Systems and methods of testing for product contamination

Abstract

One among various embodiments discloses a method to evaluate a microorganism present in a product. The method includes obtaining a sample of the product from a product reservoir or a product conduit, passing the sample through a removable microorganism filter, and returning the sample to the product reservoir or product conduit after passage through the microorganism filter. In one implementation, a residual substance trapped in the removable microorganism filter after the sample has passed through the removable microorganism filter is transferred to a microscope slide for examination under a microscope. In another implementation, the residual substance is transferred to a Petri dish for evaluation. In yet another implementation, the residual substance is transferred to a system configured to generate high-resolution images of the residual substance that can be evaluated by a computer and / or by a lab technician.

Description

SYSTEMS AND METHODS OF TESTING FOR PRODUCT CONTAMINATIONCROSS-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 product testing, and more specifically, to product testing for contaminants.Description of the Related Art

[0003] A procedure for testing a product for contamination typically involves obtaining a sample of the product from a vat or a container and placing the sample in a Petri dish for allowing microbial growth over a period of time (several hours or days, for example). Detecting microbes typically involves transferring a portion of the sample, either intermittently or periodically, on to a microscope slide and examining the slide under a microscope. Because the amount of product transferred to the microscope slide is very small, a significant portion of the sample remains in the Petri dish after conclusion of the testing. This remaining portion is discarded as waste.

[0004] There are several drawbacks in existing testing procedures such as in the testing procedure described above. More particularly, in the example described above it is desirable to eliminate waste of a product, particularly when the product is expensive. For example,discarding a sample of a pharmaceutical product can be very expensive and it is desirable to identify alternative ways to test the pharmaceutical product without incurring the cost penalty associated with discarding a sample after using just a portion of the sample for testing.

[0005] As the foregoing illustrates, what is needed in the art are more effective ways to test a product and to minimize wastage of the product as a result of testing.SUMMARY

[0006] In an example embodiment, a method to evaluate a microorganism present in a product includes obtaining a sample of the product from a product reservoir or a product conduit, passing the sample through a removable microorganism filter, and returning the sample to the product reservoir or product conduit after passage through the microorganism filter. The sample can be obtained, for example, from a pharmaceutical product stored in the product reservoir or conveyed through the product conduit. All the components of a system that can be used for perfuming the evaluation are arranged in a sterile closed loop configuration that prevents contamination of the sample from outside agents such as, for example, human touch.

[0007] In one implementation, a residual substance trapped in the removable microorganism filter after the sample has passed through the removable microorganism filter is transferred to a microscope slide. The microscope slide can be examined under a microscope to detect any microorganism present in the residual substance.

[0008] In another implementation, a residual substance trapped in the removable microorganism filter after the sample has passed through the removable microorganism filter is transferred to a Petri dish. A growth agent such as agar is added to the Petri dish to encourage growth of microorganisms, if present in the residual substance. Periodically (hourly, or daily, for example) a portion of the residual substance is transferred from the Petri dish to a microscope slide. The microscope slide can be examined under a microscope to detect any microorganism if any are present in the residual substance.

[0009] In yet another implementation, a residual substance trapped in the removable microorganism filter is transferred to a cartridge that is insertable into an imaging system that is configured to produce sub-pixel shifted images of the residual substance. A computer that is communicatively coupled to the specimen imaging system produces high-resolution images from the sub-pixel shifted images of the residual substance. In an example scenario, the high- resolution images are generated based on executing a software application that can include 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. The high-resolution images can be evaluated by the computer and / or a lab technician to detect one or more microorganisms in the residual substance.

[0010] At least one technical advantage of the disclosed techniques herein relative to the prior art is that, with the disclosed techniques, waste associated with obtaining product samples from a product, particularly an expensive product, is reduced or eliminated.

[0011] Another technical advantage of the disclosed techniques herein relative to the prior art is that, with the disclosed techniques, product contamination that can potentially occur during prior art manual actions performed for obtaining samples is eliminated. More particularly, in accordance with the example embodiments described herein, a sample of the product is obtained via a sample tap of a product reservoir or a product conduit, passed through a removable microorganism filter, and returned to the product reservoir or the product conduit via an inlet port without requiring any manual intervention or manual contact.

[0012] These technical advantages provide one or more technological improvements over prior art approaches.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] 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.

[0014] FIG. 1 illustrates a block diagram of a system for obtaining a sample of a product according to an embodiment.

