Certitest™ Single-Use System Integrity Tester
Couldn't load pickup availability
Specifications
| 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)
|
Advantages
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