Pre-filled syringes have become an essential component in modern healthcare, offering convenience, precision, and safety in drug delivery. However, ensuring the integrity of these syringes is paramount to maintaining product sterility and efficacy. Container Closure Integrity testing (CCIT) plays a crucial role in detecting leaks, pinholes, and other defects that may compromise the quality of pre-filled syringes.
Pre-filled Syringe Testing: Trends and Challenges
The pharmaceutical industry is witnessing a surge in the adoption of pre-filled syringes due to their efficiency in dose accuracy and reduced risk of contamination. With the increasing use of biologics and complex drug formulations, ensuring the integrity of pre-filled syringes has become more critical than ever. Biologic drugs require stringent packaging standards to maintain stability and sterility, and automated systems are gaining traction for their ability to deliver consistent and reliable results at high throughput. Additionally, compliance with standards such as USP Chapter <1207> emphasizes the need for robust CCI testing methodologies.
Despite these advancements, testing pre-filled syringes presents several challenges. Biologics and sterile water, for instance, have low conductivity, making them difficult to test with conventional methods. High-voltage testing can generate heat or ozone, potentially compromising the product. Furthermore, manufacturers face the challenge of meeting high throughput requirements with testing systems capable of handling large volumes efficiently without sacrificing accuracy.
CCI Testing of Pre-filled Syringes using E-Scan RTX Robotic Test System
The E-Scan RTX robotic test system from PTI offers a groundbreaking solution to address the challenges of CCI testing. Leveraging MicroCurrent High Voltage Leak Detection (HVLDmc) technology, this system provides unparalleled accuracy, reliability, and efficiency. The E-Scan RTX employs a low DC voltage mode, using less than 50% of the voltage of traditional high-voltage technologies. This approach effectively detects pinholes, micro-cracks, and seal imperfections, making it suitable for low-conductivity liquids, including sterile water and biologics.
A dynamic robotic arm seamlessly handles syringes, picking them from nested trays and positioning them for testing. The syringes are inspected at two test stations—one for the syringe body and another for needle shield defects. The entire process is automated, from test initiation to reinsertion into trays or rejection tray, delivering rapid PASS/FAIL results within seconds. The system also offers adjustable limits of detection (LOD) to ensure customizable sensitivity levels for various applications.
The E-Scan RTX not only enhances sensitivity with high signal-to-noise ratios but also aligns with regulatory standards, being recognized by USP Chapter <1207> as a recommended CCI test method. Its scalability makes it suitable for batch release testing, at-line production, and laboratory environments. Additionally, its low voltage operation reduces heat and ozone generation, safeguarding sensitive products and minimizing environmental impact. E-Scan MicroCurrent technology offers bi-lateral scalability from the laboratory to the production line.