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Why does the standard separate the accelerated aging test from the distribution simulation test?

April 26, 2017Accelerated aging distribution separate simulation standard Test

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Why does the standard separate the accelerated aging test from the distribution simulation test?

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The latest revision to ISO 11607 more clearly defines stability testing (e.g. accelerated aging and real time aging) and performance testing (e.g. environmental and distribution simulation) as separate entities, evaluating different aspects of the sterile barrier package. That is, these types of tests can be performed separately and not as a sequential series of tests on the same packages.