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Automated cold storage unit and systems for storing, monitoring, and maintaining a supply of temperature sensitive pharmaceutical and/or other products in compliance with regulatory requirements are provided. Such units contain an array of independently addressable holding locations for containers w

Automated cold storage unit and systems for storing, monitoring, and maintaining a supply of temperature sensitive pharmaceutical and/or other products in compliance with regulatory requirements are provided. Such units contain an array of independently addressable holding locations for containers with product in one or more controlled temperature zones fitted with temperature sensors. The units include a reader to track product information and status. Product movement within the unit is performed by a computer-controlled robot. A user interface device, preferably in communication with an application service provider to provide remotely managed inventory management and other services, provides users with secure access to the contents of the unit and associated product data and information.

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1. An automated temperature sensitive product cold storage unit comprising: (i) a housing having at least one product access panel for loading and/or retrieving temperature sensitive products stored in the cold storage unit; and disposed in the housing,(ii) a loading zone configured to receive one o

1. An automated temperature sensitive product cold storage unit comprising: (i) a housing having at least one product access panel for loading and/or retrieving temperature sensitive products stored in the cold storage unit; and disposed in the housing,(ii) a loading zone configured to receive one or more carriers each adapted to hold a temperature sensitive product, wherein the loading zone is accessible via the access panel, when open;(iii) a storage area framework having a plurality of independently addressable storage bays each configured to store a temperature sensitive product or a carrier for a temperature sensitive product;(iv) at least one accessible, insulated, temperature-controlled cold storage zone that bounds a volume that encloses at least a portion of the plurality of independently addressable storage bays in the storage area framework, which cold storage zone comprises at least one temperature sensor;(v) a robot to transport temperature sensitive products, or carriers for temperature sensitive products, within the cold storage unit;(vi) a reader to identify temperature sensitive products loaded into or removed from the cold storage unit;(vii) a computer configured to control operation of the cold storage unit, movement of the robot, containers and carriers, and storage and dispensing of temperature sensitive products from the cold storage unit;(viii) a refrigeration unit connected to the cold storage zone; andwherein: (a) the cold storage unit further comprises a plurality of carriers; and/or(b) the loading zone is disposed in a carousel that can be moved in relation to the access panel, optionally (A) to provide an empty carrier into which a temperature sensitive product can be loaded, or (B) to allow a temperature sensitive product to be removed from the carrier in which it is held, wherein optionally the carousel rotates atop a base disposed atop the storage area framework, optionally a cylindrical array, to position one or more empty carriers within the loading zone or to position one or more filled temperature sensitive products within the unit for transport to a storage location; and/or(c) the storage area framework is a cylindrical array that comprises a hollow central core and a plurality of stacked levels of storage bays disposed about the periphery of the hollow cylindrical array, wherein the storage bays are accessible to the robot through the hollow central core, wherein the cylindrical array optionally comprises a series of substantially parallel vertical members, and optionally substantially parallel horizontal members, spaced to produce the plurality of storage bays, each of which is configured to accommodate a temperature sensitive product to be stored or a carrier therefor; and/or(d) each of the plurality of storage bays defines a rectangular box having an open end that is accessible to the robot to insert and remove a temperature sensitive product or carrier therefrom, wherein each storage bay optionally comprises a series of spaced, substantially parallel vertical members, and optionally substantially parallel horizontal members, wherein the vertical members contain ridges to engage and suspend carriers for temperature sensitive products; and/or(e) the robot is an R, Θ, Z gantry robot, optionally an R, Θ, Z gantry robot centrally disposed in a hollow core of a cylindrically arrayed storage area framework, wherein the robot comprises pair of robotic arms that can move vertically along a central shaft that defines a Z axis of the gantry robot and can rotate the arms in relation to the storage area framework to retrieve or deliver temperature sensitive products, or carriers therefore, to and from the loading zone and/or a different storage bay, optionally wherein the robot comprises two opposing arms, 180° apart, each comprising a central rod positioned within a rectangular sleeve casing and fitted with an adaptor configured to hook and pull a carrier into the arm's sleeve casing after forming a fit with a latch on the carrier, wherein each rod optionally is fitted with a sensor, optionally, comprising a light beam generator and a reflected light detector, in communication with the computer in order to control horizontal and vertical movement of the central rod to guide connection with the latch on a carrier; and/or(f) the cold storage unit comprises an a accessible, insulated, temperature-controlled cold storage zone, wherein the cold storage zone bounds a volume that encloses the plurality of storage bays in the storage area framework and wherein each cold storage zone comprises at least one temperature sensor; and/or(g) the cold storage unit comprises at least two stacked, accessible, insulated, temperature-controlled cold storage zones, wherein each cold storage zone comprises at least one temperature sensor and bounds a volume that encloses a portion of the plurality of storage bays in the storage area framework separate from the other cold storage zone(s), wherein any two adjacent cold storage zones are connected by a key way seal and key way plug that physically and thermally separate, and provide access between, the two cold storage zones; and/or(h) each storage bay is configured to receive a carrier adapted to (A) hold a temperature sensitive product and (B) be engaged by the robot for movement inside the housing; and/or(i) an accessible, insulated, temperature-controlled cold storage zone comprises temperatures between about 1° C. and about 12° C., and/or between about −100° C. and about 0° C.; and/or(j) the cold storage unit further comprises a backup power supply, optionally one or more batteries; and/or(k) the reader is a barcode reader; and/or(l) the cold storage unit further comprises an optionally activated security interface to control internal access to the cold storage unit, wherein such access control optionally comprises a login code verification and/or a biometric sensor scan; and/or(m) the access panel comprises a pair of sliding doors positioned above the loading zone, wherein the doors optionally slidingly separate from a central point above the loading zone; and/or(n) at least some of the carriers for temperature sensitive products each include a latch configured to be releasably but connectedly engaged by an adaptor of a robotic arm; and/or(o) at least some of the carriers for temperature sensitive products each include at least one opening through which a light beam can be shone and/or reflected to assess whether the carrier has a temperature sensitive product stored therein. 