Advancing Parenteral Package Integrity Testing: Case Studies on IV Bags and Pre-Filled Syringes: Poster Presented at PDA Week 2025.

Abstract

Ensuring the integrity of parenteral drug packaging is critical for maintaining product sterility and patient safety. This poster presents case study data on two applications of non-destructive, deterministic Container Closure Integrity Testing (CCIT) technologies: Vacuum Decay for IV bags and MicroCurrent (HVLDmc) for pre-filled syringes. The first study evaluates the effectiveness of Vacuum Decay Technology in detecting micro defects in 200 mL and 300 mL IV bags. A statistical footprint was established using thirty negative controls, followed by testing IV bags with defects ranging from 5 μm to 20 μm. Results confirm reliable detection of 20 μm leaks in both sizes, with a demonstrated sensitivity down to 10 μm at six standard deviations (LOD6SD) in 300 mL bags. The study further validates the robustness of Vacuum Decay by showing consistent leak detection across various defect locations and sample orientations. The second study assesses the repeatability of the HVLDmc technology in detecting defects in pre-filled syringes over four weeks. Weekly testing confirmed consistent identification of negative controls, while all positive controls were detected in the first two weeks. In weeks three and four, two positive samples were not detected, possibly due to defect variability or clogging effects. These findings highlight the robustness of HVLDmc while emphasizing the need to understand defect characteristics and influencing factors. Key Takeaways: Gain a deeper Understanding the role of two technologies in parenteral packaging integrity testing. Effectiveness of Vacuum Decay for IV Bags • Vacuum Decay Technology reliably detects leaks as small as 10 μm in 300 mL IV bags with a statistical confidence level (LOD6SD). • Leak detection is consistent across various defect locations (bag body and ports) and sample orientations within the test chamber. • Demonstrates non-destructive and deterministic testing for IV bag integrity. Repeatability of HVLD MicroCurrent for Pre-Filled Syringes • HVLDmc provides a reliable method for leak detection in pre-filled syringes over a multi-week study. Practical Implications for Parenteral Drug Manufacturers • The importance of repeatability studies in CCIT to ensure robustness and reliability. • Considerations for sample preparation and defect consistency when implementing these technologies. • Reinforces compliance with regulatory expectations for deterministic, non-destructive integrity testing.