GBPI Y310T Oxygen Transmission Rate (OTR) Tester for Packaging Materials
| Brand | GBPI |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | Direct Manufacturer |
| Region | Domestic (China) |
| Model | Y310T |
| Price Range | USD 14,000 – 70,000 |
| Test Range | 0.02–16,500 cm³/(m²·24h) (film) |
| O₂ Resolution | 0.001 cm³/(m²·24h) |
| Temp Control | 15–45°C (5–50°C optional) |
| Temp Accuracy | ±0.1°C |
| RH Control | 30–90% RH (0–100% RH optional) |
| RH Accuracy | ±1% RH |
| Test Area | 50.24 cm² |
| Specimen Size | Φ100 mm |
| Max Thickness | ≤3 mm |
| Sample Capacity | 1–3 specimens per test cycle |
| Carrier Gas Pressure | 0.1–0.2 MPa |
| Gas Inlet | 1/8″ stainless steel tubing |
| Dimensions | 700 × 560 × 370 mm |
| Weight | 100 kg |
| Power | 750 W |
| Supply | AC 220 V, 50 Hz |
Overview
The GBPI Y310T Oxygen Transmission Rate (OTR) Tester is a gravimetric- and coulometric-based instrument engineered for precise, reproducible measurement of oxygen permeation through packaging materials under controlled temperature and humidity conditions. It operates on the principle of dynamic gas transmission analysis: a defined oxygen partial pressure gradient is established across a sealed test specimen mounted in a diffusion cell; oxygen molecules permeating through the material are swept by a carrier gas stream into a high-sensitivity electrochemical oxygen sensor, where real-time concentration is quantified and integrated over time to yield OTR in standard units (cm³/[m²·24h]). This method complies with internationally recognized diffusion kinetics models described in ASTM D3985 (coulometric detection), ASTM F1927 (moisture-permeable films), ASTM F1307 (rigid containers), ISO 15105-2 (gas permeability of plastics), and Chinese pharmacopoeial standards (YBB00082003-2015). The system is purpose-built for quality assurance in regulated environments—particularly pharmaceutical primary packaging, sterile barrier systems, and high-barrier flexible packaging—where oxygen ingress directly impacts product shelf life, oxidation stability, and microbial safety.
Key Features
- Triple-test chamber architecture enabling concurrent, independent evaluation of up to three specimens—including heterogeneous materials—with individual start/stop control and discrete report generation.
- High-resolution coulometric oxygen sensor (detection limit: 0.001 cm³/[m²·24h]), certified traceable to NIM (National Institute of Metrology, China) reference standards; supported by GBW(E)130497/8 certified national standard substances for routine calibration.
- Precision dual-gas humidity control system (dry + humid nitrogen streams) delivering stable, programmable RH from 30% to 90% (0–100% RH optional), with ±1% RH accuracy verified per ISO 17025-accredited protocols.
- Electromagnetic step-programmable temperature regulation (15–45°C standard; 5–50°C extended range), maintaining ±0.1°C uniformity across test zones—critical for Arrhenius-based barrier performance modeling.
- ARM-based embedded controller permitting standalone operation without PC dependency; full test execution, data logging, and alarm handling managed locally via 7-inch capacitive LCD touchscreen with Windows-style GUI.
- GMP-aligned software architecture compliant with Annex 11 (EU GMP) and FDA 21 CFR Part 11 requirements: role-based user access (Administrator, Operator, Reviewer), immutable audit trails (system, method, run-level), electronic signatures, and change-controlled method templates.
Sample Compatibility & Compliance
The Y310T accommodates flat and rigid geometries per standardized specimen formats: films (plastic, metallized PET/AL, SiOx/AlOx coatings), laminates, foils, rubber sheets, ceramic substrates, and rigid plastic containers (bottles, trays, blister cavities) using optional fixtures. Its extended-range face mask accessory enables OTR quantification of ultra-high-permeability materials (e.g., nonwovens, breathable medical films) up to 260,000 cm³/(m²·24h). All hardware and firmware conform to ISO/IEC 17025:2017 calibration traceability frameworks. Instrument validation documentation supports IQ/OQ/PQ protocols aligned with USP , ICH Q5C, and ISO 11607-1 for packaging integrity qualification. CE marking and RoHS compliance are provided for export-ready deployment.
Software & Data Management
GBPI OTR Studio v4.2 provides full lifecycle data governance: automated curve visualization (OTR, O2 concentration, T, RH), zoom/pan functionality, historical database queries with SQL-driven filtering, and configurable report templates (PDF, XLSX, DOCX) containing raw values, statistical summaries (mean, SD, RSD), environmental metadata, and digital signature fields. All data entries—including manual overrides, calibration events, and parameter edits—are timestamped, user-attributed, and cryptographically hashed within the audit trail. Backups adhere to 21 CFR Part 11 §11.10(e) retention rules (minimum 15 years). Raw data files are stored in vendor-neutral CSV+JSON hybrid format for third-party LIMS integration.
Applications
- Pharmaceutical packaging: Quantifying OTR of PTP blisters, cold-form foil, sachets, and polymer-coated vials to validate shelf-life predictions per ICH Q1A(R2).
- Food packaging R&D: Benchmarking barrier efficacy of multilayer coextrusions, EVOH blends, and bio-based films against spoilage thresholds (e.g., lipid oxidation in nuts, enzymatic browning in cut produce).
- Medical device packaging: Verifying sterility maintenance in Tyvek® pouches and thermoformed trays per ISO 11607-2 accelerated aging protocols.
- Electronics encapsulation: Assessing moisture/oxygen ingress resistance of OLED backplane laminates and flexible display cover films.
- Regulatory submission support: Generating GLP-compliant datasets for ANDA filings, MDR Class III dossiers, and PMDA PMDA-Japan submissions.
FAQ
What calibration standards are required for daily verification?
GBPI supplies NIST-traceable polyethylene and aluminum oxide reference films (125 µm thickness) certified per GBW(E)130497/8. Users perform routine checks using these standards before critical batches; calibration coefficients auto-update upon entry of measured vs. certified values.
Can the Y310T test pouches or bottles without custom fixtures?
No. Container testing requires optional accessories: vacuum-seal bottle adapters or clamp-type pouch holders. These maintain leak-tight integrity during differential pressure application and comply with ASTM F1307 geometry specifications.
Is remote monitoring supported?
Yes—via Ethernet-enabled OPC UA server integration. Real-time OTR trends, alarm states, and environmental logs can be ingested into SCADA or MES platforms without compromising audit trail integrity.
What maintenance intervals are recommended for the oxygen sensor?
Sensor lifespan exceeds 24 months under continuous operation. GBPI recommends quarterly zero-point verification using certified nitrogen (99.999%) and annual sensitivity recalibration using certified O2/N2 mixtures (±0.5% uncertainty).
Does the system meet FDA 21 CFR Part 11 requirements out-of-the-box?
Yes—when deployed with Windows OS configured per GBPI’s validated baseline image (Windows 10 IoT Enterprise LTSC), including disabled default accounts, enforced password policies, and enabled BitLocker encryption. Full Part 11 validation package available upon request.
