Pressure Bubble Leak Tester
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Web: standard-groups.com
Standards
YY/T 0681.5 - 2010：Test methods for sterile medical device package - Part 5: Detecting gross leaks in medical packaging by internal pressurization (bubble test)
Features
• Embedded high-speed microcomputer chip control and a simple and efficient human-machine interface provide users with a comfortable and smooth operating experience.
• 7-inch high-definition color LCD screen displays test data and curves in real time.
• Supports expansion suppression and non-suppression testing.
• Overvoltage safety protection, power-off memory, and other safety features ensure system stability during testing.
• English and Chinese interfaces can be switched freely.
• Equipped with a standard RS232 communication port for convenient external connection and data transmission between the system and a computer.
• Energy-saving and environmentally friendly design, aesthetically pleasing appearance, and ultra-low power consumption power supply meet national energy-saving and environmental protection requirements.
Technical Parameters
| Parameter | Specification |
|---|---|
| Testing Range | Suitable for the gross leak testing under internal pressure of various packages, and the testing pressure range can be customized according to requirements. |
| Testing Principle | Based on the positive-pressure testing principle, a certain pressure is applied to the inside of the package, and it is determined whether there is a gross leak by observing whether bubbles are generated on the outside. |
| Automated Control | Equipped with a PLC industrial control program, which can accurately control the pressure and time, and automatically complete the experiment after setting the test pressure and time. |
| Ease of Operation | With a touch-screen operation interface, it is highly user-friendly and simple to operate. |
| Testing Accuracy | The testing error is usually within ±1%, ensuring the accuracy of test results. |
| Constant Pressure Time | Can be set through the touch-screen, with a range of 1 - 9999 seconds. |
| Air Source Interface | Usually equipped with a Φ6mm polyurethane tube and an 8mm interface for easy connection to the air source. |
| External Dimensions | May vary depending on the model but are usually compact; e.g., some models: 420mm(L)×290mm(W)×280mm(H) |
Accessoriess
StandardAccessories:Usually includes the main unit, a puncture device, a test container, etc.
Optional Accessories:Non-standard devices such as a standard test rack, a three-side testing fixture, a constraint plate testing fixture, and an anti-theft bottle cap removal fixture (selected as needed).
Test Procedures
When selecting a gross leak tester, attention should be paid to whether it supports the full process of YY/T 0681.5-2010. covers a pressure range of 0~5kPa or higher, and has adaptability to various fixtures. Routine maintenance includes regularly calibrating the sensors, cleaning the water tank, and checking the seals to ensure long-term stable operation.
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