Tailin HTY-602S Sterile Bacterial Collection System

Overview

The Tailin HTY-602S Sterile Bacterial Collection System is an engineered solution for membrane filtration-based sterility testing in aseptic pharmaceutical manufacturing and quality control environments. It operates on the principle of vacuum-assisted, positive-pressure-driven microbial retention—where test samples are drawn through sterile, low-protein-binding 0.45 µm or 0.22 µm filter membranes housed in validated, single-use, sterile vented filter housings. Unlike conventional open-frame collection instruments, the HTY-602S integrates a fully sealed enclosure that prevents ambient particulate ingress and eliminates surface contamination pathways during operation. Its design conforms to the functional requirements outlined in USP , Ph. Eur. 2.6.1, and ISO 11737-1 for sterility assurance, supporting both direct inoculation and membrane filtration methodologies under Grade A laminar airflow or isolator conditions.

Key Features

• Hermetically sealed chassis rated to IPX4, enabling safe operation in high-humidity cleanroom zones and compatibility with routine wet decontamination protocols.
• Tempered glass capacitive touchscreen interface with intuitive icon-driven navigation—eliminating mechanical potentiometers and reducing particulate shedding risks associated with traditional rotary speed controls.
• Four programmable rotational speed presets (15, 60, 120, and 300 rpm), each independently configurable and recallable via one-touch activation—ensuring consistent flow dynamics across multiple operators and shifts.
• Integrated pump head safety architecture featuring real-time monitoring for overcurrent, overvoltage, motor overload, and rotor stall events—automatically halting operation and logging fault codes for traceability.
• Vapor-phase sterilant compatibility confirmed per VHP® (35% w/w hydrogen peroxide) exposure cycles up to 1,200 ppm·min, as well as EtO and formaldehyde fumigation protocols aligned with ISO 14937 Annex C.
• Isolator-ready form factor: compact footprint (230 × 310 × 115 mm) and height-optimized suspension geometry (430 mm total) allow unobstructed integration into standard RABS and closed isolator workspaces without floor penetration or custom mounting brackets.

Sample Compatibility & Compliance

The HTY-602S supports all commercially available, regulatory-compliant sterile filtration assemblies—including Millipore Steritop®, Pall Acrodisc® PSF, and Sartorius Minisart® NML—when used with appropriate filter membrane ratings (0.22 µm for bacteria, 0.45 µm for yeasts/molds). Its fluid path remains external to the instrument body, ensuring no contact between sample lines and internal electronics. The system complies with ISO 13485:2016 design control requirements and meets electromagnetic compatibility standards per IEC 61326-1 Class B. Documentation packages include Factory Acceptance Test (FAT) reports, IQ/OQ templates aligned with FDA 21 CFR Part 11 data integrity expectations, and sterilization validation support files for inclusion in GMP audit dossiers.

Software & Data Management

While the HTY-602S operates as a standalone hardware platform without embedded network connectivity, its control firmware logs all operational parameters—including start/stop timestamps, selected speed profile, cumulative runtime, and fault event records—with non-volatile memory retention. Audit trail export is supported via USB flash drive (FAT32 formatted), generating CSV-formatted logs compliant with ALCOA+ principles. Timestamps are synchronized to internal RTC with ±2 sec/month accuracy and may be manually corrected during maintenance intervals. Optional integration with LIMS or MES systems is achievable via discrete dry-contact I/O signals (start, stop, error, ready) and RS-232 serial output for external supervisory control.

Applications

• Sterility testing of injectables, ophthalmic solutions, and lyophilized powders per USP and Ph. Eur. 2.6.1.
• Environmental monitoring filter processing in Grade A filling lines and isolator glove ports.
• Media fill simulation support—collecting rinse fluids from component surfaces and transfer devices.
• Bioburden assessment of raw materials and excipients prior to aseptic processing.
• Validation of sterilization cycle efficacy using biological indicators placed downstream of filtration units.

FAQ

Can the HTY-602S be operated inside a nitrogen-purged isolator?
Yes—the instrument’s sealed enclosure and absence of oxygen-dependent components permit uninterrupted use in inert-gas environments.
Does it support automatic speed ramping or only fixed-step rotation?
It provides four discrete, user-defined constant-speed settings; continuous ramping is not implemented to maintain regulatory alignment with manual operator verification requirements.
Is the touch panel compatible with gloved operation in ISO Class 5 conditions?
Yes—the 5-point capacitive interface responds reliably to nitrile and polyurethane cleanroom gloves meeting ISO 13485 handling specifications.
What documentation is supplied for GMP validation?
Standard delivery includes URS reference document, FAT report, IQ/OQ protocol templates, electrical safety test certificate, and sterilization compatibility summary per ISO 14937.
How is power cable ingress protected against moisture ingress in wet decon cycles?
The rear-panel power inlet and footswitch port utilize IP67-rated threaded connectors with silicone gasket seals, verified per IEC 60529 test procedures.