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.

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.

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.

To reduce and detect particulate matter is a shared responsibility between Container Closure component suppliers and the pharmaceutical industry. Keeping the patient´s safety in mind, lively discussions about particle inspection were held in the panel session at the PDA Conference on Freeze Drying Technologies.

Parenteral drugs that are moisture sensitive are produced in a lyophilized state to protect against product degradation caused by moisture. As a result, when considering the stability and shelf life of lyophilized drugs, the residual drug moisture content is critical. It is also a crucial component in the dossier submitted for regulatory filing, which begs the question: How shall the moisture level in the lyophilized drug product cake be maintained during the drug product’s shelf life?

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.