Tailin HTY-305GP Triple-Channel Microbial Limit Tester

Overview

The Tailin HTY-305GP Triple-Channel Microbial Limit Tester is a purpose-built, GMP-aligned instrument engineered for quantitative microbial enumeration in pharmaceutical, biotechnology, and medical device manufacturing environments. It operates on the principle of membrane filtration — a standardized method defined in pharmacopoeial compendia including the Chinese Pharmacopoeia (ChP), United States Pharmacopeia (USP and ), and European Pharmacopoeia (Ph. Eur. 2.6.12). The system draws sample solutions through sterile, low-protein-binding microporous membranes (typically 0.45 µm or 0.22 µm pore size), retaining viable microorganisms on the filter surface. Subsequent transfer of the membrane to appropriate solid or liquid growth media enables colony formation and enumeration — thereby determining total aerobic microbial count (TAMC), total combined yeasts and molds count (TYMC), or specific pathogen presence per regulatory acceptance criteria.

Key Features

• Triple independent filtration channels enable parallel processing of up to three samples — significantly improving throughput in QC laboratories performing routine batch release testing.
• High-reliability European-sourced diaphragm pumps deliver consistent flow rates up to 1500 mL/min per channel, with precise pressure regulation to prevent membrane rupture during high-viscosity or particulate-laden filtrations.
• Each pump head features an integrated non-return valve, eliminating cross-contamination risk from backflow — a critical requirement for sterility assurance in aseptic processing environments.
• Pump heads are constructed from autoclavable materials and validated for repeated exposure to saturated steam at 121 °C for 30 minutes, supporting integration into cleanroom revalidation workflows.
• Capacitive color touchscreen provides intuitive, icon-driven operation with programmable run-time settings per channel (0–999 min), real-time status feedback, and password-protected parameter locking for audit compliance.
• Direct-discharge architecture eliminates need for intermediate vacuum flasks — reducing setup complexity, minimizing contamination vectors, and accelerating system cleaning between runs.
• Enlarged drain port and optimized internal fluid pathways ensure laminar waste egress without splashing or aerosol generation — enhancing operator safety and biosafety cabinet compatibility.

Sample Compatibility & Compliance

The HTY-305GP supports standard 47 mm or 50 mm diameter filter membranes and accommodates both reusable stainless-steel filter holders and single-use pre-sterilized test chambers (e.g., Millipore® Steritest™ or Pall® Envirocheck™ formats) via four interchangeable pump head configurations. It is compatible with aqueous, oily, and low-alcohol formulations, as well as buffered saline, soybean-casein digest broth (SCDB), and fluid thioglycollate medium (FTM) — all specified in USP and Ph. Eur. microbial limit testing protocols. Instrument design adheres to ISO 13485:2016 quality management requirements for medical device manufacturers and aligns with FDA expectations for equipment used in cGMP-regulated testing. All electronic controls meet IEC 61000-4 electromagnetic compatibility standards.

Software & Data Management

While the HTY-305GP operates as a standalone hardware platform without embedded PC-based software, its touchscreen interface logs timestamped operational records including channel activation time, runtime duration, and error codes (e.g., overpressure, motor stall). These entries are retained in non-volatile memory for ≥10,000 cycles and can be exported manually via USB for inclusion in laboratory notebooks or LIMS documentation. For full 21 CFR Part 11 compliance, integration with external electronic lab notebook (ELN) systems or validated data acquisition platforms is recommended. Audit trail functionality — including user login history and parameter modification logs — may be implemented through supplementary middleware in regulated environments.

Applications

• Routine microbial limit testing of raw materials, excipients, and finished dosage forms (tablets, capsules, injectables, ointments).
• Environmental monitoring program (EMP) support — filtration of rinse water from cleanroom surfaces or HVAC system sampling points.
• Validation of sterilization processes (e.g., filter integrity testing prior to use, post-sterilization challenge studies).
• Water-for-injection (WFI) and purified water (PW) system monitoring per USP .
• Bioburden assessment of medical devices prior to terminal sterilization (ISO 11737-1).
• QC/QA release testing in contract manufacturing organizations (CMOs) and API suppliers operating under ChP, USP, or Ph. Eur. mandates.

FAQ

Is the HTY-305GP compliant with USP and ?
Yes — its membrane filtration methodology, flow control precision, and sterility assurance features fully satisfy the procedural and equipment requirements outlined in USP chapters for microbial enumeration and absence-of-pathogens testing.
Can pump heads be sterilized in an autoclave?
Yes — all pump heads are rated for repeated autoclaving at 121 °C, 103 kPa (15 psi), for 30 minutes, with validation documentation available upon request.
Does the system support single-use test chambers?
Yes — optional pump head adapters allow seamless integration with commercially available pre-sterilized microbiological test chambers, eliminating manual filter handling and reducing human error.
What maintenance is required for long-term reliability?
Routine cleaning of pump heads and filter holders with 70% ethanol or approved disinfectants is recommended after each use; diaphragm replacement intervals are specified in the maintenance manual based on cumulative runtime hours.
Is technical support available internationally?
Tailin Biotech provides remote troubleshooting, application guidance, and calibration verification services globally through authorized distribution partners — with documentation supplied in English and adherence to ISO/IEC 17025 traceable standards where applicable.