Tailin HTY-310 Four-Channel Microbial Limit Tester

Overview

The Tailin HTY-310 Four-Channel Microbial Limit Tester is a fully integrated, GMP-aligned membrane filtration system engineered for quantitative microbial enumeration in pharmaceutical, biotechnology, and medical device quality control laboratories. It operates on the principle of vacuum-assisted membrane filtration—per ASTM D5798, USP , , and ISO 8573-7—where test samples are drawn through sterile, low-protein-binding microporous membranes (typically 0.45 µm or 0.22 µm pore size) to capture viable microorganisms. Retained microbes are then transferred onto appropriate solid or liquid growth media for incubation and colony-forming unit (CFU) enumeration. Designed in strict compliance with Chinese Pharmacopoeia (ChP) Volume IV General Chapter 1105 and 1106, the HTY-310 supports both total aerobic microbial count (TAMC) and controlled bacterial/fungal enumeration assays. Its four independent filtration channels enable parallel processing of multiple sample types—including injectables, ophthalmic solutions, raw materials, and purified water—without cross-contamination risk.

Key Features

• Four-channel independent operation with individually programmable run times (0–99 min, 1-sec resolution), enabling heterogeneous sample batch testing.
• Integrated Steam-in-Place (SIP) sterilization module compliant with ASME BPE 2023 requirements; validated for ≥121 °C, 15-min saturated steam exposure across all wetted surfaces and pump heads.
• European-sourced, oil-free diaphragm pumps delivering stable 1500 mL/min flow at ≤65 dB(A) acoustic pressure—optimized for low-vibration, high-reproducibility filtration across viscosity ranges typical of buffered saline, Lactated Ringer’s, and low-concentration APIs.
• 316L stainless steel chassis with electropolished internal fluid pathways; corrosion-resistant and passivation-compatible for cleanroom Class A/B environments.
• Touchscreen HMI with 7-inch color LCD and chemically strengthened glass interface—supports multi-language UI (English preloaded), audit-trail-enabled parameter logging, and real-time status visualization (flow rate, elapsed time, SIP cycle phase).
• Modular pump head design: four interchangeable configurations available (standard, high-flow, low-volume, and viscous-sample optimized); each rated for repeated autoclaving (121 °C, 20 psi, 30 cycles minimum) and equipped with integrated check valves to prevent backflow-induced contamination.
• Direct-waste drainage architecture eliminates need for intermediate vacuum flasks—reducing setup complexity, vapor condensation risks, and maintenance overhead while improving workflow continuity.

Sample Compatibility & Compliance

The HTY-310 accommodates standard 47-mm and 50-mm diameter sterile filter cups (e.g., Millipore Sterivex™-GP compatible housings) as well as proprietary Tailin-certified microbial detection cartridges (e.g., HTY-CF series). It supports aqueous, mildly buffered, and low-alcohol-content formulations within pH 4.0–8.5 and viscosity ≤25 cP. Instrument validation documentation includes IQ/OQ protocols aligned with EU Annex 15 and FDA Process Validation Guidance. All electronic controls conform to IEC 61000-6-3 (EMC) and IEC 61010-1 (safety). Data integrity meets ALCOA+ principles; system logs—time-stamped, user-ID-tagged, and immutable—are exportable via USB for regulatory submission (e.g., FDA 21 CFR Part 11-compliant review when paired with validated LIMS integration).

Software & Data Management

The embedded firmware provides non-volatile storage for ≥10,000 test records with full metadata (operator ID, date/time stamp, channel assignment, duration, SIP cycle confirmation). Audit trail functionality records all parameter changes, login/logout events, and sterilization sequence completions. Data export is supported in CSV format only—no proprietary binary formats—to ensure long-term readability and third-party analysis compatibility (e.g., JMP, Minitab, or internal QC dashboards). Optional RS-232 or Ethernet connectivity enables centralized monitoring in networked lab environments; no cloud dependency or external server requirement.

Applications

• Pharmaceutical final product release testing per USP , ChP 1105, and EP 2.6.12.
• Water-for-injection (WFI) and purified water system monitoring under ISO 14644-1 and PDA TR75.
• Raw material bioburden assessment prior to sterilization process qualification.
• Environmental monitoring support for Grade A/B cleanrooms (ISO 14644-1 classification verification).
• Medical device extractables and leachables microbiological safety evaluation (ISO 10993-7).
• Contract manufacturing organization (CMO) and contract development and manufacturing organization (CDMO) routine QC workflows requiring multi-user, multi-shift traceability.

FAQ

Is the HTY-310 compliant with FDA 21 CFR Part 11 for electronic records and signatures?

Yes—when deployed with configured user access levels, enabled audit trails, and exported CSV logs reviewed under documented SOPs, the system satisfies Part 11 predicate rule requirements for record retention and authenticity.
Can pump heads be sterilized using dry heat or ethylene oxide?

No—only validated moist-heat (steam) sterilization at 121 °C is supported. Dry heat or EtO may compromise diaphragm elastomer integrity and valve sealing performance.
What is the maximum allowable particulate load before filter clogging occurs?

Under standard operating conditions (0.45 µm PVDF membrane), the system maintains nominal flow up to 500 mg/L suspended solids; higher loads require pre-filtration or use of graded porosity depth filters.
Does the instrument support remote diagnostics or firmware updates?

Firmware updates are performed locally via USB drive; remote diagnostics are not implemented to maintain air-gapped data security per ISO/IEC 27001-aligned lab IT policies.
Are calibration certificates provided with each unit?

A factory-issued flow calibration certificate (traceable to NIM, China) is included; users must perform periodic verification per internal SOPs using calibrated flow meters or gravimetric methods.