What does the FIA-100 measure for biotech applications?
It characterizes bubble point, diffusion / forward flow and water-intrusion integrity, giving biotech teams quantitative data for media design, supplier qualification and lot acceptance.
EXPERIENCE THE Most Advanced Filter Integrity Analyzer
M19 Filter Integrity Analyzer (FIA-100) for biotech — AI-based, ultra-high-precision testing. Standards: ASTM F316, USP <1207>, ISO 4003.
Model: FIA-100 · Industry: Biotech
Technology principle
The M19 Filter Integrity Analyzer (FIA-100) measures bubble point, diffusion / forward flow and water-intrusion integrity for materials used across bioprocess, single-use and biotech R&D. Configured for sterile filtration, membrane performance and audit-ready bioprocess documentation, it delivers repeatable, audit-ready data so biotech teams can qualify media, accelerate development and defend specification decisions. Referenced to ASTM F316, USP <1207>, ISO 4003, the platform combines precise hardware control with electronic records suitable for regulated and industrial quality systems.
Applications
- Sterile filter integrity
- Single-use assembly QA
- Upstream/downstream filters
- PUPSIT-style checks
Key capabilities
- Lightweight, compact and ergonomically engineered, the M19 Filter Integrity Analyzer (FIA-100) pairs a 15" capacitive touchscreen with enhanced pressure- and flow-control hardware, so operators run a full biotech test sequence with minimal training and shorter cycle times. Available in aluminum or stainless-steel variants, it ships with real-time remote support, USB connectivity and remote-control automation. Domestic manufacturing in India and the USA keeps maintenance cost and downtime low, and a 2-year extended warranty is available.
- Modern, low-training user interface
- Lightweight and portable chassis
- IP65 rated · GAMP 5 compliant
- Three secure user levels — Operator, Supervisor and Administrator
- Versatile connectivity — USB, Ethernet and Wireless LAN
- Flexible reporting — built-in thermal printer or network / PDF / CSV export
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
Which standards apply in biotech workflows?
Typical references include ASTM F316, USP <1207>, ISO 4003. Method templates can be aligned to your internal SOP and customer specifications.
How does the software support audits and quality systems?
Electronic signatures, tamper-proof audit trails, role-based access and PDF/CSV export support regulated and industrial quality workflows, including LIMS hand-off.
Can the instrument be customised for our materials?
Yes — sample holders, pressure/flow ranges and report templates can be configured for biotech-specific media and acceptance criteria.
What are the advantages of indigenous manufacturing?
Make-in-India / USA build delivers faster service, spare-parts availability, lower cost of ownership and easier customisation — with extended warranty options.
How do we get started?
Book a demo with your sample set, download the brochure, or request a quote for an industry-configured system with IQ/OQ documentation support.