Material lineage tracing

Abstract

A method for generating a report containing genealogical information of manufacturing materials used to manufacture a product manufactured through a manufacturing process comprising multiple steps. Each individual step comprises a successive sub-process. For each step, the method performs the steps of receiving data representing multiple characteristics associated with the successive sub-process of the individual step, inputting data into a computational sub-model, and receiving an intermediate record as an output representing genealogical information of at least some of the manufacturing materials after the completion of the successive sub-process of the individual step. Based on the intermediate record of at least the last step, the method generates a report containing genealogical information of the manufacturing materials used to manufacture the product after the completion of the multiple steps. The genealogical information of the report includes at least one manufacturing parameter of each material present in the product after the completion of the multiple steps.

Description

Technology Field

[0001] The present disclosure generally relates to tracking the flow of materials throughout a manufacturing process. More specifically, the present disclosure relates to the generation of a report containing genealogy information of manufacturing materials used to manufacture a product produced through a manufacturing process having successive steps. Background Technology

[0002] The manufacture of pharmaceuticals requires input materials (e.g., raw materials, semi-processed materials) received from various suppliers or processed on-site through preliminary processing steps to be processed into a batch of the finished product through a series of steps. Input materials may include raw materials received from multiple different suppliers, and each batch of raw materials may be associated with a different lot or batch number. U.S. FDA (Food and Drug Administration) regulations and GMP (Good Manufacturing Practices) require that each finished batch of a drug product be associated with an inventory report that details the lineage of the finished batch of the drug.

[0003] An inventory report detailing the lineage of a finished batch of medicine tracks information such as the quantity, material number, and feed input batch ID of each input material added to the finished batch of medicine. The material number can be used to accurately determine what type of input material was added to the finished batch of medicine and from which supplier it was procured. The feed input batch ID can be used to determine the exact shipment of raw materials received from the said supplier, which can identify when the shipment of raw materials was manufactured, when the shipment of raw materials was shipped, when the shipment of raw materials was received, and / or how the shipment of raw materials was transported. Specifying a list of the input materials of the finished batch of medicine in an inventory report is referred to as specifying the "material lineage" of the said finished batch of medicine.

[0004] According to an exemplary embodiment, a method for generating a report containing genealogical information of manufacturing materials used to manufacture a product manufactured through a manufacturing process, wherein the manufacturing process comprises a plurality of steps performed sequentially, and the method comprises: a step of receiving data indicating a plurality of characteristics associated with a successive subprocess of an individual step among the plurality of steps for each step of the manufacturing process—each individual step comprises a successive subprocess of the manufacturing process—wherein the plurality of characteristics include a set of materials used for the individual step; and configuration data indicating a configuration of at least one manufacturing component used for the individual step—; a step of inputting data into a computational sub-model configured to model how the set of materials used for the individual step propagates through the individual step; and a step of receiving an intermediate record as an output from the computational sub-model—wherein the intermediate record indicates genealogical information of at least some of the manufacturing materials used to manufacture the product after the completion of the successive subprocess of the individual step—; and a step of generating a report containing genealogical information of manufacturing materials used to manufacture a product after the completion of multiple steps of the manufacturing process, based on an intermediate record of the last step of at least the multiple steps of the manufacturing process - the genealogical information of the report includes at least one manufacturing parameter of each material present in the product after the completion of multiple steps of the manufacturing process.

[0005] According to another exemplary embodiment, as a system, the system comprises: at least one feeder tank for storing input materials fed into each of a plurality of steps of a manufacturing process—each individual step comprises a successive subprocess of the manufacturing process; at least one pump for controlling the feeding of input materials from at least one feeder tank to the individual step; and one or more sensors disposed on the at least one feeder tank and / or at least one pump and configured to generate data regarding the at least one feeder tank and / or at least one pump; at least one processor—the at least one processor receives at least a portion of the data generated by the one or more sensors. and, when executed by at least one processor, at least one non-transient computer-readable storage medium having encoded instructions that enable at least one processor to perform a method for generating a report including genealogical information of manufacturing materials used to manufacture a product manufactured through a manufacturing process, wherein the method comprises: a step of receiving data indicating a plurality of characteristics associated with a successive subprocess of an individual step among a plurality of steps for each step of a manufacturing process, wherein the plurality of characteristics include a set of materials used for the individual step; and setting data indicating a setting of at least one manufacturing component used for the individual step, wherein the setting data includes at least a portion of data generated by one or more sensors for the individual step; and a step of inputting data into a computational submodel configured to model how the set of materials used for the individual step propagates through the individual step.and a step of receiving an intermediate record as an output from a computational submodel—the intermediate record indicates lineage information of at least some of the manufacturing materials used to manufacture a product after the completion of a successive subprocess of an individual step—; and a step of generating a report containing lineage information of the manufacturing materials used to manufacture a product after the completion of a plurality of steps of the manufacturing process, based on the intermediate record of the last step of at least the plurality of steps of the manufacturing process—the lineage information of the report includes at least one manufacturing parameter of each material present in the product after the completion of the plurality of steps of the manufacturing process.;

[0006] According to another exemplary embodiment, there is at least one non-transient computer-readable storage medium having encoded instructions that, when executed by at least one processor, cause at least one processor to perform a method for generating a report containing genealogical information of manufacturing materials used to manufacture a product manufactured through a manufacturing process, wherein the manufacturing process comprises a plurality of steps performed sequentially, and the method comprises: a step of receiving data indicating a plurality of characteristics associated with a successive subprocess of an individual step among the plurality of steps for each step of the manufacturing process—each individual step comprises a successive subprocess of the manufacturing process—the plurality of characteristics include a set of materials used for the individual step; and configuration data indicating a configuration of at least one manufacturing component used for the individual step—; a step of inputting data into a computational submodel configured to model how the set of materials used for the individual step propagates through the individual step; and a step of receiving an intermediate record as an output from the computational submodel—the intermediate record indicates genealogical information of at least some of the manufacturing materials used to manufacture the product after the completion of the successive subprocess of the individual step—; and a step of generating a report containing genealogical information of manufacturing materials used to manufacture a product after the completion of multiple steps of the manufacturing process, based on an intermediate record of the last step of at least the multiple steps of the manufacturing process - the genealogical information of the report includes at least one manufacturing parameter of each material present in the product after the completion of multiple steps of the manufacturing process.

[0007] Techniques for generating a report containing genealogical information of manufacturing materials used to manufacture a product produced through a manufacturing process having various different features are disclosed herein, and it should be noted that these features may be combined into various different configurations, including configurations not specifically exemplified or discussed. While some different combinations of such features are described herein, a person skilled in the art will recognize that additional such combinations not explicitly described herein are also possible, made possible by the disclosures herein, and are within the scope of this application. Additionally, while various techniques for achieving the disclosed features are disclosed herein, a person skilled in the art will recognize that some modifications to the disclosed techniques are possible and may be within the scope of the disclosed techniques. Furthermore, it should be understood that the phrases and terms used herein are for illustrative purposes only and should not be construed as limiting. Brief explanation of the drawing

[0008] Various aspects, techniques, and embodiments of the technology disclosed herein are described below with reference to the accompanying drawings. It should be understood that the drawings are not necessarily drawn to scale. Items appearing in multiple drawings may be indicated by the same reference numeral. For clarity, not all components in all drawings may be labeled. Features of the technology will become more apparent, and techniques for achieving the features of the technology will be better understood by referring to the following detailed description, which is taken into account in conjunction with the accompanying drawings. FIG. 1 is an exemplary schematic diagram of a report containing lineage information of a product manufactured through a manufacturing process according to some embodiments of the technology described in this specification. FIG. 2 is an exemplary schematic diagram of a first step of a manufacturing process according to some embodiments of the technology described in this specification. FIG. 3a is an exemplary schematic diagram illustrating exemplary buffer tanks of a first feeder tank at a first time, according to some embodiments of the technology described herein. FIG. 3b is an exemplary schematic diagram illustrating exemplary buffer tanks of FIG. 3a at a second time, according to some embodiments of the technology described herein. FIG. 4 is an exemplary schematic diagram of a multi-stage manufacturing process according to some embodiments of the technology described in this specification. FIG. 5 is a flowchart of an exemplary method for generating a report containing lineage information of a product manufactured through a manufacturing process, according to some embodiments of the technology described in this specification. FIG. 6 is an exemplary schematic diagram illustrating aspects of a process for generating an intermediate record containing lineage information of a product following the completion of a first step of a manufacturing process, according to some embodiments of the technology described in this specification. FIG. 7a is an exemplary schematic diagram illustrating aspects of a process for generating a report containing product lineage information following the completion of a manufacturing process, according to some embodiments of the technology described herein. FIG. 7b is an exemplary schematic diagram illustrating embodiments of assigning virtual identifiers to products following the completion of individual steps of a manufacturing process, according to some embodiments of the technology described herein. FIG. 8a is an exemplary schematic diagram of an intermediate record for a first step of a manufacturing process according to some embodiments of the technology described in this specification. FIG. 8b is an exemplary schematic diagram of an intermediate record for a second stage of a manufacturing process according to some embodiments of the technology described herein. FIG. 8c is an exemplary schematic diagram of an intermediate record for a third step of a manufacturing process according to some embodiments of the technology described herein. FIG. 9 is an exemplary schematic diagram of a system for generating a report containing lineage information of a product manufactured through a manufacturing process, according to some embodiments of the technology described in this specification. FIG. 10 is an exemplary schematic diagram illustrating applications including a system for generating a report containing lineage information of a product manufactured through a manufacturing process, according to some embodiments of the technology described in this specification. FIG. 11 is a block diagram illustrating in detail embodiments of a controller that performs embodiments of the techniques for tracing material lineages described in this specification. Specific details for implementing the invention

[0009] Exemplary embodiments of techniques for tracing the material lineage of a finished batch of a drug are provided herein. In particular, aspects of the technique include techniques for generating a report containing lineage information of manufacturing materials used to manufacture a product manufactured through a manufacturing process having a plurality of consecutive steps. The lineage information of the report may include at least one manufacturing parameter (e.g., material number, supply input batch ID, and / or amount) of each material present in the product after the completion of the plurality of steps.

[0010] As stated herein, the FDA and GMP require that each finished batch of a drug be associated with an inventory report that details the lineage of the finished batch of the drug. Specifying a list of input materials for the finished batch of the drug in the inventory report (e.g., indicating the material number, supply input batch ID, and quantity of each input material in the finished batch of the drug) is referred to as specifying the "material lineage" of a specific batch of the finished drug.

[0011] Input materials may include raw materials that are input into a manufacturing process and processed in the manufacturing process. Input materials may include semi-processed materials produced from one or more raw materials (e.g., by combining two or more raw materials and / or processing one or more raw materials). If the input materials include semi-processed materials, the semi-processed materials may have an assigned supply input batch ID, and the one or more raw materials from which the semi-processed materials are produced have their own batch IDs. The supply input batch ID of the semi-processed materials may be associated with the batch ID of the one or more raw materials from which the semi-processed materials are produced.

[0012] Compiling the material lineage of a completed drug batch can be complex, for example, when the manufacture of a drug involves multiple consecutive steps. In a single consecutive step, input materials are introduced into the step through feeder tanks. When the feeder tanks run low, they are replenished with additional input materials. Whenever feeder tanks are replenished, they may be replenished with a batch of input materials having a different feed input batch ID. Each consecutive step of the manufacturing process may include multiple feeder tanks, and one or more of the feeder tanks may be replenished with a new batch of input materials at least once during the processing of a single consecutive step. In some cases, processing a batch of drug through a single consecutive step may take time (e.g., up to 5 hours).

[0013] Previously, since drugs were typically manufactured in batches that did not require replenishing the feeder tank at intermediate stages, specifying the material lineage of a batch of finished drugs could be accomplished relatively easily. However, specifying the material lineage of a batch of finished drugs manufactured using continuous manufacturing practices is considerably more complex, because the material lineage must take into account the time the feeder tank was replenished during the intermediate process and the amount of time required for such replenished materials to propagate through the manufacturing process. Accordingly, the inventors recognized the need for techniques to trace the material lineage of drugs manufactured using one or more continuous manufacturing processes.

[0014] Additionally, the manufacture of the drug may include a number of consecutive steps. For example, in some embodiments, the manufacture of the drug may be performed in at least three consecutive steps. Between each step, an intermediate product is collected in isolation tanks before being processed in the next consecutive step. The intermediate product collected in the isolation tanks can then be supplied to the next consecutive step.

[0015] The inventors recognized that tracing the material lineage of a finished batch of a drug is difficult due to (1) the sequential nature of each step of the manufacturing process and (2) the fact that the manufacturing process includes a number of such sequential steps. Accordingly, the inventors have developed techniques for automatically tracing the material lineage of a finished batch of a drug. For example, methods for generating a report containing lineage information of manufacturing materials used to manufacture a product produced through a manufacturing process comprising a number of steps performed sequentially are provided herein. Each individual step includes a sequential subprocess. The techniques include, for each step (1), receiving data indicating a plurality of characteristics associated with a successive subprocess of an individual step (e.g., a set of materials used for the individual step, setting data indicating the setting of at least one manufacturing component used for the individual step, such as pump speed, time when the feeder tank is refilled, etc.), inputting data into a computational submodel configured to model how the set of materials used for the individual step propagates through the individual step (e.g., a residence time distribution model for a specific step), and receiving, as output, an intermediate record indicating lineage information of at least some of the manufacturing materials used to manufacture a product after the completion of a successive subprocess of an individual step. The techniques further include generating a report containing lineage information of the manufacturing materials used to manufacture a product after the completion of a plurality of steps of the manufacturing process, based on the intermediate record of at least the last step. The lineage information of the report includes at least one manufacturing parameter (e.g., material number, supply input batch ID, quantity) of each material present in the product after the completion of a plurality of steps of the manufacturing process.

