Tailin Biotech FC501 Series Endoscope Sampling Device

Overview

The Tailin Biotech FC501 Series Endoscope Sampling Device is a sterile, single-use, vacuum-assisted sampling system engineered for quantitative microbial recovery from flexible endoscopes and other complex lumened medical devices. Designed in accordance with ISO 15883-4 and AAMI ST91 requirements for reprocessing validation, the FC501 operates on a closed-loop filtration principle: after in-situ rinsing or flush sampling using the HTY-WP02 peristaltic sampling pump, the device is sealed and transported to the microbiology laboratory for immediate membrane filtration via the HTY-101 Microbial Testing Instrument. This workflow eliminates open handling, minimizes environmental contamination risk, and ensures traceable, reproducible recovery of microorganisms—including bacteria, yeasts, and spores—from narrow-bore channels (≥2.8 mm internal diameter) and irregular internal surfaces.

Key Features

• 120 mL high-transparency, impact-resistant polycarbonate cup body—optically clear for real-time volume verification and post-filtration visual inspection of filter integrity;
• Validated 0.45 µm pore-size membrane options: mixed cellulose ester (MCE), nylon, and polyethersulfone (PES)—each selected for high microbial retention efficiency (>99.9% for Pseudomonas aeruginosa ATCC 15442 at 10⁴ CFU/mL) and low background interference in subsequent culture;
• Luer-lock and Luer-slip compatible interfaces with integrated silicone sealing plugs—ensuring leak-tight connection to suction tubing, syringes, or automated fluid handlers without residual drip or air ingress;
• Threaded Luer taper interface (ISO 594-1) with ≥0.5 Nm torque retention—enabling rapid, tool-free attachment/detachment while maintaining pressure integrity during vacuum-driven filtration;
• Dual-access design: dedicated biopsy port for instrument channel sampling and side-port syringe docking for auxiliary rinse injection or pressure equalization;
• Ethylene oxide (EO) sterilized (ISO 11135-compliant cycle), individually wrapped, with full sterility assurance level (SAL) of 10⁻⁶ and bioburden documentation per batch.

Sample Compatibility & Compliance

The FC501 Series is validated for use with gastrointestinal, bronchoscopic, and urological endoscopes conforming to ISO 8600-1 and IEC 62353. It supports sampling protocols aligned with USP , EP 2.6.12, and FDA Guidance for Industry: “Reprocessing Medical Devices in Health Care Settings.” Membrane compatibility extends to standard microbiological media (TSA, SDA, R2A) and enumeration methods including colony-forming unit (CFU) counting, membrane filtration, and ATP bioluminescence assay. Device architecture meets ISO 13485:2016 design control requirements and is suitable for GLP/GMP environments requiring audit-ready documentation.

Software & Data Management

While the FC501 itself is a passive hardware component, its integration into digital quality workflows is enabled through compatibility with HTY-101 instrument firmware (v3.2+), which supports 21 CFR Part 11–compliant electronic records: user authentication, audit trails for filter lot numbers, sample IDs, operator signatures, and timestamped filtration logs. Data export is available in CSV and PDF formats for inclusion in validation reports, CAPA documentation, or regulatory submissions (e.g., FDA 510(k), CE Technical File).

Applications

• Verification of endoscope reprocessing efficacy in hospital central sterile supply departments (CSSD);
• Microbial load monitoring during routine surveillance testing per AORN and SGNA guidelines;
• Validation of automated endoscope reprocessors (AERs) under simulated worst-case soiling conditions;
• Environmental monitoring of water used in reprocessing (e.g., final rinse water bioburden assessment);
• Research applications involving biofilm recovery from lumen surfaces and antimicrobial coating performance evaluation.

FAQ

Is the FC501 Series compatible with non-Tailin filtration instruments?
Yes—its standardized Luer interfaces and 0.45 µm membrane format ensure interoperability with any vacuum-driven filtration system meeting ISO 8573-1 Class 2 compressed air purity or equivalent clean-vacuum specifications.
Can the same FC501 unit be reused after EO sterilization?
No—FC501 is designed strictly as a single-use device per ISO 15223-1 and AAMI TIR30; reuse invalidates sterility claims and compromises membrane integrity verification.
What is the maximum allowable particulate load before filter clogging occurs?
Under validated conditions (≤10⁵ particles/mL, ≤50 µm median size), the PES membrane maintains >95% flow rate stability over 120 mL filtration; higher particulate loads require pre-filtration or protocol adjustment.
Does Tailin provide method qualification support for laboratory implementation?
Yes—Tailin offers application notes, third-party validation reports (per ISO 11737-1), and on-site technical assistance for IQ/OQ/PQ execution in compliance with ISO/IEC 17025-accredited labs.