Some products require assurance that they can be stored for long periods without degradation of performance when the products are used. For example, this feature applies to the sterile barrier performance of some medicinal products. Here, the difference between real-time aging and accelerated aging often raises questions.
Real-time aging programs are part of the stability testing process. Provides data to determine product shelf life and the effects of aging on materials. This is especially important for devices and their packaging, which must be reliable right up to the point of use.
Real-time aging as a test is done literally. A product in its packaging is placed on a shelf to be exposed to these common storage conditions: temperature fluctuations and humidity. These products slowly collect dust as they sit on the shelves, and waiting for packaging data for testing can be problematic. This is the reason why companies generally lead to accelerated aging.
In the accelerated aging test, aging is accelerated by simulating the time requested for the expiry date of the product. For this purpose, the product is exposed to certain temperature and humidity levels in a certain room. In this way, the conditions that are expected to survive during the shelf life are simulated much faster.
The accelerated aging expiration date is provisional until real-time aging results are available. Real-time aging programs provide the best data for determining shelf life and the effects of aging on materials. But it is time consuming, these tests can take years. During this time, the product sits on a shelf and is exposed to environmental changes such as temperature and humidity fluctuations that simulate real-world conditions that the product may experience throughout its lifetime.
Briefly, real-time aging studies simulate the effects of storage conditions in real time. This is the requirement of the standard “ISO 11607-1 Packaging for finally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems”, which is mainly taken into account in accelerated aging tests.
Our organization also provides real-time weathering test services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
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