[0016] FIG. 1 is an exemplary schematic diagram of a report containing lineage information of a product manufactured through a manufacturing process according to some embodiments of the technology described herein. The report (100) illustrated in FIG. 1 may be referred to as a material lineage report. The report (100) describes in detail the lineage of a completed batch of a drug. In particular, the report includes lineage information of manufacturing materials used to manufacture the product after the completion of a plurality of consecutive steps of the manufacturing process.

[0017] As illustrated in FIG. 1, the report (100) includes multiple rows regarding each input material present in the finished batch of the drug. For each input material, the report (100) identifies the material number, batch identifier, and amount of the input material present in the finished batch of the drug. The report (100) illustrated in the illustrated embodiment provides the amount of each input material in kilograms, but other units of amount are also possible.

[0018] As described herein, a material number may be used to accurately determine what type of input material has been added to a finished batch of medicine and from which supplier it was procured. For example, a material number may be used to retrieve such information from a database that stores information relating the material number to a specific type of material and / or supplier. A batch identifier, also referred to herein as a “supply input batch ID,” may be used to determine the exact shipment of raw materials received from said supplier, which may be used to identify when the shipment of raw materials was manufactured, when the shipment of raw materials was shipped, when the shipment of raw materials was received, and / or how the shipment of raw materials was transported. For example, a batch identifier may be used to retrieve such information from a database that stores information relating the batch identifier to a specific shipment of raw materials. In some embodiments, the input material includes raw materials, and the supply input batch ID may directly correspond the input material to information regarding the raw materials. In some embodiments, the input material comprises a semi-processed material comprising one or more raw materials, and the supply input batch ID may correspond the input material to individual batch IDs of one or more raw materials from which the semi-processed material is made, and the individual batch IDs of one or more raw materials may be used to retrieve information regarding one or more raw materials.

[0019] As described herein, compiling the material lineage of a finished batch of a drug can be complex when the manufacture of the finished batch of the drug involves a number of consecutive steps. FIG. 2 is an exemplary schematic diagram of a first step of a manufacturing process according to some embodiments of the technology described herein. In the embodiment illustrated in FIG. 2, a first step ("Step 1") of a manufacturing process for manufacturing a drug is illustrated.

[0020] In each single consecutive "step," the drug is processed from left to right. At various stages of the step process, input materials are introduced into the step through feeder tanks. As illustrated in the illustrated embodiment, feeder tanks that allow input materials to be supplied to the step are schematically depicted. In the illustrated embodiment of FIG. 2, Step 1 includes two feeder tanks, but other configurations are possible.

[0021] Each feeder tank may be coupled to an individual pump for supplying the feed material from the feeder tank to the stage. For example, as schematically illustrated in FIG. 2, the first feeder tank is coupled to a first pump for supplying the feed material from the first feeder tank to the first mixer. The second feeder tank of FIG. 2 is coupled to a second pump for supplying the feed material from the second feeder tank to the first mixer. The feed material in the second feeder tank may be the same or a different type of material (e.g., having a different material number) as the feed material in the first feeder tank. The feed materials in the first and second feeder tanks may have different feed input batch IDs.

[0022] As illustrated in FIG. 2, the input material supplied to Step 1 through individual feeder tanks is supplied to a first mixer. The material, hereinafter referred to herein as an intermediate material to refer to the material processed through at least part of at least one step of the manufacturing process, may be mixed in the first mixer, for example, using an activator pump. In the embodiment illustrated in FIG. 2, the intermediate material is supplied from the first mixer to a second mixer, and the intermediate material is further mixed, for example, using a base pump. Subsequently, the intermediate material is supplied from the second mixer to a first plug flow reactor (PFR). Subsequently, the intermediate material is supplied from the first plug flow reactor to a surge vessel, also referred to herein as an isolation tank. The isolation tank collects the finished batch of material at the end of Step 1.

[0023] When the remaining amount of input material to be supplied to a stage in an individual feeder tank runs out, it is replenished with additional input material. Whenever feeder tanks are replenished, they may be replenished with a batch of input material having a different supply input batch ID. For example, a material having a first batch identifier may be supplied from a first feeder tank to a first mixer during a first duration of the first stage, which is shorter than the total duration of the first stage. At the end of the first duration, a second material having a second batch identifier may be supplied from a first feeder tank to a first mixer during a second duration, which is shorter than the total duration of the first stage. The second material may be a material of the same type as the first material (e.g., having the same material number). However, the second material may have a different batch identifier than the first material. In some embodiments, the second material may be a material of a different type from the first material (e.g., due to a change during an intermediate stage of the manufacturing process). The techniques described herein for tracing the material lineage of a batch of drugs determine the amount of a first material and the amount of a second material in the batch of drugs at the end of the first step.

[0024] FIGS. 3A and 3B illustrate embodiments of replenishing additional input material to the feeder tank during the first stage. For example, FIG. 3A is an exemplary schematic diagram illustrating an exemplary buffer tank of the first feeder tank at the first time, according to some embodiments of the technology described herein. For simplification, some components of the first stage are omitted from FIGS. 3A and 3B. In the exemplary embodiments of FIGS. 3A and 3B, the first feeder tank comprises a plurality of buffer tanks, each having an input material. At the first time illustrated in FIG. 3A, a first batch of input material (e.g., having a first supply input batch ID) is supplied from the first buffer tank of the first feeder tank to the first mixer. This can be achieved by activating at least one valve between the first buffer tank and the first mixer so that the material can flow from the first buffer tank to the first mixer.

[0025] The first feeder tank further includes a second buffer tank having a second batch of input materials. The second batch of input materials may be of the same type of material as the first batch of input materials in the first buffer tank (e.g., having the same material number), but may have a different supply input batch ID. At the first time illustrated in FIG. 3a, the second batch of materials in the second buffer tank cannot flow into the first mixer due to the configuration of at least one valve that blocks the flow of the second batch of input materials in the second buffer tank into the mixer.

[0026] FIG. 3b is an exemplary schematic diagram illustrating exemplary buffer tanks of FIG. 3a at a second time according to some embodiments of the technology described herein. Subsequently, the material in the first buffer tank may be depleted. At that time, the step may be configured to allow the material from the second buffer tank to flow into the first mixer. This may be achieved by activating at least one valve to allow a second batch of material to flow from the second buffer tank to the first mixer, as shown in FIG. 3b.

[0027] In this way, input materials are continuously supplied to the first stage over the duration of the first stage, despite the depletion of the first buffer tank. Therefore, the stage can be considered a "continuous" stage. That is, during the duration of the first stage, input materials are supplied to the stage at a constant rate and to the isolation tank from the subprocess at a constant rate. Due to the constant flow of materials to the first stage, the supply tanks for specific materials may need to be replenished with a new batch of materials during the first stage.

[0028] Similar to supply tanks, the isolation tank may include a plurality of buffer tanks. For example, the first stage may initially be configured such that a first buffer tank receives the intermediate product output from the first stage. When the first buffer tank is full, a second buffer tank may receive the intermediate product output from the first stage. When the second buffer tank is full, a third buffer tank may receive the intermediate product output from the first stage, and so on. The isolation tank may include any suitable number of buffer tanks (e.g., at least two, at least five, at least ten). The intermediate product collected in each buffer tank may be assigned an individual virtual identifier as described herein. For example, the batch of intermediate product collected in the first buffer tank may be VID001 AVID001 can be allocated, and for the batch of intermediate products collected in the second buffer tank B It is an example of what can be assigned.

[0029] As illustrated in FIG. 2, step 1 of the manufacturing process may include a plurality of sensors. In some embodiments, a system configured to perform the techniques described herein includes one or more sensors for each of the plurality of steps of the manufacturing process. The one or more sensors may include individual sensors associated with different components of the manufacturing process (e.g., individual feeder tanks, individual pumps, individual mixers, etc.). The one or more sensors may generate data associated with one or more of the components of the manufacturing process, for example, over the entire duration of step 1. In some embodiments, the data generated by the one or more sensors includes time-series data that tracks the state of one or more of the manufacturing components of step 1 over the entire duration of step 1.

[0030] Data generated by one or more sensors may be input into a computational submodel for Step 1, as described herein. For example, configuration data input into the computational model described herein may include at least a portion of the data generated by one or more sensors. As described herein, the computational submodel for Step 1 may be used to generate a record containing lineage information of an intermediate batch of drugs upon completion of Step 1. By generating a record using data generated by one or more sensors in the computational submodel, the generation of the record containing lineage information takes into account "live" data representing the actual operating conditions of Step 1. Instead of generating a report based on target operating parameters (e.g., desired pump speed, desired replenishment time of input material into the feeder tank) representing the intended manner in which the manufacturing process is to operate, the computational submodels utilize data indicating how the manufacturing process is actually performed by utilizing data from one or more sensors. Therefore, the resulting report displaying the material lineage of a finished batch of the drug is more accurate because it takes into account the actual operating conditions of the manufacturing process, which may include unintended or unexpected deviations from target operating conditions. Furthermore, the technologies for generating the report displaying the material lineage of the finished batch of the drug are not labor-intensive to produce because they automatically account for deviations from desired operating conditions when generating the report, rather than requiring manual corrections afterward.

[0031] In the embodiment illustrated in FIG. 2, each feeder tank of step 1 includes at least one sensor configured to track one or more states of the individual feeder tank throughout the entire duration of step 1. The sensor can track one or more states of the individual feeder tank to which it is attached. For example, the sensor can track characteristics of the feeder material in the feeder tank, such as volume, weight, or other suitable characteristics. One or more states of the feeder tank can be tracked by the sensor during the duration of the individual step. That is, data generated by the sensor includes time-series data representing characteristics of the individual step (e.g., volume, weight, etc. of the feeder material in the feeder tank). In this way, the sensor can track characteristics of the feeder tank over time, and deviations from desired values ​​can be detected. Data generated by the sensor attached to the feeder tank can indicate at least one time during the duration of the individual step when the feeder tank is replenished with a new batch of feeder material. For example, it can be determined that the feeder tank has been refilled by detecting an increase in the volume and / or weight of the input material in the feeder tank (which may exceed a threshold increase). The determined time for the feeder tank to be refilled can be used to detect any deviation from the target time at which the feeder tank is desired to be refilled under target operating conditions. The deviation from the target refill time can be input into a computational submodel for Step 1 so that the computational model can accurately track the material lineage of the intermediate batch of the drug at the completion of Step 1 in light of the deviation from the target refill time.

[0032] Each pump in Step 1 may also include one or more sensors configured to track the state of one or more individual pumps throughout the entire duration of Step 1. Each sensor may track the state of one or more of each pump to which it is coupled. For example, an individual sensor may track the pump speed of the individual pump to which it is coupled, for example, over the duration of the individual step. That is, the data generated by the sensor includes time-series data representing the pump speed of the individual pump over the entire duration of the individual step. In this way, the sensor may track the pump speed over the duration of the individual step, and deviations from the desired pump speed may be detected. The deviation from the target pump speed may be input into a computational submodel for Step 1, so that the computational model can accurately track the material lineage of the intermediate batch of the drug at the completion of Step 1 in light of the deviation in pump speed.

[0033] The use of one or more sensors illustrated in FIG. 2 is exemplary, and other configurations are possible. For example, fewer components than all components of Step 1 may have sensors associated with the components. In some embodiments, additional steps of the manufacturing process (e.g., all) may include one or more sensors associated with one or more (e.g., all) of the components of the individual steps (e.g., individual feeder tanks, individual pumps, individual mixers). For the sake of simplification of the example, one or more sensors are omitted from FIG. 3a and FIG. 3b illustrating aspects of the manufacturing process.

[0034] Each step of the manufacturing process may take several hours to complete. For example, it may take up to 5 hours to fully fill the isolation tank collecting the output of continuous step 1. During the duration of a single continuous step, one or more feeder tanks of the step may need to be refilled one or more times.

[0035] Manufacturing a finished batch of a drug may involve multiple steps. For example, in some embodiments, the manufacturing process for manufacturing the drug includes three consecutive steps (e.g., at least three, exactly three) such as Step 1 shown in FIG. 2. FIG. 4 is an exemplary schematic diagram of a multi-step manufacturing process according to some embodiments of the technology described herein.

[0036] An exemplary schematic diagram of FIG. 4 illustrates a manufacturing process for producing a product (e.g., a finished batch of a drug). In the embodiment illustrated in FIG. 4, the manufacturing process comprises a plurality of steps. Each step of the manufacturing process comprises a successive subprocess of the manufacturing process. For example, the manufacturing process includes a first step (“Step 1”) illustrated in FIG. 2 and described herein.

