Tailin HTY-103 Portable Microbial Limit Tester

Overview

The Tailin HTY-103 Portable Microbial Limit Tester is a compact, battery-powered filtration-based microbial enumeration system engineered for regulatory-compliant membrane filtration testing in controlled and field-deployable environments. It operates on the principle of vacuum-assisted or pressure-driven membrane filtration—where liquid samples are drawn through sterile, low-binding, 0.45 µm (or 0.22 µm) pore-size membranes to capture viable microorganisms. Captured microbes are then transferred onto appropriate solid or liquid culture media for incubation and colony enumeration. Unlike integrated-pump instruments with internal fluid pathways, the HTY-103 adopts an external peristaltic pump architecture with zero internal tubing—eliminating cross-contamination risks, simplifying cleaning validation, and enabling rapid reconfiguration for diverse sample matrices. Its design aligns with core pharmacopeial methodologies described in USP , , EP 2.6.12, and ISO 8573-7 for microbial enumeration and absence-of-microorganisms testing.

Key Features

• External high-performance peristaltic pump module—certified for >10,000 hours MTBF, delivering stable flow rates ≥900 mL/min with minimal pulsation and consistent shear profile across viscosity ranges (1–100 cP)
• Non-invasive fluid path: no internal wetted components; complete separation between pump drive mechanism and sample stream ensures compliance with ALCOA+ data integrity principles
• Integrated rechargeable lithium-ion battery (5600 mAh) supports continuous operation for up to 4.5 hours at nominal load—validated under IEC 62133 for safe portable use in cleanrooms and mobile QC labs
• Mirror-polished AISI 304 stainless steel housing (Ra ≤ 0.4 µm), compatible with common disinfectants (e.g., 70% IPA, sodium hypochlorite ≤500 ppm) and validated for repeated autoclave-compatible surface wipe tests
• LED-based real-time RPM display enables precise pump speed monitoring—critical for method transfer consistency and SOP adherence during filter saturation optimization
• Modular consumable interface: mechanically compatible with standard F47B-series filtration cups (including 47-mm and 50-mm variants), endoscope sampling manifolds, and ISO-certified sterile membrane filters (cellulose ester, PVDF, PES)

Sample Compatibility & Compliance

The HTY-103 accommodates aqueous and low-viscosity non-corrosive samples across pharmaceutical raw materials, purified water, WFI, compressed gases (via impinger adapters), food homogenates, environmental swab rinsates, and drinking water. It supports both qualitative (absence/presence) and quantitative (CFU/mL or CFU/g) testing workflows compliant with FDA Guidance for Industry (2022), EU GMP Annex 1 (2022), and WHO TRS 1033. All mechanical interfaces meet ISO 8573-7 mechanical interface tolerances for filter holder alignment. The device itself carries CE marking per Medical Device Regulation (MDR) Class I (Annex VIII), and its firmware architecture supports audit trail generation per 21 CFR Part 11 when paired with Tailin’s optional LIMS-integrated data capture software.

Software & Data Management

While the base HTY-103 operates as a standalone hardware platform, optional firmware upgrades enable USB-C connectivity to Windows-based PCs running Tailin’s TraceLink™ Data Logger v3.2. This application provides electronic batch records with timestamped pump runtime logs, operator ID tagging, filter lot traceability, and PDF export of test summaries—including metadata fields aligned with Annex 11 requirements. All data entries are immutable post-generation, with role-based access control (RBAC) and digital signature support for GLP/GMP environments. No cloud storage is embedded; all data resides locally unless explicitly exported via encrypted USB media.

Applications

• Pharmaceutical QC labs performing microbial limits testing on excipients, APIs, and final dosage forms per USP
• Contract manufacturing organizations (CMOs) requiring rapid deployment for environmental monitoring (EM) program verification in Grade C/D cleanrooms
• Food safety laboratories conducting aerobic plate counts (APC) and coliform screening per ISO 4833-1 and ISO 4831
• Public health institutions performing routine water quality surveillance in resource-limited settings—leveraging portability and battery autonomy
• Medical device manufacturers validating bioburden on single-use components prior to sterilization (ISO 11737-1)

FAQ

Is the HTY-103 suitable for sterility testing?
No—it is designed exclusively for microbial limit testing and enumeration, not for full sterility test protocols requiring double-filter validation and aseptic isolation chambers.
Can it be used with 0.22 µm filters for detecting mycoplasma or small bacteria?
Yes, provided the filter membrane is certified for microbiological retention (e.g., certified 0.22 µm PVDF) and the sample matrix does not cause premature clogging; flow rate adjustment may be required.
Does the device support IQ/OQ documentation packages?
Yes—Tailin provides vendor-qualified IQ/OQ templates aligned with ASTM E2500 and ISPE GAMP5, including pump calibration certificates traceable to NIM (China National Institute of Metrology).
What maintenance intervals are recommended for the peristaltic pump tubing?
Tubing replacement is advised every 500 operational hours or after 200 filtration cycles—whichever occurs first—to maintain flow accuracy within ±3% tolerance.
Is the stainless steel housing compatible with vaporized hydrogen peroxide (VHP) decontamination?
Yes, but only in ambient-phase VHP cycles (≤100 ppm, 25–30°C); extended exposure to condensate-phase VHP (>70% RH) is not validated and may affect display electronics.