Real-Time Aging Testing Services for Medical Devices

STEMart, a US-based provider of comprehensive services for all phases of medical device development, is pleased to announce the launch of its new Real-time Aging Testing services to accurately assess the long-term performance and integrity of medical device packaging under real-world storage conditions. These services offer manufacturers a reliable and accurate method for determining product stability and ensuring consumer safety.

Real-time aging testing involves placing test items on shelves and exposing them to normal storage conditions. The test provides the best available data to demonstrate that package performance is maintained over the manufacturer’s stated shelf life. It is recommended that real time aging be conducted in conjunction with accelerated aging to support and validate accelerated aging conclusions.

Common factors affecting shelf life include type and construction of the packaging material, number of times the package is handled prior to use, open or closed shelf storage, storage area conditions, and method of sealing. With extensive expertise in consulting, package validation (including packaging and sterilization configurations), material qualification and package development, and large storage facilities, STEMart offers real-time aging testing on products at specific time intervals to draw accurate conclusions about shelf life.

Guided by ISO 11607-1, STEMart’s Real-time Aging Testing services include developing Real-time Aging Protocols, conducting Post-aging Tests at Specific Intervals, establishing Product Shelf Life, and providing Final Reports. For example, based on the characteristics of the material to be tested, STEMart experts will develop a comprehensive real-time aging protocol that includes sample sizes, storage conditions, test intervals and post-aging inspection parameters to evaluate package performance.

In addition, for post-aging tests at specific intervals, the company offers Burst Test (to measure and quantify the seal strength of medical device packaging by pressurizing the package until it bursts), Bubble Leak Test (to detect defects or major leaks in sterile medical device packaging), and Dye Penetration Test (to observe any capillary movement of dyes in the bag through the sealed area). Ultimately, the team of experienced professionals will thoroughly analyze the test results and provide comprehensive reports outlining product performance and shelf life recommendations.

STEMart is committed to providing exceptional service and delivering accurate, reliable results. Backed by its state-of-the-art facilities (e.g., temperature-mapped and validated environmental chambers, light chambers for assessing photosensitive materials), STEMart's experienced experts can provide a one-stop shop for real-time aging testing services according to ISO 11607, minimizing time-to-market and helping manufacturers ensure the safety of their products in end-use environments.

If you have additional questions about the Real-time Aging Testing services or would like to consult with the experts at STEMart for medical device packaging solutions, please visit https://www.ste-mart.com/real-time-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.