How is burst strength testing performed?

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

How long will my samples stay in the accelerated aging chamber?

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.

Should I use ASTM or ISTA for my transit simulation?

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.

What happens to my samples when testing is complete?

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.

What is a Test Parameter Sheet (TPS)?

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.

What kind of data does burst strength testing provide?

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.

Where should I ship samples for testing?

Packaging Compliance Labs, LLC, C/O [Work Order #] 4334 Brockton Dr SE Suite E Kentwood, MI 49512

Which distribution channel is most common for ASTM D4169?

DC 13 AL1 is most common for sterile medical device packaging. With that said, there can be caveats so you should ask your regulatory consultant or packaging engineer for additional information.

Still have questions? Reach out through our Contact Us page and we'll help you get the information you need.