Future Trends in Pharmaceutical Packaging -The Move Towards Full Automation in CCI Testing

Container closure integrity (CCI) testing is a critical aspect of pharmaceutical packaging, ensuring that the product remains sterile and safe throughout its shelf life. Traditional methods often involve manual inspection or destructive testing, which can be time-consuming, labor-intensive, and prone to human error. To address these challenges, the pharmaceutical industry is increasingly turning to automated CCI techniques.

CCI testing verifies that the container and closure form a hermetic seal, preventing the entry of contaminants such as moisture, oxygen, and microorganisms. This is particularly important for products that require a sterile environment, such as parenteral drugs, vaccines, and biologics.

Why Are Automated CCI Techniques Gaining Popularity?

Several factors are driving the adoption of automated CCI techniques:

• Improved Accuracy: Automated systems can detect leaks with precision, reducing the risk of product recalls and ensuring patient safety.
• Increased Efficiency: Automation allows faster testing times and higher throughput.
• Enhanced Data Management: Automated systems can capture and analyze data more effectively, providing valuable insights into product quality and process performance.
• Reduced Cost: While the initial investment in automated equipment may be higher, the long-term cost savings from increased efficiency and reduced waste can be significant.

Automated CCI Techniques Offered by PTI:

PTI, a leading provider of pharmaceutical packaging solutions, offers a range of automated CCI techniques:

1. VeriPac LPX Technology

The VeriPac LPX series represents PTI’s advanced, fully automated package inspection systems designed for inline integrity testing, offering an ideal solution for stringent quality control in packaging lines. Leveraging PTI's proprietary Vacuum Decay technology—a validated test method under ASTM F2338—the LPX systems offer high-precision leak detection, recognized as a consensus standard by the U.S. Food and Drug Administration (FDA) and conforming to ISO 11607 and USP <1207> guidelines. This automated solution addresses the limitations of infrequent testing, enabling rapid identification and correction of process-related quality deviations for optimal production integrity.

The VeriPac LPX series is engineered for parenteral products as well as flexible packaging/pouch applications, facilitating uninterrupted, high-throughput testing. With a scalable and modular design, the LPX systems integrate seamlessly into manufacturing workflows, supported by a dynamic robotic architecture that adapts to various production needs, ensuring reliable, precise, and repeatable inspection across diverse packaging types.

VeriPac LPX Benefits

• Automated testing enables the highest level of container quality assurance.
• Deterministic, quantitative test method.
• ASTM Test Method F2338 and FDA standard, ISO 11607.
• Distinct PASS/FAIL results.
• Highly accurate test results - low false positives and false negatives.
• High Signal Noise Ratio (SNR) for peak sensitivity and reliability.
• Non-destructive, non-subjective, no sample preparation.
• Pick-and-Place option back into the production line.
• Auto reject option of defects removed from the production line.
• USP <1207> compliant.

2. E-Scan RTX Technology

The E-Scan RTX platform is PTI’s advanced, fully automated container closure integrity testing (CCIT) system specifically designed for pre-filled syringes. Built with a modular, robotic configuration, the RTX offers a versatile solution that can be seamlessly integrated into various production environments. Leveraging PTI’s innovative MicroCurrent High Voltage Leak Detection (HVLD) technology, this platform provides a highly efficient, non-destructive testing method for biologic liquids, ensuring product integrity with rapid PASS/FAIL results in a matter of seconds.

The MicroCurrent HVLD technology operates using a distinct mode of direct current (DC) voltage, utilizing less than 50% of the voltage applied by conventional HVLD systems. This capability allows for highly sensitive leak detection in liquid-filled containers with extremely low conductivity, such as those containing sterile water for injection. The reduced voltage and current applied during testing significantly minimize the electrical exposure to the product, making the RTX an optimal solution for testing parenteral and biologic formulations, including delicate or high-risk pharmaceuticals. Its flexibility supports both batch release and in-line testing in production, offering robust, reliable CCI testing that meets stringent regulatory requirements.

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).
• Listed in USP Chapter 1207 Guidance 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.

?By adopting automated CCI techniques like those offered by PTI, pharmaceutical manufacturers can improve product quality, reduce costs, and ensure patient safety. As technology continues to advance, we can expect to see even more innovative solutions for CCI testing in the future.

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