STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the launch of its new Accelerated Aging Testing Services for medical device manufacturers to ensure the long-term reliability and safety of their products.
The Accelerated Aging Testing utilizes high temperatures for a period of time to simulate the effects of real-time aging, artificially accelerating the aging process. This test allows manufacturers to bring products to market faster and provides data that enable manufacturers to accurately predict the effects of real-time aging on packaging and demonstrate that the packaging will provide a sterile barrier for the specified shelf life of the product. In addition, manufacturers must subsequently conduct real-time studies to validate the data generated during the accelerated aging process.
ASTM F1980 states that accelerated aging sterile barrier systems should be evaluated for physical performance and integrity. The performance of the aged packaging system during simulated distribution, handling, and storage must be evaluated, and evidence of aging characteristics of device components must be collected. The aging sample should include the simulated equipment and all packaging materials that comprise the packaging system.
Accelerated aging tests assume that the chemical reactions involved in the aging of a material follow the Arrhenius reaction rate equation. This equation states that a 10°C change in temperature during a homogenization process will result in approximately a 2- or 0.5-fold change in chemical reaction rates.
With expertise in consulting, package validation (including packaging and sterilization configurations), material qualification and package development, as well as state-of-the-art environmental stability chambers, STEMart provides a full-service experience to help manufacturers achieve regulatory goals and minimize compliance risks. Based on the characteristics of the material under study, its expert team can develop a comprehensive accelerated aging protocol, including sample size, test conditions (room temperature and accelerated aging temperature), test intervals, and post-aging inspection parameters to evaluate package performance.
STEMart's state-of-the-art facilities and experienced team utilize advanced techniques to accelerate the aging process, providing valuable insights into a product's durability and performance. By rigorously evaluating medical devices under accelerated conditions, STEMart can help manufacturers make informed decisions and bring safer, more reliable products to market.
STEMart's commitment to quality and customer satisfaction is evident in its adherence to industry standards and regulations. The company’s experienced team works closely with clients to understand their specific needs and provide customized testing solutions. For more information on accelerated aging testing services or to discuss medical device packaging solutions with the experts at STEMart, please visit https://www.ste-mart.com/accelerate-aging-testing.htm.
About STEMart
STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols to access better health worldwide.