Gross Leak Tester
ASTM F2096, ASTM F2054, ASTM F1140, ISO 11607-1, ISO 11607-2
Gross Leak Tester – ToronMed-GLT02 is designed to detect gross leaks in sterile medical device packaging using the positive pressure method (bubble test). Beyond gross leak testing, it can also be applied to seal strength, burst pressure, creep-to-failure, compression resistance, torsion force, and joint/disengaging force evaluations across a variety of flexible packages, aseptic packaging, tamper-evident closures, tubes, caps, blister packs, and aerosol valves. This versatile instrument ensures packaging integrity and compliance with international standards.
Test Principle
The Gross Leak Tester applies internal pressurization to the packaging under test. Depending on the selected mode, it evaluates packaging strength and sealing performance:
- Burst Test – Maximum burst pressure until package failure
- Creep Test – Pressure drop over time
- Creep-to-Failure Test – Time to failure at a set pressure
- Pressure Maintenance Test – Package holds specified pressure over time
- Gross Leak Test – Bubble test for major leaks
Applications
- Basic Applications
- Gross leak testing of packaging bags and boxes
- Extended Applications
- Burst strength testing of packaging bags, bottles, and boxes
- Creep and creep-to-failure testing for sealed packages
- Seal performance testing of tamper-proof closures
- Integrity testing of three-sided sealed materials
- Compression resistance testing of medical blister packs
- Leak testing of soft tubes for medical, cosmetic, or food packaging
- Seal performance of aerosol valves (pesticides, sprays, medical aerosols)
Standards Compliance
The ToronMed-GLT02 Gross Leak Tester complies with major international packaging integrity standards, including:
- ASTM F2096, ASTM F2054, ASTM F1140
- ISO 11607-1, ISO 11607-2
Standard Configuration
- Main instrument unit
- 7-inch touchscreen
- Dual sensors
- Micro printer
- Gross leak test fixture (test chamber)
Optional Accessories: - Professional software and communication cable
- Fixtures for restraining/unrestrained package tests
- Fixtures for tamper-proof closures, flexible tubes, aerosol valves, and blister packs
Why Choose Gross Leak Tester – ToronMed-GLT02
The Gross Leak Tester – ToronMed-GLT02 offers comprehensive testing capabilities for packaging used in medical, pharmaceutical, food, and consumer industries. With its multiple test modes, customizable fixtures, large data storage, and compliance with ASTM and ISO standards, it ensures accurate, reliable results for package integrity testing. Whether for R&D laboratories, production lines, or quality control, the Gross Leak Tester provides a cost-effective, versatile solution for safeguarding packaging performance and regulatory compliance.
How Can We Help You?
Contact our sales team for a quotation.
Key Features
- Multiple Test Modes
Supports gross leak, burst, creep, creep-to-failure, and pressure maintaining tests. - User-Friendly Operation
7-inch HD touchscreen with real-time data and curve display. - Flexible Testing Methods
Dual methods of restraint distension and unrestrained distension for diverse package types. - Robust Safety Design
Overvoltage protection and power-off memory guarantee operational stability. - Expanded Test Range
Dual load cells support both large and small samples. - Precision Control
High-precision electronic flow controller ensures consistent gas flow regulation. - Data Storage & Reporting
Stores up to 100,000 test records, with automated result judgment and integrated printer. - Ergonomic Test Frame
Adjustable inflatable head and test frame for simplified operation. - Customizable Functions
Supports tailored leak test methods for specialized packaging requirements.
| Specification | Value |
|---|---|
| Test Range (Sensor 1) | 0–600 kPa (0–87 psi) |
| Test Range (Sensor 2) | 0–10 kPa (0–1.45 psi) |
| Optional High Range | 0–1.6 MPa (0–232 psi) |
| Gas Injection Heads | Φ10 mm (standard), Φ4 mm, Φ1.6 mm (optional) |
| Gas Supply Pressure | 0.4–0.7 MPa (customer-supplied) |
| Gas Supply Port | Φ8 mm PU tubing |
| Number of Sensors | 2 |
| Instrument Dimensions | 370 × 310 × 150 mm |
| Pedestal Dimensions | 356 × 305 × 325 mm |
| Voltage | AC 220V 50Hz / AC 110V 60Hz |
| Net Weight | 25 kg |
