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Certitest™ Single-Use System Integrity Tester

In stock
Part No. CTBA0
Accessory
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*Not for medical use

Features

Function

  • Integrity testing of single-use bags before or after use
  • Support custom pressure parameters within 300 mbar
  • Two-stage inflation control, free combination of fast charging and fine-tuning
  • Support custom stabilization time and testing tests, and flexibly adapt to various testing scenarios
  • Equipped with high-precision sensors, real-time display of pressure drop curve
  • Confirmation when to start and stop the test, safe and controllable test operation

Fully Compliant with Data Integrity Requirements

  • Developed in accordance with GAMP5, fully compliant with 21 CFR Part 11
  • Multi-level permission settings, supporting customer customization of user groups, assigning user permissions, and fully compliant with quality management system requirements
  • Multi-level password policy, supporting customized password policies for users, meeting the verification requirements of computerized system
  • Complete audit trail function, supporting PDF file export of data and logs, easy traceability, and traceable operation
  • One-click backup and restore, easily cope with disaster recovery 
  • Support Electronic Signatures, with first/second level audit function, release compliance

Easy to Operate

  • Application software developed based on Windows 10 operating system, user-friendly for operators
  • Easy to switch between Chinese and English, and can customize other languages according to needs
  • Support USB updates, client can update independently without returning to the factory, saving costs
  • Support power-on self test, automatically determine whether internal communication, air source pressure, and control detection functions are normal
  • Quick inlet/outlet connectors, plug and test

Accessory & Hardware

  • Computer memory capacity 16G，smoothly-operation
  • Configure 128G solid-state drive with large storage capacity and fast read and write capabilities
  • Equipped with piezoelectric control components, accurate and fast pressure control, support temperature control
  • Integrated valve terminal design, with few interfaces, high sealing performance, stable system and low leakage risk

Services

  • Support 3Q documents drafting and validation, and provide comprehensive application technology training services
  • Provide remote/on-site technical support
Brand Certitest
Operating voltages&power input 100-240 VAC, 50/60Hz, 120W
Screen
10.1-inch high-definition full view color touch screen: 1280 * 800px
Size
500* 330* 270 mm (Length * Width * Height)
Weight 11.5 kg
Test pressure range
0~300 mbar
Pressure unit
mbar/Kpa/psi
Pressure display resolution
0.1mbar/0.01Kpa/0.1psi
Applicable scope
50mL~3000L 2D/3D Single-use bags
Pressure accuracy
Max ± 0.3 mbar
Pressure drop accuracy
Max ± 0.3 mbar
Detection limit
 Can detect 30 μm equivalent aperture leakage holes
Temperature
0~40°C
Humidity
≤ 80% RH (No condensation)
External interface
RJ45
USB
COM Serial port
Accessory information Pressure reducing valve (standard) Barcode Scanner (optional)

 
  • Cobetter_Certitest_Bag_Integrity_Tester_2025 Download
When using Cobetter CTBA series bag integrity tester to perform leak testing on unused bags, does it compromise the sterile environment inside the bag?

Cobetter CTBA series bag integrity tester is not designed with an air sterilization filtration function. Therefore, when using it to conduct leak testing on unused bags, an air filter must be pre-installed on the bag being tested to ensure that the sterile environment inside the bag is not compromised. Additionally, an integrity test must also be conducted for the air filter.

When using the CTBA series bag integrity tester to perform leak testing on a bag, what is the smallest leak hole (in microns) that can be detected?

The leak hole value depends on the test method provided by the bag supplier and is not significantly related to the instrument. Please consult the bag supplier for details.

Can the CTBA series bag integrity tester perform leak tests on multiple bags simultaneously?

To improve testing efficiency by performing simultaneous leak tests on multiple bags, users can purchase additional Cobetter CTBA2 testing units alongside the CTBA series bag integrity tester. Each additional CTBA2 unit enables the synchronous leak testing of one extra bag. A single CTBA series integrity tester can be configured with a maximum of four CTBA2 units, allowing leak testing of up to five bags simultaneously.

If the bag being tested is a large-volume 3D bag and it is in an unused, folded state, should it be pre-inflated to allow for some expansion before performing the leak test?

When using Cobetter CTBA series bag integrity tester to perform leak testing on a folded 3D bag, pre-inflation of the bag is not required. This is because the inflation mode of the CTBA series bag integrity tester is already designed with an automatic bag-expansion feature. Using compressed air, the bag is expanded automatically, and no manual operation is required during this process.

When a bag leak test is interrupted due to unforeseen reasons, can a second test be conducted continuously after venting the bag?

If the interruption occurs during the inflation phase and the bag is not noticeably filled, a second leak test can be performed immediately. Otherwise, the bag should be allowed to rest for 2 hours after returning to its original state before conducting the second leak test.