Previous Blogs

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By Qingyu Zeng, Ph.D.

June 07, 2021

Container closure integrity (CCI) has been a fundamental core requirement of containment and delivery solutions in the West product portfolio. Container closure systems (CCSs) must maintain both the sterility and stability of pharmaceutical products; very importantly they must be free of microbial contamination. Microbial ingress into a CCS will jeopardize product sterility.

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By Birgit Mueller-Chorus Ph.D.

April 27, 2021

For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.

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By Olga Laskina, PhD.

December 23, 2020

With the growth of gene and cell therapies, there is an increased need to characterize container closure systems (CCS) at the low temperatures experienced during their lifecycles: ultra-low (-80°C) for genes and cryogenic (-180°C) for cells. West’s Integrated Solutions platform includes the state-of-the-art container closure integrity (CCI) capabilities needed for these therapies.

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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 Harrison Ajemian

September 30, 2019

Many complex biologic drug products, such as gene and cell therapies, require storage at low temperatures (from -60oC to -180oC). This presents a challenge for containment systems when maintaining container closure integrity (CCI) – especially for glass-rubber vial systems.