In an article, What are the fundamentals of a robust Cold Chain strategy?, appearing in the UK’s Clinical Trials Arena website, Henry Kerali explains the considerations that should be made when building an effective cold chain strategy. What should you think about when transporting pharmaceuticals whose effectiveness are sensitive to changes in temperature? How do you maintain the correct temperature over a long journey?
Mr. Kerali offers an example about a hypothetical flight from London to Aukland that involves more than one stopover. Consider all the steps: the forwarder moves the product from a central warehouse to the airport in a temperature-controlled vehicle. From there, the airline’s ground handler takes responsibility for the cargo—a critical step because there could be different swings of temperature. This is where many things can go wrong. The shipment, for example, could sit too long on the tarmac. If there is a stopover and the shipment switches planes, it must still be kept within the right temperature range. And, when the shipment arrives at the destination airport, care must still be taken during the handover to ground transportation. As you can see, there are plenty of places where something can happen.
To avoid those risks, it’s important to classify the products you’re shipping (solid dose, injectable, etc.) because they can fall under different temperature ranges. Some products are more sensitive to temperature excursions. Others are less critical. Make sure to use passive or active shippers for very critical products. If the product is less critical, blankets can avoid large temperature changes (high or low).
Take your temp
When product quality is compromised during a shipment, it is suggested that you add a device that can measure temperature throughout the entire trip. It’s critical to have a track record that can that identify when and for how long the shipment went out of spec.
If the product must stay within 10-20 degrees Celsius and you can determine that it was recorded higher than 20 degrees for a certain amount of time, it might not be released because of spec requirements. By documenting the temperature throughout the journey, you can quickly evaluate where and when the problem lies, and investigate how it occurred. The QA department can determine whether or not the product could be used. Meanwhile, the logistics department can study the distribution path and consider improvements to future deliveries, communicating with partners to improve procedures.
The fundamentals of a good cold chain strategy
So what should we try to adhere to? Certainly we need to assure that we have adequate expertise and collaboration from all involved. With one mistake, the delivery can be ruined. Here are some thoughts:
- Conduct a complete desk analysis: If you have a product launch involving a long, overseas trip, for example, it’s vital that you validate the path you are taking. In doing so, choose partners that are capable of setting up this delivery while establishing the flow of the shipment (Is there 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, flight schedules, etc.).
- Then, test it in the field: See if the plan will work. Ship a placebo shipment of similar characteristics. Most people can make a plan work under the best circumstances. Ask your shippers to deliver the package under the worst-case scenario! And, make sure you have a good temperature data logger.
- Validate your protocol: Make sure your protocol considers all of your transportation partners and details all of the routing. Conduct an analysis that considers the result if everything goes wrong. For example, if there are two options to fly from South America to Belgium—one that takes 150 hours from door to door, the other 100 hours, conduct your placebo test with the longer option. If the shipment arrives in acceptable shape, then the 100-hour shipment should also arrive in prime condition as well, everything else being equal.
Making a record
American Thermal has exceptional monitors to assure that the cold chain works effectively—and quickly indicates if there has been a temperature breach.
For the test program, our LOG-IC® 360 electronic data loggers provide easy access to view time and temperature data. You’ll benefit from temperature monitoring with insightful data, paired with a support structure to help with implementation that is designed to save time and expense. You can match shipment time and temperature to shipment events, to understand where—and how—the breach occurred.
Once the test is validated, we suggest that you combine monitoring tools: both a data logger and a threshold temperature indicator—ascending, descending, or dual monitoring labels. The loggers are usually kept within a box or pallet. When broken apart for distribution, either a carton or individual items are tracked via the label. You can choose affordable, accurate, dependable monitoring solutions with response temperatures as low as 0°C. They easily apply to packaging.
We partner with our customers to develop the perfect temperature monitoring programs and offer continued support to make sure the solution is effectively implemented to meet their needs. Sounds like a good prescription for success!