When temperature or RH conditions go outside acceptable range during shipping or storage, there is a need to determine the impact of the excursion.
- Still acceptable as labeled
ASAPprime® can be used to determine excursion impacts.
- Use ASAP on product to establish fitting behavior (sensitivity to temperature and RH)
- Use data-logger information to calculate impact of excursion taking account
- Product age at the excursion point
- Change in internal RH
- Change in T
- If ³95% confidence still passes at end of shelf-life, product is acceptable
- 30 tablets in 60-cc HDPE bottle + 1 g silica gel desiccant
- Stored at 25°C/60%RH
- Two-year assigned shelf-life for degradation to specification limit of 0.5%
- ASAP study showed Ea = 27 kcal/mol, B = 0.044
- After 60-days at 25°C/60%RH, product saw one week at 48°C/78%RH
- Is it still acceptable?
In this example, the probability of passing the specification at two years remains above 95% allowing justification
for acceptability of the lot even with this extreme excursion. Note that the ASAPprime® modeling typically contains
data above 70°C, such that any excursion is within the model space.