Clinical trials are run on a global scale, and in some cases in markets with less than ideal logistic infrastructure. The complex clinical supply chain creates a challenging distribution environment because of the shipping of large volumes of refrigerated kits to patients worldwide. Given the great number of clinical sites, there is increased complexity for maintaining product quality and mitigating the risk of thermal excursions. The product distribution process should be monitored to obtain a set of data showing that it is correct and secure.” (Good Cold Chain in Clinical Trials)

The distribution of clinical trial materials is a complex process, and it is where most clinical supply chain professionals earn their coin, so to speak. The ability to ensure the product quality is safeguarded throughout the journey can have far reaching implications. But how do you maintain the temperature of a product in a long haul flight?

Ensuring the Product Quality is safe in Long Haul Flights

Let’s assume you have an air freight shipment from London to Auckland, one that includes more than one stopover. There are several steps in the process. First of all, ensure that the forwarder moves the IP (Investigational Product) from the central warehouse to the airport in a temperature controlled vehicle. Once at the airport, the forwarder moves the product to the ground handler of the airliner.

“The point at which the ground handler hands over the shipment to the airline is a critical step, ”said Erik Agterhuis, formerly of Mylan Pharmaceuticals. “Here you need to be aware of the min-max time your product is exposed to potential temp excursions or mitigate the risk by implementing protection measures.”

At Mylan, Agterhuis takes care of the distribution and warehousing of the company’s products, and feels the handover between ground handler and the airline is a point where many things might go wrong.

“You don’t want a situation where the product sits on the tarmac exposed to the elements for too long a period,” he said.

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Then of course there’s the journey itself – normally carried out by the pharma service that you book from London to Auckland. If there’s a stopover, considerations must factor how the product is offloaded and loaded onto the next plane, and kept in the right temperature condition. When the shipment arrives in Auckland, the same flow takes place in reverse from the plane to the ground handler to the forwarder and onward to the final customer.

“Throughout this process, there are a lot of players involved as the product is shifted from one party to the next,” said Agterhuis.“This incurs a lot of risk.”

To avoid those temperature risks, it’s important to make classifications based on the product your shipping (solid dose products, injectables, etc.), as they can fall under different ranges. Hence, some products are more vulnerable to temperature excursions, while others are less critical.

For very critical products, be sure to use passive shippers or active shippers. If the product is less critical, use blankets to avoid big dips or high peaks in temperature.

How to Mitigate Temperature Excursions

In instances when there’s an excursion and the quality of the product is compromised, ensure you add a device that measures the temperature throughout the entirety of the shipment. It’s vital you have a track record that identifies when and for how long the shipment went out of spec.

“Using Auckland as an example, let’s say the label claim of the product is 15-25 degrees Celsius,” said Agterhuis.“The QA in Auckland says, ‘I have seen a peak above 25 degrees’ and concludes they cannot release the product because there was an out of spec for more than 10 hours based on the measured data.

“The QA then goes to the distribution QA, they liaise with their Global Logistics department to do a full analysis of the routing. By documenting each step of the journey, they should determine any holes. Once the point where the excursion occurred has been discovered, you can start a deep dive investigation obtaining a report from all the partners involved.”

Based on the number of hours and the temperature range the product was out of spec, the QA decides whether or not the product is usable. The combination of the QA’s assessment and the investigation into the distribution path will lead to improvement measures for the forwarder.

“The distribution team should always produce a CAPA (Corrective Action and Preventive Action) report where they call on their partners to improve procedures where necessary to avoid the excursion happening again,” Agterhuis said.

The Fundamentals of a Good Cold Chain Strategy

The art of transporting clinical trial materials to destinations far and wide is a meticulous process requiring expertise and collaboration from all involved. Ensuring that a shipment arrives in peak condition is a challenging task – one misstep along the way, and there could be huge implications on the trial in question. So what are the fundamentals of a good cold chain strategy? Below are three things to consider:

Complete a thorough Desk Analysis. In the event you have a new product launch from South America into Europe, it’s essential you carry out a lane validation. In doing so, choose partners that are capable of setting up this lane while establishing the flow of the shipment (will there be a stopover? If so, where? Will the goods be offloaded or not?). Once that’s complete, determine the duration of the different options you have (different airlines, different flight schedules, etc.).

Ensure you do a Field Analysis. Typically carried out after the desk analysis, this is done by shipping a placebo. Request that your supplier prepare a placebo shipment without active pharmaceutical ingredients but with an alternative – such as water – inside. Afterward, flow the shipment through the supply chain based on the worst case option(s) of your desk analysis.

Validate your Protocol. Ensure you do a validation protocol that accounts for all the partners used, all the details of the routing, the shipping companies and so forth. While the two key parts are the desk and field analyses, it’s advised you carry out an analysis that considers the worst case scenario were your shipment goes wrong. For example, if there are two options to fly from South America to Belgium, one that would take 160 hours from door to door, the other 120 hours, do a placebo shipment choosing the former option (160 hours). If the shipment arrives in Belgium without any excursions, then an IP shipment that takes 120 hours should arrive in prime condition (ceteris paribus).



Good Cold Chain in Clinical Trials –….pdf