Container Closure Integrity (CCI) Test Method Development For Autoinjectors With An Optically Transparent Window

Ionis Pharmaceuticals has chosen to package its drug product in an autoinjector equipped with a 1mL long glass prefilled syringe, a configuration that reflects the industry's growing shift toward biologic medications. As the pharmaceutical landscape evolves, there is an increasing reliance on prefilled syringes (PFS) and autoinjectors—not only to accommodate the unique requirements of biologics but also to meet the demands of healthcare providers for more user-friendly and error-resistant delivery systems. Recognizing the critical importance of ensuring container closure integrity (CCI) in these advanced formats, Ionis Pharmaceuticals partnered with LIGHTHOUSE to implement a robust and reliable CCI testing method.

Laser-based headspace analysis has emerged as a powerful solution for CCI testing, particularly well-suited for PFS and autoinjector configurations. This technology offers precise, non-destructive testing that supports both product safety and regulatory compliance. As the industry continues to innovate, adopting advanced analytical tools like laser-based headspace analysis is essential for maintaining the highest standards of drug delivery.

Learn how these cutting-edge solutions can support your product integrity and patient safety goals.