AU2021107680A4 - System and method for monitoring and controlling environmental conditions for pharmaceutical products - Google Patents
System and method for monitoring and controlling environmental conditions for pharmaceutical products Download PDFInfo
- Publication number
- AU2021107680A4 AU2021107680A4 AU2021107680A AU2021107680A AU2021107680A4 AU 2021107680 A4 AU2021107680 A4 AU 2021107680A4 AU 2021107680 A AU2021107680 A AU 2021107680A AU 2021107680 A AU2021107680 A AU 2021107680A AU 2021107680 A4 AU2021107680 A4 AU 2021107680A4
- Authority
- AU
- Australia
- Prior art keywords
- storage enclosure
- environmental condition
- pharmaceutical products
- controlling
- module
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 239000000825 pharmaceutical preparation Substances 0.000 title claims abstract description 67
- 229940127557 pharmaceutical product Drugs 0.000 title claims abstract description 67
- 230000007613 environmental effect Effects 0.000 title claims abstract description 60
- 238000012544 monitoring process Methods 0.000 title claims abstract description 21
- 238000000034 method Methods 0.000 title claims description 20
- 238000003860 storage Methods 0.000 claims abstract description 116
- 238000012545 processing Methods 0.000 claims abstract description 61
- 238000004891 communication Methods 0.000 claims description 18
- 230000011664 signaling Effects 0.000 description 9
- 238000001514 detection method Methods 0.000 description 7
- 238000005057 refrigeration Methods 0.000 description 7
- 239000000523 sample Substances 0.000 description 6
- 230000008569 process Effects 0.000 description 5
- 230000009471 action Effects 0.000 description 4
- 238000010586 diagram Methods 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 3
- 230000002035 prolonged effect Effects 0.000 description 3
- 239000012080 ambient air Substances 0.000 description 2
- 239000000446 fuel Substances 0.000 description 2
- 239000002828 fuel tank Substances 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 230000035899 viability Effects 0.000 description 2
- 108010081667 aflibercept Proteins 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 238000013480 data collection Methods 0.000 description 1
- 230000000779 depleting effect Effects 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000005611 electricity Effects 0.000 description 1
- 238000005265 energy consumption Methods 0.000 description 1
- 229940051306 eylea Drugs 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 229940076783 lucentis Drugs 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000000737 periodic effect Effects 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000003908 quality control method Methods 0.000 description 1
- 238000009877 rendering Methods 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
Classifications
-
- 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
-
- 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
- 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
-
- 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
-
- 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
- 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
- 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
Abstract
A system for monitoring and controlling environmental condition(s) for
pharmaceutical products, the system including:
at least one signal interfacing module for:
receiving telemetry data related to an environmentally-controlled storage
enclosure; and
outputting signals for controlling the environmental condition(s) in the
storage enclosure;
a radio-frequency identification (RFID) module for obtaining stock content data
related to one or more pharmaceutical products in the storage enclosure; and
a processing module;
wherein the system is configured to:
identify, based on the telemetry data, an event that affects or potentially
affects at least one environmental condition in the storage enclosure;
assessing, based on the stock content data, the impact or potential impact of
the event on the one or more pharmaceutical products; and
generating a control signal for controlling the environmental condition in
the storage enclosure.
21898733.1:DCC- 24/8/21
U)i
00
(ZC) w ; >
l) c)) N
zz
75; Z ) U)
z U) < CY
0 j-Q Zz
<0 0
UUz
WC)~
m CN)
<) CzuC
U)<r)
0O 0
fl~0z wo5w~
~uU~DU) -< Z r L
Description
U)i
00
(ZC) w ; > c)) l) N
zz 75; Z ) U) z U) < CY 0 j-Q Zz
<0 0
UUz WC)~
m CN)
<) CzuC
U)<r) 0O 0
fl~0z wo5w~ ~uU~DU) -< Z r L
[001] The present disclosure relates to systems, apparatuses, and methods for monitoring and controlling environmental conditions for pharmaceutical products.
[002] Control of environmental conditions is crucial for quality control of pharmaceutical products. For temperature and humidity sensitive pharmaceuticals, this typically involves storing and distributing pharmaceuticals in environmentally-controlled enclosures such as cool boxes, refrigerators, cold rooms and specially equipped transportation vehicles. These 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.
