NeuronBC WGT-1000 Wireless Glove Integrity Tester

Overview

The NeuronBC WGT-1000 Wireless Glove Integrity Tester is an engineered solution for real-time, non-destructive verification of glove integrity in aseptic processing environments. Designed in strict alignment with the positive-pressure leak detection methodology specified in ISO 14644-7:2004 and GB/T 25915.7–2010, the instrument applies controlled pressurization to the interior volume of isolator or RABS gloves—measuring pressure decay over time to identify breaches exceeding 300 µm equivalent aperture size. Unlike destructive bubble tests or subjective visual inspections, this method delivers quantitative, repeatable, and auditable pass/fail determinations without compromising glove sterility or requiring glove removal. Its integrated sanitary air pump ensures contamination-free inflation of both glove body and cuff sealing ring, while continuous dual-point pressure monitoring (glove chamber + seal ring) enables dynamic compensation for thermal drift and elastic relaxation—critical for high-reproducibility results across diverse glove materials including butyl rubber, nitrile, and chloroprene.

Key Features

• Wireless architecture via embedded Wi-Fi module: Enables seamless integration into centralized monitoring systems without Ethernet cabling or fixed installation points.
• Self-contained operation: Integrated lithium battery, DC 12 V/20 W power management, and built-in sanitary air pump eliminate dependency on external compressed air or AC infrastructure.
• IP65-rated enclosure: Facilitates routine disinfection with alcohol-based or sporicidal agents without risk of ingress-related failure.
• RFID-enabled glove identification: Each test record automatically logs glove ID, operator, timestamp, and program configuration—ensuring full traceability per ALCOA+ principles.
• Adaptive pressure control algorithm: Uses micro-pulse inflation (small-volume, high-frequency air intake) to maintain uniform internal pressure ramp rates—minimizing transient stress on glove material and preventing false positives from viscoelastic deformation.
• Color touchscreen HMI with context-aware program selection: Automatically recommends optimal test parameters based on glove type, thickness, and historical performance data.
• Modular glove tray design: Interchangeable trays support standardized and custom glove sizes (including double-glove configurations), enabling rapid reconfiguration between operational zones.

Sample Compatibility & Compliance

The WGT-1000 accommodates single- and double-layer gloves used in Grade A/B cleanrooms across pharmaceutical, biotechnology, and medical device manufacturing. It supports natural rubber latex, synthetic elastomers (nitrile, neoprene, butyl), and laminated barrier gloves up to 0.8 mm nominal thickness. All test protocols adhere to the procedural rigor defined in Annex 1 (2022 revision) of the EU GMP Guidelines and are fully compatible with FDA Process Validation guidance for aseptic barrier systems. The device’s electronic record structure—including audit trail, user authentication, and electronic signatures—meets the technical and procedural requirements of 21 CFR Part 11 for computerized systems used in regulated environments. Full IQ/OQ documentation packages and vendor-supported CSV (Computer System Validation) support are available upon request.

Software & Data Management

The WGT-1000 operates with NeuronBC’s proprietary IntegritySuite™ PC software—a validated, multi-user platform supporting concurrent management of up to 32 distributed testers. Software features include role-based four-tier authority control (Administrator, Supervisor, Technician, Viewer), automated report generation (PDF/CSV), configurable alarm thresholds, and scheduled backup to network drives or cloud repositories. All data entries are immutable once recorded; modifications require documented justification, supervisor approval, and timestamped audit trail logging. Historical records (>12,000 entries) are stored redundantly—in internal Flash memory and synchronized wirelessly to the host system—ensuring continuity during temporary network outages. Exported datasets comply with CDISC SDTM standards for regulatory submission readiness.

Applications

• Pre-use qualification of isolator gloves prior to aseptic processing campaigns.
• Post-intervention verification following glove repair or replacement.
• Routine scheduled integrity checks aligned with facility SOPs and risk-based quality agreements.
• Supporting investigations into microbial excursions by correlating glove failure events with environmental monitoring trends.
• Qualification of glove material compatibility with aggressive sterilants (e.g., vaporized hydrogen peroxide) through longitudinal integrity trending.

FAQ

Does the WGT-1000 require external compressed air?
No. It incorporates a dedicated sanitary-grade air pump designed to meet ISO 8573-1 Class 0 purity requirements for critical process air.
Can test data be exported for regulatory review?
Yes. Raw data, audit trails, and electronic signatures are exportable in FDA-submission-ready formats (PDF/A-2, CSV with SHA-256 hash validation).
Is the device suitable for use inside Grade A laminar flow hoods?
It is rated IP65 and designed for peripheral use in Grade B environments; placement inside Grade A zones requires formal risk assessment and containment validation.
How is calibration maintained across multiple units?
Each unit includes NIST-traceable pressure sensor calibration certificates; field verification is supported via optional handheld reference manometers and automated self-diagnostics.
What glove sizes does the standard tray accommodate?
Standard trays support gloves ranging from size 6.5 to 9.5 (ISO 21420); custom trays for oversized or pediatric gloves are available under engineering change order (ECO).