Tailin HTY-ASL Intelligent Automatic Microbial Collection System

Overview

The Tailin HTY-ASL Intelligent Automatic Microbial Collection System is a purpose-built, GMP-aligned microbial recovery instrument engineered for sterility testing in pharmaceutical, biotechnology, and contract manufacturing organizations. It operates on the principle of vacuum-driven membrane filtration, where test samples—such as injectables, ophthalmic solutions, or sterile raw materials—are drawn under controlled negative pressure through a 0.45 µm (or 0.22 µm) sterilizing-grade filter membrane. Microorganisms retained on the membrane surface are subsequently transferred to culture media for incubation and enumeration. Unlike legacy systems reliant on manual parameter entry and mechanical timers, the HTY-ASL integrates bidirectional communication with laboratory PCs, enabling centralized SOP deployment, execution traceability, and operator-independent protocol adherence—critical for regulatory compliance in FDA-regulated environments and ISO 13485-certified facilities.

Key Features

• Two operational modes: Conventional mode for flexible, real-time parameter adjustment; SOP mode for locked-down, audit-ready execution of preloaded methods.
• Integrated pressure monitoring system with configurable response logic—supports Alarm Mode (audible/visual alert on threshold breach), Adjustment Mode (dynamic pump speed modulation to maintain target vacuum), and Off Mode (disables pressure regulation for specific validation protocols).
• Linear pump tube installation path minimizes torsional stress and ensures consistent peristaltic compression across the full 1–300 rpm range, enhancing tube life and flow reproducibility.
• Automatic tube clamping mechanism engages prior to pump activation and releases only after complete cycle termination—eliminating risk of accidental fluid egress or cross-contamination during setup or maintenance.
• Tempered glass capacitive touchscreen with color LCD display provides intuitive navigation, real-time status feedback (e.g., elapsed time, current rpm, pressure differential), and tactile confirmation of all inputs.
• Four-layer electrical safety architecture: overcurrent protection, overvoltage cutoff, thermal overload sensing, and motor stall detection—ensuring uninterrupted operation during extended filtration cycles and preventing hardware degradation under variable load conditions.

Sample Compatibility & Compliance

The HTY-ASL accommodates standard 47 mm or 50 mm diameter sterile filter membranes housed in reusable or disposable filter holders compliant with USP , Ph. Eur. 2.6.1, and JP 4.06 sterility testing requirements. Its stainless steel 316L chassis meets ASME BPE surface finish standards (Ra ≤ 0.8 µm) and supports cleanroom-compatible wipe-down and vaporized hydrogen peroxide (VHP) decontamination. All electronic subsystems conform to IEC 61000-4 electromagnetic compatibility directives. The system supports 21 CFR Part 11-compliant software integration via optional Tailin LabLink™ Suite, enabling electronic signatures, audit trails, and role-based access control—fully aligned with GLP and GMP documentation expectations.

Software & Data Management

When connected to a Windows-based host PC via USB or Ethernet, the HTY-ASL accepts encrypted SOP packages containing method parameters (target rpm, duration, pressure setpoint, alarm thresholds), user-defined metadata (batch ID, analyst ID, environmental conditions), and pass/fail criteria. Each executed run generates a timestamped binary log file (.tlog) containing raw sensor data (instantaneous pressure, motor current, encoder position), which can be exported in CSV or PDF format for inclusion in regulatory submissions. The embedded firmware maintains an immutable local event log covering power-on/off, mode switches, SOP loading events, and safety interlock activations—retained for ≥12 months without external storage.

Applications

• Sterility testing of terminally sterilized parenterals, lyophilized powders, and medical device rinsates per USP and ISO 11737-2.
• Environmental monitoring sample processing in Grade A/B cleanrooms using membrane filtration followed by TSA/TSA+TTC agar incubation.
• Validation of depyrogenation tunnels and autoclave cycles via biological indicator challenge studies requiring quantitative microbial recovery.
• Raw material release testing for excipients and active pharmaceutical ingredients (APIs) where low-bioburden verification is mandated.
• Supporting Annex 1 (2022) requirements for continuous process verification through automated, repeatable filtration kinetics recording.

FAQ

Does the HTY-ASL support integration with LIMS or MES platforms?
Yes—via optional OPC UA or RESTful API middleware modules, enabling bidirectional data exchange with major laboratory informatics systems including LabWare LIMS, Thermo Fisher SampleManager, and Siemens Opcenter Execution.

Can SOP programs be edited directly on the instrument’s touchscreen?
No—SOPs must be authored and digitally signed on a validated PC workstation using Tailin MethodStudio™ software, then securely uploaded. This design enforces change control and prevents unauthorized runtime modifications.

What pump tube materials are certified for use with the HTY-ASL?
Certified options include PharmPure™ silicone (USP Class VI), Tygon® S-50-HL (FDA 21 CFR 177.2600 compliant), and Marprene® C-2000, all validated for ≥500 hours of continuous operation at 300 rpm.

Is the system suitable for use in ISO Class 5 laminar flow hoods?
Yes—the unit’s EMI-shielded enclosure, low particulate emission profile (<0.1 CFU/m³ during operation), and absence of internal fans or oil-lubricated components meet ISO 14644-1 Class 5 operational constraints.

How is calibration verified and documented?
Annual performance qualification includes vacuum accuracy verification (±0.5 kPa against NIST-traceable manometer), rotational speed validation (±1 rpm via optical tachometer), and timer deviation assessment (±0.1 s over 600 s)—all recorded in a machine-readable PQ report generated by the onboard diagnostics utility.