Sterile Pig Isolator by Tailin Biotech

Overview

The Sterile Pig Isolator by Tailin Biotech is an engineered Class A/B biological containment system designed for the aseptic derivation, transport, and long-term housing of gnotobiotic or germ-free miniature swine. Built upon the principles of positive-pressure laminar airflow, physical barrier isolation, and validated decontamination cycles, this isolator enables full-cycle sterile pig production—from cesarean-derived uterine extraction through postnatal acclimatization—without microbial breach. It complies with core requirements of ISO 14644-1 (Class 5 cleanroom performance), ISO 14698-1 (biocontamination control), and supports alignment with USDA APHIS, NIH OLAW, and AAALAC International standards for gnotobiotic animal facility design. The system integrates mechanical, filtration, and chemical sterilization modalities to maintain ≤0.5% vol/hr leakage rate at twice operating pressure—a critical benchmark for sustained sterility assurance in large-mammal isolators.

Key Features

• Uterine extraction module with integrated transfer sluice: Dual-side flat-sealing doors and sloped stainless-steel trough enable sterile passage of uterine units while eliminating shadow zones during vaporized hydrogen peroxide (VHP) or autoclave-compatible surface sterilization.
• Aseptic docking transport cart: Equipped with interlocked pneumatic seals and ISO 5-rated HEPA-filtered air curtains, ensuring uninterrupted Class 5 integrity during animal or supply transfer between isolator chambers and adjacent cleanrooms.
• Contained waste egress system: Negative-pressure waste lock with dual-door sequencing and inline H14 (EN 1822 MPPS ≥99.995%) exhaust filtration prevents cross-contamination between internal isolator environment and external waste handling zones.
• Frontal ergonomic interface: 15° inclined front panel with seamless polycarbonate viewport and ergonomically positioned glove ports minimizes operator fatigue and maximizes dexterity during prolonged procedures.
• Integrated environmental monitoring: Real-time digital readouts for differential pressure (±0.1 Pa resolution), temperature (±0.3°C), relative humidity (±2% RH), and ammonia concentration (0–100 ppm range, electrochemical sensor) are logged with timestamped audit trails compliant with 21 CFR Part 11 requirements when paired with optional data acquisition software.
• VHP compatibility: Standardized 1/2″ NPT VHP inlet/outlet ports support external VHP generators (e.g., Steris, Systec); optional factory-integrated VHP generator module available for fully autonomous cycle execution and residual H₂O₂ catalytic decomposition.

Sample Compatibility & Compliance

The isolator accommodates neonatal to juvenile miniature pigs (typically 0.5–25 kg) and supports concurrent housing of up to four animals under continuous sterility maintenance. All internal surfaces consist of electropolished 316L stainless steel with radius ≥R3mm internal corner transitions, welds polished to Ra ≤0.4 µm, and no crevices exceeding 0.2 mm depth—ensuring full cleanability per ASTM E2656 (Standard Guide for Cleaning Validation of Isolators). Structural integrity is certified per ASME BPVC Section VIII Div. 1, with leak testing conducted using SF₆ tracer gas and mass spectrometry. Filter housings meet EN 1822-3:2019 classification for H14 grade, verified via sodium flame and oil mist tests.

Software & Data Management

A dedicated PLC-based control system manages all environmental parameters, alarm states, and sterilization cycle logs. Optional Ethernet/IP or Modbus TCP connectivity enables integration into centralized facility SCADA platforms. Data export supports CSV and PDF formats; user access levels (operator, supervisor, administrator) enforce role-based permissions. Audit trail functionality records all parameter changes, door openings, and sterilization events with immutable timestamps—fully traceable for GLP/GMP audits and FDA inspection readiness.

Applications

• Germ-free pig model development for microbiome–host interaction studies
• Cesarean-derived swine for xenotransplantation source herd establishment
• Preclinical evaluation of oral therapeutics, probiotics, and fecal microbiota transplantation (FMT)
• Immunology research requiring defined microbial status (e.g., TLR-knockout validation)
• Regulatory toxicology studies requiring strict environmental standardization (OECD 407, 408)
• Training platform for aseptic surgical technique and gnotobiotic husbandry certification

FAQ

Can this isolator be validated for ISO 5 (Class 100) cleanroom equivalence?
Yes—the system achieves ISO 5 particle counts (<3,520 particles/m³ ≥0.5 µm) under dynamic operational conditions when supplied with ISO 7 pre-filtered air and maintained at +60–80 Pa differential pressure.
Is third-party IQ/OQ/PQ documentation supported?
Tailin provides standardized URS templates and executes protocol-driven qualification with certified metrology partners; full qualification packages (including filter integrity test reports, leak test certificates, and VHP cycle mapping data) are available upon request.
What power and utility connections are required?
Standard configuration requires 208–240 VAC, 50/60 Hz, 30 A single-phase supply; compressed air (6.5 bar, oil-free, ISO 8573-1 Class 1,3,1); and chilled water (7–12°C, 1.5 L/min) for condenser cooling in humidification modules.
Are replacement gloves and HEPA filters available as consumables?
Yes—custom-fit butyl rubber gloves (ISO 13485-certified) and H14 filter cassettes (EN 1822-tested, serial-numbered, shelf-life tracked) are stocked and shipped globally with lead times under 10 business days.