[003] 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".
[004] Within the logistics processes for pharmaceuticals, a number of different products requiring different storage conditions and having different excursion profiles may
21898733.1:DCC- 24/8/21 sometimes be stored together in a single storage enclosure. An excursion event would therefore result in a variance in impacts on the viability and shelf life of those individual products affected by the excursion. However, no existing system or method is able to assess the impact of an excursion or a potential excursion to each of those pharmaceutical products stored in the enclosure, or to decide the actions to be taken accordingly.
[005] It is desired to address or ameliorate one or more disadvantages or limitations associated with the prior art, or to at least provide a useful alternative.
[006] According to a first aspect of the present invention, there is provided a system for monitoring and controlling environmental condition(s) for pharmaceutical products, the system including:
at least one signal interfacing module for: receiving telemetry data related to an environmentally-controlled storage enclosure; and outputting signals for controlling the environmental condition(s) in the storage enclosure; a radio-frequency identification (RFID) module for obtaining stock content data related to one or more pharmaceutical products in the storage enclosure; and a processing module; wherein the system is configured to: identify, based on the telemetry data, an event that affects or potentially affects at least one environmental condition in the storage enclosure; assessing, based on the stock content data, the impact or potential impact of the event on the one or more pharmaceutical products; and generating a control signal for controlling the environmental condition in the storage enclosure.
21898733.1:DCC- 24/8/21
[007] According to a second aspect of the present invention, there is provided an apparatus for monitoring and controlling environmental condition(s) for pharmaceutical products, the apparatus including:
a signal interfacing module for: receiving telemetry data related to an environmentally-controlled storage enclosure; and outputting signals for controlling the environmental condition in the storage enclosure; a radio-frequency identification (RFID) module for obtaining stock content data related to one or more pharmaceutical products in the storage enclosure; and a data communication module for providing data communication with a processing service; wherein the apparatus is configured to: receive telemetry data related to an environmentally-controlled storage enclosure; identify, based on the telemetry data, an event that affects or potentially affects at least one environmental condition in the storage enclosure; obtain stock content data; send the stock content data to the processing service; receive, from the processing service, a control signal for controlling the environmental condition in the storage enclosure; output the control signal to control the environmental condition in the storage enclosure.
[008] According to a third aspect of the present invention, there is provided a method for monitoring and controlling environmental condition(s) for pharmaceutical products, including:
receiving telemetry data related to an environmentally-controlled storage enclosure;
21898733.1:DCC- 24/8/21 identifying an event that affects or potentially affects at least one environmental condition in the storage enclosure; receiving stock content data related to one or more pharmaceutical products in the storage enclosure; assessing the impact or potential impact of the event on the one or more pharmaceutical products; and generating a control signal for controlling the environmental condition in the storage enclosure.
[009] Some embodiments of the present invention are hereinafter described, by way of example only, with reference to the accompanying drawings, wherein:
[001] FIG. 1 illustrates an example of a system for monitoring and controlling environmental conditions for pharmaceutical products;
[0010] FIG. 2 illustrates an example of a telemetry and telecommand device;
[0011] 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;
[0012] FIG. 4 is a flow diagram illustrating an exemplary processing workflow implemented by the system of FIG. 1;
[0013] FIG. 5 shows an example of the processing workflow implemented by the system in an exemplary scenario of power failure;
[0014] FIG. 6 shows an example of the processing workflow implemented by the system after an excursion event;
21898733.1:DCC- 24/8/21
[0015] FIG. 7 illustrates an example of the system with a web-based or cloud-based processing service; and
[0016] FIG. 8 is an illustrative diagram showing exemplary components of the system.
[0017] Described herein are systems, apparatuses, and methods for monitoring and controlling environmental conditions for pharmaceutical products, e.g., vaccines or pharmaceutical medications. In some embodiments, the described systems, apparatuses, and methods 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.
[0018] In some embodiments, the described systems, apparatuses, and methods provide automated data collection and decision-making 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.
