Intelligent Integrity Tester Certitest®20

Intelligent Integrity Tester

Various regulatory guidelines require integrity testing of sterilizing filters used in the processing of sterile solutions, such as large volume parenterals (LVPs) and small volume parenterals (SVPs). With many biopharmaceutical manufacturers now testing filters before and after use, there is a need for non-destructive test methods that are fast, reliable, and repeatable. The Intelligent Integrity Tester Certitest® 20 meets this need by enabling non-destructive integrity testing to be performed inline or offline on filtration devices.

Features:

  • High-level hardware to ensure data stability and accuracy
  • Special structure design effectively prevents water from sucking back and self-check function
  • Powerful windows system supports real-time display of test curves
  • 50 GB large memory capacity, backup date can be exported on users demand
  • Support multi-level user access settings to ensure data is integrated and safe

Advantages:

Rigorous

  • The powerful windows system and stable algorithm make that each test point can be accurately displayed
  • Complete audit trail can use single-level or two-level signature
  • Strict authority management, in full compliance with FDA 21CFR PART 11
     

Reliable

  • IP54 standard again dust and splashing of water
  • The whole machine adopts Stäubli interface, which is convenient for operation and has better air tightness of each connection
  • Complete self-check procedure after startup: including inlet pressure value display function, internal valve, internal pressure sensor, it can complete whether the whole system leak
     

Convenient

  • Windows operating system is very friendly to user's operation
  • User can finish system updates independently, which can save the time and labour costs
  • Equipped with network interface, which can realize automatic data upload to the server
     

Strong Hardware

  • Pressure regulating valve: Advanced Festo piezoelectric pressure regulating valve with pressure feedback function can be used to automatically adjust the feedback pressure, which has the characteristics of high-pressure accuracy and fast response
  • Pressure sensor: Digital pressure sensor made of ceramic substrate, with small temperature drift and pressure fluctuation, operational amplifier circuit has no effect on date test
  • Solenoid valve: Certitest® 20 features Burkert solenoid valve and customized valve, meanwhile with few interfaces and high sealing performance, the system is stable and not easy to leak
  • Microcontroller: STM32F429, ARM 32-bit Cortex-M4 CPU with FPU, frequency up to 180 MHz, up to 2 MB of Flash memory and 256+4 KB of SRAM, including 64 KB of CM (core coupled memory) data RAM

Operating Parameters:

  • Power: 100 - 240 V AC, 50/60 Hz, 120 W
  • Display Screen: 10 inch high-definition colour touch screen with resolution up to 1280x800
  • Test Range:
    - Bubble point: 100 to 7.000 mbar
    - Diffusion flow: 0.1 to 1.000 ml/min
    - Water intrusion: 0.01 to 100 ml/min
  • Operating Condition: Ambient temperature from 0 to 40 °C
  • History Record Function: 50 GB storage capacity for export or backup