Equipment application:
Instead of destructive bacterial challenge experiments, non-destructive testing of sterilizing grade filters before and after use has confirmed the integrity of sterilizing grade filters, thereby indirectly verifying that the filtered material is completely sterilized.
Product regulations:
China GMP and EU EP have made clear provisions on the test methods for the integrity test of sterilizing filters. Commonly used methods include bubble point test, diffusion flow test or pressure retention test. GMP stipulates that the test is performed after the sterilizing filter is used. EP stipulates that it needs to be tested before and after use. At the same time, EP stipulates that key gas and air filters need to be confirmed after use, and other filters are tested regularly.
Performance parameters:
|
Power / Voltage |
100–240 VAC, 50HZ, 120W , backup battery (optional) |
|
Operating pressure |
100-10000 mbar (150psi) |
|
Unit |
Mbar ,kpa, psi, kgf/cm2 |
|
Operating conditions |
Ambient temperature: +5℃ ~ +40℃; Relative humidity: 10-80% |
|
Dimensions (mm) |
480(L) ×300 (W) × 210(H) |
|
Test function |
Manual bubble point test; Basic bubble point test; Enhanced bubble point test; Pressure holding test; Diffusion flow test; Water immersion test; Ultrafiltration membrane package test; |
|
Test accuracy |
Net volume test: ± 4%; Bubble point: ± 50mbar; Diffusion flow: ± 4%; Water immersion method: ± 0.01ml |
|
Test range |
Bubble point: 100-8000mbar, Diffusion flow rate: 0.01-1000ml/min Water immersion: 0.01-100ml/min |
|
Scope of application |
Symmetric and asymmetric membrane testing, needle filter, capsule filter, flat filter, cartridge filter (12 cores within 20 inches), ultrafiltration membrane package, ultrafiltration column, various irregular filters; |
|
Audit tracking |
Multiple event logs, exportable but not modifiable |
|
Authorization management |
Username and password login, 4 levels of authority, meet FDA 21CFR PART 11 requirements |
|
Pre-stored solutions |
1000 groups |
|
Audit tracking record storage |
≥5 years storage |
|
Backflow prevention device |
Yes (optional) |
|
Number of users |
1000 |
|
Operating system |
Linux system |
|
Operation interface |
Using Chinese and English bilingual operation interface |
|
Dust and splash proof level |
IP54 front IP65 |
|
Printing function |
Built-in micro printer, online PC; |
|
Historical record |
Store 300,000 records (USB export can store unlimited data); |
|
Record backup |
Support USB export data (including test curves); |
|
Display |
High-definition 10" color touch screen; |
|
Serial port connection method |
RS232 serial port, USB interface; Support wireless connection; |
|
Applicable environment |
Above Class D |
|
Weight |
10KG |
|
Explosion-proof function |
Explosion-proof (optional) |
Product features:
1. Powerful functions, covering all existing test methods for filter integrity;
2. Adopting self-optimized Linux system;
3. Optimized test calculation and shortened test time;
4. 10-inch true color touch screen design, friendly human-machine interface, simple, fast and reliable operation;
5. Meet offline and online testing, use pressure sensors with higher accuracy and lower deviation band to improve the test accuracy of the instrument;
6. Automatic self-check function, self-check multiple performance functions of the instrument itself, with instrument self-check function after startup, timely report when faults are found.
7. The first domestic company to realize the integrity test of ultrafiltration system, which can test ultrafiltration templates and hollow fiber columns (self-matched interface).
8. Scientific authority management design, password login, authority classification, electronic signature, etc. Electronic records comply with 21 CFR Part 11, calibration complies with 21 CFR 820.72, supports multi-level user access rights setting, ensures data integrity, has a complete audit tracking function, and supports manual or electronic signatures;
9. The instrument has its own audit tracking function, which can record multiple operation event logs and truly meet the requirements of data integrity;
10. 1000 sets of pre-stored schemes can be established, which can fully meet the requirements of various filter types and different on-site test conditions, and the instrument is more simplified and intelligent;
11. The display curve of diffusion flow-pressure has been added, the display and printing functions of the three curves have been realized, and the air intake control unit has been optimized, which greatly increases the air intake speed and stability;
12. Supports USB data export function, which can not only export the original test data but also export source data and configuration data, so that the requirements of data integrity are perfectly reflected in this instrument;
13. Data communication and network interface requirements can be expanded according to customer requirements, and wireless communication functions are supported;
14. The instrument structure is optimized to achieve dust and splash resistance level of IP54, and quick connectors (Staubli connectors can be used) are used to avoid errors in inlet and outlet pipe connection;
15. The instrument's test records and audit trails can be queried and exported;
16. High-precision sensors and optimized algorithms can extend the gas path to 100m, making the upstream volume test more accurate, and the instrument can better meet the on-site use conditions without affecting the test results;
17. The built-in thermal printer avoids the risk of particle and ink contamination, and can keep the handwriting clear for more than 10 years under appropriate conditions;
18. The external interface can be customized according to customer requirements to facilitate customer automated control management;
19. The Chinese and English bilingual operation interface is adopted;
20. Multiple pressure units can be switched arbitrarily (mbar, kpa, psi, kgf/cm2);
21.1000
22. It can test up to 15 cores and 20-inch filter cartridges, greatly improving the work efficiency of users;
23. Rich data interfaces. The instrument not only includes standard digital and analog interfaces (RS232/USB), but also can customize a variety of industrial buses and analog control ports according to customer needs, to prepare for the intelligent upgrade of the system, such as the matching of online fully automatic sterilization control system;
24. The independent R&D team can design specific solutions according to customer needs. Years of on-site experience and strong professional services can not only ensure that customers can use the instrument with confidence, but also provide technical support for the design and configuration of customer filtration systems.
25. This instrument has passed the EU CE certification.
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