Compliance Fda 21 Part 11 Filter Integrity Tester

Beijing Neuronbc

Product Description

  • Brand Name: Beijing Neuronbc
  • Power: Electronic
  • Usage: Auto Testing Machine
  • 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 first domestic 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.



    Features
      Powerful functions, covering all the existing test methods for the filter integrity testing; The first domestic implementation of integrity testing for the ultrafiltration system; Scientific authority management design, password, permissions, authority grading, electronic signature, etc., in full compliance with FDA 21 CFR PART 11 requirements; It can create120 groups of reservation solution, so the instrument is more simplistic and intelligent; Withrich data interface, the instrument not only includes the standard configuration of digital and analog interface (RS232/USB), but also can customize a variety of industrial bus and simulation control port according to customer's need, in preparation for the intelligent system upgrade, such as the complete set of online automatic sterilization control system; Independent research and development team can carry out the design of specific solutions according to the needs of customers; Many years of field experience and strong professional services can not only ensure that the customers use the instrument at ease, but also can provide the technical support for the design and configuration of the filter system of the customers Parameters:
     
    Power Supply 100 260 VAC, 50HZ, 120W  Spare batterySelection
    Operation Pressure 100-10000 mbar (145psi) ;
    Unit mbar
    Operation Condition Ambient Temperature+5~ +40Relative Humidity10-80%
    Dimensionmm 455Depth*300Width*210Height1
    Function Manual Bubble point TestBasic Bubble Point TestExtensive Bubble Point TestPressure Holding TestDiffusion FLow TestWater Immersion TestUltrafitration Membrane Test
    Test Accuracy Upstream Volume Test±4%Bubble Point Test±50mbarDiffusion Flow Test±4%Water Immersion±0.01ml
    Test Scope BP100-8000mbar      DF1-600ml/min     WI0.01-100ml/min
    Applied Range Symmetric and asymmetric membrane test, needle filter, filter bag, flat filter,   filter cartridge (big filter volume ), ultrafiltration membrane, ultrafiltration column, a variety of irregular filters
    Authority Management User Name and Password to Login , electronic signature to meeting theFDA 21CFR PART 11requirements  Audit trail (customization)
    Reservation Solution 120 sets
    Print Function Built-in printer
    Historical Records More than1 5000 sets unlimited sets records
    Records Copy Support USB disk to exportInclude test curve
    Display Screen 7 inch, color touch screen
    Serial Connection RS232/USB
    Language Chinese/English
    Work Mode Online/Offline
    Other functions One/two-dimension cods , Scanning gun;Lithium batterycustomization)
    Applicable Environment Above B level
    Weight 8KG

     

     

Company Profile

  • Beijing Neuronbc
  • [ China ]
  • This company is registered as a free member and is not verified or authenticated by Tradekey.com
  • Beijing Neuronbc, founded in 2004, is a high-tech enterprise based on the precision testing instruments and related materials for pharmaceutical industry integrated with research and development, production and sales. We have strong R&D and service team, as both the core technology and the company's backbone are from famous scientific research institutes at home and abroad, with more powerful s...

Basic Information

  • Company Products / Services: filter integrity tester, toc analyzer, freezing point osmometer, air particle counter, rahman spectrometer, glove integrity tester, sterility testing pump
  • Year Established: 2004
  • Number of Employees: 51-100
  • Website: www.neuron-biotech.com
Contact Now