[0015] FIG. 2 shows a first example embodiment of the system illustrated in FIG. 1.

[0016] FIG. 3 shows a second example embodiment of the system illustrated in FIG. 1.

[0017] FIG. 4 shows an example removable microorganism filter that can be a part of the system illustrated in FIG. 1.

[0018] FIG. 5 shows an example microorganism trap system that includes a pair of removable microorganism filters in accordance with an embodiment.

[0019] FIG. 6 is a flow diagram of method steps for obtaining a sample of a product from a product reservoir or product conduit according to an embodiment.DETAILED DESCRIPTION

[0020] 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 case associated with a microscope, a Petri dish, and / or an imaging system, the inventive concepts described herein are broader than that particular use case and can be applied in any appropriate context / use case. More particularly, in certain instances, this application may refer to evaluating a sample using a Petri dish. In such instances, the sample can also be evaluated using ePetri technology such as 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.

[0021] Microbial contamination by, for example, Gram positive bacteria, Gram negative bacteria, fungi, yeasts, and molds, may cause severe illness and, in some cases, even death in human and animal subjects. Manufacturers in certain industries, for example, food, beverage, water, cosmetic, pharmaceutical, and medical device industries, must typically meet exacting standards to verify that their products do not contain levels of microbial contaminants that would otherwise compromise the health of a consumer or recipient. These industries require frequent, accurate, and sensitive testing for the presence of microbial contaminants to meet certain standards, such as, for example, standards imposed by the United States Food and Drug Administration or Environmental Protection Agency.

[0022] Depending upon the situation, the ability to distinguish between viable and nonviable cells can also be important. For example, during the manufacture of pharmaceuticals and biologies, it is important that the water used in the manufacturing process is sterile and free of contaminants. Furthermore, it is important that water contained in medicines (for example, liquid pharmaceutical dosage forms, biological dosage forms, and injectable dosage forms) and liquids (for example, saline) that are administered to a subject, is also sterile and free of contaminants. In order to be potable, drinking water must meet exacting standards. However, water obtained from a water supply may be deemed acceptable for human consumption when a small quantity of viable microorganisms is present. The water is deemed unfit for human consumption when the level of viable microorganisms exceeds a threshold level.

[0023] Similarly, the presence of certain predetermined levels of microorganisms in certain food products (for example, fresh produce) and drinks (for example, milk) may be acceptable. However, once those levels have been exceeded the food or drink may be considered to have spoiled and no longer be safe for human consumption.

[0024] Traditional cell culture methods for assessing the presence of microbial contamination and / or the extent of microbial contamination can take several days to perform, which can depend upon the organisms that are being tested for. During this period, the products in question (for example, the food, drink, or medical products) may be quarantined until the results are available and the product can be released. As a result, there is a need for systems and methods for rapidly detecting (for example, within hours or less) the presence and / or amount of microbial contaminants, in particular, viable microbial contaminants, in a sample. An important part of the process is capturing the cells to be analyzed, which must be completed in a quick, safe and consistent manner to enable the efficiency of the overall detection system and methods.

[0025] FIG. 1 illustrates a block diagram of an example system 100 for obtaining a sample of a product 105 according to an embodiment. The product 105 can be any material that is in a fluidic or semi-fluidic state, such as, for example, a liquid, a fluid, a gel, or a paste. In an example scenario, the product 105 can be a pharmaceutical product. The product 105 can be contained in any of various objects such as, for example, a reservoir (vat, container, tank, barrel, etc.) or a conduit (a pipe, a tube, a hose, etc.). More particularly in various embodiments, a sample of the product 105 is drawn from a container or a conduit via a sample tap 110. The sample tap 110 can include various components such as, for example, one or more outlet ports, hoses, pipes, valves, sterile connectors, and can also include a metering device that permits a preselected amount of the sample to be drawn from the reservoir or conduit. The sample tap 110 is coupled to a microorganism trap 115 via a conduit 111 (a flexible hose, a flexible pipe, or a rigid pipe, for example). When in operation, the sample of the product 105 passes from the sample tap 110 into the microorganism trap 115. The microorganism trap 115 includes a removable microorganism filter 120 that is configured to trap any residual substance that may be present in the sample while allowing the sample to flow through the removable microorganism filter 120 and out of the microorganism trap 115. The removable microorganism filter 120 can then be removed from the microorganism trap 115 and the residual substance transferred to a Petri dish, a microscope slide, or a cartridge, for examination under a microscope in order to detect any microorganism that may be present in the sample. The sample that has passed through the removable microorganism filter 120 isreturned by a sample return 125 via a conduit 112 (a flexible hose, a flexible pipe, or a rigid pipe, for example) back into the reservoir or conduit containing the product 105.

[0026] All the components of the system 100 that are in the flow path of the sample from the reservoir / conduit and back into the reservoir / conduit (sample tap 110, microorganism trap 115, and sample return 125) constitute a sterile closed loop configuration that provides a technical advantage in terms of preventing contamination of the sample from outside agents such as, for example, human touch. The system 100 provides another technical advantage in terms of preventing wastage of the product 105 when obtaining a sample of the product 105 to test for microorganism contaminants.

[0027] FIG. 2 shows a first example embodiment 200 of the system 100 that is described above. In this example embodiment, the product 105 referred to above is stored in a product reservoir 250 or obtained from a product conduit. The sample tap 110 includes a tap port 205, a flow meter 210, and optionally, a three-way valve. The tap port 205 can include a tap element (pipe stub, coupling, etc.) coupled to a first orifice provided in the product reservoir 250. The tap port 205 can further include one or more valves (pinch valves, inline shut-off valves, etc.) that can be used to stop an outflow of the product from the product reservoir 250 if necessary. The tap port 205 is coupled to a flow meter 210 by means of a conduit (flexible hose, a flexible pipe, or a rigid pipe, for example).

[0028] In one implementation, the flow meter 210 includes a control mechanism (valve, shut-off switch, etc.) that can be manually operated to allow a preselected amount of the sample to flow from the tap port 205 to the optional three-way valve 215. In another implementation, the flow meter 210 includes a control mechanism (valve, shut-off switch, etc.) that can be controlled by a computer to allow a preselected amount of the sample to flow from the tap port 205 to the optional three-way valve 215.

[0029] The three-way valve 215, which may be included in some implementations and omitted in some others, is operable (manually or by a computer) to allow a rinse agent 220 to flow through the microorganism trap system 115 after the sample of the product has passed through the microorganism trap system 115 and the removable microorganism filter 120 has been removed (or replaced after removal). The rinse agent 220, which can be distilled water, for example, flushes out the removable microorganism filter 120 and flows into the sample return 125. In this example embodiment, the sample return 125 includes an optional three- way valve 225, a peristaltic pump 235, and a return port 240. More particularly, after flushing out the removable microorganism filter 120, the rinse agent 220 passes through the optional three-way valve 225 and into a rinse sump 230 (or other disposal element such as a drain or anoutflow pipe).

[0030] The removable microorganism filter 120 includes one or more filters containing pores having one or more pore sizes selected to trap various types of microorganisms of interest. As indicated above, manufacturers in certain industries, for example, food, water, cosmetic, pharmaceutical, and medical device industries, must typically meet exacting standards to verify that their products do not contain levels of microbial contaminants that would otherwise compromise the health of a consumer or recipient. In an example implementation, the removable microorganism filter 120 includes at least one filter containing pores having a pore size ranging from 4-5 microns. In another example implementation, the removable microorganism filter can include a filter that is selected based on a contamination threshold associated with a pharmaceutical product. In this case, the contamination threshold may be set very low and correspondingly, a filter having a very small pore size (about 0.2 microns or smaller) is selected so as to ensure that the pharmaceutical product is very pure and free of contaminants.

[0031] When not performing a rinsing operation, the sample is sucked by the peristaltic pump 235 from the microorganism trap system 115 and conveyed to the return port 240 via the conduit 112. The return port 240 can include a tap element (pipe stub, coupling, etc.) coupled to a second orifice provided in the product reservoir 250. The return port can further include one or more valves (pinch valves, shut-off valves, etc.) that can be used to stop the sample of the product from re-entering the product reservoir 250 if so desired.

[0032] FIG. 3 shows a second example embodiment 300 of the system 100 that is described above. In this example embodiment, the product 105 referred to above flows through a product conduit 350, which can be, for example, a pipe in a production facility. The sample tap 110 includes a by-pass conduit 310 that is attached to, or is a part of, the product conduit 350. The flow meter 210 described above is operable to allow a sample of the product to be tapped from the product conduit 350 and routed to the microorganism trap system 115. A diameter of the by-pass conduit 310 can be selected based on various parameters such as, for example, a nature of the product (product consistency, flowability, etc.) and / or an amount of sample desired. The peristaltic pump 235 sucks the sample from the microorganism trap system 115 and into a conduit 315. The sample flows back into the product conduit 350 after passing through the peristaltic pump 235 and the by-pass conduit 316.

[0033] FIG. 4 shows an example removable microorganism filter 120 that can be a part of the microorganism trap system 115 in various embodiments. In the illustrated example, the removable microorganism filter 120 includes a coarse filter 405 located ahead or upstream of afine filter 415 in a series arrangement for passage of the sample though the removable microorganism filter 120. One or both of the coarse filter 405 and the fine filter 415 can be removed from the microorganism trap system 115 and any trapped residual substance can be examined for the presence of a microorganism in the manner described herein.

[0034] In an example implementation, the coarse filter 405 includes pores having a pore size of about 4.5 microns and the fine filter 415 includes pores having a pore size of about 0.2 microns. The coarse filter 405 traps larger size residual substances in the sample of the product such as large-sized microorganisms, substances that are irrelevant for detecting microorganisms (particles of and inorganic material, for example), and / or substances that may clog the fine filter 415.

[0035] The auxiliary functions 410 shown in dotted line is indicative of one or more of various types of mechanisms that may be inserted between the coarse filter 405 and the fine filter 415. One such element is a peristaltic pump that operates to suck the sample through the coarse filter 405 even when any residual substance(s) trapped in the coarse filter 405 offers resistance to the sample flow. Some other elements can include a flow meter, a line flushing mechanism, a rinsing mechanism, a debubbler mechanism, and a degassing mechanism.

[0036] In another embodiment more than two filters can be arranged in series with each other. Thus, for example, the removable microorganism filter 120 can be provided in the form of a filter chain that can include a first filter having a first pore size, a second filter having a second pore size that is smaller than the first pore size, a third filter having a third pore size that is smaller than the second pore size, and so on. One or more mechanisms associated with auxiliary function 410 can be included at one or more locations in such a filter chain to facilitate passage of the sample through the filter chain.

[0037] FIG. 5 shows another example microorganism trap system 115 in accordance with an embodiment. The microorganism trap system 115 includes a funnel shaped reservoir 520 that allows passage of the sample of a product into the coarse filter 405 (described above) followed by the fine filter 415 (described above) in a gravity-assisted flow. A vacuum pump 510 is coupled between the coarse filter 405 and the fine filter 415 in an arrangement that operates to suck the sample through the coarse filter 405 even when any residual substance(s) trapped in the coarse filter 405 offers resistance to the sample flow. One or both of the coarse filter 405 and the fine filter 415 can be removed from the microorganism trap system 115 and any trapped residual substance can be examined to detect microorganisms in the manner described herein.

[0038] FIG. 6 is a flow diagram of method steps for obtaining a sample of a product froma product reservoir or product conduit according to an embodiment. Although the method steps are described with respect to FIGS 1-5, persons skilled in the art will understand that any system configured to perform the method steps, in any order, is within the scope of the various embodiments. Step 605 involves obtaining a sample of the product from a product reservoir or a product conduit. Obtaining a sample of the product from a product reservoir is described above with reference to FIG. 2. Obtaining a sample of the product from a product conduit is described above with reference to FIG. 3. Step 610 involves passing the sample through a removable microorganism filter. This aspect is described above with reference to the removable microorganism filter 120. Step 615 involves returning the sample to the product reservoir or the product conduit after passage through the microorganism filter. This aspect is described above with reference to FIGs 1-3.

[0039] In sum, a method to evaluate a microorganism present in a product includes obtaining a sample of the product from a product reservoir or a product conduit, passing the sample through a removable microorganism filter, and returning the sample to the product reservoir or product conduit after passage through the microorganism filter. The sample can be obtained, for example, from a pharmaceutical product stored in the product reservoir or conveyed through the product conduit. In one implementation, a residual substance trapped in the removable microorganism filter after the sample has passed through the removable microorganism filter is transferred to a microscope slide. The microscope slide can be examined under a microscope to detect any microorganism present in the residual substance. In another implementation, a residual substance trapped in the removable microorganism filter after the sample has passed through the removable microorganism filter is transferred to a Petri dish. A growth agent such as agar is added to the Petri dish to encourage growth of microorganisms, if present in the residual substance. Periodically (hourly, or daily, for example) a portion of the residual substance is transferred from the Petri dish to a microscope slide. The microscope slide can be examined under a microscope to detect any microorganism if any are present in the residual substance. In yet another implementation, a residual substance trapped in the removable microorganism filter is transferred to a cartridge that is insertable into an imaging system that is configured to produce sub-pixel shifted images of the residual substance. A computer that is communicatively coupled to the specimen imaging system produces high-resolution images from the sub-pixel shifted images of the residual substance. The high-resolution images can be evaluated by the computer and / or by a lab technician to detect one or more microorganisms in the residual substance.

