. Patent Nos. 9,426,429, 9,643,184, 9,569,664, and 9,343,494, the disclosures of all of which are incorporated herein by reference in their entireties.

[0018] FIG. 1 shows an evaluation system 100 that includes a specimen evaluation unit 105 communicatively coupled to a computer 115. In one embodiment, the specimen evaluation unit 105 is a stand-alone unit that is communicatively coupled to the computer 115 either wirelessly or via a wired connection. An example wireless connection is a Bluetooth connection. An example wired connection is an Ethernet connection. In another embodiment, the specimen evaluation unit 105 and the computer 115 are co-located in an integrated configuration inside an enclosure.

[0019] The specimen evaluation unit 105 can include “n” sample modules 110 (n > 1). Each of the sample modules 110 can include a lighting element, nutrient cartridge, and image sensor. For example, a lighting element includes an array of light emitting elements, such as LEDs. The sample module 110 also contains one or more detection elements such as CMOS image sensors or charge coupled detectors (CCD). In an embodiment, each of the one or more sample modules 110 can be configured to evaluate a specimen, such as a liquid or substantially liquid product that can be analyzed for bioburden or sterility. Thus, for example, the “n” sample modules 110 can be configured for evaluating “n” specimens over an extended period of time under different conditions. For example, a first specimen placed in sample module (1) 110-1 can be evaluated at a first ambient temperature, a second identical specimen placed in sample module (2) 110-2 can be evaluated at a second ambient temperature, and so on. In one implementation, evaluation of each of the specimens can involve detecting a contaminant such as, for example, detecting a contaminant in a drug specimen, detecting a contaminant in a fluid specimen, or detecting a pollutant in a liquid specimen. In another implementation, evaluation of a culture specimen can involve an automated enumeration of bacterial and fungal colonies. In another implementation, two or more sample modules 110 can be configured to evaluate more than one kind of specimen 218.

[0020] Communication link 140 is selected to support conveying of electrical signals generated by one or more image sensors included in the “n” sample modules.

[0021] In this example embodiment, the memory 125 includes high-resolution imagegeneration software 130 and high-resolution image evaluation software 135. The processor 120 can execute the high-resolution image generation software 130 for generating one or more high-resolution images each based on a sequence of sub-pixel shifted images. The sub-pixel shifted images are generated based on electrical signals provided by sensing elements of an image sensor and position information of light emitting elements, such as LEDs, in the lighting element.

[0022] The processor 120 can execute the high-resolution image evaluation software 135 for evaluating one or more high-resolution images generated by the high-resolution image generation software 130. In some cases, evaluating the high-resolution image(s) can involve detecting a contaminant, and / or evaluating growth characteristics of a culture. The high-resolution image evaluation software 135 is typically configured to detect and provide an indication of contaminants that may be invisible to the human eye or are not yet at a stage where visible to the human eye. In some cases, the high-resolution image evaluation software 135 is configured to interact with a human who can visually inspect one or more images. The visual inspection may be carried out via a display screen of the computer 115.

[0023] FIG. 2 illustrates an embodiment of a sample module 110 of the specimen evaluation unit 105 shown in FIG. 1. In this example, the sample module 110 includes a lighting element 205 and an image sensor 217. The sample module 110 further includes a sealed nutrient cartridge 215 and a temperature control element 220. The sealed nutrient cartridge 215 houses the specimen 218 on a transparent layer 210. Various aspects of sealed nutrient cartridge 215 are discussed with reference to subsequent drawings. In embodiment of the disclosure, sealed nutrient cartridge 215 includes a transparent cover through which light from lighting element 205 is aimed. Sealed nutrient cartridge 215 also includes a growth medium or gelling agent, such as a tryptic soy agar (TSA). One or more nutrients are incorporated into the growth medium so that one or more microorganisms can be cultured within the sealed nutrient cartridge 215. The sealed nutrient cartridge 215 also includes a transparent layer 210, such as a transparent film that sits atop the image sensor 217 and through which the specimen 218 can be imaged. The specimen 218 can be placed in contact with a growth medium that incorporates nutrients that is filled into the sealed nutrient cartridge 215.