[0037] The manufacturing process illustrated by the schematic diagram of FIG. 4 illustrates the flow of materials through the manufacturing process. The flow of materials is from left to right in each row. For example, the manufacturing process may start at Step 1, where input materials are supplied to Step 1 through first and second feeder tanks. As described herein, intermediate materials are supplied from Step 1 to an isolation tank (the "surge vessel" in FIG. 4). Upon completion of Step 1, an intermediate batch of the drug at the completion of Step 1 is supplied to the next stage of the manufacturing process.

[0038] As illustrated in FIG. 4, an intermediate batch of the drug in the surge container of Step 1 is supplied to an intermediate processing sub-stage ("intermediate processing sub-stage A"). As described herein, the surge container of Step 1 may include a plurality of buffer tanks. The intermediate product in the surge container of Step 1 may be supplied to subsequent stages one buffer tank at a time. For example, the intermediate product in the first buffer tank of the isolation tank may be supplied to subsequent stages until the first buffer tank is depleted, at which point the intermediate product in the second buffer tank of the isolation tank may begin to be supplied to subsequent stages.

[0039] The intermediate processing sub-steps of the manufacturing process differ from the steps of the manufacturing process (e.g., steps 1-3) in that new materials are introduced into the product in steps 1-3, whereas new materials are not introduced into the product in intermediate processing sub-steps AC. The intermediate processing sub-steps may perform additional filtering and / or processing of the intermediate batch of drugs before supplying the intermediate batch of drugs to the second step. For example, intermediate processing sub-step A includes a first nanofiltration tank for performing nanofiltration of the intermediate batch of drugs before supplying the intermediate batch of drugs to the second step of the manufacturing process.

[0040] Subsequently, the manufacturing process includes a second stage ("Stage 2" in FIG. 4). The second stage may be configured similarly to the first stage described herein. However, in the second stage, an intermediate batch of the drug produced in the first stage serves as a source of input material for the second stage. That is, the intermediate batch of the drug produced in the first stage is supplied to the second stage through a feeder tank and pumped into a third mixer in the second stage. As described herein, the intermediate batch of the drug produced in the first stage may be supplied to the second stage one buffer tank at a time. Additional input material is supplied to the second stage through a third feeder tank coupled to a corresponding third pump. The processing of material through the second stage proceeds in the same or similar manner as the first stage described herein. The output of the second stage is collected in an isolation tank ("surge container") for the second stage. The surge container of the second stage may include a plurality of buffer tanks that are filled sequentially and assigned individual virtual identifiers.

[0041] The intermediate batch of the drug in the surge container of Step 2 is supplied to a subsequent intermediate processing sub-step (intermediate processing sub-step B). For example, the intermediate batch of the drug from Step 2 may be supplied to intermediate processing sub-step B one buffer tank at a time. Intermediate processing sub-step B may perform additional filtering and / or processing of the intermediate batch of the drug, as in intermediate processing sub-step A, before supplying the intermediate batch of the drug to the third step. For example, intermediate processing sub-step B includes a second nanofiltration tank for performing nanofiltration of the intermediate batch of the drug before supplying the intermediate batch of the drug to the third step of the manufacturing process.

[0042] Subsequently, the manufacturing process includes a third stage ("Stage 3" in FIG. 4). The third stage may be configured similarly to the first and second stages. For example, an intermediate batch of the drug produced in the second stage serves as a source of input material for the third stage. That is, the intermediate batch of the drug produced in the second stage is supplied to the third stage through a feeder tank and pumped to the fifth mixer of the third stage. This feeder tank of the third stage includes input materials supplied to individual stages from the first and second feeder tanks of the first stage and the third feeder tank of the second stage. The intermediate batch of the drug produced in the second stage may be supplied to the third stage one buffer tank at a time, as described herein. Additional input material is supplied to the fifth mixer of the third stage through a fourth feeder tank. The processing of materials through the third stage proceeds in the same or similar manner as the first and second stages described herein. The output of the third stage is collected in an isolation tank ("surge vessel") for the third stage. The isolation tank of the third stage may include a plurality of buffer tanks that can be filled sequentially and assigned individual virtual identifiers.

[0043] In some embodiments, the manufacturing process of FIG. 4 proceeds to one or more additional steps and / or intermediate processing substeps. For example, the output of the third step may be fed to an intermediate processing substep (intermediate processing substep C) for additional filtering and / or processing. The output of the third step may be fed to the intermediate processing substep C one buffer tank at a time. The final product of the manufacturing process may be isolated.

[0044] The final product of the manufacturing process is a finished batch of the drug. As illustrated in FIG. 4, the manufacturing process comprises a number of steps. Each step may include one or more feeder tanks for feeding input materials into individual steps. One or more of the individual feeder tanks may feed different types of input materials into individual steps. Each step of the manufacturing process may be continuous, that is, materials may flow in and out of the step throughout the duration of the step so that the input materials supplied to the step are replenished with additional input materials having different supply input batch IDs during the completion of the step. Thus, the final product of the manufacturing process comprises a finished batch of the drug having multiple input materials of different types (e.g., different material numbers). Additionally, the finished batch of the drug may have multiple input materials of the same type (e.g., the same material number) but from different batches (e.g., having different supply input batch IDs). Individual materials in the finished batch of the drug may exist in different amounts. The amounts of each material present in the finished batch of the drug depend on various settings of the manufacturing components of the manufacturing process, such as pump speed, the time for the feeder tank and / or buffer tank to be replenished with additional input material, tank size, and / or pipe diameter.

[0045] Tracking the material lineage of intermediate batches of a drug at the completion of each successive step of the manufacturing process and of the finished batch of the drug after the completion of all steps is challenging due to the numerous steps of the manufacturing process and their successive nature. However, such information is necessary to generate lineage reports required under FDA and GMP. Accordingly, the inventors have developed techniques for automatically tracking the material lineage of a drug batch. For example, FIG. 5 is a flowchart of an exemplary method for generating a report containing lineage information of manufacturing materials used to manufacture a product produced through a manufacturing process comprising a plurality of sequentially performed steps, according to some embodiments of the technique described herein. As illustrated and described in relation to FIG. 4, for example, the manufacturing process may comprise a plurality of steps, and each step may be sequential. Thus, the plurality of steps of the manufacturing process may be considered to comprise successive subprocesses of the overall manufacturing process.

[0046] The exemplary method (500) illustrated in FIG. 5 begins with an operation (502) in which data indicating a plurality of characteristics of an individual step is received for an individual step among a plurality of steps of a manufacturing process. The individual step may be a first step among the plurality of steps. Accordingly, the process (500) may begin by receiving data indicating a plurality of characteristics of a first step (e.g., "Step 1" illustrated in FIG. 2 and 4).

[0047] Multiple characteristics of an individual step are associated with a successive subprocess of the individual step. For example, the multiple characteristics may include a set of materials used for the individual step (e.g., a set of materials in the individual feeder tanks of the individual step supplied to the individual step during the completion of the successive subprocess). The set of materials may be indicated by a material number, a supply batch input ID, and / or an initial amount. In some embodiments, the multiple characteristics for the individual step include time series data indicating the time period during which an input material from the set of input materials is introduced to the individual step, the amount of input material introduced to the individual step, the material number of the input material introduced to the individual step, and the batch identifier of the input material introduced to the individual step. For example, data received in operation (502) may include event frame data containing the time series data described herein.

[0048] In some embodiments, supplying input materials to individual stages includes supplying input materials to individual stages during the duration of a first stage. Supplying input materials to stages during the duration of a first stage may include supplying a first batch of first input materials, of a set of materials having a first batch identifier, to individual stages during a first time period. At the end of the first time period, the supply tank may be replenished with a second batch of first input materials having a second batch identifier. In particular, the second batch may contain input materials of the same type as the first batch (e.g., having the same material number) but may have a different batch identifier from the first batch. Replenishing the supply tank with the second batch of input materials may include filling the supply tank with additional input materials at the end of the first duration. In some embodiments, as described herein, replenishing the feeder tank with a second batch of input material (e.g., as described in relation to FIG. 3a and FIG. 3b) involves activating a valve that allows input material from a second buffer tank of the first feeder tank to be supplied to the stage. The second batch of the first input material may be supplied to the stage during a second time period that is shorter than the duration of the individual stage and follows the first time period. The second time period may begin at the end of the first time period. A plurality of characteristics received in operation (502) may include individual time periods during which different batches of input material are supplied to the individual stage.

[0049] Multiple characteristics associated with successive subprocesses of individual steps may further include configuration data indicating the configuration of at least one manufacturing component used for the individual step. For example, at least one manufacturing component may include a pump, a tank (e.g., a feeder tank, a buffer tank, a mixer tank, etc.), a pipe, or another component of the individual step. The configuration data may include the pump speeds of individual pumps of the individual step (e.g., a first pump coupled to a first feeder tank, a second pump coupled to a second feeder tank, an activator pump coupled to a first mixer, a base pump coupled to a second mixer, etc.). For example, the configuration data may include time-series data indicating the pump speeds of the individual pumps over the entire duration of the step. The configuration data may include the time when the individual tanks are refilled (e.g., the time when the individual feeder tank is refilled, the time when the individual buffer tank is refilled). The setting data may include the time when an individual tank is coupled to the mixer (e.g., the time when at least one valve described herein is activated to couple an individual buffer tank to the mixer to allow material from an individual buffer tank to flow into the mixer through the valve). The setting data may include at least a portion of the data generated by one or more sensors of the individual steps as described herein.

[0050] Subsequently, the method (500) proceeds to operation (504), whereby data received in operation (502) is input into a computational submodel for individual steps. The computational submodel may be configured to model how a set of materials used for an individual step propagates through the individual step. In some embodiments, the computational submodel models how liquid materials are distributed and propagated through the individual step based on configuration data for the individual step (e.g., pump speeds used throughout the individual step, tank sizes, and / or pipe diameters).

[0051] For example, the computational submodel may include a residence time distribution model for individual steps. The residence time distribution model determines the probability distribution of the time a material is likely to remain in the process. In a manufacturing process such as the one described herein, which uses pumps to pump materials into individual steps, the speed of the pumps affects the residence time distribution model. Thus, the pump speed is one of a plurality of characteristics input into the computational submodel.

[0052] For each part of the material, the residence time distribution model can determine how long the corresponding part of the material stays in the stage before being discharged into the isolation tank. By knowing the length of time the part of the material stays in the stage and the initial time the part of the material is introduced into the stage, the computational submodel can determine whether the part of the material is in the isolation tank at the completion of the stage.

[0053] The computational submodel can generate an intermediate record indicating lineage information of at least some of the manufacturing materials used to manufacture a product after the completion of a successive subprocess of the individual step, based on which materials are determined to be in the isolation tank at the end of the individual step. Accordingly, in operation (506), the method (500) receives the intermediate record as an output from the computational submodel.

[0054] For example, FIG. 8a is an exemplary schematic diagram of a plurality of intermediate records for a first step of a manufacturing process according to some embodiments of the technology described herein. Specifically, FIG. 8a shows virtual identifiers VID001 A , VID001 B , and VID001 C Three intermediate records, each associated with, are illustrated. As described herein, the isolation tank of Step 1 may include a plurality of buffer tanks. During the processing of Step 1, the first buffer tank is filled with the intermediate product generated during Step 1 until it is full, at which point the intermediate product generated during Step 1 is input into the second buffer tank, and so on. An intermediate record may be generated for a batch of intermediate material within one buffer tank, and an individual virtual identifier may be assigned. For example, as illustrated in FIG. 8a, the material within the first buffer tank is assigned the virtual identifier VID001 to the first intermediate record. A Associated with, and the material in the second buffer tank is the second intermediate record assigned virtual identifier VID001 B Associated with, and the material in the third buffer tank is the third intermediate record assigned virtual identifier VID001 C It is related to.

[0055] Even if one buffer tank is in a process being filled with intermediate materials output from Step 1, another buffer tank may be in a process being emptied to Step 2. Thus, for example, as the second buffer tank is filled, the first buffer tank may be in a process being emptied to Step 2; as the third buffer tank is filled, the second buffer tank may be in a process being emptied to Step 2, and so on. When the third buffer tank is emptied to Step 2, the output of intermediate materials from Step 1 can be rerouted to the first buffer tank (which is now empty). Therefore, at that point, virtual identifier VID001 D(Not shown) may be assigned to a new batch of intermediate material collected in the first buffer tank. In this way, the virtual identifier associated with each buffer tank may not be static, but may change over time as new batches are circulated through each buffer tank. In the illustrated embodiment, three buffer tanks are described, but in some embodiments, more or fewer buffer tanks may be implemented.

[0056] Each of the intermediate records (810) of FIG. 8a includes a plurality of rows indicating a material number, a batch identifier, and a quantity (in kg) for each material present in the individual buffer tank of the isolation tank at the completion of the first stage. As described herein, the material number may be used to retrieve additional information (e.g., type of material, supplier, etc.) stored in a database corresponding to the material number. The batch identifier may be used to retrieve additional information (e.g., when the batch was manufactured, when the batch was shipped, when the batch was received, how the batch was transported, etc.) stored in a database corresponding to the batch identifier.

