GBPI Y110 Coulometric Oxygen Transmission Rate (OTR) Analyzer
| Brand | GBPI |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | OEM/ODM Producer |
| Country of Origin | China |
| Model | Y110 |
| Price Range | USD 14,000 – 70,000 |
| Testing Principle | Coulometric Sensor-Based Oxygen Permeation Measurement |
| Standards Compliance | GB/T 19789–2005, YBB 00082003–2015, ASTM D3985, ASTM F2622, ASTM F1927, ASTM F1307, ISO 15105-2, DIN 53380-3, JIS K 7126-B |
| OTR Range | 0.02–16,500 cm³/(m²·24h) (up to 260,000 cm³/(m²·24h) with optional face mask adapter) |
| OTR Resolution | 0.001 cm³/(m²·24h) |
| Temperature Control | 15–45 °C, ±0.1 °C |
| Humidity Control | 30–90% RH (and 100% RH), ±1% RH |
| Test Area | 50.24 cm² (down to 0.785 cm² with accessory kits) |
| Specimen Size | Ø100 mm |
| Max 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 |
Overview
The GBPI Y110 Coulometric Oxygen Transmission Rate (OTR) Analyzer is a precision laboratory instrument engineered for quantitative determination of oxygen permeation through polymeric films, laminates, rigid sheets, and packaged containers. It operates on the coulometric detection principle: oxygen molecules permeating through a conditioned test specimen are carried by a dry nitrogen stream into an electrochemical sensor, where they undergo stoichiometric reduction at a platinum cathode. The resulting current—directly proportional to the molar flow rate of O₂—is measured with high linearity and stability, enabling trace-level OTR quantification down to 0.001 cm³/(m²·24h). Designed for compliance-driven environments, the Y110 meets stringent requirements of pharmaceutical packaging validation (YBB 00082003–2015), food contact material assessment (GB/T 19789–2005), and international barrier testing protocols including ASTM D3985 (film testing), ASTM F1307 (container testing), and ISO 15105-2 (dual-sensor gravimetric/coulometric correlation methodology). Its dual-path humidity control system, ARM-based embedded controller, and GMP-aligned software architecture make it suitable for GLP/GMP-regulated laboratories requiring full data integrity and audit readiness.
Key Features
- Coulometric Sensor Architecture: High-stability electrochemical O₂ sensor with automatic over-range protection and long-term baseline drift compensation; certified reference materials (GBW(E)130497/8) traceable to China’s National Institute of Metrology ensure measurement traceability.
- Precision Environmental Control: Dual-gas humidity generation (dry + saturated N₂ blending) achieves ±1% RH accuracy across 30–100% RH; Peltier-assisted thermoelectric temperature regulation maintains ±0.1 °C uniformity within the test chamber.
- Modular Test Configuration: Standard 50.24 cm² test area (Ø100 mm clamp); optional micro-area fixtures reduce effective area to 0.785 cm² for ultra-high-barrier films (e.g., AlOx-coated PET, SiOx-laminates); face-mask adapter enables direct OTR measurement of bottles, pouches, and trays per ASTM F1307.
- Embedded ARM Control System: Standalone operation without PC dependency; real-time display of OTR, O₂ concentration, temperature, and RH as synchronized time-series curves; zoom/pan functionality and curve overlay support comparative analysis.
- GMP-Compliant Software Suite: Role-based access control (Administrator, Operator, Viewer); configurable user permissions; full audit trail per 21 CFR Part 11—including system events, method edits, result modifications, and login/logout logs.
- Calibration Flexibility: Supports both certified standard films (e.g., NIST-traceable polyester reference) and certified O₂/N₂ gas mixtures for dual-mode verification; automated calibration workflow requires only entry of certified reference values post-measurement.
Sample Compatibility & Compliance
The Y110 accommodates flat specimens up to 3 mm thick—including monolayer plastics (LDPE, PP), metallized films (Al-coated PET), oxide-coated substrates (SiOx, AlOx), rubber sheets, ceramic wafers, and laminated structures used in medical device packaging. With container adapters, it measures headspace O₂ ingress in rigid and semi-rigid packages such as HDPE bottles, aluminum-plastic blister packs, and thermoformed trays. All testing workflows align with regulatory expectations for barrier validation: method suitability per ICH Q2(R2), equipment qualification (IQ/OQ/PQ), and data integrity per ALCOA+ principles. Full compliance documentation—including factory calibration certificates, standard operating procedures (SOPs), and 21 CFR Part 11 configuration files—is provided upon delivery.
Software & Data Management
GBPI OTR Studio v4.x provides intuitive Windows-native interface with drag-and-drop test setup, customizable pass/fail criteria, and multi-parameter trending. Raw sensor output, environmental logs, and calculated OTR values are stored in encrypted SQLite database with immutable timestamps. Export functions support CSV, PDF, and Microsoft Office formats (DOCX, XLSX); reports include instrument ID, operator ID, calibration status, environmental conditions, and uncertainty estimation per GUM (Guide to the Expression of Uncertainty in Measurement). Database queries support retrospective analysis by date range, sample ID, or test parameter—enabling root-cause investigations during stability studies or deviation management.
Applications
- Pharmaceutical packaging: OTR validation of blister foil, cold-forming aluminum, and child-resistant closures per USP and Ph. Eur. 5.1.3.
- Food packaging R&D: Shelf-life modeling of modified atmosphere packaging (MAP) films; barrier performance comparison of bio-based polymers vs. conventional PE/EVOH structures.
- Electronics encapsulation: Moisture-oxygen co-permeation assessment of backsheet materials for photovoltaic modules (IEC 61215-2 MQT18).
- Medical device sterility assurance: Quantitative O₂ ingress rates for Tyvek® pouches, peel-open trays, and silicone elastomer gaskets.
- Academic research: Structure–property relationships in nanocomposite films; accelerated aging correlation studies under elevated T/RH stress conditions.
FAQ
What standards does the Y110 comply with for pharmaceutical packaging validation?
The instrument fully supports YBB 00082003–2015 (China Pharmacopoeia packaging standard) and ASTM F1307 for container testing, with documented method equivalence to USP and ISO 11607-1 Annex C.
Can the Y110 measure ultra-high-barrier materials like silicon oxide coatings?
Yes—using the micro-test area fixture (0.785 cm²), the system achieves sub-0.01 cm³/(m²·24h) resolution, validated against certified low-permeability reference films.
Is remote monitoring or network integration supported?
The embedded ARM platform supports Ethernet connectivity; OPC UA and Modbus TCP protocols are available via optional firmware module for LIMS/SCADA integration.
How often must the coulometric sensor be replaced or recalibrated?
Sensor lifetime exceeds 18 months under normal use; annual recalibration using GBPI-certified standard films is recommended, with interim verification using gas-phase standards every 90 days.
Does the system meet FDA 21 CFR Part 11 requirements for electronic records?
Yes—audit trail, electronic signatures, role-based access, and data immutability are implemented per Part 11 Subpart B specifications; full validation documentation package is included.
