It has long been the argument of stabilitarians that you can’t speed up, slow down, or stop the real time stability calendar. Time is a continuous dimension and discussions with regulatory authorities about literally freezing time in processing samples have not been fruitful. However, the COVID-19 pandemic and impositions on staff availability may bring us to accepting some new ideas about our traditional stability protocols and timetables. Our test results are plotted to yield a line. The more points on the line, the better our statistical confidence. However, it’s a matter of our convenience that we think in terms of intervals such as 3, 6, 9 and 12 months (and as a more mature stabilitarian, I really like that convenience).
In the uncharted waters we find ourselves in, modifying our protocols to move the points on the line to better staffing periods may be worth discussing. Statisticians can tell us where the line passed while we were sheltering in place. In the world of biologics and vaccines, pull and freeze tactics have found a greater degree of acceptance. We could also explore how the relatively new technology of Isoconversion can supply some numbers to be confirmed in better times.
At the very least, we may cross-train more members of our team in sample control and chamber management/monitoring so higher absentee rates will have less impact on our process. If you’ve been waiting on being supplied a laptop or gaining access to chamber monitoring from home, COVID-19 may just have a thread of silver lining. If you have some innovative ideas to counter the impositions of the pandemic, we would love to hear about them via the StabilityHub forum.