Microbiology-PTM-OMA_Modules_1-5

Accelerated Study Design

Accelerated Stability Study

Claimed Shelf Life

Required Storage  Temperature

Storage  Temperature

Component

Shelf Life

Time Points

Test Solution 1

25°C

9 mos. (270 d)

55°C

0, 2, 5, 8, 11, 14 d

Test Solution 2

‐20°C

9 mos. (270 d)

25°C

0, 1, 2, 4, 6, 8 d

Test Solution 3

‐20°C

9 mos. (270 d)

25°C

0, 1, 2, 4, 6, 8 d

• Data generated is based on the Arrhenius model  • Assuming Ea = 20 kcal ex.  1 year at 5°C ≈ 32 days at 25°C, and 1 year at 25°C ≈ 45 days at 45°C • Test kit is stored at an elevated temperature to age the product more quickly • Number of replicates/time points is consistent with standard stability study