最新的帖子

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

以前的博客

四月 27, 2021

Container Closure Integrity Testing (CCIT) - What Does It Mean?

Birgit Mueller-Chorus Ph.D.

Manager, TCS. Components Development

三月 02, 2021

Understanding Risks of Coring and Fragmentation of Rubber Stoppers

Bjoern Henze

Björn Henze

Manager, TCS. Commercial, EU

十二月 15, 2020

Choosing the Right Analytical Method – Identification of Extractables

Eric Tan

Sr. Specialist, Scientific Affairs, Jurong

Stoppers

十二月 07, 2020

Best Practice for Reducing Coring and Fragmentation

Candice Sun

Candice Sun

Specialist, Scientific Affairs, CN

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