FIELD

[0001] The present invention relates to a system and method for cold management of a temperature sensitive product. While the present invention will be described with respect to its application for medical vaccines, it is to be appreciated that the present invention is not restricted to this application, and other applications are also envisaged.

BACKGROUND

[0002] The following discussion of the background to the invention is intended to facilitate an understanding of the present invention only. It should be appreciated that the discussion is not an acknowledgement or admission that any of the material referred to was published, known or part of the common general knowledge of the person skilled in the art in any jurisdiction as at the priority date of the invention.

[0003] Temperature sensitive products such as medical vaccines need to be stored within a constrained low temperature range. Failure to do so can result in the vaccine being spoilt and/or being no longer viable. Such products therefore need to be stored within a predetermined low temperature range in a refrigerated storage environment.

[0004] Therefore, the current procedures required for cold management of medical vaccines requires that numerous temperature checks and validations be conducted through the entire warehousing and distribution of such vaccines to ensure that the vaccines are being stored within the required temperature range. These medical vaccines, which generally need to be distributed to many locations to persons requiring vaccinations, are typically transported within insulated cool boxes containing frozen gel packs. The gel packs help to maintain the stored vaccine within the required low temperature range for an extended period during and following the delivery of the cool boxes to a distribution site where the vaccines are being administered. [0005] It is however not possible to adequately manage the temperature of the vaccines once they are delivered. The cooler boxes may be left open for extended period while the vaccine vials are dispensed, which can lead to an unacceptable raise in the temperature within the cool box. This can potentially result in the vaccine being administered being no longer viable because of the storage temperature within the cooler box being no longer within the required low temperature range. Furthermore, any remaining vaccine that was not at the time administered may no longer be useable due to an increase in temperature within the cool box resulting in wastage of that remaining vaccine.

[0006] It would therefore be advantageous to improve the cold management process so that that vaccines or other temperature sensitive products are maintained within the optimum temperature range though the entire warehousing and distribution process.

SUMMARY

[0007] According to one aspect of the present disclosure, there is provided a system for cold management of a temperature sensitive product comprising; at least one apparatus having a storage container, a cooler assembly for cooling an enclosed storage space within the storage container, a data logger, a temperature sensor for measuring the temperature within the storage space, the temperature sensor providing temperature readings to the data logger for periodically logging the temperature readings within the storage space, and a wireless transmission module for transmitting temperature readings from the data logger to a control centre, the control centre comprising a data collection server for receiving and recording temperature readings for the at least one apparatus, a data processor for determining whether the received temperature readings of the at least one apparatus is within a required temperature range for the product.

[0008] In some embodiments, the processor sends an alert signal when the temperature readings fall outside of the required temperature range. [0009] In some embodiments, the alert signal is received by an alert module provided on the storage container.

[0010] In some embodiments, the control centre comprises a display for showing the temperature readings received by the centralised data collection server for the storage container.

[0011] In some embodiments, the apparatus comprises a location module for transmitting location information of the storage container via the wireless transmission module to the control centre.

[0012] In some embodiments, the display shows the location of the or each apparatus.

[0013] According to another aspect of the present disclosure, there is provided a method of cold management of temperature sensitive products, comprising; storing the product within at least one apparatus having a storage container comprising a cooler assembly for cooling an enclosed storage space therein, a data logger, a temperature sensor for measuring the temperature within the storage space, the temperature sensor providing temperature readings to the data logger for periodically logging the temperature readings within the storage space, and a wireless transmission module for transmitting temperature readings from the data logger to a control centre, receiving and recording temperature readings for the at least one apparatus storage container, and determining whether the received temperature readings of the at least one apparatus is within a required storage temperature range for the products.

[0014] In some embodiments, the method may comprise sending an alert signal when the temperature readings fall outside of the required temperature range.

[0015] Other aspects and features will become apparent to those of ordinary skill in the art upon review of the following description of specific embodiments in conjunction with the accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In the figures, which illustrate, by way of example only, embodiments of the present invention,

[0017] Figure 1 A is a photographic image of an apparatus for cold management of temperature sensitive products according to the present disclosure;

[0018] Figure 1 B is a perspective view of a platform for the apparatus of Fig. 1 A; and

[0019] Figure 2 is a graphical image showing aspects of the system for cold management of temperature sensitive products according to the present disclosure.

DETAILED DESCRIPTION

[0020] Throughout this document, unless otherwise indicated to the contrary, the terms “comprising”, “consisting of”, “having” and the like, are to be construed as non- exhaustive, or in other words, as meaning “including, but not limited to”.

[0021] Furthermore, throughout the specification, unless the context requires otherwise, the word “include” or variations such as “includes” or “including” will be understood to imply the inclusion of a stated integer or group of integers but not the exclusion of any other integer or group of integers.

