Tailin HTY-FT223Pro Automated Filter Integrity Tester

Overview

The Tailin HTY-FT223Pro Automated Filter Integrity Tester is an engineered solution for quantitative, non-destructive verification of membrane filter integrity in pharmaceutical, biotechnology, and sterile manufacturing environments. It operates on established physical principles defined in regulatory guidance—including ASTM F838-22 (for bacterial retention), ISO 13408-2 (sterile processing), and USP (Package Integrity Evaluation)—to validate the pore structure and defect-free continuity of hydrophilic and hydrophobic filters used in final product filtration, buffer preparation, and process air/gas systems. The instrument supports five primary test modes: Forward Flow (Diffusive Flow), Bubble Point, Water Intrusion, Combined Forward Flow/Bubble Point, and Pressure Hold—each executed under programmable pressure ramping, stabilization, and measurement protocols compliant with current Good Manufacturing Practice (cGMP) documentation requirements.

Key Features

• Fully automated test execution with integrated pneumatic control, eliminating manual pressure regulation and operator-induced variability.
• Dual-sensor architecture: high-resolution pressure transducer (1 mbar resolution) and mass flow sensor calibrated for both gas diffusion (forward flow) and liquid displacement (water intrusion) measurements.
• Intelligent leak compensation algorithm that distinguishes true diffusive flow from system leakage during forward flow testing, improving pass/fail decision robustness.
• Hydrophobic filter validation via Water Intrusion Test (WIT), enabling low-surface-tension integrity assessment without organic solvents—aligned with environmental, health, and safety (EHS) best practices.
• Real-time graphical display of pressure vs. time and flow vs. time curves during test execution, supporting immediate visual verification of test behavior.
• Onboard data storage with timestamped test records, including operator ID, filter lot number, test parameters, raw sensor outputs, and pass/fail conclusions.

Sample Compatibility & Compliance

The HTY-FT223Pro accommodates standard filter housings (e.g., cartridge, capsule, disc) with common connection interfaces (e.g., 222 O-ring, 226 flat-bottom, luer-lock). It supports integrity testing of filters ranging from 0.1 µm to 0.45 µm pore size, including polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, and mixed cellulose ester (MCE) membranes. All test methods conform to internationally recognized standards: forward flow and bubble point tests meet the criteria outlined in FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004) and EMA Annex 1 (2022); water intrusion testing follows the methodology referenced in USP . The system architecture supports 21 CFR Part 11-compliant electronic records when integrated with validated LIMS or MES platforms—enabling audit-ready traceability, user access controls, and electronic signatures.

Software & Data Management

The embedded firmware provides intuitive touch-screen navigation with multilingual UI (English, Chinese, Spanish). Test methods are stored as configurable templates—each defining pressure setpoints, ramp rates, hold durations, acceptance criteria, and auto-calculation logic per USP equations. Raw data export is supported via USB drive in CSV format, preserving all intermediate readings (pressure, temperature, flow, elapsed time) for external statistical analysis (e.g., trend monitoring, SPC charts). Optional PC-based software (HTY-Control Suite v3.2) enables centralized method management, remote test initiation, batch report generation (PDF/Excel), and integration with electronic batch records (EBR) systems. All data modifications are logged with immutable audit trails, including timestamp, user ID, action type, and pre-/post-change values—fully satisfying ALCOA+ principles.

Applications

• Pre-use and post-use integrity verification of sterilizing-grade filters in biopharmaceutical downstream processing (e.g., monoclonal antibody purification).
• Validation of vent filters in stainless-steel tanks, single-use bioreactors, and fluid transfer assemblies.
• Quality control release testing of pre-sterilized filter cartridges supplied to contract manufacturing organizations (CMOs).
• Supporting filter suitability studies during process validation (Stage 1–3 per ICH Q5A/R2).
• Environmental monitoring filter integrity checks in cleanroom HVAC systems and compressed gas networks.

FAQ

Does the HTY-FT223Pro support IQ/OQ/PQ documentation packages?
Yes—Tailin provides standardized qualification protocols (including test scripts, acceptance criteria, and blank record templates) aligned with ASTM E2500 and ISPE GAMP 5 for installation, operational, and performance qualification.
Can the instrument be calibrated in-house?
Yes—built-in calibration routines allow verification of pressure and flow sensors using NIST-traceable reference standards; full calibration certificates are issued upon completion by authorized service engineers.
Is temperature compensation applied during forward flow testing?
Yes—the system measures ambient temperature in real time and applies correction factors per the ideal gas law to normalize flow readings to 20 °C, ensuring consistency across laboratory environments.
What regulatory audits has this model been successfully inspected under?
The HTY-FT223Pro has been cited in multiple FDA pre-approval inspections (PAIs) and EMA GMP inspections for its role in filter integrity data integrity, particularly regarding electronic record retention and change control compliance.
How is data backup and recovery managed?
Local data is mirrored automatically to internal flash memory and external USB storage at test completion; encrypted database backups can be scheduled daily via network share when connected to a corporate domain.