The determination of the shelf life of a product is essential. For medical products, the FDA requires manufacturers to provide test data to support an expiry date. The product must maintain its sterility and integrity throughout that period of time.
There are two processes of determining the shelf life of a product. The first is real-time aging and the second is accelerated aging. This is important for many products, but can also be a requirement. The European Medical Device Directive (MDD) requires all sterile medical devices to have an expiration date. Before a manufacturer can make a claim about the shelf-life of a product, test results must be available to substantiate those claims.
Real-Time Package Aging
Real-time product aging is the process of aging a product at ambient conditions for a specific period of time. For most products, the real-time aging testing lasts from a range of a couple of months to several years.
The length of the real-time aging is the length of time from when the product is produced and packaged to its stated expiration date. At the conclusion of that time, the product is inspected to determine its integrity and sterility.
Accelerated-Aging Package Testing
The accelerated aging packaging test is the process of introducing temperature and humidity to expedite the deterioration of materials. An increase in ambient temperature escalates the chemical reaction of materials, causing a breakdown.
There are two primary test standards that outline accelerated aging testing. These package test standards are ISO 11607-1 and ASTM F1980. It should be noted that there are two other standards, AAMI 11607-1 and ANSI 11607-1, which are identical to the ISO 11607-1 package test standard.
The Arrhenius Equation
The chemical reaction rate of deterioration doubles for every 10 degrees Celsius increase in temperature. The calculation behind the deterioration is called the Arrhenius equation. In physical chemistry, the Arrhenius equation is a formula for the temperature dependence of reaction rates.
Using the Arrhenius equation, a sterile barrier package system that is exposed to 55 degrees Celsius for 40 days will have similar characteristics as a sterile barrier package system that has experienced one year of real-time aging.
The Arrhenius equation does have an upper limit of the temperature of 60 degrees Celsius. An increase above that will can deliver inaccurate results.
The Process of Aging Testing Packages
Products must initially undergo both real-time and accelerated-aging package testing simultaneously. This process is required so that the conclusions drawn from the accelerated aging testing can be verified with the real-time aging results.
The parameters of the package aging testing are set by the manufacturer. Recommended duration and conditions are set forth in the previously-mentioned test standards. In addition to temperature and humidity, the effects of solar radiation can also be considered. This light testing can be completed using regular UV light and cool white UV.
Once the accelerated aging package test has been accepted to return similar results of the real-time package test, the accelerated data can be used going forward. This provides the manufacturer with the ability to generate data quickly. This also expedites the time to market.
Follow the link for Keystone’s easy-to-use Accelerated Aging Calculator
Aging Package Testing at Keystone Package Testing
Keystone Package Testing is recognized as an industry leader in package testing. Our lab features dozens of temperature and humidity chambers of various sizes and capabilities. We can test packages ranging in sizes of small vials and boxes to oversized pallets.
Our temperature and humidity capabilities are limitless. In addition to having a wide operating range from low to high temperature, we also offer thermal shock testing. Our thermal shock chambers have a temperature transition time of three to five seconds.
In addition to thermal testing, we also offer shock, drop, vibration, seal, tensile, and many other specialty package testing services. As an ISTA and Amazon-certified lab, our test reports are recognized around the globe.
For more information on our capabilities, please contact us. If you are ready to see firsthand why so many companies rely on Keystone Compliance for their packaging aging testing, please request a quote.