NeuronBC WGT-1200 Wireless Glove Integrity Tester
| Brand | NeuronBC |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Product Category | Domestic (China-manufactured) |
| Model | WGT-1200 |
| Price | Upon Request |
| Power Supply | DC 12 V, 20 W |
| Built-in Battery | 12 V Li-ion |
| Detection Accuracy | Minimum Detectable Hole Size: 300 µm |
| Test Duration | 3–8 min |
| Pressure Range | 500–3000 Pa |
| Pressure Resolution | 0.1 Pa |
| Noise Level | ≤50 dB(A) |
| Communication | Wi-Fi |
| Air Source | Integrated Sanitary-Grade Diaphragm Pump |
| Maximum Seal Pressure | ≤200 kPa |
| Data Storage Capacity | >12,000 test records |
| Data Storage Medium | Onboard Flash Memory |
| Glove Identification | RFID or Manual Entry |
| Unit Weight | 4.2 kg |
| Max. Controlled Test Units per Controller | 10 |
| Operating Time | Up to 8 h continuous / >48 h standby |
| User Accounts | 120 max |
| Predefined Test Protocols | 120 max |
| Access Control | Four-Tier Role-Based Permissions |
| Software Compliance | FDA 21 CFR Part 11 (Electronic Records & Signatures), GMP Annex 11, ALCOA+ Principles |
Overview
The NeuronBC WGT-1200 Wireless Glove Integrity Tester is a fully integrated, portable pressure decay-based integrity verification system engineered for routine and qualification-grade testing of isolator gloves, sleeve ports, and flexible barrier interfaces in aseptic manufacturing environments. It operates on the principle of controlled pressurization followed by high-resolution monitoring of pressure decay over time—enabling quantitative detection of leakage paths ≥300 µm in diameter. Designed explicitly for compliance-critical pharmaceutical cleanrooms, the WGT-1200 eliminates reliance on external air sources or fixed infrastructure, delivering validated, auditable results directly at the point of use. Its architecture supports both standalone operation and centralized fleet management via secure Wi-Fi connectivity, making it suitable for multi-isolator facilities undergoing routine glove change cycles, periodic requalification, or commissioning of new containment systems.
Key Features
- Integrated sanitary-grade diaphragm pump with precise flow control—ensures consistent, low-turbulence inflation without inducing glove deformation or false-negative artifacts.
- High-stability pressure transducer with 0.1 Pa resolution and full-scale linearity across 500–3000 Pa range—optimized for ISO 14644-7 Annex C and ASTM F2096-compliant decay rate calculation.
- RFID-enabled glove identification: automatically logs glove ID, batch number, and operator credentials into each test record—reducing transcription errors and supporting traceability per ICH Q5A and EU GMP Annex 1.
- Four-tier hierarchical user authentication (Administrator, Supervisor, Technician, Viewer) with encrypted electronic signatures—fully aligned with 21 CFR Part 11 Subpart B requirements for audit trails, record retention, and signature linkage.
- Color capacitive touchscreen interface with adaptive protocol selection—dynamically adjusts ramp rate, hold duration, and pass/fail thresholds based on glove material, thickness, and historical performance data.
- Onboard flash memory storing ≥12,000 timestamped test records with embedded metadata (pressure curve, ambient temperature/humidity, operator ID, RFID tag, firmware version).
- Modular glove tray system—interchangeable trays support standard sizes (S/M/L/XL) and custom geometries (e.g., elbow-length sleeves, double-glove configurations), validated per USP Chapter on Container Closure Integrity Testing (CCIT).
Sample Compatibility & Compliance
The WGT-1200 accommodates single- and double-layer gloves made from natural rubber latex, nitrile, neoprene, and chloroprene—commonly used in Grade A/B isolators per EU GMP Annex 1 and FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing. Each test sequence complies with the pressure decay methodology described in ISO 14644-7:2018 Clause 7.3.2 and referenced in PDA Technical Report No. 27 (Revised) for barrier system qualification. All firmware, software binaries, and configuration files undergo annual computer system validation (CSV) per GAMP 5 guidelines. The device’s embedded operating system maintains immutable audit trails—including login/logout events, parameter modifications, and report generation—with tamper-evident hashing applied to all stored records.
Software & Data Management
The WGT-1200 is managed through NeuronBC’s IntegritySuite™ v3.2—a validated Windows-based supervisory application supporting concurrent control of up to 10 distributed testers. IntegritySuite™ implements role-based access, configurable electronic signatures, and automated report generation in PDF/A-2b format compliant with long-term archival standards (ISO 19005-2). Data export options include CSV (for LIMS integration), XML (for MES/MES/SCADA ingestion), and direct API endpoints compatible with industry-standard platforms including SAP PM, Siemens Desigo CC, and Rockwell FactoryTalk. All communications between tester and host PC are encrypted using TLS 1.2; local database backups adhere to 21 CFR Part 11 §11.10(d) retention policies. Historical records remain accessible for ≥30 years via offline archive mode.
Applications
- Routine pre-use and post-use integrity verification of isolator gloves prior to aseptic interventions.
- Periodic requalification of glove ports during facility certification (e.g., every 6 months per EU GMP Annex 1 §8.65).
- Commissioning and FAT/SAT documentation for new isolator installations.
- Root cause analysis of glove failures—integrated pressure-time curve visualization aids in distinguishing pinhole leaks from seal interface issues.
- Supporting risk-based lifecycle management under ICH Q9 principles—test frequency and acceptance criteria may be adjusted based on glove material fatigue history and environmental exposure logs.
- Integration into continuous monitoring ecosystems via OPC UA or MQTT protocols for real-time dashboarding in control rooms.
FAQ
Does the WGT-1200 require external compressed air or vacuum sources?
No—the unit contains a self-contained, oil-free, sanitary-grade diaphragm pump certified to ISO 8573-1 Class 0 for particle and oil-free output.
Can test data be exported to an existing LIMS or MES platform?
Yes—IntegritySuite™ supports standardized data export formats (CSV, XML) and offers RESTful API integration with documented Swagger specifications.
Is the device suitable for use inside Grade A laminar airflow hoods?
Yes—its compact footprint (280 × 220 × 160 mm), low acoustic emission (≤50 dB[A]), and absence of heat-generating components permit safe operation within critical zones when placed on stainless steel trolleys.
How is calibration maintained across multiple units in a facility?
Each unit ships with NIST-traceable calibration certificate; field recalibration is performed annually using a certified deadweight tester (±0.05% FS) per ISO/IEC 17025 requirements.
What cybersecurity safeguards are implemented for Wi-Fi communication?
Wi-Fi operates exclusively on segregated WPA3-Enterprise networks; all firmware updates are digitally signed and verified prior to installation; no remote vendor access is enabled by default.
