STABILITY STUDIES

Manufacturers of medical products must demonstrate that the product, in combination with its packaging components, performs efficiently, safely and effectively throughout its intended shelf life. Accelerated aging should be performed prior to distribution of the product. Both the FDA and international regulatory bodies are focusing increasing emphasis on compliance with ISO 11607. Packaging for terminally sterilized medical devices and EN 868-1. Packaging Materials and systems for medical devices which are to be sterilized. These standards define the test requirements necessary to insure that the terminally sterilized package/device will maintain its design performance over the intended life of the product and will not degrade as a result of sterilization, shelf life, transport or storage. Determining the effects of aging on a package/product in real time is a lengthy process that would severely delay market introduction of new products.

Therefore, a standardized test methodology was developed to accurately evaluate the environmental effect of storage on a package/product during its expected usable shelf life. Accelerated aging, which subjects samples to elevated temperatures for specific periods of time, is used to simulate the effects of real-time aging and provides data which allows the manufacturer to accurately predict the effect of real-time aging on his package/product. A product can be released to market based upon successful accelerated aging of the package/product that simulates the period claimed for product expiration. (1 year, 2 years, etc.) Concurrent with the accelerated aging process, the manufacturer should still conduct real-time studies in order to substantiate the data generated during the accelerated aging process.

The Med devices Limited has developed protocol and facility as per Standard Test Method: ASTM F1980 for ‘Accelerated Aging of Sterile Medical Device Packages’ Methodology: Accelerated aging techniques are based on the assumptions that the chemical reactions involved in the deterioration of materials follow the Arrhenius reaction rate function. This function states that a 10 C increase or decrease in the temperature of a homogenous process, results in approximately a two times or ½ time change in the rate of a chemical reaction.