Filter Integrity Tester-V8

Product Introduction

The integrity tester is an instrument that performs non-destructive testing on filters as an alternative to bacterial challenge tests. Since integrity test standards and bacterial challenges are correlated, qualified integrity test data accurately reflects the bacteria retention capability. This device has bubble point, diffusion flow, pressure hold, and water intrusion testing functions that meet GMP, CE, and FDA requirements. It also features upgraded four-level permissions and audit trail functions to meet the latest regulatory requirements for integrity testing.

Instrument Features: 
1. Powerful functions, covering all existing test methods for filter integrity; 
2. Uses an independently optimized Linux system; 
3. Optimized test calculations, shortening test time; 
4. 10-inch true color touch screen design, user-friendly interface, simple, fast, and reliable operation; 
5. Supports offline and online testing, using higher precision and lower deviation pressure sensors to improve instrument testing accuracy; 
6. Automatic self-check function, self-checking multiple performance functions of the instrument itself. The instrument has a self-check function after power-on, reporting any faults promptly. 
7. The first in China to achieve integrity testing of ultrafiltration systems. 
8. Scientific access control design, password login, hierarchical permissions, electronic signatures, etc., compliant with GMP and FDA CFR 21 part 11, supporting multi-level user access permission settings to ensure data integrity, with complete audit trail functions, and supporting manual or electronic signatures; 
9. The instrument has a built-in audit trail function, which can record multiple operation event logs, truly meeting the requirements of data integrity; 
10. Multiple preset schemes can be established to fully meet the different test conditions of various filter types and sites, making the instrument simpler and more intelligent; 
11. Added diffusion flow-pressure display curve, realizing the display and printing function of three curves, optimizing the air intake control unit, greatly increasing the air intake speed and stability; 
12. Supports USB data export function, not only exporting the original test data but also exporting the source data and configuration data, making the data integrity requirements perfectly reflected in this instrument; 
13. Data communication and network interfaces can be expanded according to customer requirements, and wireless communication is supported; 
14. Optimized instrument structure, making its dust and splash protection level reach IP54, using quick connectors to avoid incorrect connection of inlet and outlet pipelines; 
15. Instrument test records and audit trails can be queried and exported; 
16. High-precision sensors and optimized algorithms allow the gas path to be extended to 100m, making upstream volume testing more accurate, and the instrument better meets on-site usage conditions without affecting the test results; 
17. Built-in thermal printer avoids particle and ink contamination risks, and can maintain clear characters for more than 10 years under suitable conditions; 
18. External interfaces can be customized according to customer requirements for easy automated control management; 
19. Uses a bilingual (Chinese and English) operating interface; 
20. Multiple pressure units can be switched arbitrarily (mbar, kpa, psi, kgf/cm2); 
21. Up to four levels of user management permissions, and the permissions of each user can be determined by default or custom methods, more flexibly meeting the management needs of on-site production and laboratories, improving user information and permission configuration; 
22. Can test up to 12 cores of 20-inch filter cartridges, greatly improving user work efficiency;

Performance Parameters: