LOGISTICS

From laboratory to real world

Richard Harrop, commercial manager, SCA Cool Logistics

I recently had the task of reviewing 24 month’s worth of real cold chain temperature data; these recordings were taken from within the payload area of temperature control packages as well as from the external environments that these packages met during global distribution to durations of up to 72 hours. The sheer scale of data acquired was immense and the task of sorting through and extrapolating the conclusions from it seemed a rather daunting task. It was not until I had completed many of the necessary correlation steps that I managed to pull out the data providing high quality evidence of an unbroken cold chain coupled with examples of how to further reduce risk and cost.

Although I am in a very fortunate position within this market with regards to having the opportunity to review performance and temperature data from all over the globe, this was the first time I had received such a high volume from a single company and could follow the evolution of the solution that had been put in place at study start point and had now run for a full two years. The level and quality of data was exceptional and it was great to see not only control temperature packaging working as it should in the real world, but also a team of professionals working to get the very best out of the solution by fully understanding the science behind the design, as well as proactively responding to environment changes rather than reactively responding to excursions and failures.

To maintain such a high cold chain success rate it is key to work through discovering the transition from Laboratory Validated temperature control package into Working Qualified temperature control package. Although only a wording difference it is important that we note the difference between the two at the development stage and from this understand the best methods for temperature control package release and monitoring.

In completing the development of a temperature control package specific protocol criteria would need to have been achieved. Examples of these would be:

Maintain the product between two pre-specified temperatures, (this is more commonly referred to as a product threshold (the most common being between +2°C and +8°C)), for a required period of time (relative to the shipping duration), whilst within a pre-specified temperature environment (producing temperatures that would reflect those experienced during the previously mentioned shipping duration).

The initial criteria used in the development of the system I was tasked with reviewing had been set out clearly in the protocol. However, this was a new product and the customer’s first involvement in the development of a solution for shipping a +2°C to +8°C product, which became a tiny band when they started to consider the impact of distributing the product across Europe.

As no research had been undertaken by the customer into the transit ambient temperatures for each of their destinations (this task alone would have taken at least 12 to 24 months). It was decided that the development of the control temperature package should be phased in.

A phased approach meant that initially the development criteria were extremely broad. The initial solution had to maintain product temperature when tested to a number of ambient profiles with temperatures ranging from -10°C up to +35°C. Due to the lack of actual temperature data relating to the customer’s specific routes, the data used to create the test ambient profiles came from SCA Cool Logistics’ own research into transit temperature profiles, which was made up from a three year study across Europe using the network of an established courier company. The final design was extremely robust and it was understood that the solution could be far in excess of what was truly needed. However, without true transit data to develop to, the high value of the product dictated that the initial solution work in all circumstances, with high levels of resistance to some of the more uncommon environments.

Live shipping was then initiated with the robust packaging solution and alongside this the large temperature monitoring study began. The customer had already decided that the inclusion of portable data loggers was necessary, due to the high value of the product and so a portable logger was placed inside the payload space to monitor product temperature during transportation. A second logger was then added to the outside of the control temperature package to measure the temperature of the shipping environment. With both of these readings being taken, a full picture of system performance could be built up and any excursions or anomalies could be swiftly diagnosed.

Most commonly when asked to review a set of portable data logger readings by a customer, only the internal payload space would have been monitored (often due to the cost of purchasing the logging device coupled with the risk of losing the often costly externally placed device during transportation). Diagnosis of the issue then relies more on the reviewer’s experience; although the mystery is often solved it still removes the ability to fully review the system’s suitability as many aspects of the transit environment often remain unknown even to the customer. Without the addition of the external temperature monitor only a snap shot of system performance is provided. This can diminish the ability to review the system’s performance against the actual shipping environment as handling errors cannot be as effectively discounted and there is no growth in understanding of the shipping temperatures experienced.

With full sets of both internal and external data coming in for review from a range of locations from project start, an immediate picture of suitability was being developed. Initially the amount of data provided allowed for a rapid awareness and response to any handling and shipping issues occurring outside standard operating procedures. Problems such as loading full systems back into the +5°C environment whilst waiting for pickup, delays caused in customs and the true temperature of the temperature controlled warehouse, were noticed quickly through the review process. The solution for many of these initial problems was extra education and staff training with most of the logistical issues solved through increased communication.

The first official review point was after 12 months of shipping and although a number of observations had been made during the 12 month period it proved a key time to accumulate all findings and to build up a strong overview of system suitability going forward. The findings of the review illustrated that the system in use was exceeding all requirements. The majority of journeys were lasting for 60 to 70 hours and the average temperature experienced for the 12 months was +22°C. High temperature spikes were occurring to +35°C and sub zero temperatures were also experienced, with -18°C being the lowest temperature reached. However, these low and high temperatures were experienced for only short bursts, with maximum time periods of around four hours. Testing on the system to a number of the “real world” profiles showed that the system could maintain product temperature for a further 48 hours in some cases. Although it was comforting to think that there could be a buffer of 48 extra hours within the temperature control package, the external data from the customer was showing little need for this. Early issues with transport delays had been reduced due to the early stage data review increasing understanding and prompting better communication.

It was concluded at this point that a cost engineering programme be considered. The initial control temperature package was brought back into the lab and, through bringing together the external data readings, a more appropriate solution was developed. The existing solution had been developed to maintain product temperature throughout the year, with resistance to both extreme temperature highs and lows for continued periods. With not only the greater level of shipping temperature knowledge, but also the increased cold chain awareness in the customer’s packing and logistics teams, it was felt that the initial design could be split into three lower cost solutions. Each solution was developed to work specifically within seasonal temperature environments. These three systems were also developed using the same component parts throughout as it was felt that the impact on stock control of a move from one set of components to three could offer potential limitations in flexibility of stock holding and configuration choice.

This approach offered the greatest level of cost engineering as each design had a narrower range over which it needed to maintain product temperature. Most commonly it would be preferred that a single solution is used for the entire year as this puts the least amount of pressure on the logistics department and offers the lowest risk of “mis-packing”. However, due to the ability of the packing and logistics teams the change over to three solutions was supported. Further support for this move came with the decision to continue with the internal and external monitoring. Through monitoring both the positive and negative results and comparing these back to the laboratory data, project teams were able to make swift decisions regarding the correct configuration to use rather than working back to seasonal change assumptions from generic sources.

The three solutions released for use were a summer configured solution, a winter configured solution and an extreme solution developed to cope specifically with prolonged exposure to sub zero environments. It was understood that the third system would be rarely needed and of the three it was the more costly. However, by separating out this configuration 98% of the shipments made during winter periods travelled within the standard winter configured solution, not carrying the extra cost of the component increase needed in the extreme solution. With the three solutions in use there were again some product temperature excursions and these were once again quickly diagnosed and corrective actions were taken to ensure that repetition did not occur. As an example, a number of excursions were traced back to the chosen courier company misreading the outer labelling and placing the entire package into a +5°C environment whilst on site. The labelling was quickly amended and the issue was resolved with zero recurrence.

With the 24 month’s worth of data it could be clearly seen that the solutions in place were fit for purpose and evidence of system failure could not be found. This result, however, came from the combination of laboratory results and continuing data review. Without the same level of information, a programme such as this would have suffered a number of unanswerable questions and the move to more cost effective solutions would have been impossible. To date, a number of additional laboratory tests have been run on the three systems to give further information for determining the cause of excursion. there has also been the need to increase the temperature resistance of the solutions due to the product now being shipped globally. The increase in delivery locations has led to the continuation of internal and external monitoring for a further 12 months. It is hoped that the data collected over the coming months will illustrate the system’s global suitability, giving further guidance on managing configuration changes when considering increased ambient temperature ranges and instances of shipping from opposing seasonal environments.

After the next 12 month logging programme it is anticipated that both internal and external data logging will be halted due to the proven performance of the packaging solutions. Going forward, data logging projects will be undertaken at three year intervals. My own observation from this project to date is that the key to successfully delivering cold chain products within highly cost engineered control temperature packaging is continual review and communication between customer, packaging supplier and logistics provider. Aspects of this could be viewed as a cumbersome interference to a standard operating procedure and successful laboratory result, but attention must be paid to how a system is working within real environments if a highly cost engineered and still effective solution is to be attained and maintained.

RICHARD HARROP

Richard Harrop has been Commercial Manager of SCA Cool Logistics and has been involved in the temperature control packaging industry for six years, working predominately within design.

During this time Richard has developed and implemented several successful temperature control solutions for many of the world’s leading pharmaceutical corporations.

Please contact Richard at cool.info@sca.com or www.sca-cool-logistics.com

 

 

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