Tailin HTY-602A Intelligent Microbial Collection System

Overview

The Tailin HTY-602A Intelligent Microbial Collection System is a purpose-built, microprocessor-controlled membrane filtration apparatus engineered for sterility testing in pharmaceutical, biotechnology, and clinical laboratory environments. It operates on the principle of vacuum-assisted, positive-pressure-driven filtration—where test samples (e.g., large-volume parenterals, antibiotic solutions, or buffered saline preparations) are drawn through sterile, low-protein-binding 0.22 µm or 0.45 µm membrane filters under controlled rotational pump action. The system’s core function is to concentrate viable microorganisms from liquid specimens onto the filter surface, enabling subsequent incubation and colony enumeration per USP , EP 2.6.1, and ISO 11737-2 requirements. Unlike legacy peristaltic systems, the HTY-602A integrates real-time environmental monitoring (ambient temperature and relative humidity) directly into its operational workflow—critical for maintaining GLP-compliant documentation integrity during validation and routine testing.

Key Features

• Stepless speed control (15–300 rpm) with four user-defined presets and automatic speed memory retention across power cycles
• High-contrast color LCD interface displaying real-time rotational speed, elapsed filtration time, ambient temperature (±0.5 °C accuracy), and relative humidity (±3% RH resolution)
• Tempered glass capacitive touch panel with digital pulse rotary encoder for precise, glove-compatible operation in cleanroom environments (ISO Class 5–8)
• Dual manual tubing clamps supporting standard 13 mm or 16 mm silicone or Santoprene® peristaltic tubing—compatible with both open- and closed-system filtration assemblies
• IP67-rated waterproof footswitch enabling hands-free start/stop actuation without compromising barrier integrity during aseptic processing
• Integrated quadruple safety architecture: electronic overcurrent cutoff, voltage surge suppression, motor torque limiting, and stall detection with audible and visual alarm signaling

Sample Compatibility & Compliance

The HTY-602A is validated for use with aqueous, low-viscosity pharmaceutical preparations ranging from 10 mL to 50 mL volumes—including intravenous infusions, ophthalmic solutions, and injectables. Its pump head design minimizes shear stress on sensitive microorganisms (e.g., Candida albicans, Bacillus subtilis spores), preserving viability during filtration. The system conforms to mechanical and electrical safety standards IEC 61010-1 and GB 4793.1. While not intrinsically compliant with FDA 21 CFR Part 11 out-of-the-box, its digital audit trail—capturing speed settings, runtime, date/time stamps, and environmental metadata—supports traceable data reconstruction required for GMP Annex 11 and EU GMP Chapter 4 assessments when paired with validated electronic record procedures.

Software & Data Management

The HTY-602A operates as a standalone hardware platform with no embedded firmware-based data export capability. All operational parameters and environmental readings are retained locally on the device’s non-volatile memory for up to 100 test cycles. For regulatory-grade documentation, users must manually transcribe timestamped values into laboratory notebooks or LIMS-integrated worksheets. Future integration with Tailin’s optional HTY-Link data bridge module (sold separately) enables RS-232 or USB-C output of CSV-formatted logs—including speed profile ID, duration, ambient conditions, and fault event codes—for alignment with ALCOA+ data integrity principles.

Applications

• Sterility testing of terminally sterilized large-volume parenterals (LVPs) per USP
• Microbial load assessment in pre-filtration process streams for biologics manufacturing
• Environmental monitoring sample concentration in HVAC system validation studies
• Method suitability verification for new drug product formulations containing surfactants or viscosity modifiers
• Training and competency assessment of QC microbiologists in aseptic filtration technique

FAQ

Is the HTY-602A suitable for testing viscous or particulate-containing formulations?
The system is optimized for low-viscosity, particle-free solutions. Samples exceeding 15 cP or containing >5 µm suspended solids require pre-filtration or alternative validation per USP .

Does the unit include calibration certificates or IQ/OQ documentation?
Factory calibration reports are provided with each unit. Full qualification packages (IQ/OQ/PQ) must be generated by the end-user’s QA department using Tailin’s protocol templates and NIST-traceable reference standards.

Can the pump head be autoclaved?
No—the pump head assembly contains electronic components and is not autoclavable. Sterilization is achieved via VHP (vaporized hydrogen peroxide) or 70% IPA wipe-down per manufacturer-recommended SOPs.

What tubing materials are validated for use with this system?
Tailin validates silicone (Shore A 50) and Santoprene® 101-64 tubing. Use of third-party tubing requires revalidation of flow consistency and microbial retention integrity.