What types of tests is FIA-100 capable of?
M19's FIA-100 supports a complete suite of filter integrity tests:
EXPERIENCE THE Most Advanced Filter Integrity Analyzer
M19 Filter Integrity Analyzer (FIA-100) for pharmaceutical — AI-based, ultra-high-precision testing. Standards: ASTM F316, USP <1207>, ISO 4003.
Model: FIA-100 · Industry: Pharma
Technology principle
The M19 Filter Integrity Analyzer (FIA-100) is a next-generation Filter Integrity Analyzer engineered for high-precision gas flow and pressure measurement in filter testing & validation. Unlike conventional volume-based or pressure decay methods, it leverages cutting-edge Mass Flow Controller (MFC) technology for exceptional accuracy, stability, and real-time responsiveness. M19’s proprietary MFC-based approach eliminates inaccuracies, ensuring superior reproducibility even at ultra-low flow rates. Equipped with automated self-calibration, it adjusts for environmental factors and filter variations, delivering consistent results without manual recalibration. Ideal for Bubble Point Testing, Forward Flow Testing, Water Intrusion, and Pressure Decay Tests, the M19 FIA streamlines filter integrity validation, aiding Sterility Assurance, Product Quality, and Regulatory Compliance in pharmaceutical manufacturing and biotechnology.
Applications
- Cartridge Filter
- Capsule Filter
- Syringe Filter
- Flat Sheet
- TFF
- Bag Filter
Key capabilities
- Lightweight, compact, and ergonomically designed, the M19 FIA-100 features a revolutionary 15" touchscreen interface that simplifies operation and requires minimal user training. Enhanced pressure and flow control systems guarantee measurement precision while significantly reducing test durations.
- Modern User Interface
- Light Weight & Portable
- IP65 Rated & GAMP 5 Compliant
- Three user levels (Operator, Supervisor, Administrator) with secure access
- Versatile connectivity: USB, Ethernet, Wireless LAN
- Flexible printing: Built-in thermal printer or network/PDF exports
Technical specifications
| Specification | Value |
|---|---|
| Test methods | Bubble point · Forward flow · WIT · Pressure decay |
| Bubble point | 50–8000 ± 50 mbar |
| Forward flow | 0.1–1000 ± 0.1 mL/min |
| Interface | 15" color LCD touchscreen |
| Compliance | 21 CFR Part 11 · GAMP 5 · GMP |
| Enclosure | IP65 rated |
Standards compliance
- ASTM F316
- USP <1207>
- ISO 4003
Frequently asked questions
How does M19 FIA-100 outperform traditional integrity testers?
Compared to imported systems, the M19 FIA-100 is:
How does the MFC-based system improve test accuracy?
The M19 FIA-100 uses a proprietary Mass Flow Controller (MFC) that:
What are the advantages of domestic manufacturing?
Can FIA-100 be integrated into existing pharma workflows?
Yes — FIA-100 supports seamless integration via:
How does the M19 FIA-100 support global regulatory compliance (e.g., US FDA, EU GMP, WHO GMP)?
The M19 FIA-100 is engineered with full 21 CFR Part 11 compliance at its core — including: