Tailin HTY-602ISO Isolator-Integrated Microbial Collection System

Overview

The Tailin HTY-602ISO Isolator-Integrated Microbial Collection System is an engineered solution designed for seamless integration into aseptic isolators used in sterility testing laboratories. It operates on the principle of vacuum-assisted membrane filtration—drawing liquid samples through sterile, low-protein-binding filter membranes under controlled negative pressure to capture viable microorganisms (bacteria, yeasts, molds) from pharmaceutical preparations, injectables, ophthalmic solutions, and other non-sterile or terminally sterilized products. Unlike standalone microbial collectors, the HTY-602ISO is physically mounted within the isolator’s interior workspace, eliminating glove-port manipulation of external pumps and minimizing contamination risk during filter transfer and membrane handling. Its compact footprint (23.0 × 30.5 × 1.0 cm) and low-profile suspension mount (33 cm total height) allow unobstructed access to critical work zones while maintaining ISO 5 (Class 100) air integrity inside the isolator chamber.

Key Features

• Isolator-native mechanical integration: Designed for rigid mounting onto standard isolator internal support rails or custom brackets—no external cabling or pump housings breach the isolator barrier.
• Three-step programmable speed control: Preconfigured rotational speeds (e.g., 60 rpm for viscous suspensions, 180 rpm for aqueous injections, 300 rpm for rapid throughput) selected via intuitive touch interface—no analog dials or mechanical potentiometers.
• Tempered glass capacitive touch panel: Chemically resistant surface compatible with alcohol-based disinfectants and vaporized hydrogen peroxide (VHP®) decontamination cycles; supports gloved operation with haptic feedback confirmation.
• Linear tube-loading architecture: Enables direct, alignment-free insertion of sterile vented filter funnels and tubing sets—reducing operator-induced misalignment errors and flow-path resistance variability.
• Comprehensive motor protection suite: Real-time monitoring of current draw, supply voltage, torque load, and rotor stall conditions ensures uninterrupted operation during extended filtration runs and prevents thermal degradation of pump components.
• Manual clamp actuation with tactile feedback: Ergonomic lever mechanism provides positive closure indication and consistent clamping force across repeated use—critical for maintaining laminar flow profiles during membrane wetting and sample passage.

Sample Compatibility & Compliance

The HTY-602ISO accommodates standard 47-mm or 50-mm diameter sterile membrane filters (e.g., mixed cellulose ester, polyethersulfone, or nylon) and supports filtration volumes ranging from 10 mL to 2,000 mL per test unit. It complies with core regulatory expectations for sterility test instrumentation as outlined in USP , Ph. Eur. 2.6.1, and ISO 11737-1. The system’s design supports GLP and GMP environments: all electronic operations are logged with timestamped event records (start/stop/pause/speed change), and firmware maintains audit-trail capability aligned with FDA 21 CFR Part 11 requirements when integrated with compliant laboratory information management systems (LIMS). No internal data storage is present—data export occurs exclusively via isolated USB-C port or RS-485 serial interface to external validated controllers.

Software & Data Management

The HTY-602ISO operates in embedded mode without onboard operating system or network stack. All control logic resides in a hardened ARM Cortex-M4 microcontroller with write-protected firmware. Parameter settings—including active speed profile, runtime duration, and pause status—are retained across power cycles using non-volatile EEPROM. For traceability, the device transmits operational metadata (e.g., “Speed=180 rpm; Duration=247 s; Event=FilterComplete”) via Modbus RTU over RS-485 to central process controllers or LIMS endpoints. Optional companion configuration utility (Windows-based, validated per ICH GCP Annex 11) enables batch-level parameter templates, user access level assignment, and electronic signature capture for method execution authorization.

Applications

• Sterility testing of parenteral drug products according to USP and EU Annex 1 requirements.
• Environmental monitoring filter processing within Grade A isolator workspaces.
• Media fill simulation filtration steps where reproducible flow dynamics are essential for challenge organism recovery validation.
• Bioburden assessment of raw materials and intermediates prior to sterilization cycle qualification.
• Validation of filter compatibility and flow-rate consistency across multiple lots of sterile-grade membrane assemblies.

FAQ

Can the HTY-602ISO be retrofitted into existing isolators from other manufacturers?
Yes—mechanical mounting interfaces are configurable per isolator OEM specifications; Tailin provides dimensional drawings and bracket CAD files upon request.
Does the device support automatic speed ramping or variable rate profiles?
No—only three fixed-speed presets are implemented to ensure deterministic performance and simplify qualification under GMP.
Is the touch interface compatible with double-gloved operation in VHP-decontaminated isolators?
Yes—the panel responds reliably to ASTM D3359-tested nitrile and chloroprene gloves up to 0.15 mm thickness.
What maintenance intervals are recommended for the peristaltic pump head assembly?
Pump tubing replacement is required every 500 hours of cumulative operation or after 200 full-speed cycles, whichever occurs first; no lubrication or calibration is needed.
How is electrical safety ensured inside the isolator’s nitrogen-purged or VHP-exposed environment?
The unit meets IP54 ingress protection rating and carries CE marking per EN 61000-6-2/6-4 and EN 61010-1:2010 for laboratory equipment in controlled atmospheres.