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With the advancement of high-value biologic, gene, and cell therapy drugs, there is a growing interest in assessment of container closure systems (CCS) at the low temperatures experienced during processing, storage, and shipment. A vial-based CCS is usually capped at room temperature, but thereafter it may be exposed to low temperature conditions (0oC to -180oC), depending on both the drug characteristics and the expected duration of storage.
The sealing performance of the CCS is both time- and temperature-dependent and is determined by its structure and component material properties. The CCS sealing performance inherently will change while undergoing both time and temperature transitions. Exposure to lower temperature has a significant impact on CCS sealing performance, in particular, its container closure integrity (CCI) results. This is critical, as good CCI results are needed to maintain product sterility and stability. Any breach could lead to oxygen, carbon dioxide, moisture or microbiological ingress and, consequently, could risk both drug product integrity and patient safety.
These points are discussed in the recent publication by Q. Zeng, A. Bucci, and L. Ho. Time Temperature Superposition Evaluation and Modeling for Container Closure System’s Seal Performance at Low Temperatures. PDA J. Pharm. Sci. Technol., 74 (1), 27-40 (2020). Both experimental and modeling results clearly demonstrate that exposure to low temperatures results in a decrease in sealing force within a CCS. Understanding these physical phenomena enables development of components and processes that can meet the challenge of ensuring good CCS sealing performance, and concomitant good CCI, at such low temperatures.
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At the recent 2018 PDA Parenteral Packaging in Rome, Dr. Qingyu Zeng, Principal Scientist in the Scientific Insights Lab in Scientific Affairs & Technical Services, gave a presentation entitled <a href="https://www.westpharma.com/west-login">Critical Time- & Temperature- Dependent Container Closure Integrity (CCI) Through the Sealed Drug Product Life Cycle</a>. This presentation gave an update on research that aims to provide fresh insights to the parenteral packaging industry.<br />
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.
Selecting the best vial container closure system (CCS) components and capping process for a drug product ensures optimal performance and patient safety. An optimized CCS requires compatible components (rubber stopper, aluminum seal, glass or polymer vial) and proper capping setup. This provides predictable sealing performance, which maintains the container closure integrity (CCI) needed for patient safety and visual acceptance.
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.
With the help of the FDA’s expedited programs for approval, a new wave of high-value biologic drugs is on the rise in the pharma industry.1 These drugs require cryogenic storage (-80oC to -180oC) to maintain stability. This presents a new challenge: how to measure and demonstrate container closure integrity (CCI) of storage and delivery systems at such low temperatures.<br />
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