[0057] As shown in Fig. 8a, the intermediate record VID001 for Step 1 A indicates that the intermediate product in the first buffer tank comprises 8 kg of first material A1 associated with batch identifier B1, and 20 kg of second material A2 associated with batch identifier B3. Similarly, intermediate record VID001 for Step 1 C indicates that the intermediate product in the third buffer tank comprises 15 kg of first material A1 associated with batch identifier B2, and 3 kg of second material A2 associated with batch identifier B4. Intermediate record VID001 BThis indicates that two different batches of the first material A1 (e.g., having batch identifiers B1 and B2) are present in the intermediate product in the second buffer tank. During the processing of the intermediate product in the second buffer tank, the first material A1 may be supplied to the first stage through the first feeder tank. During the completion of the first stage, the first batch B1 of material A1 may be depleted and replenished with the second batch B2 of material A1. Thus, at the end of stage 1, the intermediate product in the second buffer tank contains multiple batches of the same material.

[0058] Intermediate Record VID001 B It further indicates that the intermediate product in the second buffer tank at the end of Step 1 contains the second material A2. Two different batches of the second material A2 (as indicated by different batch identifiers B3 and B4) are present in the intermediate product at the end of Step 1. This is due to replenishing a new batch of material A2 in the second feeder tank, which is configured to supply the second material A2 to Step 1 during the processing of the intermediate product in the second buffer tank and during the completion of Step 1. Thus, the intermediate product in the second buffer tank contains multiple materials, and for each material, contains multiple batches of that material.

[0059] Virtual Identifiers VID001 A , VID001 B , and VID001 C It serves as a cross-reference for intermediate records and the information within them. For example, intermediate record (810) "VID001 A The virtual identifier of "as described in this specification is the first intermediate record VID001 A It can be used in subsequent records to refer to the information within. The correspondence between a virtual identifier of a specific record and genealogical information regarding the materials described in that record can be stored in a database.

[0060] Operations (502-506) can be performed for each of the multiple steps of the manufacturing process. Accordingly, in operation (508), it is determined whether additional steps of the multiple steps of the manufacturing process remain.

[0061] In operation (508), if it is determined that additional steps remain, the method (500) returns to operation (502) via a "Yes" branch, and data indicating multiple characteristics for subsequent individual steps of the manufacturing process is obtained. Operations (502-506) may be repeated for each subsequent step of the multiple steps until operations (502-506) have been performed for each step of the manufacturing process and no additional steps remain.

[0062] For example, operations (502-506) may be performed for a second step of the manufacturing process described herein (e.g., with reference to FIG. 4) following the performance of operations (502-506) for a first step. Then, operations (502-506) may be performed for a third step of the manufacturing process described herein (e.g., with reference to FIG. 4) following the performance of operations (506) for a second step.

[0063] FIGS. 8B and 8C illustrate exemplary schematic diagrams of intermediate records for the second and third stages of the manufacturing process. For example, FIG. 8B shows a virtual identifier VID002 according to some embodiments of the technology described herein. A and VID002 B This is an exemplary schematic diagram of two intermediate records for the second stage of the manufacturing process associated with. Similar to Stage 1, VID002 A While can be associated with an intermediate record for the batch of intermediate products in the first buffer tank collecting the output of Step 2, VID002 BIt may be associated with an intermediate record for the batch of intermediate products in a second buffer tank that collects the output of step 2. The intermediate records indicate lineage information of the materials present in the intermediate products within individual buffer tanks at the completion of step 2. For example, the intermediate record (820) indicates the material number, batch identifier, and quantity of each material present in the intermediate products at the completion of step 2.

[0064] As illustrated in FIG. 8b, the intermediate records (820) for step 2 are virtual identifiers VID001 of the first intermediate records (810). A-C Refer to. For example, intermediate record VID002 A The intermediate product in the first buffer tank collecting the output from Step 2 is virtual identifier VID001 A 28 kg of intermediate product output from Step 1 associated with, and virtual identifier VID001 B Indicates that it includes 9 kg of intermediate product output from Step 1 associated with. Similarly, intermediate record VID002 B The intermediate product in the second buffer tank collecting the output from Step 2 is virtual identifier VID001 B 15 kg of intermediate product output from Step 1 associated with, and virtual identifier VID001 C Indicates that it includes 18 kg of intermediate product output from Step 1 associated with. VID001 A-C By referring to, the second intermediate records (820) for the second stage indicate that the intermediate product at the completion of stage 2 includes all the materials indicated in the first intermediate records (810) without the need to specifically refer to each of the materials. Virtual identifiers VID001 A-CIt can be used to identify each of the materials and their genealogical information indicated in the first intermediate records (810). In some embodiments, each of the materials and their genealogical information indicated by the first intermediate record (810) may be explicitly included in the second intermediate record (820) instead of being referenced by their individual virtual identifiers. As illustrated in FIG. 8b, the second intermediate records (820) may include virtual identifiers VID002 that can be used in subsequent records to reference information within the second intermediate records (820). A-B Includes. VID002 A can be assigned to the intermediate product in the first buffer tank of the isolation tank of Step 2, and VID002 B It can be assigned to the intermediate product in the second buffer tank of the isolation tank in Step 2. As discussed above for Step 1, the virtual identifier associated with each buffer tank may not be static and may change over time as new batches are circulated through each buffer tank.

[0065] As illustrated in FIG. 8b, at the completion of the second stage, the intermediate product comprises all the materials present in the intermediate product at the completion of the first stage, in addition to the additional materials added to the product during the second stage. For example, a third type of material (indicated by material number A3) may be added to the second stage via a third feeder tank, as described herein. Multiple different batches of the third material A3 (as indicated by batch identifiers B5 and B6) are present in the intermediate product at the completion of the second stage (for example, due to replenishing the third feeder tank with a new batch of input material during the completion of the second stage).

[0066] FIG. 8c is an exemplary schematic diagram of intermediate records for a third stage of a manufacturing process according to some embodiments of the technology described herein. Specifically, FIG. 8c shows virtual identifiers VID003 A and VID003 B Two intermediate records associated with each are illustrated. The intermediate record (830) displays genealogical information of the materials present in the intermediate product at the completion of the third stage. For example, the intermediate record (830) displays the material number, batch identifier, and quantity of each material present in the intermediate product at the completion of the third stage.

[0067] As illustrated in FIG. 8c, the intermediate records (830) are virtual identifiers VID002 of the second intermediate record (820). A-B Refer to VID002 A-B By referring to, the third intermediate record (830) for the third stage indicates that the intermediate product at the completion of stage 3 includes all of the materials without the need to specifically refer to each of the materials indicated in the second intermediate record (820). Virtual identifiers VID002 A-B It may be used to identify each of the materials and their genealogical information indicated in the second intermediate record (820). In some embodiments, each of the materials and their genealogical information indicated by the first intermediate record (810) and / or the second intermediate record (820) may be explicitly included in the third intermediate record (820) instead of being referenced by virtual identifiers. As illustrated in FIG. 8c, the third intermediate record (830) may be used in subsequent records to reference information within the third intermediate record (830) using virtual identifiers VID003. A-B Includes. For example, VID003 A may refer to an intermediate batch of the product in the first buffer tank of the isolation tank of Step 3, and VID003 Bmay refer to an intermediate batch of the product in the second buffer tank of the isolation tank of step 3. Additionally, as discussed above for steps 1 and 2, the virtual identifier associated with each buffer tank may not be static and may change over time as new batches are circulated through each buffer tank.

[0068] As illustrated in FIG. 8c, the third intermediate record (830) refers to the virtual identifier VID002 of the second intermediate record (820). As described herein, the second intermediate record (820) refers to the first intermediate record (810), and thus the materials present in the intermediate product after the completion of the third stage include materials supplied to the first stage (e.g., through the first and second feeder tanks), materials supplied to the second stage (e.g., through the third feeder tank), and materials supplied to the third stage (e.g., through the fourth feeder tank). For example, as described herein, a material of the fourth type (indicated by material number A4) may be added to the third stage through the fourth feeder tank. Multiple different batches of the fourth material A4 (as indicated by batch identifiers B7 and B8) are present in the intermediate product at the completion of the third stage (for example, due to replenishing the fourth feeder tank with a new batch of input material during the completion of the third stage).

[0069] As illustrated in FIGS. 8a through 8c, intermediate records of subsequent steps of the manufacturing process may refer to previous steps of the manufacturing process (e.g., using virtual identifiers). Accordingly, in some embodiments, data input into the computational submodel of the subsequent step may include lineage information of the intermediate product after the completion of the previous step. This can be accomplished by inputting the intermediate records of the previous step into the computational submodel of the subsequent step.

[0070] In operation (508), if it is determined that no additional steps of the manufacturing process remain, the method (500) proceeds to operation (510) via a “No” branch, and a report is generated that includes lineage information of the manufacturing materials used to manufacture the product after the completion of multiple steps of the manufacturing process. For example, the lineage information of the report generated in operation (508) may include at least one manufacturing parameter of each material present in the product after the completion of multiple steps of the manufacturing process. The manufacturing parameter may include the material number, batch identifier, and / or quantity of each material present in the product after the completion of multiple steps.

[0071] The report (100) illustrated in FIG. 1 is an example of a report that can be generated in operation (508). For example, the report (100) indicates the material number, batch identifier, and quantity (in kg) of each material present in the finished batch of the drug after the completion of a plurality of steps of the manufacturing process (e.g., the manufacturing process illustrated and described in FIG. 4). As described herein, the material number and batch identifier may be used to determine additional information regarding each material present in the finished batch of the drug.

[0072] Generating a report in operation (508) is performed based on at least the intermediate record of the final stage. Referring to the exemplary manufacturing process described herein (e.g., with reference to FIG. 4), “Stage 3” may be the final stage of the manufacturing process. Accordingly, the third intermediate record (830) may be the intermediate record of the final stage upon which the report generated in operation (508) is based. For example, if the third stage is the final stage of the manufacturing process, the third intermediate record (830) displays lineage information for each of the materials present in the finished batch of the product, as well as for each of the materials. The report (100) is virtual identifiers VID002 A-BIt can be generated by replacing with information represented by virtual identifiers (e.g., information in an appropriate second intermediate record (820)). The second intermediate record also includes virtual identifiers VID001 A-C Because it includes virtual identifiers VID001 included in the second intermediate record A-C It may also be replaced with information represented by a virtual identifier in the first report. Accordingly, the report (100) may be generated based on an intermediate record of the last step among at least a plurality of steps. When the intermediate record of the last step includes a reference to an intermediate record of one or more of the steps preceding the last step (e.g., a virtual identifier described herein), generating a report containing genealogical information is additionally based on the intermediate records of said one or more steps preceding the last step.

[0073] It should be noted that virtual identifiers may not be used in some embodiments. Additionally, in some embodiments, virtual identifiers in the intermediate record may be replaced after the completion of all steps of the manufacturing process in operation (508) and before generating a report containing lineage information of materials in the finished batch of the drug. For example, the intermediate record for the final step may be generated without using virtual identifiers. In particular, generating the intermediate record for the final step may involve replacing any existing virtual identifiers with their corresponding information. In such embodiments where the intermediate record for the final step does not contain any virtual identifiers, the intermediate record for the final step may be a report generated in operation (508).

[0074] Accordingly, the method (500) provides a method for generating a report containing lineage information of manufacturing materials used to manufacture a product manufactured through a manufacturing process comprising a plurality of consecutive steps. The method described herein overcomes the challenge of tracing material lineage throughout a multi-stage manufacturing process in which each step is consecutive (e.g., having output and supplied materials throughout the steps such that input materials must be replenished with new batches during the completion of the steps). Using a computational submodel to generate reports displaying material lineage information for intermediate products at the completion of each step eliminates the need to determine material lineage information through a cumbersome manual process. Rather, by inputting specific data (e.g., sets of materials used, time frames indicating when such materials are fed into the feeder tank, pump speeds, pipe diameters, etc.) into the computational submodel at each step, the composition of the final product of each step can be automatically determined.

[0075] A method for generating a report containing genealogical information of manufacturing materials used to manufacture a product produced through a manufacturing process may be implemented in software. For example, embodiments of the technology described herein include at least one non-transient computer-readable storage medium having encoded instructions that, when executed by at least one processor, cause at least one processor to perform any of the methods described herein.

[0076] Aspects of the technology described herein further include systems comprising at least one processor and at least one non-transient computer-readable storage medium. The system may include one or more (e.g., all) of the components of the manufacturing process illustrated in FIG. 4. For example, the system may include one or more pumps, one or more feeder tanks, one or more isolation tanks, etc. FIG. 4 illustrates a controller (1100). The system may include at least one controller (1100). The controller (1100) may include at least one processor and a memory having instructions that execute the methods described herein (e.g., method (500)) when executed by at least one processor. The controller (1100) further includes the subcomponents described herein in relation to FIG. 11.

[0077] FIG. 6 is an exemplary schematic diagram illustrating aspects of a process for generating an intermediate record containing lineage information of a product following the completion of a first stage of a manufacturing process, according to some embodiments of the technology described herein. In particular, FIG. 6 illustrates a schematic diagram of a process for generating lineage information of manufacturing materials in a product after the completion of a first stage of a manufacturing process.