[0019] According to at least some embodiments, where a number of different pharmaceutical products (including different types of products, and/or different batches of the same type of product) are stored together in a single storage enclosure, the systems, apparatuses, and methods 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, and to decide the actions to be taken accordingly. This involves, e.g., assessing the viability and shelf life individually for each product affected by the excursion, based on the excursion profile 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. In this way, the
21898733.1:DCC- 24/8/21 described systems, apparatuses, and methods provide for an optimised or improved outcome of an event external to the system that might create an excursion event.
[0020] According to at least some embodiments, 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.
[0021] In some embodiments, the systems, apparatuses, and methods 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.
[0022] In some embodiments, 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.
[0023] In some further embodiments, the described systems, apparatuses, and methods 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.
[0024] In some embodiments, 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. Upon the detection of an excursion or a potential excursion, the described systems, apparatuses, and methods provide early controlling decisions in relation to the use of the supplementary power source to reduce the
21898733.1:DCC- 24/8/21 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.
[0025] Given the limitation in the amount of power that the supplementary power source can provide (e.g., due to the limited battery capacity or generator fuel tank capacity), this allows for more efficient utilisation of the supplementary power source and better protection to the pharmaceutical products in stock, especially in the event of a prolonged impact of external actors. This also reduces the demand for manual intervention at host environments where supplementary power management decisions would have to be enacted.
Exemplary Structure of the System
[0026] FIG. 1 shows an example of a system 100 for monitoring and controlling environmental conditions for pharmaceutical products according to an illustrative embodiment.
[0027] 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.
[0028] The telemetry and telecommand device 103 illustratively includes interfacing electronic circuitry and software to enable local connection to an environmentally controlled storage enclosure 104, a supplementary power source 105, 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.
21898733.1:DCC- 24/8/21
[0029] Optionally, the telemetry and telecommand device 103 may further be in connection with supplementary temperature and humidity measuring probes (not shown in FIG. 1).
[0030] 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").
[0031] 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.
[0032] FIG. 2 shows an exemplary structure of the telemetry and telecommand device 103.
[0033] In this example, the telemetry and telecommand device 103 includes a network signalling interfacing module 201, a local signalling interfacing module 202, a processing module 203, a radio frequency identification (RFID) transponder module 204, and a sensor interfacing module 205.
[0034] 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.
21898733.1:DCC- 24/8/21
[0035] As shown in FIG. 2 and FIG. 3, the network signalling interfacing module 201 enables data communication with the processing service 102 via the wired or wireless telemetry and telecommand link 101.
[0036] 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.
[0037] 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.
[0038] 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.
[0039] 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.
[0040] 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.
21898733.1:DCC- 24/8/21
[0041] 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.
[0042] In some embodiments, the processing service 102 may be a web-based or cloud based 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.
[0043] Alternatively, the processing service 102 may be provided by a local or remote on premises server.
[0044] 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 UPS and 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;
21898733.1:DCC- 24/8/21 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; g) the communications link 101 including a telecommunications module 812 configured to connect/couple to a telecommunications infrastructure; h) a GPS module 814 configured to determine a GPS location of the refrigerator 802; i) the RFID antenna array 110; j) a supplementary door sensor 816 connected to, and configured to indicate to, the microprocessor module 804 whether the door is closed, e.g., via an OPEN or CLOSED signal; k) the processing service 102 in a computing cloud 818 , including a controller identity and location register IoT database 820, a controller update management database 822 (linked to SQL server), and a central data repository 824 (e.g., SQL Server);
1) 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
21898733.1:DCC- 24/8/21 telecommand device 103 and supplementary power source 105 (via the processing service 102 and the communications link 101)
[0045] 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.
Exemplary workflow
[0046] FIG. 4 is a flow diagram illustrating an exemplary process 400 for processing signals in the system 100.
[0047] As step 402, the system 100 receives periodical or event-driven telemetry data.
[0048] The telemetry data may include, for instance:
• data received from the environmentally-controlled storage enclosure 104, e.g., logical status monitoring (power ON/OFF, door OPEN/CLOSED etc.);
• data received from the supplementary power source 105, e.g., working status monitoring (ON/OFF) and power heath monitoring (voltage, current, autonomy); and
• 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.
21898733.1:DCC- 24/8/21
[0049] The "automony" is a measure of the predicted battery (or other fuel) life remaining in the supplementary power source 105, e.g., a product of the capacity and the demanded load. (More load will shorten the "autonomy" by depleting the batteries or other fuel faster.)
