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Measuring container closure integrity (CCI) of polymer–based containers and syringes is a challenge. Tracer gas leak detection (i.e., Helium-leak)—the method endorsed by USP <1207> (Package Integrity Evaluation – Sterile Products)—cannot be used directly, because gases permeate polymers. Helium permeates at a very high rate, in part due to its small size. As such, direct use of Helium-leak with a polymer-based system will result in a leak rate above that measured with a glass-based system, that may be misinterpreted as resultant from a non-integral system, but is actually from Helium permeation.
Figure 1 Figure 2
To overcome this challenge, the use of special fixtures is needed. Two fixtures have been custom-designed and built. Figures 1 and 2 show the configurations for vials and syringes, respectively. For vials, a key consideration is integrity of the seal with elastomer stopper. The fixture comprises a compression fitting enabling insertion of the area of the seal in the vacuum chamber. A flow of Helium is maintained on the other side of the fixture. This fixture can be employed to evaluate integrity of vials/jars assembled by customers. For syringes, a key consideration is integrity of the plunger interface with syringe barrel. The fixture likewise comprises a compression fitting enabling insertion of the syringe within the vacuum chamber with a flow of Helium on the other side. For both fixtures, surface area of polymer within the vacuum chamber is minimized - assuring that measured Helium results from elastomer/polymer interface – not the polymer itself.
West Analytical Laboratory Services is focused on staying at the forefront of CCI technology to help customers determine the appropriate testing strategy for their products. To learn more about West’s offerings, please visit the Analytical Lab Services section of our website.
<span style="color: #000000;">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.</span>
Many injectable drug products, such as monoclonal antibodies and recombinant proteins, are susceptible to degradation over time when stored at ambient temperature. As such, they are stored, and subsequently delivered, in a lyophilized state - which enables a much longer shelf life. Lyophilization (also known as <em>freeze-drying</em>) is a process by which all water is removed from a drug product. Absent water, all metabolic processes stop, and drug products thus stored in a lyophilized condition are far more stable. At the time of use, the lyophilized drug product is reconstituted with water (or other appropriate solution) and delivered to the patient.
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).
With the help of the FDA’s expedited programs for approval, a new wave of high-value biologic drugs is on the rise in the pharma industry.1 These drugs require cryogenic storage (-80oC to -180oC) to maintain stability. This presents a new challenge: how to measure and demonstrate container closure integrity (CCI) of storage and delivery systems at such low temperatures.<br />
Most physicians agree - of all the services that can be performed for patients, eliminating the pain and fear of injections is at the top of the list. How can pain be minimized? One approach is to maximize syringe performance - whether the syringe is employed by a clinician, in an autoinjector, or in a wearable device. A critical element of syringe performance is the break-loose force. This is the force needed to overcome the plunger inertia in a filled syringe to initiate plunger movement and introduction of drug product. A lower, more consistent, break-loose force can provide for increased patient comfort.
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