ISTA Transit Testing Simulation
ISTA Transit Testing procedures are intended to model a variety of distribution scenarios and packaging configurations. Medical device manufacturers seeking to validate a packaging system for small parcel delivery would select ISTA 3A procedure, an FDA-recognized consensus standard. Whereas, alternatives ISTA 1A and 2A also model small parcel scenarios, they are less comprehensive and intended to be used during development only (not final validation).
ISTA package testing procedures offer an alternative to the traditional ASTM D4169 transit tests for packaging. A key advantage is the ISTA procedures are much more ‘user friendly’ compared to the more complicated ASTM D4169 counterpart – fewer options to select and fewer choices that the user must make in designing their study plan. These ISTA test procedures provide schedules that can cater to many types of shipping units.
For medical packaging testing, the small parcel environment often represents the “worst case” shipping configuration. ISTA 1A, 2A or 3A are good starting points for small parcel testing, with 3A representing the most severe conditions. It is important to note that ISTA 3A is the only FDA-recognized consensus standard from this series. This is not to say that other simulations are not used in practice. We can help you identify a simulation that best represents your expected shipping environment for validations.
Frequently asked questions
What is the difference between ASTM Transit Simulation and ISTA Transit Simulation?
ISTA testing procedures offer an alternative to the traditional ASTM D4169 transit simulation. Both include the same underlying activities such as drop testing, vibration, compression, and shock, for example.
Which ISTA procedure is recommended for medical device packaging transit simulation?
ISTA 3A is the only FDA-recognized consensus standard from this series. Therefore, ISTA 3A is likely the only standard a medical device manufacturer that has a sterile barrier would be able to use.