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五月 06, 2021

Seal Integrity Testing Using the Tracer Gas Method

Moisture-sensitive drug products are commonly lyophilized to enhance their shelf life and to prepare them for storage and transport. Maintaining a constant moisture level in a lyophilized drug product “cake” ensures product quality. Not only is proper selection of a container closure system (vial, stopper, seal) necessary, but sealing conditions are as well. This is achieved through demonstration of container closure integrity (CCI).

Birgit Mueller-Chorus, Ph.D.

Manager, TCS, Components Development

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