STEMart, a US-based provider of comprehensive services for all phases of medical device development, proudly announces the launch of its comprehensive suite of Packaging Solutions to meet the unique needs of the pharmaceutical and medical device industries. These services are designed to ensure the quality, sterility, and regulatory compliance of medical devices throughout their lifecycle.
Packaging is an advertisement for a brand. Effective packaging that meets the needs of the pharmaceutical or medical device industry should be able to validate the quality of the seals and the overall packaging to ensure the stability of the packaged samples, the integrity for clinical trials and production runs, and the shelf life of the medication, thus providing safe and effective products to the marketplace.
“Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems and packaging systems,” part of the International Organization for Standardization’s ISO 11607-1:2019, provides a general approach to the requirements for materials, prefabricated sterile barrier systems, sterile barrier systems and packaging systems intended to maintain the sterility of terminally sterilized medical devices until use.
STEMart offers state-of-the-art technology and facilities to provide comprehensive medical device packaging solutions, e.g., the Sterile Barrier / Seal Integrity Testing, Package Material Testing, Real-time Aging Testing, Transportation and Distribution Simulation Studies, and Accelerate Aging Testing. STEMart’s expertise in consulting, packaging validation (including packaging and sterilization configurations), material qualification, and packaging development provides a full-service experience that assists manufacturers in achieving regulatory goals and minimizing compliance risks.
For example, STEMart offers a wide range of strength and seal integrity testing services, including seal peel and burst testing, bubble emission testing, and dye migration testing to assess overall package integrity. Furthermore, STEMart provides a wide variety of options for package material testing. This in-depth analysis empowers manufacturers to optimize their packaging design and guarantee the best possible performance for their products.
In addition, STEMart takes quality assurance a step further by offering both real-time and accelerated aging testing. Real-time aging testing can help customers evaluate the preparation, sterilization, and storage of packaging materials/systems under real-time aging conditions during testing. For situations requiring a faster evaluation, STEMart offers accelerated aging tests that utilizes elevated temperatures to simulate real-time aging and artificially accelerate the aging process, providing valuable insights in a condensed timeframe.
With a commitment to excellence and a focus on safety, STEMart can provide medical device manufacturers with cost-effective, comprehensive services that deliver reliable results. The company’s experts can evaluate medical devices and propose appropriate test plans to ensure regulatory compliance.
STEMart offers various services to ensure that medical devices are packaged effectively to maintain sterility, meet regulatory requirements, and deliver a positive brand experience. If you have additional questions or would like to find out more about Medical Device Packaging Solutions, please visit https://www.ste-mart.com/medical-device-packaging-solutions.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.
