Dye penetration testing is a common method of checking for seal leaks in medical packaging such as pouches, trays, and blisters. The intent of this article is to review and clarify the recent developments in test methods for both Porous (ASTM F1929-12) and Nonporous (ASTM F3039-13) packaging. ASTM F1929 – 12 Standard Test Method for […]
Packaging for medical devices, related products and materials is highly regulated and must meet very specific requirements. The most critical factor for medical device packaging is product sterility, which must be maintained throughout distribution and storage, allowing for safe and effective use of the device.
Distribution Simulation Testing assesses a medical package’s ability to protect and maintain sterility of the products within. This is accomplished by exposing the package to real-life hazardous conditions that it could face through the handling, distribution and storage stages of its journey. The package/container and its contents are subjected to a test plan involving shock, […]