[0050] The telemetry data may be collected by the system 100 periodically, e.g., by the telemetry and telecommand device 103. Alternatively, 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.
[0051] As step 404, the system 100 receives periodical or event-driven data of the stock contents of the environmentally-controlled storage enclosure 104.
[0052] For example, 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.
[0053] 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.
[0054] The data of the stock contents may be collected by the system 100 periodically, e.g., by the telemetry and telecommand device 103. Alternatively, 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.
21898733.1:DCC- 24/8/21
[0055] At step 406, the system 100 receives event-driven alarms notifying affecting actors on the stock.
[0056] For example, 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; or an excessive external ambient temperature, i.e., a higher temperature than a predefined temperature threshold value.
[0057] At step 408, the system 100 processes and calculates the impact of the event (caused by the external actor) on the stock.
[0058] 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.
[0059] If the collected data meet a predetermined condition, the telemetry and telecommand device 103 will raise an alarm, either locally with a buzzer or via a message to the processing service 102.
[0060] The processing service 102 then automatically assesses a risk profile, and determines control instructions accordingly.
[0061] 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.
[0062] The control instructions may include control signals for the environmentally controlled storage enclosure 104 and/or the supplementary power source 105, e.g., for
21898733.1:DCC- 24/8/21 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.
[0063] Alternatively or additionally, the 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.
[0064] At step 410, the system 100 sends the control instructions (e.g., signals adjusting the target cooling and humidity levels in the storage enclosure 104, 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. This allows controlling the environmental conditions in the storage enclosure 104 to adapt to the excursion profile of the pharmaceutical product(s) in stock.
Exemplary Scenarios
[0065] In some embodiments, a number of mutually different pharmaceutical products (e.g., different types of products, and/or different batches of the same type of product) are stored in a single storage enclosure.
[0066] Upon the detection of an event likely to cause excursion, 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.
[0067] In this example, 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. A power failure occurs "out of hours", with the length of the failure unknown at outset of the event.
21898733.1:DCC- 24/8/21
[0068] In such a situation, 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. The term "Priority 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.
[0069] As shown in FIG. 5, at step 502, 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.
[0070] At step 504, 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., "Lucentis 0.165 mL syringe", "Eylea 0.1 mL vial", "Beovu 0.23mL 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 select the target temperature.
[0071] At step 506, the processing service 102 sends, via the telemetry and telecommand device 103, the updated target temperature to the fridge controller.
21898733.1:DCC- 24/8/21
[0072] At step 508, the processing service 102 revises the battery autonomy based on the updated target temperature and fridge compressor duty cycle from previous days, and the ambient temperature.
[0073] At step 510, the processing service 102 alerts the response team of active status and awaits input.
[0074] At step 512, the processing service 102 accepts manually provided power restoration estimates and recalculates target temperature.
[0075] Following the restoration of power, the full extent of the temperature excursion is known, and the impact on all affected pharmaceutical stock can be calculated by the system 100.
[0076] More specifically, 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. In some cases, the stock may need to be marked as unsuitable for use.
[0077] An exemplary workflow 600 of the automated actions taken by the system 100 following an excursion event is illustrated in FIG. 6.
[0078] At step 602, the telemetry and telecommand device 103 reports that power has been restored.
[0079] At step 604, the processing service 102 assesses product temperature excursion of stock.
[0080] At step 606, for each pharmaceutical product affected, its impact table provided in its excursion profile by the respective manufacturer is applied to the product.
21898733.1:DCC- 24/8/21
[0081] At step 608, the processing service 102 determines the impact on priority and secondary stock.
[0082] At step 610, 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").
[0083] At step 612, 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.
Implementations of the Embodiments
[0084] The illustrative embodiments described hereinabove may provide significant technical advantages relative to existing systems and methods for monitoring and controlling environmental conditions for pharmaceutical products.
[0085] According to at least some embodiments, 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.
[0086] According to at least some embodiments, the system 100 reduces the demand for manual intervention at host environments where supplementary power management decisions would have to be enacted.
[0087] According to at least some embodiments, the system 100 enables automated decision-making of which stock to favour within a host environment to reduce the impact on logistic value.
