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Pharmaceutical products are designed to enhance health and support effective treatment. Ensuring the quality and safety of these products relies on maintaining intact packaging that protects against contamination, moisture, and other external factors. Integrity testing methods, such as Vacuum Decay, helium leak detection, and high voltage leak detection, verify that packaging meets regulatory standards like USP <1207>. These methods identify even the smallest leaks, confirming that containers perform their intended function. Comprehensive integrity testing helps manufacturers achieve compliance, mitigate risks, and ensure product safety and reliability.

VeriPac Delta for Package Integrity Testing

VeriPac Delta is a dual technology non-destructive quantitative test system for pharmaceutical CCI applications. Capable of detecting leak rates as small as 5 microns, depending on package specifications, it provides a non-destructive, quantitative testing solution for pharmaceutical and food applications. It is specifically designed for testing gas leaks in dry product containers, such as lyophilized and powder-filled vials, as well as liquid leaks in liquid-filled vials and prefilled syringes.

The VeriPac Delta employs two primary technologies: Vacuum Decay and Pressure Decay. Vacuum Decay leak testing, based on ASTM F2338-09 and recognized by the FDA as a consensus method, delivers sensitivity down to 5 microns. Pressure Decay testing, compliant with ASTM F2095, achieves similar sensitivity with rapid test cycles of just 10 seconds. Together, these technologies provide precise, efficient, and reliable solutions for comprehensive package integrity assessments.

Technology Overview

The VeriPac Delta connects to a specially engineered test chamber. During testing, vacuum or pressure is applied to the package within the chamber. Using high-resolution absolute transducer technology, the system monitors the applied vacuum or pressure levels and detects changes over a specified test duration. This enables accurate detection of gross and micro leaks. The test cycle completes in a few seconds, delivering objective, non-destructive results that preserve both the product and its packaging.

The sensitivity of the test depends on factors such as transducer capability, package design, test fixture, and key parameters like time and pressure. The VeriPac Delta system can be configured for manual or semi-automatic operation, making it suitable for laboratory offline testing and QA/QC statistical process control.

Benefits of VeriPac Delta Technology

• Non-destructive, non-subjective, no sample preparation
• Deterministic, quantitative test method
• Small footprint and modular portable design
• Defect detection down to 0.2 ccm (5 micron)
• ASTM test method and FDA standard
• High level of sensitivity, repeatability and accuracy

The integrity of pharmaceutical products relies on robust packaging that preserves quality and prevents contamination. The VeriPac Delta is an effective and versatile solution for pharmaceutical package integrity testing. By combining non-destructive methodologies, rapid testing cycles, and exceptional sensitivity, it offers more than just leak detection—it provides a comprehensive approach to safeguarding product integrity. Its adaptability across diverse packaging formats ensures its value in advancing quality assurance processes within the pharmaceutical industry.