Filter Integrity Analyzer | Products M19 Material Intelligence lab Vadodara Gujarat

EXPERIENCE THE WORLD’S MOST ADVANCED
FILTER INTEGRITY ANALYZER

5x Faster
Unlimited Data Storage
21 CFR Part 11 Compliant
Audit Trail & Access Controls

TRUSTED BY

DISCOVER WHY INDUSTRY LEADERS ARE CHOOSING M19 FIA

TECHNOLOGY

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

CUTTING EDGE DESIGN

SIMPLE | INTELLIGENT | MORE INTEGRATED

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.

Available in aluminum or stainless steel variants, it includes real-time remote support, USB connectivity, and remote-control automation for unmatched flexibility. Engineered for negligible maintenance costs and domestic manufacturing in India and USA to eliminate downtime with quick service support.

2-Year Extended Warranty Available – Ensuring long-term reliability and peace of mind.

Modern User Interface
Light Weight & Portable
IP65 Rated & GAMP 5 Complaint

ADVANCED SOFTWARE

AI BASED | DYNAMIC REPORTS | EASY TO USE

Experience unprecedented visualization and collaboration with the M19 cognitive software control program. AI-driven features virtually eliminate user bias in data acquisition and interpretation, redefining how your team generates and consumes data.

Unlimited data and user storage, audit trails, and electronic signatures ensure 21 CFR Part 11 compliance. Supports PLC/SCADA integration for remote operation and automated data transfer.

KEY FEATURES

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

HIGH PERFORMANCE COMPUTING

INCREASED PRECISION | ACCURACY | REPRODUCIBILITY

Powered by cutting-edge ARM7 32-bit processors, the M19 FIA delivers consistent, reliable results across all platforms. With proprietary MFC based system, intelligent test algorithms, it sets a new standard for filter characterization in pharmaceutical integrity testing.

Domestic supply chain ensures rapid service and no downtime, backed by global calibration centers.

FAQ's

1 - WHAT TYPES OF TESTS IS FIA 100 CAPABLE OF?−

M19's FIA 100 supports a complete suite of filter integrity tests:

Bubble Point (BP) Test
Forward Flow / Diffusional Flow (FF/DF) Test
Combined BP + DF Test
Water Intrusion Test (WIT)
Pressure Decay Test

2 - HOW DOES M19 FIA 100 OUTPERFORM TRADITIONAL INTEGRITY TESTERS?+

Compared to imported systems, the M19 FIA 100 is:

5x faster in Bubble Point testing
Performs Forward Flow testing (0.1–1000 mL/min) in under 10 minutes
Offers unlimited data storage, intelligent auto-calibration, and an AI-driven software interface
Designed for rapid validation and minimal downtime in GMP facilities
Fully 21 CFR Part 11 compliant, including audit trails, role-based access controls, and secure data logging

3 - HOW DOES THE MFC-BASED SYSTEM IMPROVE TEST ACCURACY?+

The M19 FIA 100 uses a proprietary Mass Flow Controller (MFC) that:

Directly measures gas flow at constant pressure for highest accuracy
Eliminates variability and errors common in volume-based/pressure decay methods
Delivers ±3% or ±0.05 mL/min flow accuracy
Enables ultra-stable testing at 0.01–1000 mL/min
Features automated self-calibration for zero-drift performance

4 - WHAT ARE THE ADVANTAGES OF DOMESTIC MANUFACTURING?+

Faster service response and local support
Reduced lead times and spare parts availability
Lower shipping/import costs
Easy customization and upgrades
Complies with Make in India & global GMP norms
Comes with 2-year warranty and on-site support team across India

5 - CAN FIA-100 BE INTEGRATED INTO EXISTING PHARMA WORKFLOWS?+

Yes — FIA 100 supports seamless integration via:

USB, Ethernet, RS232, and SCADA/PLC compatibility
Remote support and data backup on cloud/local servers
Easy implementation into 21 CFR Part 11 GMP workflows
Supports high-volume batch testing, validation reporting, and electronic approvals

6 - 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:

Electronic signatures, multi-tier user access control, and tamper-proof audit trails
Secure storage of test data, metadata, and PDF/CSV reports
Time-stamped logging of every test action, parameter change, and result
Validation-ready documentation (DQ, IQ, OQ, PQ) for regulatory audits

The system is built to align with US FDA guidelines, EU Annex 11, MHRA, and WHO GMP principles — ensuring that sterility validation data from M19’s FIA is legally defensible and audit-ready in all major markets

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