WO2023023747A1 - Système, appareil et procédé/processus de surveillance et de régulation de conditions environnementales pour produits pharmaceutiques - Google Patents

Système, appareil et procédé/processus de surveillance et de régulation de conditions environnementales pour produits pharmaceutiques Download PDF

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Publication number
WO2023023747A1
WO2023023747A1 PCT/AU2022/050974 AU2022050974W WO2023023747A1 WO 2023023747 A1 WO2023023747 A1 WO 2023023747A1 AU 2022050974 W AU2022050974 W AU 2022050974W WO 2023023747 A1 WO2023023747 A1 WO 2023023747A1
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WIPO (PCT)
Prior art keywords
storage enclosure
environmental condition
pharmaceutical products
power source
controlling
Prior art date
Application number
PCT/AU2022/050974
Other languages
English (en)
Inventor
Shaun Patrick JACKSON
William Peter Garrett
Roger Philip DUNKERLEY
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Fridge Insights Pty Ltd
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Publication of WO2023023747A1 publication Critical patent/WO2023023747A1/fr

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Classifications

    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B19/00—Programme-control systems
    • G05B19/02—Programme-control systems electric
    • G05B19/04—Programme control other than numerical control, i.e. in sequence controllers or logic controllers
    • G05B19/042—Programme control other than numerical control, i.e. in sequence controllers or logic controllers using digital processors
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05D—SYSTEMS FOR CONTROLLING OR REGULATING NON-ELECTRIC VARIABLES
    • G05D23/00—Control of temperature
    • G05D23/19—Control of temperature characterised by the use of electric means
    • G05D23/1927—Control of temperature characterised by the use of electric means using a plurality of sensors
    • G05D23/193—Control of temperature characterised by the use of electric means using a plurality of sensors sensing the temperaure in different places in thermal relationship with one or more spaces
    • G05D23/1931—Control of temperature characterised by the use of electric means using a plurality of sensors sensing the temperaure in different places in thermal relationship with one or more spaces to control the temperature of one space
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D29/00—Arrangement or mounting of control or safety devices
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D29/00—Arrangement or mounting of control or safety devices
    • F25D29/008—Alarm devices
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B13/00—Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion
    • G05B13/02—Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion electric
    • G05B13/0205—Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion electric not using a model or a simulator of the controlled system
    • G05B13/024—Adaptive control systems, i.e. systems automatically adjusting themselves to have a performance which is optimum according to some preassigned criterion electric not using a model or a simulator of the controlled system in which a parameter or coefficient is automatically adjusted to optimise the performance
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B19/00—Programme-control systems
    • G05B19/02—Programme-control systems electric
    • G05B19/04—Programme control other than numerical control, i.e. in sequence controllers or logic controllers
    • G05B19/048—Monitoring; Safety
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05D—SYSTEMS FOR CONTROLLING OR REGULATING NON-ELECTRIC VARIABLES
    • G05D23/00—Control of temperature
    • G05D23/19—Control of temperature characterised by the use of electric means
    • G05D23/1902—Control of temperature characterised by the use of electric means characterised by the use of a variable reference value
    • G05D23/1905—Control of temperature characterised by the use of electric means characterised by the use of a variable reference value associated with tele control
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/06—Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
    • G06Q10/063—Operations research, analysis or management
    • G06Q10/0639—Performance analysis of employees; Performance analysis of enterprise or organisation operations
    • G06Q10/06395—Quality analysis or management
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/08—Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/08—Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
    • G06Q10/083—Shipping
    • G06Q10/0832—Special goods or special handling procedures, e.g. handling of hazardous or fragile goods
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/08—Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
    • G06Q10/087—Inventory or stock management, e.g. order filling, procurement or balancing against orders
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/30—Administration of product recycling or disposal
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q50/00—Information and communication technology [ICT] specially adapted for implementation of business processes of specific business sectors, e.g. utilities or tourism
    • G06Q50/10—Services
    • G06Q50/22—Social work or social welfare, e.g. community support activities or counselling services
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16Y—INFORMATION AND COMMUNICATION TECHNOLOGY SPECIALLY ADAPTED FOR THE INTERNET OF THINGS [IoT]
    • G16Y20/00—Information sensed or collected by the things
    • G16Y20/10—Information sensed or collected by the things relating to the environment, e.g. temperature; relating to location
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L67/00—Network arrangements or protocols for supporting network services or applications
    • H04L67/01—Protocols
    • H04L67/12—Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L67/00—Network arrangements or protocols for supporting network services or applications
    • H04L67/01—Protocols
    • H04L67/12—Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
    • H04L67/125—Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks involving control of end-device applications over a network
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04Q—SELECTING
