Accelerated Aging Package Testing

Accelerated Aging Package Testing

Accelerated-Aging package integrity testing plays a crucial role in determining the shelf life of a product. In the case of medical products, the FDA mandates that manufacturers furnish test data to substantiate an expiry date. The product must preserve its sterility and integrity throughout the transit timeframe.

There are two processes to 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. Both the Food and Drug Administration (FDA) and the European Medical Device Directive (MDD) require all sterile medical devices to have an expiration date. Before a manufacturer can claim the shelf-life of a product, test results must be available to substantiate those claims.

This comprehensive framework is essential for medical device manufacturers to ensure that all their products meet the highest standards of quality and reliability before reaching the end users.

Real-Time Package Aging

Real-time product aging is the process of aging a product at ambient conditions for a specific time. 

In aging studies, researchers draw comparisons to real-time product aging. This process involves the thorough assessment of a product’s integrity and sterility over periods ranging from a few months to several years. Such thorough evaluations in aging studies mirror the methods used to understand the aging process across various contexts.

The real-time aging length equals the period from product production and packaging to its stated expiration date. After that time, the product is inspected to determine its integrity and sterility.

Accelerated-Aging Package Testing

The packaging test introduces temperature and humidity to expedite the deterioration of materials. An increase in ambient temperature escalates the chemical reaction of materials, causing a breakdown.

Two primary test standards outline accelerated aging testing. These package test standards are ISO 11607-1 and ASTM F1980. Two similar standards, AAMI 11607-1 and ANSI 11607-1, are identical to the ISO 11607-1 package test standard.

ASTM F1980 focuses specifically on Accelerated-Aging Package Testing for sterile medical device packages. It provides detailed procedures for subjecting packages to elevated temperature and humidity conditions to simulate the effects of real-time aging and assess package integrity and shelf life.

On the other hand, ISO 11607 testing is a broader standard encompassing multiple aspects of medical device packaging systems. It outlines requirements for package design, material selection, and validation of packaging processes. ISO 11607 includes considerations for packaging integrity testing.

However, it does not provide as specific and detailed procedures for accelerated aging testing as ASTM F1980 does.

The Arrhenius Equation

The chemical reaction rate of deterioration doubles for every 10 degrees Celsius increase in temperature. The Arrhenius equation is the calculation used to determine the deterioration process. The Arrhenius equation is a formula for the temperature dependence of reaction rates.

By applying the Arrhenius equation, we can determine that subjecting a sterile barrier package system to 55 degrees Celsius for 40 days will result in similar characteristics to a sterile barrier package system that undergoes one year of real-time aging.

The Arrhenius equation has an upper limit of 60 degrees Celsius. An increase above that may deliver inaccurate results.

The Process of Aging Testing Packages

Products must initially undergo both real-time and accelerated-aging package testing simultaneously. This process verifies the conclusions drawn from the aging results.

The manufacturer sets the parameters for package aging testing. This includes the recommended duration and conditions specified in the test standards.

Additionally, the effects of solar radiation can be considered. This light testing can be conducted using regular UV light and cool white UV.

Once the accelerated aging package test yields comparable results to the real-time package test, the manufacturer can utilize the accelerated data for future storage, sample, and environmental purposes. This enables the manufacturer to rapidly generate data, thereby expediting the time to market.

Follow the link for Keystone’s easy-to-use Accelerated Aging Calculator

Why is Aging Integrity Testing Important?

Aging packaging testing is important for several reasons. It is especially crucial in industries where products must demonstrate long-term durability, stability, and reliability.

Product Development and Improvement

Accelerated aging testing aids in the development and improvement of products by providing insights into potential issues and weaknesses. Identifying and resolving problems early in the development process can lead to better product designs and increased overall quality.

Quality Assurance

Testing products under accelerated conditions helps ensure their reliability and performance over time. Manufacturers can verify that their products meet the required quality standards and provide consistent performance throughout their intended lifespan.

Regulatory Compliance

In many industries, regulatory bodies require products to undergo aging tests to ensure their safety and effectiveness. Accelerated aging testing helps manufacturers demonstrate compliance with these regulations more efficiently.

Cost-Effectiveness

By using accelerated aging testing, companies can reduce the time and resources required for long-term product evaluation. This approach can save costs by avoiding extended real-time testing and allowing faster product development cycles.

Expert Accelerated Aging Laboratory Testing

Keystone’s package testing facility features dozens of temperature and humidity chambers of various sizes and capabilities. We can test packages ranging in sizes from flexible pouches, small vials, and boxes to oversized pallets.

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. Keystone also offers 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.

Interested in the EMC/EMI, climatic, dynamic, shielding effectiveness, or IP Code testing of a product? Follow the corresponding links or www.keystonecompliance.com for more information.