IGT‑400 Glove Integrity Tester

Wireless, Integrated Glove Testing for Isolators and RABS

The IGT‑400 is Ravona’s most advanced glove integrity testing system, offering full integration with isolator and RABS controls. It uses pressure decay technology to automatically verify glove integrity with minimal operator intervention. Designed for high-containment and aseptic environments, the IGT‑400 combines wireless connectivity, system interlocks, and full regulatory compliance in a compact, battery-powered design.

Key Features

System Integration
Directly interfaces with isolator or RABS HMI/PLC systems to enable automated glove testing cycles and enforce chamber entry restrictions.

Wireless Communication
Fully wireless unit enables seamless data transmission to your existing control systems and centralized SCADA networks.

Battery-Powered Operation
Cord-free testing improves ergonomics and allows flexible use across multiple glove ports or isolators.

Advanced Leak Detection
Detects glove leaks down to 50 microns using validated pressure decay technology for reliable results.

Regulatory Compliance
Designed to meet 21 CFR Part 11, EU GMP Annex 1, and ISO 14644-7 Annex E. Generates secure, audit-ready documentation.

Automated Reporting
Generates PDF reports with timestamps, electronic signatures, and full traceability for validation and inspections.

Real-Time Operator Alerts
Provides audible and visual feedback if a test fails, ensuring immediate action is taken.

Compact, Cleanroom-Ready Design
Constructed from stainless steel for use in sterile environments. Easy to disinfect and store between tests.

Technical Specifications

  • Testing Method: Pressure decay with automated cycle control

  • Leak Detection Sensitivity: Detects holes as small as 50 microns

  • Communication: Wireless data transmission to isolator/RABS HMI and SCADA

  • Power Supply: Rechargeable battery for mobile operation

  • System Integration: PLC/HMI compatibility with interlocks for access control

  • Regulatory Compliance: 21 CFR Part 11, EU GMP Annex 1, ISO 14644-7 Annex E

  • Report Generation: Secure PDF with audit trail and electronic signature

  • Alert System: Audible and visual alerts for glove failure detection

  • Material: Stainless steel construction with touchscreen HMI interface

Applications

Aseptic Manufacturing
Supports routine glove integrity testing for sterile fill-finish operations, reducing contamination risks and ensuring GMP compliance.

High-Containment Environments
Ideal for handling cytotoxic, biohazardous, or high-potency compounds where strict leak prevention is critical.

Isolator & RABS Validation
Verifies glove and sleeve integrity as part of routine maintenance or batch-changeover protocols in barrier systems.

Cell & Gene Therapy
Protects sensitive biological materials and supports quality control in environments requiring ultra-sterile conditions.

Pharmaceutical & Biologics Production
Provides routine glove testing for operators handling injectable drugs, biologics, or sterile ingredients.

Inspection & Audit Readiness
Ensures traceable, validated testing records are available for regulatory inspections under 21 CFR Part 11 and EU GMP Annex 1.