    • H04Q9/00—Arrangements in telecontrol or telemetry systems for selectively calling a substation from a main station, in which substation desired apparatus is selected for applying a control signal thereto or for obtaining measured values therefrom
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D11/00—Self-contained movable devices, e.g. domestic refrigerators
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2700/00—Means for sensing or measuring; Sensors therefor
    • F25D2700/02—Sensors detecting door opening
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2700/00—Means for sensing or measuring; Sensors therefor
    • F25D2700/08—Sensors using Radio Frequency Identification [RFID]
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2700/00—Means for sensing or measuring; Sensors therefor
    • F25D2700/12—Sensors measuring the inside temperature
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F25—REFRIGERATION OR COOLING; COMBINED HEATING AND REFRIGERATION SYSTEMS; HEAT PUMP SYSTEMS; MANUFACTURE OR STORAGE OF ICE; LIQUEFACTION SOLIDIFICATION OF GASES
    • F25D—REFRIGERATORS; COLD ROOMS; ICE-BOXES; COOLING OR FREEZING APPARATUS NOT OTHERWISE PROVIDED FOR
    • F25D2700/00—Means for sensing or measuring; Sensors therefor
    • F25D2700/14—Sensors measuring the temperature outside the refrigerator or freezer
    • G—PHYSICS
    • G08—SIGNALLING
    • G08B—SIGNALLING OR CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
    • G08B21/00—Alarms responsive to a single specified undesired or abnormal condition and not otherwise provided for
    • G08B21/18—Status alarms
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04Q—SELECTING
    • H04Q2209/00—Arrangements in telecontrol or telemetry systems
    • H04Q2209/40—Arrangements in telecontrol or telemetry systems using a wireless architecture
    • H04Q2209/47—Arrangements in telecontrol or telemetry systems using a wireless architecture using RFID associated with sensors
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04Q—SELECTING
    • H04Q2209/00—Arrangements in telecontrol or telemetry systems
    • H04Q2209/80—Arrangements in the sub-station, i.e. sensing device
    • H04Q2209/88—Providing power supply at the sub-station

Definitions

  • the present disclosure relates to systems, apparatuses, and methods/processes for monitoring and controlling environmental conditions for pharmaceutical products.
  • Control of environmental conditions is crucial for quality control of pharmaceutical products.
  • this typically involves storing and distributing pharmaceuticals in environmentally-controlled enclosures such as cool boxes, refrigerators, cold rooms and specially equipped transportation vehicles.
  • enclosures may have connected systems for monitoring environmental conditions, as well as alternate “stand-by” energy sources to maintain operation during failures of primary energy supplies.
  • the recommended storage conditions (e.g., temperature and humidity) of a pharmaceutical product are usually specified by the manufacturers on the product information datasheet or product pack.
  • a deviation from the manufacturer-recommended storage conditions (e.g., temperature and humidity) is known as an excursion, which may occur as a result of environment control system failure or through poor management of the storage or distribution process.
  • the extent of an excursion can affect its potential to deteriorate the product quality, ranging from reduced shelf life to ultimately rendering the item unusable.
  • the impact of different levels of excursion on the quality of the product is usually referred to as an “excursion profile”.
  • a system (100) for monitoring and controlling at least one environmental condition for pharmaceutical products including: a) at least one signal interfacing module (201,202) for:
  • the system (100) is configured to: a) identify, based on the telemetry data, an event that affects or potentially affects at least one environmental condition in the storage enclosure (104); b) assessing, based on the stock content data, an impact or potential impact of the event on the one or more pharmaceutical products; and c) in response to the assessed impact or potential impact of the event, generating a control signal for controlling the environmental condition in the storage enclosure (104), wherein the control signal includes a signal for controlling the supplementary power source and/or the storage enclosure (104) to set a target environmental condition for the storage enclosure (104), wherein the target environmental condition is determined based at least partially on a determined autonomy of the supplementary power source to allow for efficient utilisation of the supplementary power source to protect the pharmaceutical
  • RFID radio-frequency identification
  • the target environmental condition may be determined based at least partially on a manufacturer-recommended storage condition for the one or more pharmaceutical products.
  • the target environmental condition may be determined based at least partially on an ambient environmental condition obtained by a supplementary sensor.
  • the system may be configured to generate a signal for applying a revised status to at least one of the plurality of pharmaceutical products.
  • the revised status may include: revising expiry data associated with the at least one of the plurality of pharmaceutical products; or indicating that the at least one of the plurality of pharmaceutical products is unusable.
  • the control signal may be generated based on (pre-defined) priorities of the plurality of pharmaceutical products.
  • the at least one environmental condition may include temperature and/or humidity, and the target environmental condition may include substantially 2 to 8 degrees, or substantially 7.5 degrees.
  • the system (100) may include: a) a telemetry and telecommand device (103); and b) a processing service (102); wherein the telemetry and telecommand device (103) includes: a) a network signalling interfacing module (201), of the at least one signal interfacing module (201,202), configured to provide data communication with the processing service; and b) the RFID module (204).
  • the telemetry and telecommand device (103) includes: a) a network signalling interfacing module (201), of the at least one signal interfacing module (201,202), configured to provide data communication with the processing service; and b) the RFID module (204).
