Filter Integrity Tester, Bubble Point Tester, Audit FDA/GMP

• After-sales Service: Free Spare Parts
• Warranty: One Year
• Voltage: 100–240 VAC, 50Hz,
• Power: 120W
• Operation Pressure: 100-10000 Mbar (1.5-145psi)
• How to Use: Online / Offline
• Model NO.: FIT-8.0
• Applicable Environment: Grade B or Above
• Operating System: Linux System
• Transport Package: Export Packing
• Specification: 10KG
• Trademark: Xiangyi
• Origin: China
• Production Capacity: 100 PCS/Month

Product Description

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	+5ºC ~ +40ºC
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 ºC ~ + 40 ºC; relative humidity: 10-80%	Ambient temperature: + 5 ºC ~ + 40 ºC; relative humidity: 10-80%	Ambient temperature: + 5 ºC ~ + 40 ºC; 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