Filter Integrity Tester, Bubble point tester, audit FDA/GMP
FIT-8.0
FIT Serials Integrity Tester are designed for testing integrity of filters and filter systems . The test meet to verify the sterilizing filter in the FDA, the State Pharmacopoeia and GMP specification requirements.
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Product info
Features
Powerful, covers all existing test methods regarding the integrity of the filter;
Adopt optimized Linux system;
Optimized test operation and shortened test time;
10-inch true-color touch screen design, friendly human-machine interface, simple, fast and reliable operation;
To meet offline online testing, using pressure sensors with higher accuracy and lower deviation bands to improve the test accuracy of the instrument;
Automatic self-test function, self-test of multiple performance functions of the instrument itself, after turning on the instrument has instrument self-test function, report faults in time.
The first domestic company to implement the integrity test of an ultrafiltration system.
Scientific user management, password login, user classification, electronic signature, etc., in compliance with GMP and FDA CFR 21 part 11, support multi-level user access permission settings, ensure data integrity, have comprehensive audit trail functions, and support manual or electronic signature;
The instrument comes with an audit trail function, truly meets the requirements of data integrity; 10.Can establish 1000 sets of pre-stored programs, which can fully meet multiple filter types and different test conditions in the field, and the instrument is more simple and intelligent; 11.Increased the display curve of diffusion flow-pressure, realized the display and printing function of three curves, optimized the air intake control unit, and greatly increased the air intake speed and stability;
Support USB disk data export function, which can not only export the original test data, but also the source data and configuration data, so that the data integrity requirements are perfectly reflected in the instrument; if single data can export PDF style directly;
Can expand data communication and network interface requirements according to customer requirements, and support wireless communication functions;
Optimize the structure of the instrument so that its dustproof and splashproof level reaches IP54, and use quick connectors (Staubli connectors can be used) to avoid incorrect connection of the inlet and outlet pipes;
Test records and audit trails of the instrument both can be queried and exported ；
High-precision sensors and optimized algorithms can extend the gas path to 100m, make the upstream volume test more accurate, and the instrument can better meet the conditions of field use without affecting the test results;
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;
External interfaces can be customized according to customer requirements, which is convenient for customers' automated control and management;
Using Chinese and English bilingual interface;
Multiple pressure units can be switched flexibly (mbar,kpa,psi,kgf/cm2)
1000 user accounts, four level of user management, and each user's authority can be determined by default or customized methods, more flexible to meet the needs of on-site production and laboratory management, and perfect user information and authority configuration;
Can test most up to 12-core 20-inch filter cartridges, which greatly improves the user's work efficiency;
Rich data interface, 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 intelligent upgrade of the system, such as online full automation supporting bacteria control system;
The independent R & D team can design specific solutions according to the needs of customers. Many years of field experience and strong professional services not only ensure that customers can use the instrument at ease, but also provide technical support for the design and configuration of customer filtration systems.
Specifications
Model | FIT-8.0 |
Voltage | 100–240v/ 50HZ , Spare battery (Optional） |
Power | 120W |
Operation Pressure | 100-10000 mbar (150psi) |
Unit | Mbar ,kpa, psi, kgf/cm2 |
Ambient Temperature | +5℃ ~ +40℃ |
Relative Humidity | 10-80% |
Dimension(mm) | 485 ×300 × 211 |
Function | Manual Bubble point Test； Basic Bubble Point Test； Extensive Bubble Point Test； Pressure Holding Test； Diffusion FLow Test； Water Immersion Test； Ultrafitration Membrane Test |
Test Accuracy | Upstream Volume Test: ± 4%； Bubble Point Test: ± 50mbar ； Diffusion Flow Test: ± 4% ； Water Immersion: ± 0.01ml |
Test Scope | BP: 100-8000mbar DF: 1-900ml/min WI: 0.01-100ml/min |
Applied Range | Symmetric and asymmetric membrane test needle filters, capsule filters flat filters cartridge filters (within 12 cores and 20 inches) ultrafiltration membrane packages ultrafiltration columns various irregular filters |
Audit Trial | Audit trail records can exportable and irreversible |
Authority Management | User Name and Password to Login 4 Authority Grades meeting FDA 21CFR PART 11 |
Reservation Solution(programs) | 1000sets |
Audit trail record storage | ≥5 years storage |
Anti-backflow(liquid) device | Customized |
Number of users | 1000sets |
Operating System | Linux system |
Operation Interface | English bilingual operation interface |