[0078] As illustrated in FIG. 6 and described herein, step 1 of the manufacturing process comprises a plurality of “feeds” of input materials into the step. That is, step 1 comprises a plurality of feeder tanks that supply input materials to step 1. The input materials from the feeds are fed into a plug flow reactor (PFR) and processed in the PFR. The processed materials are output from the PFR to a surge vessel, also referred to herein as an isolation tank. The contents of the isolation tank (e.g., intermediate materials and their lineage information) are assigned a virtual identifier, as described herein. In particular, the isolation tank may comprise a plurality of buffer tanks, and an individual virtual identifier may be assigned to the contents of each buffer tank. In the illustrated embodiment, the virtual identifier “VID001” is assigned to the contents of the isolation tank after the completion of the first step.

[0079] The process illustrated in FIG. 6 includes inputting data into a computational submodel for a first step of a manufacturing process and outputting data from the computational submodel for the first step. As illustrated in FIG. 6, the input data for the computational submodel for step 1 includes initial conditions and processes the inputs and measurements of the first step. For example, the input data may include configuration data indicating a set of materials used for an individual step and a configuration of at least one manufacturing component used for the first step. Such information may include time-series data indicating materials supplied to the step, including pump speeds, pipe diameters, material numbers and / or supply input batch IDs, the duration for which a specific material is supplied to the first step, which may be in the form of event frames as described herein, and / or valve activity (e.g., indicating the time when a valve is opened / closed to allow / restrict the flow of material from a buffer tank to the step).

[0080] The output of the computational submodel for a step includes the contents of one or more components of the step. For example, the output of the computational submodel includes information regarding the contents of a surge container (also referred to herein as an "isolation tank") at the end of the first step. Information regarding the contents of the surge container may be reflected in an intermediate report containing genealogical information of the materials present in the intermediate product after the completion of the first step. The output of the computational submodel may further include information regarding the contents of other equipment in the step. For example, the computational submodel may include a residence time distribution model that estimates the residence times of parts of the material throughout the step. By understanding the residence times of parts of the material throughout the step, the computational submodel can determine which material and what amount thereof is present in each part of the step (e.g., a piece of equipment) at a specific time. Such information may be used to generate error reports and / or to prepare equipment for subsequent rounds of the manufacturing process.

[0081] As described herein, a manufacturing process for producing a finished batch of a drug may include a plurality of sequentially performed steps. A computational submodel may be used for each of the plurality of steps to determine product lineage information following the completion of an individual step. FIG. 7a is an exemplary schematic diagram illustrating an aspect of a process for generating a report containing product lineage information following the completion of a manufacturing process. The manufacturing process of FIG. 7a corresponds to the manufacturing process illustrated and described in FIG. 4. FIG. 7a illustrates that individual computational submodels may be used to determine product lineage information at each step comprising intermediate processing substeps AC. The intermediate processing substeps may perform filtration, separation, and / or processing steps (e.g., nanofiltration as indicated by "NF" in FIG. 7a). The output of each model (e.g., material lineage information generated at the end of each step and / or a report containing such information) contains an individual virtual identifier (e.g., VID001 A , VID001 B , VID002 e , VID002 e , VID003 A etc. can be assigned.

[0082] FIG. 7b is an exemplary schematic diagram illustrating embodiments of assigning virtual identifiers to a product following the completion of individual steps of a manufacturing process, according to some embodiments of the technology described herein. As described herein, the output of each model for each individual step may be assigned a virtual identifier (e.g., VID001). For example, each individual filling of a buffer tank of an isolation tank may be assigned an individual virtual identifier (e.g., VID001 A , VID001 B , VID001 C(etc.) may be assigned. The first continuous manufacturing (CM) stage may be assigned VID001. The first nanofiltration (NF) intermediate processing substage (intermediate processing substage A) following the first CM stage may be assigned VID001'. Since the first NF intermediate processing substage follows the CM stage, the contents of the product at the completion of the first NF intermediate processing substage depend on the contents of the product at the completion of the first CM stage. That is, since the contents output from the first CM stage are fed into the first NF intermediate processing substage, the virtual identifier VID001' for the first NF intermediate processing substage may consider the virtual identifier VID001 of the first CM stage. As the manufacturing process proceeds through additional CM stages and NF intermediate processing substages, each subsequent stage must consider all of the preceding stages. Upon completion of the manufacturing process (e.g., upon completion of the third CM stage), a final virtual identifier VID003' is assigned to an isolated batch of the finished drug. The final virtual identifier VID003' takes into account the output of each stage completed in the manufacturing process. A report displaying lineage information (e.g., material number, supply input batch ID, quantity) for each material in the finished batch of the drug can be generated based on the final virtual identifier VID006.

[0083] FIG. 9 is an exemplary schematic diagram of a system for generating a report containing lineage information of a product manufactured through a manufacturing process, according to some embodiments of the technology described herein. The system (900) illustrated in FIG. 9 is a material tracing system configured to perform the technologies for tracing the material lineage of a product described herein. The system (900) provides a platform for storing and executing the material tracing models described herein. The system (900) can be accessed through a web user interface (UI) using a web browser.

[0084] As illustrated in FIG. 9, the system (900) includes a historian platform (910), an interface platform (920), and a model platform (930). Each of the components of the system is configured to communicate with one another. For example, the interface platform (920) may be configured to communicate with the historian platform (910) (e.g., to request data from the historian platform (910)), and the historian platform (910) may be configured to provide data to the interface platform (920). The interface platform (920) may be configured to provide data to the model platform (930) and receive data from it. Thus, the interface platform (920) may serve as an interface between the historian platform (910) and the model platform (930).

[0085] The historian platform (910) is a source of data for the interface platform (920), and the interface platform (920) provides data to the model platform (930). In particular, the historian platform (910) may include a data historian (e.g., as one example, an OSi Pi data historian). The historian platform (910) may be configured to provide time-series data to the interface platform (920) that can be used as model input. The historian platform (910) may include a data source provider that enables the retrieval of asset framework data (e.g., a PI OLEDB enterprise provider) and a data source provider that enables the retrieval of time-series data from a data archive (e.g., a PI OLEDB provider). The historian platform (910) tracks which input materials (each associated with a material number and a supply input batch ID) are introduced into the supply tank of the individual stage while processing the medicine at the individual stage.

[0086] The historian platform (910) is processed by the interface platform (920) and then used by the model platform (930) to generate data structures that generate lineage information. In particular, the data structures generated by the historian platform (910) are referred to as "event frames." An event frame is a time window of information extending from the start of a stage to the end of a stage. The event frame time window begins when the individual buffer tanks of the isolation tank begin to be filled with intermediate product output from the individual stage. The event frame ends when the buffer tanks of the isolation tank are filled (e.g., no additional material is supplied from the stage into the individual buffer tanks). A subsequent event frame may begin when intermediate material is supplied from the stage into the second buffer tank of the isolation tank. The event frame contains time-series data representing all inputs to the stage during the time window of the event frame. For example, the event frame contains time-series data representing the pump speeds of each pump operating during the time window. The event frame contains information indicating when a batch of input material is depleted and when a new batch of input material is supplied to the stage.

[0087] As described in this specification, the Historian platform communicates event frame data to the interface platform (920). The interface platform (920) receives event frame data from the Historian platform (910). The interface platform (920) may optionally perform processing on the event frame data received from the Historian platform (910) before transmitting the event frame data to the model platform (930). An exemplary embodiment of the interface platform is business automation workflow (BAW) software produced by IBM.

[0088] The interface platform (920) may include a programmable operating system that enables the two software applications to operate together by providing the output of one software application to another software application. The interface platform (920) may monitor model execution by the model platform (930). The interface platform (920) may further complete user tasks regarding the material lineage tracing processes described herein. For example, a user interface may be provided as part of a system for interfacing with the interface platform (920). Through the user interface, the user may monitor, manage, and document the completion of model tasks.

[0089] The model platform (930) includes software configured to execute a model. For example, the model platform (930) includes software configured to execute computational submodels for individual steps of the manufacturing process described herein. The model platform (930) receives processed event frame data provided by the interface platform (920) and executes one or more models based on the event frame data. In particular, the model platform (930) may execute a dwell time distribution model on the input data to generate material lineage information of a batch of intermediate products resulting from a single execution of a successive step. The model platform (930) may then transmit the results of the model execution back to the interface platform (920). This process may be repeated for each batch of event frame data generated by the historian platform (910). For example, the model platform (930) may execute individual models on the event frame data corresponding to each individual step of the manufacturing process and transmit the results of the model execution back to the interface platform (920) for each step.

[0090] The task of the model requires modeling how long it takes for input materials introduced into the feeder tank to propagate through the entire continuous stage and end with a batch of intermediate products collected in the isolation tank at the end of the stage. For example, consider a batch of products processed through continuous stage 1. The output of this batch is collected in the isolation tank at the end of stage 1. Stage 1 starts execution at time T0, and at time T F Assume that it terminates at. Also, at time T0, a specific feeder tank A was initially filled with input material having supply input batch ID "X", but at time T in the middle of consecutive step 1 N (i.e., T0 < T N < T F Assume that in ), the supply of material X in feeder tank A is exhausted, and feeder tank A is switched to provide input material with supply input batch ID "Y".

[0091] The task of the model is processing in time T F When terminating at the end of Step 1, the task is to model how the liquid materials are dispersed and propagated during the processing of Step 1 in order to estimate the number of kilograms of material "X" versus the number of kilograms of material "Y" that have ended in the isolation tank at the end of Step 1. The model must do this not only for materials X and Y and feeder tank A, but also for all feeder tanks that supply input materials at any point to Step 1. This task requires considering pump speeds, tank sizes, pipe diameters, etc., throughout Step 1.

[0092] The output of the model platform is the material lineage of the product collected in the isolation tank at the end of Step 1. This process can be repeated for the remaining steps of the manufacturing process to reach the final material lineage of the finished drug at the end of the last step of the manufacturing process.

[0093] The interface platform (920) receives the results of the model execution from the model platform (930). In some embodiments, the results of the model execution for each step include an intermediate record containing lineage information of each material present in the intermediate batch of the drug after the completion of the individual step, as described herein. The interface platform (920) can compile a report containing lineage information of each material present in the completed batch of the drug based on the intermediate records for each step. The interface platform (920) can update inventory information based on the materials indicated as used in the manufacturing process. For example, the material lineage report can be used to update the SAP for inventory adjustment and to record the material lineage.

[0094] In some embodiments, the system (e.g., interface platform (920)) may propose investigation-based detection of logical errors, such as missing virtual identifiers or mismatched batches. Additionally, the system may rerun the computational model to modify and / or generate new intermediate records (e.g., updated intermediate records for individual steps of the manufacturing process). For example, the user may detect errors in operating conditions that were not considered by the model during the initial execution (e.g., leakage in a tank causing missing material). The user may rerun the model with additional information regarding the error (e.g., information regarding missing material) so that the intermediate report generated by the model takes into account the errors in operating conditions raised by the user.

[0095] For example, one or more sensors may be associated with each individual step of the manufacturing process. One or more sensors may track the state of one or more components of an individual step (e.g., at least one feeder tank configured to store input materials fed into the individual step, at least one pump configured to pump input materials into the individual step). In some embodiments, there is a sensor placed on each pump of the individual step. The sensor may track the state of one or more of the individual pumps to which it is coupled. For example, the sensor may track the pump speed of the individual pump to which it is coupled over the duration of the individual step. That is, the data generated by the sensor includes time-series data representing the pump speed of the individual pump over the duration of the individual step. In this way, the sensor may track the pump speed over the duration of the individual step, and deviations from the desired pump speed may be detected.

[0096] In some embodiments, there is a sensor placed on each individual feeder tank of an individual stage. The sensor can track one or more states of the individual feeder tanks to which it is coupled. For example, the sensor can track characteristics of the feeder material in the feeder tank, such as volume, weight, or other suitable characteristics. One or more states of the feeder tanks can be tracked by the sensor during the duration of the individual stage. That is, data generated by the sensor includes time-series data representing characteristics of the individual stage (e.g., volume, weight, etc. of the feeder material in the feeder tank). In this way, the sensor can track characteristics of the feeder tank over time, and deviations from desired values ​​can be detected. For example, data generated by a sensor coupled to the feeder tank may represent at least one time during the duration of the individual stage when the feeder tank is replenished with a new batch of feeder material. For example, it can be determined that the feeder tank has been replenished by detecting an increase in the volume and / or weight of the feeder material in the feeder tank (which may exceed a threshold increase). The determined time for the supply tank to be refilled can be used to detect any deviation from the target time at which the supply tank is desired to be refilled.

[0097] Data generated by one or more sensors may be input into a computational submodel for the individual steps described herein. For example, the configuration data described herein includes, in some embodiments, at least a portion of the data generated by one or more sensors. In this way, the computational submodel considers "live" data representing the operation of the manufacturing process. Instead of operating only on target operation parameters (e.g., desired pump speed, desired replenishment time) that indicate how the manufacturing process is intended to operate, the computational submodels utilize data that indicates how the manufacturing process is actually performed. Therefore, the resulting report showing the material lineage of the finished batch of the drug is more accurate because it considers the actual operating conditions of the manufacturing process. Furthermore, the techniques for generating the report showing the material lineage of the finished batch of the drug are not labor-intensive to produce because they automatically account for deviations from the desired operating characteristics when generating the report, rather than requiring manual corrections afterward.