[0024] The image sensor 217 is positioned beneath the sealed nutrient cartridge 215 to capture one or more images of specimen 218 through transparent layer 210. The computer 115 includes a processor 120 and a memory 125 and can further include components (notshown) such as associated with an input / output interface (keyboard, display, etc.) and associated with communications (wireless communications, connectivity to a communication network, etc.).

[0025] In an example embodiment, the processor 120 performs a digital focusing operation to obtain focus upon a high-resolution image corresponding to a plane of interest through the specimen 218. The plane of interest provides a cross-sectional view of the specimen 218 and can be located height- wise, for example, along a horizontal axis that extends cross-sectionally through a central portion of the specimen 218. The focusing operation includes determining and using a motion vector calculated at the plane of interest. In general, a motion vector can refer to a translational motion of projection images in a sequence of low-resolution projection images. The translational motion can be dependent on one or more factors, primarily on an amount of shift observed in any of various 2D planes that are parallel to the transparent layer 210 on which the specimen 218 is placed and / or parallel to the surface of the image sensor 217 upon which light propagated through the specimen 218 is incident. In an example implementation, the motion vector is defined by 2D Cartesian coordinates, and a high-resolution image of the specimen 218 is constructed by use of an algorithm that operates upon data associated with a sequence of a subpixel shifted projection images and a motion vector of the sub-pixel shifted images of the sequence. In this embodiment, the sequence of sub-pixel shifted images used for generating the high-resolution image corresponds to the number of lighting elements of the lighting element 205 that are activated for generating the sub-pixel shifted images. Sub-pixel shifted images corresponding to a pixel boundary (between two sensing elements of the image sensor 217) if any are generated are omitted during generation of a high-resolution image.

[0026] In an embodiment, the computer 115 is configured to generate a set of high-resolution images over an extended time period based on electrical signals provided by the specimen evaluation unit 105. In various implementations, the electrical signals can be provided by the specimen evaluation unit 105 to the computer 115 in accordance with one of a repetitive schedule, an intermittent schedule, or a random schedule.

[0027] As shown, a separation distance exists between the transparent layer 210 of the sealed nutrient cartridge 215 and a top surface of the image sensor 217 upon which light is incident after propagating through the specimen 218 contained in the sealed nutrient cartridge 215. The separation distance can vary in accordance with various factors such as, for example, the structure of the sealed nutrient cartridge 215 and the structure of the sample module 110.The electrical signals generated by the image sensor 217 are provided to the computer 115 via an I / O 225 (an Ethernet card or Bluetooth circuit, for example). The computer 115 generates one or more high resolution images that can be evaluated for purposes such as detecting the presence of contaminants in the specimen 218 if any such contaminants are present.

[0028] In various embodiments, the sealed nutrient cartridge 215 is disposable after use. An advantage offered by the disposable cartridge is savings in cost compared to a prior art image sensor, such as, for example, the image sensor, which is typically discarded after a single use. The reason for discarding the prior art image sensor after a single use is due to residual contamination of a top surface of the sensor upon which a specimen has been placed. The prior art image sensor is typically more expensive than the disposable sealed nutrient cartridge 215.

[0029] The temperature control element 220 can be provided in the sample module 110 for incubation purposes of the specimen 218. In a prior art scenario, heat generated by a CMOS image sensor was used to generate heat. Heating control was implemented in a relatively crude fashion by turning the CMOS image sensor on and off by use of a “bang-bang” control loop. Cooling was achieved by use of an additional component in the form of a forward-biased thermo-electric cooler (TEC).

[0030] An improvement provided in accordance with one or more embodiments involves the use of a single component to achieve both heating and cooling. In one such embodiment, the temperature control element 220 is a TEC configured to operate in a dual-purpose role as both a heating element and a cooling element. In an example implementation, the TEC is a part of a H-bridge circuit that is configured to place the TEC in a forward bias condition over a first period of time to operate as a heating element, and to place the TEC in a reverse bias condition over a second period of time to operate as a cooling element. The time periods, repetition rate, and other factors of the forward bias and reverse bias conditions can be controlled by a computer in order to achieve a desired ambient temperature processor in the sample module 110. In terms of heating operations, a TEC intrinsically operates as a heat pump and thus achieves very high operating efficiency. The efficiency can be greater than 100% in some cases when used for heating.

