AIRTECH GLT-10 Glove Integrity Tester
| Brand | AIRTECH |
|---|---|
| Origin | Jiangsu, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | GLT-10 |
| Power Supply | AC 220 V, 1φ, 50 Hz |
| Rated Power | 100 W |
| Max Test Pressure | 5000 Pa |
| Operating Environment | Controlled cleanroom (20–25 °C, RH 40–60%, minimal thermal fluctuation) |
| Dimensions (W×D×H) | 500 × 400 × 1100 mm |
| Weight | ~35 kg |
| Accessories | Sealing Plug or Glove Ring (optional, scalable per glove count) |
Overview
The AIRTECH GLT-10 Glove Integrity Tester is an engineered pressure-decay-based verification system designed for quantitative assessment of physical integrity in elastomeric gloves used in isolators, gloveboxes, and aseptic processing environments. It operates on the principle of controlled pressurization followed by high-resolution differential pressure monitoring over time—compliant with the fundamental methodology outlined in ISO 14644-7:2015 (Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)) for leak detection in flexible barrier systems. The instrument applies regulated positive pressure (up to 5000 Pa) to the internal volume of a sealed glove assembly and continuously records pressure decay rate, enabling detection of leaks as small as sub-100 µm equivalent orifice diameter under optimized conditions. Its architecture supports both static (offline) and dynamic (online) configurations—making it suitable for routine QC release testing, periodic qualification, and post-maintenance validation in GMP-regulated pharmaceutical, biotechnology, and nuclear handling facilities.
Key Features
- Triple-tier test protocol: Rapid Test (≤90 s), Standard Test (pressure stabilization + 120–300 s decay monitoring), and Precision Test (extended stabilization and ≥600 s decay analysis) — each calibrated to different sensitivity thresholds and operational risk profiles.
- Modular sealing interface: Supports single or multi-glove testing via interchangeable sealing plugs or optional glove rings—scalable to accommodate up to four gloves simultaneously without hardware modification.
- Integrated microprocessor-controlled pressure regulation: Digital PID control ensures stable ramping, precise setpoint maintenance (±15 Pa), and automatic termination upon reaching user-defined pass/fail criteria.
- Embedded data logging: Stores ≥10,000 test records locally with timestamp, operator ID, pressure curve metadata, and pass/fail status—exportable via USB to CSV or PDF report format.
- Intuitive 7-inch capacitive touchscreen HMI: English-language interface with configurable test templates, real-time pressure waveform visualization, and contextual help prompts aligned with ISO 14644-7 Annex C guidance.
- Rugged industrial enclosure: IP54-rated chassis constructed from 304 stainless steel and anodized aluminum—designed for long-term operation in ISO Class 5–8 cleanroom environments with minimal particulate generation.
Sample Compatibility & Compliance
The GLT-10 accommodates standard glove materials including natural rubber latex, nitrile, chloroprene, and butyl rubber—tested across thicknesses ranging from 0.15 mm to 0.6 mm and nominal diameters of 120–220 mm. It meets the functional requirements of ASTM D6978-05 (Standard Practice for Selection of Gloves for Protection Against Chemical Permeation), aligns with USP “Packaging – Sterility Assurance and Integrity Testing”, and satisfies the performance criteria referenced in FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004) for isolator glove qualification. While not certified to IEC 61010-1, its electrical design conforms to EN 61010-1:2010 safety standards for laboratory equipment. All test protocols are fully traceable and support ALCOA+ data integrity principles—including audit trail functionality for critical parameters (test type, pressure setpoint, duration, result).
Software & Data Management
The embedded firmware implements role-based access control (Operator, Supervisor, Administrator) and enforces electronic signature workflows for result approval. Data export includes raw pressure vs. time arrays, calculated decay rates (Pa/s), and derived leak equivalents (µm orifice diameter per ISO 14644-7 Annex B). Optional PC software (GLT-Link v3.x) enables centralized database synchronization, statistical process control (SPC) charting (X̄-R charts), and automated report generation compliant with 21 CFR Part 11 requirements—including electronic signatures, audit trail review, and secure user authentication. All stored data retain immutable timestamps synchronized to NTP servers when connected to facility network infrastructure.
Applications
- Pre-use qualification of isolator and glovebox gloves prior to aseptic manufacturing campaigns.
- Post-repair or post-replacement verification following glove change-out procedures.
- Periodic surveillance testing per facility SOPs (e.g., weekly or per batch cycle).
- Root cause investigation of environmental excursions linked to suspected barrier failure.
- Supporting regulatory submissions requiring documented evidence of continuous containment assurance (e.g., EMA Annex 1, PIC/S PI 032-2).
- Training and competency assessment for operators performing manual glove inspection.
FAQ
What pressure range does the GLT-10 support, and how is accuracy maintained across that range?
The instrument delivers regulated pressure from 500 Pa to 5000 Pa with ±1.5% full-scale repeatability, verified using NIST-traceable deadweight testers during factory calibration.
Can the GLT-10 be integrated into a facility’s MES or SCADA system?
Yes—via optional RS-485 Modbus RTU or Ethernet TCP/IP interface; integration requires configuration of register mapping per facility communication protocol specifications.
Is validation documentation provided with the instrument?
AIRTECH supplies IQ/OQ protocols compliant with ASTM E2500-13, along with calibration certificates for pressure transducers and temperature sensors (valid for 12 months from shipment).
Does the device meet requirements for use in radiological containment applications?
The GLT-10 has been successfully deployed in low-activity nuclear glovebox environments; however, users must perform site-specific radiation tolerance assessment per IEC 62582-2 for electronics exposed to gamma fields >10 Gy/h.
How often does the system require recalibration?
Annual recalibration is recommended; pressure sensor drift is monitored automatically during startup self-test, and deviation alerts trigger preventive maintenance notifications.
