Pharmaceutical primary packaging with built-in RFID tag

Abstract

The present disclosure is directed to plastic pharmaceutical containers, such as vials, pre-filled syringes and cartridges, having electronic components, such as RFID tags, embedded in and completely enclosed by their walls. The electronic components may be located at specific sites that allow the components to be hidden by conventional closures, such as the neck of a vial or the needle or luer hub of a syringe barrel. The present disclosure is also directed to methods of preparing and using pharmaceutical containers with electronic components incorporated therein.

Description

[Technical field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 187,385, filed May 11, 2021, and U.S. Provisional Patent Application No. 63 / 215,879, filed June 28, 2021, both of which are incorporated by reference in their entireties.

[0002] Traceability of pharmaceutical packaging is becoming increasingly important. In an ideal scenario, a pharmaceutical package such as a drug-containing vial, cartridge, or prefilled syringe is traceable over a timeline that includes: (1) the manufacture of the container, (2) the filling of the container with the pharmaceutical product, and (3) the supply chain of the filled pharmaceutical package. Traceability of individual packages is a key feature to enable better control of pharmaceutical products throughout the supply chain. [Background technology]

[0003] To date, it has been proposed that RFID tags may be attached to the exterior surface of the vial as a "flag tag" or other external element such as one attached to the metal crimp of the vial closure, as an insert in the bottom of a specially designed vial, see US Patent Publication No. 9,589,226 B2, US Patent Publication No. 2011 / 0199187 A1, or as part of a vial lid, see US Patent Publication No. 2019 / 0026616 A1. Similarly, it has been proposed that RFID tags may be incorporated into a rigid needle shield that is attached to a syringe, see US Patent Publication No. 2019 / 0328485 A1. Notably, most of these options would only allow tracking of the pharmaceutical package after the container has been filled and sealed. Many of these options also require specially designed components, which are costly to manufacture and unlikely to be widely adopted. Finally, RFID tags located on the exterior of the container may be easily damaged. Summary of the Invention

[0004] The present disclosure relates to pharmaceutical packages, such as vials, pre-filled syringes, cartridges, and other drug delivery devices, that incorporate electronic components that provide traceability throughout the complete value chain, including (1) the manufacture of the container, (2) the filling of the container with pharmaceutical products, and (3) the supply chain of the filled pharmaceutical package. The electronic components may be attached directly to the container to be filled and sealed to create the primary pharmaceutical package, e.g., a vial body, a syringe barrel, or a body / barrel of a cartridge. In some embodiments, the electronic components may be embedded in the container, e.g., molded into the wall of a thermoplastic container, such that the electronic components are integrated into the final pharmaceutical package, and optionally are not exposed to the exterior of the package, the interior of the package, or both.

[0005] Embodiments of the present disclosure are directed to a pharmaceutical package comprising a container defining a lumen, a pharmaceutical solution within the lumen, a closure, and an electronic component attached to the container and configured to provide the package with tracking capabilities and / or to detect and / or record compliance or non-compliance with one or more storage conditions, and / or provide information regarding one or more administration parameters.

[0006] The pharmaceutical package of any embodiment, wherein the container is a syringe barrel, cartridge, or vial.

[0007] The pharmaceutical package of any embodiment, wherein the electronic component is an RFID tag, optionally an RFID tag utilizing one or more frequencies within the range of 865-928 MHz, optionally an RFID tag utilizing a frequency of about 13.56 MHz.

[0008] The pharmaceutical package of any embodiment, wherein the electronic component comprises an integrated circuit.

[0009] The pharmaceutical package of any embodiment, wherein the electronic component includes data storage.

[0010] The pharmaceutical package of any embodiment, wherein the container comprises at least one wall made of a thermoplastic material.

[0011] The pharmaceutical package of any embodiment, wherein the thermoplastic material comprises one or more of polypropylene, polyethylene, COP, COC, or CBC.

[0012] The pharmaceutical package of any embodiment, wherein the electronic component is embedded in the thermoplastic wall of the container.

[0013] The pharmaceutical package of any embodiment, wherein the electronic component is overmolded onto the wall of the container.

[0014] The pharmaceutical package of any embodiment, wherein the thermoplastic material making up at least a portion of the container completely or substantially completely surrounds the electronic component.

[0015] The pharmaceutical package of any embodiment, wherein no part of the electronic component is on the exterior surface of the container.

[0016] The pharmaceutical package of any embodiment, wherein the package is a pre-filled syringe and the electronic components are embedded in a hub portion of the syringe barrel.

[0017] The pharmaceutical package of any embodiment, wherein the package is a pre-filled syringe and the electronic components are embedded in a transition area between the body of the syringe barrel and a hub portion of the syringe barrel.

[0018] The pharmaceutical package of any embodiment, wherein the hub portion is a needle hub or a luer hub.

[0019] The pharmaceutical package of any embodiment, wherein the closure comprises a rigid needle shield or luer cap, and the electronic components are visually concealed by the closure.

[0020] The pharmaceutical package of any embodiment, wherein the package is a pre-filled syringe and the electronic components are embedded in the body of the syringe barrel adjacent the rear flange.

[0021] The pharmaceutical package of any embodiment, wherein the package is a filled vial and the electronic components are embedded in the neck portion of the vial, optionally in a thickened flange area.

[0022] The pharmaceutical package of any embodiment, wherein the closure comprises a stopper and a crimp, and wherein the electronic components are visually concealed by the closure.

[0023] The pharmaceutical package of any embodiment, wherein the package is a filled cartridge and the electronic components are embedded in the needle mounting portion of the cartridge.

[0024] The pharmaceutical package of any embodiment, wherein the closure comprises a cap, and the electronic component is visually concealed by the closure.

[0025] The pharmaceutical package of any embodiment, further comprising a label, wherein the electronic component is embedded in a portion of the container that is visually concealed by the label.

[0026] The pharmaceutical package of any embodiment, wherein the package is a filled cartridge and the electronic component is configured to be read directly by the delivery device, optionally an auto-injector or injection pen.

[0027] The pharmaceutical package of any embodiment, wherein the electronic component is visually concealed by a portion of the package.

[0028] The pharmaceutical package of any embodiment, wherein the package is configured such that the container may also be tracked prior to filling the lumen with a pharmaceutical solution and sealing the lumen with a closure.

[0029] The pharmaceutical package of any embodiment, wherein the electronic component is detectable by automated visual inspection of the container in an empty state.

[0030] The medication package of any embodiment, wherein the electronic component is configured to be written to using an external writer.

[0031] The pharmaceutical package of any embodiment, wherein the pharmaceutical solution is an injectable drug-containing solution.

[0032] The pharmaceutical package of any embodiment, wherein the electronic component has a length of 5mm or less, optionally 4mm or less, optionally 3mm or less, optionally 2mm or less, optionally 1mm or less, and a width of 5mm or less, optionally 4mm or less, optionally 3mm or less, optionally 2mm or less, or optionally 1mm or less.

[0033] The pharmaceutical package of any embodiment, wherein the electronic component has a thickness of 500 microns or less, optionally 400 microns or less, optionally 300 microns or less, optionally 200 microns or less, optionally 100 microns or less, optionally 50 microns or less.

[0034] The pharmaceutical package of any embodiment, wherein the pharmaceutical package has been subjected to sterilization, optionally by irradiation, optionally by gas sterilization.

[0035] The pharmaceutical package of any embodiment, wherein the electronic components are configured to withstand sterilization of the pharmaceutical package, optionally sterilization by radiation, optionally sterilization by gas.

[0036] The medication package of any embodiment, wherein the electronic component comprises a temperature sensor, optionally the electronic component is a passive RFID temperature sensor.

[0037] The medication package of any embodiment, wherein the medical solution within the lumen must be maintained within a defined temperature range, and the electronic component is configured to detect and register deviations from that temperature range.

[0038] The medication package of any embodiment, wherein the electronic component comprises a pressure sensor, optionally the electronic component is a passive RFID pressure sensor.

[0039] The medication package of any embodiment, wherein the medical solution within the lumen must be maintained within a defined pressure range, and the electronic component is configured to detect and register deviations from that pressure range.

[0040] The medication package of any embodiment, wherein the medical solution is administered at a defined dispense rate or within a defined range of acceptable dispense rates, and the electronic component includes information regarding the defined dispense rate or the defined range of acceptable dispense rates.

[0041] The pharmaceutical package of any embodiment, wherein the information regarding the defined dispensing rate or the defined range of acceptable dispensing rates is configured to be read by a delivery device, optionally an auto-injector or an injection pen.

[0042] The medication package of any embodiment, wherein the medicinal solution is administered using a defined needle insertion depth or a defined range of acceptable needle insertion depths, and the electronic component includes information regarding the defined needle insertion depth or the defined range of acceptable needle insertion depths.

[0043] The pharmaceutical package of any embodiment, wherein the information regarding the defined needle insertion depth or the defined range of acceptable needle insertion depths is configured to be read by a delivery device, optionally an autoinjector or an injection pen.

[0044] The medication package of any embodiment, wherein the electronic component is configured to register the interrogation event in a database.

[0045] An auto-injector or injection pen comprising a cartridge or syringe of any embodiment, wherein the auto-injector or injection pen comprises a reader configured to read electronic components of the cartridge or syringe.

[0046] The auto-injector or injection pen of any embodiment, wherein the auto-injector or injection pen is configured to adjust one or more injection settings in response to information obtained from the electronic component.

[0047] The pharmaceutical package of any embodiment, wherein the interior surface, exterior surface, or both of the wall in which the electronic component is embedded is substantially identical to the interior surface, exterior surface, or both of the wall of the same container prepared without the electronic component.

[0048] The pharmaceutical package of any embodiment, wherein the interior surface, exterior surface, or both of the wall in which the electronic component is embedded is free of surface irregularities such as those caused by the insertion of the electronic component.

[0049] The medication package of any embodiment, wherein the electronic component includes information, optionally identifying information, stored directly on the component.

[0050] The pharmaceutical package of any embodiment, wherein the electronic component is readable without connection to a computing network, such as a cloud computing network.

[0051] The pharmaceutical package of any embodiment, wherein the electronic component is writable without connection to a computing network, such as a cloud computing network.

[0052]

[0013] Embodiments of the present disclosure are also directed to containers having electronic components attached thereto and configured to provide both unfilled containers and pharmaceutical packages resulting from filling the lumen of the container with a pharmaceutical solution and then sealing the lumen with the ability to be tracked. The container may be a syringe barrel, a vial, or a cartridge.

[0053] Embodiments of the present disclosure are directed to a syringe barrel having electronic components attached thereto and configured to provide both an unfilled syringe barrel and a medication package resulting from filling the lumen of the syringe barrel with a medical solution and then sealing the lumen with the ability to be tracked.

[0054] Embodiments of the present disclosure are directed to vials having electronic components attached to the vial and configured to provide both unfilled vials and pharmaceutical packages that result from filling the lumen of the vial with a pharmaceutical solution and then sealing the lumen with the ability to be tracked.

[0055] Embodiments of the present disclosure are directed to injection cartridges having electronic components attached to the cartridge and configured to provide both an unfilled cartridge and a medication package resulting from filling the lumen of the cartridge with a medical solution and then sealing the lumen with the ability to be tracked.

[0056] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component is an RFID tag, optionally an RFID tag utilizing one or more frequencies within the range of 865-928 MHz, optionally an RFID tag utilizing a frequency of about 13.56 MHz.

[0057] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component comprises an integrated circuit.

[0058] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component includes data storage.

[0059] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the container, syringe barrel, vial, or cartridge comprises at least one wall made of a thermoplastic material.

[0060] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the thermoplastic material comprises one or more of polypropylene, polyethylene, COP, COC, or CBC.

[0061] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component is embedded in the thermoplastic wall of the container, syringe barrel, vial, or cartridge.

[0062] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component is overmolded onto the wall of the container, syringe barrel, vial, or cartridge.

[0063] The container, syringe barrel, vial or cartridge of any embodiment, wherein the thermoplastic material making up at least a portion of the container, syringe barrel, vial or cartridge completely or substantially completely surrounds the electronic component.

[0064] The container, syringe barrel, vial, or cartridge of any embodiment, wherein no part of the electronic component is on an exterior surface of the container, syringe barrel, vial, or cartridge.

