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Pharmaceutical Manufacturing and Packing Sourcer

Communication Skills

There are many elements of risk involved during the transportation of temperature-sensitive pharmaceuticals. A break in the cold chain can make a product nusable or shorten its shelf life, leading to an increased risk for patients and loss of revenue. Minimising product loss is increasingly important for competitiveness. It demands tighter control over the cold chain and procedures to ensure all transportation is carried out in an optimal manner.

A variety of monitoring technologies help to manage risks in the cold chain, and telemetry has great potential as an additional safeguard. Telemetry is an automated communications process where measurements are made, and data is collected, at remote locations and transmitted to receiving equipment for monitoring. Data can be transferred by a variety of means, including radio systems, optical links, and telephone or computer networks. Many of today’s systems use GSM networks and SMS to communicate, as these are widely accessible and economical.

Coming of Age

Currently, telemetry solutions address many key issues for cold chain shippers. The latest technology enables fully automated solutions suitable for mass transportation, yet it has not been widely adopted for pharmaceuticals.

Previous generations of telemetry devices, which transmitted data continuously, were not allowed on board aircraft for safety reasons. The main reason for this has been airline restrictions on electronic equipment that transmits a signal, which would have to be switched on and off manually – rendering the technology impracticable for routine shipments.

However, technology has evolved, and today there are telemetry devices that are capable of enabling a flight mode feature, allowing the devices to automatically power communication off while in flight, as well as power communication back on after landing, paving the way for approval by aviation authorities. In turn, such approvals will enable telemetry to contribute to the efficiency and economy of pharmaceutical transportation.

Real-Time Troubleshooting

Today’s shipment data collection is focused on timestamps and temperature measurement, with two primary sources of data: GPS tracking of the shipment and data logger extraction. Telemetry gives the potential to add additional parameters, including shock, motion, pressure and light. These can add significant depth to the reporting.

One of the most important advances with telemetry is the real-time nature of information gathering. Traditionally, data has only become available after the shipment has been received by a consignee. On the other hand, with telemetry, the data is received on a continuous basis throughout the transportation. This opens up the possibility for transporters to correct issues while the container is still in transit, potentially saving a valuable cargo that might otherwise have been deemed compromised and therefore unusable.

There is also the potential to amass statistical data over time, which could give a much more detailed picture of the realities of transportation in particular regions, over particular routes, or based on a wide range of other variables – enabling transport planning based on actual experiences.

Data relating to a large spectrum of variables can be mapped in new and innovative ways, giving a completely new dimension to virtually every parameter that might affect a shipment anywhere in the world. For example, standard operational procedures (SOPs) can be dynamically followed up on.

Key Impact Areas

Telemetry could address issues of interest to customers in three key areas:

Product Integrity
Additional data parameters and live data transmission can enable improvements in shipment handling, helping to ensure that products arrive in optimum condition. This in turn could increase patient safety and reduce wastage.

Regulatory Compliance
More comprehensive documentation could make it easier for shippers to demonstrate compliance with relevant regulations, speeding up product release times.

Process Optimisation
Telemetry gives access to a wide range of data, as well as making it possible to amass statistics over time and visualise trends. This feedback could be valuable in improving practices and efficiency.

Telemetry Test Shipment

To test out the technology’s effectiveness, a telemetry-equipped shipment of medicals, packaged in a temperature-controlled container, was transported from the US to France via Germany last year.

The shipment was taken first by truck to Washington Dulles Airport, then fl own to Frankfurt Airport on 16 August 2013. The final stage required transfer by inland carrier to Limoges, France, where it arrived safely on 21 August 2013.

The telemetry devices were all programmed to measure and report data every 15 or 30 minutes until arrival in Frankfurt, when units automatically switched to reporting data every 30 minutes. Email notifications were set to be triggered by different variables, such as:
  • The unit arriving at Frankfurt Airport
  • Temperature rising above a certain threshold
  • Accelerometer readings above a certain threshold (indicating a drop or other trauma)
  • Light sensor reading above a threshold (indicating container opening)
In addition, the units were set to be reconfigured automatically to:
  • Increase the sampling rate at a specified temperature threshold
  • Decrease the sampling rate when at a stand still 
Test Results

It could be seen that the shipment had successfully maintained a temperature of 2-8°C for the duration of the transport. This corresponded with data from the container’s regular sensors. A drop in pressure could be observed when the container was in the air, and indications of increased vibration correlated with road transport. No unusual shock or vibration was measured, so it could be concluded that the shipment had not been subjected to trauma, or otherwise compromised during the journey.

Data Reality

To secure the cold chain, data needs to be collected from a range of sources. Telemetry is therefore not a complete solution, but rather a complement to current practices. One of the key areas where telemetry could be infl uential is in the development of SOPs, which are cornerstones of the relationship between shipper and customer. With more comprehensive data, SOPs can be more effectively fine-tuned to reflect the reality of the transport scenario. Furthermore, amassing statistical information over time offers new possibilities for cold chain planning and adjustment.

Naturally, the greatest gains are achieved when all partners involved in the transport are open to sharing and utilising this data. Processes and working practices can then be improved to a higher degree.

In summary, the key benefits to be gained from the implementation of telemetric technology are as follows:

  • Potential for real-time updates and troubleshooting
  • Quick and informative overview of the shipment data
  • Critical points in the transport can be identified and planned for
  • Additional parameters (for example, light, motion or shock) may improve assessment of the shipment
  • Improvement areas can be identified and followed up with a range of measurements
  • SOPs can be adjusted more precisely to each scenario
  • Changes to the cold chain can be evaluated based on statistics
  • Improved feedback can be given to cold chain partners
  • Smart data management and learning from aggregated data could generate great value throughout the whole supply chain

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Hans Börjesson is Chief Executive Officer of Starbright Consulting, a company with expertise in telemetry and auto-ID solutions. He has extensive experience of building and managing companies within mobility and IT. Hans holds a Master of Science degree in Business Administration, and specialises in using IT to enhance business processes.

Gabriel Andersson is Chief Operating Officer and Vice President of Operations for Envirotainer, with global responsibility for IT, logistics, customer service, network and route optimisation, and the global service network. He has extensive experience of setting up and managing game-changing projects within the supply chain sector, with a focus on business process automation and traceability.

Hans Börjesson
Gabriel Andersson
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