compliance 21 Part 11Filter Integrity Tester V8.0

Company profile: Beijing Neuronbc was established in 2004. After more than ten years of development,.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.

Features：

1. Powerful, 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. 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.
7. The first domestic company to implement the integrity test of an ultrafiltration system.
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.

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