Aseptic Isolators

Closed-barrier systems for Grade A aseptic processing and contamination control

Ravona’s aseptic isolators provide a sealed, sterile environment for pharmaceutical and biologic manufacturing processes. Designed to maintain ISO 5 / Grade A air quality, these systems offer total protection from contamination, with integrated decontamination, glove testing compatibility, and seamless integration with filling, sampling, and quality control equipment.

Key Features

  • Grade A / ISO 5 Environment
    Ensures particle- and microbe-free conditions for sterile operations.

  • Positive or Negative Pressure Operation
    Supports aseptic processing (positive pressure) or containment of cytotoxic materials (negative pressure).

  • Integrated H₂O₂ Decontamination
    Built-in vaporized hydrogen peroxide (VHP) system enables rapid, validated decontamination cycles.

  • HEPA H14 Filtration
    High-efficiency filtration system with real-time particle monitoring.

  • Glove Integrity Tester Compatibility
    Fully compatible with Ravona’s IGT-300 and IGT-400 testers for in-place glove validation.

  • SCADA and HMI Integration
    Supports centralized control, real-time data monitoring, and automated report generation.

  • Custom Process Interfaces
    Configurable for seamless integration with filling lines, robotics, lyophilizers, and sampling ports.

Technical Specifications

  • Air Classification: ISO 5 / Grade A

  • Pressure Modes: Positive for aseptic / negative for HPAPI or cytotoxic processing

  • Filtration: HEPA H14 with integrated particle counter

  • Decontamination: VHP/H₂O₂ system with cycle validation

  • Construction: GMP-grade stainless steel with frameless glove ports

  • Control System: Touchscreen HMI and SCADA-ready industrial PC

  • Glove Testing Ports: Compatible with Ravona IGT-300 and IGT-400 systems

  • Power & Utility Requirements: Configurable per site specs

Applications

  • Aseptic fill-finish (vials, syringes, cartridges)

  • Sterility testing and batch release

  • Cell and gene therapy processing

  • Biologics and API handling

  • Cytotoxic and high-potency compound containment

  • Equipment integration: robotics, freeze dryers, sampling systems

Why Choose Ravona Aseptic Isolators?

  • Certified Cleanroom Performance — Built to meet FDA, cGMP, ISO 14644-7, and EU Annex 1 requirements

  • Fully Customizable — Designed to meet specific process, space, and equipment needs

  • Easy Equipment Integration — Compatible with upstream and downstream automation