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FT-1.2 Filter Integrity Tester 100-8000 Mbar For Sterile Filtration Membrane
| MOQ: | 1 set |
| Price: | Negotiable |
| Standard Packaging: | Plywood packing |
| Delivery Period: | 5~8 working days |
| Payment Method: | L/C,T/T |
| Supply Capacity: | 500 sets/month |
Filter Integrity Tester 8000 Mbar
,Filter Integrity Tester 100 Mbar
Introduction
SHUOBODA Filter Integrity Testers are special instruments of integrity testing for sterile filtration membrane and filter system, where the testing method and instrument design fully meet the requirements for relevant laws and regulations in GMP, EP, FDA and USP.
◎ Regulatory requirements
1. Chinese GMP and EU EP have made specific provision for the integrity testing of sterile filter on the test method, where the commonly used methods include bubble point test, diffusion flow test or pressure holding test. GMP regulates that the test is required after the use of sterile filtration. EP regulates that the test is required before and after the use, and at the same time EP regulates that the critical gas and air filter must be confirmed after use, while other filters must be tested on a regular basis.
2. According to Drug Manufacturing Quality Management Standard (revised in 2010) Article 310, two appendices of Computerized System and Confirmation and Validation are now issued, as the supportive documents for Drug Manufacturing Quality Management Standard (revised in 2010), effective as of December 1, 2015.
3. The requirements for electronic records and electronic signatures as specified in 21 CFR Part 11.
◎ Solutions
Connection diagram of online test
◎Applied range
1. Disc Membrane:Φ25mm-Φ300mm; 2. Standard Cartridge:2.5″- 40″
3. Capsule & Mini Cartridge 4. Air filter test :2.5″- 40″
5. Ultrafiltration membrane
Model Selection Guide
|
Model Function |
FT8.0 |
FT6.5 |
FT4.0 |
FT1.2 |
Customer-made |
|
Manual Bubble Point Test |
√ |
|
|
|
Can be customized according to customer's actual require |
|
Basic Bubble Point Test |
√ |
√ |
√ |
√ |
|
|
Extensive Bubble Point Test |
√ |
√ |
√ |
|
|
|
Pressure Holding Test |
√ |
√ |
|
|
|
|
Diffusion Flow Test |
√ |
√ |
√ |
|
|
|
Water( intrusion) Test |
√ |
√ |
√ |
|
|
|
Ultrafiltration Test |
√ |
√ |
|
|
|
|
Input Method |
Chinese/English/Number |
English/Number |
English /Number |
English/Number |
|
|
Electronic Signature |
√ |
√ |
|
|
|
|
4 level user management Users’ quantity |
√ 1000 sets |
√ 80 sets |
|
|
|
|
Audit trail |
√ |
operational |
|
|
|
|
Reservation Solution |
1000sets |
80sets |
|
|
|
|
Screen |
Touch Screen |
Touch Screen |
|
|
|
|
Historical Records |
300000sets |
5000 sets |
500s sets |
20sets |
|
|
Records Print |
√ |
√ |
√ |
√ |
|
|
Export Data |
√ |
√ |
|
|
|
|
Password lock screen after setting time |
√ |
|
|
|
|
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More unit (mbar, kpa, psi, kgf/cm2) |
√ |
|
|
|
|
|
Blow sweeping inside tube |
√ |
|
|
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FT-1.2 Filter Integrity Tester
Features
Online testing, does not interfere the downstream aseptic conditions
It has system self-check function, with an error report function for the system tightness and wrong operation;
It is microcomputer control of automatic detection, with many kinds of test functions such as bubble point scanning, fast bubble point test and pressure holding method;
Real-time print of test results;
It can be used to test the single core filter and multi-core filter.
Performance Parameter
|
Model |
FT-1.2 |
|
Power requirements / power |
100 – 260 VAC, 50HZ, 120W |
|
Operating pressure |
100-8000 mbar (115psi); |
|
sensor |
U.S. imported sensors |
|
unit |
mbar |
|
Self-check function |
not support |
|
Operating conditions |
Ambient temperature: + 5 ℃ ~ + 40 ℃; relative humidity: 10-80% |
|
Dimensions (mm) |
400 (L) × 240 (W) × 270 (H 1) × 220 (H 2) |
|
Test function |
Basic bubble point test; diffusion flow test (semi-automatic); |
|
Test accuracy |
Bubble point: ± 75mbar; Diffusion flow: ± 4%; |
|
Test Range |
Bubble point: 590-6900mbar Diffusion flow rate: 1-180ml / min |
|
Scope of application |
Symmetric and asymmetric membrane testing, needle filter, bladder filter, flat filter, cartridge filter (with 3 cores within 20 inches); |
|
Audit trail |
not support |
|
authority management |
not support |
|
Pre-existing solutions |
not support |
|
Print function |
built-in micro printer; |
|
History recordS |
20 sets |
|
Record backup |
not support |
|
Display |
3.2 ", single color |
|
Serial connection |
not support |
|
Language |
Chinese / English |
|
How to use |
Online / offline |
|
Applicable environment |
Grade B or above |
|
weight |
7.5KG |
|
Audit trail storage |
not support |
|
operating system |
Stand-alone mechanical nesting system |
|
number of users |
not support |
|
Anti-backflow device |
Matching |
|
Dust and splash resistance |
IP22 |
