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By Candice Sun

October 09, 2020

Vial-based primary packaging systems for sterile drug products must provide protection over shelf life. This requires demonstration of container closure integrity (CCI); this testing should be performed early in the drug product development stage. As we all know, there is not one CCI test method that fits all systems/conditions.

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By Dr. Xiaoyu Xiang

November 15, 2019

Packaging components are an integral part of a drug product. Selecting the right packaging system is not trivial--it can impact patients' health, operational efficiency, drug compatibility and drug stability. A good container closure system includes a glass or polymer vial, an elastomer stopper and an aluminum seal.

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By Shi Min Tan

February 06, 2018

Many parenteral drug products, such as monoclonal antibodies, are susceptible to degradation over time. To enable a longer shelf life, such drugs are often stored in a lyophilized state. Lyophilization (freeze-drying) is a process by which water is removed from a drug product. In the absence of water, all metabolic processes stop, making lyophilized drug products far more stable.