[0022] Current procedures involved in the cold chain management for the warehousing and distribution of temperature sensitive products such as medical vaccines do not always ensure that the vaccine is always stored within the required temperature range. These current procedures can be summarised as follows: a) The vaccine is initially delivered to the warehouse from the pharmaceutical company. The vaccine is stored within delivery boxes, which are themselves accommodated within outer insulated pack. The delivery boxes containing the vaccine are therefore maintained within a low temperature environment during delivery to the warehouse. The warehouse supervisor initially conducts a temperature check within the outer pack to ensure that the temperature is within the required temperature range. b) The vaccines are then quickly transferred to a staging area within the warehouse, preferably within 5 minutes, which helps to ensure cold chain integrity. A pharmacist then conducts a further temperature check of the outer pack as well as checking the integrity of the outer pack. c) The outer pack is them removed so that the delivery boxes containing the vaccine can be moved into a refrigerated cool room. The pharmacist and warehouse supervisor will then check the internal temperature of each delivery box to ensure that the internal temperature is within the required temperature range for the vaccines. The product name, quantity, lot no. and expiry date of the vaccine shipment is also checked at this time. d) During storage of the vaccine, the temperature within the cold room is monitored, with a temperature logger being respectively placed at both a cold and hot spot within the cold room. The temperature logger can then periodically record the temperature within the cool room, preferably every 5 minutes, to ensure that the cold room temperature is maintained within the correct temperature range. e) In an event where the storage temperatures within the cold room are found to have been above the required temperature range, then the procedures may require the quarantining of the vaccines stored within that cold room. This then prevents accidental use of the now quarantined vaccine. A new batch of vaccines is then ordered to replace the quarantined vaccine. f) Prior to distribution of the vaccine, the vaccines are packed into a large insulated container having a hinged lid within which can also be accommodating gel-packs containing a frozen or chilled coolant therein. A tally check of the vaccine quantity, product code, lot no., and expiry date is done, and a temperature check is done of the temperature within the insulated container. A pharmacist and warehouse supervisor then verify that the vaccine is not from any quarantined supply, and that the vaccine storage temperature is within the required temperature range. g) Following arrival of the vaccine at a distribution point such as a school or medical centre, a nurse checks the pharmacist verification as well as checking the temperature within each insulated container. The vaccine is then transferred to a portable chiller located at the distribution site. h) The nurses administering the vaccine will then periodically check the temperature within the portable chiller during the day as well as just before going off duty. i) The quantity of any remaining vaccine is tallied, and the batch no. recorded before being returned to the warehouse. A final temperature check of the storage temperature of the remaining vaccine is done before the vaccine is returned to storage.

[0023] Improvements in these procedures have been envisaged to address this issue by requiring that the vaccines undergo numerous temperature checks along the entire cold chain. These improvements include having the temperature checks conducted and updated in real time. These temperature checks are also envisaged as being conducted automatically, in comparison with current procedures requiring the temperature checks to be manually conducted at certain milestones which may be arbitrary and cumbersome.

[0024] While the above described procedure does provide regular monitoring of the storage temperature of the vaccine prior to and after distribution of the vaccine, there are still periods when no temperature checks can be conducted. This can for example be the situation during transportation of the vaccine to a distribution site. It is also possible for the storage temperature to move above the required temperature range while the vaccine is being administered if the lid of the portable chiller is opened for an extended period as previously discussed. This can result in spikes in the storage temperature during the day that can be detrimental to the viability of the remaining vaccine stored within the insulated container. There are also inherent contamination risks associated with the use of gel packs which can potentially leak and contaminate the vaccine vials with coolant. Furthermore, it is not possible to track the location of each vaccine shipment in real time as it is being delivered to different distribution centres.

[0025] A possible way of addressing one or more of the abovenoted issues according to the present disclosure is to provide an apparatus 3 for cold management of temperature sensitive products. The apparatus 3 includes a storage container 5 having a cooler assembly 7 for cooling an enclosed storage space 9 within the storage container 5. The storage container 5 may include an upper lid 6 to allow for access to the storage space 9. A temperature sensor 11 is also included for measuring the temperature within the storage space 9, the temperature sensor 11 providing temperature readings to a data logger 15 for periodically logging the temperature readings within the storage space 9 automatically and in real time. A transmission module 17 transmits temperature readings from the data logger 15 to a control centre 2 that manages the distribution and cold management for the apparatus 3 when off-site from the warehouse. The transmission module 17 can transmit this data using a wireless channel to the control centre 2. The apparatus 3 can therefore be loT enabled and can remain in regular or constant real time contact with the control centre 2. The apparatus 3 further includes a backup battery power supply (not shown) for providing power to the cooler assembly 7, data logger 15 and wireless transmission module 17 when the apparatus 3 is away from any mains power supply to which it can be connected, or if there is any power outage. This helps to ensure that the apparatus 3 can continue to operate to maintain the required temperature range ad continue to be in contact with the control centre 2.

