Pharmaceutical manufacturers naturally want to select packaging that complies with regulatory requirements for all shipments. The question remains as to what standard should be used for the testing of such packaging. Many default to the International Safe Transit Association’s (ISTA) 7D tests but these standards only offer a baseline suggestion for qualifying packaging. The trials and tribulations that may be encountered during shipping often make the simulated challenges of the 7D test irrelevant. As such, there’s a large push to improve qualification testing and make it more accurate in order to reflect the actual challenges of modern-day shipping.
Exceed current standards
ISTA 7D summer and winter standards were formulated to simulate specific conditions that occurred over 80 shipments made during summer and winter in Kentucky and Tennessee, US, to other locations in North America. The stepped temperature profiles in the standard are therefore appropriate for shipments from Kentucky but may not offer much useful qualification for a shipment from Norway to Saudi Arabia, or Australia to Taiwan.
In most cases, it is not enough to rely on the industry standard. Manufacturers need to know that the packaging will perform correctly for the precise conditions that will be encountered on the route.
If ISTA 7D alone does not provide a completely reassuring qualification, how is packaging tested for real-world conditions?
To provide an improved qualification, packaging can be tested with more cycles. At World Courier’s Climate Optimisation Research and Engineering (CORE) labs, tests for the next-generation passive Cocoon system included seven test cycles, which can extend the verified temperature-stable period to 168 hours.
ISTA 7D also recommends fully loading the packaging with preconditioned material during testing. This is a reasonable recommendation since nobody is likely to pay to ship a partially full package. But a preconditioned payload helps maintain the correct temperature within the package, so, to provide a more challenging test, packaging qualification is done by CORE and most other testers with only a 30% load or even an empty container.
Monitoring probes are used to verify temperature stability inside the packaging. The positioning and number of probes is important to ensure that temperature is mapped and consistent in all parts of the package.
Five is the minimum number of probes needed to provide a reliable and conclusive result in the thermal performance throughout the unit interior. When qualifying a solution for the most demanding regulatory regimes, many more probes can be required. For one customer’s requirements, CORE used 15-21 probes within Cocoon containers.
Individualised qualification for a specific route and product
Because of the elevated risk and potential losses inherent in shipping more valuable and sensitive material over longer distances, extended testing offered through CORE allows manufacturers to collaborate on an individualised qualification of packaging and the temperature-controlled delivery chain for a specific route and pharmaceutical product combination. Manufacturers need to be able to audit the entire testing methodology and results produced at whatever testing facility they use, precisely simulating the conditions that could be encountered on the route.
Of course, this necessitates having detailed shipment data available, including all the factors that may affect a shipment on a particular route, which can then be built into the qualification, giving the manufacturer a much more accurate and secure verification for its quality processes.
Due to the great diversity of regulatory regimes encountered in a global market, many manufacturers want to be sure that a packaging solution will meet more extreme regulatory requirements. Companies need to consider the importance of going beyond this outdated industry standard in order to offer the best packaging qualification to manufacturers shipping time and temperature-sensitive materials. The application of science, continuous data collection and detailed analysis will provide clearer insight into a product’s capabilities when exposed to even more difficult conditions than might be expected.
To understand more about key issues and new developments in temperature-controlled shipping, download World Courier’s new ebook, Packaging for the Most Challenging Shipments.
