PTFE Filter Integrity Tester

PTFE Filter Integrity Tester

PTFE Filter Integrity Tester Integtest series 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 and USP. Beijing Neuronbc R&D water intrusion test in China.

Product Introduction

Company profile: Beijing Neuronbc was established in 2004. After more than ten years of development, the filter integrity tester produced by our company has become the domestic famous brand, and the test accuracy has reached the level of imported instruments. At present, we have accumulated for thousands of pharmaceutical enterprise customers, the latest model V8.0 take the lead in completing the system upgrade of the audit trail function to meet the latest requirements for data integrity. We believe our quality products and service,  will be your most correct choice.

 

Specification

Power Supply

100–240 VAC, 50HZ, 120W

Operation Pressure

100-10000 mbar (150psi)

Unit

Mbar ,kpa, psi, kgf/cm2

Operation Condition

Ambient Temperature+5 ~ +40;Relative Humidity10-80%

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

BP100-8000mbarDF1-900ml/minWI0.01-100ml/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 ireeversible

Authority Management

User Name and Password to Login ,4 Authority Grades,meeting the FDA 21CFR PART 11requirements

Records Copy

Support USB disk to export (include test curve);

Display Screen

High definition 10 inch ,color touch screen;

Language

Chinese/English

Work Mode

Online/Offline

Applicable Environment

Above D level

Weight

10KG

 Detail:

8.0

Side interface for inlet  outlet , buffer tank ...

product-350-220

Back interface

 

Features

1. THis filter integri tester covers all existing test methods regarding the integrity of the filter;

2. Adopt optimized Linux system;

3. Optimized test operation and shortened test time;

4. 10-inch true-color touch screen design, friendly human-machine interface, simple, fast and reliable operation;

5. THis  PTFE filter integrity tester To meet offline online testing, using pressure sensors with higher accuracy and lower deviation bands to improve the test accuracy of the instrument;

6. 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.

8. 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;

9.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;

12.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;

13.Can expand data communication and network interface requirements according to customer requirements, and support wireless communication functions;

14.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

15.Test records and audit trails of the instrument both can be queried and exported;16.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;

17.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;

18.External interfaces can be customized according to customer requirements, which is convenient for customers' automated control and management;

19.Using Chinese and English bilingual interface;

20.Multiple pressure units can be switched flexibly(mbar,kpa,psi,kgf/cm2);

21.1000 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;

22.Can test most up to 12-core 20-inch filter cartridges, which greatly improves the user's work efficiency;

23.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;

24.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.

 

Applied range

Disc Membrane:Φ25mm-Φ300mm;
Standard Cartridge:2.5
- 40
Capsule & Mini Catridge
Air filter test :2.5
- 40
Ultrafiltration membrane

Warranty:

  1. 3month quality problem change for free;

  2. 1year warranty;

  3. Whole life maitanence;

     

Certificate:

ISO 9001:2015        CE

ISO900

8.0CE

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