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Comprehensive Altitude Testing for Medical Devices

STEMart, a US-based provider of comprehensive services for all phases of medical device development, is pleased to announce the expansion of its services to include comprehensive Altitude Testing. This new offering will help medical device manufacturers ensure the safety and efficacy of their products under extreme altitude conditions.

Altitude testing is used to simulate the storage or transport of a product at different altitudes and to assess the possible adverse physical or operational effects of a low pressure environment. In general, the tests simulate the low air pressure of a product operating at high altitude or under air transport conditions. Given that products and packaging may be sensitive to low pressure environments, the purpose of high altitude testing is to provide an indication of the reduction in air pressure that would be expected when a product is transported by air or ground at high altitude. In particular, hermetically sealed liquid containers or non-porous packaging can be severely affected by high altitude environments.

When performing altitude tests, the simulated heights are usually fixed, with typical times ranging from 1 hour to 1 day for each simulated height. It is also necessary to simulate the gradient between two heights that may occur during transport. Altitude tests are sometimes carried out in conjunction with other tests. For example, to better simulate high altitude, an altitude test may be performed in conjunction with a temperature test. Alternatively, a less expensive way to simulate the effects of low density air at high altitude is to perform a high temperature test on air cooled equipment without reducing the air pressure.

In addition, vibration testing is sometimes carried out in conjunction with high altitude testing. For example, to simulate the vibration that can cause wear on sealed packages containing sterile medical devices, altitude and vibration testing must be performed simultaneously.

To support medical device manufacturers in meeting regulatory objectives and ensuring the safety of their medical devices, STEMart offers comprehensive Altitude Testing Services to assess any adverse physical or operational effects that may result from low pressure environments. With extensive expertise in high altitude testing, STEMart can help manufacturers to ensure the functionality and safety of medical devices when transported, stored or operated in high altitude environments.

STEMart provides a full range of services to help manufacturers meet regulatory objectives and minimize compliance risks. This recent expansion demonstrates STEMart's commitment to providing comprehensive testing solutions that meet the evolving needs of the medical device industry. For more information on Altitude Testing services or or other offerings, please visit https://www.ste-mart.com/medical-device-altitude-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.

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.