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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.
The following regulatory documents provide information on CCI requirements/testing, in particular, methods such as tracer gas leak detection, laser-based headspace analysis, high-voltage leak detection, and vacuum decay:
West supports evaluation of CCI through its Integrated Solutions platform, especially in the early development stage:
To Simplify the Journey™, West offers its Ready Pack™ systems – combinations of vials, stoppers and seals that are rigorously evaluated and demonstrated to perform well over time. The studies conducted in Technical Report 2020/219 "Container Closure Integrity Testing on EU NovaPure®Closure Configurations for Ready Pack™ System with SCHOTT No Blowback Vials"–demonstrate performance over 24 months . Offered in small quantities, they are an ideal choice for new drug products.
West’s commitment to patient safety involves developing and supplying components that can meet the requirements of even the most sensitive drug products. For more on how West can help, contact a Technical Customer Service (TCS) representative or Account Manager.
Simplify the Journey™, NovaPure® and Ready Pack™ are trademarks or registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
West’s Ready Pack™ system with adaptiQ<sup>®</sup> products, that are part of the SCHOTT iQ<sup>®</sup> platform, enables both small and large customers the convenience and flexibility to purchase small quantities of sterile, high-quality, ready-to-use (RTU) components. Ready Pack system components are packaged separately but tested for use as an integrated system. Designed to support customers throughout small-scale R&D, clinical trials, fill-finish evaluation, and commercial-scale manufacturing, the Ready Pack system is a comprehensive, scalable packaging solution that helps customers get to market faster by making the same high-quality packaging available from start to finish. Ready Pack systems keep up with emerging ISO standards and our Ready Pack offering includes the latest glass packaging formats such as adaptiQ<sup>®</sup> clip nest, cup nest, and tray solution.
Are you planning a container closure integrity (CCI) study, or making an addendum to an existing file? Make sure you are aware of the latest USP guidelines for testing prior to initiating a study.
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 />
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.
West’s Integrated Solutions program brings together all West’s products/services and industry knowledge into customer-focused solutions that Simplify the Journey™. One aspect of Integrated Solutions is wide-ranging analytical services, which includes state-of-the-art container closure integrity (CCI) capabilities. Understanding CCI as it relates to industry expectations, manufacturing, and regulations can be a challenge.
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