Three days at 40 °C is about 34 refrigerated days of equivalent exposure. 40 °C is 35 kelvin above the 5 °C middle of a 2–8 °C refrigerator. The ten-degree rule of thumb — degradation rate roughly doubling per 10 K — makes that about 11 times the refrigerated rate, which is an order-of-magnitude statement and not a shelf life. At 34 equivalent days a test is more likely to reassure you than to tell you something, which is a legitimate reason to run it and a poor reason to expect a finding. Either way, record the three days and the temperature now, while you still know them; an excursion you did not write down is an excursion you cannot interpret later.
Answer first: for a lyophilised solid the cold chain matters far less than people believe, and for a solution it matters far more than they act as though it does.
Arrhenius behaviour means the degradation rate roughly doubles per ten degrees. A week at thirty degrees is therefore a meaningful exposure for a solution and an immaterial one for a dry solid.
That is the argument for shipping lyophilised rather than for shipping colder. A dry powder with low residual moisture is stable at ambient for months; the pathways that matter need water.
Phase-change pack hold time is a function of mass, latent heat and insulation, and published figures for small parcels are on the order of one to two days.
A cold pack tells you nothing about the eleven days before the last one.
Buy a logger if you actually want to know. Everything else is inference.
The doubling-per-ten-degrees rule is the part I did not know and now use constantly. – meniscus_film 7 months ago add a comment