Tailin Biotech HTY-WP02 Endoscope Sampling Peristaltic Pump

Overview

The Tailin Biotech HTY-WP02 Endoscope Sampling Peristaltic Pump is a purpose-built, portable fluid transfer device engineered for controlled, low-contamination sampling in clinical endoscopy reprocessing validation and microbiological surveillance workflows. Unlike general-purpose peristaltic pumps, the HTY-WP02 operates as a critical interface between point-of-use endoscope channel sampling and downstream membrane filtration analysis. It delivers consistent, pulse-free aspiration at regulated flow rates—enabling reproducible recovery of residual microorganisms from narrow-lumen endoscopic channels (e.g., biopsy ports, suction channels, and irrigation lines). Its design conforms to the operational logic defined in ISO 15883-4 and AAMI ST91, where quantitative sampling volume and minimal carryover are prerequisites for valid bioburden assessment prior to sterilization or high-level disinfection.

Key Features

• Integrated silent diaphragm pump architecture—eliminates peristaltic tubing wear, reduces maintenance frequency, and ensures stable flow without pulsation-induced channel turbulence.
• Compact footprint (11 × 17 × 12 cm) and lightweight construction (2.0 kg) allow seamless integration inside biosafety cabinets (Class II A2/B2) or mobile reprocessing carts without compromising workspace ergonomics.
• Mirror-polished stainless-steel housing meets ISO 13485 surface finish requirements (Ra ≤ 0.8 µm), enabling validated wipe-down with alcohol-based or sporicidal disinfectants between samples.
• LED-illuminated tactile push-button switch provides unambiguous status feedback during operation—critical in gloved-hand environments where visual confirmation must be immediate and reliable.
• Zero-dead-volume internal fluid path: all wetted surfaces follow smooth-radius bends with no recessed joints or threaded fittings, minimizing biofilm nucleation sites and supporting routine ATP bioluminescence verification.

Sample Compatibility & Compliance

The HTY-WP02 is functionally and mechanically optimized for use with Tailin’s FC501 Series Endoscope Sampling Devices—single-use, sterile, dual-chamber units designed to capture and seal aspirated rinse volumes (typically 50–100 mL) directly from endoscope channels. The pump’s flow profile and pressure response have been validated across the full range of FC501 configurations (standard, pediatric, and high-flow variants). It supports compliance with FDA Guidance for Reprocessing Medical Devices in Health Care Settings (2023), EU MDR Annex I General Safety and Performance Requirements (GSPR 10.1–10.3), and CLSI MM12-A standard procedures for endoscope bioburden testing. All materials in contact with sampled fluid comply with USP and cytotoxicity and extractables testing.

Software & Data Management

The HTY-WP02 operates as a standalone hardware module with no embedded firmware or digital connectivity. This analog architecture eliminates cybersecurity vulnerabilities and simplifies regulatory validation—particularly under FDA 21 CFR Part 11 and EU Annex 11 requirements for audit-trail integrity. Sample metadata (operator ID, endoscope serial number, sampling time, channel type) is recorded manually or via integration with LIMS using barcode-scanned FC501 device labels. The pump’s mechanical consistency supports GLP-compliant documentation: flow rate stability is verified quarterly using calibrated volumetric flasks and stopwatch timing per ASTM D1193 Grade III water standards.

Applications

• Quantitative microbial recovery from gastrointestinal, bronchoscopic, and urological endoscopes post-reprocessing.
• Validation of automated endoscope reprocessors (AERs) per AAMI TIR30 and ISO 15883-5.
• Environmental monitoring of reprocessing room air and sink surfaces using impinger-based collection protocols.
• Controlled dilution series preparation for MALDI-TOF MS identification workflows—leveraging its precise low-flow capability (adjustable via external rheostat, not included).
• Supporting ISO 14644-1 Class 5 cleanroom sampling when paired with sterile filter holders and vacuum manifolds.

FAQ

Is the HTY-WP02 compatible with non-Tailin sampling devices?
The pump’s flow dynamics and connector geometry are calibrated specifically for FC501-series devices; third-party adapters may compromise seal integrity and invalidate ISO 15883-4 compliance.
Does it require calibration or scheduled maintenance?
No scheduled calibration is mandated; however, flow verification against a certified volumetric standard is recommended before each daily shift per internal SOPs aligned with ISO/IEC 17025 Clause 7.7.
Can it be used with corrosive disinfectants such as ortho-phthalaldehyde (OPA)?
The diaphragm material (EPDM/FKM composite) is resistant to OPA, glutaraldehyde, and peracetic acid at typical use concentrations; prolonged exposure to >2% hydrogen peroxide is not advised.
What electrical safety certifications does it hold?
Certified to GB 4793.1–2019 (equivalent to IEC 61010-1:2010) for laboratory equipment, including protection against electric shock, mechanical hazards, and abnormal temperature rise.
Is the battery replaceable by the end user?
Yes—the 12 V / 5600 mAh LiFePO₄ pack is field-replaceable using Torx T8 tools; replacement kits include CE-marked cells with integrated thermal cutoffs and UL 1642 compliance documentation.