[0031] Referring next to FIG. 3, shown is an example of a specimen collection system 700 that can be used to collect a specimen 218, or a sample of a product, for bioburden or sterility testing. The specimen collection system 700 includes a product reservoir 701 into which a sample of a product, such as a pharmaceutical product, a food and beverage product, or anyother liquid or substantially liquid product can be deposited. The specimen collection system 700 also includes a vacuum port 703 to which a vacuum pump is coupled and can apply a suction force to the product reservoir 701. Specimen collection system 700 also includes a filter assembly 705 that includes, for example, a membrane filter that operates as a barrier and captures microorganisms or other particles larger than a pore size. In one embodiment, the filter assembly 705 incorporates a membrane filter with a 0.45 micron pore size. The filter assembly 705 forms a portion of sealed nutrient cartridge 215 according to various embodiments. Accordingly, a sample of a product is deposited into product reservoir 701 and a suction force is applied using vacuum port 703 to draw the product through the filter assembly 705. In some cases, rather than depositing the product onto a membrane filter within filter assembly 705, the filter assembly 705 can be omitted and the product can be deposited directly onto the surface of a growth medium within the sealed nutrient cartridge 215. Once assembled, the product is sandwiched between the growth medium and a transparent film that sits atop the image sensor 217 that images the product. In some cases, omitting a filter within filter assembly 705 yields the benefits of faster sample deposition onto the growth medium and improved image quality. Utilizing a filter, in some instances, increases the amount of time required to perform detection of microorganisms within the product sample and reducing image quality of images captured by image sensor 217.

[0032] Referring next to FIG. 4, shown is the specimen collection system 700 transferring the filter assembly 705 to the sealed nutrient cartridge 215. In the depicted scenario of FIG. 4, an outlet port is removable from product reservoir 701 and filter assembly 705. Accordingly, after the suction force via the vacuum port 703 is applied and the product is drawn through the membrane filter of filter assembly 705, the product reservoir 701 and filter assembly 705 are transferred to the sealed nutrient cartridge 215. Sealed nutrient cartridge 215 can include one or more locking tabs or other mechanisms onto which the filter assembly 705 is secured. As shown in FIG. 5, product reservoir 701 from specimen collection system 700 is removable from sealed nutrient cartridge 215 such that filter assembly 705 remains coupled to sealed nutrient cartridge 215. In one example, product reservoir 701 can be twisted to engage one or more locking tabs of filter assembly 705 or sealed nutrient cartridge 215 onto each other, respectively. Once filter assembly 705 and sealed nutrient cartridge 215 are secured to one another, product reservoir 701 can be removed, allowing the filter assembly 705 containing the specimen 218 to remain on sealed nutrient cartridge 215.

[0033] As shown in FIG. 6 a transparent film assembly 1001 can be positioned atop the filter assembly 705. The transparent film assembly 1001 includes a viewing window formedby a transparent film that is positioned over the filter within the filter assembly 705 containing specimen 218. The transparent film can include an approximate 13-micron film that is optically transparent. The transparent film corresponds to transparent layer 210. For imaging, the transparent film is positioned atop sealed nutrient cartridge 215 so that image sensor 217 can image the specimen 218 within sealed nutrient cartridge 215. FIG. 7 illustrates the transparent film assembly 1001 secured to sealed nutrient cartridge 215 and covering filter assembly 705. Transparent film assembly 1001 includes one or more seals to maintain an airtight and / or watertight environment within the sealed nutrient cartridge 215 to reduce desiccation of the specimen 218 and growth medium within the sealed nutrient cartridge 215. The seals can be made of silicone, butyl rubber, or other types of materials that facilitate an airtight and / or watertight environment.

[0034] FIG. 8 illustrates an opposing side of transparent film assembly 1001 relative to the view shown in FIG. 7. In the view shown in FIG. 8, a transparent cover 1003 is shown. Light from lighting element 205 can be aimed through transparent cover 1003 and towards specimen 218. In one embodiment, light from multiple light emitting elements of lighting element 205 can be sequentially activated and emit light through transparent cover 1003 and towards specimen 218 within the sealed nutrient cartridge 215. FIG. 8 also illustrates a flexible seal 1005, which can form a part of a flexible seal assembly. The flexible seal 1005 can be a radial seal that provides a watertight and / or airtight environment within sealed nutrient cartridge 215. Additionally, flexible seal 1005 allows the 1003 to be movable or translatable in response to a force being applied sealed nutrient cartridge 215. In one example, a force applied to a plunger top 1007 or an upper nutrient cartridge housing 1009 causes vertical movement of transparent cover 1003. The vertical movement of transparent cover 1003 causes a compressive force to be applied to the nutrient medium within the sealed nutrient cartridge 215. By applying a compressive force to sealed nutrient cartridge 215, consistent contact with an image sensor beneath the sealed nutrient cartridge 215 is maintained, which enables the synthesis of superresolution imagery of the specimen 218 within sealed nutrient cartridge 215.

