None of the five major thermal packaging systems used by specialty pharmacies to protect temperature-sensitive pharmaceuticals maintained their specified temperatures for 24 hours, according to a new report by pharmaceutical logistics specialist Modality Solutions.
The tests involved, insulated bubble bags, insulated envelopes, insulated box liners, EPS panel sheet coolers and EPS molded coolers. “All five performed below expectations when tested to the ISTA 7D industry standard. Most did not perform against their own published claims,” according to the report, “The Cold, Hard Facts: What You Need To Know About Thermal Shipping Technologies.” Cold chain shippers, therefore, should investigate other, more effective technologies to ensure that pharmaceuticals do not experience temperature excursions.
This packaging failure is particularly critical during the last mile, when medications and test kits are delivered to the customer’s home, where they may be left in the mail box or on the porch. Temperature excursions can change medications, reducing their potency and shelf-life, and make some even dangerous.
“The need for visual indicators is more acute, especially for mail order specialty pharmacies shipping self-administered specialty drugs, because caregivers or patients who self-administer medical treatments at home have no accurate way to identify potentially temperature-compromised medicine,” the report says.
Duriong summer temperatures, with ambient air temperatures between 22°C and 37°C, two of the bubble bags allowed temperature excursions within six hours for products that must maintain 2°C to 8°C. Three others allowed excursions at about 14 hours, and the remaining two at about 19 hours.
Insulated box liner maintained temperature for at least 18 hours, while three was effective for more than 24 hours. The EPS molded coolers each maintained temperatures for at least 18 hours, while one maintained them for about 21 hours. However,insulated envelopes provided no benefits, and each of the EPS sheet panel coolers allowed the product to freeze despite summer temperatures. This can be as damaging as overheating.
In tests designed to simulate winter conditions, all thermal protection measures failed, allowing the products to freeze. Only the EPS cooler maintained desired temperatures beyond five hours.