Simplified approaches to temperature-controlled clinical trial packaging

Pharmaceutical CommercePharmaceutical Commerce - November/December 2014

Often, needless cost and complexity--without improving quality and safety--impede cold chain packaging planning

As there are thousands of clinical trials going on today involving temperature-controlled products, blood and tissue samples, and related clinical trial materials (CTMs), the design and selection of tertiary packaging (i.e., for shipping) is vital to the success of the trials. Often, CTM managers will take a belt-and-suspenders approach, employing multiple levels of temperature assurance to protect the valuable trial materials. Some will call on packaging vendors to develop a customized approach, with dimensions, packaging materials and other components tailored to the exact characteristics of size and stability of the CTMs themselves.

We propose a checklist of appropriate actions in developing a temperature-assurance CTM packaging program, built on a specific approach: using modular components to assemble the CTM packaging. Use of modular components, which are designed to be “mixed and matched” according to the technical requirements of the program, are considered. Surprisingly, this approach can not only save time and money in the overall clinical trial; it can offer better quality assurance as well.

Prequalification: Be careful and thorough

Since clinical trials can fail if materials aren’t kept in the proper temperature ranges or if they are not delivered on time, properly vetting vendors’ qualification metrics is critical. This can be complicated by the fact that most clinical trial companies vet vendors based on reports the vendors prepare showing that, in theory, their solutions work in the real world. The vendors “test” their solutions in the lab, thus producing the prequalifying report—which brings up the first checklist item.

Prequalifying reports are an area where CTM managers have to be very careful. While most prequalifying reports may appear authoritative and thorough, a careful look under the hood may show areas of concern. For example, a prequalifying report will describe the changes in ambient temperatures the packaging system was tested against in laboratory conditions. What it may not reveal, or may not immediately make clear without careful probing, is how long the ambient temperatures were changed during testing. Some vendors may “spike” the temperatures for very short times, thus not truly testing their refrigerant and packaging systems.

Our recommendation is to run tests that hold temperatures for six hours. This is more of a “real world” test than if a company only spiked or lowered the temperature for an hour. Look for this information in the report. If it’s not there, be wary.

Also on the prequalifying testing checklist are two questions about payload: Precisely what kind of payload did the vendor use when testing the performance of its packaging and refrigerant? A single 5-ml vial of water will react much differently than a gallon of water, and 100 discrete 5-ml vials will react differently as well. Likewise, how fully was the container packed during testing? A partially packed container will react differently to changes in temperature. And if the “maximum load” during testing leaves two inches of space that may well be filled in the real world, you won’t be comparing apples to apples.

There are tools and equations to properly vet qualifying profiles, and Cold Chain Technologies is happy to share them. For more, simply contact the company.

Modular Packaging Provides Lowest TCO

The next major item on the checklist is whether the provider truly offers modular packaging and refrigerating solutions. This is important because addressing these challenges using packaging unique to each trial—the traditional way of attempting to meet these challenges—too often results in an operational nightmare in terms of cost, storage, efficiency and quality.

Our experience shows that a modular “mix and match” approach to cold chain packaging reduces costs, enhances operational performance, reduces errors and improves efficiencies in ways that resonate throughout the clinical trials logistics chain—benefitting multiple companies in multiple ways.

The vendor should offer refrigerants and insulation that work for all packaging sizes and can be mixed and matched depending on how long the shipment will take, the required temperature ranges and the volume of items to be shipped.

Reducing the pain of storage while also reducing errors

Without a modular approach to CTM temperature assurance, shipping companies might have to stock, handle and learn to quickly pack multiple types and sizes of containers for multiple clients. This would require excessive storage space and additional training, so that employees know how to handle each different type of container. Different-size boxes would carry with them their own quality requirements, cooling solutions and certification paperwork. With so many different packaging solutions needed on site, warehouse space is squeezed, inventory costs are increased and the cost in terms of time for managing the various types of packaging could be excessive. Training demands are increased as well, and with them are also often issues with the size of containers. Some would exceed 100 pounds, which isn’t easy for office staff at end destinations to lift and manage.

Increasing flexibility without increased complexity

Other solutions also keyed in on the idea of simplicity, but continue to be limited in the number of sizes they offer. And because they are more expensive, they must be reused to provide the required economic value. This adds complexity to the supply chain and, ultimately, additional costs.

The small-parcel packaging solutions offered by Cold Chain Technologies include four sizes for domestic shipping and four for international shipping. The simplicity of the modular solution reduces the number of refrigerants trial shipping companies have to manage, which in turn reduced their space requirements. This is a welcome advantage, because few companies have all the space they need. In addition, reduced chargebacks to clients for refrigeration means shipping companies can charge less, increase their margins or invest in their business to grow and offer better products and services to their customers—a win-win-win that adds value through the logistics chain.

The mix-and-match approach can be extended to pallet-sized loads as well, with KoolTemp Pallet Shippers providing secure, easy-to-use and superior thermal protection for large size loads of temperature-sensitive products. This includes seasonal and universal temperature protection coverage, with half-pallet and full-pallet solutions capably handling frozen, refrigerated, or controlled room temperature shipments.

From scalability to training, the key is simplicity

One of the true advantages of simplicity in clinical trial packaging is that scale becomes easier. With multiple types of packaging from multiple suppliers, larger trials and increased shipping demands translate to headaches regarding warehouse space, refrigeration costs, certification of temperatures, training and increased errors. But a modular system enables greater scale without a logarithmic increase in complexity and costs.


TJ Rizzo, Vice President, Sales & Marketing, for Cold Chain Technologies, is active in numerous industry groups, including the PCCIG “Last Mile” task force and the “Risk Management for Temperature Controlled Distribution” task force. He possesses a strong understanding of industry requirements and FDA regulations and logistics, particularly as they pertain to the pharmaceutical and biotech sectors. He has a BS in mechanical engineering from Penn State University and an MBA from the University of Massachusetts.

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