A Medication Storage Temperature Witness for Homes Without Climate Control

SIMULATED, NOT MEASURED. An Arrhenius degradation model (activation energy 100 kJ/mol, range 80-120; time to 10% potency loss 90 days at 25 C) for a representative insulin-like drug class is applied to five home storage locations under winter, summer and heat-wave conditions. A working refrigerator is safe by a wide margin; every unrefrigerated location exceeds its exposure budget within one summer (windowsill red in 21.7 heat-wave days). A 48-hour fridge failure costs only 3.9% of budget. The required witness specification is derived from model sensitivity: +/-0.5 C accuracy, 10-minute sampling, 550-day coin-cell life, GBP 12.50 unit budget, showing cumulative green/amber/red. Only 11.4% of amber readings correspond to true potency loss above 10% under stated variation assumptions, so amber must not trigger discard.

Authors

Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2026-11-10
DOI
https://doi.org/10.5281/zenodo.24109816
Primary Topic
Quality and Safety in Healthcare
Type
preprint
Controls
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preprint

A Medication Storage Temperature Witness for Homes Without Climate Control

William Alexander Aldred
Zenodo (CERN European Organization for Nuclear Research)
Quality and Safety in Healthcare
preprint

A Medication Storage Temperature Witness for Homes Without Climate Control

William Alexander Aldred
preprint en

Abstract

SIMULATED, NOT MEASURED. An Arrhenius degradation model (activation energy 100 kJ/mol, range 80-120; time to 10% potency loss 90 days at 25 C) for a representative insulin-like drug class is applied to five home storage locations under winter, summer and heat-wave conditions. A working refrigerator is safe by a wide margin; every unrefrigerated location exceeds its exposure budget within one summer (windowsill red in 21.7 heat-wave days). A 48-hour fridge failure costs only 3.9% of budget. The required witness specification is derived from model sensitivity: +/-0.5 C accuracy, 10-minute sampling, 550-day coin-cell life, GBP 12.50 unit budget, showing cumulative green/amber/red. Only 11.4% of amber readings correspond to true potency loss above 10% under stated variation assumptions, so amber must not trigger discard.

Zenodo (CERN European Organization for Nuclear Research)
Quality and Safety in Healthcare
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