[0065] The syringe barrel of any embodiment, wherein the electronic components are embedded in a hub portion of the syringe barrel.

[0066] The syringe barrel of any embodiment, wherein the electronic components are embedded in a transition region between the body of the syringe barrel and a hub portion of the syringe barrel.

[0067] The syringe barrel of any embodiment, wherein the hub portion is a needle hub or a luer hub.

[0068] The syringe barrel of any embodiment, wherein the syringe barrel is configured such that the electronic components are visually hidden by a rigid needle shield or luer cap.

[0069] The syringe barrel of any embodiment, wherein the electronic components are embedded in the body of the syringe barrel adjacent the rear flange.

[0070] The vial of any embodiment, wherein the electronic components are embedded in the neck portion of the vial, optionally in a thickened flange area.

[0071] The vial of any embodiment, wherein the vial is configured such that the electronic components are visually hidden by the stopper and crimp closure.

[0072] The cartridge of any embodiment, wherein the electronic components are embedded in the needle mounting portion of the cartridge.

[0073] The cartridge of any embodiment, wherein the cartridge is configured such that the electronic components are visually concealed by a cap disposed over the needle mounting portion.

[0074] The container, syringe barrel, vial, or cartridge of any embodiment further comprising a label, wherein the electronic component is embedded in a portion of the container, syringe barrel, vial, or cartridge that is visually concealed by the label.

[0075] The cartridge of any embodiment, wherein the cartridge is configured such that the electronic components are directly readable by the delivery device, optionally an auto-injector or injection pen.

[0076] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the container, syringe barrel, vial, or cartridge is configured such that the electronic component is visually concealed by a portion of the finished pharmaceutical package.

[0077] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component is detectable by automated visual inspection of the container, syringe barrel, vial, or cartridge in an empty state.

[0078] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component is configured to be written to using an external writer.

[0079] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component has a length of 5mm or less, optionally 4mm or less, optionally 3mm or less, optionally 2mm or less, optionally 1mm or less, and a width of 5mm or less, optionally 4mm or less, optionally 3mm or less, optionally 2mm or less, optionally 1mm or less.

[0080] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component has a thickness of 500 microns or less, optionally 400 microns or less, optionally 300 microns or less, optionally 200 microns or less, optionally 100 microns or less, optionally 50 microns or less.

[0081] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the container, syringe barrel, vial, or cartridge is configured such that the electronic components can withstand sterilization, optionally sterilization by e-beam or gamma irradiation, optionally sterilization by Eto or VHP gas.

[0082] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component comprises a temperature sensor, optionally the electronic component is a passive RFID temperature sensor.

[0083] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component comprises a pressure sensor, optionally the electronic component is a passive RFID pressure sensor.

[0084] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component includes information regarding a defined dispense rate or a defined range of acceptable dispense rates.

[0085] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the information regarding the defined dispense rate or the defined range of acceptable dispense rates is configured to be read by a delivery device, optionally an autoinjector or injection pen.

[0086] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component includes information regarding a defined needle insertion depth or a defined range of acceptable needle insertion depths.

[0087] The container, syringe barrel, vial, or cartridge of any embodiment, configured such that information regarding the defined needle insertion depth or the defined range of acceptable needle insertion depths is read by a delivery device, optionally an autoinjector or injection pen.

[0088] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component is configured to register interrogation events in a database.

[0089] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the inner surface, outer surface, or both of the wall in which the electronic component is embedded and encapsulated is identical or substantially identical to that of the wall of the same container, syringe barrel, vial, or cartridge prepared without the electronic component.

[0090] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the interior surface, exterior surface, or both of the wall in which the electronic component is embedded and encapsulated is free of surface irregularities such as those caused by the insertion of the electronic component.

[0091] The container, syringe barrel, vial, or cartridge of any embodiment wherein the electronic component includes information, optionally identifying information, stored directly on the component.

[0092] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component is readable without connection to a computing network, such as a cloud computing network.

[0093] The container, syringe barrel, vial, or cartridge of any embodiment, wherein the electronic component is writable without connection to a computing network, such as a cloud computing network.

[0094] Embodiments of the present disclosure are directed to a method of preparing a container having an electronic component embedded in a thermoplastic material constituting at least a portion of the container, the method including inserting the electronic component into a mold and injecting a thermoplastic material into the mold to form the container or at least a portion of the container, where the thermoplastic material surrounds or substantially surrounds the electronic component, thereby embedding the electronic component within a portion of the container. In some embodiments, the container may be a syringe barrel, a pharmaceutical cartridge, or a vial.

[0095] An embodiment of the present disclosure is directed to a method of preparing a container having an electronic component embedded in a thermoplastic material constituting at least a portion of the container, the method including providing a preform having an electronic component embedded therein, optionally with the electronic component embedded in a top portion of the preform coinciding with a neck of the container, and injection blow molding or injection stretch blow molding the preform to produce the container. In some embodiments, the container may be a syringe barrel, a pharmaceutical cartridge, or a vial.

[0096] Embodiments of the present disclosure are directed to a method of preparing a syringe barrel having an electronic component embedded in a thermoplastic material making up at least a portion of the syringe barrel, the method including inserting the electronic component into a mold and injecting a thermoplastic material into the mold to form the syringe barrel or at least a portion of the syringe barrel, wherein the thermoplastic material surrounds or substantially surrounds the electronic component, thereby embedding the electronic component within a portion of the syringe barrel.

[0097] Embodiments of the present disclosure are directed to a method of preparing a syringe barrel having an electronic component embedded in a thermoplastic material constituting at least a portion of the syringe barrel, the method including injection molding a first polymer layer, cooling the first polymer layer, e.g., to a temperature below its glass transition temperature, positioning the electronic component on a surface of the first polymer layer, and injection molding a second polymer layer such that the second polymer layer covers the electronic component.

[0098] An embodiment of the present disclosure is directed to a method of preparing a vial having an electronic component embedded in a thermoplastic material constituting at least a portion of the vial, the method including providing a preform having an electronic component embedded therein, optionally with the electronic component embedded in a top portion of the preform that corresponds to a neck of the vial, and injection blow molding or injection stretch blow molding the preform to produce the vial.

[0099] The method of any embodiment, further comprising inspecting the container, syringe barrel, or vial to ensure the presence, positioning, and / or functionality of the electronic component.

[0100] The method of any embodiment, wherein inspecting comprises an automated machine operated visual inspection of the container, syringe barrel, or vial to identify the presence of the electronic component.

[0101] The method of any embodiment, wherein the machine-operated visual inspection also determines whether the electronic component is in an acceptable position within the container, syringe barrel, or vial.

[0102] The method of any embodiment, wherein the inspecting includes ensuring that the electronic component is readable using a remote reader.

[0103] The method of any embodiment, wherein the electronic component is an RFID tag, optionally an RFID tag that utilizes one or more frequencies within the range of 865-928 MHz, optionally an RFID tag that utilizes a frequency of about 13.56 MHz.

[0104] The method of any embodiment, wherein the electronic component comprises an integrated circuit.

[0105] The method of any embodiment, wherein the electronic component comprises data storage.

[0106] The method of any embodiment, wherein the thermoplastic material comprises one or more of polypropylene, polyethylene, COP, COC, or CBC.

[0107] The method of any embodiment, wherein no part of the electronic components is on an exterior surface of the container, syringe barrel, vial, or cartridge, and optionally, no part of the electronic components is on an interior surface of the container, syringe barrel, vial, or cartridge.

[0108] The method of any embodiment, wherein the electronic components are embedded in a hub portion of the syringe barrel.

[0109] The method of any embodiment, wherein the electronic components are embedded in a transition area between the body of the syringe barrel and a hub portion of the syringe barrel.

[0110] The method of any embodiment, wherein the hub portion is a needle hub or a luer hub.

[0111] The method of any embodiment, wherein the syringe barrel is configured such that the electronic components are visually hidden by a rigid needle shield or luer cap.

[0112] The method of any embodiment, wherein the electronic components are embedded in the body of the syringe barrel adjacent the rear flange.

[0113] The method of any embodiment, wherein the electronic components are embedded in the neck portion of the vial, optionally in a thickened flange area.

[0114] The method of any embodiment, wherein the vial is configured such that the electronic components are visually hidden by the stopper and crimp closure.

[0115] The method of any embodiment, wherein the container is a cartridge and the electronic component is embedded in a needle mounting portion of the cartridge.

[0116] The method of any embodiment, wherein the cartridge is configured such that the electronic components are visually concealed by a cap disposed over the needle mounting portion.

[0117] The method of any embodiment, wherein the container, syringe barrel, vial, or cartridge further comprises a label, and the electronic component is embedded in a portion of the container, syringe barrel, vial, or cartridge that is visually concealed by the label.

[0118] The method of any embodiment, wherein the cartridge is configured such that the electronic components are directly readable by the delivery device, optionally an auto-injector or injection pen.

[0119] The method of any embodiment, wherein the container, syringe barrel, vial, or cartridge is configured such that the electronic component is visually concealed by a portion of the finished pharmaceutical package.

[0120] The method of any embodiment, wherein the electronic component is detectable by automated visual inspection of the container, syringe barrel, vial, or cartridge in an empty state.

[0121] The method of any embodiment, wherein the electronic component is configured to be written to using an external writer.

[0122] The method of any embodiment, wherein the electronic component has a length of 5mm or less, optionally 4mm or less, optionally 3mm or less, optionally 2mm or less, optionally 1mm or less, and a width of 5mm or less, optionally 4mm or less, optionally 3mm or less, optionally 2mm or less, optionally 1mm or less.

[0123] The method of any embodiment, wherein the electronic component has a thickness of 500 microns or less, optionally 400 microns or less, optionally 300 microns or less, optionally 200 microns or less, optionally 100 microns or less, optionally 50 microns or less.

[0124] The method of any embodiment, wherein the container, syringe barrel, vial, or cartridge is configured such that the electronic components can withstand sterilization, optionally sterilization by e-beam or gamma irradiation, optionally sterilization by Eto or VHP gas.

[0125] The method of any embodiment, wherein the interior surface, exterior surface, or both of the walls of the container, syringe barrel, vial, or cartridge in which the electronic component is embedded and enclosed is identical or substantially identical to that of the walls of the same container, syringe barrel, vial, or cartridge prepared without the electronic component.

[0126] The method of any embodiment, wherein the interior surface, exterior surface, or both of the walls of the container, syringe barrel, vial, or cartridge in which the electronic component is embedded and enclosed, is free of surface irregularities such as those caused by the insertion of the electronic component.

[0127] The method of any embodiment, wherein the step of providing a preform having an electronic component embedded therein comprises injection molding a first polymer layer, cooling the first polymer layer, e.g., to a temperature below its glass transition temperature, positioning the electronic component on a surface of the first polymer layer, and injection molding a second polymer layer such that the second polymer layer covers the electronic component.

[0128] The method of any embodiment, wherein the step of providing a preform having electronic components embedded therein further comprises: transferring a polymer body resulting from cooling of the first polymer layer from the first injection mold to a second injection mold; and injection molding the second polymer layer into the second injection mold.

[0129] The method of any embodiment, wherein the electronic component is positioned in a portion of the preform such that the injection blow molding or injection stretch blow molding process to produce the container or vial does not impose substantial stress on the electronic component.

[0130] The method of any embodiment, wherein the method of preparing a syringe barrel having an electronic component embedded in a thermoplastic material constituting at least a portion of the syringe barrel further comprises: transferring a polymer body resulting from cooling of the first polymer layer from the first injection mold to a second injection mold; and injection molding the second polymer layer into the second injection mold.

[0131] The method of any embodiment, wherein the syringe barrel resulting from the molding process comprises a needle, the proximal end of which is embedded in a needle hub.

[0132] The method of any embodiment, wherein the injection molding of the first polymer layer, positioning of the electronic component, and injection molding of the second polymer layer are performed without moving needles or mold cores relative to one another.

[0133] The method of any embodiment, wherein a portion of the injection mold surrounding the needle hub opens to allow positioning of the electronic component.

[0134] The method of any embodiment, wherein the needle is firmly embedded in the polymer body resulting from cooling of the first polymer layer.

[0135] The method of any embodiment, wherein a needle is inserted into the second injection mold, and optionally, the needle is not present in the first injection mold.

[0136] The method of any embodiment, wherein the electronic component includes information, optionally identifying information, stored directly on the component.

