[Question] how do you actually verify data logger
Trying to get a straight answer on this: how do you actually verify data logger. On loggers, since I was sceptical and then bought one. A small transit logger costs a fraction of a vial and records the whole journey rather than the moment of arrival. What I learned from three of them: my lane is far more stable than…
Kept a vial at room temperature for eleven days by accident. Tested it out of guilt. It was fine.
a logger costs less than a vial and answers the question permanently
Agreed. The dry powder is the robust state; it is the solution that needs the care.
Kept a vial at room temperature for eleven days by accident.
anya_rautio is right that the pack failing is not the material failing. Two separate claims.
You cannot infer potency from a temperature record. The record tells you what happened to the box; only a test tells you what happened to the material.
Do you know what storage condition the stability statement covers?
Gel packs are designed for a duty cycle. A liquid pack at the end of a longer-than-expected transit is a pack behaving as specified, not evidence of an excursion in the vial.
Lyophilisation removes the water that drives most degradation pathways. That is why the dry cake is comparatively robust and the reconstituted solution is not.