Application

• Medical Quality Control: Ensures syringes and infusion sets meet strict leakage standards to protect patient safety.
• Pharmaceutical Manufacturing: Validates packaging integrity for sterile medical products.
• R&D & Certification: Supports compliance with global medical device regulations.

Standard

• GB 8368-2005: Infusion Equipment – Airtightness Testing Requirements
• ISO 8536-4: Sterile Syringes for Medical Use – Leakage Test Methods

Product Advantages

1. Precision Negative Pressure Testing: Applies -10 to -30 kPa pressure with ±0.5 kPa accuracy.
2. Dual-Temperature Testing: Conducts tests at 23 ±1°C and 40 ±1°C to simulate real-world conditions.
3. Automated Control: PLC-driven system ensures repeatable results and reduces operator error.
4. Safety First: Auto-shutoff and pressure overload protection prevent device damage.
5. Compact Design: Portable footprint (500×600×500 mm) suits lab and production line use.
6. User-Friendly: Adjustable test time (1–16 seconds) and intuitive digital interface.

Product Features

• Vacuum Chamber System: Distilled water flushing eliminates air bubbles for accurate leakage detection.
• Adjustable Pressure Range: -10 kPa to -30 kPa (customizable via touchscreen).
• Temperature Control: Tests at 23°C (room temp) and 40°C (accelerated aging conditions).
• Automatic Data Logging: Records pressure decay and leakage rates in real time.
• Safety Interlocks: Prevents operation if chambers are improperly sealed.
• Easy Maintenance: Stainless steel components resist corrosion and simplify cleaning.

Technical Parameters