[0040] At least one technical advantage of the disclosed techniques herein relative to theprior art is that, with the disclosed techniques, wastage associated with obtaining product samples from a product, particularly an expensive product, is eliminated.

[0041] Another technical advantage of the disclosed techniques herein relative to the prior art is that, with the disclosed techniques, product contamination that can potentially occur during prior art manual actions performed upon a product for obtaining samples is eliminated. More particularly in accordance with the example embodiments described herein a sample of the product is obtained via a sample tap of a product reservoir or a product conduit, passed through a removable microorganism filter, and returned to the product reservoir or the product conduit via an inlet port without requiring any manual intervention or manual contact.

[0042] 1. In some embodiments, a method to evaluate a microorganism present in a product comprises obtaining a sample of the product from a product reservoir or a product conduit, passing the sample through a removable microorganism filter, and returning the sample to the product reservoir or the product conduit after passage through the removable microorganism filter.

[0043] 2. The method of clause 1, wherein the product is a pharmaceutical product.

[0044] 3. The method of clauses 1 or 2, wherein the removable microorganism filter comprises a filter that is selected based on a contamination threshold associated with the pharmaceutical product.

[0045] 4. The method of any of clauses 1-3, further comprising transferring a residual substance from the removable microorganism filter to one of a microscope slide or a Petri dish for evaluating the residual substance to detect a microorganism.

[0046] 5. The method of any of clauses 1-4, wherein the removable microorganism filter includes a plurality of filter pores, each filter pore ranging in size from about 0.2 microns to about 5 microns.

[0047] 6. The method of any of clauses 1-5, wherein the removable microorganism filter comprises a first filter having a first pore size and a second filter having a second pore size that is smaller than the first pore size.

[0048] 7. The method of any of clauses 1-6, wherein the first filter is located upstream of the second filter in a series arrangement for passage of the sample though the removable microorganism filter.

[0049] 8. The method of any of clauses 1-7, wherein a sample tap of the one of the product reservoir or the product conduit is coupled to the removable microorganism filter via a sterile tube that includes an inline shut-off valve.

[0050] 9. The method of any of clauses 1-8, further comprising transferring a residual substance from the removable microorganism filter to a cartridge that is insertable into an imaging system configured to produce sub-pixel shifted images of the residual substance, and detecting a microorganism based on evaluating high resolution images generated from the subpixel shifted images of the residual substance.

[0051] 10. The method of any of clauses 1-9, wherein obtaining the sample of the product further comprises configuring a flow meter to obtain a predetermined quantity of the sample from a sample tap coupled to the one of the product reservoir or the product conduit.

[0052] 11. In some embodiments, a system for evaluating a microorganism present in a product comprises a sample tap configured for obtaining a sample of the product from one of a product reservoir or a product conduit, a microorganism trap comprising a removable microorganism filter, the microorganism trap configured to enable passage of the sample through the removable microorganism filter, and a peristaltic pump configured for returning the sample to the one of the product reservoir or the product conduit after passage through the removable microorganism filter.

[0053] 12. The system of clause 11, wherein the product is a pharmaceutical product.

[0054] 13. The system of clauses 11 or 12, wherein the removable microorganism filter comprises a filter that is selected based on a contamination threshold associated with the pharmaceutical product.

[0055] 14. The system of any of clauses 11-13, wherein the removable microorganism filter includes a plurality of filter pores, each filter pore ranging in size from about 0.2 microns to about 5 microns.

[0056] 15. The system of any of clauses 11-14, wherein the removable microorganism filter comprises a first filter having a first pore size and a second filter having a second pore size that is smaller than the first pore size.

[0057] 16. The system of any of clauses 11-15, wherein the first filter is located upstream of the second filter in a series arrangement for passage of the sample though the removable microorganism filter.

