The integrity tester is a precision analytical instrument independently developed by Tailin Biotechnology with rich experience and professional knowledge, which is computerized, intelligent, and highly sensitive.
The product can achieve multiple standard functions, including forward flow detection, bubble point detection, water intrusion detection, forward flow bubble point joint detection, and pressure attenuation. The equipment performs self inspection, automatically controls stability time and detection time, stores and prints current test results, etc; Historical data displayed in graphics can more intuitively reflect changes in detection time and gas flow rate. Developed in accordance with GMP guidelines, fully compliant with GAMP (Good Manufacturing Practice), electronic records comply with 21 CFR Part 11, calibration complies with 21 CFR 820.72, and has complete validation documentation.
1. High performance CPU, automated control, fast detection speed.
2. 10 inch true color touch screen design, friendly human-machine interface, simple, fast, and reliable operation.
3. Perfect software system, powerful storage function and formula management mode, data can be queried at designated points, and intelligent fault prompts.
4. Equipped with a built-in printer, it can quickly print out test results, historical data, or real-time data curves.
5. Fully comply with GMP requirements and meet the requirements of 21 CFR Part 11 regarding electronic data integrity, electronic signatures, and audit trails.
6. Dust and splash prevention technology is designed specifically for production environments.
7. Small size, light weight, low energy consumption, and easy to carry.
8. Level 4 user permission management
1. Input voltage: (100-240) VAC
2. Input frequency: 50/60HZ
3. Input power: 160W
4. Detection accuracy:
Forward flow: ± 4%
Water intrusion: ± 4%
Bubble point: ± 50mbar
5. Detection scope:
Forward flow: (0.1-600) ml/min
Water intrusion: (0.01-100)ml/min
Bubble point: (100-8000)mbar
6. Sensitivity:
Forward flow: 0.1ml/min
Water intrusion: 0.01ml/min
Bubble point: 50mbar
7. Repetitive error: ≤ 3%
8. Dimensions: 36cm × 28cm × 28cm
This instrument can be used for checking the integrity of membrane filters (membranes or filter cartridges) in sterilization and filtration processes in the pharmaceutical industry and biological fields.