Parenteral products, such as pre-filled syringes, vials, and cartridges require stringent quality control to ensure sterility and product integrity. A compromised container closure can lead to contamination, posing severe risks to patient safety. To address this, automated Container Closure Integrity Testing (CCIT) solutions like the E-Scan RTX offer a highly reliable and efficient approach.
Understanding Parenteral Products
Parenteral products are sterile pharmaceuticals, mainly liquid form, administered via injection, including pre-filled syringes, vials, cartridges, and ampoules. These products bypass the body's natural defense mechanisms, making sterility and container closure integrity critical to patient safety.
Ensuring their container closure integrity (CCI) is critical to maintaining sterility and preventing microbial contamination, oxidation, or loss of potency. Given the delicate nature of biologic drugs, traditional destructive test methods like dye ingress are inadequate. Instead, non-destructive methods such as HVLDmc technology provide reliable and repeatable testing.
Automated Container Closure Integrity Testing (CCIT) is a non-destructive method used to test the integrity of pharmaceutical packaging, ensuring it remains sealed and free from contamination. Unlike traditional probabilistic methods such as dye ingress or microbial ingress tests, automated CCIT provides precise, repeatable, and high-throughput testing, making it ideal for large-scale production. It eliminates human error, increases sensitivity to micro leaks, and complies with regulatory guidelines such as USP Chapter 1207, which recommends deterministic testing methods. By integrating advanced technologies like MicroCurrent High Voltage Leak Detection (HVLDmc), automated CCIT ensures that parenteral products, including pre-filled syringes and vials, meet the highest quality and safety standards while maintaining efficiency in manufacturing.
Automated CCI Testing Using E-Scan RTX
The E-Scan RTX platform is PTI’s fully automated, modular container closure integrity (CCI) testing solution designed specifically for pre-filled syringes. Engineered with a dynamic robotic system, the RTX delivers a practical, reliable, and adaptable approach to CCI testing, seamlessly integrating with your production requirements.
This advanced platform features MicroCurrent HVLD technology, an innovative form of high-voltage leak detection (HVLD) optimized for high-risk, delicate biologic liquids. The RTX ensures fast and accurate PASS/FAIL results within seconds, making it ideal for batch release testing, inline production environments, or laboratory applications.
Unlike conventional HVLD methods, PTI’s MicroCurrent HVLD operates with a unique DC voltage mode, using no more than 50% of the voltage typically applied in traditional high-voltage testing. This enables precise leak detection even in low-conductivity liquids, such as sterile water. Additionally, the reduced voltage minimizes product exposure to high electrical stress, making it the preferred CCI solution for parenteral and biologic products.
Benefits of E-Scan RTX
- MicroCurrent HVLD technology is effective across all parenteral products, including biologics and extremely low conductivity liquids including sterile water (WFI).
- Robust CCI technology, MicroCurrent HVLD offers bi-lateral scalability from the lab to production line.
- Listed in USP Chapter 1207 as the recommended method for parenteral liquid package inspection.
- Robust method and good Signal-Noise-Ratio between good and defective products.
Low voltage exposure reduces production of ozone.