As the biotech world has grown, the need to ship high value cell- and tissue-based materials has increased exponentially. An invaluable tool in the quest to move material in a safe and effective manner is the dry shipper and its counterpart, the data logger. While the dry shipper is key to successfully shipping materials both internationally and domestically, misconceptions about the workings of these devices can jeopardize your success (read more about this in my other cell therapy blog - "Commercially Successful Cell Therapies: Navigating the Ultra Cold Chain Minefield").
This will be a two-part blog that follows the most common misconceptions I have encountered among users of dry shippers. While this is not a complete guide, my hope is that these 10 tips will illustrate the questions you need to ask before you ship high value biologics with dry shippers.
1. Not all dry shippers are created equal
There are wide variations in dry shippers with regard to size and temperature (static) hold times and you should select the shipper that best fits your application. Sizes can range from space for a dozen vials or canes to shippers that can hold 25,000 vials. Temperature hold times can vary from a few days to more than two weeks. Variations also exist in how well they hold temperature under different environmental and handling conditions.
2. Significant variations can occur among dry shippers of the same make and model
The manufacturers' spec is no guarantee of a specific hold time. While some units are better than others, even among the best, variations of up to 40% are not uncommon. This is particularly important if you plan to use the dewar for temporary storage. In addition, in shipping a dewar internationally, you should anticipate a complicated customs process or an unusually long transit time. Imagine a scenario in which you accounted for eight days maximum!
3. Data loggers will reduce static hold over time
Data loggers allow us to create a record of the internal temperature of the dry shipper while in transit. In addition, they set acceptable temperature windows that will alert the recipient if a temperature excursion occurred during the shipping process. While data loggers are an invaluable tool in tracking and documenting temperature, attaching one to a dry-shipper will invariably reduce static hold times. The logger and probe set create a “heat wick” that draws heat into the interior of the dry shipper, reducing the static hold time. The extent of this wicking effect depends on the logger and probe configuration.
4. Get usable results by evaluating the location of the data logger on a dry-shipper and how it is secured and protected
Data loggers are an aftermarket addition and the quality of their performance is contingent on how they are installed and protected during transit. Not all models work well in the same locations so pick the dry shipper and data logger combination that is best for your particular situation.
5. The ability of dry shippers to hold temperature decreases over time
While dry-shippers have no moving parts, they do have two components that deteriorate over time. The first is the vacuum between the inner and outer vessel. This vacuum is critical and diminishes with use. The other element is the absorbent material that traps the liquid nitrogen. A simple 24-hour evaporation test will allow you to determine if there has been significant deterioration in either or both.
The importance of the temperature monitoring equipment and evaluating the size and static hold time of a dry shipper cannot be understated (learn more about ultra cold chain and logistical challenges at my upcoming webinar). Companies must ship materials the right way to ensure compliance with FDA requirements, patient safety, and success in their research. Stay tuned for Part II of this blog post that will cover the remaining five tips. What problems have you encountered when shipping high value biologics? Do you agree with these five tips?