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By Birgit Mueller-Chorus Ph.D.

April 27, 2021

For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.

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By Jessica Mangus

August 25, 2015

The Japanese Pharmacopeia (JP) has updated chapter 7.03 “Test for Rubber Closures for Aqueous Infusions” and the last date to transition to the new version is September 30, 2015.