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Keeping the cold chain on the level

Maintaining an optimal temperature is vital during the transit of pharmaceutical products. The data captured as evidence of product conditions must be of the highest possible quality or the entire cold chain is put at risk. Temperature monitoring services provider TSS’s cold chain information system offers shipment analysis from a risk management perspective.

Cold-chain management is of vital importance when it comes to maintaining the quality of pharmaceutical products. If such items are exposed to suboptimal temperatures during shipment – either too high or too low – there is a risk that they will be damaged and their efficacy reduced. For this reason, Temperature Sensitive Solutions (TSS) has developed a cold chain information system (CCIS), a webbased program designed to monitor and analyse temperatures at every step of the transportation chain.

Pharma-attuned service
Based in Stockholm, Sweden, TSS has been supplying temperature monitoring solutions since 1992. As one of the leading providers of such services, the company designed CCIS in conjunction with its partners in the pharmaceutical industry. As such, it is highly attuned to its customers’ specific needs.

"The CCIS supplies quality managers with key data, helping them make decisions and adapt risk management processes."  
   

The key benefit of CCIS is that it offers automated data processing with a global approach, supporting corporate SOPs for temperature control. Created with a view to minimising human error, the system ensures that cold-chain management remains straightforward. It is ERP-integrated, which leads to streamlined, efficient processes and reduces workload across an organisation. This, in turn, means saving time and, importantly, cutting costs.

The decision on product temperature profile and data logger configuration is controlled by qualified people, as it is the logistics experts who set up the shipment rules in an ERP system. At the product dispatching site, the ERP system provides the warehouse operators with instructions for issues such as packaging solutions, quantity and the location of temperature data loggers. This information, along with data logger temperature intervals, are applied to the data logger using a 2D barcode. This enables a leaner process in the warehouse, where the data logger is started in the online application without any manual input of information.

The information carrier, known as the TempTracer data logger, is sourced from Maxim Integrated Products. The unique iButton data logger technology is robust, resilient and reliable, it has been rigorously tested for accuracy and each unit is calibrated separately. The TempTracer comes in single or multiple-use formats and its temperature intervals are configured by the customer. There is no need to keep data loggers of independent intervals in stock as a multiple-use TempTracer data logger can be configured for one type of product on one trip and go with a completely different product on its next trip.

When a shipment arrives at its destination, the data is secured in the global web database and automatic notifications are sent if the shipment is out of the temperature range. The control over product quality and release is with the qualified experts as the temperature result of a shipment is not displayed until it is downloaded online.

As well as considering temperature data from an excursion perspective, CCIS assesses shipments in terms of risk. The CCIS supplies quality managers with key data helping them make decisions and adapt risk management processes. Data can be compared from different products, packaging solutions and regions, while suppliers are appraised against agreed key performance indicators. Freight forwarder milestone data is integrated with the CCIS temperature data, outlining the exact position in the supply chain where goods are at risk.

High-quality data, high-quality decisions
The overriding advantage for pharmaceutical companies is that CCIS provides a detailed overview of the complete supply chain. High-quality data is secured online, using automated processes for the launch and download of data loggers with superior reliability. Keeping track of suppliers’ KPIs, identifying risk lanes in the supply chain or creating thermal profiles for packaging solutions, the data is already available in CCIS, where reports generated to the user’s specification translates the data into a core business decision.

TSS’s temperature monitoring system provides flexibility, simplicity, reliability and, above all, full visibility. It helps pharmaceutical companies gain insight into the modern cold chain and develop an all-encompassing corporate strategy for fast and intelligent temperature management.

Company profile

TSS

For further information, visit: www.tss.se

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