  • the at least one signal interfacing module (201,202) may be connected to and communicable with a controller for the storage enclosure (104).
  • the system (100) may be further configured to: a) update a manufacturer-recommended storage condition for the one or more pharmaceutical products; and b) generate the control signal for controlling the environmental condition in the storage enclosure (104) based on the updated manufacturer- recommended storage condition.
  • the system (100) may be configured to: a) send the stock content data to the processing service (102); and b) receive, from the processing service (102), the control signal for controlling the environmental condition in the storage enclosure (104).
  • the control signal may include a signal to control a refrigeration compressor of the environmentally-controlled storage enclosure (104).
  • the primary power source may include a mains power connection and the event may include failure of the mains power connection, and/or the supplementary power source may include a battery.
  • the determined autonomy may be based on: measurements of the supplementary power source including fuel volume remaining, and/or electric charge remaining; and/or measurements of energy/power usage of the environmentally-controlled storage enclosure (104), including a duty cycle of the energy/power usage of the environmentally-controlled storage enclosure (104).
  • the apparatus is configured to: a) receive telemetry data related to an environmentally-controlled storage enclosure (104); b) identify, based on the telemetry data, an event that affects or potentially affects at least one environmental condition in the storage enclosure (104); c) obtain stock content data; d) send the stock content data to the processing service (102); e) receive, from the processing service, a control signal for controlling the environmental condition in the storage enclosure (104); f) output the control signal to control the environmental condition in the storage enclosure (104).
  • RFID radio-frequency identification
  • Described herein is a method/process for monitoring and controlling environmental condition for pharmaceutical products, including: a) receiving telemetry data related to an environmentally-controlled storage enclosure (104); b) identifying an event that affects or potentially affects at least one environmental condition in the storage enclosure (104); c) receiving stock content data related to one or more pharmaceutical products in the storage enclosure (104); d) assessing the impact or potential impact of the event on the one or more pharmaceutical products; and e) generating a control signal for controlling the environmental condition in the storage enclosure (104), wherein the control signal includes a signal for controlling the supplementary power source and/or the storage enclosure (104) to set a target environmental condition for the storage enclosure (104), wherein the target environmental condition is determined based at least partially on a determined autonomy of the supplementary power source to allow for efficient utilisation of the supplementary power source to protect the pharmaceutical products in the storage enclosure (104).
  • FIG. 1 illustrates an example of a system for monitoring and controlling environmental conditions for pharmaceutical products
  • FIG. 2 illustrates an example of a telemetry and telecommand device
  • FIG. 3 illustrates an exemplary implementation of the interconnection of the telemetry and telecommand device of FIG. 2 with a supplementary power source and an environmentally-controlled storage enclosure
  • FIG. 4 is a flow diagram illustrating an exemplary processing workflow implemented by the system of FIG. 1
  • FIG. 5 shows an example of the processing workflow implemented by the system in an exemplary scenario of power failure
  • FIG. 1 illustrates an example of a system for monitoring and controlling environmental conditions for pharmaceutical products
  • FIG. 2 illustrates an example of a telemetry and telecommand device
  • FIG. 3 illustrates an exemplary implementation of the interconnection of the telemetry and telecommand device of FIG. 2 with a supplementary power source and an environmentally-controlled storage enclosure
  • FIG. 4 is a flow diagram illustrating an exemplary processing workflow implemented by the system of FIG. 1
  • FIG. 5 shows an example of the processing workflow
  • FIG. 6 shows an example of the processing workflow implemented by the system after an excursion event
  • FIG. 7 illustrates an example of the system with a web-based or cloudbased processing service
  • FIG. 8 is an illustrative diagram showing exemplary components of the system.
  • Described herein are systems, apparatuses, and methods/processes for monitoring and controlling environmental conditions for pharmaceutical products, e.g., vaccines or pharmaceutical medications.
  • the described systems, apparatuses, and methods/processes can manage or optimise one or more environmental conditions for pharmaceutical products in storage and/or transportation, particularly where temperature and humidity are important factors.
  • the described systems, apparatuses, and methods/processes provide automated data collection, decision-making and control for the management and optimisation of pharmaceutical stock in the event that such stock is affected by an external actor (or “action”) such that the stock’s storage has deviated from the manufacturer’s recommended storage/transportation conditions, e.g., when an excursion event occurs.
  • the systems, apparatuses, and methods/processes described herein are able to assess the impact of an excursion or a potential excursion to each of those pharmaceutical products stored in the storage enclosure, to decide the actions to be taken accordingly, and/or to take such action. This involves, e.g., assessing the viability and shelf life individually for each product affected by the excursion, based on the excursion profde of each individual product provided by its manufacturer.
  • the assessed impact or potential impact may be reported immediately to permit prescient manual intervention in cases of prolonged impact of an external actor, or be used for generating early control signals for managing or optimising the pharmaceutical stock.
