Accelerated Aging is an artificial procedure for accelerating the life or shelf life of a product. The data obtained from the study are based on conditions that simulate the effects of aging on the material. It is critical to launch a product based on successful accelerated aging test results that simulate the time required for the product expiration date (1 year, 2 year, 5 year, etc.). Accelerated Aging data is considered by regulatory authorities to be a decisive estimate of shelf life, but only until these tests are repeated on "real-time" aged samples.

standards

Primary accelerated aging standards for building materials, medical devices and sterile barrier systems for determining shelf life:

• ANSI / AAMI / ISO 11607-1: 2006
• ASTM F1980-07 (2011)
• ISO 4892-3, ISO 11507, ISO 11895, ISO 11997-2,
• ASTM D4329 ASTM D4587 ASTM D4799 ASTM D5208 ASTM D154
• TS EN 927, TS EN 6, TS EN 1297, TS EN 1224-13523, TS EN 10, TS EN 1898-1062
• SAE J2020

Quick Aging Test Calculation

The Accelerated Aging calculation is based on the Arrhenius equation, which states that an increase in 10C at a given temperature doubles the chemical reaction rate. Four variables were used to calculate the accelerated aging test time. A calculator is given below to easily examine the difference test scenarios.

• Test Temperature (° C)
• Ambient Temperature (° C)
• Q10 (Reaction Rate Factor)
• Real-time equivalent (Days)

procedures

Test Temperature is typically from 50 to 60C, most commonly 55 ° C

The ambient storage temperature is typically between 22 ° C and 25 ° C. The shortest test time is 22 ° C.

Conservative / common for medical devices is Q10 2.

Relative Humidity (RH) is not a factor in the Arrhionus equation. However, RH should be kept below 20% so that the material is not damaged.

The expiry date of the medicinal product is usually based on the production date. Therefore, some will add an extra month to the aging study to allow sterilization. For example, a shelf life of 12 months is simulated based on 13 months.

Accelerated aging means that more heat, moisture, oxygen, sunlight, vibration, etc. can be used to accelerate the normal aging process of items. It is often used to determine the long-term effects of expected stress levels in a shorter period of time by controlled standard test methods in a laboratory. Used to estimate the useful life of a product or shelf life when no actual life information is available. This occurs with products that are not long enough during their lifetime: for example, a new car engine or new polymer exchange parts.

Representative levels of stress for long time periods,

Unusually high stress levels or stress levels that deliberately fail to accelerate the effects of natural aging.

Mechanical parts operate at very high speed in normal use. Polymers are generally maintained at elevated temperatures to accelerate chemical degradation. Surrounding rooms are often used.

In addition, the device or material being tested may be subjected to temperature, humidity, pressure, strain, and so on. You may be exposed to such rapid (but controlled) changes. For example, heat and cold cycles can simulate the effect of day and night for several hours.

You can work with our laboratory EUROLAB for Rapid Aging Tests.