Package and Product Integrity Blog

Listed below are several questions and corresponding answers that have come up in the recent past, concerning ISTA conditioning.  The answers to our questions, which have been supplied by Meredith Dougherty of ISTA, can be utilized to make decisions on how we quote, conduct these tests and help answer any customer questions that may come up.

DDL Question #1:

I have a question on time tolerances for the ISTA 2A conditioning.

Ex. -29C Uncontrolled for 72 hours.

Let’s say we went over the required 72 hours by 3 hours for a total of 75 hours. Is there a tolerance on the time or does this become a deviation, because we went over the 72 hour requirement?

ISTA Answer to Question #1:

The test levels in ISTA procedures and projects are considered required minimums.  If those levels are exceeded there is no problem – as long as the minimum level is achieved the test report will be acceptable.

DDL Question #2:

I would like to know if the ISTA 2A conditionings needs to be performed continuously for 72hrs (minimum) or can this be cumulative.

Say we are running an ISTA cycle and somehow a chamber malfunctions after 38hrs of conditioning, I understand it is best to start the conditioning over for 72hrs. However, can we choose to add in the additional 34hrs to complete the 72hrs cycle.

ISTA Answer to Question #2:

You can look at this in two ways:

1.    If the customer is a member of ISTA and is looking for packaged-product certification, then the conditioning would need to be re-started and run for a continuous 72 hours in order to comply with the procedure.

2.    If the customer is not a member, and is looking for a test report direct form the lab, then you could do as you propose.  As always, I would recommend documenting however it was handled, so that if a repeat is needed in the future it could be done easily.
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