  • the described systems, apparatuses, and methods/processes provide for an optimised or improved outcome of an event external to the system that might create an excursion event.
  • data indicating the extent of the excursion and data representing the excursion profile of each individual product affected by the excursion are collected automatically upon the detection of the excursion or potential excursion, which considerably simplifies the process of applying a revised status to each of those products being affected by the excursion.
  • the revised status may range from reduced shelf life to the product being rendered unusable.
  • the systems, apparatuses, and methods/processes described herein enable automated determination and application of a revised status for each instance of the product.
  • the revised status may be, e.g., a revised shelf-life expiry date, or an indication that the pharmaceutical product is unsuitable for use.
  • the revised status may be automatically reported to provide an immediate status update on each instance of a pharmaceutical affected by an event.
  • all the relevant data are automatically collected and reported to a data processing service, to allow comprehensive and timely decisions to be made automatically, which enables the provision of optimised or improved outcomes as a result of uncontrollable external actors.
  • the described systems, apparatuses, and methods/processes allow active control of environmental conditions of the storage enclosure to favour certain stored stock, so as to optimise the stock preservation and minimise logistic impact.
  • the storage enclosure that stores the pharmaceutical products is provided with at least one supplementary power source, e.g., a battery unit or a generator fuel tank, providing an alternative power supply for controlling the environmental conditions in the storage enclosure.
  • a supplementary power source e.g., a battery unit or a generator fuel tank
  • the described systems, apparatuses, and methods/processes provide early controlling decisions in relation to the use of the supplementary power source to reduce the impact on the stock. In some embodiments, this involves enacting or adjusting the use of the supplementary power source. In some other embodiments, this involves setting a target environmental condition for the storage enclosure to reduce the impact on the pharmaceutical products in stock.
  • the described system uses measured/determined capacity of the supplementary power source to mitigate overuse of the environmental control apparatus, e.g., a fridge compressor, in order to keep the known stored priority stock stored for as long as possible, thus providing "tailored survivability" in the cold chain. This also reduces the demand for manual intervention at host environments where supplementary power management decisions would have to be enacted.
  • FIG. 1 shows an example of a system 100 for monitoring and controlling environmental conditions for pharmaceutical products according to an illustrative embodiment.
  • the system 100 includes a telemetry and telecommand device 103 coupled via either a wired or wireless communications link 101 to a processing service 102.
  • the telemetry and telecommand device 103 illustratively includes interfacing electronic circuitry and software to enable local connection to an environmentally-controlled storage enclosure 104 (including a primary power source that powers the environmentally-controlled storage enclosure 104, e.g., a mains electrical power connection), a supplementary power source 105 (separate from and additional to the primary power source, albeit potentially connected to the primary power source while the primary power source is supplying power), and a radio frequency identification (RFID) antenna array 110.
  • the RFID antenna array 110 is mounted to or near the environmentally- controlled storage enclosure 104.
  • the environmentally-controlled storage enclosure 104 may take the form of a refrigerator including a refrigeration compressor.
  • the telemetry and telecommand device 103 may further be in connection with supplementary temperature and humidity measuring probes (not shown in FIG. 1).
  • the telemetry and telecommand device 103 collects telemetry data from the environmentally-controlled storage enclosure 104 and the supplementary power source 105, as well as stock data regarding and identifying the pharmaceutical products stored in the storage enclosure 104 by using the RFID antenna array 110.
  • the collected data are transmitted from the telemetry and telecommand device 103 to the processing service 102 via the wired or wireless communications link 101 (which may also be referred to as the “telemetry and telecommand link”).
  • the processing service 102 receives periodic and event data from the telemetry and telecommand device 103, applies algorithmic processing of the received data, and generates and sends subsequent control instructions to the telemetry and telecommand device 103. In this way, the processing service 102 makes data-driven decisions to optimise or improve utilisation of the supplementary power source 105, and/or to optimise or improve target settings of environmental conditions of the storage enclosure, e.g., temperature and/or humidity.
  • FIG. 2 shows an exemplary structure of the telemetry and telecommand device 103.
  • the telemetry and telecommand device 103 includes at least one signal interfacing module including a network signalling interfacing module 201, and a local signalling interfacing module 202.
  • the telemetry and telecommand device 103 may also include a processing module 203, a radio frequency identification (RFID) transponder module 204, and a sensor interfacing module 205.
  • RFID radio frequency identification
  • FIG. 3 illustrates an exemplary implementation of the interconnection of the telemetry and telecommand device of FIG. 2 with a supplementary power source and an environmentally-controlled storage enclosure.
  • the network signalling interfacing module 201 enables data communication with the processing service 102 via the wired or wireless telemetry and telecommand link 101.
  • the local signalling interfacing module 202 provides for telemetry and telecommand link to the environmentally-controlled storage enclosure 104, e.g., by connecting to a storage environment controller 316 (e.g., a refrigeration controller) of the storage enclosure 104, as shown in FIG. 3.