21898733.1:DCC- 24/8/21
[0088] According to at least some embodiments, 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.
[0089] According to at least some embodiments, the system 100 permits prescient manual intervention in cases of prolonged impact of an external actor.
Additional Features and Possible Variations
[0090] In the embodiment described hereinbefore, 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.
[0091] In some embodiments, 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.
[0092] In some embodiments, the system 100 may be configured to monitor and control a plurality of environmentally-controlled storage enclosures 104 of the same or various types.
[0093] For example, 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
21898733.1:DCC- 24/8/21 range of storage enclosures, or to provide updates on expiry information for pharmaceutical products stored in a plurality of storage enclosures.
[0094] In some embodiments, 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.
[0095] In addition, the system 100 may be configured to automatically review the stock contents, obtain and update the manufacturer-recommended storage conditions (e.g., temperature and humidity) for pharmaceutical products in stock, and update the settings for the refrigeration controller. This is particularly advantageous where the manufacturer recommended storage conditions for certain products may change over time.
[0096] In the embodiment described hereinbefore, 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.
[0097] In some further embodiments, the processing service 102 may be configured to take additional information into consideration when determining the target temperature.
[0098] For example, in the event of a power outage, 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
21898733.1:DCC- 24/8/21 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.
[0099] These arrangements provide for a more comprehensive and accurate determination of the target temperature for the storage enclosure 104, thereby providing better protection to the pharmaceutical products in stock.
Interpretation
[00100] The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of the common general knowledge in the field of endeavour to which this specification relates.
[00101] Many modifications will be apparent to those skilled in the art without departing from the scope of the present invention.
21898733.1:DCC- 24/8/21
Claims (15)
1. A system for monitoring and controlling environmental condition(s) for pharmaceutical products, the system including: at least one signal interfacing module for: receiving telemetry data related to an environmentally-controlled storage enclosure; and outputting signals for controlling the environmental condition(s) in the storage enclosure; a radio-frequency identification (RFID) module for obtaining stock content data related to one or more pharmaceutical products in the storage enclosure; and a processing module; wherein the system is configured to: identify, based on the telemetry data, an event that affects or potentially affects at least one environmental condition in the storage enclosure; assessing, based on the stock content data, the impact or potential impact of the event on the one or more pharmaceutical products; and generating a control signal for controlling the environmental condition in the storage enclosure.
2. The system of claim 1, wherein the control signal includes a signal for controlling a supplementary power source for the storage enclosure.
3. The system of claim 1, wherein the control signal includes a signal for setting a target environmental condition for the storage enclosure.
4. The system of claim 3, wherein the target environmental condition is determined based at least partially on the autonomy of a supplementary power source for the storage enclosure.
21898733.1:DCC- 24/8/21
5. The system of claim 3, wherein the target environmental condition is determined based at least partially on a manufacturer-recommended storage condition for the one or more pharmaceutical products.
6. The system of claim 3, wherein the target environmental condition is determined based at least partially on an ambient environmental condition obtained by a supplementary sensor.
7. The system of claim 1, wherein the control signal includes a signal for applying a revised status to at least one of the plurality of pharmaceutical products.
8. The system of claim 7, wherein applying the revised status includes: 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.
9. The system of claim 1, wherein the control signal is generated based on the priorities of the plurality of pharmaceutical products.
10. The system of claim 1, wherein the at least one environmental condition includes temperature and/or humidity.
11. The system of claim 1, including: a telemetry and telecommand device; and a processing service; wherein the telemetry and telecommand device includes: the at least one signal interfacing module; and the RFID module;
21898733.1:DCC- 24/8/21 a data communication module for providing data communication with the processing service.
12. The system of claim 1, wherein the at least one signal interfacing module is connected to and communicable with a controller for the storage enclosure.
13. The system of claim 1, wherein the system is further configured to: update a manufacturer-recommended storage condition for the one or more pharmaceutical products; and generating a control signal for controlling the environmental condition in the storage enclosure based on the updated manufacturer-recommended storage condition.
