Sterile Isolator – Hard-Walled Turbulent-Flow Type RT Series by Tailin Biotechnology

Overview

The Tailin RT Series Sterile Isolator is a hard-walled, turbulent-flow isolator engineered for aseptic pharmaceutical processing, including membrane filtration-based sterility testing, environmental monitoring sample handling, and pre-sterilized component manipulation. Unlike laminar-flow isolators that rely on unidirectional airflow to maintain ISO Class 5 conditions, the RT Series employs controlled turbulent airflow—designed to achieve rapid and uniform distribution of vaporized hydrogen peroxide (VHP) while maintaining robust containment integrity (ISO 14644-7 compliant). Its architecture meets the stringent environmental control requirements defined in USP <71>, European Pharmacopoeia Chapter 5.1.1, and Chinese Pharmacopoeia Appendix XIX K for sterility test isolators. The system operates as a self-contained barrier technology solution, eliminating dependency on external cleanroom infrastructure—enabling installation in standard laboratory or manufacturing spaces without classified air handling.

Key Features

• Integrated VHPS® dry-process sterilization system delivering ≥3-log microbial reduction within ≤30 minutes, with documented 30% faster cycle times versus legacy VHP systems due to optimized vapor dispersion and catalytic decomposition pathways.
• Hard-wall stainless steel 316L construction with welded seams and electropolished interior surfaces—designed for chemical resistance, ease of decontamination, and long-term structural stability under repeated sterilization cycles.
• Turbulent airflow pattern validated via smoke studies and particle challenge testing to ensure consistent bioburden neutralization across all internal surfaces—including under shelves, behind ports, and within glove interfaces.
• Embedded programmable logic controller (PLC) with 10.1-inch HMI touchscreen interface supporting multi-level user authentication, electronic signatures, and configurable alarm thresholds for all critical parameters.
• Real-time environmental monitoring suite tracking chamber temperature (±0.5°C), relative humidity (±3% RH), differential pressure (±1 Pa), and H₂O₂ vapor concentration (0–2000 ppm, electrochemical sensor) with automatic data logging to internal SSD and optional network export.
• Dual interlocked transfer ports with integrated HEPA-filtered airlocks support simultaneous material ingress/egress while maintaining negative pressure differentials (>30 Pa) between isolator and ambient environment.

Sample Compatibility & Compliance

The RT Series accommodates standard sterility test configurations—including 0.45 µm and 0.22 µm membrane filters, culture media-filled bottles (TSB, FTM), and pre-sterilized swab kits. It supports integration of multiple commercially available microbiological sampling pumps (e.g., APL02ISO, HTY-600ISO, Merck Millipore Equinox Pump, Steriart® Universal Pump) via standardized mounting brackets and power/data interfaces. All operational protocols are aligned with GMP Annex 1 (2022 revision) principles for isolator qualification, including ISO 14644-1 Class 5 particle counts (<3,520 particles/m³ ≥0.5 µm), leak-tightness verification (≤0.5% volumetric leakage/hour at 100 Pa), and periodic requalification per ASTM E2997-21. Full documentation packages—including IQ/OQ/PQ templates, risk assessments (FMEA), and raw sensor calibration certificates—are provided to support regulatory submissions and FDA/EMA inspection readiness.

Software & Data Management

The embedded control software includes built-in audit trail functionality compliant with FDA 21 CFR Part 11 requirements—recording operator ID, timestamp, parameter changes, alarm events, and sterilization cycle logs with SHA-256 hash integrity verification. Data export is supported via USB 3.0, Ethernet (TCP/IP), and optional OPC UA server integration for MES/SCADA connectivity. Historical records are retained for ≥12 months onboard and can be archived externally in CSV or PDF format. Optional software modules enable remote monitoring via secure TLS 1.2 web interface, automated report generation (including sterility test batch summaries), and deviation alerting via email/SMS gateways.

Applications

• Sterility testing of injectables, ophthalmic preparations, and medical device extracts per USP <71> and Ph. Eur. 5.1.1.
• Aseptic assembly of pre-sterilized components (e.g., filter housings, tubing sets) prior to use in fill-finish operations.
• Handling of environmental monitoring samples (settle plates, contact plates, air samplers) under controlled bioburden-free conditions.
• Stability study sample preparation where particulate or microbial contamination must be excluded from analytical workflows.
• Support of QC microbiology laboratories operating under GLP or ISO/IEC 17025-accredited frameworks.

FAQ

Can the RT Series isolator be installed in a non-classified room?
Yes. Its hard-wall design, negative-pressure containment, and integrated air filtration eliminate reliance on external cleanroom HVAC—allowing safe deployment in standard ISO Class 8 or unclassified environments.
What validation documentation is included with delivery?
Each unit ships with factory-verified IQ/OQ protocols, as-built drawings, material certifications (EN 10204 3.1), sensor calibration reports, and a VHPS® performance qualification summary per ISO 14644-3 Annex B.
Is the system compatible with third-party sterility test pumps not listed in the specifications?
Yes—provided the pump meets electrical safety standards (IEC 61010-1), operates within 24 VDC or 115/230 VAC input ranges, and offers analog/digital I/O for status feedback; custom integration support is available upon request.
How frequently must the VHPS® generator be serviced?
The VHPS® module requires preventive maintenance every 1,000 operational hours or annually—whichever occurs first—including catalyst bed inspection, vapor line cleaning, and sensor recalibration using NIST-traceable standards.
Does the system support electronic record retention for regulatory audits?
Yes. All process data—including sterilization cycles, environmental logs, and user actions—are stored with immutable timestamps and digital signatures, meeting ALCOA+ data integrity principles and facilitating 21 CFR Part 11 compliance verification.