In general ASAP is a stability program that can be executed in a few days or weeks. However pH changes with temperature could lead to complex kinetics which makes the prediction from high-temperature data not accurate. 2-3īoth aspects are potentially not relevant for solutions, since all molecules are in the same microenvironment having the same reactivity. Each of those states could have its own kinetics which leads to an overall complex kinetic. It could be on the surface, it could be available as a crystal structure or as amorphous or it can be dissolved in other materials. The second aspect is that, for example, in solid state pharmaceuticals the API is in different micro-environments. In other drug products the oxygen level could play an important role. But especially for solid state drug products the relative humidity is an important factor. The first aspect is that in the Arrhenius equation only temperature is considered. So, why is it that the data generated from accelerated stability studies cannot be easily transferred to real time stability studies? 1 Current Limitations of Accelerated Stability Studies Baking a cake at 160☌ for 30 minutes is not the same as baking a cake at 240☌ for 1 minute. On the other hand, it is not possible to increase the temperature unlimited to get meaningful results at high temperature. On the one hand, long-term studies or real-time studies are still needed and experience shows often different results between accelerated and long-term conditions. However, the predictive power of those experiments is not always sufficient. Based on the Arrhenius equation the chemical degradation increases with the temperature and therefore it should be possible to project the degradation rate at low temperature from the data generated under accelerated or stressed conditions. Therefore products are tested under accelerated conditions to increase the rate of chemical and/or physical degradation. This testing allows medical device manufacturers to determine a newly developed product’s shelf life and witness the long-term effects of aging without having to wait for years to see the real-time results.Stability studies are a time consuming and resource intensive task in the development of new drugs. Accelerated aging is a type of testing that simulates the effects that time has on a product or package by subjecting it to elevated temperatures. However, sometimes it may take many months or even years before you can witness the toll aging takes on a product in real-time This is where accelerated aging, also known as accelerated shelf-life testing, comes into play. Therefore, the FDA requires medical device manufacturers to determine a product's shelf life before sending the product to market in the United States.
If a Sterile Barrier System becomes compromised, this can jeopardize the efficacy and safety of the medical device in question. That’s because as time goes on, a product’s Sterile Barrier System can become altered as it faces stresses from time and the ambient environment. The medical device industry, in particular, places a large emphasis on testing the shelf life of products. This knowledge is critical across industries, from consumer goods to pharmaceuticals.
When you produce a product, it’s essential to understand how the aging process impacts its condition or quality.
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