Compatible with multiple tests
- Bubble Point Test
- Forward Flow Test
- Water Intrusion Test
- Pressure Decay Test
- Combined Forward Flow + Bubble Point Test
- Automated pre & post-use checks
Filter Integrity Tester Built for Validation, Speed, and Compliance
Key features
- 15" Color LCD Touch Screen
- Unlimited Data Storage
- AI-enabled with LAN connectivity
- Integrated testing methods
- Bubble Point: 50–8000 ± 50 mbar
- Forward Flow: 0.1–1000 ± 0.1 ml/min
- Water Intrusion: 0.01–100 ± 0.01 ml/min
- Pressure Decay: 50–8000 ± 1 mbar
- Built in thermal printer or network/PDF exports
Your assurance matters
- 5x Faster results
- 21 CFR Part 11 compliant with audit trail
- Multiple user access levels (Operator, Supervisor, Administrator)
- Fast installation, M19 Expert training, and Intelligent method setup
- IQ/OQ documentation and M19 Expert support for seamless validation
- 2-year warranty with spare parts assurance
Why M19 Filter Integrity Tester?
Validation-First Service
Our specialists support every stage of implementation from installation and operator training to IQ/OQ qualification, calibration, preventive maintenance, and Annual Maintenance Contracts helping your facility stay compliant and productive.
Global Expertise. Local Support.
With offices in both the United States and India, M19 provides responsive technical support, faster procurement, and local engineering expertise whenever you need it.
Maximum Operational Uptime
Preventive maintenance programs, stocked spare parts, and rapid-response service help keep production running without interruption.
Built for Data Integrity
Fully compliant with 21 CFR Part 11, the M19 software platform delivers secure electronic records, complete audit trails, unlimited data storage, and scalable user management for growing manufacturing operations.
Complete Validation Documentation
Receive comprehensive DQ, IQ, OQ, and PQ documentation, calibration certificates, and validation support that accelerate qualification and simplify regulatory inspections.
Engineered in New York.
Supported Across the United States.
Our US engineering and service teams provide local technical expertise, stocked spare parts, faster response times, and convenient USD billing eliminating the delays often associated with overseas suppliers.
Testimonials
“Audit stress is a thing of the past.”
Switching to the M19 Filter Integrity Analyzer has completely transformed our validation workflow. The automated data logging and bulletproof 21 CFR Part 11 compliance made our last FDA audit the smoothest one yet. It's incredibly precise, easy to operate, and has significantly reduced our batch release cycle times.
“Zero learning curve, flawless performance.”
Our team used to spend hours troubleshooting false failures on our old integrity testers. The M19 is a game-changer. The touchscreen interface is highly intuitive, and the quick-connect fixtures mean our lab techs can run bubble point and forward flow tests flawlessly with minimal training. It paid for itself in reduced downtime within the first three months.
“The most reliable unit on the market.”
In sterile processing, there is zero room for error. We chose the M19 for its exceptional accuracy at low pressures, but its rugged, portable design has been an unexpected blessing. We easily move it between cleanrooms without worrying about calibration drifts. It's the most reliable, heavy-duty piece of kit in our facility.
BACKED BY THE CERTIFICATIONS THAT MATTER
Independently audited and recognized across quality, compliance, and safety standards for Filter Integrity Tester
- 21 CFR Part 11
- ISO 9001:2015
- UKAS
- GAMP Certified
- CE Mark
See Why Pharma Companies Are Switching to the M19 FIA System
See how the Filter Integrity Test Machine compares with leading legacy systems used in regulated manufacturing.
| Performance ParameterParameter | M19 FIA SystemM19 FIA | Legacy SystemsLegacy |
|---|---|---|
 |  | |
| Test Duration | < 5 minutes | 20–30 minutes (Pressure decay) |
| Measurement Method | Real-time flow-pressure measurement | Indirect pressure-volume decay based |
| System Adaptability | AI auto-recognition (All sizes/EFAs) | Manual configuration, size-specific |
| Operator Dependency | Significantly reduced operator variability with guided AI workflows | Higher variability from manual, human-dependent setup |
| Data Storage | Up to 500 GB & Expandable | 12+ Years Data Backup | Limited Storage |
| Accuracy Standard | High precision (±0.1%) designed for regulated workflows | Good accuracy, legacy limitations |
| Flow Range | 0.01 – 1000 mL/min (Dynamic) | Limited range, fixed parameters |
Expo & Events
Meet the M19 team at leading pharmaceutical and biotechnology events across North America.
Experience live demonstrations, connect with our technical experts, and discover how M19 helps manufacturers improve compliance, reduce validation time, and optimize operational efficiency.