  • a storage environment controller 316 e.g., a refrigeration controller
  • the local signalling interfacing module 202 also provides for telemetry and telecommand link to the supplementary power source 105, e.g., by connecting to a supplementary power source controller 314, as shown in FIG. 3.
  • the sensor interfacing module 205 receives supplementary sensor inputs from supplementary sensors (e.g., supplementary temperature and humidity measuring probes) for measuring environmental conditions (e.g., the temperature and/or the humidity) in the storage enclosure 104 and/or in the ambient air.
  • the RFID transponder module 204 receives RFID data from the RFID antenna array 110.
  • the RFID data are generated by scanning an RFID tag associated with the pharmaceutical product, e.g., an RFID label attached to the pharmaceutical product, or a package of the pharmaceutical product.
  • the RFID data provide product identification data associated with the pharmaceutical product.
  • the product identification data may include, e.g., data representing one or more of the following information: product name, type, batch, expiry date, manufacture date, manufacturer.
  • the product identification data can be used for determining the required environmental conditions (e.g., in the form of an excursion profile) of the product.
  • Telemetry data received by the local signalling interfacing module 202 and the sensor interfacing module 205, as well as the RFID data received from the RFID transponder module 204, are collected by the processing module 203, and sent to the processing service 102 for processing via the network signalling interfacing module 201.
  • control signals representing control instructions are received from the processing service 102, and then sent to the environmentally-controlled storage enclosure 104 and/or the supplementary power source 105 via the local signalling interfacing module 202.
  • the control signals may include a signal to control the refrigeration compressor of the environmentally-controlled storage enclosure 104.
  • the processing service 102 may be a web-based or cloudbased service. Such an example is illustrated in FIG. 7, where the telemetry and telecommand device 103 is in data communication with the cloud-based processing service 102 via a wired or wireless communications link 101.
  • the processing service 102 may be provided by a local or remote onpremises server.
  • FIG. 8 is an illustrative diagram showing exemplary components of the system 100, including: a) the environmentally-controlled storage enclosure 104 in the form of a refrigerator 802; b) the telemetry and telecommand device 103 and its microprocessor module 804 (including its computing processor, memory and input/output ports); c) the supplementary power source 105 coupled/connected to the microprocessor module 804 for control and monitoring of the supplementary power source 105 (e.g., UPS and/or generator); d) a refrigeration controller 804, in communication with a temperature probe 806 and the microprocessor module 804 (e.g., via a Modbus(TM) interface) for measuring the environmental conditions in the refrigerator 802; e) supplementary temperature probe 808 in communication with the microprocessor module 804 and configured to measure the environmental conditions in the refrigerator 802; f) a supplementary temperature probe 810 in communication with the microprocessor module 804 and configured to measure the environmental conditions outside the refrigerator 802, e.g., during transportation;
  • a remote user interface 826 remote from the environmentally-controlled storage enclosure 104, e.g., in a different room, building, geographical location, population centre and/or country/jurisdiction configured to allow data reporting from the processing service 102, and to allow remote control of the refrigerator 802 via the telemetry and telecommand device 103 and supplementary power source 105 (via the processing service 102 and the communications link 101).
  • the remote user interface 826 may be configured to receive the reporting data from, and to remotely control, more than 1, e.g., at least 10, 50, 100, 200, 500 or 1,000 of the refrigerator 802 in locations that are remote from the remote user interface 826.
  • the processing service 102 provides the information to the remote user interface 826 in a fast, or real-time manner, and allows control by a fast or real-time manner, thus allowing effective remote control by a person who may be in a different country and/or time zone from the many environmentally-controlled storage enclosures 104.
  • FIG. 4 is a flow diagram illustrating an exemplary process 400 for processing signals in the system 100.
  • the system 100 receives periodical or event-driven telemetry data.
  • the telemetry data may include, for instance: a) data received from the environmentally-controlled storage enclosure 104, e.g., logical status monitoring (power ON/OFF, including the power from the primary power source , door OPEN/CLOSED etc.); b) data received from the supplementary power source 105, e.g., working status monitoring (ON/OFF) and power heath monitoring (voltage, current, autonomy); and c) data received from supplementary sensors (e.g., supplementary temperature and humidity measuring probes) for measuring the environmental conditions in the storage enclosure 104 and/or in the ambient air.
  • supplementary sensors e.g., supplementary temperature and humidity measuring probes
  • the “autonomy” is a measure of the predicted battery (or other fuel) life remaining in the supplementary power source 105, e.g., a ratio or quotient of the (remaining) .capacity and the demanded load. (More load will shorten the "autonomy” by depleting the batteries or other fuel faster.)
  • the determined autonomy can be based on measurements of the supplementary power source 105 including: fuel volume remaining; electric charge remaining.
  • the determined autonomy can be based on measurements of the energy/power usage of the environmentally-controlled storage enclosure 104, including rated/measured power usage of the refrigeration compressor, including a duty cycle of the energy/power usage of the environmentally-controlled storage enclosure 104, e.g., a fridge compressor duty cycle from previous days.
