Tailin STI Series Sterile Isolation System
| Brand | Tailin |
|---|---|
| Origin | Zhejiang, China |
| Manufacturer Type | Manufacturer |
| Origin Category | Domestic |
| Model | STI Series |
| Pricing | Upon Request |
Overview
The Tailin STI Series Sterile Isolation System is a soft-wall, flexible isolator engineered for pharmaceutical aseptic processing and compendial sterility testing per USP <71>, Ph. Eur. 5.1.3, and JP 4.07. It operates on the principle of physical barrier containment combined with unidirectional, HEPA-filtered laminar airflow (Class ISO 5 / Grade A) within a fully enclosed, pressure-controlled environment. Unlike rigid stainless-steel isolators, the STI Series utilizes optically transparent, medical-grade PVC film to construct its chamber walls—enabling rapid visual inspection, simplified decontamination cycles, and reduced installation footprint. The system integrates a closed-loop air handling unit with dual-stage filtration (pre-filter + H14 HEPA), a built-in vaporized hydrogen peroxide (VHP®) generator with real-time H2O2 concentration and saturation monitoring, and independent environmental control of pressure differential, temperature, relative humidity, and face velocity. Designed for compliance-driven environments, it supports both membrane filtration and direct inoculation methods for sterile product testing of APIs and finished dosage forms—including injectables, ophthalmics, and lyophilized products.
Key Features
- ISO 5 (Grade A) internal environment maintained via H14 HEPA filtration (99.995% @ 0.3 µm) and continuous positive pressure control (typically +60–100 Pa vs. surrounding area)
- Integrated VHP® decontamination system utilizing Tailin’s proprietary VHPS® technology, delivering validated bioburden reduction ≥6-log for Geobacillus stearothermophilus spores in ≤90 minutes
- Automated leak integrity testing per ISO 10648-2: pressure decay method at 2× test pressure; volumetric leakage rate ≤0.5% per hour
- Glove integrity testing per ISO 14644-7: automated positive-pressure decay test on each glove port; detection sensitivity down to 300 µm pinhole defects
- Real-time environmental monitoring of chamber pressure, temperature (±0.5 °C), RH (±3% RH), and face velocity (±0.02 m/s) with configurable alarm thresholds and trend logging
- Modular architecture supporting scalable configurations—from single-glove transfer chambers to multi-glove operation chambers (2–8 glove ports), with optional pass-throughs, glove ports, and integrated weighing stations
Sample Compatibility & Compliance
The STI Series accommodates standard sterility test components including Millipore® Sterivex™ filter housings, Sartorius™ Minisart™ filters, and reusable stainless-steel filtration manifolds. It supports both open- and closed-system filtration workflows and is compatible with common culture media (e.g., TSB, FTG, SCDA). All operational parameters are traceable and compliant with regulatory expectations for aseptic process simulation (APS), environmental monitoring (EM), and routine sterility testing under GMP conditions. The system meets ISO 14644-1 (cleanroom classification), ISO 14644-2 (monitoring requirements), and aligns with EU Annex 1 (2022) principles for isolator qualification. Its data management architecture satisfies FDA 21 CFR Part 11, EU Annex 11, and PIC/S PI 011-3 requirements for electronic records, audit trails, role-based access control, and electronic signatures.
Software & Data Management
The STI Series employs an industrial PC-based control platform running embedded Windows OS with Tailin’s proprietary Isolator Control Software (ICS v3.x). The software provides multi-tier user authentication (admin, operator, reviewer), full audit trail recording (including parameter changes, alarm events, cycle logs, and login/logout timestamps), and exportable CSV/Excel reports compliant with ALCOA+ data integrity principles. All critical process data—including VHP cycle parameters (injection time, dwell time, aeration duration), environmental setpoints, and glove integrity test results—are timestamped, digitally signed, and stored locally with optional network backup. The system supports integration with LIMS via OPC UA or Modbus TCP protocols for centralized data aggregation.
Applications
- Sterility testing of sterile drug products and active pharmaceutical ingredients (APIs) per pharmacopoeial methods
- Aseptic sampling and manipulation of high-potency compounds in non-sterile manufacturing areas (e.g., D-class background environments)
- Environmental monitoring preparation and media fill simulation support
- Isolated handling of microbiological reference standards and challenge organisms
- Controlled transfer of sterile components between classified zones without compromising barrier integrity
FAQ
What cleanroom classification is required for STI Series installation?
The STI Series is qualified for operation in ISO Class 8 (D-grade) environments due to its self-contained ISO 5 internal classification and robust pressure cascade design.
Can the STI Series be validated for routine use in GMP manufacturing?
Yes—full IQ/OQ/PQ documentation packages are available, including risk assessments (FMEA), VHP cycle mapping studies, and glove integrity performance qualification per ISO 14644-7.
Does the system support remote monitoring and alarms?
Yes—via optional Ethernet connectivity and web-based dashboard interface with SNMP alerting and email/SMS notification configuration.
How often must glove integrity testing be performed?
Per EU Annex 1 and industry best practice, gloves shall be tested before each use, after any maintenance event, and at defined intervals (e.g., every 24 hours during continuous operation).
Is third-party calibration and certification supported?
Tailin provides factory calibration certificates traceable to NIST standards; external validation services and UKAS-accredited calibration are available through authorized partners.
