Mass extraction container closure integrity physical testing method development for parenteral container closure systems.

@article{Yoon2012MassEC,
  title={Mass extraction container closure integrity physical testing method development for parenteral container closure systems.},
  author={Seung-Yil Yoon and Hemi Sagi and Craig Goldhammer and Lei Li},
  journal={PDA journal of pharmaceutical science and technology},
  year={2012},
  volume={66 5},
  pages={403-19}
}
UNLABELLED Container closure integrity (CCI) is a critical factor to ensure that product sterility is maintained over its entire shelf life. Assuring the CCI during container closure (C/C) system qualification, routine manufacturing and stability is important. FDA guidance also encourages industry to develop a CCI physical testing method in lieu of… CONTINUE READING