Accelerated Aging Laboratory Package Testing

Introduction

Accelerated or Real-Time package testing simulates time-related deterioration of packages by exposing them to stress conditions. It involves evaluating the packaging system, the shelf life, and the product. This testing assists in improving design, selecting materials, and ascertaining the shelf life of products to maintain their standards and safety even in extreme conditions.

Scope

Determining a product’s shelf life is crucial. The FDA mandates that manufacturers submit test results to support an expiration date for medical products. Throughout that time, the product must maintain its sterility and integrity. There are two methods for determining a product’s shelf life. The first is accelerated aging, while the second is aging in real-time. This is crucial for many products, but it might also be necessary. All sterile medical equipment must expire by the European Medical Device Directive (MDD). Test results must be available to support claims about a product’s shelf life before a manufacturer can make them.

Current Package Aging

A product is aged in real time by being exposed to ambient conditions for a predetermined time. For most products, the real-time aging testing lasts between a few months and several years. Real-time aging refers to the period between the product’s production and packaging and its stated expiration date. After that time has passed, the product is examined to determine its sterility and integrity.

Package Testing for Accelerated Aging

Increasing temperature and humidity to hasten material deterioration is known as the “accelerated aging packaging test.” A breakdown results from materials’ chemical reactions intensifying as the environment’s temperature rises.

Standards

Two primary test standards define accelerated aging testing: ASTM F1980 and ISO 11607-1. The AAMI 11607-1 and ANSI 11607-1 standards are the only two that are exact replicas of the ISO 11607-1 package test standard.

The Arrhenius Formula

Every 10 degrees Celsius increase in temperature doubles the rate of chemical reactions that cause degradation. The Arrhenius equation is the formula responsible for the deterioration. In physical chemistry, the Arrhenius equation expresses the temperature dependence of reaction rates. According to the Arrhenius equation, a sterile barrier package system exposed to 55 degrees Celsius for 40 days will resemble a system aged in real time for a year. The Arrhenius equation has a maximum temperature of 60 degrees Celsius. Over time, the results could become unreliable.

Programs for Testing Aging Process

• Products must first go through simultaneous real-time and accelerated aging package testing. This procedure is necessary so that the results of the real-time aging testing may be used to verify the findings from the accelerated aging testing.
• The manufacturer sets the parameters for the package aging tests. The test above standards outlines the recommended timeframe and circumstances. The impacts of solar radiation, in addition to temperature and humidity, can be considered. You can test this light with both ordinary UV and excellent white UV.
• The accelerated data can be used moving forward if it has been determined that the accelerated aging package test results are comparable to those of the real-time package test. Thanks to this, the manufacturer can now swiftly create data, reducing the time to market.

Conclusion

Accelerated aging testing summarizes the status regarding package usage well. It tells manufacturers how much time a product can safely remain in the pack, how best it can be designed, and what other factors should be considered to comply with regulations. This allows packaging wear and tear assessment to be done realistically and accurately without incurring years of natural wear.

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