ISTA, the International Safe Transit Association, has long enjoyed a reputation within the packaging industry as a leading organization for developing standardized test protocols focusing on specific hazards within a distribution environment. Their hierarchical approach to developmental and performance testing is a readily accepted model among packaging designers across many industries.

Test protocols are grouped into what ISTA calls a Series. Testing moves from non-simulation of transport environmental hazards, through simulation in general or broad terms, and finally to a test developed from a comprehensive collection of field data.

Among their menu of test series are two that apply specifically to thermal performance. They are ISTA 5B, Focused Simulation Guide for Thermal Performance Testing of Temperature Controlled Transport Packaging, and ISTA 7D, Thermal Controlled Transport Packaging for Parcel Delivery System Shipment.

The initial test for temperature control was first published in 1999. It was known as 3G Thermal Performance Testing of Temperature Sensitive Transport Packages, and was as well-received by the biopharmaceutical industry as a hernia belt at a weightlifter’s convention. It provided the first-ever test methodology that was easy to comprehend and execute and it came from a reputable and recognizable source in ISTA. It later evolved into Series 7D, and the Focused Simulation outlined in Series 5B came later. The only other thermal testing specific to insulated transport packages was in the American Society for Testing Methodology, ASTM 3103, which had long languished under unpublished and un-finalized revisions.

Package developers within the eager biopharmaceutical industry quickly accepted 5B as “the standard,” and many self-respecting companies, attempting to qualify their packages in order to meet the growing regulatory requirements, clung to it like a security blanket because of its practical, logical approach.

“But it was never designed to be that cut-and-dry,” said Ed Church, executive director of ISTA. “It was meant to be used as a guide; 3G [later 7D] was created as a test procedure, a way to measure the environment and develop profiles using tribal knowledge and some data from UPS and FedEx to come up with guidelines. But the profiles in it were taken as gospel.” To his point, ISTA clearly mentions — in bold lettering no less — that “it is the responsibility of the user to know that ISTA strongly recommends that Focused Simulation Performance Guide 5B be used to develop specific focused profiles in place of the generalized profile examples illustrated in Procedure 7D.” Likewise, the second paragraph of the preface of Series 5B states, “These thermal-testing procedures should be considered as a general starting point for thermal analysis due to the many variables that can affect the thermal and distribution performance of a package.”

Mr. Church added, “Our intent was, if you had a high-risk, high-value product, you should collect your own data. We created a test procedure that wasn’t originally developed for Pharma specifically, but came at the request of the electronics industry.”

At the time, few within the biopharmaceutical field had the expertise, time and resources to devote to the significant effort required to capture time and temperature data from their distribution environments, so 5B was embraced as a sort of surrogate. Those who took ISTA’s recommendation and began to collect data soon discovered just how general the guidelines were and noticed there could be wide variability specific to their distribution systems not captured in the ISTA profile examples, and that could have a significant impact on package design, performance and longevity. These forward-thinking companies developed their own unique profiles which they felt confident in defending in the event of a regulatory audit, even though there was no standard approach to defining how to collect data and convert it into realistic and representative profiles.

Companies that ship temperature-sensitive healthcare products — ranging from biologics to medical devices — continue to gather, analyze and convert their data into profiles which they use to qualify their packaging. This has resulted in an infinite variety of profiles, collected by different means, using different protocols with results more statistically sound and realistic than others. The Parenteral Drug Association Pharmaceutical Cold Chain Interest Group (PDA-PCCIG) has recognized this and has organized a working group whose challenge is to standardize the process and develop a series of common profiles, beginning with the parcel delivery carriers. ISTA is a partner in this effort.

The working group consists of industry process and packaging engineers, statisticians, and faculty and researchers from the University of Florida’s Center for Food Distribution and Retailing. All have experience in pharmaceutical logistics. The group has spent the past several months meticulously preparing a complex and thorough protocol for collecting data. Their purpose is to record ambient temperatures that parcel packages are exposed to during two-day shipments in a typical hub-and-spoke delivery system. They have analyzed the trends between regions of the country using predefined climatic zones. The data collection will occur in triplicate for several weeks in what have historically been the most extreme weather months — July and January, round trip, along 86 domestic lanes that coincide with drug wholesaler’s distribution routes. Each test package shipped will contain multiple data loggers to record the temperature exposure on each of the six surfaces of the box for temperature variability. Pressure data will be collected to determine when the package is on the ground or in the air. Shock and vibration lane data will also be collected and analyzed and incorporated into profiles by ISTA which they intend to publish at some point in the future.

It is the goal of the group to produce profiles (ranging from 95% – 99% confidence levels) from the data and these will cover air and ground shipments. Additionally, they want the profiles to be flexible enough to incorporate regional trends, time of day, and duration. They will segment the data to capture modes of transport, as well as departure, cruising and arrival variability during air transport.

ISTA plans to raise funding to accomplish this and once the U.S. profiles are developed they plan to do the same in Europe. They will incorporate these profiles into Series 7D and make the lane data available to members for a fee in a manner similar to the purchase of their current test Series, although Mr. Church did not define exactly how ISTA will do this.

The expedited parcel delivery models of UPS, FedEx and DHL are unique to North America, and the U.S. in particular. Distribution models vary widely on international shipments — especially once they are in-country. Just as there is no universal package solution for the transport of temperature sensitive healthcare products, there is no universal profile that can define the environmental hazards in multi-national distribution. While the efforts of the PCCIG Temperature Profile Working Group are significant and the process for collecting the data is sound, it will take considerable time and expense to accomplish this on a global basis, particularly in emerging nations where the need for healthcare is great but the infrastructure for distribution is not.

Increased regulatory scrutiny has forced the biopharmaceutical industry to learn much about U.S. parcel delivery over the past decade — mostly by “walking the system.” Many assumptions have been dispelled, and many companies have a clearer understanding of their distribution process as a result, fine-tuning their packaging requirements to meet the challenges and potential hazards of the distribution environment with optimized and qualified packaging.

But there is another approach to addressing the challenges of distribution that goes beyond treating the symptoms. Cross-industry collaborations are emerging where the principle players in the process — shippers, freight forwarders, integrators and airlines — are partnering to understand the limits and liabilities, cultures and capabilities of their respective industries and they are attempting to develop minimum standards to help improve the delivery of healthcare on a global basis.

Meantime, ISTA has plans to further their forays into the world of temperature-sensitive packaging and distribution, recently announcing a partnership with leaders in the field of thermal testing and package development to implement a certification program specific to the unique environments of thermal test labs and the personnel who run them.

Kevin O’Donnell is director and chief technical advisor to industry at Tegrant Corp., ThermoSafe Brands. He blogs at Where Cooler Heads Prevail.