NeuronBC GT-2.0 Glove Integrity Tester
| Origin | Beijing, China |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Domestic (China) |
| Model | GT-2.0 |
| Pricing | Available Upon Request |
Overview
The NeuronBC GT-2.0 Glove Integrity Tester is a purpose-built, regulatory-compliant instrument engineered for non-destructive, in-situ leak detection of elastomeric gloves mounted on aseptic isolators, RABS (Restricted Access Barrier Systems), and gloveboxes. It operates on the principle of controlled positive-pressure decay testing—fully aligned with the methodology specified in ISO 14644-7:2004 and its Chinese national adoption GB/T 25915.7–2010. Unlike qualitative bubble or smoke tests, the GT-2.0 quantifies leakage rate by monitoring pressure decay dynamics within the glove cavity under precisely regulated overpressure conditions. The system introduces gas incrementally and repeatedly to maintain stable internal pressure without inducing mechanical stress or deformation—ensuring both measurement fidelity and glove longevity. Designed for integration into GMP-compliant manufacturing environments, it supports continuous operation in cleanroom Class A/B (ISO 5/6) settings and meets foundational requirements for process validation, routine qualification, and periodic requalification per EU Annex 1 and USP <1116>.
Key Features
- Regulatory-ready architecture: Fully compliant with FDA 21 CFR Part 11 for electronic records and electronic signatures (ERES), including role-based user authentication, audit trail logging, and tamper-evident data storage.
- Intelligent adaptive test protocol: Automatic selection of optimal pressurization profile and decay analysis algorithm based on real-time pressure response, glove volume estimation, and ambient temperature compensation.
- High-resolution color touchscreen interface (7-inch capacitive display): Intuitive navigation, multilingual UI support (English default), timestamped test initiation, and dynamic parameter visualization during execution.
- Integrated thermal printer: On-demand hardcopy output of full test reports—including test ID, operator ID, date/time stamp, pressure curve plot, pass/fail status, and deviation flags—printed directly post-test.
- Robust pneumatic design: Dual-stage pressure regulation with built-in filter-dryer assembly; compatible with compressed air, nitrogen, or other inert process gases (max inlet pressure ≤ 0.8 MPa).
- Portable benchtop form factor: Compact footprint (400 × 260 × 250 mm), lightweight chassis (7.5 kg), and integrated carry handle enable rapid deployment across multiple isolator stations without dedicated mounting.
Sample Compatibility & Compliance
The GT-2.0 accommodates standard single- or double-layer nitrile, latex, chloroprene, and butyl rubber gloves ranging from size 6.5 to 9.5 (EU sizing), including those fitted on stainless-steel or polymer glove ports with flanged or threaded interfaces. It supports custom adapter kits for OEM glove port geometries (e.g., Bausch + Ströbel, IMA, Bosch). All firmware and software modules are validated per GAMP 5 guidelines. System-level compliance includes adherence to IEC 61000-6-3 (EMC), IEC 61010-1 (safety), and ISO 13485:2016 quality management system requirements. Test reports satisfy documentation expectations under EU GMP Annex 11 (Computerised Systems) and PIC/S PI 011-3.
Software & Data Management
Data integrity is enforced via embedded SQLite database with encrypted storage and write-once archival logic. Each test generates a unique alphanumeric identifier and stores raw pressure vs. time series (10 Hz sampling), calculated decay slope, leak rate (Pa/s), and pass/fail determination against configurable acceptance criteria (default: ≤ 50 Pa pressure drop over 120 s at 3000 Pa target). Historical records exceed 10,000 entries with searchable filters (date range, operator, glove ID, result status). Export options include CSV (for LIMS integration) and PDF (with digital signature embedding). Audit trails capture all critical events—including login/logout, parameter modification, report generation, and calibration log access—with immutable timestamps and user attribution.
Applications
- Routine pre-use and post-use integrity verification of isolator gloves prior to aseptic processing operations.
- Periodic requalification during equipment lifecycle (e.g., weekly/monthly scheduled checks per internal SOPs).
- Root cause investigation following glove puncture incidents or environmental excursions.
- Supporting validation protocols for new isolator installations or glove replacement programs.
- Complementing filter integrity testing workflows where glove systems serve as primary personnel barrier elements.
FAQ
What pressure ranges does the GT-2.0 support for integrity testing?
The instrument operates within a calibrated pressure range of 500–5000 Pa (gauge), with resolution of 1 Pa and repeatability better than ±10 Pa under controlled ambient conditions.
Is external calibration required, and how often?
Yes—annual traceable calibration against NIST-traceable pressure standards is recommended; internal zero-point auto-calibration occurs at power-up and before each test sequence.
Can test data be exported to a central LIMS or MES platform?
Yes—via USB host port (CSV format) or optional RS-232/Modbus RTU serial interface for direct SCADA or LIMS integration.
Does the GT-2.0 support multi-language UI beyond English?
Yes—localized interfaces are available for Simplified Chinese, German, French, and Japanese upon firmware configuration.
What is the maximum allowable ambient temperature and humidity for reliable operation?
The device is rated for continuous use at 15–30 °C and ≤ 70% RH (non-condensing), consistent with ISO 14644-1 Class 7 cleanroom support environments.