[0035] Referring next to FIG. 9, shown is an exploded perspective view of a sealed nutrient cartridge 215 according to various embodiments. In the example of FIG. 9, the transparent film assembly 1001 shown. The transparent film assembly 1001 contains a transparent film that spans the plane of the transparent film assembly 1001 that is adjacent to the image sensor 217 of evaluation system 100. The transparent film prevents liquid, media, and microbes from reaching the image sensor 217 so that the image sensor 217 is reusable with another sealed nutrient cartridge 215, in contrast to prior art embodiments. In oneembodiment, the transparent film is adhered to the transparent film assembly 1001 using a pressure-sensitive adhesive, glue, or ultrasonic welding. Adjacent to the transparent film assembly 1001 is the filter 1011 on which a specimen 218 is deposited. An elastomer gasket 1013 surrounds the filter 1011 to provide an airtight and / or watertight environment within the sealed nutrient cartridge 215. A lower nutrient cartridge housing 1015 provides one or more slots for the elastomer gasket 1013, filter 1011 and transparent film assembly 1001 to attach thereto. In one embodiment, the transparent film assembly 1001 is snap-fitted to the lower nutrient cartridge housing 1015, securing the filter 1011 and elastomer gasket 1013 to the lower nutrient cartridge housing 1015.

[0036] Lower nutrient cartridge housing 1015 further includes a fill port 1018 that can be used to fill the sealed nutrient cartridge 215 with a growth medium when the sealed nutrient cartridge 215 is assembled. Fill port 1018 is associated with a fill plug 1019 and a stopper 1017. The fill plug 1019 and stopper 1017 allow the fill port 1018 and a corresponding airflow port to be sealed once the sealed nutrient cartridge 215 is filled with a growth medium, nutrients, or other fluids, gels, or solid material.

[0037] In one example, the growth medium comprises a tryptic soy agar (TSA). One or more nutrients can also be incorporated into the growth medium with which the sealed nutrient cartridge 215 is filled. In some implementations, an anaerobic environment within the sealed nutrient cartridge 215 is desired. Accordingly, an equivalent mechanical design is used for the sealed nutrient cartridge 215 with the exception of different materials chosen for the various seals such as stopper 1017 or elastomer gasket 1013. For example, oxygen impermeable materials such as butyl rubber rather than silicone can be chosen for the seals associated with the sealed nutrient cartridge 215. Additionally, oxygen-reducing agents such as thioglycolate, cysteine, sodium sulfate, ascorbate, or a palladium catalyst can also be incorporated into the growth medium to promote an anaerobic environment within sealed nutrient cartridge 215.

[0038] The growth medium can include chemical compounds such as colorimetric indicators like resazurin, resorufin, or dihydroresorufin, that change color when exposed to specific chemical conditions. For example, oxygen indicators like resazurin may be employed to determine the redox level of the media, confirming an anaerobic environment. Ph indicators like phenol red or methylene blue may be employed to verify that the media is at an expected ph, or to indicate that growing colonies are changing the ph of the media. In some implementations, specifically chosen colorimetric indicators may help classify the type of organism growing on the cartridge.

[0039] The imaging and software can be configured to automatically measure the spectral content or color of the sealed nutrient cartridge 215. The spectral content or color of the sealed nutrient cartridge 215 can be used to alert a user if anomalies are detected. For example, should an anaerobically configured sealed nutrient cartridge 215 leak and become aerobic, the high-resolution image evaluation software 135, based on images generated by high-resolution image generation software 130, can generate a corresponding alert.Additionally, based on the spectral content or color of the sealed nutrient cartridge 215 as detected by the image sensor 217, high-resolution image generation software 130, or high-resolution image evaluation software 135, the high-resolution image evaluation software 135 can also classify the types of microorganism colonies growing on or within the sealed nutrient cartridge 215.

