Sterile Mouse Isolator by Tailin Biotech

Overview

The Sterile Mouse Isolator by Tailin Biotech is an engineered containment system designed for the housing, handling, and experimental manipulation of germ-free or gnotobiotic rodents under rigorously controlled aseptic conditions. Built upon the principles of positive-pressure physical isolation and HEPA-grade air filtration, this isolator maintains a Class 100 (ISO 5) internal environment through continuous laminar airflow, validated leak integrity, and integrated environmental monitoring. It serves as a critical infrastructure component in preclinical research facilities, microbiome studies, immunology laboratories, and GLP-compliant toxicology units where maintenance of host-associated microbial status is non-negotiable. The system supports full lifecycle management—from sterile animal introduction and long-term housing to terminal surgical procedures—without compromising barrier integrity.

Key Features

• Double-door transfer cart with aseptic docking interface ensures contamination-free animal and material transfer between adjacent isolators or cleanrooms, eliminating exposure during transit.
• Supply and exhaust air paths are equipped with H14-grade high-efficiency particulate air (HEPA) filters compliant with EN 1822-1:2019, achieving ≥99.995% efficiency at MPPS (Most Penetrating Particle Size), ensuring sustained ISO Class 5 air quality within the work chamber.
• Ergonomically inclined front panel minimizes operator fatigue during extended procedures and improves visual alignment with the work surface.
• Optically clear acrylic viewport with integrated, replaceable butyl rubber gloves enables tactile dexterity while maintaining dynamic seal integrity via active inflation pressure control.
• Monolithic stainless steel 316L chamber fabricated using orbital TIG welding; interior surfaces electropolished to Ra ≤ 0.4 µm, with fully radiused corners (R ≥ 15 mm) and zero crevices—designed for repeatable cleaning validation and residue-free decontamination.
• Leak-tightness verified per ISO 10648-2:1995; chamber holds pressure differential at 2× operational setpoint (typically 150 Pa) with leakage rate <0.5% volume/hour—meeting stringent requirements for barrier integrity in SPF and GF rodent facilities.
• Integrated VHP (Vaporized Hydrogen Peroxide) port compatible with third-party sterilization systems (e.g., Bioquell, Steris); optional factory-installed VHP generator module available for automated, cycle-validated bio-decontamination.

Sample Compatibility & Compliance

The isolator accommodates standard IVC-compatible mouse and rat cages (up to 12 cages per chamber), including individually ventilated caging systems with passive or active air exchange interfaces. All materials in contact with the internal environment—including glove ports, lighting fixtures, and sensor housings—are USP Class VI certified and autoclavable. The system meets ISO 14644-1 (Cleanrooms), ISO 10648-2 (Leak-tight enclosures), and EN 12469 (Biological safety cabinets) design reference criteria. Environmental monitoring outputs (differential pressure, temperature, relative humidity, NH₃ concentration) are logged with timestamped records compliant with FDA 21 CFR Part 11 Annex 11 audit trail requirements when paired with optional data acquisition software.

Software & Data Management

A programmable logic controller (PLC)-based embedded system manages real-time environmental regulation, alarm thresholds, and event logging. Optional Ethernet-enabled data logger provides CSV export of all monitored parameters at user-defined intervals (1–60 min). Alarm events—including filter saturation, pressure deviation >±15 Pa, humidity excursion beyond 30–70% RH, or VHP cycle failure—are stored with UTC timestamps and severity classification. Full system logs support retrospective analysis for facility qualification (IQ/OQ/PQ), regulatory inspections, and root cause investigation in accordance with GLP and GMP frameworks.

Applications

• Germ-free and gnotobiotic rodent husbandry in microbiome and immunometabolism research
• Surgical implantation of telemetry devices or orthotopic tumor models under sterile conditions
• Long-term pharmacokinetic or toxicokinetic studies requiring strict microbial control
• Production and quality control of monoclonal antibodies in murine hybridoma lines
• Validation of sterilization processes for medical devices using biological indicators housed in situ
• Training platforms for aseptic technique certification in academic and industrial settings

FAQ

What certifications does this isolator meet for international use?
It conforms to ISO 10648-2 for leak integrity, EN 1822-1 for HEPA filter performance, and incorporates design elements aligned with ISO 14644-1 Class 5 cleanroom standards. Documentation packages include EU Declaration of Conformity and CE marking support files.
Can the isolator be integrated into an existing cleanroom HVAC network?
Yes—the unit features configurable supply/exhaust duct interfaces (DN150 flanged connections) and supports both recirculating and once-through airflow configurations with external air handling units.
Is remote monitoring supported?
With optional IoT gateway add-on, real-time parameter dashboards and SMS/email alerts are enabled via secure HTTPS API endpoints compatible with LabVantage, STARLIMS, and custom LIMS deployments.
What is the typical validation timeline for installation qualification?
Standard IQ/OQ documentation is provided; PQ execution typically requires 5–7 working days, including smoke visualization, particle counting (ISO 21501-4), and leak testing per ASTM E2951-14.