Product Overview

Leak-S MicroLeak Tester is a premium, high-precision instrument designed for the ultimate seal integrity testing of packaging. Utilizing the industry-standard Vacuum Decay Method, it achieves 100% non-destructive detection of leaks in packages. With advanced sensing technology, the Leak-S is capable of identifying microscopic pinhole leaks down to 1-2μm (0.001mm), ensuring uncompromising quality control for critical pharmaceutical and medical device packaging.

Key Features & Advantages

Premium Imported Components for High Precision

Utilizes top-tier imported vacuum pneumatic components to guarantee superior testing accuracy. It is also equipped with an imported high-end micro gas flow meter, allowing the system to accurately simulate different leak aperture sizes.

Patented Multi-Use Chamber Design

Features a unique, patented "one-chamber, multi-use" design. This significantly reduces the cost of purchasing multiple chambers and eliminates the operational hassle of frequently swapping out test chambers for different samples.

Ultimate Pharmaceutical Compliance (FDA & GMP Ready)

FDA 21 CFR Part 11 Compliant: Features a comprehensive audit trail system meeting strict electronic record and electronic signature requirements.

Advanced User Authority: Robust password protection with a 4-level authority management system. Each operator has unique login credentials.

GMP Standard Data Management: Supports local data storage, automatic processing, and statistical analysis. Data is exported in an unalterable format to guarantee permanent, tamper-proof record keeping.

Infinite Storage Capacity: Allows for an unlimited number of registered users and limitless test data storage capacity.

100% Non-Destructive & Automated

Tests medicine-filled packages without causing any damage. Samples can return to the production line, drastically cutting testing costs. It performs automated testing with objective "Pass/Fail" verdicts for both micro leaks and gross leaks without human intervention.

Applications

Suitable for non-destructive leak detection in various sterile packaging systems, including:

Vials

Ampoules

Pre-filled Syringes (PFS)

Plastic Bottles & Flexible Soft Bags

Other hermetically sealed packaging systems.

Technical Specifications

Compliance & Standards

ISO 11607-1、ISO 11607-2、GB/T 10440、GB 18454、GB 19741、GB 17447、ASTM F1140、ASTM F2054、GB/T 17876、GB/T 10004、BB/T 0025、QB/T 1871、YBB 00252005、YBB 00162002