[0137] The method of any embodiment, wherein the electronic component is readable without connection to a computing network, such as a cloud computing network.

[0138] The method of any embodiment, wherein the electronic component is writable without connection to a computing network, such as a cloud computing network.

[0139] An embodiment of the present disclosure is directed to a method of monitoring whether a pharmaceutical package of any embodiment is maintained within defined storage conditions, comprising providing a pharmaceutical package according to any embodiment and registering any non-conformity events detected by a temperature sensor (if applicable), a pressure sensor (if applicable), or both.

[0140] Embodiments of the present disclosure are directed to a method of facilitating administration of a medical solution contained within a lumen of a medical package according to any embodiment, comprising interrogating an electronic component prior to administration, thereby obtaining information regarding whether there has been an incompatibility event detected by a temperature sensor (if applicable), a pressure sensor (if applicable), or both, and optionally rejecting the medical package if an incompatibility event is detected.

[0141] The method of any embodiment, wherein the interrogation is performed by a medication delivery device, optionally an auto-injector or an injection pen.

[0142] The method of any embodiment, wherein the medication delivery device is configured to reject the medication package if an incompatibility event is detected.

[0143] Embodiments of the present disclosure are directed to a method of facilitating proper dosing of a medical solution contained within a lumen of a medical package according to any embodiment, the method including interrogating an electronic component prior to dosing, thereby obtaining information regarding one or more dosing parameters, and administering the medical solution in accordance with the one or more dosing parameters.

[0144] The method of any embodiment, wherein the interrogation and administration is performed by a drug delivery device, optionally an auto-injector or an injection pen.

[0145] The method of any embodiment, further comprising adjusting one or more settings of the drug delivery device to comply with one or more administration parameters, optionally wherein the adjustments are performed automatically by the drug delivery device.

[0146] Embodiments of the present disclosure are directed to a method of monitoring administration of a medication package, for example as part of a clinical trial, comprising providing a medication package according to any embodiment and registering in a database the date and time of interrogation of electronic components and / or incompatibility events detected by a temperature sensor (if applicable), a pressure sensor (if applicable), or both.

[0147] An embodiment of the present disclosure is directed to a method of providing identification information to a pharmaceutical product, the method comprising obtaining a container, syringe barrel, vial or cartridge according to any of the preceding claims, optionally with an electronic component including identification information associated with the container, syringe barrel, vial or cartridge, filling the container with a pharmaceutical formulation, and writing information associated with the pharmaceutical formulation to the electronic component, optionally without connection to a computing network, such as a cloud computing network.

[0148] The method of any embodiment, wherein the identification information on the container, syringe barrel, vial, or cartridge is readable directly from the electronic component. [Brief description of the drawings]

[0149] [Figure 1] Figure 1A is a cross-sectional view of an embodiment of a staked needle syringe barrel having electronic components embedded in and completely encapsulated by the needle hub portion of the syringe barrel. Figure 1B is a cross-sectional view of (a) an embodiment of a pre-filled syringe having electronic components embedded in and completely encapsulated by the needle hub portion of the syringe barrel and hidden by a conventional rigid needle shield, and (b) an embodiment of a pre-filled syringe having electronic components embedded in and completely encapsulated by the luer hub portion of the syringe barrel and hidden by a conventional luer cap. [Diagram 2] FIG. 2 is a partial cross-sectional view of one embodiment of a pre-filled staked needle syringe showing electronic components embedded in and completely enclosed by the needle hub portion of the syringe barrel and hidden by a conventional rigid needle shield. [Diagram 3] FIG. 3 is a reproduction of an image showing that automated visual inspection, according to an embodiment of the present disclosure, can detect electronic components embedded in and fully enclosed by the hub portion of a syringe barrel. [Figure 4A]FIG. 4A is a cross-sectional view of an embodiment having electronic components embedded in and completely encapsulated by the neck portion of the vial, and more specifically, the thickened flange area of ​​the neck portion of the vial. [Figure 4B] FIG. 4B is a cross-sectional view of one embodiment of a pharmaceutical vial having electronic components hidden by a conventional closure assembly embedded in and completely encapsulated by the neck portion of the vial, more specifically, in a thickened flange area of ​​the neck portion. [Diagram 5] FIG. 5 is a schematic diagram illustrating a method for incorporating electronic components into a vial according to one embodiment of the present disclosure. [Figure 6] FIG. 6 is a perspective view of a set of vials having electronic components hidden by a conventional closure assembly embedded in, and completely sealed by, the neck portions of the vials in accordance with an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0150] The present disclosure will now be described more fully with reference to the accompanying drawings showing several embodiments. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments described herein. Rather, these embodiments are examples of the present invention having the full scope indicated by the language of the claims. Similar reference numerals refer to similar or corresponding elements throughout. The following disclosure relates to all embodiments unless specifically limited to a particular embodiment.

[0151] The electronic components can be selected from among known electronic components including, for example, an RFID tag or an integrated circuit (IC). If an RFID component is utilized, the one or more transmission frequencies can be within the range of 865-928 MHz, or within a subset of that range, such as 902-928 MHz, 865.5-867.5 MHz, or about 915 MHz. In other embodiments in which an RFID component is utilized, the transmission frequency can be about 13.56 MHz.

[0152] By embedding the electronic components within the container and the resulting pharmaceutical packaging, the components may include information that may be read and optionally modified through a wireless interface. This allows for improved product identification, routing, and tracking, and enhanced inventory control and security. Because the electronic components may be embedded within the walls of the container itself (and are not located on the exterior surface of the container), the electronic components may be protected from damage, may be separately incorporated, and cannot be physically separated from the packaging, which is a major improvement over previously proposed tags. Furthermore, molding the electronic components directly into the walls of the container allows for lost cost and repeatable manufacturing without the need for significant additional manufacturing steps or specially designed or customized components. In some embodiments, for example, vials, syringes, cartridges, etc. may be equipped with electronic components without modifying the materials and / or dimensions of existing vial, syringe, or cartridge designs. In some embodiments, the electronic components may also be attached to or incorporated into the container in a fully automated manner, for example, molded into a portion of the thermoplastic container. Optional process conditions for molding vials, syringes, and cartridges are disclosed below, each of which is incorporated herein by reference in its entirety, in U.S. Patent No. 9,381,687, U.S. Patent No. 10,639,421, U.S. Patent No. 9,475,225, and International Application No. PCT / US2019 / 061293 (published as WO2020102434A2).

[0153] In some embodiments, the electronic components may be positioned on the container / package such that the electronic components are not visible to downstream users, such as pharmacies and medical personnel. For example, in some embodiments, the electronic components may be embedded in the neck portion of the vial and then hidden by a closure, e.g., a stopper and a metal crimp. Similarly, the electronic components may be embedded in the needle hub portion of the syringe barrel, or in the transition area between the primary barrel portion and the hub portion of the syringe barrel, and then hidden by a rigid needle shield (or cap, in the case of Luer Lock syringes). Because the electronic components are invisible and do not require significant changes to existing container designs, they do not affect existing processes and quality checks used within the pharmaceutical industry and throughout the pharmaceutical packaging supply chain.

[0154] Additionally, each container may be inspected to confirm the presence and / or functionality of the electronic components before being filled and sealed, thereby preventing a filled container from having to be discarded due to problems with the electronic components or due to installation of the electronic components after filling. The inspection may be performed wholly or partly visually, for example, using high resolution cameras of the kind already routinely used for quality control of containers, to detect the presence and location of the electronic components. An exemplary image from an automated machine-based visual inspection of the kind capable of identifying the electronic component 1 embedded in the hub portion 12 of the syringe barrel is shown in FIG. 3. The inspection may also be performed wholly or partly electronically, for example, by ensuring that the electronic component can be detected by an appropriate reader.

[0155] In some embodiments, the electronic components may be configured to enable connected medication delivery options. For example, in some embodiments, a syringe or cartridge may be equipped with an electronic component, e.g., an RFID tag, as described herein, and an auto-injector, pen, or other delivery system may be equipped with a reader configured to directly read the electronic component, e.g., the RFID tag, to ensure that the medication package is suitable for administration. In other embodiments, a medication package, such as a vial, syringe, or cartridge, may be equipped with an electronic component, e.g., an RFID tag, as described herein, and an administrator may read the electronic component, e.g., the RFID tag, to ensure that the medication package is suitable for administration, for example, using a reader, including a separate reader or one associated with a smartphone or tablet.

[0156] For example, if a particular medication must be maintained within a defined temperature range, the electronic component, e.g., an RFID tag, can monitor the temperature of the pharmaceutical package via an associated temperature sensor, such as the passive RFID temperature sensor described in Temperature Sensor Tag for Passive UHF RFID Systems by Virtanen et al., published at 2011 IEEE Sensors Applications Symposium, Feb. 22-24, 2011, available at: https: / / ieexplore.ieee.org / document / 5739788, which is incorporated herein by reference in its entirety, and a reader may be used to interrogate the electronic component to ensure that the package and / or drug formulation have been maintained within the defined temperature range prior to administration. Similarly, if a particular medication must be maintained within a defined pressure range, the electronic component, e.g., an RFID tag, may monitor the pressure of the medication package via an associated pressure sensor, such as, for example, the passive RFID pressure sensors manufactured by Farsens under the names Vortex and Cyclon, and a reader may be used to interrogate the electronic component to ensure that the package and / or drug formulation has been maintained within the defined pressure range prior to administration.

[0157] In some embodiments, the electronic component, e.g., an RFID tag, may also be configured to facilitate and / or ensure proper administration of the fluid contained within the pharmaceutical package. For example, in some embodiments, a pharmaceutical package, such as a vial, syringe, or cartridge, may be provided with an electronic component as described herein, including information regarding proper administration of the fluid, e.g., one or more delivery parameters. That information may be obtained, e.g., by a reader, from the electronic component, and a user / administrator provided with guidance regarding the delivery parameters may thereby ensure that those delivery parameters are met. Further, in some embodiments, a pharmaceutical package, such as a vial, syringe, or cartridge, may be provided with an electronic component including information regarding proper administration of the fluid, e.g., one or more delivery parameters, and an auto-injector, pen, or other delivery system may be provided with a reader configured to read the electronic component, e.g., an RFID tag, to control certain delivery parameters and / or ensure that certain delivery parameters identified from the electronic component are met.

[0158] In some embodiments, the electronic component, e.g., an RFID tag, may include information related to the strength of the pharmaceutical formulation contained within the lumen of the container. For medications that may be provided in multiple different strengths (e.g., concentration of active agent, total amount of active agent, etc.), it is important to ensure that the appropriate dose is administered to the patient. By providing information related to the strength of the pharmaceutical formulation on the electronic component, e.g., an RFID tag, a manager of the formulation may obtain the strength of the pharmaceutical formulation by reading the electronic component. In some embodiments, access to this information may be recorded, for example, in a data log and used to ensure that the manager performs the necessary checks (or double checks, since the information may be provided on the label) of the strength of the pharmaceutical product prior to administration.

[0159] Some drugs, particularly drugs for the treatment of cancer and autoimmune diseases, as well as mRNA drugs, require that the drug formulation be dispensed at a defined dispensing rate or within a defined range of dispensing rates, at a defined needle insertion depth or within a defined range of needle insertion depths (e.g., into a particular area, such as subcutaneously, intramuscularly, etc.), or combinations thereof.

[0160] In some embodiments, the electronic component, e.g., an RFID tag, may include information regarding a defined drug dispensing rate or a defined range of acceptable drug dispensing rates. A delivery system, e.g., an auto-injector, pen, or other delivery system, may be configured to read the electronic component and automatically set one or more injection parameters related to the drug dispensing rate, e.g., controlling the force applied to the plunger, to ensure that the drug formulation dispensing rate meets the defined rate or falls within the defined acceptable range. In other embodiments, an administrator may obtain information from the RFID tag, e.g., by a reader, such as a separate reader or a reader that may be associated with a smartphone, tablet computer, or other device, and manually set one or more injection parameters of the delivery device or manually control the dispensing rate to ensure that the defined dispensing rate meets or falls within the defined range.

