Tailin HTY-601 Membrane Filtration Assay System

Overview

The Tailin HTY-601 Membrane Filtration Assay System is a compact, manually operated vacuum-assisted microbial retention instrument engineered for sterility testing in compliance with pharmacopoeial standards including USP , EP 2.6.1, and JP 4.07. It operates on the principle of membrane filtration—drawing test samples through a sterile, low-protein-binding 0.45 µm (or 0.22 µm, when specified) filter membrane under controlled negative pressure. Microorganisms retained on the membrane surface are subsequently transferred to culture media for incubation and enumeration. Designed specifically for large-volume parenteral preparations—including intravenous infusions, irrigation solutions, and ophthalmic products—the HTY-601 delivers consistent flow dynamics across volumes up to 2 L per unit, minimizing operator variability while maintaining mechanical integrity during extended filtration cycles.

Key Features

• Compact footprint (22.5 × 34.0 × 10.5 cm) optimized for laminar flow hoods and Grade A/B cleanroom benchtop integration
• Side-mounted tactile power switch with sealed housing—prevents ingress of disinfectants or condensate during aseptic processing
• Stepless rotational speed control (15–300 rpm) with non-volatile speed memory: retains last-used setting after power cycle
• Dual-mode operation: compatible with both standard stainless-steel pump heads and disposable single-use assemblies (e.g., HTY-D series)
• Integrated pump head safety interlock: automatically halts rotation if tubing displacement or occlusion is detected
• IP67-rated footswitch with reinforced silicone sheathing—enables hands-free start/stop without compromising ISO 14644-1 Class 5 environmental integrity
• Low thermal load design (60 W max power draw) ensures stable temperature profile during multi-sample sequential runs

Sample Compatibility & Compliance

The HTY-601 supports filtration of aqueous, oily, and low-viscosity non-polar pharmaceutical preparations—including saline, dextrose, Ringer’s lactate, propylene glycol-based formulations, and ethanol-diluted antiseptics—provided they do not exceed 15 cP viscosity at 25 °C. It accommodates standard 47 mm diameter sterile filters (cellulose acetate, mixed ester, or PVDF membranes) and integrates seamlessly with commercially available filter funnels meeting ASTM F838-22 specifications. The system meets structural and functional requirements outlined in ISO 13408-2:2018 (Aseptic processing of health care products — Part 2: Filtration) and supports audit readiness for FDA 21 CFR Part 11-compliant workflows when paired with Tailin’s optional HTY-Link data logger (sold separately). All wetted surfaces comply with USP for polymeric components.

Software & Data Management

The HTY-601 is a standalone electromechanical device with no embedded firmware or onboard data storage. Its operational parameters—speed, runtime, and activation sequence—are recorded manually or via external time-stamped logbooks per GLP/GMP Annex 11 guidance. For digital traceability, it is interoperable with third-party laboratory information management systems (LIMS) through analog signal output (0–10 V DC) from the footswitch activation circuit. When used with Tailin’s HTY-Link companion module (optional accessory), users gain timestamped event logging—including start/stop timestamps, cumulative runtime, and speed setpoint history—with export to CSV format for 21 CFR Part 11–aligned review and electronic signature workflows.

Applications

• Sterility testing of bulk drug substances and finished dosage forms per USP and Ph. Eur. 2.6.1
• Microbial load assessment in water-for-injection (WFI) and purified water distribution loops
• Environmental monitoring filter analysis in isolator and RABS configurations
• Validation of pre-sterilization filtration steps for biologics and cell therapy intermediates
• Process simulation studies supporting aseptic process qualification (APQ) per PDA Technical Report No. 54
• Quality control release testing of compounded sterile preparations (CSPs) under USP

FAQ

Is the HTY-601 suitable for use with viscous ointments or suspensions?
No. The HTY-601 is validated only for low-viscosity liquids ≤15 cP. High-viscosity or particulate-laden samples require alternative filtration methods or pre-dilution per USP Section 3.
Does the system include filter membranes or funnels?
No. Filters and funnels are consumables and must be selected based on sample chemistry and regulatory requirements. Tailin recommends certified 0.22 µm PVDF membranes for bacterial retention validation.
Can the HTY-601 be integrated into a fully automated sterility testing line?
It functions as a semi-automated station. Full automation requires integration with robotic liquid handlers and vision-guided filter transfer modules—not supported natively but feasible via custom I/O signaling.
What maintenance intervals are recommended for the pump head assembly?
Inspect tubing compression and rotor alignment every 200 operating hours; replace silicone tubing every 500 hours or after 50 autoclave cycles (if steam-sterilizable grade is used).
Is calibration certification provided with shipment?
A factory-issued performance verification report (including speed accuracy ±2 rpm at 150 rpm, vacuum stability ±5 mbar over 30 min) is included. Full metrological calibration per ISO/IEC 17025 requires third-party service.