[0026] The vaccine vials to be distributed are packed into the enclosed storage space 9 of the storage container 5 while within the warehouse. The cooler assembly 7 cools the storage space 9, while the data logger 15 automatically conducts regular checks of the storage temperature to ensure that it is within the required temperature range. The vaccine is then delivered to the distribution centre within the apparatus 3 and provides storage for and allows access to the vaccine vials/syringes while being administered during the day. Temperature readings are also provided through the day in real time to the control centre 2 so that the storage temperature of the vaccines can be constantly monitored while off-site from the warehouse.

[0027] A platform 19 may be provided having a support surface 21 upon which the storage container 5 can be located for elevating the apparatus 3 to thereby facilitate access into the storage space 3 by nurses and other persons. The platform 19 also includes opposing side panels 23 for retaining in place the storage container 5 on the platform 21. An aperture 25 is provided though the support surface 25 so that accessories such as the battery power supply and data logger 15 can be passed though the aperture 25 and supported within a tray 27 underlying the support surface 21.

[0028] The location of each apparatus 3 can also be constantly monitored, using GPS or other locational information for each apparatus 3, this information being recorded at the control centre 2. The locational information can for example be provided by a GPS system on the delivery truck. It is also envisaged that a GPS system be provided as part of the apparatus 3.

[0029] The present disclosure also provides for a system for cold management of temperature sensitive products. That system includes at least one of the above described apparatus 3, and a control centre 2 for receiving the temperature readings from the or each apparatus 3, and location information from the delivery truck 8 or apparatus 3 while being delivered to a distribution site. The control centre 2 further comprises a data collection server for receiving and recording temperature readings of the storage space 9 of each apparatus 3, and the location information from the delivery truck 2 or apparatus 3. A data processor is provided for determining whether the received temperature readings of the or each apparatus 3 is within the required temperature range. This information may be shown on an information display at the control centre 2 that shows the temperature readings received by the centralised data collection server for the or each apparatus 3. The information display can also provide location information for each apparatus 3, which may for example be graphically shown as a locational icon on a map of the distribution area.

[0030] The system can provide an alert signal when the temperature readings of an apparatus 3 falls above the required temperature range. As previously noted, this can for example occur when the lid 5 of the apparatus 3 is left open for an extended period resulting in a temperature increase within the enclosed space 9 of that apparatus 3. The alert signal may be sent to the mobile phone or email of a nurse or other person using the apparatus 3 to warn them of the temperature rise within the apparatus 3. It is also envisaged that an alert module such as a flashing light or audio alarm signal is provided as part of the apparatus 3.

[0031] The loT live temperature control provided by the system according to the present disclosure provided many advantages over existing cold management procedures. In addition to reducing the number of times where staff need to physically measure and record the storage temperature of the products prior to, during and after the return of the remaining product, the system according to the present disclosure provides other advantages.

[0032] Firstly, the system allows for centralised monitoring of the temperature readings from every apparatus 3 that has been deployed though the distribution area. This ensures that there is real time monitoring of the temperature readings which will help to ensure that the quality of the temperature sensitive product is preserved while off-site and away from the warehouse cold room.

[0033] Furthermore, the live temperature fed can be maintained even during transportation of the product when stored within an apparatus 3 according to the present disclosure. This ensures that the cold chain management of the product is maintained even during transportation of the product.

[0034] The system also enables alert signals to for example be sent to the mobile phone or email of staff when any adverse temperature readings are received so that they can take the necessary remedial action to address that temperature issue.

[0035] The system further reduces the amount of unused product that could otherwise be spoiled though exposure to excessively high temperatures during distribution.

[0036] Throughout the description, it is to be appreciated that the term ‘processor’ and its plural form include microcontrollers, microprocessors, programmable integrated circuit chips such as application specific integrated circuit chip (ASIC), computer servers, electronic devices, and/or combination thereof capable of processing one or more input electronic signals to produce one or more output electronic signals. The processor includes one or more input modules and one or more output modules for processing of electronic signals.

[0037] Throughout the description, it is to be appreciated that the term ‘server’ and its plural form can include local, distributed servers, and combinations of both local and distributed servers.

[0038] Throughout the description, it is to be appreciated that the term ‘channel’ or ‘channels’ include wired or wireless electronic communication channels. The wireless electronic communication channels may include, but is not limited to, Wi-Fi, Bluetooth, Bluetooth LE, GPRS (General Packet Radio Service), Enhanced Data GSM Evolution (EDGE) etc.

[0039] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by a skilled person to which the subject matter herein belongs.

[0040] It should be appreciated by the person skilled in the art that the above invention is not limited to the embodiment described. It is appreciable that modifications and improvements may be made without departing from the scope of the present invention.

[0041] It should be further appreciated by the person skilled in the art that one or more of the above modifications or improvements, not being mutually exclusive, may be further combined to form yet further embodiments of the present invention.