Medical Package Testing
Accelerated Aging


Definition of variables:

  • AAR: Accelerated Aging Rate
  • AATD: Accelerated Aging Time Duration
  • DRTA: Desired Real Time Aging
  • AAT: Accelerated Aging Temperature
  • AT: Ambient Temperature
  • Q10: Accelerated Aging Factor
    • Q10 = 2 (industry standard)
    • Q10 = 1.8 (more conservative option)


Equations

Step 1:
AAR = Q10(AAT - AT) / 10)

Step 2:
AATD = DRTA / AAR


Example
Time duration calculation for accelerated aging of a medical product:

One year shelf study at 55 degrees Celcius, where ambient temperature is 22 degrees Celcius and Q10= 2

Equation

Sample Data

AAR = Q10((AAT - AT) /10) AAR = 2(55 - 22 )/ 10) = 9.85
DRTA = 1 year x 365 = 365 days
AATD = DRTA / AAR AATD = 365 / 9.85 = 37 days

NOTE: 55° C AAT and Q10 =2 are the most commonly used factors for medical devices and medical packaging components.


Accelerated Aging Calculator

This calculator generates a table of values for calculations based upon ASTM F1980, Accelerated Aging of Sterile Medical Device Packages.

Input

Accelerated Aging Temperature
Higher temp. = Less days
°C
Ambient (warehouse) Temperature
Higher temp. = More days
°C
Q10 Value:
Higher value = Less days

Results

Real-Time Shelf Study
Accelerated Aging Test
Days
Weeks
3 Months
6 Months
12 Months
24 Months
36 Months
48 Months
60 Months
72 Months





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