2. An automated temperature sensitive product cold storage unit of claim 1, wherein the presence of the product within a carrier is detected by a light beam generator positioned outside an outer perimeter of the carousel, and a sensor located outside an inner portion of the carousel. 3. An automated temperature sensitive product cold storage unit of claim 1 that comprises at least two stacked, accessible, insulated, temperature-controlled cold storage zones, wherein each cold storage zone comprises at least one temperature sensor and bounds a volume that encloses a portion of the plurality of storage bays in the storage area framework separate from the other cold storage zone(s), wherein any two adjacent cold storage zones are connected by a key way seal and key way plug that physically and thermally separate, and provide access between, the two cold storage zones. 4. An automated temperature sensitive product cold storage unit of claim 1 that comprises at least two stacked, accessible, insulated, temperature-controlled cold storage zones, wherein each cold storage zone comprises at least one temperature sensor and bounds a volume that encloses a portion of the plurality of storage bays in the storage area framework separate from the other cold storage zone(s), wherein any two adjacent cold storage zones are connected by a key way seal and key way plug that physically and thermally separate, and provide access between, the two cold storage zones, wherein the key way plug comprises a disk that sits on the key way seal within the insulation layer, forming an insulating barrier between the two adjacent cold storage zones and is free to rotate with the gantry robotic arms when the robot is an R, 0, Z gantry robot. 5. An automated temperature sensitive product cold storage unit according to claim 1 wherein the temperature of each cold storage zone is monitored by one or more temperature sensors and temperature data from the temperature sensors is stored in a memory associated with the computer. 6. An automated temperature sensitive product cold storage unit according to claim 5 wherein the cold storage zone temperature(s) is(are) displayed on a display panel visible to a user of the cold storage unit. 7. An automated temperature sensitive product cold storage unit according to claim 1 that further comprises a user interface device (UID), optionally a tablet computing device docked on the cold storage unit, in communication with the computer and an application service provider (ASP), wherein the tablet computing device, if present, optionally comprises (A) a touch screen to display, enter, and/or access information and (B) an internet connection that uses a local internet router or a cell phone card embedded in the cold storage unit. 8. An automated temperature sensitive product cold storage unit according to claim 7 wherein the UID is configured to display a home screen showing information on the cold storage unit and its contents, wherein the information displayed on the home screen optionally includes one or more of: names, dosages, quantities, and/or expiration dates of temperature sensitive products stored in the cold storage unit; current temperature of the cold storage zone(s); alerts; and/or order status of additional temperature sensitive products ordered for storage in the cold storage unit. 9. An automated temperature sensitive product cold storage unit according to claim 7 wherein by selecting on the UID a particular displayed temperature sensitive product further information about the temperature sensitive product is displayed on the UID, such further information comprising at least one of the following: location of individual unit(s) of such temperature sensitive product by storage bay, cold storage zone, and/or temperature zone; temperature history; lot number(s); expiration date(s); and/or internet links to additional information about the temperature sensitive product. 10. An automated management system for temperature sensitive products, the system comprising: (i) an automated temperature sensitive product cold storage unit according to claim 1 in communication with an application service provider (ASP);(ii) a UID to provide user access to the cold storage unit and information regarding its contents and/or operation;(iii) a data collection system wherein the cold storage unit's computer or UID and/or the ASP capture and store data related to the cold storage unit and temperature sensitive products stored in the cold storage unit; and(iii) an ASP, wherein the ASP is a cloud-based hosted environment that provides at least one service selected from the group consisting of inventory management, system administration, alerting, and reporting;wherein inventory management comprises: (a) tracking of inventory of temperature sensitive products stored in the cold storage unit;(b) tracking of temperature sensitive product dispensing and stocking transactions in the cold storage unit;(c) tracking expiration dates of individual temperature sensitive products stored in the cold storage unit;(d) automated transmission of re-order messages when temperature sensitive products become depleted;(e) automated transmission of expired product and/or about-to-expire messages; and(f) providing product and/or regulatory information about temperature sensitive products contained in temperature sensitive products stored or to be stored in the cold storage unit. 11. A system according to claim 10 wherein system administration comprises one or more of: (i) monitoring the cold storage unit location information; and/or(ii) monitoring information related to the physical status of the cold storage unit, including function, power, temperature, and/or temperature sensor data; and/or(iii) maintaining communication between a cold storage unit's computer, UID, ASP, and cell phone card applications; and/or(iv) maintaining optionally secure access to the cold storage unit and ASP; and/or(v) facilitating unit maintenance. 12. A system according to claim 10 wherein alerting comprises transmission of alerting messages to one or more pre-selected recipients and/or a UID that relate to one or more events selected from the group consisting of a cold storage zone temperature excursion that exceeds a preset threshold, inventory of a particular type of temperature sensitive product stock is depleted or reaches a preset lower limit, a temperature sensitive product has expired or will expire within a preset number of days, and a power disruption to the cold storage unit. 13. A system according to claim 10 wherein reporting comprises providing an authorized user access to information and reports related to status of the cold storage unit, product information, regulatory requirements, or inventory management, wherein the access is provided via a secure website and is optionally customizable based on a user profile.