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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.
USP Chapter <1207> Package Integrity Evaluation – Sterile Products details recommended CCI testing methods for primary containers of sterile dose forms. The most recent version was implemented in August 2016.
While probabilistic methods such as bubble testing and dye ingress do have value, Chapter <1207> strongly endorses the use of deterministic methods whenever possible (e.g., tracer gas leak detection, high-voltage leak detection, laser-based headspace analysis). Further, Chapter <1207> endorses CCI testing throughout the product life cycle. If you make a submission or addendum, do not be surprised if regulators challenge data from probabilistic methods, and require data from the deterministic methods detailed in Chapter <1207>.
CCI method selection depends upon the container system being evaluated; a single method is not suitable for all systems. West can help. Let our experts assist with the determination of the right test method for your system. West Analytical Laboratory Services has a team of experienced scientists dedicated to CCI and the full range of deterministic methods. Together, we can design and execute a CCI study based on your system, providing the support you need.
For more information, contact your Account Manager or TCS representative, and see West’s recent review of Chapter <1207> in West’s Knowledge Center in the CCI section under Technical Bulletins, “Summary of ‘Packaging Integrity Evaluations – Sterile Products’ USP <1207>.”
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 />
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.
West strives to be the world leader in the integrated containment and delivery of injectable medicines. The achievement of this goal relies on many factors, including a heightened awareness of industry and regulatory trends. By being able to anticipate these trends, West is better able to support its customers with the knowledge and services needed to ensure that drug products reach market on schedule.
For vial containment and pre-filled syringe systems, it is essential to maintain drug sterility over shelf life. Ordinarily, such maintenance comprises prevention of ingress of oxygen, water, and microbes. To demonstrate this, it is essential to perform "container closure integrity testing” (CCIT), or leak testing.
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.
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