Tailin HTY-601C Intelligent Microbial Collection System

Overview

The Tailin HTY-601C Intelligent Microbial Collection System is a precision-engineered, laboratory-grade device designed for membrane filtration-based microbial recovery in pharmaceutical, biotechnology, and clinical quality control environments. It operates on the principle of vacuum-assisted, controlled-flow filtration—drawing sample fluid through sterile, low-protein-binding filter membranes (typically 0.22 µm or 0.45 µm pore size) to retain viable microorganisms on the membrane surface for subsequent enumeration or identification. Unlike generic vacuum pumps, the HTY-601C integrates closed-loop motor control and real-time torque feedback to maintain consistent volumetric flow rates across variable backpressure conditions—critical for reproducible recovery of stressed or slow-growing organisms such as Pseudomonas aeruginosa, Bacillus subtilis, or Candida albicans. Its design complies with core procedural requirements outlined in USP Chapter <71> Sterility Tests, EP 2.6.1 Sterility Testing, and ISO 11737-1:2018 for microbiological validation of medical devices.

Key Features

• Intelligent Speed Regulation: Brushless DC motor with digital PID control enables continuous 0–300 rpm adjustment in 1-rpm increments; speed is retained after power cycle via non-volatile memory.
• Four-Layer Electrical Protection: Integrated circuitry monitors current draw, input voltage, load torque, and rotor position to prevent damage during tubing occlusion, filter clogging, or power fluctuation.
• Pump Head Safety Mechanism: Mechanical interlock prevents operation unless the pump head is fully seated and the silicone tubing is correctly aligned—reducing risk of accidental detachment or leakage during prolonged filtration.
• Ergonomic Human-Machine Interface: 3.5-inch color LCD display with backlight provides real-time rpm readout, elapsed time, and system status icons; PET membrane keypad supports glove-compatible operation and resists ethanol-based disinfectants.
• Compact Modular Architecture: Footprint of only 23.0 × 31.0 cm facilitates placement inside biosafety cabinets (Class II A2/B2) or laminar flow hoods without compromising workspace clearance or airflow integrity.
• Low-Noise Operation: Acoustic emission ≤52 dB(A) at 1 m distance ensures compatibility with quiet-zone laboratories and reduces operator fatigue during multi-hour sterility testing batches.

Sample Compatibility & Compliance

The HTY-601C is validated for use with standard 47-mm and 50-mm diameter sterile filter holders (e.g., Millipore® Sterivex™, Sartorius® Minisart™ NML), compatible with both aqueous and moderately viscous pharmaceutical preparations—including injectables, ophthalmic solutions, and buffered saline formulations. It supports filtration volumes from 10 mL to 2,000 mL per test unit, accommodating single-dose vials, multi-dose containers, and bulk process intermediates. All wetted parts are constructed from FDA-compliant, USP Class VI-certified polymers (polypropylene housing, silicone peristaltic tubing). The system meets electromagnetic compatibility (EMC) requirements per IEC 61326-1:2020 and electrical safety standards per IEC 61010-1:2010. While not inherently 21 CFR Part 11 compliant, audit trails and electronic records can be generated when integrated with validated LIMS or ELN platforms supporting ALCOA+ data integrity principles.

Software & Data Management

The HTY-601C operates as a standalone hardware platform with no embedded firmware-based data logging. However, its analog/digital I/O interface (optional RS-232 or USB-to-serial adapter) allows integration with third-party laboratory information management systems (LIMS) or electronic lab notebooks (ELN) for automated timestamped capture of start/stop events, selected rpm, and runtime duration. For GLP/GMP environments, users may deploy external programmable logic controllers (PLCs) or industrial PCs to enforce SOP-driven workflows, including pre-set speed profiles, automatic shutdown upon completion, and digital signature capture for operator verification. Calibration certificates traceable to NIM (National Institute of Metrology, China) are provided with each unit, covering speed accuracy (±1 rpm at 100–300 rpm) and timer deviation (< ±0.5 s/h).

Applications

• Sterility testing of finished pharmaceutical products per USP <71> and Ph. Eur. 2.6.1
• Microbial limit testing of non-sterile APIs and excipients (USP <61>)
• Environmental monitoring filter analysis in cleanroom classification (ISO 14644-1)
• Bioburden assessment of medical device packaging components (ISO 11737-1)
• Validation of depyrogenation tunnels and autoclave cycles using biological indicators
• QC release testing of cell culture media and buffer solutions in biomanufacturing

FAQ

Is the HTY-601C suitable for use with corrosive solvents such as acetone or isopropanol?
No. The pump head and tubing are rated for aqueous and mildly acidic/basic solutions only. Exposure to organic solvents may degrade silicone tubing and compromise seal integrity.
Can the device be calibrated in-house using standard weights or tachometers?
Speed calibration requires a certified optical tachometer traceable to national standards; torque and overload thresholds must be verified using manufacturer-supplied diagnostic firmware—only authorized service centers perform full recalibration.
Does the system support dual-channel parallel filtration?
The HTY-601C is a single-pump-head configuration. Parallel processing requires two independent units or upgrade to the HTY-602 series with dual independent drive modules.
What maintenance intervals are recommended for routine operation?
Silicone tubing should be replaced every 200 hours of cumulative operation or after 100 sterilization cycles (autoclave or gamma); pump head bearings require inspection every 12 months by qualified technical personnel.
Is there a CE mark or UKCA certification for export to Europe or the UK?
The HTY-601C carries CE marking under the Machinery Directive 2006/42/EC and EMC Directive 2014/30/EU; UKCA marking is available upon request with updated DoC referencing UK Statutory Instrument 2019 No. 632.