Accelerated aging of medical device sterile barrier systems by ASTM F1980

ASTM F1980 establishes a standardized approach for accelerated aging of medical device sterile barrier systems (SBS), either with or without devices.

Accelerated aging studies help manufacturers assess the shelf life of the product more rapidly than real-time aging studies. The results of accelerated aging studies may be used as a preliminary indication of a product’s stability and packaging integrity until real-time aging results become available. This approach aligns with regulatory expectations, including FDA guidance (21 CFR - Process Validation) and ISO 11607-1.

In accelerated aging studies, materials are exposed to elevated temperatures for a shorter period, simulating the effects of real-time aging. Based on the results, manufacturers can estimate how long the packaging will maintain its protective properties under real-world storage and transportation conditions.

Product stability can be evaluated both upon completion and throughout the aging process using various methods. The assessed properties are selected based on the manufacturer’s specific requirements and regulatory considerations, and they may include the following:

• Sterility

• Mechanical performance (e.g. shear, tensile, and compression strength)

• Chemical properties (e.g. product degradation)

Measurlabs can provide accelerated and real-time aging in parallel. We can also help with stability and integrity testing during and after the aging period.