[0161] Additionally, in some embodiments, either the electronic component, e.g., the RFID tag, or the delivery system, e.g., the auto-injector, may be configured to detect the speed at which the plunger advances within the syringe barrel corresponding to the drug dispense rate. The delivery system may respond to readings obtained from the electronic component, e.g., the RFID tag, that do not correlate with the defined dispense rate or are outside of a defined range of acceptable dispense rates by automatically adjusting one or more injection parameters, e.g., the force applied to the plunger, to adjust the dispense rate upward or downward, as necessary, to meet the defined dispense rate or to fall within the defined acceptable range. Alternatively, the delivery system may alert an administrator that the dispense rate is too high or too low, which may allow the administrator to manually adjust the dispense rate upward or downward, as necessary, to meet the defined dispense rate or to fall within the defined acceptable range. In some embodiments, for example, the delivery device may include one or more tachometers, accelerometers, combinations thereof, and the like.

[0162] In some embodiments, the electronic component, e.g., an RFID tag, may include information regarding a defined needle insertion depth or a range of acceptable needle insertion depths. A delivery system, e.g., an autoinjector, pen, or other delivery system, may be configured to read the electronic component and set one or more injection parameters associated with needle insertion depth, e.g., control of the force applied to the syringe barrel during needle insertion, to ensure that the needle insertion depth meets the defined depth or falls within the defined acceptable range. In other embodiments, an administrator may obtain information from the RFID tag, e.g., by a reader, such as a separate reader or a reader that may be associated with a smartphone, tablet computer, or other device, and manually set one or more injection parameters of the delivery device or manually control the needle insertion depth to ensure that the defined depth meets or falls within the defined range.

[0163] Additionally, in some embodiments, either the electronic component, e.g., the RFID tag, or the delivery device may be configured to detect the proximity of an injection site that corresponds to the needle insertion depth. The delivery system may respond to readings obtained from the electronic component, e.g., the RFID tag, that do not correlate with the defined needle insertion depth or that are outside of a defined range of acceptable needle insertion depths by automatically adjusting one or more parameters to adjust the needle insertion depth as necessary to meet the defined needle insertion depth or fall within the defined acceptable range. Alternatively, the delivery system may alert an administrator that the needle insertion depth is too high or too low, so that the administrator may manually adjust the needle insertion depth as necessary to meet the defined needle insertion depth or fall within the defined acceptable range. In some embodiments, for example, the delivery system may include a proximity sensor oriented axially forward (parallel to the needle) and configured to measure the proximity of the injection site relative to the needle insertion depth during needle insertion.

[0164] In some embodiments, electronic components, such as RFID tags, may be used by administrators to enable record-gathering. For example, many medications may need to be administered to patients in a home or group home environment. Often, medical personnel need to administer medications to multiple patients in a group home or across multiple homes, and record-keeping of those administrations may be complicated and time-consuming. The built-in RFID tags of the disclosed embodiments may simply be such record-gathering, for example, by recording the date / time, location, or both reading and storing that information in a data log.

[0165] In some embodiments, the electronic components may include storage elements and may themselves be used for data storage. In other words, the container itself may act as a data carrier, rather than a cloud. Data may also be easily transferred from the container, i.e., from the electronic components, to a data cloud. The electronic components are configured to be interrogated by an external reader and, optionally, written to using an external writer.

[0166] As described herein, embodiments of pharmaceutical packages, e.g., syringes, cartridges, and vials, may provide any combination of the above capabilities, thereby improving patient or administrator compliance with delivery guidelines for a particular drug formulation.

[0167] Additionally, in some embodiments, the RFID tag may be loaded with specific information related to the identity, storage conditions, and / or administration parameters of the emerging drug to enhance the validity and reliability of the clinical trial. For many emerging drugs, the validity of the clinical trial depends on the maintenance of specific protocols related, for example, to the temperature of the drug, the depth of injection, and / or the rate of injection into the patient. As discussed above, the use of an RFID tag associated with a pharmaceutical package may be used to ensure proper adherence to these parameters. Embodiments of the present disclosure are directed to, for example, a method of conducting a clinical trial, including providing a pharmaceutical package having an RFID tag attached or incorporated therein, and prompting or otherwise interrogating the RFID tag of the pharmaceutical package to determine whether one or more protocols have been maintained and / or to determine the specific protocols associated with the delivery of the pharmaceutical formulation contained therein prior to administration of the pharmaceutical formulation.

[0168] RFID tags may also be used, for example, for post-approval studies, to demonstrate that a drug was administered in a manner consistent with a controlled protocol of a clinical trial. In some embodiments, for example, an electronic component, e.g., an RFID tag, may be configured to record certain data in a central database, e.g., drug storage data, drug administration data, etc. For example, as described herein, when queried by a reader prior to administration, the RFID tag may register the query (corresponding to the date / time of administration) in a central data log. Registering all packages, e.g., vials, syringes, or cartridges utilized in a clinical trial in the same data log creates a reviewable record of all administrations during the clinical trial. RFID tags may also be configured to register any data that is not consistent with the clinical trial protocol, e.g., any deviations from a defined temperature storage protocol, etc. Such types of monitoring may help to create a reviewable record of the clinical trial and ensure that post-approval studies and monitoring of drug efficacy in larger patient populations are properly evaluated.

[0169] Embodiments of the present disclosure are directed, for example, to a method of conducting a clinical trial that includes providing a pharmaceutical package having an RFID tag attached or incorporated therein, optionally prompting or otherwise causing the RFID tag of the pharmaceutical package to be interrogated to determine whether one or more protocols have been maintained and / or to determine a particular protocol associated with the delivery of a pharmaceutical formulation contained therein prior to administration of the pharmaceutical formulation, optionally recording the location, date, and / or time of such interrogation using the RFID tag, and optionally using the RFID tag to record data related to the clinical trial, e.g., medication storage data, in a central data log.

[0170] In some embodiments, telematics may be used. Telematics involves the use of long-range communication devices to transmit, receive, and store information to control remote objects. In the context of the present disclosure, the location where the medicine package is administered, i.e., where the electronic components are interrogated prior to administration, may be used to access relevant information from clinical trials. For example, if the medicine package was administered in a particular region of Asia, appropriate clinical studies from that demographic group may be accessed.

[0171] In some embodiments, any combination of data described herein may be stored on the electronic components, e.g., RFID tags themselves, rather than on a cloud computing network. By writing data directly to the electronic components, and thus directly to the containers themselves, embodiments of the present disclosure provide a number of advantages over embodiments in which data is stored in the cloud. For example, each container may be tracked throughout the pharmaceutical supply chain by identification information stored directly on the electronic components, e.g., RFID tags. This allows identification information (e.g., unique identifiers, batch numbers, pharmaceutical material numbers, etc.) to be matched without the need to connect the systems of multiple different entities (e.g., container manufacturers, fillers, secondary packaging providers, shippers, etc.) to the same cloud network.

[0172] In some embodiments, storing data directly on the electronic component, such as an RFID tag, also allows multiple steps along the supply chain to write data directly onto the electronic component. For example, a container manufacturer can write container identification information to the electronic component, a filler can write pharmaceutical composition, e.g., pharmaceutical material identification information to be filled into the lumen of the container to the electronic component, and a secondary packaging provider can optionally write additional identification information to the electronic component. In particular, by providing a container with a built-in RFID tag where the data is stored directly and not in a cloud computing network, each different entity along the supply chain can add information to the RFID tag without the multiple entities having to be connected to the same cloud network.

[0173] By allowing identification information to be read and / or written directly from electronic components, e.g., RFID tags, the container and its pharmaceutical contents can be tracked from the point of manufacture of the container to the point of administration of the pharmaceutical, without the need to connect multiple entities to a common cloud. This provides significant benefits in terms of cost savings and greatly simplifies supply chain management. For example, independent entities do not need to acquire equipment and / or build infrastructure to connect to a shared cloud and share data via the shared cloud (which is often undesirable).

[0174] The electronic components may be attached to the container and / or pharmaceutical package via any of a variety of methods, such as adhesives, mechanical attachment, or overmolding. As described herein, molding techniques in which the electronic components become part of the package during the molding process, and preferably where the electronic components are embedded in and completely encapsulated by the container walls, are desirable because they offer more benefits than other methods.

[0175] In some embodiments, for example, electronic components can be embedded into a portion of a thermoplastic container by mold labeling. Using this technique, electronic components (also called inlays) can be laminated with a film substrate. The film substrate is desirably made of a plastic compatible with pharmaceutical packaging. In a mold label process, the inlay is inserted into the mold prior to plastic injection molding. In some embodiments, for example, the inlay can be presented to the mold in label format. During the injection molding stage of the container molding process, the inlay is overmolded, and the inlay becomes an integral part of the package.

[0176] Some of the materials used to manufacture thermoplastic containers used as pharmaceutical packaging include, but are not limited to, polypropylene, polyethylene, cyclic olefin polymers (COP), cyclic olefin copolymers (COC), and cyclic block copolymers (CBC).

[0177] Embodiments of the present disclosure are directed to a pharmaceutical vial 20 made of plastic and having an electronic inlay 1 integrated into the plastic wall of the vial. More specifically, embodiments of the present disclosure are directed to a pharmaceutical vial 20 made of plastic and having an electronic inlay 1 embedded in and completely encapsulated by the plastic wall of the vial.

[0178] A vial 20 of the present disclosure may include a bottom wall 21, a sidewall 22 extending upwardly from the bottom wall, a curved lower edge joining the bottom wall and the sidewall 23, a radially inwardly extending shoulder 24 formed at an upper portion of the sidewall, and a neck 25 extending upwardly from the shoulder, the neck defining an opening 26 at an upper portion thereof that leads to the interior, or lumen, of the vial. In many embodiments, the neck may include an outwardly extending flange 27 configured to receive a portion of a closure. An example of such a vial 20 is shown in FIG. 4A.

[0179] Once filled with a pharmaceutical product, typically an injectable pharmaceutical product, the vial 20 is sealed. Typically, the pharmaceutical vial 20 is sealed with a two-piece closure including a rubber stopper 28 and a cap 29, such as a crimp cap, a Flip-Off® Seal of the type manufactured by West Pharmaceutical and others. The crimp cap is typically made of a metal such as aluminum and is crimped over the top of the stopper 28 and neck flange 27 of the vial. The combination of the filled vial 20, stopper 28, and cap 29 may be referred to as a pharmaceutical vial or vial package. An example of a pharmaceutical vial package is shown in FIG. 4B.

[0180] In some embodiments, the electronic inlay 1 may be embedded in and completely encapsulated by the plastic that makes up the neck 25 of the vial, for example the thickened plastic area that makes up the top flange 27.

[0181] The top of neck 25, including upper flange 27, must be prepared with relatively low dimensional tolerances to ensure a uniform seal with commercially available stopper 28 and cap 29. Thus, both the inner surface of neck portion 25, including flange 27, and the outer surface of the neck portion must have uniform surfaces. In some embodiments, upper flange 27 may also have one or more exterior surface features that may assist in gripping and / or securing cap 29.

[0182] A pharmaceutical vial 20 made of plastic is prepared by blow molding, for example, using injection blow molding or injection stretch blow molding techniques. An example of an injection stretch blow molding technique is shown in FIG. 4. In a first step 41, a preform 30 is injection molded. A thermoplastic resin 33, for example a COP or COC resin, is melted and delivered to an injection mold that forms the shape of the preform 30. The preform 30 is then injection stretch blow molded to form the vial 20. In a second step 42 of such a process, the preform 30 is heated above its glass transition temperature and stretched, for example, by a mandrel 34 or core rod of a stretch blow molding machine. In a third step 43 of such a process, high pressure air is blown into the preform 30, thereby expanding the preform until it contacts the mold and thus assumes the shape of the vial 20. Stretching 42 may be performed prior to or as part of blow molding 43, for example through a core rod of a stretch blow molding machine (in which case the process may be viewed as a two-step process), as shown in Figure 4. In other embodiments, for example, when vial 20 is prepared by extrusion blow molding, stretching step 42 may be omitted entirely.

[0183] During the blow molding process, the neck portion 31 of the preform 30 is held in place and does not undergo deformation unlike the remainder of the preform, and thus the neck portion 31 of the preform 30 is injection molded to have the dimensions and elements of the neck portion 25 of the resulting pharmaceutical vial 20, such as the flange 27 and any surface features of the flange.

