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Blogs: Extractables+and+Leachables+Testing

Helium Leak Testing

By Bettine Boltres Ph.D.

十二月 05, 2018

In determining extractables from parenteral drug packaging systems, the FDA is clearly looking for appropriate choices of solvents, times, temperatures and other conditions that could impact the results of studies. The outcome of the studies should support the intended purpose – to allow for practical correlations and design of leachables studies.