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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.
Take, for example, United States Pharmacopeia Chapter <1207> Package Integrity Evaluation – Sterile Products. Published in 2016, the chapter specifies methods to measure the container closure integrity (CCI) of container/delivery systems. In particular, it advocates the use of deterministic methods (e.g., trace gas leak detection), as opposed to probabilistic methods (e.g., dye ingress). Anticipating publication of <1207>, West equipped its laboratories with the facilities, and the staff, needed to perform the specified methods, and upon publication, West immediately offered public comment:
As a result of these and similar efforts, Customers know that West is by their side – not only for advice on what to do, but how to get it done. This supports the goal we all share – safe and efficient delivery of drug products to the patients who need them.
#SimplifytheJourney #WestByYourSide
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 />
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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