[0184] To incorporate the electronic inlay 1 into the vial 20, the inlay may be incorporated during a step of injection molding the preform 30, such as step 41. In particular, the electronic inlay 1 may be incorporated into the upper portion 31 of the preform 30 (corresponding to the neck region 25 of the vial), which is not dimensionally affected by the downstream blowing and any stretching steps. This allows the electronic inlay 1 to avoid being subjected to stresses that would occur if the inlay were located in a portion of the preform that was converted into the sidewall 22 or base 21 of the vial during the blow molding process. This also has the added advantage of allowing the electronic component 1 to be hidden by the closure assembly 28, 29 that is subsequently applied to the filled vial, as shown, for example, in FIG. 5.

[0185] Desirably, the electronic inlay 1 is embedded and completely encapsulated by the plastic walls of the vial 20. In this manner, the interior and exterior surfaces of the vial 20 can be identical or substantially identical to those of a vial prepared without the electronic inlay 1 (i.e., made of the same polymeric material and lacking any surface irregularities resulting from the insertion of the electronic inlay). In some embodiments, the electronic inlay 1 is embedded and completely encapsulated by the plastic that makes up the neck portion 25 of the vial, and more specifically, the thickened flange region 27.

[0186] Desirably, the electronic inlay 1 is embedded and completely encapsulated by the plastic walls of the vial in a manner that does not cause surface irregularities or variability. For example, the electronic inlay 1 may be introduced into the neck portion 31 of the preform during step 41 of injection molding the preform 30. In such a process, the injection molding of the preform 30 is performed in multiple steps, similar to a two-shot molding process or an overmolding process. In a first step, a first amount of thermoplastic material 33, such as a COP or COC resin, is melted and delivered to an injection mold where it forms a first layer of polymer. The electronic inlay 1 is then positioned at a desired location on the surface of the first layer. This may involve cooling the first layer of polymer before placing the electronic inlay 1 on its surface, especially if the total thickness of the first layer is small. After the electronic inlay 1 is positioned on the surface of the first layer, a second injection of thermoplastic material 33 is delivered to the injection mold where it flows over the surface of the first layer with the electronic inlay positioned thereon. The molded preform 30 is then cooled and removed from the mold. In this manner, the electronic inlay 1 may be sandwiched between the first and second polymer layers, resulting in a preform wall with the electronic inlay fully embedded and encapsulated therein.

[0187] In some embodiments, the injection molding step 41 may involve the use of two injection molds. In a first step, a first amount of thermoplastic material 33, e.g., COP or COC resin, is melted and delivered to a first injection mold forming an intermediate polymer body. The intermediate polymer body is then cooled and transferred to a second injection mold. The electronic inlay 1 is optionally positioned at a desired location on the surface of the intermediate polymer body after it has been placed in the second injection mold or during the transfer of the intermediate polymer body to the second injection mold. A second amount of thermoplastic material 33, e.g., COP or COC resin, is melted and delivered to the second injection mold where it flows over the surface of the intermediate polymer body and the electronic inlay 1 positioned thereon to form the final molded preform 30. The final molded preform 30 is then cooled and removed from the second injection mold. As described above, the result is a preform wall with the electronic inlay fully embedded and encapsulated therein.

[0188] When the preform 30 includes an electronic inlay 1 in an upper portion 31 of the preform that is injection molded to conform to the vial neck 25 and, optionally, the thickened flange portion 27 of the neck, the preform may be converted into a vial 20 by a conventional blow molding process such as that described above. Because the electronic inlay 1 is embedded and fully encapsulated by the upper portion 31 of the preform, which does not undergo deformation during the blow molding process, the electronic inlay does not experience any actual stress during the blow molding process and its presence does not interfere with the blowing and molding of the vial 20.

[0189] Moreover, by incorporating the electronic inlay 1 into the vial 20 in this manner, the dimensions of the neck 25 of the vial, and optionally the thickened flange portion 27 of the neck, may be repeatably manufactured within tight tolerances. Moreover, because the electronic inlay 1 is not introduced into the preform 30 or the vial 20 during or after the blow molding process, the exterior and interior surfaces of the vial wall in which the electronic inlay is embedded and encapsulated may be uniform. In some embodiments, for example, both the interior surface of the vial neck 25 and the exterior surface of the vial neck may be free of surface irregularities caused by electronic inlay insertion. For example, the interior surface of the vial neck 25 may be smooth and the exterior surface may be smooth or may include one or more conventional surface features, such as those shown in Figures 4A and 4B. Finally, because the electronic inlay 1 is completely encapsulated by the polymeric wall of the vial 20, no portion of the electronic inlay is exposed to either the interior or exterior surfaces of the vial.

[0190] Incorporating the electronic inlay 1 into the neck portion 25 of the vial 20 is complicated by the fact that the neck portions of multiple vials must be manufactured with a uniform surface and close dimensional tolerances (to enable effective sealing with the closure assemblies 28, 29), but the process described above enables the manufacture of vials having such uniform surfaces and close dimensional tolerances.

[0191] Embodiments of the present disclosure are directed to pre-filled syringes 10 made of plastic and having an electronic inlay 1 embedded in the plastic wall of the syringe barrel. More specifically, embodiments of the present disclosure are directed to syringe barrels made of plastic and having an electronic inlay 1 embedded and completely encapsulated in the needle or luer lock hub 12 or in the transition area 13 between the primary portion of the syringe barrel 11 and the needle or luer hub, and pre-filled syringes 10 utilizing such syringe barrels. In other embodiments, the syringe barrel may have an electronic inlay 1 embedded and completely encapsulated in the syringe barrel wall just above the rear flange 14.

[0192] A pre-filled syringe typically includes a syringe barrel, an injectable pharmaceutical composition contained within the lumen of the syringe barrel, a plunger 17 inserted into the rear opening of the syringe barrel to provide a rear seal, and either a rigid needle shield 15 or a luer cap 16, depending on whether the syringe is a staked needle syringe or a luer lock syringe. In some embodiments, a plunger rod may also be inserted into the rear opening of the syringe barrel and communicate with the plunger 17. In the case of a pre-filled syringe 10, the electronic inlay 1 may desirably be positioned within the needle or luer lock hub 12, or within the transition region 13 between the primary portion of the syringe barrel 11 and the needle or luer hub, as shown, for example, in FIG. 1B. Positioning the electronic inlay 1 in this manner has the advantage of allowing the electronic components to be hidden by a rigid needle shield 15 or luer cap 16 that is then applied to the pre-filled syringe, as shown, for example, in FIG. 1B. In an alternative embodiment, the inlay 1 may be incorporated into a primary portion of the wall of the syringe barrel 11, for example just above the rear flange 14.

[0193] Desirably, the electronic inlay 1 is embedded and completely encapsulated by the plastic that comprises either the wall, transition region 13, or hub portion 12 of the syringe barrel 11. In this manner, the interior and exterior surfaces of the syringe barrel, and particularly the portion of the syringe barrel in which the electronic inlay 1 is embedded, may be the same or substantially the same (i.e., made of the same polymeric material) as those of a syringe barrel prepared without the electronic inlay 1. In some embodiments, the electronic inlay 1 is embedded and completely encapsulated by the plastic that comprises the needle or luer hub 12 of the syringe barrel.

[0194] Desirably, the electronic inlay 1 is embedded and completely encapsulated by the plastic wall of the vial in a manner that does not cause surface irregularities or variability. For example, the electronic inlay 1 may be introduced into a portion of the syringe barrel as an intermediate step during molding. Plastic syringe barrels are typically manufactured by an injection molding process. In such a process, a thermoplastic material 33, such as a COP or COC resin, is melted and delivered to an injection mold that forms the shape of the syringe barrel. In the case of a staked needle syringe, the needle is held against a mold core during the injection molding process, and the thermoplastic material flows around the sides of the proximal portion of the needle, thereby forming the needle hub portion 12 of the syringe barrel. When the thermoplastic material that makes up the needle hub portion 12 cools, the proximal portion of the needle is fixed within the hub portion of the syringe barrel. In contrast, for a Luer lock syringe, one or more mold elements are used to form a flow passage that extends centrally through the hub portion 12.

[0195] In an embodiment of the present disclosure, the electronic inlay 1 may be embedded in and completely encapsulated by a portion of the syringe barrel, such as the needle or luer hub 12. To obtain such an arrangement, the injection molding of the syringe barrel may be performed in multiple steps, similar to a two-shot molding process or an overmolding process. In a first step, a first amount of thermoplastic material 33, such as a COP or COC resin, is melted and delivered to an injection mold where it forms a first layer of polymer. The first layer of polymer is then cooled to provide some rigidity to the first layer, and then the electronic inlay 1 is positioned in a desired location on the surface of the first layer. After the electronic inlay 1 is positioned on the surface of the first layer, a second injection of thermoplastic material 33 is delivered to the injection mold, where it flows over the surface of the first layer and the electronic inlay is positioned thereon. The molded syringe barrel is then cooled and removed from the mold. In this manner, the electronic inlay 1 may be sandwiched between the first polymer layer and the second polymer layer, resulting in a syringe barrel in which the electronic inlay is fully embedded and encapsulated within a portion of the wall, such as wall 11, transition region 13, flange 14, or hub portion 12.

[0196] In some embodiments, injection molding may involve the use of two injection molds. In a first step, a first amount of thermoplastic material 33, e.g., COP or COC resin, is melted and delivered to a first injection mold forming an intermediate polymer body. The intermediate polymer body is then cooled and transferred to a second injection mold. An electronic inlay 1 is optionally positioned at a desired location on the surface of the intermediate polymer body after it is placed in the second injection mold or during the transfer of the intermediate polymer body to the second injection mold. A second amount of thermoplastic material 33, e.g., COP or COC resin, is melted and delivered to the second injection mold where it flows over the surface of the intermediate polymer body with the electronic inlay 1 positioned thereon forming a molded syringe barrel. The final molded syringe barrel is then cooled and removed from the second injection mold. As discussed above, the result is a syringe barrel having an electronic inlay completely embedded and encapsulated by a portion of the wall, such as wall 11, transition region 13, flange 14, or hub portion 12.

[0197] By incorporating the electronic inlay 1 into the syringe barrel in this manner, the dimensions of the syringe barrel, and particularly the portion of the syringe barrel in which the inlay is embedded and encapsulated, can be repeatably manufactured within tight tolerances and with high uniformity. This is particularly important when dealing with small volume syringe barrels, such as those having internal lumens with nominal fill volumes of 0.25-10 mL, optionally 0.5-5 mL, optionally 0.5-1 mL, optionally 0.5 mL, optionally 1 mL, optionally 2.25 mL. For example, dimensional and surface uniformity are critical to maintaining container closure integrity (CCI).

[0198] Additionally, the electronic inlay 1 is completely encapsulated by the polymeric walls of the syringe barrel 11 such that no portion of the electronic inlay is exposed to either the interior or exterior surfaces of the syringe barrel, and in the case of a staked needle syringe, the electronic inlay 1 does not contact the needle.

[0199] The incorporation of the electronic inlay 1 into the hub portion 12 of the staked needle syringe barrel is complicated by the particular structural arrangement of its elements, including, for example, the requirement to fix the proximal portion of the needle therein, and the fact that the end of the needle holder typically forms part of the mold. Thus, the molding process must be specifically adapted when incorporating the electronic inlay 1 into the hub portion 12 of the staked needle syringe barrel. In some embodiments, for example, the injection mold may comprise an independently releasable element surrounding at least a portion of the hub portion 12, which may be opened to allow placement of the electronic inlay 1 without movement of the needle holder or mold core. In some embodiments, the thickness of the first polymer layer or intermediate polymer body is carefully controlled so that, upon cooling, the needle is fixed therein, but does not incorporate too much of the overall thickness of the hub portion 12 such that the second polymer layer is insufficient to completely cover and encapsulate the electronic inlay 1.

[0200] Electronic inlays may be relatively small so as not to require significant changes to the dimensions of existing vials, syringes, cartridges, etc. In some embodiments, for example, electronic inlays may have lengths of 5 mm or less, 4 mm or less, 3 mm or less, 2 mm or less, or 1 mm or less, and widths of 5 mm or less, 4 mm or less, 3 mm or less, 2 mm or less, or 1 mm or less. Electronic inlay embodiments may have thicknesses of 500 microns or less, 400 microns or less, 300 microns or less, 200 microns or less, 100 microns or less, or 50 microns or less.