[0098] FIG. 10 is an exemplary schematic diagram illustrating an application comprising a system for generating a report containing lineage information of a product manufactured through a manufacturing process, according to some embodiments of the technology described herein. The schematic diagram of FIG. 10 illustrates applications performed by components of the exemplary system (900) described herein. For example, FIG. 10 illustrates a historian platform that generates event frame data (e.g., OSIsoft PI data historian in the illustrated embodiment). The event frame data generated by the historian platform is communicated to an interface platform that processes data (e.g., a business automation workflow in the illustrated embodiment). For example, in the illustrated embodiment, a BAW connects to OSIsoft PI using a SQL Server linked server and retrieves event frames that describe data related to unit operations involved in model execution. The event frames contain attribute data and specify PI points to be retrieved during the event frame time period. When an event frame is closed (i.e., completed), the event frame is associated with a unique human-readable label called a Virtual Identifier (VID). The attributes, time series data, and VID are then written to a file and forwarded to a model platform (e.g., Domino in the illustrated embodiment) as input for model execution.

[0099] As described in this specification, processed event frame data can be communicated by an interface platform to a model platform (e.g., the Domino platform in the illustrated embodiment) capable of executing a model based on the event frame data. For example, in the illustrated embodiment, the BAW is integrated with Domino by invoking model execution and retrieving results. Model configurations and data from previous model executions are stored in Domino and are automatically provided to the model during execution. The entire dataset used during each model execution is stored in Domino. Results generated by the model execution are stored by the BAW in a SQL Server database. SQL Server is a relational database management system.

[0100] The SQL Server database serves as the database for the material tracking process. Where possible, the system does not replicate source system data. Rather, it stores metadata that enables the system to retrieve source system data on demand.

[0101] As illustrated in FIG. 10, the system may further include one or more user interfaces for interacting with one or more components of the system. For example, the system illustrated in FIG. 10 includes a plurality of user interfaces that allow a user to perform one or more of the following functions.

[0102] The system can enable users to perform near real-time and historical material tracking process monitoring. For example, BAW provides users with a UI to view real-time insights, including information regarding VIDs obtained by the system, the status of model runs, and investigations into model runs. Historical model runs and isolated batches can be examined against the same information. Domino provides users with a UI to view historical model run data stored within the application.

[0103] The system allows the user to perform straight-through processing workflow management. For example, the system handles all straight-through processing workflows and ETL tasks related to retrieving and storing data from OSIsoft PI, running models, and receiving and storing data from models. BAW periodically searches for event frames and automatically triggers workflows when an event frame is closed.

[0104] The system allows users to manage investigation workflows. For example, if an event affecting the execution of a material traceability model occurs during a continuous manufacturing process, this event will be captured by the system by the end user. BAW provides users with a UI to open new investigations and link any affected model executions to them. If there is a Trackwise record related to the event, it will be referenced in the BAW investigation. The investigation process allows users to access the Domino UI and manually re-run any models affected by the investigation. Once re-run and verified, the updated model execution results are integrated into the SQL Server database by BAW.

[0105] The system can enable users to perform automated investigation logging. For example, BAW can also be configured to automatically flag investigations when events or data meet specific conditions. These investigations can then be followed up on by users.

[0106] The system allows users to perform user task management. For example, BAW automatically assigns tasks to users (or teams) as part of the workflow management process. BAW provides users with a UI to view pending tasks assigned to them (or their team) and to claim tasks. Once a task is claimed by a user, it will not be available to other users (or team members). Users can complete claimed tasks through task-specific UIs. Workflows for activities considered critical have included two-person verification (2PV) tasks. BAW manages these 2PV tasks and ensures that the user who completed the original task cannot complete the 2PV for that task. BAW also provides users with a UI to view the task history related to isolated batches and a list of tasks completed by the user themselves.

[0107] The system may allow the user to generate material trace lineage reports. For example, as described herein, BAW provides a report generated for isolated batches that integrates data from relevant model executions. The report includes a list of feed input batch IDs and their associated quantities included in the isolated batches. It also includes a list of feed input batch IDs and quantities converted to waste.

[0108] The system can enable users to generate SAP inventory reports. For example, BAW provides reports generated for isolated batches that integrate data from related model executions. The report lists all supply input batches associated with the isolated batch and the quantities of those supply input batches, which are used to update SAP for inventory adjustments. If materials are converted during the period of the isolated batch, the report will list the batches and quantities associated with the conversion process sequence.

[0109] The system may allow users to generate residual reports and / or audit trail reports. For example, Power BI reports may be generated from the system to monitor the performance of residuals across model runs for the same stage in order to identify trends. Power BI reports may be generated from the system that enumerate electronic records and BAW and / or domino configuration changes performed by non-system users, and enumerate electronic signatures associated with the approval of BAW operations.

[0110] The system may assist in compliance with one or more federal, state, and / or local laws. The system may be a closed system with in-place data integrity controls, such as role-based security, automatic data audit trail capture, and human-readable reporting and views of system data. The system provides a robust, controlled, automated, and, where necessary, manual workflow management environment for implementing material traceability requirements under this regulation. A SQL Server database maintains a complete history of the material traceability lineage, including the material mass fraction, for each batch generated by a continuous manufacturing process. Data may be recalled and presented in a human-readable format in various ways, including through reports in the system's user interface or visual inspection.

[0111] FIG. 11 is a block diagram detailing embodiments of a controller that performs techniques for tracing material lineages according to one or more exemplary embodiments. The controller (1100) may include, for example, one or more processors (1110) that implement the exemplary method illustrated in FIG. 5. Instructions processed by one or more processors (1110) to implement the method (500) may be stored in a non-transient computer-readable medium, for example, a non-volatile storage (1120). Any one or more processors (1110) may be referred to as "processors," and any subsequent reference to "processors" should be interpreted as referring to any one or more of the processors (1110). That is, different processors among the processors (1110) may implement different embodiments of the method (500) and other processes discussed herein. The memory (1130) can store lineage information generated by the process, such as intermediate records and / or lineage reports as well as other data. The display (1140) can display the output of implementing the method (500) illustrated in FIG. 5 (e.g., a report displaying lineage information of materials in a finished batch of medicine following the completion of one or more intermediate records and / or multiple steps of the manufacturing process).

[0112] The technology described in this specification may have any of the configurations described below.

[0113] (1) A method for generating a report containing genealogical information of manufacturing materials used to manufacture a product manufactured through a manufacturing process, wherein the manufacturing process comprises a plurality of steps performed sequentially, and the method comprises: a step of receiving data indicating a plurality of characteristics associated with a successive subprocess of an individual step among the plurality of steps for each step of the manufacturing process - each individual step comprises a successive subprocess of the manufacturing process - the plurality of characteristics include a set of materials used for the individual step; and setting data indicating a setting of at least one manufacturing component used for the individual step -; a step of inputting data into a computational submodel configured to model how the set of materials used for the individual step propagates through the individual step; and a step of receiving an intermediate record as an output from the computational submodel - the intermediate record indicates genealogical information of at least some of the manufacturing materials used to manufacture the product after the completion of the successive subprocess of the individual step -; and a step of generating a report containing genealogical information of manufacturing materials used to manufacture a product after the completion of multiple steps of the manufacturing process, based on an intermediate record of the last step of at least the multiple steps of the manufacturing process - the genealogical information of the report includes at least one manufacturing parameter of each material present in the product after the completion of multiple steps of the manufacturing process.

[0114] (2) A method of (1), wherein, for a second step among a plurality of steps, at least part of the data indicating a plurality of characteristics associated with a successive subprocess of the second step includes at least part of the information in an intermediate record for a first step preceding the second step in the plurality of steps.

[0115] (3) A method of (1) wherein the multiple characteristics of the individual steps include the pump speed for each of the multiple pumps that supply material to the individual steps.

[0116] (4) A method of (3), wherein the multiple characteristics of the individual steps include time series data indicating the time period during which the input material of the set of materials is introduced into the individual step, the amount of the input material introduced into the individual step, the material number of the input material introduced into the individual step, and the batch identifier of the input material introduced into the individual step.

[0117] (5) A method of (1), wherein the first step among the plurality of steps comprises supplying an input material to the first step during the duration of the first step, and supplying the input material to the first step comprises supplying a first batch of a first input material having a first batch identifier to the first step during a first time period shorter than the duration of the first step; and supplying a second batch of a first input material having a second batch identifier different from the first batch identifier to the first step during a second time period shorter than the duration of the first step and subsequent to the first time period.

[0118] (6) A method of (5) in which an intermediate report indicates the amount of a first input material having a first batch identifier and the amount of a first input material having a second batch identifier present in the final product of the first stage.

[0119] (7) Method of (5), in which the second time period begins at the end of the first time period.

[0120] (8) As a method of (1), the calculation submodel models how liquid materials are dispersed and propagated based on pump speeds, tank sizes, and pipe diameters used throughout the individual steps of a plurality of manufacturing processes.

[0121] (9) As a method of (1), the calculation submodel includes a dwell time distribution model.

[0122] (10) A method of (1), wherein the multiple steps of the manufacturing process include at least three steps.

[0123] (11) A method of (1) wherein at least one manufacturing parameter comprises a material number, a batch identifier, and an amount of each material present in the product after the completion of a plurality of steps of the manufacturing process.

[0124] (12) A method of (1) wherein, when the intermediate record of the final step includes a reference to the intermediate record of one or more of the steps preceding the final step, the step of generating a report containing genealogical information is additionally based on the intermediate records of the one or more steps preceding the final step.

[0125] (13) A method of (1) further comprising a step of re-executing a calculation submodel for at least one of a plurality of steps based on user input indicating an error detected in a manufacturing process, wherein the step of re-executing the calculation submodel comprises inputting data regarding an error detected in a manufacturing process into the calculation submodel and receiving an updated intermediate record as an output from the calculation submodel.

[0126] (14) A method of (1), wherein the setting data comprises at least a portion of the data generated by one or more sensors for an individual step, and the one or more sensors are placed on at least one feeder tank for storing the input material fed into the individual step and / or on at least one pump for controlling the input of the input material from at least one feeder tank to the individual step, and the one or more sensors are configured to generate data regarding at least one feeder tank and / or at least one pump.

[0127] (15) A method of (14) in which one or more sensors for each individual step track the state of at least one feeder tank and / or at least one pump over the duration of each individual step.

[0128] (16) A method of (15) wherein at least one state of at least one pump includes the pump speed of at least one pump, and the data generated by at least one sensor for each individual step includes time series data representing the pump speed of at least one pump over the duration of the individual step.

[0129] (17) A method of (15) wherein at least one state of at least one feeder tank comprises the volume of input material in at least one feeder tank, and data generated by at least one sensor for each individual step comprises time series data representing the volume of input material in at least one feeder tank over the duration of each individual step.

[0130] (18) A method of (17) wherein data generated by one or more sensors indicates at least one time during the duration of an individual step in which at least one feeder tank is replenished with a new batch of input material.

[0131] (19) As a system, the system comprises: at least one feeder tank for storing input materials fed into each of the multiple steps of a manufacturing process, each of which includes a successive subprocess of the manufacturing process; at least one pump for controlling the feeding of input materials from at least one feeder tank to the individual step; and one or more sensors disposed on the at least one feeder tank and / or at least one pump and configured to generate data regarding the at least one feeder tank and / or at least one pump; at least one processor, at least one processor receives at least a portion of the data generated by the at least one sensor; and at least one non-transient computer-readable storage medium having encoded instructions that, when executed by the at least one processor, cause the at least one processor to perform a method for generating a report including genealogical information of the manufacturing materials used to manufacture a product manufactured through the manufacturing process, and the method comprises a step receiving data indicating a plurality of characteristics associated with a successive subprocess of the individual step of the multiple steps, for each of the multiple steps of the manufacturing process, the plurality of characteristics being a set of materials used for the individual step; and includes setting data indicating the settings of at least one manufacturing component used for an individual step, wherein the setting data includes at least a portion of the data generated by one or more sensors for an individual step; a step of inputting data into a computational submodel configured to model how a set of materials used for an individual step propagates through the individual step; and a step of receiving an intermediate record as an output from the computational submodel, wherein the intermediate record indicates lineage information of at least some of the manufacturing materials used to manufacture a product after the completion of a successive subprocess of the individual step;and a step of generating a report containing genealogical information of manufacturing materials used to manufacture a product after the completion of multiple steps of the manufacturing process, based on an intermediate record of the last step of at least the multiple steps of the manufacturing process—the genealogical information of the report includes at least one manufacturing parameter of each material present in the product after the completion of multiple steps of the manufacturing process.;

[0132] (20) A system of (19), wherein for a second step among a plurality of steps, at least part of the data indicating a plurality of characteristics associated with a successive subprocess of the second step includes at least part of the information in an intermediate record for a first step preceding the second step in the plurality of steps.

[0133] (21) A system of (19) in which the multiple characteristics of individual stages include pump speeds for each of the at least one pump for each individual stage.

