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Container closure integrity (CCI) is a fundamental requirement of every sterile drug package. Recently, the United States Pharmacopeia Convention (USP) published a guidance in this area that, among other key topics, addresses test methods in detail: Chapter <1207> Package Integrity Evaluation – Sterile Products. However, proper test method is only one aspect of achieving good CCI.
In the article Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity [PDA Journal of Pharmaceutical Science and Technology, 72 (1), 15-34 (2018)] Fran L. DeGrazio, Vice-President of Scientific Affairs & Technical Services, presents a comprehensive strategy and best practices recommendations to achieve good CCI that comprises consideration of all critical aspects, including test methods. This strategy begins with an understanding of the maximum allowable leak limit (MALL) for the drug product. Following this is a science-based understanding of all critical aspects, namely:
Understanding the interplay among these aspects enables control and minimization of risk. Resultant from employment of this strategy is a package that provides proper CCI – by comprising the right components assembled the right way. More important, this strategy provides for patient safety.
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We are pleased to announce our recent publication in the November/December 2019 Issue of the International Journal of Pharmaceutical Compounding. In the article “How to Qualify Container Closure Systems, Part 1,” we address how compounding pharmacies (503Bs) can qualify systems for intended use via container closure integrity (CCI) to meet FDA Guidance requirements.<sup>1</sup>
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 />
The challenge of assuring integrity of a sterile package is more complicated than many realize. As such, drug formulators in pharmaceutical and biotechnology companies often times underestimate the potential impact of the primary packages they select. A critical aspect to understand is container closure integrity (CCI) and leakage (i.e., failure of CCI or package integrity), is a major quality issue for sterile injectable products, as shown below.
The regulatory environment is moving to a more science-based approach to Container Closure Integrity (CCI). This is driven by the recent publication of United States Pharmacopeia Chapter <1207> Package Integrity Evaluation – Sterile Products. Recently, West gave a webinar (377 registrants) titled <a href="https://www.youtube.com/watch?v=5K8R1jumXyU&feature=youtu.be">Container Closure Integrity: Six Keys to Simplify Your Strategy and Execution</a>, that addressed Chapter <1207> and other topics. The survey questions (over 100 responses) from this webinar are instructive.
Effective change control systems are important for pharmaceutical packaging materials – especially those in direct contact with drugs. This topic has high visibility in the China pharmaceutical packaging industry as a new change control strategy for pharmaceutical packaging materials is coming.
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