👉 What is Accelerated Aging?
Accelerated Aging is a standard practice in several different industries. It is a packaging test sequence that determines the effects of time, by subjecting samples to elevated temperatures on a product. Medistri specialises in conducting Accelerated Aging tests on medical devices.
👉 Why performs Accelerated ageing test?
Accelerated Aging Test is performed on products to simulate the effects of time by subjecting samples to elevated temperatures. Accelerated Aging is used in the medical device industry to determine the effects of time on a Sterile Barrier System to establish Shelf Life parameters. Accelerated Aging is based on the relationship of temperature and reaction rate where an increase in temperature increases the reaction rate.
👉 How does Accelerated Aging test work?
Accelerated Aging process is based on the relationship between temperature and reaction rate, in which the reaction rate increases as temperature rises. Accelerated Aging test uses higher temperatures to accelerate the aging process by simulating Real-Time Aging. Manufacturers can utilize the results of Accelerated Aging’s to get their product to market faster and establish necessary safety and efficiency assurance. Real-Time and Accelerated Aging studies must be performed in parallel to completion and the claimed shelf life of the product.
👉 What should we consider when performing accelerated aging tests?
There are 4 factors to consider:
- Desired Real-Time
- Accelerated Aging Temperature
- Ambient Temperature
- Aging Factor
👉 What are the benefits for performing accelerated aging tests?
Accelerated Aging tests offer insight into the effects of time and environmental conditions on a product and its packaging. With this information, manufacturers can:
- Identify product shelf life
- Establish expiration dates
- Comply with regulatory standards
- Improve Logistical Constraints
- Set parameters for safe transportation and storage
- Get products to market faster and with less risk
- Boost consumer confidence
👉 What happens at the end of the accelerate aging test?
Once accelerated aging test has been performed, we compare the the physical qualities and sterile integrity of the testing sample unexposed samples. We focus on materials affected by aging or package functionality. Medistr provides a full report detailing the aging conditions and testing standards employed and documentation of the equipment utilized after Accelerated Aging testing is complete.
Medistri performs a series of sterile barrier integrity testing in its in-house laboratory such as:
- Accelerated Ageing Tests according to ASTMF1908
- Real-Time Ageing Tests
- Visual Inspection Tests according to ASTMF1886
- Dye Migration Tests according to ASTM F1929 & F3039
- Bubble Emission Tests according to ASTM F2096
- Seal Tensile Strength Test according to ASTM F88
- Peel Strength Test according to EN 868–5
- Burst Test according to ISO2758
- The Medistri Team