[0134] (22) A system of (21) wherein the multiple characteristics of the individual steps include time series data indicating the time period during which the input material of the set of materials is introduced into the individual step, the amount of the input material introduced into the individual step, the material number of the input material introduced into the individual step, and the batch identifier of the input material introduced into the individual step.

[0135] (23) A system of (19), wherein the first step among the plurality of steps comprises supplying input materials to the first step from at least one supply tank for the first step during the duration of the first step, and supplying input materials to the first step comprises supplying a first batch of first input materials having a first batch identifier for a set of materials during a first time period shorter than the duration of the first step; and supplying a second batch of first input materials having a second batch identifier different from the first batch identifier for a second time period shorter than the duration of the first step and subsequent to the first time period.

[0136] (24) As a system of (23), the intermediate report displays the amount of first input material having a first batch identifier and the amount of first input material having a second batch identifier present in the final product of the first stage.

[0137] (25) A system of (23) in which the second time period begins at the end of the first time period.

[0138] (26) As a system of (19), the computational submodel models how liquid materials are dispersed and propagated based on pump speeds, tank sizes, and pipe diameters used throughout the individual steps of a plurality of manufacturing processes.

[0139] (27) As a system of (19), the computational submodel includes a dwell time distribution model.

[0140] (28) As a system of (19), a plurality of steps of the manufacturing process include at least three steps.

[0141] (29) A system of (19) in which at least one manufacturing parameter includes a material number, a batch identifier, and a quantity of each material present in the product after the completion of a plurality of steps of the manufacturing process.

[0142] (30) A system of (19) in which, when the intermediate record of the last step includes a reference to the intermediate record of one or more of the steps preceding the last step, the step for generating a report containing genealogical information is additionally based on the intermediate records of the one or more steps preceding the last step.

[0143] (31) As a system of (19), one or more sensors for each individual stage track the state of at least one feeder tank and / or at least one pump over the duration of each individual stage.

[0144] (32) A system of (31) wherein at least one state of at least one pump includes the pump speed of at least one pump, and data generated by at least one sensor for each individual step includes time series data representing the pump speed of at least one pump over the duration of the individual step.

[0145] (33) A system of (31) wherein at least one state of at least one feeder tank includes the volume of input material in at least one feeder tank, and data generated by at least one sensor for each individual step includes time series data representing the volume of input material in at least one feeder tank over the duration of the individual step.

[0146] (34) A system of (33) in which data generated by one or more sensors indicates at least one time during the duration of an individual step in which at least one feeder tank is replenished with a new batch of input material.

[0147] (35) As a system of (19), the method further comprises a step of re-executing a calculation submodel for at least one of a plurality of steps based on user input indicating an error detected in a manufacturing process, and the step of re-executing the calculation submodel comprises inputting data regarding an error detected in a manufacturing process into the calculation submodel and receiving an updated intermediate record as an output from the calculation submodel.

[0148] (36) At least one non-transient computer-readable storage medium having encoded instructions that, when executed by at least one processor, cause at least one processor to perform a method for generating a report containing genealogical information of manufacturing materials used to manufacture a product manufactured through a manufacturing process, wherein the manufacturing process comprises a plurality of steps performed sequentially, and the method comprises: a step of receiving data indicating a plurality of characteristics associated with a successive subprocess of an individual step among the plurality of steps for each step of the manufacturing process - each individual step comprises a successive subprocess of the manufacturing process - the plurality of characteristics include a set of materials used for the individual step; and setting data indicating a setting of at least one manufacturing component used for the individual step -; a step of inputting data into a computational submodel configured to model how the set of materials used for the individual step propagates through the individual step; and a step of receiving an intermediate record as an output from the computational submodel - the intermediate record indicates genealogical information of at least some of the manufacturing materials used to manufacture a product after the completion of a successive subprocess of the individual step -; and a step of generating a report containing genealogical information of manufacturing materials used to manufacture a product after the completion of multiple steps of the manufacturing process, based on an intermediate record of the last step of at least the multiple steps of the manufacturing process - the genealogical information of the report includes at least one manufacturing parameter of each material present in the product after the completion of multiple steps of the manufacturing process.

[0149] (37) At least one non-transient computer-readable storage medium of (36), wherein at least one portion of the data indicating a plurality of characteristics associated with a successive subprocess of the second step among a plurality of steps includes at least one portion of information in an intermediate record for a first step preceding the second step in the plurality of steps.

[0150] (38) (36) at least one non-transient computer-readable storage medium, wherein the plurality of characteristics of individual steps include the pump speed for each of the plurality of pumps supplying material to the individual steps.

[0151] (39) (38) at least one non-transient computer-readable storage medium, wherein the plurality of characteristics of individual steps include time series data indicating the time period during which an input material of a set of materials is introduced into an individual step, the amount of an input material introduced into an individual step, the material number of the input material introduced into an individual step, and the batch identifier of the input material introduced into an individual step.

[0152] (40) At least one non-transient computer-readable storage medium of (36), wherein the first step among the plurality of steps comprises supplying an input material to the first step during the duration of the first step, and supplying the input material to the first step comprises supplying a first batch of a first input material having a first batch identifier during a first time period shorter than the duration of the first step to the first step; and supplying a second batch of a first input material having a second batch identifier different from the first batch identifier during a second time period shorter than the duration of the first step and subsequent to the first time period to the first step.

[0153] (41) At least one non-transient computer-readable storage medium of (40), wherein the intermediate report indicates the amount of a first input material having a first batch identifier and the amount of a first input material having a second batch identifier present in the final product of the first stage, at least one non-transient computer-readable storage medium.

[0154] (42) At least one non-transient computer-readable storage medium of (40), wherein the second time period begins at the end of the first time period.

[0155] (43) At least one non-transient computer-readable storage medium of (36), wherein the computational submodel models how liquid materials are dispersed and propagated based on pump speeds, tank sizes, and pipe diameters used throughout individual steps of a plurality of manufacturing processes.

[0156] (44) At least one non-transient computer-readable storage medium of (36), wherein the computational submodel includes a residence time distribution model.

[0157] (45) (36) at least one non-transient computer-readable storage medium, wherein the multiple steps of the manufacturing process include at least three steps.

[0158] (46) At least one non-transient computer-readable storage medium of (36), wherein at least one manufacturing parameter comprises a material number, a batch identifier, and a quantity of each material present in the product after completion of a plurality of steps of the manufacturing process.

[0159] (47) At least one non-transient computer-readable storage medium of (36), wherein when the intermediate record of the last step includes a reference to the intermediate record of one or more of the steps preceding the last step, the step of generating a report containing genealogical information is additionally based on the intermediate records of the one or more steps preceding the last step.

[0160] (48) At least one non-transient computer-readable storage medium of (36), the method further comprises a step of re-executing a computational submodel for at least one of a plurality of steps based on user input indicating an error detected in a manufacturing process, and the step of re-executing the computational submodel comprises inputting data regarding an error detected in a manufacturing process into the computational submodel and receiving an updated intermediate record as an output from the computational submodel.

[0161] (49) At least one non-transient computer-readable storage medium of (36), wherein the setting data comprises at least a portion of the data generated by one or more sensors for individual steps, and one or more sensors are placed on at least one feeder tank for storing input materials fed into individual steps and / or on at least one pump for controlling the input of input materials from at least one feeder tank to individual steps, and one or more sensors are configured to generate data regarding at least one feeder tank and / or at least one pump.

[0162] (50) (49) at least one non-transient computer-readable storage medium, wherein one or more sensors for each individual step track the state of at least one feeder tank and / or at least one pump over the duration of each individual step, at least one non-transient computer-readable storage medium.

[0163] (51) At least one non-transient computer-readable storage medium of (50), wherein at least one state of at least one pump includes the pump speed of at least one pump, and data generated by at least one sensor for each individual step includes time-series data representing the pump speed of at least one pump over the duration of the individual step.

[0164] (52) At least one non-transient computer-readable storage medium of (50), wherein at least one state of at least one feeder tank comprises the volume of input material in at least one feeder tank, and data generated by at least one sensor for each individual step comprises time-series data representing the volume of input material in at least one feeder tank over the duration of the individual step.

[0165] (53) At least one non-transient computer-readable storage medium of (53), wherein data generated by one or more sensors indicates at least one time during the duration of an individual step in which at least one feeder tank is replenished with a new batch of input material.

[0166] Technologies operating according to the principles described herein may be implemented in any suitable manner. The processing and decision blocks of the above flowcharts represent steps and operations that may be included in algorithms performing these various processes. Algorithms derived from these processes may be implemented as software that is integrated with one or more single-purpose or multi-purpose processors and directs their operation, or as functionally equivalent circuits such as digital signal processing (DSP) circuits or application-specific integrated circuits (ASICs), or in any other suitable manner. It should be understood that the flowcharts included in this specification do not illustrate any specific circuit or any specific programming language or type of programming language syntax or operation. Rather, the flowcharts illustrate functional information that a person skilled in the art may use to manufacture circuits or implement computer software algorithms to perform the processing of a specific device performing the types of technologies described herein. Unless otherwise indicated in this specification, it should be understood that the specific sequence of steps and / or operations described in each flowchart is merely an example of algorithms that may be implemented and may be modified in implementations and embodiments of the principles described in this specification.

[0167] Accordingly, in some embodiments, the techniques described herein may be implemented as computer-executable instructions implemented as software comprising application software, system software, firmware, middleware, embedded code, or any other suitable type of computer code. Such computer-executable instructions may be written using any of a number of suitable programming languages ​​and / or programming or scripting tools, and may also be compiled into executable machine code or intermediate code that runs on a framework or virtual machine.

[0168] When the techniques described herein are implemented as computer-executable instructions, these computer-executable instructions may be implemented in any suitable manner, including a plurality of functional facilities, each of which provides one or more operations to complete the execution of algorithms that operate according to these techniques. However, the "functional facilities" exemplified are structural components of a computer system that, when integrated with and executed by one or more computers, enable one or more computers to perform specific operational roles. A functional facility may be part or all of a software element. For example, a functional facility may be implemented as a function of a process, as an individual process, or as any other suitable processing unit. If the techniques described herein are implemented as a plurality of functional facilities, each functional facility may be implemented in its own way and not all need to be implemented in the same way. Additionally, these functional facilities may be executed in parallel and / or serially where appropriate, and may transmit information to one another using shared memory on the computer(s) on which they are running, using message passing protocols, or in any other suitable manner.

[0169] Generally, functional facilities include routines, programs, entities, components, data structures, etc., that perform specific tasks or implement specific abstract data types. Typically, the functions of functional facilities can be combined or distributed as desired across the systems in which they operate. In some implementations, one or more functional facilities performing the descriptions herein may together form a complete software package. In alternative embodiments, these functional facilities may be adapted to interact with other unrelated functional facilities and / or processes to implement software program applications.

[0170] Some exemplary functional units for performing one or more tasks have been described herein. However, it will be understood that the described functional units and divisions of tasks are merely illustrative of the types of functional units capable of implementing the exemplary techniques described herein, and that the embodiments are not limited to being implemented in any specific number, division, or type of functional units. In some implementations, all functions may be implemented in a single functional unit. Furthermore, it should be understood that in some implementations, some of the functional units described herein may be implemented together with others or separately from others (i.e., as a single unit or as separate units), or that some of these functional units may not be implemented.

[0171] Computer-executable instructions that implement the technologies described herein (when implemented as one or more functional facilities or in any other way) may, in some embodiments, be encoded on one or more computer-readable media to provide functionality to the media. Computer-readable media include magnetic media such as hard disk drives, optical media such as CDs (Compact Disks) or DVDs (Digital Versatile Disks), permanent or non-permanent solid-state memory (e.g., flash memory, magnetic RAM, etc.), or any other suitable storage media. Such computer-readable media may be implemented in any suitable way. As used herein, "computer-readable media" (also referred to as "computer-readable storage media") refers to tangible storage media. Tangible storage media are non-transient and have at least one physical and structural component. In "computer-readable media" as used herein, at least one physical and structural component has at least one physical characteristic that can be changed in a certain way during a process of creating a medium having embedded information, a process of writing information thereon, or any other process of encoding a medium having information. For example, the magnetization state of a part of the physical structure of a computer-readable medium may change during the recording process.

[0172] Additionally, some of the aforementioned technologies include operations for storing information (e.g., data and / or instructions) in specific ways for use by these technologies. In some implementations of these technologies, such as those in which the technologies are implemented as computer-executable instructions, the information may be encoded on a computer-readable storage medium. Where specific structures are described herein as advantageous formats for storing this information, these structures may be used to provide a physical configuration of the information when encoded on the storage medium. These advantageous structures may then provide functionality to the storage medium by influencing the operations of one or more processors interacting with the information, for example, by increasing the efficiency of computer operations performed by the processor(s).