[0201] The electronic inlay may also be configured to withstand sterilization of the pharmaceutical package, such as sterilization by irradiation (eg, electron beam or gamma) and gas (eg, ethylene oxide (EtO), vaporized hydrogen peroxide (VHP), etc.).

[0202] The electronic inlay may also be configured to undergo PECVD coating of one or more surfaces of the container wall, such as described in, for example, U.S. Patent No. 9,554,968, Trilayer Coated Pharmaceutical Packaging, and U.S. Patent No. 9,863,042, PECVD Lubricity Vessel Coating, Coating Process And Apparatus Providing Different Power Levels in Two Phases, which are incorporated herein by reference in their entireties. These coating processes may involve, for example, the electronic inlay being subjected to an electric field.

[0203] In some embodiments, a syringe barrel with an integrated staked needle and embedded electronic components may be prepared. Another aspect of the technology disclosed herein is a method of making a syringe with an electronic component and an integrated staked needle by injection molding at least a portion of the barrel around the needle to fix and seal the needle in place. At least a portion of the needle is inserted into a mold before injecting plastic or other material to form the syringe body. When the plastic cools in the mold cavity, the plastic syringe body bonds to the needle, forming a permanent attachment between the needle and the syringe. The bond between the needle and the syringe is optionally sufficient to maintain moisture-proof, liquid-tight, sterility, and can hold a vacuum.

[0204] In some embodiments, vials with embedded electronic components may be prepared. Bottles or vials may typically be formed using blow molding. Blow molding is a manufacturing process in which hollow plastic parts, such as bottles or vials (with a relatively narrow neck and / or opening), are formed. In general, there are three types of blow molding: (1) extrusion blow molding, (2) injection blow molding, and (3) injection stretch blow molding. In any type of blow molding, the process begins with providing molten plastic and forming it into a parison or preform. A parison is a tube-like piece of plastic with an opening at one end through which compressed air can pass. The parison is clamped into a mold and air is blown into it. The air pressure forces the plastic to conform to the contours of the mold (almost like blowing a balloon), thereby forming the finished part as the plastic cools. After the container cools and hardens, the mold is opened and the part is ejected.

[0205] Extrusion blow molding is a process substantially as described above, but also requires spin trimming, which is an additional step that involves trimming off excess material. Extrusion blow molded parts are known to have low strength and as a result are undesirable for most containers. Also, an additional processing step involved performing extrusion blow molding, which is undesirable for making lyophilization vials.

[0206] In a standard injection blow molding (IBM) process, the polymer is injection molded onto a core pin, which is then rotated into a blow molding station to expand and cool. It is the least used of the three blow molding processes and is typically used to make small medical bottles and single-use bottles. The process is divided into three steps: injection, blow, and ejection. An injection blow molding machine is based on an extruder barrel and screw assembly that melts the polymer. The molten polymer is fed into a hot runner manifold and injected through a nozzle into a heated cavity and core pin. The cavity mold forms the external shape of the container and is clamped around a core rod that forms the internal shape of the preform. The preform consists of a fully formed bottle / journal neck with a thick tube of polymer attached to it, which is similar in appearance to a test tube with a threaded neck to form the body. An example of such a preform can be found in U.S. Patent Publication No. 2009 / 0220809. The preform mold opens and the core rod rotates and is clamped into a hollow, cooled blow mold. The end of the core rod opens, allowing compressed air to enter the preform and expand it to the finished shape. After a cooling period, the blow mold opens and the core rod rotates to the ejection position. Typically, injection blow molding is only suitable for small volume bottles because it is difficult to control the base center during blowing. In addition, there is no increase in barrier strength because the material is not biaxially stretched. Therefore, the standard injection blow molding method is not desirable for most containers and vessels due to limited use or product configuration, barrier strength limitations, and other manufacturing inconveniences.

[0207] Conventional injection stretch blow molding (ISBM) is typically carried out using one of two different processes: one-stage and two-stage.

[0208] In a two-stage injection stretch blow molding process, plastic is first molded into a preform using an injection molding process. These preforms are manufactured with the neck of a bottle, optionally including a thread at one end. These preforms are packaged and later (after cooling) fed into a reheat stretch blow molding machine. In the ISBM process, the preform is heated above its glass transition temperature and then blown into a bottle using a metal blow mold with high pressure air. The preform may also be stretched with a core rod or mandrel as part of the process.

[0209] FIG. 5 shows a schematic diagram of the steps involved in stretch blow molding according to one embodiment of the disclosed concept. It should be noted that the final vial shown in FIG. 5 is merely intended to illustrate the process and does not accurately and intricately depict all the structural features of the vial. As shown in step 41, the process may involve the initial steps of providing a plastic resin 33 (e.g., cycline olefin polymer), melting the resin, delivering the melt to an injection mold, and molding a preform 30 from the resin. In the next step 42, the heated preform 30 is optionally stretched in the blow mold using a mandrel. When in the blow mold, the preform is stretched past the bottom (i.e., the base mold is not yet in position to blow, such that the mold is not in the blowing position). In the final step 43, while the molded part and base mold are collectively in the blowing position (i.e., the base mold is pushed up from its previous position during the stretching step), gas is blown into the stretched heated preform to form the final shape of the vial. Raising the base mold in this manner after stretching and then blowing with gas helps optimize material distribution, especially at the corners. The blow pressure may be adjusted and controlled during steps 42 and 43. For example, a low pressure blow may optionally be utilized during stretching step 42 to help disperse the material of the preform. Gas may be blown in at high pressure when the base mold is in place after the desired shape of the vial has been partially formed. Optionally, a four component injection mold is used to help optimize the process and provide improved material distribution.

[0210] During the drawing process, the mandrel may be controlled pneumatically or by a servo. A servo may be preferred as it provides more precise control of the mandrel drawing speed and position. A servo may also be optionally used to monitor the plastic temperature and adjust the speed profile to help achieve a vial with the desired dimensions and tolerances required for thermal efficiency.

[0211] Applicants have found that the lower stretch ratios produced using injection stretch blow molding, compared to other forms of blow molding, allow for better control of part sidewall thickness variation. The resulting dimensional control and tolerance of the part can improve the thermal efficiency of the container or vessel (e.g., vial). Minimizing sidewall thickness variation facilitates more consistent heat transfer during the freeze drying (lyophilization) cycle. In particular, uniform sidewall thickness measured radially (i.e., 360° around the central axis of the vial) appears to be more important than uniformity of wall thickness measured axially (i.e., wall thickness near the bottom relative to wall thickness at the top of the vial). In addition to benefits related to thermal efficiency, the consistency of sidewall thickness of vials produced according to the injection stretch blow molding method of the disclosed concept results in improved optical properties. Such properties in parenteral containers are necessary to allow visual inspection through the transparent container for any foreign body contamination. Inconsistencies in sidewall thickness can create optical distortions that limit a person's ability to visually inspect the contents of the vial. The methods and vials of the disclosed concepts reduce or eliminate this problem of the prior art.

[0212] Furthermore, it has been found that the density of the polymeric vials made according to the above process is much more uniform and precisely controlled than that of glass vials. Density variations can affect the cycle time of freeze-drying. Thus, the more uniform density of the vials according to the disclosed concept provides improved uniformity in the freeze-drying process.

[0213] By providing a container with an electronic component, e.g., an RFID tag, that is incorporated therein during the manufacture of the container, embodiments of the present disclosure may also enable a more efficient process for identifying rejected containers, e.g., vials, syringe barrels, cartridges, etc. Conventionally, when one or more empty containers or one or more filled and sealed containers (i.e., pharmaceutical products) are identified as needing to be rejected, for example, because one or more process parameters have been found not to be met, it may be difficult to determine which individual containers of a batch or part of a batch need to be rejected. This may lead to the entire batch or a large portion of a batch being discarded. By providing each individual container with an electronic component, e.g., an RFID tag, that has a unique identifier, embodiments of the present disclosure enable the identification of individual containers or pharmaceutical products for rejection, thereby limiting the amount of product that is discarded.

[0214] Exemplary embodiments Pharmaceutical packaging 1. A pharmaceutical package comprising: a vessel defining a lumen; a medicinal solution within the lumen; A closure; Attached to the container, Providing the ability for packages to be tracked; and / or Detect and / or record compliance or non-compliance with one or more storage conditions; and / or and an electronic component configured to provide information regarding one or more administration parameters. 2. The pharmaceutical package of embodiment 1, wherein the container is a syringe barrel, cartridge, or vial. 3. The pharmaceutical package of any of embodiments 1-2, wherein the electronic component is an RFID tag, optionally an RFID tag utilizing one or more frequencies within the range of 865-928 MHz, optionally an RFID tag utilizing a frequency of about 13.56 MHz. 4. The pharmaceutical package of any one of embodiments 1 to 3, wherein the electronic component comprises an integrated circuit. 5. The pharmaceutical package of any of embodiments 1-4, wherein the electronic component comprises data storage. 6. A pharmaceutical package according to any of the preceding embodiments, wherein the container comprises at least one wall made of a thermoplastic material. 7. The pharmaceutical package of any of embodiments 1-6, wherein the thermoplastic material comprises one or more of polypropylene, polyethylene, COP, COC, or CBC. 8. A pharmaceutical package according to any of the preceding embodiments, wherein the electronic component is embedded in the thermoplastic wall of the container. 9. A pharmaceutical package according to any of the preceding embodiments, wherein the electronic component is overmolded onto the wall of the container. 10. A pharmaceutical package according to any of the preceding embodiments, wherein the thermoplastic material constituting at least a portion of the container completely or substantially completely surrounds the electronic components. 11. A pharmaceutical package according to any of the preceding embodiments, wherein no part of the electronic component is on the exterior surface of the container. 12. A pharmaceutical package according to any of the preceding embodiments, wherein the package is a pre-filled syringe and the electronic components are embedded in a hub portion of the syringe barrel. 13. A pharmaceutical package according to any of embodiments 1-12, wherein the package is a pre-filled syringe and the electronic component is embedded in the transition area between the body of the syringe barrel and a hub portion of the syringe barrel. 14. A pharmaceutical package according to any of embodiments 1-13, wherein the hub portion is a needle hub or a luer hub. 15. A pharmaceutical package according to any of the preceding embodiments, wherein the closure comprises a rigid needle shield or luer cap, and the electronic components are visually concealed by the closure. 16. A pharmaceutical package according to any of the preceding embodiments, wherein the package is a pre-filled syringe and the electronic components are embedded in the body of the syringe barrel adjacent the rear flange. 17. A pharmaceutical package according to any of the preceding embodiments, wherein the package is a filled vial and the electronic component is embedded in the neck portion of the vial, optionally in the thickened flange area. 18. A pharmaceutical package according to any of the preceding embodiments, wherein the closure comprises a stopper and a crimp, and the electronic components are visually concealed by the closure. 19. A pharmaceutical package according to any of the preceding embodiments, wherein the package is a filled cartridge and the electronic component is embedded in the needle mounting portion of the cartridge. 20. A pharmaceutical package according to any of the preceding embodiments, wherein the closure comprises a cap and the electronic component is visually concealed by the closure. 21. The pharmaceutical package of any of embodiments 1-20, further comprising a label, wherein the electronic component is embedded in a portion of the container that is visually concealed by the label. 22. A pharmaceutical package according to any of embodiments 1 to 21, wherein the package is a filled cartridge and the electronic component is configured to be read directly by a delivery device, optionally an autoinjector or injection pen. 23. A pharmaceutical package according to any of embodiments 1-22, wherein the electronic component is visually concealed by a portion of the package. 24. A pharmaceutical package according to any of the preceding embodiments, wherein the package is configured such that the container can also be tracked prior to filling the lumen with a pharmaceutical solution and sealing the lumen with a closure. 25. A pharmaceutical package according to any of embodiments 1-24, wherein the electronic component is detectable by automated visual inspection of the container in an empty state. 26. A pharmaceutical package according to any of the preceding embodiments, wherein the electronic component is configured to be written to using an external writer. 27. A pharmaceutical package according to any of embodiments 1 to 26, wherein the pharmaceutical solution is an injectable drug-containing solution. 28. A pharmaceutical package according to any of embodiments 1-27, wherein the electronic component has a length of 5 mm or less, optionally 4 mm or less, optionally 3 mm or less, optionally 2 mm or less, optionally 1 mm or less, and a width of 5 mm or less, optionally 4 mm or less, optionally 3 mm or less, optionally 2 mm or less, optionally 1 mm or less. 29. The pharmaceutical package of any of embodiments 1-28, wherein the electronic component has a thickness of 500 microns or less, optionally 400 microns or less, optionally 300 microns or less, optionally 200 microns or less, optionally 100 microns or less, optionally 50 microns or less. 30. The pharmaceutical package according to any of the preceding embodiments, wherein the pharmaceutical package has been subjected to sterilization, optionally sterilization by irradiation, optionally sterilization by gas. 31. A pharmaceutical package according to any of the preceding embodiments, wherein the electronic components are configured to withstand sterilization of the pharmaceutical package, optionally sterilization by radiation, optionally sterilization by gas. 32. A pharmaceutical package according to any of the preceding embodiments, wherein the electronic component comprises a temperature sensor, and optionally the electronic component is a passive RFID temperature sensor. 33. A pharmaceutical package according to any of embodiments 1-32, wherein the pharmaceutical solution within the lumen must be maintained within a defined temperature range, and the electronic component is configured to detect and register deviations from that temperature range. 34. A pharmaceutical package according to any of the preceding embodiments, wherein the electronic component comprises a pressure sensor, optionally the electronic component being a passive RFID pressure sensor. 35. A pharmaceutical package according to any of embodiments 1 to 34, wherein the pharmaceutical solution within the lumen must be maintained within a defined pressure range, and the electronic component is configured to detect and register deviations from that pressure range. 36. A pharmaceutical package according to any of embodiments 1 to 35, wherein the pharmaceutical solution is administered at a defined dispensing rate or within a defined range of acceptable dispensing rates, and the electronic component includes information regarding the defined dispensing rate or the defined range of acceptable dispensing rates. 37. A pharmaceutical package according to any of embodiments 1 to 36, wherein information regarding the defined dispensing rate or the defined range of acceptable dispensing rates is configured to be read by a delivery device, optionally an autoinjector or an injection pen. 38. A pharmaceutical package according to any of embodiments 1 to 37, wherein the pharmaceutical solution is administered using a defined needle insertion depth or a defined range of acceptable needle insertion depths, and the electronic component includes information regarding the defined needle insertion depth or the defined range of acceptable needle insertion depths. 39. A pharmaceutical package according to any of embodiments 1 to 38, wherein information regarding the defined needle insertion depth or the defined range of acceptable needle insertion depths is configured to be read by the delivery device, optionally an autoinjector or injection pen. 40. A pharmaceutical package according to any of embodiments 1 to 39, wherein the electronic component is configured to register interrogation events in a database. 41. An automatic injector or injection pen comprising a cartridge or syringe according to any one of embodiments 1 to 40, wherein the automatic injector or injection pen comprises a reader configured to read electronic components of the cartridge or syringe. 42. The auto-injector or injection pen of embodiment 41, wherein the auto-injector or injection pen is configured to adjust one or more injection settings in response to information obtained from the electronic component. 43. A pharmaceutical package according to any of embodiments 1 to 42, wherein the inner surface, the outer surface, or both of the wall in which the electronic component is embedded is identical or substantially identical to the inner surface, the outer surface, or both of the wall of the same container prepared without the electronic component. 44. A pharmaceutical package according to any of embodiments 1 to 43, wherein the inner surface, outer surface, or both of the wall in which the electronic component is embedded is free of surface irregularities, such as those caused by the insertion of the electronic component. 45. A pharmaceutical package according to any of embodiments 1 to 44, wherein the electronic component includes information, optionally identification information, stored directly on the component. 46. ​​A pharmaceutical package according to any of embodiments 1 to 45, wherein the electronic component is readable without connection to a computing network, such as a cloud computing network. 47. A pharmaceutical package according to any of embodiments 1 to 46, wherein the electronic component is writable without connection to a computing network, such as a cloud computing network.