  • the telemetry data may be collected by the system 100 periodically, e.g., by the telemetry and telecommand device 103.
  • the telemetry data may be collected by system 100 upon the detection of one or more predefined events, e.g., the opening of a door of the storage enclosure 104, switching "on" of the supplementary power source 105, or an excessive external ambient temperature.
  • the system 100 receives periodical or event-driven data of the stock contents of the environmentally-controlled storage enclosure 104.
  • the telemetry and telecommand device 103 may receive, via the RFID transponder module 204, RFID data representing stock contents data from the RFID antenna array 110, the data being generated by scanning an RFID tag associated with the pharmaceutical product, e.g., an RFID label attached to the pharmaceutical product, or a package of the pharmaceutical product.
  • the data provide product identification data associated with the pharmaceutical products stored in the storage enclosure 104.
  • the product identification data may include, e.g., data representing one or more of the following information: product name, type, batch, expiry date, manufacture date, manufacturer.
  • the data of the stock contents may be collected by the system 100 periodically, e.g., by the telemetry and telecommand device 103.
  • the telemetry data may be collected by system 100 upon the detection of one or more predefined events, e.g., when adding a new pharmaceutical product into, or removing a pharmaceutical product from the storage enclosure 104, e.g., due to detection of the opening of a door of the storage enclosure 104.
  • the system 100 receives event-driven alarms notifying affecting actors on the stock.
  • this alarm may be generated automatically by the telemetry and telecommand device 103 upon the detection of one or more predefined events, e.g., a door of the storage enclosure 104 being detected left open for a longer time than a predefined duration threshold value, power loss of the storage enclosure 104 (from its primary power source, e.g., failure/loss of the mains power connection); or an excessive external ambient temperature, i.e., a higher temperature than a predefined temperature threshold value.
  • predefined events e.g., a door of the storage enclosure 104 being detected left open for a longer time than a predefined duration threshold value
  • power loss of the storage enclosure 104 from its primary power source, e.g., failure/loss of the mains power connection
  • an excessive external ambient temperature i.e., a higher temperature than a predefined temperature threshold value.
  • the system 100 processes and calculates the impact of the event (caused by the external actor) on the stock.
  • the data collected at steps 402, 404 and 406 are processed by the telemetry and telecommand device 103, and periodically logged to the processing service 102 via the wired or wireless communications link 101.
  • the telemetry and telecommand device 103 will raise an alarm, either locally with a buzzer or via a message to the processing service 102.
  • the processing service 102 then automatically assesses a risk profile, and determines control instructions accordingly.
  • the risk profile indicates the impact of an excursion or a potential excursion to the pharmaceutical product(s) stored in the storage enclosure 104. This can be determined based on the excursion profile of the product provided by its manufacturer, e.g., by querying a local or remote database using the product identification data (which is generated based on the RFID data received from the antenna array 110) associated with the pharmaceutical product.
  • the control instructions may include control signals for the environmentally- controlled storage enclosure 104 and/or the supplementary power source 105, e.g., for controlling the use of the supplementary power source 105 and/or for setting target environmental conditions that will provide optimised or improved protection for the pharmaceutical stock at risk, including the (control) signal that controls the refrigeration compressor.
  • control instructions may include determining a revised status for the pharmaceutical product(s) affected, and sending an alert signal notifying the revised status, e.g., via an electronic message such as an email or text message.
  • the system 100 sends the control instructions (e.g., signals adjusting the target cooling and humidity levels in the storage enclosure 104, e.g., by controlling the refrigeration compressor, or switching "on” or “off the supplementary power source 105) to the corresponding device(s) (e.g., the environmentally-controlled storage enclosure 104 and/or the supplementary power source 105) via telecommand.
  • the control instructions e.g., signals adjusting the target cooling and humidity levels in the storage enclosure 104, e.g., by controlling the refrigeration compressor, or switching "on” or “off the supplementary power source 105
  • the corresponding device(s) e.g., the environmentally-controlled storage enclosure 104 and/or the supplementary power source 105
  • This allows controlling the environmental conditions in the storage enclosure 104 to adapt to the excursion profile of the pharmaceutical product(s) in stock.
  • a number of mutually different pharmaceutical products are stored in a single storage enclosure.
  • the system 100 may allow active control of environmental conditions of the storage enclosure 104 to favour or prioritise certain stored stock.
  • An exemplary workflow 500 is illustrated in FIG. 5.
  • the environmentally-controlled storage enclosure 104 is a fridge with known size and stock information recorded at the processing service 102.
  • the supplementary power source 105 is an Uninterruptible Power Supply (UPS) battery.
  • UPS Uninterruptible Power Supply
  • the system 100 will attempt to set a revised target temperature of the fridge to reduce standby energy consumption and thus “flatten the curve” of a potential temperature excursion. This curve will be chosen to favour priority stock.
