Filter Integrity Tester

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Filter integrity tester, Bubble point tester, Audit trail

FIT-8.0

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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

Power Supply

100–240 VAC, 50HZ, 120W

Spare battery (Optional）

Operation Pressure

100-10000 mbar (150psi)

Unit

Mbar ,kpa, psi, kgf/cm2

Operation Condition

Ambient Temperature: +5°C ~ +40°C; Relative Humidity: 10-80%

Dimension(mm)

480(Depth) ×300 (Width) × 210(Height1)

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 the FDA 21CFR

PART 11requirements

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

Support USB disk to export  （include test curve）;

Display Screen

High definition 10 inch ,color touch screen;

Serial Connection

RS232/USB/Support wireless connection;

Language

Chinese/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 °C ~ + 40 °C; relative humidity: 10-80%

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

Ambient temperature: + 5 °C ~ + 40 °C; 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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