Vacuum Leakage Tester: Ensuring Package Integrity in Compliance with USP 1207

Understanding the Vacuum Leakage Tester

The vacuum leakage tester is a critical instrument for detecting leaks in sealed packaging across industries such as pharmaceuticals, food, and medical devices. It plays a crucial role in Container Closure Integrity Testing (CCIT), ensuring that products remain uncontaminated throughout their shelf life. The vacuum decay method, an industry-preferred approach, offers a non-destructive, reliable, and quantitative solution for detecting micro leaks.

CCIT Testing Requirements and Leak Test as per USP 1207

USP 1207 outlines the methods and regulatory expectations for Container Closure Integrity Testing (CCIT). The vacuum decay test, recommended under USP 1207, is widely recognized for its high sensitivity in detecting leaks in various package types, including:

• Rigid and flexible packaging
• Parenteral vials and ampoules
• Blister packs and syringes

Key USP 1207 Requirements:

• Teste nedistructive: Ensures product integrity without causing damage.
• Quantitative analysis: Measures pressure variations to detect leaks.
• Reproducibility: Reliable and repeatable results for quality control.

How the Vacuum Leakage Tester Works

The tester, such as the Microtester de scurgeri MLT-01, employs the vacuum decay method, consisting of the following key steps:

1. FILL Stage: The test chamber is evacuated to a specified vacuum level.
2. SETTLE Stage: The system allows time for pressure stabilization.
3. TEST Stage: The instrument monitors pressure changes, indicating potential leaks.
4. VENT Stage: The vacuum is released, and the test concludes with a pass/fail result based on predefined thresholds.

Advantages of Vacuum Decay Leak Testing

• Highly sensitive detection of micro leaks (1-3μm sensitivity).
• Fast and reliable results in seconds to minutes.
• Non-invasive approach ensures product safety.
• Complies with ASTM F2338, an industry standard for vacuum decay testing.

Choosing Our Best Vacuum Leakage Tester

Technical Feature – Vacuum Leakage Tester

Main Parameter – Vacuum Leakage Tester

Applications of Vacuum Leakage Testing

Vacuum leakage testers are widely used in industries where package integrity is crucial, including:

• Produse farmaceutice: Ensuring sterility of parenteral drugs and medical devices.
• Food & Beverage: Preventing contamination and maintaining shelf life.
• Medical Devices: Verifying the integrity of sterile packaging.
• Cosmetics & Chemicals: Protecting sensitive formulations from leakage.

Întrebări frecvente

1. What is the purpose of a vacuum leakage tester?
The tester detects micro leaks in sealed packaging, ensuring product integrity and regulatory compliance.

2. How does the vacuum decay test work?
It measures pressure changes within a vacuum-sealed chamber to determine whether a package has leaks.

3. Why is USP 1207 important for leak testing?
USP 1207 sets the regulatory framework for non-destructive şi quantitative CCIT methods, including vacuum decay testing.

4. What industries use the testers?
Industries such as pharmaceuticals, medical devices, food, and cosmetics rely on testers for package integrity verification.

5. How does the MLT-01 Micro Leak Tester improve testing accuracy?
With its high-resolution pressure sensors şi PLC-controlled system, the MLT-01 ensures precise, reliable, and repeatable test results.

A vacuum leakage tester is essential for detecting leaks in various packages while ensuring compliance with USP 1207 standards. The Microtester de scurgeri MLT-01 provides a precise, non-destructive, and highly efficient solution for CCIT testing.