The new T.I.M.S. Suite helps ensure that all refrigerated pharmaceuticals taken by patients will work as they should.

Although “cool chain” sounds rather like a ’60s pop song, it is quite serious business. Twenty-five percent of pharmaceutical and biotech products need constant refrigeration to stay potent. The pharmaceutical cool-chain market has been increasing 10 percent per year, and, with the high value of pharmaceuticals, billions of dollars are at stake.

Keeping products within the right temperature range is the goal, so monitoring the temperature of the products during shipping is also a must. This offers some challenges. Temperature readings must be ignored until the temperature data logger is placed in the shipping container with the product. Once packed, the data logger must be readable from within the shipping container. During shipping, the data logger can be dropped, get wet, be x-rayed, and be subjected to magnetic fields. Once the product arrives, the data must be readable by both the shipper and the receiver, regardless what system the receiver is using. And the receiver must remember to return the data logger to the shipper.

The SensoTag data logger with integrated temperature sensor stores temperature and other data (Photo: Siemens AG)

A solution for temperature tracking

Siemens has developed a solution to handle such issues and more, with its Temperature Information and Management System (T.I.M.S.) Suite. The suite consists of two related applications, the T.I.M.S. Operator and the T.I.M.S. Controller. The T.I.M.S. Operator operates the HFST-T109 (SensoTag) data logger with an integrated temperature sensor. It starts, stops, and configures measurements; stores, analyzes, imports, and exports measurement data; and displays and prints reports of recorded data in charts, curves, and so on. Fully compliant with GMP (Good Manufacturing Practice) regulations, the HFST-T109 SensoTag data logger is equipped with an RFID (radio-frequency identification) interface. Therefore the logger can be handled like a common 13.56 MHz RFID transponder that allows data to be transmitted through packaging and liquids. A flashing LED signals the user if a temperature violation has been detected. Each logger holds its calibration data that is valid for three years where 3 years is also the battery life-time.

The T.I.M.S. Controller plans and monitors the logger logistics and quality of transport conditions. It manages transport data such as ID numbers and shipment type; plans transport details such as the number of devices per packet and the logger configuration; prints temperature monitoring sheets, return slips, and other relevant papers; automatically reminds receivers to send back the data logger if they have not done so; and reports management data.

The T.I.M.S. Suite in action

The T.I.M.S. Suite was recently put to use by one of the world’s largest diagnostic products manufacturers. Distribution is global, with transportation by air, ship, or truck.

Once the product is ready to be packed for shipping, the enterprise resource planning (ERP) system indicates the number of data loggers needed and their positions within the packaging, allowing packaging personnel to place the data loggers in predefined positions. When a box passes a specific conveyor position, the data loggers are automatically started. Before shipment begins, the shipper also inserts freight data into the T.I.M.S. data bank. This information includes transportation modes as well as an estimated time of arrival, which is used in a reminder system for the receivers, to ensure that the data loggers are returned. The T.I.M.S. Operator stores this information and also automatically sends an e-mail notifying the receiver when to expect the shipment.

A temperature monitoring sheet (TMS) containing these details is placed in the package along with the data logger. The TMS tells when a shipment has started – this is essential because all recorded temperature values before this time can be ignored. When the package is received, the personnel write the receiving time on the TMS. This date/time marks the changeover of risk from the shipper to the receiver.

When the package is received, the T.I.M.S. Operator stops measurement, and the data are automatically stored in a network database. If the receiver is not connected to the network, the receiver can export the data from the data logger into a local version of the T.I.M.S. software. Based on the estimated time of arrival, the T.I.M.S. Operator also reminds the receiver to send the data logger back to the shipper. With the T.I.M.S. Suite, the customer now has full control and a continuous tracking and tracing option for its drug supply chain – a major benefit for both patient safety and manufacturer liability.

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