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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.1
The FDA Guidance requires container closure systems be tested for integrity under appropriate storage conditions and beyond the desired beyond-use date (BUD).2 The article breaks down the USP <1207> concept of maximum allowable leak limit (MALL) (i.e., the smallest gap, or leak rate, that places drug product quality at risk) and methods for measuring CCI.3 CCI data can show loss of sterility, permeation of gas, or loss of vacuum due to defects in container closure systems. Assessing CCI data against MALL and drug product critical sensitivities can establish whether container closure systems can provide required performance over drug BUD at required storage conditions, i.e. intended use. Our article shows representative CCI data on vial systems, along with the benefits and other type of information gleaned from different CCI methods.
West can guide 503Bs through the agency and compendia requirements. West’s Integrated Solutions strategy can help Simplify the Journey™ for customers by taking the guesswork out of designing and executing CCI studies. For a breakdown of how CCI can demonstrate container closure systems are fit-for-purpose, purchase the full text article here.
For more information, contact an Account Manager or Technical Customer Support (TCS) representative.
Simplify the Journey™ is a trademark of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
In 2017 there were many changes in the Chinese pharmaceutical industry. China Food and Drug Administration (CFDA) has published several new regulations and guidelines – for example, <em>Technical Requirements for Consistency Evaluation on Marketed Chemical Generic Drugs (Injection) (Exposure Draft)</em> by Center for Drug Evaluation, CFDA. This addresses the point that consistency evaluations of drugs have been extended from oral medicines to injectable medicines. This will further help to improve pharmaceuticals quality in China, and of course, be of great interest to generics suppliers.<br />
“Choosing the Right Components for Container Closure Systems,” the second part of our “How to Qualify Container Closure Systems” series, was recently published in the International Journal of Pharmaceutical Compounding. The article addresses ways in which packaging component selection is critical to ensuring that the closure container system will protect and maintain compounded drug quality.<sup>1</sup>
Moisture-sensitive drug products are commonly lyophilized to enhance their shelf life and to prepare them for storage and transport. Maintaining a constant moisture level in a lyophilized drug product “cake” ensures product quality. Not only is proper selection of a container closure system (vial, stopper, seal) necessary, but sealing conditions are as well. This is achieved through demonstration of container closure integrity (CCI).
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.
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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