气泡点检测仪/完整性检测仪是对过滤材质及滤器进行完整性测试的专用仪器,它可以进行气泡点、扩散流、水侵入和压力衰减测试,运用这些工业上可接受的物理测试,检测滤材及滤器的过滤精度及完整性,这些方法满足我国药典及GMP规范中对CJ过滤器进行验证的要求,亦为美国FDA所推荐。该仪既可以离线测试又可以在线测试,既可以判断滤材精度是否合格又可以检查滤壳以及密封件是否完好,测试时不影响下游的无菌状态,是过滤器用户对滤材或滤器在使用前后进行完整性测试的选择。适用于生物、医药、食品、饮料等行业对CJ过滤器的完整性测试。也是过滤器制造商进行出厂检验的必要设备。
Scope of application:
Wafer membrane filter (Disc be) : 25 mm to 300 mm Φ Φ various membrane filter
Standard folding filter (Standard cartridge) : 2.5 to 40 "and" core core 1 to 9
Capsule type filter (Capsule),
Small filter (Mini cartridge)
Air filter to 40 test 2.5 ""
Power/power 170-240 v AC, 50/60 hz. 100 w.
The maximum operating pressure 7999 mbar
The minimum inlet pressure 3000 mbar
Installation dimensions 240 x320 (wide) (deep) x 260 (high)
Mbar test pressure range: 500-500
Testing precision sensitivity: + / - 1.0 mbar; Bubble point: plus or minus 60 mbar;
Operating conditions of ambient temperature: 0 ℃ to + 50 ℃; Relative humidity: 10-80%
Basic bubble point test: test takes 2 min plus or minus 2 min; Diffusion flow test 7 plus or minus 2 min; Water immersion flow test 7 plus or minus 2 min; The system tightness: 3 + 1 min;
Print function in English/Chinese printing, print test conditions, test results, test curve;
History function 32 gb storage space, save the data support of article 1 million of the SD card and U disk derived data
Screen size: 5.7 to 7 inches; 256 color; Touch screen
Language option in English/Chinese
The software functions:
1. The system has a bit, bubble point tests, diffusion flow testing functions.
2. All units standardization; The system can retain data 500 times.
3. All data shall not be modified, but can pass the password can modify the date, time and data.
4. Test by diffusion flow method, the volume of upstream can automatically detect and display.
5. Detection of hydrophobic filter can use organic solvent as infiltration media, version 4.0 can direct water infiltration
6. Printing paper to reflect on: the serial number, specification, the operator, operation date.
7. All the components required: lists the chosen instrument, material producers.
8. Supplier free installation and debugging equipment and training operators.
Automatic filter integrity tester is integrity test was carried out on the filter material and filter the special instrument, it can carry out bubble point, the diffusion flow, water intrusion and the pressure attenuation test, using these industrial acceptable physical test, on the detection of filter material and filter filtration precision and completeness, these methods meet in pharmacopoeia of our country and the requirements of GMP requirement for validated aseptic filter is recommended by the FDA. The instrument can either offline test and online testing, is qualified to judge whether the accuracy of the filter material and can check the filter shell and packings are in good condition, when the test will not affect the downstream of the aseptic condition, is the user to filter material filter or filter integrity tests before and after the use of the best choice. The instrument is suitable for biological, pharmaceutical, food, beverage and other industries to the integrity of the aseptic filter test. Is the necessary equipment to do inspection for filter manufacturers.