GBPI Y110A Coulometric Oxygen Transmission Rate (OTR) Analyzer
| Brand | GBPI |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | Direct Manufacturer |
| Model | Y110A |
| Test Range | 0.02–16,500 cm³/(m²·24h) |
| Extended Range (with shroud) | up to 260,000 cm³/(m²·24h) |
| Measurement Accuracy | 0.001 cm³/(m²·24h) |
| Temperature Control Range | 15–45 °C |
| Temp. Stability | ±0.1 °C |
| Humidity Control Range | 30–90 %RH (including 100 %RH) |
| RH Stability | ±1 %RH |
| Permeation Area | 50.24 cm² (down to 0.785 cm² with optional fixtures) |
| Specimen Diameter | Φ100 mm |
| Max. Specimen Thickness | ≤3 mm |
| Sample Capacity | 1 unit per test |
| Carrier Gas Pressure | ≥0.1 MPa |
| Gas Inlet | Φ3 mm tubing / 1/8″ NPT |
| Dimensions | 600 × 400 × 330 mm |
| Weight | 80 kg |
| Power | 750 W, AC 220 V, 50 Hz |
| Compliance | GB/T 19789–2005, YBB00082003–2015, ASTM D3985, ASTM F2622, ASTM F1927, ASTM F1307, ISO 15105-2, DIN 53380-3, JIS K-7126-B |
Overview
The GBPI Y110A Coulometric Oxygen Transmission Rate (OTR) Analyzer is a precision laboratory instrument engineered for quantitative determination of oxygen permeability through planar and contoured packaging materials. It operates on the principle of coulometric detection—where oxygen molecules permeating through a sealed test specimen are swept by a carrier gas stream into an electrochemical sensor that quantifies oxygen concentration via Faraday’s law of electrolysis. This method delivers high reproducibility, low detection limits, and intrinsic traceability to national standard reference materials. Designed for compliance-critical environments—including pharmaceutical packaging validation, medical device barrier assessment, and food shelf-life modeling—the Y110A supports both flat-sheet and container testing (e.g., bottles, pouches, trays) with modular fixtures. Its dual-stream humidity control, ARM-based embedded controller, and metrologically traceable calibration architecture make it suitable for GLP, GMP, and ISO/IEC 17025-accredited laboratories.
Key Features
- Coulometric Sensor Technology: High-stability electrochemical oxygen sensor with automatic over-range protection and >12-month operational stability under continuous use.
- Precision Environmental Control: Electromagnetic programmable temperature regulation (±0.1 °C) and dual-gas (dry/wet) humidity generation (30–100 %RH, ±1 %RH), enabling strict adherence to standardized test conditions per ASTM and ISO protocols.
- Modular Permeation Area Configuration: Standard 50.24 cm² test area (Φ100 mm); optional mini-fixtures support down to 0.785 cm² for micro-scale or high-barrier film evaluation (e.g., Al foil, SiOx-coated PET).
- Extended Dynamic Range: With integrated shroud accessory, upper OTR limit extends to 260,000 cm³/(m²·24h), accommodating highly permeable substrates such as non-woven fabrics or uncoated paperboard.
- Embedded ARM Controller: Fully autonomous operation without PC dependency; real-time data logging, curve visualization (OTR, O2 concentration, temperature, RH), zoom/pan functionality, and background SQL database access.
- GMP-Compliant Software Architecture: Role-based user authentication (Administrator, Operator, Viewer), configurable privilege tiers, and full audit trail—covering system events, method execution, and data edits—in accordance with FDA 21 CFR Part 11 and EU Annex 11 requirements.
Sample Compatibility & Compliance
The Y110A accommodates rigid and flexible specimens up to 3 mm thick, including polymer films (LDPE, PET, PP), metallized laminates, aluminum foils, coated papers, rubber sheets, ceramic tiles, and molded plastic containers. Its fixture system enables standardized testing of pouches (via clamp-seal), bottles (using custom cradles), and shallow trays. Regulatory alignment includes full support for pharmacopeial methods (YBB00082003–2015), Chinese national standards (GB/T 19789–2005), and international consensus protocols: ASTM D3985 (film/sheet), ASTM F1307 (rigid containers), ASTM F1927 (high-barrier), ASTM F2622 (multi-layer), ISO 15105-2 (differential pressure variant), DIN 53380-3, and JIS K-7126-B. All calibrations are traceable to GBW(E)130497/8 certified reference materials issued by China’s National Institute of Metrology.
Software & Data Management
Equipped with Windows-style GUI software, the Y110A provides intuitive workflow configuration—test duration, stabilization thresholds, environmental setpoints, and pass/fail criteria are fully programmable. Real-time graphical output displays four synchronized parameters: OTR, residual O2, chamber temperature, and relative humidity—with interactive scaling and overlay toggling. Reports auto-generate in PDF, Excel, and Word formats, embedding metadata (operator ID, timestamp, instrument serial number, calibration status). The relational database stores raw sensor outputs, environmental logs, and audit records with immutable timestamps. Exported datasets retain full traceability for regulatory submissions or inter-laboratory comparison studies.
Applications
- Pharmaceutical packaging qualification per USP and ICH Q5C stability guidelines
- Oxygen barrier validation of blister lidding foils, sachets, and cold-forming aluminum strips
- Shelf-life prediction modeling for oxygen-sensitive biologics and lyophilized formulations
- Quality control of solar backsheet films (EVA, PVF) and OLED encapsulation layers
- Development and specification of medical transdermal patches and contact lens packaging
- Regulatory submission support for FDA 510(k), CE Marking, and NMPA registration dossiers
- Research on nanocomposite barrier coatings, plasma-deposited oxides, and bio-based films
FAQ
What calibration standards are supported?
The Y110A accepts both certified reference films (e.g., GBW(E)130497/8) and standard gases for multi-point verification. Calibration is performed via guided software wizard without external hardware.
Can the instrument test filled containers?
Yes—when equipped with appropriate sealing fixtures and purge protocols, the Y110A measures headspace O2 ingress into sealed bottles, vials, and pouches per ASTM F1307 and ISO 15105-2 Annex B.
Is remote monitoring or network integration possible?
The embedded controller supports Ethernet connectivity; optional OPC UA or Modbus TCP modules enable integration into MES/LIMS infrastructure and centralized fleet monitoring.
How is sensor longevity maintained?
The coulometric cell features active dry-gas purging during idle cycles and automatic zero-drift compensation. Typical service life exceeds 24 months under routine QC usage.
Does the system meet 21 CFR Part 11 requirements?
Yes—electronic signatures, role-based access control, tamper-evident audit logs, and electronic record retention comply with predicate rule requirements for regulated pharmaceutical and medical device manufacturing.
