Chamber Smarty Pants
All Situation Room examples are constructed and not descriptions of actual events.
Published on: April 6, 2024
Walter Routh
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What is the stability situation?
The chambers in our R&D stability program are now monitored by a system that thinks it’s intelligent—it records cumulative excursion times and intensities and provides a graphical representation of those outages along with analyses like Mean Kinetic Temperature (MKT), duration above alert limits, etc. Besides the normal chamber alarms, we get monthly status reports and summaries of each excursion as they are resolved, along with alerts regarding cumulative excursion limits. It may be too intelligent for our good.
The problem is we are not prepared to know this information, having been blissfully ignorant until 6 months ago when this monitoring system went live. We have a 5°C (±3°C) chamber containing primary stability studies for filings planned this year, but we just reached a cumulative 21 hours of excursions—some above 10°C. Most of the time (18 hours or so) the excursions remained within 2°C of the upper limit, though. Still, we thought this chamber was our best actor with no deviation reports for excursions in the past, just the occasional open-door alarm or brief maintenance outage and such. Now we’re nearing 24 hours of excursions—a threshold that we have expected would require some formal deviation report process—but embarrassingly, that’s not actually required, yet.
How should this be resolved?
Which of the following three action plans would you most recommend?
1. Open a deviation for the fact that we didn’t have a procedure for this quality process. Cover this situation and others within that event and take action accordingly.
2. Write a procedure for immediate implementation but don’t build a hard 24-hour requirement—limit cumulative excursion times within various intensity ranges, like an excursion budget, or even exempt excursions that might artificially extend shelf life (such as colder temperatures).
3. Do nothing at this time. Revert to the long-time process of not actually addressing cumulative excursions times and consider this additional information as only a tool for determining potential causes of unexpected results.
We’d be happy to hear from you on any other thoughts you might have, as well.
We Want to Hear Your Thoughts!
March 30, 2025
When it comes to filings we expect no surprises from stability data. One company found aberrant data like a rude April Fool’s joke, so what process can they implement to eliminate these surprises?
March 2, 2025
Your Honor, where do we turn if money is not available to purchase stability chambers and alternative storage options are not readily available? Budget timing and quality roadblocks are putting stability chamber space in danger of overflowing.
February 7, 2025
Upper management has a dangerously low awareness and vigilance of stability. They haven’t had a significant event or audit observation to raise alarms and put us at top of mind. As a result, we get the dregs of personnel and budget—this needs to change.
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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!