[0215] Containers (before filling, etc.) A1. A container having an electronic component attached to the container and configured to provide both an unfilled container and a pharmaceutical package resulting from filling the lumen of the container with a pharmaceutical solution and then sealing the lumen with the ability to be tracked. A2. The container of embodiment A1, wherein the container is a syringe barrel, vial, or cartridge. A3. A syringe barrel having an electronic component attached to the syringe barrel and configured to provide both an unfilled syringe barrel and a medication package resulting from filling the lumen of the syringe barrel with a medicinal solution and then sealing the lumen with the ability to be tracked. A4. A vial having an electronic component attached to it and configured to provide both an unfilled vial and a pharmaceutical package resulting from filling the lumen of the vial with a pharmaceutical solution and then sealing the lumen with the ability to be tracked. A5. A cartridge having electronic components attached to the cartridge and configured to provide both an unfilled cartridge and a pharmaceutical package resulting from filling the lumen of the cartridge with a pharmaceutical solution and then sealing the lumen with the ability to be tracked. A6. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A5, wherein the electronic component is an RFID tag, optionally an RFID tag utilizing one or more frequencies within the range of 865-928 MHz, optionally an RFID tag utilizing a frequency of about 13.56 MHz. A7. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A6, wherein the electronic component comprises an integrated circuit. A8. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A7, wherein the electronic component comprises data storage. A9. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A8, wherein the container, syringe barrel, vial, or cartridge comprises at least one wall made of a thermoplastic material. A10. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A9, wherein the thermoplastic material comprises one or more of polypropylene, polyethylene, COP, COC, or CBC. A11. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A10, wherein the electronic component is embedded in a thermoplastic wall of the container, syringe barrel, vial, or cartridge. A12. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A11, wherein the electronic component is overmolded onto a wall of the container, syringe barrel, vial, or cartridge. A13. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A12, wherein the thermoplastic material constituting at least a portion of the container, syringe barrel, vial, or cartridge completely or substantially completely surrounds the electronic components. A14. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A13, wherein no part of the electronic component is on an exterior surface of the container, syringe barrel, vial, or cartridge. A15. A syringe barrel of any of embodiments A1-A14, wherein the electronic components are embedded in a hub portion of the syringe barrel. A16. The syringe barrel of any of embodiments A1-A15, wherein the electronic component is embedded in the transition area between the body of the syringe barrel and a hub portion of the syringe barrel. A17. A syringe barrel according to any of embodiments A1-A16, wherein the hub portion is a needle hub or a luer hub. A18. The syringe barrel of any of embodiments A1-A17, wherein the syringe barrel is configured such that the electronic components are visually hidden by a rigid needle shield or luer cap. A19. The syringe barrel of any of embodiments A1-A18, wherein electronic components are embedded in the body of the syringe barrel adjacent the rear flange. A20. A vial according to any of embodiments A1-A19, wherein the electronic components are embedded in the neck portion of the vial, optionally in a thickened flange region. A21. The vial of any of embodiments A1-A20, wherein the vial is configured such that the electronic components are visually concealed by the stopper and crimp closure. A22. A cartridge of any of embodiments A1-A21, wherein the electronic component is embedded in the needle mounting portion of the cartridge. A23. The cartridge of any of embodiments A1-A22, wherein the cartridge is configured such that the electronic components are visually concealed by a cap disposed over the needle attachment portion. A24. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A23, further comprising a label, wherein the electronic component is embedded in a portion of the container, syringe barrel, vial, or cartridge that is visually concealed by the label. A25. The cartridge of any of embodiments A1-A24, wherein the cartridge is configured such that the electronic component is directly readable by the delivery device, optionally an autoinjector or injection pen. A26. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A25, wherein the container, syringe barrel, vial, or cartridge is configured such that the electronic component is visually concealed by a portion of the finished pharmaceutical package. A27. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A26, wherein the electronic component is detectable by automated visual inspection of the container, syringe barrel, vial, or cartridge in an empty state. A28. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A27, wherein the electronic component is configured to be written to using an external writer. A29. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A28, wherein the electronic component has a length of 5mm or less, optionally 4mm or less, optionally 3mm or less, optionally 2mm or less, optionally 1mm or less, and a width of 5mm or less, optionally 4mm or less, optionally 3mm or less, optionally 2mm or less, optionally 1mm or less. A30. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A29, wherein the electronic component has a thickness of 500 microns or less, optionally 400 microns or less, optionally 300 microns or less, optionally 200 microns or less, optionally 100 microns or less, optionally 50 microns or less. A31. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A30, wherein the container, syringe barrel, vial, or cartridge is configured such that the electronic components can withstand sterilization, optionally sterilization by e-beam or gamma irradiation, optionally sterilization by Eto or VHP gas. A32. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A31, wherein the electronic component comprises a temperature sensor, and optionally the electronic component is a passive RFID temperature sensor. A33. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A32, wherein the electronic component comprises a pressure sensor, optionally wherein the electronic component is a passive RFID pressure sensor. A34. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A33, wherein the electronic component includes information regarding a defined dispense rate or a defined range of acceptable dispense rates. A35. A container, syringe barrel, vial, or cartridge according to any of embodiments A1-A34, wherein the information regarding the defined dispensing rate or the defined range of acceptable dispensing rates is configured to be read by a delivery device, optionally an autoinjector or injection pen. A36. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A35, wherein the electronic component includes information regarding a defined needle insertion depth or a defined range of acceptable needle insertion depths. A37. A container, syringe barrel, vial, or cartridge according to any of embodiments A1 to A36, configured such that information regarding a defined needle insertion depth or a defined range of acceptable needle insertion depths is read by a delivery device, optionally an autoinjector or injection pen. A38. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A37, wherein the electronic component is configured to register interrogation events in a database. A39. A container, syringe barrel, vial, or cartridge according to any of embodiments A1-A38, wherein the inner surface, outer surface, or both of the wall in which the electronic component is embedded and encapsulated is identical or substantially identical to that of the wall of the same container, syringe barrel, vial, or cartridge prepared without the electronic component. A40. A container, syringe barrel, vial, or cartridge of any of embodiments A1-A39, wherein the interior surface, exterior surface, or both of the wall in which the electronic component is embedded and encapsulated is free of surface irregularities such as those caused by insertion of the electronic component. A41. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A40, wherein the electronic component includes information, optionally identifying information, stored directly on the component. A42. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A41, wherein the electronic component is readable without connection to a computing network, such as a cloud computing network. A42. The container, syringe barrel, vial, or cartridge of any of embodiments A1-A41, wherein the electronic component is writable without connection to a computing network, such as a cloud computing network.

