Accelerate Aging Testing

The Accelerate Aging Testing simulates the effects of real-time aging using elevated temperatures for specific periods of time to artificially speed up the aging process. This test enables manufacturers to get their products to market faster as well as provides data that allows the manufacturer to accurately predict the effect of real-time aging on a package and prove that the packaging can provide a sterile barrier for the defined lifetime of the product. Also, the manufacturer must subsequently conduct real-time studies to validate the data generated during the accelerated aging process.

Standard Guide for Accelerate Aging Testing

ASTM F1980 states that sterile barrier systems which have been subjected to accelerated aging should be evaluated for both physical properties and integrity. It's essential to evaluate the performance of the aged packaging system during simulated distribution, handling, and storage as well to gather evidence of the device components’ aging characteristics. The aging samples should include the simulated devices and all the packaging materials that comprise the packaging system.

Arrhenius Reaction Rate

Accelerated aging testing is built on the assumption that the chemical reactions involved in the deterioration of materials follow the Arrhenius reaction rate formula. This formula shows that a 10°C change in the temperature of a homogenous process will result in approximately 2 or 0.5 times change in the rate of a chemical reaction.

Our Accelerate Aging Testing Service

With extensive expertise in consulting, package validations encompassing package and sterilization configurations, material qualification, and package development, as well as state-of-the-art environmental stability chambers, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks.

• Develop Accelerate Aging Protocol

  Depending on the characterization of the materials under investigation, our experts will develop comprehensive accelerate aging protocol including sample size, test conditions (room temperature and accelerated aging temperature), test intervals and post-aging inspection parameters for evaluation of package performance.

• Accelerated Aging Testing Conditions

  According to ICH guidelines, the accelerated aging conditions provided by STEMart include, but are not limited to:

  25℃/60% RH; 30℃/65% RH; 40℃/65% RH; 45℃/75% RH; 45℃; 50℃;55℃; 60℃; 65℃; 70℃; 75℃.

  Custom conditions depending on the specific sample requirement are also available.

• Post-Aging Test Items

  Post-ageing inspections including flexure test, puncture test, tensile test, elongation test, impact resistance test, abrasion resistance test, yellowness index, microbial barrier, burst test, dye penetration test, bubble leak test and peel test are repeated at the desired time periods.

If you have any additional questions about Accelerate Aging Testing or would like to consult with the experts at STEMart, please feel free to contact us.

Reference

• Hukins, D. W. L., et al. "Accelerated aging for testing polymeric biomaterials and medical devices." Medical engineering & physics 30.10: 1270-1274 (2008).