GBPI Y310E Oxygen Transmission Rate (OTR) Analyzer
| Brand | GBPI |
|---|---|
| Model | Y310E |
| Origin | Guangdong, China |
| Manufacturer | GBPI Packaging Instruments Co., Ltd. |
| Test Range | 0.02–16,500 cm³/(m²·24h) (film) |
| O₂ Detection Resolution | 0.001 cm³/(m²·24h) |
| Temperature Control | 15–45°C (5–50°C optional), ±0.1°C accuracy |
| Humidity Control | 30–90% RH (0–100% RH optional), ±1% RH accuracy |
| Test Area | 50.24 cm² |
| Specimen Size | Ø100 mm |
| Max. Specimen Thickness | ≤3 mm |
| Sample Capacity | 1–3 independent chambers |
| Carrier Gas Pressure | 0.1–0.2 MPa |
| Gas Inlet | 1/8″ stainless steel tubing |
| Dimensions (W×D×H) | 700×560×370 mm |
| Weight | 100 kg |
| Power | 750 W, AC 220 V, 50 Hz |
| Compliance | GB/T 19789–2005, ASTM D3985, ASTM F1927, ASTM F1307, ASTM F2622, ISO 15105-2, YBB 00082003–2015, DIN 53380-3, JIS K-7126-B |
Overview
The GBPI Y310E Oxygen Transmission Rate (OTR) Analyzer is a gravimetrically referenced, coulometric sensor-based instrument engineered for precise and traceable measurement of oxygen permeation through polymeric films, laminates, foils, rigid containers, and advanced functional materials. It operates on the principle of dynamic gas transmission under controlled temperature and humidity conditions, where oxygen diffuses across a conditioned test specimen into a nitrogen carrier stream; the permeated O₂ is quantified in real time using a high-stability coulometric oxygen sensor. This method ensures compliance with core international standards—including ASTM D3985 (electrochemical sensor), ASTM F1927 (moisture-corrected OTR), ISO 15105-2 (differential pressure method), and pharmaceutical packaging requirements per YBB 00082003–2015—making it suitable for regulatory submissions, stability studies, and quality control in GxP environments.
Key Features
- Triple independent test chambers enable concurrent evaluation of up to three specimens—identical or dissimilar—with individual start/stop control and autonomous data logging per chamber.
- High-resolution coulometric O₂ sensor with 0.001 cm³/(m²·24h) detection limit, validated using NIST-traceable standard reference materials certified by China’s National Institute of Metrology (GBW(E)130497/8).
- Precision environmental control: electromagnetic step-programmable thermostatic system (±0.1°C over 15–45°C range) and dual-stream humidity regulation (dry/wet gas mixing) delivering ±1% RH accuracy from 30–90% RH (0–100% RH optional).
- ARM-based embedded controller allows fully autonomous operation without continuous PC connection; all test protocols, calibration routines, and data storage are managed onboard.
- Comprehensive software architecture compliant with FDA 21 CFR Part 11 and EU Annex 11 requirements, featuring role-based user access (Administrator, Operator, Reviewer), audit trail logging (system, method, and run-level), electronic signatures, and immutable data archiving.
- Expandable configuration: optional OTR mask extends upper detection limit to 260,000 cm³/(m²·24h) for low-barrier materials; container testing kits support bottles, pouches, trays, and blister packs per ASTM F1307 and ISO 15105-2 Annex B.
Sample Compatibility & Compliance
The Y310E accommodates flat specimens up to 3 mm thick and Ø100 mm in diameter—including monolayer plastics (e.g., PET, PP, PE), metallized films (AlOx, SiOx), aluminum foil, rubber elastomers, ceramic coatings, and multilayer composites. With appropriate fixtures, it measures headspace O₂ ingress in rigid and semi-rigid packaging (e.g., HDPE bottles, CPET trays, aluminum-plastic blisters). Applications span regulated sectors: pharmaceutical primary packaging (sterile barrier validation), medical device packaging (ISO 11607-1), food shelf-life modeling (MAP integrity), photovoltaic backsheet qualification, flexible OLED encapsulation, and transdermal patch permeability assessment. All measurements adhere to GLP/GMP-aligned workflows, with full traceability to national standard substances and documented instrument qualification (IQ/OQ/PQ templates available upon request).
Software & Data Management
GBPI OTR Studio v4.x provides intuitive Windows-native interface with real-time visualization of OTR, O₂ concentration, temperature, and RH curves—each scalable, overlayable, and exportable as SVG or PNG. Automated report generation supports customizable templates in PDF, Excel, and Word formats, including statistical summaries (mean, SD, RSD), pass/fail criteria per specification limits, and raw time-series datasets. Database backend stores all metadata—operator ID, calibration history, environmental logs, method parameters—with encrypted SQL-based storage and daily automated backup. Audit trails record every action: user login/logout, parameter edits, result approvals, and calibration events—including timestamps, IP addresses (if networked), and pre-/post-change values—ensuring full ALCOA+ compliance (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Pharmaceutical packaging: Validation of blister foil lamination integrity, sachet seal performance, and vial stopper O₂ ingress for lyophilized biologics.
- Food & beverage: Shelf-life prediction for modified atmosphere packaging (MAP), barrier optimization of snack pouches, and ethanol barrier assessment for wine closures.
- Electronics: Moisture/oxygen permeation screening of thin-film encapsulation layers for flexible displays and perovskite solar cells.
- Medical devices: Sterility maintenance verification of Tyvek® pouches, silicone hydrogel lens packaging, and wound dressing film permeability.
- Material R&D: Structure–property correlation studies of nanocomposite films, plasma-treated surfaces, and bio-based polymer blends.
FAQ
What calibration standards are supported?
The Y310E accepts both certified reference films (e.g., 125 µm polyethylene standard) and certified O₂/N₂ gas mixtures (99.999% purity) for dual-mode verification. Calibration is performed via guided software workflow requiring no external tools.
Is the instrument suitable for GMP-regulated environments?
Yes. The embedded software implements full 21 CFR Part 11 controls—including electronic signatures, audit trails, and permission hierarchies—and supports IQ/OQ documentation packages aligned with ISO/IEC 17025 and Annex 15.
Can container testing be performed without modification?
Container testing requires optional accessories (headspace adapter kits, custom fixtures). Standard film mode uses a 50.24 cm² diffusion area; container mode employs differential pressure methodology per ASTM F1307.
What maintenance is required for the oxygen sensor?
The coulometric sensor has a typical service life of ≥24 months under normal use. GBPI recommends annual verification with standard film and sensor zero-check using nitrogen purge. No field recalibration is needed between certifications.
Does the system support network integration and LIMS connectivity?
Yes. RS232 and optional Ethernet interfaces enable bidirectional communication with LIMS via ASTM E1384 or HL7-compliant protocols. Raw data export supports CSV, XML, and SQL dump formats.
