Tailin HTY-FT224 Automated Filter Integrity Tester

Overview

The Tailin HTY-FT224 Automated Filter Integrity Tester is an engineered solution for quantitative, regulatory-compliant integrity verification of hydrophilic and hydrophobic membrane filters used in sterile pharmaceutical manufacturing, bioprocessing, and parenteral drug production. It operates on established physicochemical principles—namely gas diffusion (forward flow), capillary flow (bubble point), and liquid intrusion (water intrusion)—to non-destructively assess pore structure integrity prior to and after filtration processes. Designed to meet the stringent requirements of cGMP environments, the HTY-FT224 delivers repeatable, traceable, and auditable test outcomes aligned with global pharmacopeial standards including USP , EP 2.6.27, JP 6.07, and ISO 13408-2. Its fully automated architecture eliminates operator-dependent variability, ensuring consistency across shifts and facilities.

Key Features

• Fully automated execution of five core integrity test methods: forward flow (diffusive flow), bubble point, water intrusion, combined forward flow + bubble point, and pressure hold (pressure decay).
• Integrated high-resolution pressure transducers and mass flow sensors calibrated per ISO/IEC 17025-accredited procedures, enabling precise quantification across wide dynamic ranges.
• Intuitive 7-inch color touchscreen interface with multilingual support (English, Chinese, Spanish), configurable user roles, and built-in electronic signature capability compliant with FDA 21 CFR Part 11 Annex 11 requirements.
• Onboard audit trail with time-stamped, immutable records of all test events, parameter changes, user logins, and system alerts—retained for ≥12 months without external database dependency.
• Modular pneumatic design with stainless-steel manifolds and chemically resistant wetted materials (e.g., PTFE, 316L SS), supporting compatibility with aggressive solvents and high-purity water systems.
• Self-diagnostics and real-time sensor health monitoring—including leak detection, zero drift compensation, and pressure ramp validation—to ensure measurement integrity before each test cycle.

Sample Compatibility & Compliance

The HTY-FT224 accommodates filter housings ranging from 10-inch cartridge formats to large-scale capsule filters (up to 40-inch length) and flat-sheet membranes mounted in custom fixtures. It supports both aqueous and organic wetting agents (e.g., water, ethanol, isopropanol, 60% IPA/water), enabling validated use with hydrophobic PTFE, PVDF, and PP membranes as well as hydrophilic nylon, PES, and cellulose ester media. All test protocols are pre-configured to align with compendial acceptance criteria and can be customized to reflect site-specific SOPs. The instrument’s firmware and documentation package includes IQ/OQ templates, calibration certificates, and a full 21 CFR Part 11 compliance statement—facilitating rapid qualification in regulated environments subject to FDA, EMA, PMDA, and NMPA inspections.

Software & Data Management

Tailin IntegritySuite™ v3.2 software—embedded and optionally available for PC deployment—provides comprehensive data lifecycle control. It supports structured export of raw test data (CSV, PDF), XML-based report generation with embedded digital signatures, and seamless integration with LIMS and MES platforms via ASTM E1384-compliant interfaces. All data files include cryptographic hash values for tamper-evident archiving. Audit trail entries capture operator ID, timestamp, test method, parameters, pass/fail status, and deviation annotations—all retained locally with optional encrypted cloud backup. Electronic signatures adhere to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and support multi-level approval workflows for critical batch release decisions.

Applications

• Pre-use integrity testing of sterilizing-grade filters in aseptic processing lines.
• Post-use integrity confirmation following filtration of bulk drug substances, cell culture harvests, or final fill solutions.
• Validation of filter performance during process characterization and technology transfer studies.
• Quality control release testing for single-use bioprocess containers and integrated fluid management systems.
• Supporting root cause analysis during filter-related deviations or sterility failures under CAPA investigations.
• Facilitating regulatory submissions by providing fully documented, reproducible integrity evidence meeting ICH Q5A(R2) and Q9 expectations.

FAQ

Does the HTY-FT224 support both hydrophilic and hydrophobic membrane testing?
Yes—it is validated for use with water-wetted hydrophilic filters (e.g., PES, nylon) and solvent-wetted hydrophobic filters (e.g., PTFE, PVDF) using forward flow, bubble point, and water intrusion methods.
Can test methods be customized to match internal SOPs?
Yes—users may define custom test sequences, acceptance limits, pressure ramps, hold times, and pass/fail logic within the instrument’s configuration module, with full version-controlled change management.
Is the system compatible with existing facility automation infrastructure?
Yes—the HTY-FT224 offers Ethernet/IP and Modbus TCP connectivity, enabling direct integration with DCS, SCADA, and central monitoring systems for real-time status reporting and remote diagnostics.
What calibration and maintenance documentation is provided?
Each unit ships with a factory calibration certificate traceable to NIM (China National Institute of Metrology), annual preventive maintenance kits, and a complete set of service manuals compliant with ISO 9001 and ISO 13485 quality systems.
How is data security and long-term retention ensured?
Data encryption at rest (AES-256), role-based access control, automatic daily backups to removable SSD, and optional FIPS 140-2 certified network encryption ensure confidentiality, integrity, and availability per GAMP 5 and Annex 11 guidance.