Inconsistent Standards and Infrastructure Across Climate Zones

Client Basics

Client: European Based Pharmaceutical
Destination: China
Project Scope: Single Shipment
Unique Factors: Potential Temperature Deviation

Background

After unloading a passive container from an aircraft, a ground handling agent at the destination identified that the product temperature label read “2° to 8°C.” The agent confidently proceeded to store the container in a 2° to 8°C environment. Unfortunately, according to packaging validation, it was too early to store the container in the cool room. As a result, storing the product in this temperature-controlled room caused the product to reach a dangerously low temperature near freezing point. 

Approach

This incident is quite common, and the World Health Organisation has performed several studies to understand the implications of product freezing.

Good temperature control during the storage and transport of vaccines is critical to ensure their potency and safety. Liquid formulations of aluminum-based vaccines against diphtheria, pertussis, tetanus, hepatitis B and Haemophilus influensatype b, alone or in combination (adsorbed vaccines), should not be frozen. Between 14 and 35 percent of refrigerators or transport shipments were found to have exposed vaccines to freezing temperatures, while in studies that examined all segments of the distribution chain, between 75 and 100 percent of the vaccine shipments were exposed. More rigorous study designs were associated with higher levels of exposure to freezing. When a vaccine is damaged by freezing, the potency lost can never be restored — the damage is permanent. Freeze-damaged vaccines have lower immunogenicity and are more likely to cause local reactions, such as sterile abscesses."

Source: WHO, Ümit Kartoglu, Nejat Kenan Ösgüler, Lara J Wolfson, WiesÅ‚aw Kursatkowski, “Validation of the shake test for detecting freeze damage to adsorbed vaccines,” Feb. 9, 2010

Solution

LifeConEx life science cold chain specialists proactively discovered the mistake in the handling of the container and instructed the ground handler agent to move the shipment into an ambient warehouse as addressed in the packaging protocol. 

Results

The product temperature was stabilised and brought back to an acceptable temperature range. This avoided a potential loss of product — product integrity was preserved.