  • Primary stock is defined herein as the stock requiring the highest protection from care criticality, while the term “Secondary stock” is defined as all other stock in the fridge.
  • the telemetry and telecommand device 103 reports power failure, reports UPS battery autonomy and provides the latest fridge stock information to the processing service 102.
  • the processing service 102 prioritises the stock type and sets a target temperature for the fridge, including by: a) delivering the latest fridge stock information to the remote user interface 826, which typically includes a plurality of product names/stock types (e.g., “Uucentis 0.165 mU syringe”, “Eylea 0.1 mU vial”, “Beovu 0.23mU vial”); b) delivering a known temperature range and corresponding expiry date for each identified stock in the environmentally-controlled storage enclosure 104 (e.g., a stock type, a plurality of corresponding (e.g., 8 to 25 degrees, 25 to 30 degrees, over 30 degrees), and respective expiry date results (“original date”, “30 days from excursion”, “ expired”)), the known temperature range and corresponding expiry date being automatically obtained by the processing service 102 based on the stock types / identifiers in the latest fridge stock information; and c) receiving a user input at the remote user interface 826 to
  • the processing service 102 revises the battery autonomy based on the updated target temperature and updated autonomy values (including fridge compressor duty cycle from previous days), and the ambient temperature.
  • the processing service 102 alerts the response team of active status and awaits input.
  • the processing service 102 accepts manually provided power restoration estimates and recalculates target temperature.
  • each stock item is compared to its respective manufacturer’s excursion profile, which may take the form of an impact table (including, for each stock type, a plurality of corresponding temperature ranges (e.g., 8 to 25 degrees, 25 to 30 degrees, over 30 degrees), and respective expiry date results (“original date”, “30 days from excursion”, “expired”)), and a new expiry date is calculated based on its current expiry date.
  • excursion profile which may take the form of an impact table (including, for each stock type, a plurality of corresponding temperature ranges (e.g., 8 to 25 degrees, 25 to 30 degrees, over 30 degrees), and respective expiry date results (“original date”, “30 days from excursion”, “expired”)), and a new expiry date is calculated based on its current expiry date.
  • the stock may need to be marked as unsuitable for use.
  • FIG. 6 An exemplary workflow 600 of the automated actions taken by the system 100 following an excursion event is illustrated in FIG. 6.
  • step 602 the telemetry and telecommand device 103 reports that power has been restored.
  • step 604 the processing service 102 assesses product temperature excursion of stock.
  • step 606 for each pharmaceutical product affected, its impact table provided in its excursion profile by the respective manufacturer is applied to the product.
  • the processing service 102 determines the impact on priority and secondary stock.
  • the processing service 102 updates the expiry date of each individual stock item based on the respective impact of the excursion, e.g., based on the determined excursion matching one of the temperature ranges the impact table, and then determining the new expiry date from the expiry date value in the corresponding row of the impact table (e.g., unchanged for “original date”, reduced to 30 days from excursion for “30 days from excursion”, or zero for “expired”).
  • the processing service 102 reports the revised expiry date of the stock, which may include marking some of the pharmaceutical products as unsuitable for use.
  • the illustrative embodiments described hereinabove may provide significant technical advantages relative to existing systems and methods/processes for monitoring and controlling environmental conditions for pharmaceutical products.
  • the system 100 allows for more effective control of environmental conditions for pharmaceutical products in storage and/or transportation, and significantly reduces the potential damage or the impact of an excursion event to the pharmaceutical products.
  • the system 100 reduces the demand for manual intervention at host environments where supplementary power management decisions would have to be enacted.
  • the system 100 enables automated decision-making of which stock to favour within a host environment to reduce the impact on logistic value.
  • the system 100 enables automated determination of a revised status for the affected pharmaceutical product(s), including automatic calculation of revised shelf-life expiry date after an excursion event.
  • the system 100 permits prescient manual intervention in cases of prolonged impact of an external actor. Additional Features and Possible Variations
  • the telemetry and telecommand device 103 is a device independent from the environmentally-controlled storage enclosure 104. This means that it may be connected to and used with any suitable type of environmentally-controlled storage enclosure 104. This provides improved adaptability and reduces manufacturing costs significantly compared to existing products in which the functions of monitoring and controlling environmental conditions are provided by the storage enclosure (e.g., a refrigerator) itself.
  • the storage enclosure e.g., a refrigerator
  • the telemetry and telecommand device 103 may be integrated with a controller for the environmentally-controlled storage enclosure 104, e.g., a refrigeration controller such as the CAREL IR33 refrigeration controller.
  • the telemetry and telecommand device 103 may be integrated with or configured to interact with any other suitable type of refrigeration controller.
  • the system 100 may be configured to monitor and control a plurality of environmentally-controlled storage enclosures 104 of the same or various types.
  • the processing service 102 may be in data communication with a plurality of telemetry and telecommand devices 103, each telemetry and telecommand device 103 is in turn connected to or integrated with a refrigeration controller for a storage enclosure 104.
