NeuronBC GT-2.0 Offline Glove Integrity Tester
| Brand | NeuronBC |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Domestic (China) |
| Model | GT-2.0 |
| Power Supply | 100–220 VAC, 50 Hz |
| Rated Power | 120 W |
| Test Duration | 2–8 min |
| Pressure Range | 500–5000 Pa |
| Response Threshold | ≤50 Pa |
| Noise Level | ≤50 dB(A) |
| Operating Mode | Continuous |
| External Gas Source | Compressed Air, Nitrogen, or Inert Gas |
| Max Seal Pressure | ≤0.8 MPa |
| Data Storage Capacity | ≥10,000 test records |
| Dimensions | 400 × 260 × 250 mm |
| Weight | 7.5 kg |
Overview
The NeuronBC GT-2.0 Offline Glove Integrity Tester is a dedicated, non-destructive pressure decay-based integrity verification system engineered for rapid, repeatable assessment of elastomeric glove integrity in isolators, RABS (Restricted Access Barrier Systems), and gloveboxes used across aseptic pharmaceutical manufacturing, biotechnology cleanrooms, and containment laboratories. It operates in strict accordance with the principles defined in ISO 14644-7:2004 and GB/T 25915.7–2010, which specify positive-pressure decay methodology for detecting micro-leaks at glove-to-flange interfaces and along glove body surfaces. Unlike destructive bubble tests or subjective visual inspections, the GT-2.0 quantifies leakage rate by monitoring pressure stabilization and decay kinetics under controlled pressurization—delivering objective, auditable pass/fail outcomes traceable to calibrated transducers and time-synchronized data acquisition.
Key Features
- Pressure decay integrity testing compliant with ISO 14644-7 and GB/T 25915.7 standards
- Intelligent auto-program selection: touchscreen interface dynamically selects optimal test protocol based on user-input glove geometry (e.g., length, diameter, material compliance)
- Gradual, pulsed gas injection strategy minimizes transient stress on glove membranes—preventing false positives from elastic deformation or localized bulging
- Integrated dual-stage sealing: primary seal via inflatable glove盘 gasket (rated ≤0.8 MPa), secondary validation through real-time pressure hold stability monitoring
- Full 21 CFR Part 11 compliance: role-based access control (3-tier permission levels), electronic signatures with audit trail, tamper-evident record timestamps
- Onboard thermal printer with automatic report generation (test ID, date/time, operator ID, pressure curve snapshot, result status)
- Portable benchtop architecture: lightweight (7.5 kg), compact footprint (400 × 260 × 250 mm), integrated casters and ergonomic carry handles
Sample Compatibility & Compliance
The GT-2.0 accommodates standard single- and double-glove configurations mounted on stainless-steel or polymer gloveports (diameters 120–220 mm). It supports natural rubber, nitrile, chloroprene, and butyl gloves up to 800 mm in length. All firmware and hardware design elements meet IEC 61000-6-3 (EMC emissions) and IEC 61010-1 (safety for electrical equipment). Data integrity architecture satisfies ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) for GMP-regulated environments. Device calibration certificates are traceable to NIM (National Institute of Metrology, China) standards, and validation documentation supports IQ/OQ/PQ execution per Annex 1 and EU GMP Chapter 4 requirements.
Software & Data Management
Embedded firmware (v3.2+) manages all test execution, data logging, and reporting without external PC dependency. Each test record includes raw pressure vs. time series (sampled at 10 Hz), calculated leak rate (Pa/s), pass/fail threshold application logic, and operator authentication metadata. Stored records (≥10,000 entries) support chronological search, filter-by-date/operator/glove ID, and export via USB 2.0 to CSV or PDF. Audit trails log all critical events—including parameter changes, user logins/logouts, print actions, and firmware updates—with immutable hash signatures. Electronic signatures comply with FDA 21 CFR Part 11 Subpart B requirements for closed systems, including identity verification, signature association, and retention of signed records for minimum 15-year archival periods as required under USP and EU Annex 11.
Applications
- Routine pre-use and post-use integrity verification of isolator gloves prior to aseptic processing
- Periodic qualification of glove integrity during media fill simulations (ISO 13408-1)
- Leak localization support when used in conjunction with handheld ultrasonic detectors or tracer gas sniffers
- Validation of glove replacement procedures following maintenance or damage incidents
- Supporting risk-based quality agreements between contract manufacturers and API suppliers under ICH Q5A(R2) and Q9 frameworks
- Documentation for regulatory inspections (FDA, EMA, NMPA) requiring evidence of continuous environmental control assurance
FAQ
What gas sources are compatible with the GT-2.0?
Compressed air (oil-free, ISO 8573-1 Class 2:2:2), nitrogen, or other inert gases with inlet pressure ≤0.5 MPa and dew point ≤−40°C.
Does the GT-2.0 require annual recalibration?
Yes—pressure transducers must be verified annually against NIST-traceable standards; calibration certificate and adjustment log are stored internally and exportable.
Can test data be integrated into a LIMS or MES?
Yes—via optional RS-232 or Ethernet module (firmware v3.3+), supporting ASTM E1384-compliant data exchange protocols and HL7-compatible metadata tagging.
Is glove盘 hardware included or separately ordered?
Standard glove盘 kits (for 120/160/200 mm ports) ship with the instrument; custom flange adapters are available upon request with dimensional specifications.
How is user training delivered?
NeuronBC provides on-site or remote operator qualification packages including SOP development support, IQ/OQ protocol templates, and 2-hour virtual competency assessments certified per ISO/IEC 17025 Clause 6.2.5.
