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Container closure integrity is defined as the ability and quality of a container closure system to provide protection and maintain efficacy and sterility during the shelf life of a sterile drug product. The ability of rubber components to prevent microbial ingress of parenteral containers can be measured by seal integrity.
In practice, there are numerous types of container closure integrity methods that are available with varying sensitivities. West Analytical Services offers as part of our standard capabilities a validated Helium Leak Test Method that is state of the art in addition to other traditional methods that have been used by the industry for many years.
Helium Leak Testing
The most sensitive seal integrity testing technique is the use of helium leak detection. This technique offers advantages over other conventional seal integrity test methods. West uses a Seal Integrity Monitoring System (SIMS™) for helium leak detection. The system is based on a helium mass spectrometer leak detector equipped with custom fixtures for the particular vial or parenteral container to be tested. The instrument is calibrated against a NIST-traceable standard leak and measures the rate of helium leak from the vial/container as well as the actual percent of helium that is filled within the vial/container. Various types of containers including vials, syringe systems, cartridges and blister packs can be evaluated.
By using the tracer helium gas technique, the leakages could be determined quantitatively. Published research [see Kirsch, et. al., PDA J. Pharm. Sci. & Tech., Vol. 51, pp. 195-207 (1997)] has demonstrated that a helium leak rate greater than 10-6 cc/sec can be considered a failure for closure integrity. Helium leak rates lower than 10-6 cc/sec have been associated with acceptable microbial challenge results. For sensitivity comparison, conventional seal integrity methods (i.e. dye leakage) have leak rates of 10-3 cc/sec.
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Traditional Methods
West Analytical Services provide other traditional seal integrity test methods that are widely accepted by the industry and are routinely used by clients for research and development studies, problem solving and to generate baseline data. Options available for client testing include:
<em>General chapter USP <382> Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems</em> is slated to become official on December 1, 2025. This allows five years from the date of publication in December of 2020 for stakeholders to implement the new testing requirements for full compliance. While that date seems to be far off in the future, there has been interest in early adoption of the new chapter and implementation of the various tests it requires.
Moisture-sensitive drug products are commonly lyophilized to enhance their shelf life and to prepare them for storage and transport. Maintaining a constant moisture level in a lyophilized drug product “cake” ensures product quality. Not only is proper selection of a container closure system (vial, stopper, seal) necessary, but sealing conditions are as well. This is achieved through demonstration of container closure integrity (CCI).
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’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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