  • This allows the system 100 to set and/or update target temperatures for a range of storage enclosures, or to provide updates on expiry information for pharmaceutical products stored in a plurality of storage enclosures.
  • the processing service 102 may determine if an external actor (e.g., a power outage) is affecting a single storage enclosure 104 only, or affecting a number of storage enclosures 104 connected to the system 100 (e.g., a number of refrigerators in a clinic, or a whole area). Based on the determination, the processing service 102 may be configured to automatically syndicate the correspondence with and the control of the affected storage enclosures 104. This may further improve the efficiency and accuracy of the monitoring and control of the storage conditions.
  • an external actor e.g., a power outage
  • the system 100 may be configured to: (a) automatically review the stock contents and generate updated stock data by scanning the stock contents in the storage enclosure 104 with the RFID antenna array 110; (b) send this updated stock data to the processing service 102; (c) obtain updated manufacturer-recommended storage conditions including the at least one target environmental condition (e.g., temperature and/or humidity) for the pharmaceutical products in stock in the storage enclosure 104; and (d) update the settings for the refrigeration controller by generating the control signal to set an update target environmental condition based on the updated at least one target environmental condition (in the updated storage conditions).
  • the manufacturer-recommended storage conditions for certain products may change over time, e.g., during transport/storage of the products.
  • the processing service 102 determines the target temperature for the storage enclosures 104 based on information such as the battery autonomy and the manufacturer-recommended storage conditions for the pharmaceutical products in stock.
  • the processing service 102 may be configured to take additional information into consideration when determining the target temperature.
  • the processing service 102 may check if there is a supplementary power source available, and take control of it (e.g., via the telemetry and telecommand device 103).
  • the processing service 102 may check the electricity supplier’s website based on the location of the storage enclosures 104 (e.g., the registered address of the clinic that manages the storage enclosures 104, or the GPS location of the storage enclosure 104) to determine when power will be restored.
  • the processing service 102 may automatically weather information (e.g., accessing a data feed provided by the bureau of meteorology or a commercial weather service) to report to the remote user interface 826 the external ambient temperature for the next few hours or days.
  • the processing service 102 may also report to the remote user interface 826 the size of the storage enclosures 104 (e.g., a smaller refrigerator may be affected by the external ambient temperature quicker than a larger refrigerator).
  • the processing service 102 may further report to the remote user interface 826 other potentially relevant factors stored in a database of the processing service 102 referenced by an identifier (ID) of the telemetry and telecommand device 103 and/or the environmentally-controlled storage enclosure 104, e.g., whether a fridge has a glass door or solid door (e.g., glass door fridges may lose heat quicker), etc.
  • ID identifier
  • FIGs. included herewith show aspects of non-limiting representative embodiments in accordance with the present disclosure, and particular structural elements shown in the FIGs. may not be shown to scale or precisely to scale relative to each other.
  • the depiction of a given element or consideration or use of a particular element number in a particular FIG. or a reference thereto in corresponding descriptive material can encompass the same, an equivalent, an analogous, categorically analogous, or similar element or element number identified in another FIG. or descriptive material associated therewith.
  • the presence of "/" in a FIG. or text herein is understood to mean “and/or” unless otherwise indicated, i.e., "A/B" is understood to mean “A” or "B” or "A and B".
  • a particular numerical value or value range herein is understood to include or be a recitation of an approximate numerical value or value range, for instance, within +/- 20%, +/- 15%, +/- 10%, +/- 5%, +/- 2.5%, +/- 2%, +/- 1%, +/- 0.5%, or +/- 0%.
  • the term "essentially all” or “substantially” can indicate a percentage greater than or equal to 50%, 60%, 70%, 80%, or 90%, for instance, 92.5%, 95%, 97.5%, 99%, or 100%.

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Abstract

Système de surveillance et de régulation d'une ou de plusieurs conditions environnementales destinées à des produits pharmaceutiques, le système comprenant : au moins un module d'interfaçage de signal permettant : de recevoir des données de télémesure liées à une enceinte de stockage à environnement régulé, et d'émettre des signaux afin de réguler la ou les conditions environnementales dans l'enceinte de stockage ; un module d'identification par radiofréquence (RFID) permettant d'obtenir des données de contenu de stock liées à un ou plusieurs produits pharmaceutiques dans l'enceinte de stockage ; et un module de traitement. Le système est configuré : pour identifier, en fonction des données de télémesure, un événement affectant ou pouvant affecter au moins une condition environnementale dans l'enceinte de stockage ; pour évaluer, en fonction des données de contenu de stock, l'impact ou le possible impact de l'événement sur le ou les produits pharmaceutiques ; et pour générer un signal de régulation permettant de réguler la condition environnementale dans l'enceinte de stockage.
PCT/AU2022/050974 2021-08-24 2022-08-24 Système, appareil et procédé/processus de surveillance et de régulation de conditions environnementales pour produits pharmaceutiques WO2023023747A1 (fr)

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