Excursions

 

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
  • Re-date
  • Discard

 

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

 

Example

  • 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?

 

excursions-graph

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.

 

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