To qualify as validated packaging in the pharmaceutical Industry, materials and methods must undergo a series of rigorous scientific tests to prove their ability to maintain a specific temperature range for a certain period. These tests must be conducted under simulated transportation and storage conditions, and the results must be consistent and reproducible.
The packaging must also be able to withstand the rigors of transportation and storage, such as vibration, shock, and changes in temperature and humidity. Additionally, the packaging must be able to protect the drugs from external factors, such as light and moisture.