Dust and splash level | IP54 , Front is IP65 |
Print Function | Built-in printer, can control on PC |
Historical Record | 300000 sets records storage |
Records Copy | USB export （include test curve） |
Display Screen | High definition 10’’ color touch screen |
Serial Connection | RS232 USB Support wireless connection |
Language | English |
Work Mode | Online/Offline |
Applicable Environment | Above B level |
Battery | customization |
Weight | 10KG |
Comparing of FIT-6.0/FIT-6.5/FIT-8.0
Model | FIT-6.0 | FIT-6.5 | FIT-8.0 |
Image | | | |
Power requirements / power | 100 – 240 VAC, 50HZ, 120W backup battery (optional) | 100 – 240 VAC, 50HZ, 120W backup battery (optional) | 100–240 VAC, 50HZ, 120W backup battery (optional) |
Operating pressure | 100-10000 mbar (150psi); | 100-10000 mbar (150psi); | 100-10000 mbar (150psi) |
sensor | High-precision sensors imported from the United States | High-precision sensors imported from the United States | Optimization algorithm of low-pressure and high-precision sensors imported from the United States |
unit | mbar | mbar | Mbar, kpa, psi, kgf / cm2 |
Self-check function | not support | not support | stand by |
Operating conditions | Ambient temperature: + 5 ℃ ~ + 40 ℃; relative humidity: 10-80% | Ambient temperature: + 5 ℃ ~ + 40 ℃; relative humidity: 10-80% | Ambient temperature: + 5 ℃ ~ + 40 ℃; relative humidity: 10-80% |
Dimensions (mm) | 450 (L) × 280 (W) × 190 (H) | 400 (L) × 240 (W) × 270 (H 1) × 220 (H 2) | 480 (L) × 300 (W) × 210 (H) |
Test function | Manual bubble point test; basic bubble point test; enhanced bubble point test; holding pressure test; diffusion flow test; water immersion test; ultrafiltration membrane package test | Manual bubble point test; basic bubble point test; enhanced bubble point test; holding pressure test; diffusion flow test; water immersion test; ultrafiltration membrane package test | Basic bubble point test; enhanced bubble point test; holding pressure 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 | Net volume test: ± 4%; bubble point: ± 50mbar; diffusion flow: ± 4%; water immersion method: ± 0.01ml | Net volume test: ± 4%; bubble point: ± 50mbar; diffusion flow: ± 4%; water immersion method: ± 0.01ml |
Test Range | Bubble point: 100-8000mbar Diffusion flow rate: 1-600ml / min Water immersion: 0.01-100ml / min | Bubble point: 100-8000mbar Diffusion flow rate: 1-600ml / min Water immersion: 0.01-100ml / min | Bubble point: 100-8000mbar Diffusion flow rate: 1-900ml / min Water infiltration: 0.01-100ml / min |
Scope of application | Symmetric and asymmetric membrane testing, needle filter, capsule filter, flat filter, cartridge filter (within 9 cores and within 20 inches), ultrafiltration membrane bag, ultrafiltration column, various irregular filters | Symmetric and asymmetric membrane testing, needle filter, capsule filter, flat filter, cartridge filter (within 9 cores and within 20 inches), ultrafiltration membrane bag, ultrafiltration column, various irregular filters | Symmetric and asymmetric membrane testing, needle filter, capsule filter, flat filter, cartridge filter (within 12 cores and within 20 inches), ultrafiltration membrane bag, ultrafiltration column, various irregular filters; |
Audit trail | Multiple event logs can be queried according to time (optional) | Multiple event logs can be queried according to time (optional) | 32 event logs, exportable and unmodifiable |
authority management | User name and password login, level 4 authority, meet FDA 21CFR PART 11 requirements | User name and password login, level 4 authority, meet FDA 21CFR PART 11 requirements | Fully meet the FDA EU GMP and other regulations require user name and password login, level 4 authority, meet FDA 21CFR PART 11 requirements |
Pre-existing solutions | 120 groups | 120 groups | 1000 groups |
Print function | Comes with built-in micro printer, online PC; | Comes with built-in micro printer, online PC; | Comes with built-in micro printer, online PC; |
history record | No more than 15,000 groups of unlimited record storage, | No more than 15,000 groups of unlimited record storage, | Unlimited number of record storage for more than 300,000 groups, |
Record backup | Support U disk export data (including test curve); | Support U disk export data (including test curve); | Support U disk export data (including test curve); |
Display | High-definition 7 "color touch screen; | High-definition 7 "color touch screen; | High definition 10 "color touch screen; |
Serial connection | RS232 serial port, USB interface; | RS232 serial port, USB interface; | RS232 serial port, USB interface; support wireless connection; |
Language options | Chinese / English | Chinese / English | Use Chinese and English bilingual operation interface |
How to use | Online / offline | Online / offline | Online / offline |
Applicable environment | Grade B or above | Grade B or above | Grade B or above |
weight | 8KG | 8KG | 10KG |
Audit trail storage | ≥5 years storage | ≥5 years storage | ≥5 years storage |
operating system | Stand-alone mechanical nesting system | Stand-alone mechanical nesting system | Linux system |
number of users | 80 | 80 | 1,000 |
Anti-backflow device | Matching | Matching | Standard |
Dust and splash resistance | IP22 | Frontal IP65 | IP54 Front IP65 |
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