Accelerated Aging Calculator
In order to sell a medical device or pharmaceutical
product in the United States, the FDA requires that the manufacturer prove the
sterility and viability of the product on the expiration date prior to selling
the product. That means if you market a product "use before June 17, 2019", you must prove that the product is
viable on that date before you begin selling it today. To accomplish
this, manufacturers employ a derivation of the Arrhenius equation which states
(in essence) that molecular activity doubles in organic molecules for every 10°
C. rise in temperature above ambient.
Since ambient temperature is (conservatively) considered to be 25° C., storing
a product for six months at 35° C. will result in a one-year accelerated aging.
Similarly, storing a product at 45° C. for three months will result in an
accelerated aging period of one year, and so on. Obviously there is a limit to
the upper temperature at which this process is valid and, as a practical
matter, most accelerated aging occurs at temperatures at or below 55° C.
To validate this information, most practitioners use a
process of real-time aging wherein samples subjected to accelerated aging are
compared to those from an equivalent “real-time”. For example, at the beginning
of the sales cycle, product can be real-time aged for 3 to 6 months and
compared to samples subjected to accelerated aging for the same accelerated
period, say 6 months. If the samples of both groups showed similar
characteristics, accelerated aging is considered to be validated with real-time
aging results. In this manner, a manufacturer can post a lengthy expiration
date, begin distributing the product with real-time validation of accelerated
aging data, and continue this process through the expiration date of the
medical device. It is crucial to maintain careful records throughout this
process to avoid recalls and other disastrous potential results.
Accelerated Aging Time (AAT) Calculator