[0040] In some embodiments, to account for desiccation, settling, or contraction of the growth medium over time, a tryptic soy broth (TSB) reservoir can be integrated into or attached to sealed nutrient cartridge 215. TSB can be pressure or gravity fed into the sealed nutrient cartridge 215 to fill any gaps created by desiccation or contraction of the growth medium over time. A TSB reservoir can be connected to the vessel or reservoir within the sealed nutrient cartridge 215 to ensure that any moisture loss due to desiccation or contraction of the TSA gelling medium is replenished, thereby improving the quality of super-resolution images of the specimen 218 that are generated by high-resolution image generation software 130.

[0041] Transparent cover 1003 represents an optical window into to image sensor 217 through which light emitted by lighting element 205 enters the sealed nutrient cartridge 215. Transparent cover 1003 can be optically transparent or tinted with a color depending upon the image capture needs of a specific implementation. Flexible seal 1005, as noted above, forms part of a flexible seal assembly. Flexible seal 1005 promotes an airtight and / or watertight environment within the sealed nutrient cartridge 215 to limit desiccation of the growth medium. Additionally, the flexible nature of the flexible seal 1005 allows a force to be applied to upper nutrient cartridge housing 1009 or plunger top 1007 to promote contact of the transparent film assembly 1001 with the image sensor 217.

[0042] FIG. 10 illustrates a cross-sectional view of an alternative implementation of a sealed nutrient cartridge 215 according to various embodiments. As shown, the sealed nutrient cartridge 215 implementation of FIG. 10 includes the transparent film assembly 1001, filter 1011, transparent cover 1003, and a flexible seal assembly 1100 that permits verticaltranslation of the transparent cover 1003 in response to a force applied to the sealed nutrient cartridge 215.

[0043] FIGS. 11-15 illustrate alternative implementations of a sealed nutrient cartridge 215 including the transparent film assembly 1001, filter 1011, transparent cover 1003, and a flexible seal assembly 1100 that permits vertical translation of the transparent cover 1003 in response to a force applied to the sealed nutrient cartridge 215

[0044] FIG. 16 illustrates an alternative implementation of an alternative implementation of a sample module 1200 according to various embodiments. In the depicted embodiment, as in the example of FIG. 2, a lighting element 205 is positioned above a fluid growth medium nutrient cartridge 1203. In the example shown in FIG. 16, the fluid growth medium nutrient cartridge 1203, unlike the sealed nutrient cartridge 215 in the previous examples, does not incorporate a gel-based growth medium such as TSA. Instead, for applications requiring a liquid growth medium such as TSB, fluid growth medium nutrient cartridge 1203 provides a conical structure 1205 in which a transparent cover 1207 is positioned above a sample. In some embodiments, the conical structure 1205 is consumable or a one-time use structure.

[0045] TSB 1211 or another liquid growth medium is wicked by filter 1209 from a fluid source, such as a fluid reservoir that is coupled to a filter 1209, to provide a nutrient source for a sample that has been deposited on the filter 1209. A transparent film 1213 is positioned between the 1209 and the image sensor 217. The image sensor 217 captures one or more images of the specimen 218 deposited on the filter 1209 as with a specimen 218 within the sealed nutrient cartridge 215. Accordingly, the filter 1209 is sandwiched between transparent cover 1207 and transparent film 1213. The TSB 1211 is provided to the filter 1209 as a liquid growth medium. In some cases, one or more nutrients or other chemicals or materials can be provided along with the TSB 1211.

[0046] In sum, a sealed nutrient cartridge for bioburden or sterility testing is described above that includes a transparent cover, a flexible seal assembly coupled to the transparent cover, a transparent film assembly coupled to the flexible seal assembly providing a transparent film on an opposing side of the transparent cover, wherein the transparent cover, the flexible seal assembly, and the transparent film assembly form an interior vessel for receiving a growth medium and a filter on which a sample is deposited

[0047] At least one technical advantage of the disclosed techniques herein relative to the prior art is that, with the disclosed techniques, desiccation of a sample contained within a sealed cartridge is reduced or eliminated in either anerobic or aerobic test environments.Another technical advantage of the disclosed techniques is that the disclosed cartridge maintains improved contact with an image sensor that is positioned beneath the cartridge. Another technical advantage of the disclosed techniques is that a sample within the cartridge can be imaged through a film that is positioned beneath the cartridge through a transparent film.

