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With our wide range of testing equipment we provide solutions for the early stages in the development processes as well as for quality control in commercial manufacturing.
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How to Choose a Package Leak Tester
The correct leak tester machine depends on both the package and the testing objective.
| Testing Requirement | Recommended Technology | Related Equipment |
|---|---|---|
| Non-destructive quantitative leak testing | Vacuum decay | MC-V12 |
| Automated vacuum decay testing | Automatic vacuum decay | RC-V12 |
| Liquid-filled package testing | High-voltage leak detection | MC-E23 |
| High-sensitivity microleak measurement | Helium leak testing | MC-H52 |
| Negative-pressure package testing | Negative-pressure method | MC-B82 Series |
| Positive and negative pressure testing | Dual pressure modes | MC-D73 |
| Combined vacuum and pressure testing | Dual-system testing | MC-DUO(VP) |
| Oxygen or dissolved oxygen analysis | Gas analysis | MH-F13 |
| Test sensitivity verification | Positive controls | Laser, capillary, micropipette or natural defect controls |
Before selecting equipment, consider:
- Package type and dimensions
- Rigid, semi-rigid or flexible material
- Dry, liquid or lyophilized product
- Required detection limit
- Destructive or non-destructive testing
- Laboratory or production-line use
- Sample testing speed
- Data recording and reporting requirements
- Applicable test methods and regulations
Packaging Applications
Zholion leak testing equipment can be configured for different pharmaceutical packaging and medical device applications, including:
- Glass and plastic vials
- Ampoules
- Prefilled syringes
- Cartridges
- Bottles and containers
- Blow-fill-seal packages
- Flexible pouches
- Injection device components
- Sealed medical device components
- Other rigid and semi-rigid packages
Because each package has different materials, closure interfaces and internal volumes, sample evaluation is recommended before finalizing the test method and fixture.
From Laboratory Testing to Production Quality Control
Container closure integrity requirements may change throughout the product lifecycle.
During package development, leak testing equipment can be used to compare package materials, closure designs and sealing parameters. During method development, intact samples and positive controls can help establish test sensitivity and operating conditions.
For process validation and routine quality control, the selected system should provide consistent test parameters, repeatable results and clear pass-or-fail criteria. Automated equipment may be considered when higher throughput and standardized sample handling are required.
Why Choose Zholion as Leak Detector manufacturer?
Founded in 2005 and headquartered in Shanghai, Zholion specializes in pharmaceutical and medical device container closure integrity testing and gas analysis. Our team provides equipment together with technical support for packaging quality and compliance throughout the product lifecycle.
Our support includes:
- Package and application assessment
- Test method selection
- Equipment configuration
- Customized fixture development
- Positive control selection
- Method development support
- Installation and operator training
- Testing and troubleshooting assistance
Frequently Asked Questions-Leak Tester Machine
What is a leak tester machine?
A leak tester machine detects leakage or loss of integrity in a package, container or sealed component. Different instruments use vacuum, pressure, high voltage, tracer gas or gas analysis technologies.
Which leak tester is suitable for pharmaceutical vials?
Vacuum decay, high-voltage leak detection and helium leak testing may all be suitable depending on the vial material, product state, closure structure and required detection limit.
Can the equipment test different package sizes?
Yes. Different package sizes can often be tested by changing the chamber, fixture or sample holder. The package dimensions should be provided before equipment configuration.
What is the difference between vacuum decay and helium leak testing?
Vacuum decay measures pressure changes in a sealed chamber and is generally non-destructive. Helium leak testing uses helium as a tracer gas and is selected when high sensitivity or quantitative microleak measurement is required.
Why are positive controls required?
Positive controls demonstrate that the equipment and test method can detect known defects. They are important for system suitability, method development, validation and routine performance verification.
Can Zholion provide customized fixtures?
Yes. Test chambers, fixtures and connectors can be developed according to the package shape, dimensions, closure system and selected testing method.
Do you provide technical support?
Zholion provides equipment selection, application assessment, method support, fixture development, installation guidance and operator training.
Find the Right Leak Testing Equipment
Not sure which leak tester machine is suitable for your pharmaceutical package?
Send us your package type, dimensions, product state, expected testing speed and target leak level. Zholion will help you select an appropriate CCIT method, equipment configuration and test fixture.
