Product packaging on the shelf or in storage has a natural lifecycle. That’s because natural forces work in tandem to slowly break down packaging materials and seals. Eventually, sterility cannot be maintained any longer.
Part of medical package testing is to ensure sterile barrier packaging can withstand those forces for a specific length of time. To establish a firm expiration date.
Real time aging is a process to determine how long package integrity will hold up (your audit WILL require them at some point). But not everyone has the luxury of waiting years to determine expiration. Devices need to be delivered to the market. As fast as possible.
But there is a convenient way to obtain age testing much faster in the meantime. It’s known as accelerated aging and can identify how long your sterile barrier packaging will hold up over time. Accelerated aging is recognized and accepted by regulatory bodies until real-time aging samples can be obtained.
What is medical package accelerated aging?
The accelerated aging process uses a series of tests and tools to mimic those natural forces we mentioned earlier, only a bit faster. It tests the sterile barrier packaging for breakdown to establish expiration date accuracy and mimics real-time aging.
Standards for this process are outlined in ANSI/AAMI/ISO 11607-1 and ASTM F1980-07 (2011).
Why do we need accelerated aging?
You don’t actually need to perform accelerated aging – if you have one or two years to wait around for real-time aging test results. Most companies prefer to get their product to market as quickly as possible. The accelerated aging process can verify your sterile barrier packaging life cycle, meet regulatory requirements in the meantime, and allow you to move forward to market. All within a matter of a few months.
How does accelerated aging work?
Accelerated aging is accomplished using heat inside specialized equipment which meets ISO standards. The heat variance acts as accelerated time exposure. Accelerated aging test temperature is most commonly 55°C. The basis for this heat application is Arrhenius’ equation. This equation states a 10°C increase in temperature will double the rate of the chemical reaction. It is a way to “fast forward” the natural impact to sterile barrier packaging and estimate its longevity.
How to proceed with accelerated aging
Working with a strong medical package testing partner will help you fast-track your package testing needs. You will still need the real-time aging results, so be sure to work with your chosen resource on both real-time and accelerated aging results.
You can also utilize tools such as our LSO accelerated aging calculator. This will help you anticipate questions to move your project forward.
Do you have more questions on the accelerated aging process? One of our service representatives will be happy to assist you!
Learn more about the Life Science Outsourcing Medical Package Testing (MPT) division, and our real-time and accelerated aging services.
