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Pharmaceutical Manufacturing and Packing Sourcer

The Data Tells The Story

Temperature-controlled shipping by air has become a high-visibility product for air carriers and their forwarder partners. Increasingly, shippers of temperature-sensitive products as well as regulatory entities around the globe are looking for a different type of visibility. The visibility sought comes in the form of assurances that products requiring strict temperature management are transported as required to maintain product efficacy. In today’s world of airline temperature management, the gold standard is fast becoming the compressor-based unit load device (ULD). The system uses compressors to cool or heat strips to warm the cargo in order to manage transport temperatures to the product’s specific parameters. But more importantly, this cutting-edge technology offers the opportunity to provide everyone in the supply chain with wide-ranging visibility 2013into transport conditions experienced by the shipment.

Cold Chain Reliability

According to UNICEF data, every day 4,000 children die around the world and many more will fall ill from diseases that could be prevented by a simple vaccination. What is more, one in four childhood deaths could be prevented through proactive vaccination.

One of the biggest barriers to success is the reliability of the cold chain and, with the cost of immunisation climbing from $1 per child ten years ago to over $14 today, the cost of wastage for non-governmental organisations (NGOs) and national governments’ health departments is unsustainable. But how does a regulatory authority in the destination country know if the vaccine has been transported at the correct temperature? By having downloadable data, as the example below shows.

Data Tracking

A recent shipment of 10 containers of vaccines, belonging to our case study company, had been held up for several days in Brazilian customs. During the delay, the devices utilised to track the temperature of the cargo held within the ULDs stopped logging the critical data.

The problem was that, in order to clear customs, the product manufacturer and their forwarder partner had to prove that the drugs were not exposed to temperatures outside the recommended 2-8°C range during transportation. If such evidence could not be produced, the entire shipment of 10 containers was going to be seized and all the much-needed vaccines destroyed, resulting in a huge blow to the Brazilian clinics awaiting them. The loss of the shipment for both the pharmaceutical company and the freight forwarders would also, of course, have potentially been very damaging from a moral and financial perspective.

However, as the company’s active equipment featured on-board data tracking capabilities, including a sophisticated data logging system, all internal and ambient conditions – as well as key data such as door openings – had been recorded. Thus it was a straightforward process for Brazilian customs to verify the cargo’s temperature during transit.

The detailed downloadable report of the unit’s temperature during all phases of transport provided irrefutable proof that the temperature inside the containers had been retained within the recommended range, and that the shipment had not been compromised at any point during transportation and the unexpected delay in customs.

The containers were eventually loaded onto trucks and taken by road (still at the correct temperature) to their ultimate destination – clinics with patients in need. This episode could have turned out very differently had the data not been instantly retrievable and validated.

The importance of efficient and extended temperature control within a container and, just as importantly, easy monitoring and data collection, confirmed the efficacy of potentially life-saving product.

Clinical Trials

One of the biggest growth areas for cold chain solutions is clinical trials. These important research efforts are being carried out globally and the need for these drugs to be maintained at very precise temperatures is vital – particularly for biopharmaceuticals.

The stakes here are high because, apart from the need to find drugs for the treatment and cure of rising diseases such as cancer and diabetes, the costs are staggering. As much as 60 per cent of a drug’s cost is spent on its development and, as of 2007, due in part to the rigid regulations of the Food and Drug Administration, the average cost for moving a new drug from test tube to market ranges from $500 to $800 million, and one day’s delay costs the sponsor an average of $8 million (1,2).

Around 8,617 drugs are currently in trials (from preclinical through to Phase 3) and, for various reasons, many trials are carried out in clinics around the world. Therefore, the delivery time from factory to clinic can be long and challenging, while the need to be able to maintain the drugs in perfect condition remains absolutely vital. This can present the supply chain with many challenges, as the example below highlights.

Temperature Management

A pharmaceutical shipment was collected from a factory in Israel and transported by air carrier from Tel Aviv to Newark, US, and then onward by truck to its final destination in New Jersey. This shipment contained a product requiring a controlled room temperature environment; thus the payload needed to stay at a relatively constant 20°C throughout the 43-hour journey.

The goods were transported by temperature-controlled truck to the airport’s Maman storage facility; here the shipment was loaded into active ULD containers set to 20°C, data loggers were attached to each skid, and the units were sealed and stored overnight. The Federal Aviation Administration and European Aviation Safety Agency-approved containers used in this case were active compressor-based ULDs with precise temperature management of 4-25°C in ambient temperatures as extreme as -30°C all the way to +49°C.

The digital displays on the containers provided instant temperature readings in degrees Celsius and Fahrenheit, as well as information on the battery life, and monitoring and logging the temperature inside the containers was automatically accomplished. The internal temperature of the goods varied by no more than 0.1°C at any time over the 43-hour journey, despite the outside temperature fluctuating by as much as 35°C during this shipment’s transit.

In Newark, customs could clearly see that the temperature had been held constant despite the external conditions. The shipment was then transported by truck to its destination in perfect condition and the battery life was never challenged.

Keeping goods at 20°C could have been a challenge for the supply chain, because many solutions are designed to keep products at much cooler temperatures and cannot be adapted to maintain this much higher temperature. It would also have been nearly impossible and/or very costly to maintain a constant 20°C at these ambient conditions in anything other than active ULD containers.

It is currently estimated that 25 per cent of all transportation losses in the pharma industry are a result of inadequately managed transport temperature conditions and, as it is expected that biopharmaceuticals will account for 8 out of 10 pharma sales by 2015, this level of loss is not sustainable for the insurers, healthcare product manufacturers, their customers and patients.

The Yawning Gap

Regulatory compliance within the pharmaceutical cold chain in many parts of the world can be challenging, particularly as individual regulatory agencies may have contradictory rules and guidance. However, one area that is particularly clear is management of ambient temperature ranges during transport, which has been identified as a ‘gap’ in the temperature-controlled supply chain.

A recent CSafe survey confirmed the risk factors inherent with this gap. While it is identified and recognised by all parties in the supply chain, it is ultimately the manufacturer/ shipper that carries the weight of true ownership and responsibility for temperature management during product transport.

Closing this break within a frequently complex network of supply chain stakeholders needs to be carefully managed in order to ensure that the Qualified Person – who holds legal responsibility for releasing the product to market – is not faced with making a difficult decision because of evident breaks in temperature control during transportation.

Looking Forward

Greater regulatory compliance at all temperature ranges is needed to remove this breach, and biopharmaceutical shippers are increasingly reliant upon more efficient transportation solutions to maintain consistent temperatures within their supply chain. The way in which regulations will be interpreted in the future will remain in flux for some time to come, but one thing is clear – to keep life-saving medicines out of the ‘gap in the chain’, effective transportation equipment that reliably maintains temperatures while retaining accurate data records is essential in the industry.

References

1. Visit: www.emedonline.com

2. Centre for Information and Study on Clinical Research


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Mark Mohr joined CSafe Global in 2011 and currently serves as Director of Customer Support and Partner Management for the organisation. He has over 30 years of expertise in sales, business development, marketing and process management, as well as extensive experience in the air cargo business. Mark serves on the International Air Transport Association’s Time and Temperature Task Force, charged with enhancing and expanding airline regulations related to proper handling of temperaturecontrolled healthcare shipments.
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