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 | √ | | | |
| More unit (mbar, kpa, psi, kgf/cm2) | √ | | | |
| Blow sweeping inside tube | √ | | | |
FT-6.5 Filter Integrity Tester
Features
Powerful functions, covering all the existing test methods for the filter integrity testing;
The first domestic implementation of integrity testing for the ultrafiltration system;
Scientific authority management design, password, permissions, authority grading, electronic signature, etc., in full compliance with FDA 21 CFR PART 11 requirements;
It can create120 groups of reservation solution, so the instrument is more simplistic and intelligent;
With rich data interface, the instrument not only includes the standard configuration of digital and analog interface (RS232/USB), but also can customize a variety of industrial bus and simulation control port according to customer's need, in preparation for the intelligent system upgrade, such as the complete set of online automatic sterilization control system;
Independent research and development team can carry out the design of specific solutions according to the needs of customers; Many years of field experience and strong professional services can not only ensure that the customers use the instrument at ease, but also can provide the technical support for the design and configuration of the filter system of the customers;
Specifications
| Model | FT-6.5 |
| Power Supply | 100 -260 VAC,50HZ,120W |
| Operation Pressure | 100-10000 mbar(1.5-145psi) |
| Pressure Unit | mbar |
| Operation Condition | Ambient Temperature: +5C - +40C; Relative Humidity: 10-80 |
| Dimension (mm) | 400 (Depth)*240 (Width)*270 (Height1) *220(Height2) |
| Function | Manual Bubble point Test; Basic Bubble Point Test; Extensive Bubble Point Test; Pressure Holding Test; Diffusion Flow Test; Water Intrusion Test; Ultrafiltration Membrane Test |
| Test Accuracy | Upstream Volume Test: ± 4%; Bubble Point Test: +50mbar Diffusion Flow Test: ± 4% ; Water Immersion: ± 0.01% |
| Test Scope | BP: 100-8000mbar DF: 1-600ml/min Wl: 001-100ml/min |
| Applied Range | Symmetric and asymmetric membrane test, needle filter, filter bag, flat filter, filter cartridge (big filter volume), ultrafiltration membrane, ultrafiltration column, a variety of irregular filters |
| Authority Management | User Name and Password to Login ,electronic signature to meeting the FDA 21CFR PART 11requirements |
| Reservation Solution | 120 sets |
| Audit trail (customization) | More subject logs |
| Print Function | Built-in printer； |
| Historical Records | More than1 5000 sets unlimited sets records |
| Records Copy | Support USB disk to export (Include test curve) |
| Display Screen | 7-inch, color touch screen |
| Serial Connection | RS232/USB |
| Language | Chinese/English |
| Work Mode | Online/Offline |
| Other functions | One/two-dimension cods, Scanning gun; Lithium battery (customization |
| Applicable Environment | Above D level |
| Weight | 8KG |
| Anti-liquid level | Front IP65 |
| Signal output | (4-20)MA,RS485,12V Alarm output |
