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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 Critical Time- & Temperature- Dependent Container Closure Integrity (CCI) Through the Sealed Drug Product Life Cycle. This presentation gave an update on research that aims to provide fresh insights to the parenteral packaging industry.
By employing both testing evaluation and modeling calculations, research results demonstrate that container closure sealing performance has a critical nature of both time- and temperature-dependency. Discussion included how to develop a systematic approach to proactively and practically consider: design, set up, control, and management of stopper sealing performance. In addition, cosmetic vial assembly acceptance through proper considerations in container closure system (CCS) and capping processes was discussed. These techniques are intended for the purpose of ensuring sufficient sealing performance throughout the entire sealed product life cycle.
With the advancement of high-value biologic,<span> 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 (0<sup>o</sup>C to -180<sup>o</sup>C), depending on both the drug characteristics and the expected duration of storage. </span>
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.
Parenteral drug products must be stored in a container system that provides good container closure integrity (CCI) over shelf life for the purpose of preventing environmental contamination. This system typically comprises a glass vial, elastomer stopper, and an aluminum seal. USP Chapter <1207> <em>Packaging Integrity Evaluation – Sterile Products</em> discusses in detail methods to measure CCI to determine if the system can meet the maximum allowable leak limit (MALL) for its specific drug product (i.e., the smallest gap, or leak rate, that places quality at risk). Critical to achieving good CCI is proper capping of the vial with the stopper and seal, making sure that the compression level of the stopper is appropriate.
Have you ever faced the need to identify a primary package for your drug product, but do not know where to start? Are you faced with tight timelines and component data constraints when evaluating stoppers, seals, and vials for container closure systems (CCS)? Do you need the right data for regulatory filing to support the choice of CCS for your drug product?
The <a href="/sitecore/service/notfound.aspx?item=web%3a%7bC259A4B6-8C8C-4BA9-8AA3-4616BDD03CE1%7d%40zh-CN">LyoSeal® cap</a>— an all-plastic, instant sealing solution for lyophilized drugs—recently launched at Pharmapack 2017. Plastic seals present a unique opportunity for commercial pharmaceutical manufacturing, as well as for R&D and pre-clinical applications seeking simplified manual capping options (no tools required).
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