[0048] 1. In some embodiments, a sealed nutrient cartridge for bioburden or sterility testing comprises a transparent cover, a flexible seal assembly coupled to the transparent cover, a transparent film assembly coupled to the flexible seal assembly providing a transparent film on an opposing side of the transparent cover, wherein the transparent cover, the flexible seal assembly, and the transparent film assembly form an interior vessel for receiving a growth medium and a sample of a product.

[0049] 2. The sealed nutrient cartridge of clause 1, further comprising a fill port coupled to the at least one flexible seal assembly.

[0050] 3. The sealed nutrient cartridge of clauses 1 or 2, wherein the transparent film is approximately thirteen microns in thickness.

[0051] 4. The sealed nutrient cartridge of any of clauses 1-3, wherein the transparent film assembly comprises a rigid outer assembly to which the transparent film is adhered.

[0052] 5. The sealed nutrient cartridge of any of clauses 1-4, wherein the transparent film is adhered to the transparent film assembly using a pressure sensitive adhesive.

[0053] 6. The sealed nutrient cartridge of any of clauses 1-5, wherein the transparent film assembly is removably coupled to the flexible seal assembly.

[0054] 7. The sealed nutrient cartridge of any of clauses 1-6, wherein the transparent film assembly is snap-fitted to the flexible seal assembly.

[0055] 8. The sealed nutrient cartridge of any of clauses 1-7, wherein the transparent cover is translatable in response to a force applied to at least one of the transparent cover or the flexible seal assembly.

[0056] 9. The sealed nutrient cartridge of any of clauses 1-8, wherein the flexible seal assembly comprises a gasket coupled to the transparent cover.

[0057] 10. The sealed nutrient cartridge of any of clauses 1-9, wherein the gasket comprises one of a silicone gasket or a butyl rubber gasket.

[0058] 11. The sealed nutrient cartridge of any of clauses 1-10, further comprising a first fill port for injection of the growth medium into the interior vessel.

[0059] 12. The sealed nutrient cartridge of any of clauses 1-11, further comprising a reservoir for feeding a liquid growth medium in response to desiccation or compression of the growth medium in the interior vessel.

[0060] 13. The sealed nutrient cartridge of any of clauses 1-12, wherein the liquid growth medium is gravity fed into the interior vessel.

[0061] 14. The sealed nutrient cartridge of any of clauses 1-13, wherein the liquid growth medium comprises a tryptic soy broth (TSB).

[0062] 15. The sealed nutrient cartridge of any of clauses 1-14, wherein the interior vessel further comprises a bioburden or sterility test sample deposited on the filter.

[0063] 16. The sealed nutrient cartridge of any of clauses 1-15, wherein the filter comprises a 0.45 micrometer pore size.

[0064] 17. The sealed nutrient cartridge of any of clauses 1-16, further comprising a linear force mechanism configured to apply a force to the transparent cover to maintain contact of the transparent film assembly with an image sensor.

[0065] 18. The sealed nutrient cartridge of any of clauses 1-17, wherein the transparent film assembly comprises a gasket configured to seal a connection between the transparent film assembly and the flexible seal assembly.

[0066] 19. The sealed nutrient cartridge of any of clauses 1-18, further comprising a cartridge housing, wherein the cartridge housing is coupled to a sample collection system.

[0067] 20. The sealed nutrient cartridge of any of clauses 1-19, wherein the sample collection system deposits the sample on the filter.

[0068] Any and all combinations of any of the claim elements recited in any of the claims and / or any elements described in this application, in any fashion, fall within the contemplated scope of the present invention and protection.

[0069] The descriptions of the various embodiments have been presented for purposes of illustration but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments.

[0070] Aspects of the present embodiments can be embodied as a system, method or computer program product. Accordingly, aspects of the present disclosure can take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that can all generally be referred to herein as a “module,” a “system,” or a “computer.” In addition, any hardware and / or software technique, process, function, component, engine, module, or system described in the present disclosure can be implemented as a circuit or set of circuits. Furthermore, aspects of the present disclosure can take the form of a computer program product embodied in one or more computer readable medium having computer readable program code embodied thereon.

