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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.
CCIT uncovers issues that can result in loss of sterility, such as improper component fit, improper assembly, cracks, scratches, or fibers/particles. Smaller issues may allow only gas ingress, where larger issues may allow liquid or microbial ingress. A key concept in CCIT is the "maximum allowable leakage limit" (MALL). This was introduced in United States Pharmacopeial Convention (USP) Chapter <1207> Sterile Product – Package Integrity Evaluation. MALL is the greatest leakage rate that can be accepted for a given drug package system. It is unique to each drug package system and should form the basis of CCIT.
Many methods are available to perform CCIT. USP <1207> provides an overview and categorizes them as “deterministic” or “probabilistic”. A “deterministic method” directly and quantitatively measures a physicochemical property that generates the potential for leakage. An example is tracer gas leak detection with helium. Deterministic methods can be used to generate science-based data throughout the product life cycle to develop a package integrity profile that can be used as input for risk management. A “probabilistic method” is based on an event having a probability of occurring, and thus is less precise. USP <1207> endorses deterministic methods as preferred, but does support probabilistic methods when no deterministic method is available.
West's Analytical Lab Services has the capability to perform the full range of CCIT – deterministic and probabilistic. For more on how West can advise and support CCIT, contact a Technical Customer Support (TCS) representative or Account Manager.
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.
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.
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 />
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.
What does it mean to have package integrity for your container closure system? It means an absence of breaches that can lead to product loss or ingress. Container closure integrity testing should not be just a “one and done” study. It should be understood throughout the life cycle of the product.
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