Medical Device Development with Advanced Package Material Testing

1. Medical Device Development with Advanced Package Material Testing STEMart, a US-based provider of comprehensive services for all phases of medical device development, is proud to announce the launch of its new Package Material Testing solutions for medical device professionals. This expanded service line provides manufacturers with a robust suite of tests to ensure the integrity and suitability of packaging materials throughout the medical device lifecycle, safeguarding product sterility, functionality, and patient safety. Material testing is applied to determine the performance of packaging materials. Tensile, torque, tear, burst, and flexure tests are common methods used to test packaging materials. Proper design of effective packaging requires an understanding of the properties of packaging materials and how these properties may change over time or after sterilization. ISO 11607-1 outlines appropriate approach for distribution simulation, package integrity, and package strength, and also notes the need to ensure that materials used in the packaging of medical devices conform to physical properties. Medical devices rely on robust packaging to maintain sterility and functionality until they reach the end user, so proper packaging is critical to the success of any medical device. To meet the needs of its medical device customers, STEMart now offers Package Material Testing services to empower companies to bring safe and effective medical devices to market with confidence. This expanded service line helps medical device manufacturers identify and address potential issues early in the development process, ensuring their products arrive in a pristine and functional state. STEMart’s Package Material Testing utilizes advanced technologies to assess various aspects of packaging performance. For packing materials, STEMart offers Leakage Tests to assess container integrity by filling them with water and inverting them, while Collapsibility Tests measure the ease of removing contents by squeezing. In addition, Water Vapor Permeability Tests quantify the weight loss of the heat-sealed container filled with a nominal volume of water, and Transparency Tests detect the cloudiness of the diluted suspension in each container. STEMart also provides Material Testing Services for glass containers, closures, and plastic containers, including Hydrolytic Resistance Test, Systemic Injection Test, Sterility Test, and Penetrability Test. With expertise in consulting, packaging validation (including packaging and sterilization configurations), material qualification, and packaging development, STEMart offers a full-service experience to help manufacturers achieve regulatory goals and minimize compliance risks. STEMart offers comprehensive suite of Package Material Testing services to empower manufacturers to optimize package design and performance, guaranteeing the integrity of their products throughout processing, distribution, and storage. If you

2. have any questions or would like to learn more about medical device packaging solutions, please visit https://www.ste-mart.com/package-material-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.