Introduction

Ampoules are widely used in pharmaceutical and medical industries to package liquid drugs, ensuring sterility and product safety. A critical aspect of ampoule packaging is leak integrity, as even the slightest leakage can compromise the sterility and effectiveness of the medication. To ensure high-quality packaging, non-destructive leak testing has become the preferred method, allowing accurate and reliable detection without damaging the ampoule.

Labthink’s C690H Package Non-Destructive Leak Detector is an advanced testing solution designed to detect leaks in ampoules, vials, and other pharmaceutical packaging without causing any destruction to the samples.

Why Non-Destructive Leak Testing?

Traditional ampoule leak testing methods, such as dye penetration tests or bubble emission tests, are destructive and time-consuming. Non-destructive leak testing offers the following advantages:

• Preserves Sample Integrity: The test does not damage or contaminate the ampoule, allowing it to be used after testing.
• High Sensitivity Detection: Can identify microleaks that are not visible to the naked eye.
• Fast and Reliable: Provides accurate results within seconds, improving efficiency in production lines.
• Eliminates Human Error: Automated testing reduces operator-dependent variability.
• Meets Regulatory Standards: Compliant with USP <1207> and other pharmaceutical packaging integrity testing guidelines.

Labthink C690H Non-Destructive Leak Detector for Ampoule Testing

Working Principle

The Labthink C690H Package Leak Detector utilizes vacuum decay testing technology, one of the most reliable and non-invasive methods for detecting leaks in pharmaceutical packaging. The process involves:

The sample is placed in the sample feeder and automatically delivered into the test cell. The leak rate and other results can be calculated and obtained by analyzing pressure changes measured by the sensor.

Key Features of Labthink C690H

• High Sensitivity: Capable of detecting microleaks as small as 3 μm.
• Non-Destructive & Non-Invasive: Ensures product sterility and usability post-testing.
• Fully Automated Testing: Reduces manual handling errors and enhances efficiency.
• Data Recording & Traceability: Provides digital reports for quality control compliance.
• Versatile Applications: Suitable for ampoules, vials, blister packs, and other pharmaceutical packaging.

Applications of Non-Destructive Ampoule Leak Testing

• Pharmaceutical Industry: Ensures sterility and safety of injectable drugs.
• Biotech & Healthcare: Validates the integrity of biologics and sensitive formulations.
• Quality Control in Production: Identifies faulty packaging before distribution.
• Regulatory Compliance: Helps manufacturers meet FDA, USP, and GMP requirements.

Conclusion

Ensuring the integrity of ampoule packaging is critical in the pharmaceutical industry. The Labthink C690H Package Non-Destructive Leak Detector provides an advanced, reliable, and efficient solution for ampoule leak testing. By adopting vacuum decay technology, manufacturers can achieve high accuracy, fast testing, and compliance with regulatory standards without compromising product integrity.

For companies looking to enhance their quality control processes, investing in non-destructive leak testing technology like the Labthink C690H is the ideal choice to maintain safety, efficiency, and compliance in pharmaceutical packaging.