[0071] Any combination of one or more computer readable medium can be utilized. The computer readable medium can be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium can be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium would include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable readonly memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium can be any tangible medium that can contain or store a program for use by or in connection with an instruction execution system, apparatus, or device.

[0072] Aspects of the present disclosure are described above with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the disclosure. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine. The instructions, when executed via the processor of the computer or other programmable data processing apparatus, enable the implementation of the functions / acts specified in the flowchart and / or block diagram block or blocks. Suchprocessors can be, without limitation, general purpose processors, special-purpose processors, application-specific processors, or field-programmable gate arrays.

[0073] The flowchart and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods and computer program products according to various embodiments of the present disclosure. In this regard, each block in the flowchart or block diagrams can represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function. It should also be noted that, in some alternative implementations, the functions noted in the block can occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks can sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and / or flowchart illustration, and combinations of blocks in the block diagrams and / or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.

[0074] While the preceding is directed to embodiments of the present disclosure, other and further embodiments of the disclosure can be devised without departing from the basic scope thereof, and the scope thereof is determined by the claims that follow.

Claims

WHAT IS CLAIMED IS:

1. A sealed nutrient cartridge for bioburden or sterility testing, comprising:a transparent cover;a flexible seal assembly coupled to the transparent cover;a transparent film assembly coupled to the flexible seal assembly providing a transparent film on an opposing side of the transparent cover; wherein the transparent cover, the flexible seal assembly, and the transparent film assembly form an interior vessel for receiving a growth medium and a sample of a product.

2. The sealed nutrient cartridge of claim 1, further comprising a fill port coupled to the flexible seal assembly.

3. The sealed nutrient cartridge of claim 1, wherein the transparent film is approximately thirteen microns in thickness.

4. The sealed nutrient cartridge of claim 1, wherein the transparent film assembly comprises a rigid outer assembly to which the transparent film is adhered.

5. The sealed nutrient cartridge of claim 4, wherein the transparent film is adhered to the transparent film assembly using a pressure sensitive adhesive.

6. The sealed nutrient cartridge of claim 4, wherein the transparent film assembly is removably coupled to the flexible seal assembly.

7. The sealed nutrient cartridge of claim 5, wherein the transparent film assembly is snap-fitted to the flexible seal assembly.

8. The sealed nutrient cartridge of claim 1, wherein the transparent cover is translatable in response to a force applied to at least one of the transparent cover or the flexible seal assembly.

9. The sealed nutrient cartridge of claim 1, wherein the flexible seal assembly comprises a gasket coupled to the transparent cover.

10. The sealed nutrient cartridge of claim 9, wherein the gasket comprises one of a silicone gasket or a butyl rubber gasket.

11. The sealed nutrient cartridge of claim 1, further comprising a first fill port for injectionof the growth medium into the interior vessel.

12. The sealed nutrient cartridge of claim 1, further comprising a reservoir for feeding a liquid growth medium in response to desiccation or compression of the growth medium in the interior vessel.

13. The sealed nutrient cartridge of claim 12, wherein the liquid growth medium is gravity fed into the interior vessel.

14. The sealed nutrient cartridge of claim 12, wherein the liquid growth medium comprises a tryptic soy broth (TSB).

15. The sealed nutrient cartridge of claim 1, wherein the interior vessel further comprises a bioburden or sterility test sample deposited on the growth medium or a filter within the interior vessel.

16. The sealed nutrient cartridge of claim 15, wherein the filter comprises a 0.45 micrometer pore size.

17. The sealed nutrient cartridge of claim 1, further comprising a linear force mechanism configured to apply a force to the transparent cover to maintain contact of the transparent film assembly with an image sensor.

18. The sealed nutrient cartridge of claim 1, wherein the transparent film assembly comprises a gasket configured to seal a connection between the transparent film assembly and the flexible seal assembly.

19. The sealed nutrient cartridge of claim 1, further comprising a cartridge housing, wherein the cartridge housing is coupled to a sample collection system.

20. The sealed nutrient cartridge of claim 19, wherein the sample collection system deposits the sample on the filter.

Images