[0173] In some but not all of the implementations where the technologies can be implemented as computer-executable instructions, these instructions may be executed on one or more suitable computing device(s) operating on any suitable computer system, or one or more computing devices (or one or more processors of one or more computing devices) may be programmed to execute computer-executable instructions. A computing device or processor may be programmed to execute instructions when the instructions are stored in a manner accessible by the computing device or processor, for example, in a data storage (e.g., on-chip cache or instruction register, computer-readable storage media accessible via a bus, computer-readable storage media accessible via one or more networks and accessible by the device / processor, etc.). Function facilities including these computer-executable instructions may be integrated with a single multi-purpose programmable digital computing device, a cooperative system of two or more multi-purpose computing devices that share processing power and jointly perform the techniques described herein, a single computing device or a cooperative system of computing devices dedicated to performing the techniques described herein (located in the same place or geographically dispersed), one or more Field-Programmable Gate Arrays (FPGAs) that perform the techniques described herein, or any other suitable system to direct its operation.

[0174] A computing device may include at least one processor, a network adapter, and a computer-readable storage medium. The computing device may be, for example, a desktop or laptop personal computer, a personal digital assistant (PDA), a smart mobile phone, a server, or any other suitable computing device. The network adapter may be any suitable hardware and / or software that enables the computing device to communicate wired and / or wirelessly with any other suitable computing device through any suitable computing network. The computing network may include any suitable wired and / or wireless communication medium or medium for exchanging data between two or more computers, including wireless access points, switches, routers, gateways, and / or other networking equipment, as well as the Internet. The computer-readable medium may be adapted to store data to be processed by the processor and / or instructions to be executed. The processor enables the processing of data and the execution of instructions. Data and instructions may be stored on the computer-readable storage medium.

[0175] A computing device may further comprise one or more components and peripherals, including input and output devices. These devices, in particular, may be used to present a user interface. Examples of output devices that may be used to provide a user interface include printers or display screens for visual presentation of output and speakers or other sound generating devices for auditory presentation of output. Examples of input devices that may be used for a user interface include keyboards and pointing devices such as mice, touchpads, and digitizing tablets. As another example, the computing device may receive input information via voice recognition or in other audible formats.

[0176] Embodiments in which the technologies are implemented in circuits and / or computer-executable instructions have been described. It should be understood that some embodiments may be in the form of a method in which at least one example is provided. The operations performed as part of the method may be ordered in any suitable manner. Accordingly, even though they are illustrated as sequential operations in exemplary embodiments, embodiments may be constructed in which operations are performed in a different order from that illustrated, which may include performing some operations simultaneously.

[0177] Various aspects of the embodiments described above may be used alone, in combination, or in various arrangements not specifically discussed in the embodiments described above, and thus are not limited to the details and arrangements of components presented in the description above or illustrated in the drawings in their application. For example, the aspects described in one embodiment may be combined in any way with the aspects described in other embodiments.

[0178] The use of ordinal terms such as "first," "second," "third," etc., in claims to modify claim elements does not, in itself, imply any priority, precedence, or order of one claim element over another, or the temporal order in which the operations of the method are performed; rather, they are used merely as labels to distinguish one claim element with a specific name from another element with the same name (but using ordinal terms) in order to differentiate claim elements.

[0179] Furthermore, the phrases and terms used in this specification are for illustrative purposes only and should not be construed as restrictive. The use of "including," "comprising," "having," "containing," "involving," and variations thereof in this specification is intended to encompass additional items as well as the items and their equivalents listed thereafter.

[0180] The word "exemplary" is used herein to mean serving as an example, case, or illustration. Accordingly, any embodiment, implementation, process, feature, etc. described as exemplary herein should be understood as an exemplary example and, unless otherwise indicated, should not be understood as a preferred or advantageous example.

[0181] In order to clarify public use and thereby provide notice to the public, phrases " , , .. and <n>At least one of "" or "< / n> , , .. <n> At least one of, or a combination thereof" or "< / n> , , .. and / or <n>"is defined by the applicant in its broadest sense to mean one or more elements selected from the group comprising A, B, ..., and N, replacing any other prior or subsequent implied definitions unless expressly asserted by the applicant to the contrary. That is, these phrases mean any combination of one or more of elements A, B, ..., or N, comprising any one element alone or in combination with one or more other elements that may also include any one element in combination with additional elements not enumerated."

[0182] Although various embodiments have been described, it will be apparent to those skilled in the art that more embodiments and implementations are possible. Accordingly, the embodiments described herein are examples and are not the only possible embodiments and implementations. Furthermore, the aforementioned advantages are not necessarily the only advantages, and it is not expected that all described advantages will be achieved in all embodiments.< / n>

Claims

Claim 1 A method for generating a report containing genealogical information of manufacturing materials used to manufacture a liquid product manufactured through a manufacturing process, wherein the manufacturing process comprises a plurality of steps performed sequentially, and the method comprises, for each step among the plurality of steps of the manufacturing process - each individual step comprises a successive subprocess of the manufacturing process - a step of receiving data indicating a plurality of characteristics associated with the successive subprocess of the individual step among the plurality of steps - said characteristics include a set of liquid materials used for the individual step; and setting data indicating a setting of at least one manufacturing component used for the individual step -; a step of inputting said data into a computational submodel configured to model how the set of liquid materials used for the individual step propagates through the individual step; and a step of receiving an intermediate record as an output from said computational submodel - said intermediate record indicates genealogical information of at least some of said manufacturing materials used to manufacture the product after the completion of the successive subprocess of said individual step -; A method comprising: a step of generating a report containing genealogical information of the manufacturing materials used to manufacture the product after the completion of the plurality of steps of the manufacturing process, based on the intermediate record of the last step of at least the plurality of steps of the manufacturing process, wherein the genealogical information of the report includes at least one manufacturing parameter of each material present in the product after the completion of the plurality of steps of the manufacturing process. Claim 2 A method according to claim 1, wherein, for a second step among the plurality of steps, at least a portion of the data indicating the plurality of characteristics associated with a successive subprocess of the second step comprises at least some information in the intermediate record for a first step preceding the second step in the plurality of steps. Claim 3 A method according to claim 1, wherein the plurality of characteristics of the individual steps include pump speeds for each of the plurality of pumps supplying material to the individual steps. Claim 4 A method according to paragraph 3, wherein the plurality of characteristics of the individual steps include at least one of time series data indicating a time period during which an input material of the set of materials is introduced into the individual step, an amount of the input material introduced into the individual step, a material number of the input material introduced into the individual step, and a batch identifier of the input material introduced into the individual step. Claim 5 A method according to claim 1, wherein a first step among the plurality of steps comprises supplying an input material to the first step during the duration of the first step, and supplying the input material to the first step comprises supplying a first batch of a first input material having a first batch identifier of the set of materials to the first step during a first time period shorter than the duration of the first step; and supplying a second batch of the first input material having a second batch identifier different from the first batch identifier to the first step during a second time period shorter than the duration of the first step and subsequent to the first time period. Claim 6 A method according to claim 5, wherein the above intermediate report indicates the amount of the first input material having the first batch identifier and the amount of the first input material having the second batch identifier present in the final product of the first stage. Claim 7 In paragraph 5, the method wherein the second time period begins at the end of the first time period. Claim 8 A method according to claim 1, wherein the calculation submodel models how liquid materials are dispersed and propagated based on pump speeds, tank sizes, and pipe diameters used throughout the individual steps of the plurality of steps of the manufacturing process. Claim 9 In claim 1, the method wherein the calculation submodel includes a dwell time distribution model. Claim 10 A method according to claim 1, wherein the plurality of steps of the manufacturing process comprises at least three steps. Claim 11 A method according to claim 1, wherein the at least one manufacturing parameter comprises a material number, a batch identifier, and an amount of each material present in the product after the completion of the plurality of steps of the manufacturing process. Claim 12 A method according to claim 1, wherein when the intermediate record of the last step includes a reference to the intermediate record of one or more of the plurality of steps preceding the last step, the step of generating a report containing the genealogical information is additionally based on the intermediate records of the one or more steps preceding the last step. Claim 13 The method of claim 1 further comprises a step of re-executing the calculation submodel for at least one of the plurality of steps based on user input indicating an error detected in the manufacturing process, wherein the step of re-executing the calculation submodel comprises inputting data regarding the error detected in the manufacturing process into the calculation submodel and receiving an updated intermediate record as an output from the calculation submodel. Claim 14 As a system, for each of a plurality of steps of a manufacturing process—each individual step comprises a successive subprocess of said manufacturing process—at least one feeder tank for storing a liquid input material introduced into said individual step; at least one pump for controlling the introduction of said input material from said at least one feeder tank into said individual step; and one or more sensors disposed on said at least one feeder tank or said at least one pump and configured to generate data regarding said at least one feeder tank or said at least one pump; at least one processor—said to receive at least a portion of said data generated by said one or more sensors—; and, when executed by the at least one processor, the at least one processor has encoded instructions that enable the at least one processor to perform a method for generating a report including genealogical information of manufacturing materials used to manufacture a liquid product manufactured through the manufacturing process, the method comprising: a step of receiving data indicating a plurality of characteristics associated with a successive subprocess of the individual step among the plurality of steps for each step of the manufacturing process, wherein the plurality of characteristics include a set of materials used for the individual step; and setting data indicating a setting of at least one manufacturing component used for the individual step, wherein the setting data includes at least a portion of the data generated by the one or more sensors for the individual step; and a step of inputting the data into a computational submodel configured to model how the set of materials used for the individual step propagates through the individual step.A system comprising: a step of receiving an intermediate record as an output from the calculation submodel, wherein the intermediate record indicates lineage information of at least some of the manufacturing materials used to manufacture the product after the completion of the successive subprocesses of the individual steps; and a step of generating the report containing the lineage information of the manufacturing materials used to manufacture the product after the completion of the plurality of steps of the manufacturing process, based on the intermediate record of the last step of at least the plurality of steps of the manufacturing process, wherein the lineage information of the report includes at least one manufacturing parameter of each material present in the product after the completion of the plurality of steps of the manufacturing process. Claim 15 A system according to claim 14, wherein, for a second step among the plurality of steps, at least a portion of the data indicating the plurality of characteristics associated with a successive subprocess of the second step comprises at least some information in the intermediate record for a first step preceding the second step in the plurality of steps. Claim 16 In paragraph 14, the plurality of characteristics of the individual steps include pump speeds for each of the at least one pump for the individual steps. Claim 17 A system according to claim 16, wherein the plurality of characteristics of the individual steps include at least one of time series data indicating a time period during which an input material of the set of input materials is introduced into the individual step, an amount of input material introduced into the individual step, a material number of the input material introduced into the individual step, and a batch identifier of the input material introduced into the individual step. Claim 18 A system according to claim 14, wherein a first step among the plurality of steps comprises supplying the input material to the first step from at least one feeder tank for the first step during the duration of the first step, and supplying the input material to the first step comprises supplying a first batch of the first input material having a first batch identifier for a set of the materials to the first step during a first time period shorter than the duration of the first step; and supplying a second batch of the first input material having a second batch identifier different from the first batch identifier to the first step during a second time period shorter than the duration of the first step and subsequent to the first time period. Claim 19 In paragraph 18, the system, wherein the above intermediate report indicates the amount of the first input material having the first batch identifier and the amount of the first input material having the second batch identifier present in the final product of the first stage. Claim 20 In paragraph 14, the above calculation submodel is a system including a dwell time distribution model. Claim 21 In paragraph 14, the system wherein the one or more sensors for each individual step track the state of at least one of the at least one feeder tank and / or at least one of the at least one pump over the duration of the individual step. Claim 22 A system according to claim 21, wherein the one or more states of the at least one pump include the pump speed of the at least one pump, and the data generated by the one or more sensors for each individual step includes time series data representing the pump speed of the at least one pump over the duration of the individual step. Claim 23 A system according to claim 21, wherein the one or more states of the at least one feeder tank include the volume of input material in the at least one feeder tank, and the data generated by the one or more sensors for each individual step includes time-series data representing the volume of input material in the at least one feeder tank over the duration of the individual step. Claim 24 In paragraph 23, the system, wherein the data generated by the one or more sensors indicates at least one time during the duration of the individual step in which the at least one feeder tank is replenished with a new batch of input material. Claim 25 At least one non-transient computer-readable storage medium having encoded instructions that, when executed by at least one processor, cause the at least one processor to perform a method for generating a report containing genealogical information of manufacturing materials used to manufacture a liquid product manufactured through a manufacturing process, wherein the manufacturing process comprises a plurality of steps performed sequentially, and the method comprises a step of receiving data indicating a plurality of characteristics associated with the successive subprocess of the individual step among the plurality of steps for each step of the manufacturing process—each individual step comprises a successive subprocess of the manufacturing process—the plurality of characteristics include a set of liquid materials used for the individual step; and setting data indicating a setting of at least one manufacturing component used for the individual step—; and a step of inputting the data into a computational submodel configured to model how the set of materials used for the individual step propagates through the individual step. A step of receiving an intermediate record as an output from the calculation submodel, wherein the intermediate record indicates lineage information of at least some of the manufacturing materials used to manufacture the product after the completion of the successive subprocesses of the individual steps; and a step of generating the report containing the lineage information of the manufacturing materials used to manufacture the product after the completion of the plurality of steps of the manufacturing process, based on the intermediate record of the last step of the plurality of steps of the manufacturing process, wherein the lineage information of the report includes at least one manufacturing parameter of each material present in the product after the completion of the plurality of steps of the manufacturing process.

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