Tailin HTY Series Sterile Test Isolator

Overview

The Tailin HTY Series Sterile Test Isolator is a hard-wall, laminar-flow isolator engineered for aseptic processing and sterility testing in regulated life science environments. Constructed from electropolished AISI 304 stainless steel and tempered glass, the isolator provides a physically sealed barrier between operators and critical processes—eliminating direct human contact and minimizing microbiological contamination risk. Its internal environment maintains dynamic Grade A (ISO Class 5) air quality per ISO 14644-1 and EU GMP Annex 1, supported by an integrated H14 HEPA filtration system delivering ≥99.995% particle removal efficiency at 0.3 µm. The isolator operates under positive pressure relative to surrounding cleanroom areas (typically Grade D), with real-time monitoring of chamber pressure, temperature, relative humidity, airflow velocity, and settle plate microbial counts—ensuring continuous environmental control throughout operation cycles.

Key Features

• Aseptic Assurance Architecture: Combines structural integrity (welded stainless steel frame, gas-tight silicone gaskets compliant with USP <85> and EP 2.6.1), validated VHPS® (Vaporized Hydrogen Peroxide) sterilization with precise H₂O₂ concentration and saturation control, and redundant HEPA filtration to achieve and sustain sterile conditions.
• Automated Integrity Verification: Integrated pressure decay leak testing per ISO 10648-2: leakage rate <0.5% per hour at 2× test pressure; glove integrity testing per ISO 14644-7 using positive-pressure decay method, capable of detecting holes ≥300 µm in diameter on each glove port independently.
• GMP-Compliant Automation: Siemens S7-series PLC governs all critical process parameters—including differential pressure, supply air volume, and sterilization cycle sequencing—with configurable alarm thresholds and automatic shutdown on loss-of-pressure events.
• Human-Centric Ergonomics: Optimized glove port placement, adjustable work height, anti-fatigue floor matting, and glare-free LED lighting reduce operator strain and support sustained procedural accuracy during extended aseptic manipulations.
• Energy-Efficient Operation: Low-pressure variable-frequency drive (VFD) fans minimize power consumption across operational phases; compatibility with Grade D ambient environments reduces facility HVAC load and lifecycle energy costs.

Sample Compatibility & Compliance

The HTY Series accommodates a broad range of sterile handling workflows including aseptic sampling of bulk drug substances, sterility testing of finished pharmaceuticals (per USP <71> and Ph. Eur. 2.6.1), lyophilization loading/unloading, buffer/media preparation, and QC microbiological assay setup. All materials in contact with product or critical surfaces comply with USP Class VI biocompatibility requirements. The isolator’s design and validation documentation align with ICH Q5A, ISO 14644-1/2/3/7, EU GMP Annex 1 (2022), and FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004). Structural welds meet ASME BPE-2021 surface finish standards (Ra ≤ 0.4 µm).

Software & Data Management

Control is executed via an industrial-grade touch-panel PC running embedded Windows OS, preconfigured to meet 2010 EU GMP Annex 11 and FDA 21 CFR Part 11 requirements. The system supports role-based multi-level user authentication (operator, supervisor, administrator), full electronic audit trail with immutable timestamped records of all parameter changes, manual interventions, and cycle executions, and digital signature capability for critical actions such as sterilization start, environmental qualification approval, and batch release. Data export is available in CSV and PDF formats; secure remote access is enabled via TLS 1.2–encrypted VPN tunnels for technical support and firmware updates—fully auditable and compliant with GLP/GMP data integrity principles.

Applications

• Sterility testing of injectables, ophthalmic solutions, and biologics per USP <71>, JP 4.07, and Ph. Eur. 2.6.1
• Aseptic sampling of fermentation broths, cell culture harvests, and purified protein intermediates
• Pre-sterilization handling and transfer of lyophilized vials into freeze dryers
• Preparation of media and reagents for microbial enumeration and identification assays
• Environmental monitoring sample processing under controlled Grade A conditions
• QC laboratory validation of filter integrity (e.g., pre-use post-sterilization bubble point tests)

FAQ

What regulatory standards does the HTY Series isolator comply with?
The system meets EU GMP Annex 1 (2022), ISO 14644-1/2/7, ISO 10648-2, USP <71>, Ph. Eur. 2.6.1, and FDA 21 CFR Part 11 for electronic records and signatures.
Can the isolator be integrated into an existing SCADA or MES infrastructure?
Yes—via Modbus TCP/IP or OPC UA protocol interfaces, enabling bidirectional data exchange with central manufacturing execution systems while preserving audit trail integrity.
Is VHPS® sterilization cycle validation included with delivery?
Tailin provides IQ/OQ documentation templates and supports PQ execution; full cycle validation (including biological indicator challenge studies with Geobacillus stearothermophilus spores) is performed on-site by qualified third-party vendors per ISO 14937.
How frequently must glove integrity testing be performed?
Per EU GMP Annex 1 §6.61, gloves shall be tested before first use, after any repair or replacement, and at defined intervals during routine operation—typically prior to each shift or batch, as defined in the site’s SOPs.
Does the system support automated environmental monitoring data logging?
Yes—continuous acquisition of pressure differentials, temperature, RH, and airflow velocity is stored locally with 12-month retention; optional integration with centralized EMS platforms is available.