GBPI Y210 Oxygen Transmission Rate (OTR) Analyzer
| Brand | GBPI |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | OEM/ODM Manufacturer |
| Region | Domestic (China) |
| Model | Y210-aa |
| Price Range | USD 14,000 – 70,000 |
Overview
The GBPI Y210 Oxygen Transmission Rate (OTR) Analyzer is a precision laboratory instrument engineered for quantitative determination of oxygen permeation through polymeric films, laminates, foils, rigid containers, and advanced functional barriers. It operates on the coulometric sensor principle—internationally standardized per ASTM D3985, ISO 15105-2, and GB/T 19789—where oxygen molecules permeating across a test specimen are carried by a pure nitrogen carrier gas stream to a high-stability electrochemical oxygen sensor. The resulting current output is linearly proportional to oxygen concentration, enabling trace-level OTR quantification with sub-milligram sensitivity. Designed for regulated environments, the Y210 delivers metrologically traceable results suitable for quality control in pharmaceutical packaging, food shelf-life modeling, medical device barrier validation, and emerging applications including photovoltaic backsheet evaluation and flexible OLED encapsulation integrity assessment.
Key Features
- High-resolution OTR measurement down to 0.001 cm³/(m²·24h), validated for ultra-high-barrier materials such as aluminum foil and SiOₓ-coated PET
- Dual independent test chambers support concurrent analysis of two dissimilar specimens—reducing throughput time without cross-contamination risk
- Integrated environmental control: temperature range 15–45 °C (optional 5–50 °C), ±0.1 °C stability; humidity range 0–90 %RH, ±1 %RH accuracy via dual-stream dry/wet gas mixing
- ARM-based embedded control system enables standalone operation—no host PC required for routine testing or data logging
- Comprehensive GxP compliance architecture: role-based user access (Administrator, Operator, Reviewer), full audit trail (system, method, run-level), electronic signature support per FDA 21 CFR Part 11
- Modular hardware design facilitates field maintenance; sensor over-range protection prevents damage during abnormal operating conditions
- Standardized calibration protocol using NIST-traceable reference films (GBW(E)130497/8) and certified gas mixtures ensures inter-laboratory comparability
Sample Compatibility & Compliance
The Y210 accommodates flat specimens up to Φ100 mm and ≤3 mm thickness—including monolayer plastics, metallized films, coextrusions, rubber sheets, ceramic substrates, and rigid containers (bottles, trays, pouches) via optional fixtures. Its 50.24 cm² defined test area conforms to ISO 15105-2 and ASTM F1307 geometrical requirements. The instrument meets or exceeds performance criteria specified in GB/T 19789-2005, ASTM D3985 (film), ASTM F1927 (container), ASTM F2622 (high-flow OTR), YBB00082003-2015 (Chinese pharmaceutical packaging standard), DIN 53380-3, and JIS K-7126-B. All firmware and software modules undergo periodic verification against ISO/IEC 17025:2017 clause 5.9 requirements for measurement uncertainty estimation and traceability.
Software & Data Management
GBPI OTR Studio v4.x provides intuitive Windows-native interface with real-time visualization of OTR, O₂ concentration, temperature, and RH trends—each curve fully scalable and navigable. Test methods are configurable via drag-and-drop workflow editor; automated pass/fail evaluation applies user-defined specification limits. Reports comply with GLP/GMP documentation standards: generated in PDF, Excel, and XML formats with embedded metadata (operator ID, timestamp, instrument serial number, calibration certificate ID). Database engine supports SQL-based querying, version-controlled method archiving, and secure export with digital watermarking. Audit logs record every parameter change, result modification, or user login—retained for ≥36 months per internal SOP-IT-02.
Applications
- Pharmaceutical primary packaging: blister foil OTR validation per USP , IV bag film integrity, transdermal patch barrier assessment
- Food packaging R&D: shelf-life prediction for modified atmosphere packaging (MAP), ethylene-sensitive produce films, retort pouch barrier degradation studies
- Electronics encapsulation: moisture/oxygen ingress modeling for flexible printed circuits, OLED display laminates, solar module backsheets
- Medical device sterility assurance: Tyvek® pouch permeation kinetics, silicone elastomer O₂ diffusion coefficients, hydrogel contact lens material characterization
- Regulatory submission support: generation of analytical data packages compliant with ICH Q5C, FDA Guidance for Industry: Container Closure Systems, and EMA CHMP/Q5C Annex
FAQ
What standards does the Y210 comply with for pharmaceutical packaging testing?
The Y210 satisfies USP , YBB00082003-2015, and ISO 15105-2 for OTR measurement in sterile barrier systems and complies with data integrity requirements of Annex 11 and FDA 21 CFR Part 11.
Can the Y210 measure OTR for rigid containers like HDPE bottles?
Yes—using the optional container test fixture, the Y210 performs ASTM F1927-compliant headspace analysis with internal N₂ purge and external O₂ exposure.
How is instrument calibration verified?
Calibration uses GBPI-certified reference films (GBW(E)130497/8) and/or NIST-traceable O₂-in-N₂ gas standards; calibration certificates include uncertainty budgets per ISO/IEC 17025.
Is remote monitoring supported?
The embedded Ethernet port enables secure remote access via TLS-encrypted web interface; live data streaming and alarm notifications are configurable.
What maintenance intervals are recommended?
Sensor replacement every 18 months under continuous use; quarterly verification with reference film; annual full system validation per IQ/OQ protocol supplied with instrument.