[0216] Molding / Inspection Process B1. A method for preparing a container having an electronic component embedded in a thermoplastic material that constitutes at least a portion of the container, comprising: -inserting an electronic component into a mold; - injecting a thermoplastic material into a mold to form a container or at least a portion of a container; The method, wherein the thermoplastic material surrounds or substantially surrounds the electronic component, thereby embedding the electronic component within a portion of the enclosure. B2. A method for preparing a container having an electronic component embedded in a thermoplastic material that constitutes at least a portion of the container, comprising: - providing a preform having electronic components embedded therein, optionally the electronic components being embedded in an upper portion of the preform corresponding to the neck of the container; - injection blow molding or injection stretch blow molding the preform to produce the container. B3. The method of any of embodiments B1-B2, wherein the container is a syringe barrel, a pharmaceutical cartridge, or a vial. B4. A method of preparing a syringe barrel having an electronic component embedded in a thermoplastic material that constitutes at least a portion of the syringe barrel, comprising: -inserting an electronic component into a mold; - injecting a thermoplastic material into a mold to form a syringe barrel or at least a portion of a syringe barrel; The method of any of embodiments B1-B3, wherein the thermoplastic material surrounds or substantially surrounds the electronic component, thereby embedding the electronic component within a portion of the syringe barrel. B4A. A method of preparing a syringe barrel having an electronic component embedded in a thermoplastic material that constitutes at least a portion of the syringe barrel, comprising: - injection molding a first polymer layer; - cooling the first polymer layer, for example to a temperature below its glass transition temperature; - positioning an electronic component on a surface of the first polymer layer; - injection molding a second polymer layer such that the second polymer layer covers the electronic component. B5. A method for preparing a vial having an electronic component embedded in a thermoplastic material constituting at least a portion of the vial, comprising: - providing a preform having electronic components embedded therein, optionally the electronic components being embedded in an upper portion of the preform corresponding to the neck of the vial; - injection blow molding or injection stretch blow molding the preform to produce the vial. B6. The method of any of embodiments B1-B5, further comprising inspecting the container, syringe barrel, or vial to ensure the presence, positioning, and / or functionality of the electronic component. B7. The method of any of embodiments B1-B6, wherein inspecting comprises an automated machine-operated visual inspection of the container, syringe barrel, or vial to identify the presence of the electronic component. B8. The method of any of embodiments B1-B7, wherein the machine-operated visual inspection also determines whether the electronic component is in an acceptable location within the container, syringe barrel, or vial. B9. The method of any of embodiments B1-B8, wherein the inspecting includes ensuring that the electronic component is readable using a remote reader. B10. The method of any of embodiments B1-B9, wherein the electronic component is an RFID tag, optionally utilizing one or more frequencies within the range of 865-928 MHz, optionally utilizing a frequency of about 13.56 MHz. B11. The method of any of embodiments B1-B10, wherein the electronic component comprises an integrated circuit. B12. The method of any of embodiments B1-B11, wherein the electronic component comprises data storage. B13. The method of any of embodiments B1-B12, wherein the thermoplastic material comprises one or more of polypropylene, polyethylene, COP, COC, or CBC. B14. The method of any of embodiments B1-B13, wherein no part of the electronic component is on an exterior surface of the container, syringe barrel, vial, or cartridge, and optionally no part of the electronic component is on an interior surface of the container, syringe barrel, vial, or cartridge. B15. The method of any of embodiments B1-B14, wherein the electronic component is embedded in a hub portion of the syringe barrel. B16. The method of any of embodiments B1-B15, wherein the electronic component is embedded in a transition area between the body of the syringe barrel and a hub portion of the syringe barrel. B17. The method of any of embodiments B1-B16, wherein the hub portion is a needle hub or a luer hub. B18. The method of any of embodiments B1-B17, wherein the syringe barrel is configured such that the electronic components are visually hidden by a rigid needle shield or luer cap. B19. The method of any of embodiments B1-B18, wherein the electronic components are embedded in the body of the syringe barrel adjacent the rear flange. B20. The method of any of embodiments B1-B19, wherein the electronic components are embedded in the neck portion of the vial, optionally in a thickened flange area. B21. The method of any of embodiments B1-B20, wherein the vial is configured such that the electronic components are visually concealed by the stopper and crimp closure. B22. The method of any of embodiments B1-B21, wherein the container is a cartridge and the electronic component is embedded in a needle mounting portion of the cartridge. B23. The method of any of embodiments B1-B22, wherein the cartridge is configured such that the electronic components are visually concealed by a cap placed over the needle mounting portion. B24. The method of any of embodiments B1-B23, wherein the container, syringe barrel, vial, or cartridge further comprises a label, and wherein the electronic component is embedded in a portion of the container, syringe barrel, vial, or cartridge that is visually concealed by the label. B25. The method of any of embodiments B1-B24, wherein the cartridge is configured such that the electronic component is directly readable by the delivery device, optionally an autoinjector or injection pen. B26. The method of any of embodiments B1-B25, wherein the container, syringe barrel, vial, or cartridge is configured such that the electronic component is visually concealed by a portion of the finished pharmaceutical package. B27. The method of any of embodiments B1-B26, wherein the electronic component is detectable by automated visual inspection of the container, syringe barrel, vial, or cartridge in an empty state. B28. The method of any of embodiments B1-B27, wherein the electronic component is configured to be written to using an external writer. B29. The method of any of embodiments B1-B28, wherein the electronic component has a length of 5 mm or less, optionally 4 mm or less, optionally 3 mm or less, optionally 2 mm or less, optionally 1 mm or less, and a width of 5 mm or less, optionally 4 mm or less, optionally 3 mm or less, optionally 2 mm or less, optionally 1 mm or less. B30. The method of any of embodiments B1-B29, wherein the electronic component has a thickness of 500 microns or less, optionally 400 microns or less, optionally 300 microns or less, optionally 200 microns or less, optionally 100 microns or less, optionally 50 microns or less. B31. The method of any of embodiments B1-B30, wherein the container, syringe barrel, vial, or cartridge is configured such that the electronic components can withstand sterilization, optionally sterilization by e-beam or gamma irradiation, optionally sterilization by Eto or VHP gas. B32. The method of any of embodiments B1-B31, wherein the interior surface, exterior surface, or both of the walls of the container, syringe barrel, vial, or cartridge in which the electronic component is embedded and enclosed is identical or substantially identical to that of the walls of the same container, syringe barrel, vial, or cartridge prepared without the electronic component. B33. The method of any of embodiments B1-B32, wherein the interior surface, exterior surface, or both of the walls of the container, syringe barrel, vial, or cartridge in which the electronic component is embedded and enclosed, does not contain surface irregularities such as those caused by insertion of the electronic component. B34. Providing a preform having electronic components embedded therein, - injection molding a first polymer layer; - cooling the first polymer layer, for example to a temperature below its glass transition temperature; - positioning an electronic component on a surface of the first polymer layer; The method of any of embodiments B1-B33, comprising: - injection molding the second polymer layer such that the second polymer layer covers the electronic component. B35. Providing a preform having electronic components embedded therein, - conveying the polymer body resulting from cooling of the first polymer layer from the first injection mold to a second injection mold; The method of embodiment B34, further comprising injection molding the second polymer layer into a second injection mold. B36. The method of any of embodiments B1-B35, wherein the electronic component is positioned in a portion of the preform such that the injection blow molding or injection stretch blow molding process to produce the container or vial does not impose substantially stress on the electronic component. B37. A method of preparing a syringe barrel having an electronic component embedded in a thermoplastic material constituting at least a portion of the syringe barrel, comprising: - conveying the polymer body resulting from cooling of the first polymer layer from the first injection mold to a second injection mold; The method of embodiment B4A, further comprising: injection molding the second polymer layer into a second injection mold. B38. The method of any of embodiments B1-B37, wherein the syringe barrel resulting from the molding process comprises a needle, the proximal end of which is embedded in a needle hub. B39. The method of any of embodiments B1-B38, wherein the injection molding of the first polymer layer, positioning of the electronic component, and injection molding of the second polymer layer are performed without moving needles or mold cores relative to one another. B40. The method of any of embodiments B1-B39, wherein a portion of the injection mold surrounding the needle hub opens to allow positioning of the electronic component. B41. The method of any of embodiments B1-B40, wherein the needle is firmly embedded in the polymer body resulting from cooling of the first polymer layer. B42. The method of any of embodiments B1-B41, wherein a needle is inserted into the second injection mold, and optionally, the needle is not present in the first injection mold. B43. The method of any of embodiments B1-B42, in which the electronic component includes information, optionally identifying information, stored directly on the component. B44. The method of any of embodiments B1-B43, wherein the electronic component is readable without connection to a computing network, such as a cloud computing network. B45. The method of any of embodiments B1-B44, wherein the electronic component is writable without connection to a computing network, such as a cloud computing network.

[0217] How to use C1. A method for monitoring whether a pharmaceutical package is maintained within a defined storage condition, comprising: Providing a pharmaceutical package according to any one of embodiments 1 to 47; and registering a non-conformance event detected by a temperature sensor (if applicable), a pressure sensor (if applicable), or both. C1a. A method for facilitating administration of a pharmaceutical solution contained within a lumen of a pharmaceutical package according to any one of embodiments 1-47, comprising: interrogating the electronic component prior to administration to obtain information regarding whether there has been a non-conformance event detected by the temperature sensor (if applicable), the pressure sensor (if applicable), or both; Optionally, rejecting the medication package if a non-compliance event is detected. C1b. The method of embodiment C1a, wherein the interrogating is performed by a medication delivery device, optionally an auto-injector or injection pen. C1c. The method of embodiment C1b, wherein the medication delivery device is configured to reject the medication package if an incompatibility event is detected. C2. A method for facilitating proper administration of a pharmaceutical solution contained within a lumen of a pharmaceutical package according to any one of embodiments 1-47, comprising: interrogating the electronic component prior to administration to thereby obtain information regarding one or more administration parameters; administering the pharmaceutical solution according to one or more administration parameters. C3. The method of embodiment C2, wherein the interrogating and administering are performed by a drug delivery device, optionally an autoinjector or injection pen. C4. The method of embodiment C3, further comprising adjusting one or more settings on the drug delivery device to comply with one or more administration parameters, optionally wherein the adjusting is performed automatically by the drug delivery device. C5. A method for monitoring administration of a pharmaceutical package, e.g., as part of a clinical trial, comprising: Providing a pharmaceutical package according to any one of embodiments 1 to 47; In the database The date and time of the inquiry into the electronic component, and / or and registering a non-conformity event detected by a temperature sensor (if applicable), a pressure sensor (if applicable), or both. C6. A method for providing identification information to a pharmaceutical product, comprising: Obtaining a container, syringe barrel, vial, or cartridge according to any of embodiments A1 to A42, where the electronic component optionally includes identification information relating to the container, syringe barrel, vial, or cartridge; Filling the container with a pharmaceutical formulation; 1. A method comprising: writing information related to a pharmaceutical formulation to an electronic component, optionally without connection to a computing network, such as a cloud computing network. C7. The method of embodiment C6, wherein the identification information on the container, syringe barrel, vial, or cartridge is readable directly from the electronic component.

Claims

**Claim 1**: A container, wherein the container has an electronic component attached thereto, and is configured to provide both an unfilled container and a pharmaceutical package resulting from filling the interior cavity of the container with a pharmaceutical solution and then sealing the interior cavity in a manner that can be traced. The container comprises at least one wall made of a thermoplastic material, and the electronic component is embedded in the thermoplastic wall of the container. **Claim 2** The container according to claim 1, wherein the container is a syringe barrel, a vial, or a cartridge. **Claim 3** The container according to any one of claims 1 - 2, wherein the electronic component is an RFID tag, optionally an RFID tag utilizing one or more frequencies within the range of 865 - 928 MHz, or optionally an RFID tag utilizing a frequency of approximately 13.56 MHz. **Claim 4** The container according to any one of claims 1 - 2, wherein the electronic component comprises an integrated circuit. **Claim 5** The container according to any one of claims 1 - 2, wherein the electronic component comprises data storage. **Claim 6** The container according to any one of claims 1 - 2, wherein the thermoplastic material comprises one or more of polypropylene, polyethylene, COP, COC, and CBC. **Claim 7** The container according to any one of claims 1 - 2, wherein the electronic component is overmolded onto the wall of the container. **Claim 8** The container according to any one of claims 1 - 2, wherein the thermoplastic material constituting at least a portion of the container completely or substantially completely surrounds the electronic component. **Claim 9** The container according to any one of claims 1 - 2, wherein no portion of the electronic component is on the outer surface of the container. **Claim 10**: The container according to any one of claims 1 - 2, further comprising a label, and the electronic component is embedded in a portion of the container that is visually hidden by the label. **Claim 11** The container according to any one of claims 1 - 2, wherein the container is configured such that the electronic component is visually hidden by a portion of the completed pharmaceutical package. **Claim 12** The container according to any one of claims 1 - 2, wherein the electronic component is detectable by an automated visual inspection of the container in its empty state. **Claim 13** The container according to any one of claims 1 to 2, wherein the electronic component is configured to be written using an external writer.

14. The container according to any one of claims 1 to 2, wherein the container is configured such that the electronic component can withstand sterilization, optionally sterilization by electron beam or gamma irradiation, and optionally sterilization by Eto or VHP gas.

15. The container according to any one of claims 1 to 2, wherein the electronic component includes a temperature sensor, and optionally, the electronic component is a passive RFID temperature sensor.

16. The container according to any one of claims 1 to 2, wherein the electronic component includes a pressure sensor, and optionally, the electronic component is a passive RFID pressure sensor.

17. The container according to any one of claims 1 to 2, wherein the electronic component is configured to register an interrogation event in a database.

18. The container according to any one of claims 1 to 2, wherein the inner surface, the outer surface, or both surfaces of the wall in which the electronic component is embedded are the same as or substantially the same as those of the wall of the same container prepared without the electronic component.

19. The container according to any one of claims 1 to 2, wherein the electronic component includes information directly stored on the component, optionally including identification information.

20. The container according to any one of claims 1 to 2, wherein the electronic component is readable, writable, or both without connection to a computing network such as a cloud computing network.

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