How to qualify a vaccine thermal shipping container
In this article, Vaisala Senior GxP regulations expert Paul Daniel discusses the importance of qualifying thermal shippers. While the shipment needs of the COVID-19 vaccines have generated innovation in shipping containers, the need to qualify containers has not changed. Daniel outlines the anatomy of thermal shippers, describes how to qualify them, and emphasises the importance of the standard operating procedure (SOP). Included with this article is a recorded webinar on understanding and applying mean kinetic temperature, especially in distribution applications.
Over the last 20 years, there has been a new regulatory focus on good distribution practices, which prescribe how regulated products should be shipped. Luckily, the emergence of GDP created a strong and capable cold chain just in time to handle the high volume of temperature-controlled vaccine shipments that are required to fight COVID-19.
Pfizer’s vaccine, for example, has storage specifications of -70°C, and is one of the highest profile instances of new challenges facing temperature-controlled distribution. The current distribution channels were not equipped to handle -70°C products. Most distribution centres do not have ultralow-temperature freezers and our trucks and planes cannot be kept this cold. This presented a problem for distribution of a vaccine that requires ultralow conditions.
Pandemic meets ultralow-temperature shipping solution
The answer was found in the thermal shipper.
A thermal shipper is basically a combination of a shipping box and ice chest equipped with cold packs that keep contents at the correct temperature. Pfizer’s version of this was rather ingenious, with highly efficient vacuum panel insulation and dry ice packs. The shippers also contain a GPS-enabled temperature data logger to track temperatures and location. None of these items are cheap. But given the critical nature of the vaccines, an effective low-temperature shipping container was a necessary innovation.
A fully packed shipper holds almost 5000 doses of vaccine, with price per dose around US$20. At $100,000 worth of product in each box, the cost for data loggers, insulation and cold packs becomes nominal.
However, data loggers can fail, due either to a technical problem with the logger or human error in deployment. This uncertainty creates the need to qualify the thermal shippers to prove they are fit for their intended use.
Anatomy of a thermal shipper
Qualifying a drug and vaccine thermal shipper
To understand how to qualify a thermal shipper, it is helpful to look at its basic anatomy. On the outermost layer, it’s simply a durable cardboard box; usually triple-ply and water-resistant. Because a shipper can cost up to $100 a piece, the boxes must tough so they can be reused.
The next layer is insulation. In our diagram, these are the white panels. For a normal frozen shipment, this would just be polystyrene foam. For an ultralow-temperature shipment, Pfizer relied on vacuum insulated panels.
The next layer contains cold packs. In our diagram, these are the silver panels. For a normal frozen shipment, this would be a cold pack of some alcohol mixture engineered to have a phase change (to change from solid to liquid) at the product’s target temperature. The phase change temperature matters, because the cold pack will remain at the phase change temperature until the phase change is complete.
The innermost layer of the shipper contains the product boxes.
Qualification: proving it works
Validation proves that a process achieves its intended result. Qualification is the term used when validating a piece of equipment. So, at the same time, when we are qualifying the thermal shipper, we are also validating the standard operating procedure for packing the shipper.
To illustrate a qualification process, imagine a shipper meant to transport a frozen product on a four-day trip during summer. The product’s allowable temperature range is between -10 and -30°C.
Qualification gives confidence
The end result of a qualified shipper is confidence that the product will be at the right temperature during shipment. Even with an onboard temperature sensor, one still needed to have a qualified shipper. They had to prove that their single sensor accurately represented the conditions of the entire product area.
The focus on good distribution practices has provided a more robust cold chain and new technologies have emerged to support it. Many shipments can now be directly monitored with inexpensive and disposable data loggers that, while low on accuracy, are still good enough for this application.
The very low-temperature COVID-19 vaccines are a great example of the role of qualification of thermal shippers and its continued relevance.
Read the whole article here: https://bit.ly/3zf53RE.
Download the Application Note ‘Mean Kinetic Temperature in GxP Environments’ here: https://bit.ly/3zf53RE.
Join the ‘Mean Kinetic Temperature’ webinar recording here: https://bit.ly/3tHH5gQ.
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