Sample Mixup Trashes a Study
All Situation Room examples are constructed and not descriptions of actual events.
Published on: January 4, 2025
Walter Routh
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What is the stability situation?
The lab contacted me this morning with a very unexpected result for our 6-month assay result at long term storage. This is for a package study involving a liquid dose stored in nude glass bottles with multiple conditions from freeze/thaw to 40°C/75%RH accelerated. The results are so close to the lower spec limit that it clearly would not meet spec at the 9-month interval—we have a 24-month shelf life. This announcement started all the alarm bells ringing, since a major new marketing push is in the works with this new, more user-friendly packaging.
We quickly figured out that the long-term and accelerated samples were switched—probably when they were pulled and labeled in the staging room at the storage facility. We deduced this because the 40°C/75%RH results were also inconsistently high compared to the 3-month interval, and after interviewing the technician we confirmed that they had pulled the two conditions from the chamber at the same time and brought them to the staging room together. Unfortunately, inventory in both conditions are correct, so we don’t have a true smoking gun.
This has now happened three times in the last two years—that we know of. Previous exception reports led to training and counseling, but clearly that is not working. We need a solution that will both prevent and detect dispensing from incorrect storage conditions—on the surface, this looks like a mis-labeling issue, but it ultimately resulted in incorrect storage conditions being tested and casts a long shadow over all of our sample integrity.
What safeguards would you put in place to detect and prevent dispensing errors like this?
How should this be resolved?
A very high-tech digitalization solution to this would be to have a system where entry into and exit from a chamber is logged via a portable scanner, while any samples placed in or removed from the chamber are logged at the same time, automatically adjusting inventory. A second person verifier is still an option, but that really becomes unnecessary as full traceability is covered digitally.
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A stabilitarian encounters new situations every day. StabilityHub’s discussion forums give Stabilitarians an opportunity to ask questions and offer solutions to specific scenarios. Join in the conversations with other Stabilitiarians and share your knowledge!
