The Masterfilter Certitest® 20 Plus 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® 20 Plus 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.
Test methods:
- Bubble Point
- Diffusion
- Combined Diffusion and Bubble Point
- Water Flow Test
- Pressure Decay
Measuring ranges:
- Bubble Point 100 to 7.000 mbar
- Diffusion 0.1 to 1.000 ml/min
- Water Flow Test 0.005 to 100 ml/min
- Pressure Decay 1 to 7.000 mbar
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
- 128 GB hard disk drive capacity and 16 GB RAM
- Backup date can be exported on user demand
- Support multi-level user access settings to ensure data is integrated and safe
- Automated network function (optional)
Automated Network Functions (Optional):
In addition to basic testing functions, Certitest® 20 Plus integrates advanced automated network functions, which can realize automatic archiving of all data and databases; and synchronize users, settings and multi-device management through the network framework, saving time; the device also supports Modbus TCP and OPC-UA protocols, and compatible with other automation network control protocols, such as PLC (programmable logic controller), SCADA system (supervisory control and data acquisition system), HMI (human-machine interface), etc.
Onsite Services:
- Installation Qualification (IQ) and Operational Qualification (OQ)
- Annual Calibration
- Preventative and Corrective Maintenance