Dry vapor shipping dewars used for transport of critical temperature-controlled biomaterials and lifesaving materials, such CAR-T and other regenerative medicines, can be purchased and used by anyone.
These dewars are qualified and validated by their manufacturers to generally have a 10+ day hold time. However, this cannot be assumed to always be the case—as they can be variable in their actual performance, both initially and over time. In fact, not only is there variability in initial hold time performance, but in-transit events invisible to the human eye can have dramatic impacts on the hold time of the dewar during its next use and beyond.
Additionally, dewars do “age” and have reduced hold times as they get older. Most organizations using these dewars do very little or nothing at all to track, test and document past or future potential performance.
So what does this mean for your precious cargo? If full testing and requalification of the dewar is not done after each use, you will have no idea if you are sending out a 10-day dewar or a 5-day dewar. When transporting critical, irreplaceable or lifesaving therapies, this could mean the loss of priceless samples or, at worst, a human life when a dewar fails to have an adequate hold time for an autologous therapy such as a CAR-T therapy. Image 1 below depicts some of the factors involved in holding time variation.
(Image 1: Factors Involved in Holding Time Variation)
At Cryoport we take your trust in our shippers’ performance very seriously. Therefore, we completely re-qualify all of our shippers after every single use and do so in a “Quality by Design” manner.
There are several factors that should be addressed utilizing GMP/GDP type practices in a re-qualifying process—which will be fully documented in a quality compliant system.
A few of these factors include:
- The shippers must be serialized in a complaint quality system. This is to ensure knowledge of unit level performance over time and allow for an adequate CAPA investigative process should a shipper ever fail.
- There must be a documented receiving and inspection process for shippers coming back after each use.
- The units must be cleaned with a proper biocidal agent that will kill any potential contaminants and prevent cross contamination for future shipments commodities.
- Physically inspect each dewar for damage during the previous transit events.
- Upon receiving a dewar, the NER or nitrogen evaporation rate should be tested for 24 hours. Cryoport has created an algorithm that over 10 years is constantly being refined to predict hold times of individual shippers to the tenth of a day using this methodology.
- Have a near real-time monitoring system to ensure the unit is performing as expected during the next transit event. Cryoport does this with our SmartPak II™ Condition Monitoring System.
- Validated SOPs for all re-qualifying processes and full training records for all personnel performing those activities.
- A certificate should accompany every shipper with re-qualification documenting the performance data, serial numbers of the dewar and monitoring system and associated calibration data etc.
That is our mission.
Written by: Kirk Randall, Senior Director, Business Development, Cryoport
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