14. An apparatus for monitoring and controlling environmental condition(s) for pharmaceutical products, the apparatus including: a signal interfacing module for: receiving telemetry data related to an environmentally-controlled storage enclosure; and outputting signals for controlling the environmental condition(s) in the storage enclosure; a radio-frequency identification (RFID) module for obtaining stock content data related to one or more pharmaceutical products in the storage enclosure; and a data communication module for providing data communication with a processing service; wherein the apparatus is configured to: receive telemetry data related to an environmentally-controlled storage enclosure; identify, based on the telemetry data, an event that affects or potentially affects at least one environmental condition in the storage enclosure; obtain stock content data;
21898733.1:DCC- 24/8/21 send the stock content data to the processing service; receive, from the processing service, a control signal for controlling the environmental condition in the storage enclosure; output the control signal to control the environmental condition in the storage enclosure.
15. A method for monitoring and controlling environmental condition(s) for pharmaceutical products, including: receiving telemetry data related to an environmentally-controlled storage enclosure; identifying an event that affects or potentially affects at least one environmental condition in the storage enclosure; receiving stock content data related to one or more pharmaceutical products in the storage enclosure; assessing the impact or potential impact of the event on the one or more pharmaceutical products; and generating a control signal for controlling the environmental condition in the storage enclosure.
21898733.1:DCC- 24/8/21
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2021107680A AU2021107680A4 (en) | 2021-08-24 | 2021-08-24 | System and method for monitoring and controlling environmental conditions for pharmaceutical products |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2021107680A AU2021107680A4 (en) | 2021-08-24 | 2021-08-24 | System and method for monitoring and controlling environmental conditions for pharmaceutical products |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AU2021107680A4 true AU2021107680A4 (en) | 2023-08-17 |
Family
ID=87560428
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2021107680A Active AU2021107680A4 (en) | 2021-08-24 | 2021-08-24 | System and method for monitoring and controlling environmental conditions for pharmaceutical products |
Country Status (1)
| Country | Link |
|---|---|
| AU (1) | AU2021107680A4 (en) |
-
2021
- 2021-08-24 AU AU2021107680A patent/AU2021107680A4/en active Active
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| WO2023023747A1 (en) | System, apparatus and method/process for monitoring and controlling environmental conditions for pharmaceutical products | |
| US11402279B2 (en) | Continuous calibration of sensors in a remotely monitored cooling system | |
| US7658334B2 (en) | System for the real time inventory and localization of refrigerating containers and related method | |
| US9436853B1 (en) | Methods and apparatus for combining temperature data from separate segments of handling | |
| US7796528B2 (en) | Electronic device centralized management apparatus and electronic device centralized management method | |
| JP6707470B2 (en) | Intelligent routing codes to improve product distribution | |
| US7545267B2 (en) | Arrangement and method for product information interaction with building control system elements | |
| CA2956093A1 (en) | Wireless monitoring system | |
| JP2009519875A (en) | Cabinet monitoring and reporting device and system | |
| US11200535B1 (en) | Systems and methods of wireless communication for inventory management | |
| US20070174148A1 (en) | Method for resource management in a supply chain | |
| JP2019212131A (en) | Prediction device, electrical appliance, management system, prediction method, and control program | |
| US20230252410A1 (en) | Rfid based inventory system and method | |
| US20120280797A1 (en) | System And Apparatus For Item Level Inventory Management Within A Virtual Warehouse Established For Short-Term And Long-Term Disaster Relief Operations | |
| AU2021107680A4 (en) | System and method for monitoring and controlling environmental conditions for pharmaceutical products | |
| US11200534B1 (en) | Systems and methods of managing inventory of battery-powered devices in a retail setting | |
| US20080270270A1 (en) | System and method for monitoring and management of inventory of products and assets in real time | |
| CN205262616U (en) | Cold chain logistics temperature remote monitering system | |
| JP2018054161A (en) | Freezer monitoring device, freezer monitoring method and computer program | |
| CN114819710A (en) | Management method and device of electric energy metering device, computer equipment and storage medium | |
| CN115208053A (en) | Abnormity warning method, abnormity warning device, computer equipment and storage medium | |
| JP7117888B2 (en) | Distribution management device and program | |
| JP2004302593A (en) | Medicine distribution management system and medicine distribution management program | |
| Haque et al. | IoT based smart refrigerator monitoring system | |
| WO2021205784A1 (en) | Medicine management system |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FGI | Letters patent sealed or granted (innovation patent) |