System Integrity Tester
The Certitest™ System Integrity Tester ensures an accurate filter integrity testing with a reduction in test duration and complies entirely with the FDA 21 CFR Part 11 guidance on electronic records. Features as automation and network integration will save time and effort. Designed to be used in cleanroom environment, the Certitest™ has been developed and validated in accordance with the current GAMP guidelines. The Integrity tester includes the requisite controls and other features for operation in a 21 CFR Part 11 compliant environment. Data integrity controls, electronic records and signatures are available to support quality risk analysis.
Features
- 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 and Hardware
- Computer memory capacity 16 Gbyte smoothly-operation
- Configure 128 GByte 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
Specification
| Parameters | Values |
Operating voltages and power input | 100 - 240 VAC, 50/60 Hz, 120 W |
| Screen | 10.1-inch high-definition full view colour touch screen, 1280 x 800 px |
| Size | 500 x 330 x 270 mm (Length x Width x Height) |
| Weight | 11.5 kg |
| Test pressure range | 0 to 300 mbar |
| Pressure unit | mbar / Kpa / psi |
| Pressure display resolution | 0.1 mbar / 0.01 Kpa / 0.1 psi |
| Applicable scope | 50 ml to 3,000 l 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 to 40 °C |
| Humidity | ≤ 80 % RH (No condensation) |
| External interface | RJ45, USB, COM Serial port |
| Accessory information | Pressure reducing valve (standard), Barcode scanner (optional |