[0058] 17. The system of any of clauses 11-16, wherein a sample tap of the one of the product reservoir or the product conduit is coupled to the removable microorganism filter via a sterile tube that includes an inline shut-off valve.

[0059] 18. In some embodiments, an apparatus for evaluating a microorganism present in a product comprises a microorganism trap that includes a first removable microorganism filterhaving a first pore size and a second microorganism filter having a second pore size that is smaller than the first pore size.

[0060] 19. The apparatus of clause 18, wherein the first microorganism filter is located upstream of the second microorganism filter in a series arrangement for passage of a sample of the product though the microorganism trap.

[0061] 20. The apparatus of clauses 18 or 19, further comprises a pump configured to suck the sample through at least one of the first microorganism filter or the second microorganism filter.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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-onlymemory (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.

[0066] 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. Such processors can be, without limitation, general purpose processors, special-purpose processors, application-specific processors, or field-programmable gate arrays.

[0067] 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.

[0068] 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 method to evaluate a microorganism present in a product, comprising: obtaining a sample of the product from a product reservoir or a product conduit; passing the sample through a removable microorganism filter; and returning the sample to the product reservoir or the product conduit after passage through the removable microorganism filter.

2. The method of claim 1, wherein the product is a pharmaceutical product.

3. The method of claim 2, wherein the removable microorganism filter comprises a filter that is selected based on a contamination threshold associated with the pharmaceutical product.

4. The method of claim 1, further comprising: transferring a residual substance from the removable microorganism filter to one of a microscope slide or a Petri dish for evaluating the residual substance to detect a microorganism.

5. The method of claim 4, wherein the removable microorganism filter includes a plurality of filter pores, each filter pore ranging in size from about 0.2 microns to about 5 microns.

6. The method of claim 4, wherein the removable microorganism filter comprises a first filter having a first pore size and a second filter having a second pore size that is smaller than the first pore size.

7. The method of claim 6, wherein the first filter is located upstream of the second filter in a series arrangement for passage of the sample though the removable microorganism filter.

8. The method of claim 1, wherein a sample tap of the one of the product reservoir or the product conduit is coupled to the removable microorganism filter via a sterile tube that includes an inline shut-off valve.

9. The method of claim 1, further comprising: transferring a residual substance from the removable microorganism filter to a cartridge that is insertable into an imaging system configured to produce subpixel shifted images of the residual substance; anddetecting a microorganism based on evaluating high resolution images generated from the sub-pixel shifted images of the residual substance.

10. The method of claim 1, wherein obtaining the sample of the product further comprises: configuring a flow meter to obtain a predetermined quantity of the sample from a sample tap coupled to the one of the product reservoir or the product conduit.

11. A system for evaluating a microorganism present in a product, comprising: a sample tap configured for obtaining a sample of the product from one of a product reservoir or a product conduit; a microorganism trap comprising a removable microorganism filter, the microorganism trap configured to enable passage of the sample through the removable microorganism filter; and a peristaltic pump configured for returning the sample to the one of the product reservoir or the product conduit after passage through the removable microorganism filter.

12. The system of claim 11, wherein the product is a pharmaceutical product.

13. The system of claim 12, wherein the removable microorganism filter comprises a filter that is selected based on a contamination threshold associated with the pharmaceutical product.

14. The system of claim 11, wherein the removable microorganism filter includes a plurality of filter pores, each filter pore ranging in size from about 0.2 microns to about 5 microns.

15. The system of claim 11, wherein the removable microorganism filter comprises a first filter having a first pore size and a second filter having a second pore size that is smaller than the first pore size.

16. The system of claim 15, wherein the first filter is located upstream of the second filter in a series arrangement for passage of the sample though the removable microorganism filter.

17. The system of claim 11, wherein a sample tap of the one of the product reservoir or the product conduit is coupled to the removable microorganism filter via a sterile tube that includes an inline shut-off valve.

18. An apparatus for evaluating a microorganism present in a product, comprising: a microorganism trap that includes a first removable microorganism filter having a first pore size and a second microorganism filter having a second pore size that is smaller than the first pore size.

19. The apparatus of claim 18, wherein the first microorganism filter is located upstream of the second microorganism filter in a series arrangement for passage of a sample of the product though the microorganism trap.

20. The apparatus of claim 19, further comprising: a pump configured to suck the sample through at least one of the first microorganism filter or the second microorganism filter.

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