In some medical devices, double pouch packing is used although these devices are light in weight. What is the specific reason of using a double pouch?
Usually when a dual (double) pouch is used it is for providing a dual sterile barrier because the delivery of the device to the sterile field requires that the inner package be dropped into or is handled in the sterile field. There is no requirement from FDA that all devices have a dual barrier. It depends on the application of the device. A worst-case scenario would be to perform environmental conditioning and distribution simulation testing after accelerated aging, and then to perform the performance testing. Why does DDL recommend environmental conditioning and distribution simulation testing separate from the accelerated aging? Following this type of testing regiment would be in compliance with ISO 11607-1:2006. ISO 11607 Subsection 6.4.4 “Note” – Stability testing (AA) and performance testing (4169) are separate entities. Performance testing evaluates the interaction between the packaging system and the products in response to the stress imposed by the manufacturing and sterilizat
