Testing

Burst strength testing is performed by internally pressuring a package until it bursts.

Chamber duration depends on the temperature of your chamber and your shelf-life claim. For example, a product that claims a shelf life of 55°C for one year would require 40 days in the chamber.

ASTM D4169 and ISTA 3A are both acceptable standards for medical device transit validations per ISO 11607. The decision about which to use depends on how you will be shipping your product once it is for sale. We can give feedback about what we typically see, but would ask that you rely on your regulatory consultant.

You tell us. We can discard the samples or return them to you for further evaluation. Sample disposition is discussed in the return shipment instruction that your operations supervisor will provide.

The TPS is our way of ensuring that your team and ours are accurately interpreting the details of your study. You review and agree or clarify before we begin your packaging testing.

The test measure is the maximum pressure detected before the package fails. These test methods provide rapid means of evaluating tendencies for package failure when the package is exposed to a pressure differential.