FilterCheck® 08 : Integrity Test Equipment
FilterCheck 08 is a fully automatic, compact, 21 CFR part 11 compliant integrity tester for reliable testing of your critical filters. It uses the latest mass flow technology in combination with advanced analytics to deliver accurate and precise test results in less time. The user friendly, easy to use validated software and calibrated sensors ensure test reliability.
SS 316 L body and a light weight compact design, allows it to be stationed within the aseptic process area for online integrity testing of sterilizing filters. It then wirelessly transfers test results to the laboratory network as well as to a printer.
It is supported by extensive documentation including IQ, OQ, PQ and a user manual.
- High Precision and Accuracy
- Compatibility with Sterile Processing Areas
- – Electropolished SS316L Surface
- – No Instrument Cooling Fan
- – Wireless and Paperless to minimize particle generation in sterile areas
- Easy Portability
- – Smallest Integrity Tester on the Market
- – Weight: 8.8 kg
- All types of Integrity tests
- – For Hydrophilic and Hydrophobic Filters
- – Test Methods:
- Bubble Point (BP)
- Diffusion Flow (DF)
- Combined DF + BP
- Water Intrusion Test (WIT)
- Fast Bubble Point (Fast BP)
- Pressure Decay
- 21 CFR part 11 Compliance for Data Reliability and Security
- – Three Access levels with Password Security
- – System Audit Trail
- Self Diagnosis
- – Internal Leakages
- – External Leakages to ensure Test Filter Connectivity
- Enhanced network connectivity
- – WiFi & Wired support
- – Automatic Network backup
- – Print on Network printers
- Remote access to data
- – Remote report view & approval
- – Remote audit trail access
- Large Storage Space (10,000+) for
- – Test Templates
- – Test Reports
Dimensions
| Dimensions (Main Test Unit) | 30cm X 30cm X 12cm |
| Weight | 8.8 Kg |
Electrical Data
| Voltage | 100-240V AC |
| Input Frequency | 50-60 Hz |
Operating Range
| Maximum Inlet Pressure | 120psi |
| Operating Temperature | 5°-35° C |
| Storage Temperature | 8°-30° C |
| Relative Humidity | 10-80 % |
Measuring Range
| Bubble Point | 5-95 psi |
| Diffusion Flow | 0.5-500 ml/min |
| Water Intrusion | 0.05-50 ml/min |
Accuracy
| Bubble Point | + 0.7psi (50 mbar) |
| Diffusion Flow | Greater of ± 5% of measurement or ± 0.05 mL/min |
| Water Intrusion | Greater of ± 5% of measurement or ± 0.02 mL/min |
To order, please specify:
FC08XXXXXXXXX01 for 110V/220V
FilterCheck 08 comes with comprehensive easy-tounderstand documentation. Documents include:
- Certificate of Quality
- User Manual
- Installation Qualification (IQ)
- Operational Qualification (OQ) Equipment
- Operational Qualification (OQ) Software
- Performance Qualification (PQ)
- Calibration Report
| File Type | Download |
|---|---|
| Datasheet | Download |
Have questions or need assistance?
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