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July 13, 2016

USP Chapter 1207 Package Integrity Evaluation – Sterile Products

The challenge of assuring integrity of a sterile package is more complicated than many realize. As such, drug formulators in pharmaceutical and biotechnology companies often times underestimate the potential impact of the primary packages they select. A critical aspect to understand is container closure integrity (CCI) and leakage (i.e., failure of CCI or package integrity), is a major quality issue for sterile injectable products, as shown below.

Fran DeGrazio

VP, Scientific Affairs & Technical Services

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