Product Overview

Leak-DS Intelligent MicroLeak Tester is a flagship, high-precision leak detection system designed for comprehensive container closure integrity testing (CCIT). Integrating both the Vacuum Decay Method and Pressure Decay Method into a dual-testing system, it provides a 100% non-destructive testing solution for various finished packages. Powered by an advanced Windows operating system and HD LCD touchscreen, the Leak-DS delivers real-time test curves and absolute data integrity, making it the premier choice for pharmaceutical quality control and regulatory compliance.

Key Features & Advantages

Intelligent Windows OS & Real-Time Test Curves

Equipped with a built-in, reliable Windows operating system. The intuitive interface displays live test comparison curves on the LCD screen, allowing operators to visually monitor micro-pressure changes and vacuum decay in real time for smarter, data-driven analysis.

Dual Testing System (Vacuum & Pressure Decay)

Combines both vacuum and pressure decay technologies to accommodate a wider range of packaging materials. It features top-tier imported vacuum and pressure pneumatic components to ensure unmatched measurement precision.

Simulated Leak Aperture (Imported Flow Meter)

Configured with a premium imported micro gas flow meter that precisely simulates different micro-leak sizes, ensuring highly accurate calibration and system validation.

Ultimate Pharmaceutical Compliance (FDA 21 CFR Part 11 & GMP)

Audit Trail System: Fully satisfies FDA 21 CFR Part 11 compliance for electronic records and signatures.

4-Level User Access: Secure login management with individual credentials for operators, supervisors, and administrators.

Tamper-Proof Data Storage: Automatically processes and saves test data locally in an unalterable format, allowing permanent data preservation and compliant PDF report exporting.

Infinite Storage Capacity: Supports unlimited user accounts and limitless test data records.

100% Non-Destructive & Cost-Effective

Performs rapid testing (< 50s) on medicine-filled packages without any physical damage. Samples can safely return to the production line, eliminating product waste and cutting QC costs.

Patented Multi-Use Chamber & Error Alarms

Features a patented "one-chamber, multi-use" design to accommodate various sample geometries without frequent, costly chamber replacements. It also includes an intelligent error-alert function and power-failure memory to secure data during unexpected outages.

Applications

Designed for precise leak testing of a wide volume range (0.25ml - 500ml), highly suitable for:

Ampoules & Vials (Liquid & Freeze-dried)

Glass & Plastic Infusion Bottles

Plastic Infusion Bags / Soft Bags

Cartridges & Pre-filled Syringes (PFS)

Eye Dropper Bottles & other hermetically sealed finished packages.

Technical Specifications

Compliance & Standards

This instrument fully meets the stringent global regulatory mandates for sterile drug packaging integrity:

ASTM F2338: Standard Test Method for Non-Destructive Detection of Leaks in Packages by Vacuum Decay Method

USP <1207>: Sterile Product Packaging-Package Integrity Evaluation (American Pharmacopeia)

FDA 21 CFR Part 11: Electronic Records and Electronic Signatures

National GMP Guidelines: Technical Guidelines for Container Closure Integrity Testing of Sterile Drug Packaging