How to Qualify A Vaccine Thermal Shipping Container
The pandemic brought major changes to nearly every aspect of our lives, including how vaccines are produced, stored, and transported. Vaccinating the population against COVID-19 required a high volume of vaccines that had to be strictly temperature-controlled, and the current distribution methods were not equipped to handle such a task. Take the Pfizer vaccine, for example.
TSS Thermalist
June 22, 2023 | R value, Sustainable Leadership
Learn How to Qualify the Right Container to Ship Vaccines
The pandemic brought major changes to nearly every aspect of our lives, including how vaccines are produced, stored, and transported. Vaccinating the population against COVID-19 required a high volume of vaccines that had to be strictly temperature-controlled, and the current distribution methods were not equipped to handle such a task. Take the Pfizer vaccine, for example. That specific vaccine requires storage at -70°C, a temperature that the cold chain simply could not accommodate. Many distribution centers did not have ultralow freezers, and trucks and planes could not maintain the required temperatures. The solution to this problem was the thermal shipping container.
A thermal shipping container is a package that can maintain a controlled temperature for shipping temperature-sensitive products, such as food, flowers, and pharmaceuticals. Effective thermal shipping containers must use highly efficient materials and construction to ensure reliability during transit.
The importance of
proper handling
Ensuring the appropriate storage and handling of vaccines is crucial in the prevention and eradication of preventable illnesses. Nonetheless, storage and handling mistakes each year necessitate the revaccination of numerous patients and lead to significant financial losses due to wasted vaccines.
Improper vaccine storage and handling may also cause a reduction in vaccine potency, leading to insufficient immune responses in patients and insufficient protection against diseases. If patients require revaccination owing to compromised vaccines, they may lose faith in vaccines and providers.
At TSS, our liners are sourced from PET for the thermal performance of Styrofoam, in a lighter, 100% curbside recyclable package. This innovative design and highly flexible material improves edge seals and reduces air loss, and it has been compression-tested for maximal protection in harsh handling environments. Our liners are also anti-microbial, hypoallergenic, and hygienic.
We use Gel Ice Packs for our cold packs, which is made from a non-toxic gel and safe for the transport of food, pharmaceuticals, and medical products. Our Gel Packs provide a precise climate, ensuring delicate products are properly delivered, and they are reusable and cost-effective.
Anatomy of a thermal
shipping container
A thermal shipping container consists of an outer box, usually made of cardboard. A thermal liner is fitted inside the box, the product is placed in the box with a cold pack on top and bottom, and a final insulation layer goes across the top.
The cold chain flow
Failure to maintain the cold chain can lead to a loss of vaccine potency, rendering the vaccine unusable and lead to the waste of thousands of dollar’s worth of vaccines.
To ensure proper storage and handling, an effective vaccine cold chain must be established. A cold chain is a temperature-controlled supply chain that encompasses all equipment and procedures related to vaccines. The cold chain commences at the cold storage unit in the manufacturing plant and extends to vaccine transport and delivery, appropriate storage at the provider facility, and finally ends with vaccine administration to the patient.
Improper storage conditions such as exposure to excessive heat, cold, or light can result in a reduction of potency, which cannot be restored. Any refrigerated vaccine is susceptible to potency loss due to exposure to inappropriate conditions, but exposure to freezing temperatures (0°C [32°F] or below) can actually destroy potency. Liquid vaccines containing an adjuvant can permanently lose potency if exposed to freezing temperatures.
How the qualification process works
Qualification confirms that a procedure achieves its intended outcome. When we qualify a thermal shipper, we are also validating that the equipment and the process of packing accomplishes its intended result.
The qualification process will replicate the exact equipment and standard operating procedure (SOP), but it will use a placebo product and temperature sensors. The duration of the testing and the environmental temperatures are determined based on the intended shipping routes and expected weather patterns. It may be necessary to qualify different thermal shippers and SOPs for different seasons, such as one for summer and another for winter.
Here’s how it would work. Imagine a scenario where you need to ship a frozen product on a 48-hour trip during the height of summer, and your product must maintain a temperature range of between 0°C and -20°C.
Example 7E Summer Test
1. Test probes are embedded in a 5ml buffer vial stored at 5°C. The temperature quickly drops to a lower temperature as air in the container is cooled by the frozen gel packs.
2. Placing too much ice in a package can cause the contents to freeze. Proper SOP design can eliminate this problem easily. The temperature stabilizes after the surface of the frozen ice pack nears 0°C.
3. After much of the gel packs have melted, the internal temperature starts to rise. The slope of the line at this point is a stronger indicator of insulating value.
4. The probe goes out of spec, demonstrating a controlled 2-8°C environment for an extended Next-Day shipment profile.
The qualification process begins by assembling the thermal shipper in accordance with the SOP, which includes specific instructions on the type of cold pack and the conditioning time and temperature for the cold pack before assembly.
Next, place the placebo product in the lined box, along with temperature sensors. Since efficient use of space is key in these packages, we recommend a thermistor probe instead of an entire data logger. Thermistor probes are small and accurate and available in a range of calibrated options.
The packed shipper is then placed in an environmental chamber that can simulate the temperatures expected during shipping. In our scenario, the chamber may be set to 40°C for 12 hours to represent a sunny day and to 15°C for 12 hours to represent the night. This cycle would repeat for the number of hours you’re qualifying. In our case, the cycle would repeat twice for our 48-hour transport time.
After time has elapsed, the temperature data from the sensors is reviewed to determine whether the placebo product remained within the specified temperature range throughout the entire time. This should be repeated three times. In our scenario, if the thermal shipper maintained a temperature between 0°C and -20°C over 48 hours with a maximum daytime temperature of 40°C for all three tests, the thermal shipper is qualified.
Choosing the right products.
Transporting refrigerated medications requires careful handling to maintain their efficacy and safety. We provide reliable and eco-friendly options for shipping refrigerated medications. Our thermal packaging solutions offer precise temperature control and protection, ensuring that your medications arrive at their destination in optimal condition. Our innovative and sustainable packaging options for shipping refrigerated medications include insulated boxes, coolers, and gel packs that are reusable and recyclable. Trust our shipping solutions to deliver your refrigerated medications with care and precision.
We recommend our Kangaroo Mailer and RenewMailer for shipping pharmaceutical products.
RenewMailer
PET fiber insulated curbside recyclable liner, sourced from recycled drink bottles.
+ Delicate Items
+ High-Performance Requirements
+ Shipment Durations 24-72+ hours
Kangaroo Mailer
Self-expanding protective mailer for insulating, safeguarding and cushioning perishables during shipment.
+ Delicate Items
+ Smaller Payload Requirements
+ High-Performance Requirements
+ Shipment Durations 24-72+ hours
