I once called a manufacture for a 00 refrigerated medication and was told it only had stability data going out 8 hours, so I had to throw it away.
· Determine the maximum possible time it could’ve been out of range.
That way, if an excursion occurs, you can quickly recognize it and bring it back within range.
· If you’re using a thermometer that doesn’t have the ability to continuously monitor temperatures, be sure to 1) check the minimum and maximum (this lets you know if you had an excursion since the last time you checked it) and 2) reset the minimum and maximum afterwards so it’s ready for the next time period.
This is where continuous-read thermometers can save you a lot of money.
If you’re only checking the temperatures twice-daily and you find an excursion, it’s likely your maximum possible time out of range will be 12 hours, or close to it.