Long-term accelerated shelf-life testing is performed in artificial environments where the temperature and humidity exceeds normal conditions of sale and consumption. After accelerated aging testing, the product must be subjected to the necessary physical, microbiological and chemical analyses to ensure that we have prior knowledge of the product's stability. CD Formulation offers rapid aging testing in medical products performed as accelerated aging testing. According to the standard, the rapid aging time is calculated based on the product's construction and packaging characteristics, taking into account the temperature and real-time shelf life that the product can withstand.
Intermediate accelerated aging studies at 30°C and 65% relative humidity (RH) are designed to modestly increase the rate of chemical degradation or physical change of a substance or product intended for storage in a warm climate region.
We offer the following stability conditions for customer procedures.
25°C ± 2°C / 60% relative humidity ± 5% relative humidity
30°C ± 2°C / 65% RH ± 5% RH
40°C ± 2°C/ 75% RH ± 5% RH
5°C ± 3°C
-20°C ± 5°C
As a result of calculations using the Arrhenius equation, the rapid aging time of the product can be calculated. At the end of this period, performance tests as well as physicochemical and microbiological tests are performed. CD Formulation also offers a variety of other tests to meet the shelf life and packaging testing needs of medical products, the main tests being the Starilite test and the leak test.
Product storage recommendations can specify temperature, humidity and pH. For accelerated shelf life testing, companies need to maintain product samples in the correct conditions and monitor them to determine when they fail. Technicians can also perform a second accelerated test to estimate when the product will fail and prepare a reasonable shelf life extrapolation so that the product can be marketed and sold. Accelerated testing accelerates the decomposition process with high temperatures, improper humidity and pH imbalances.
Controlled conditions are critical to accelerated stability testing. Technicians carefully monitor all environmental factors when testing products and repeat the test until the product begins to fail. This can be used to evaluate pharmaceuticals and food products, both of which have perishability issues. In the case of drugs, an expired drug may be ineffective and may make people sick, while an old food product may be chemically altered or colonized by organisms that could destroy it and cause disease.
If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.
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