MOCON OX-TRAN® Model 2/12 Oxygen Transmission Rate Analyzer
| Brand | MOCON |
|---|---|
| Origin | USA |
| Model | OX-TRAN® Model 2/12 |
| Test Range (Film) | 0.5–144,000 cc/m²·day |
| Test Range (Container) | 0.0025–720 cc/pkg·day |
| Resolution (Film) | 0.05 cc/m²·day |
| Repeatability | ±0.25 cc/m²·day |
| Temperature Range | 5–50 °C |
| Humidity Range (Film) | 0–90 %RH (±3 %RH) |
| Dual Test Cells | 2 × 50 cm² |
| Sample Size (Film) | 10.8 cm × 10.8 cm |
| Container Capacity | Up to 3 L |
| Compliance | ASTM F2622, ASTM D3985 |
Overview
The MOCON OX-TRAN® Model 2/12 is a high-precision, dual-cell oxygen transmission rate (OTR) analyzer engineered for quantitative permeation measurement of packaging materials and rigid containers under controlled temperature and humidity conditions. It employs the coulometric sensor principle—where oxygen molecules diffusing through a test specimen are quantitatively reduced at an electrochemical sensor—and delivers trace-level detection sensitivity with inherent linearity across five orders of magnitude. Designed for routine QC/QA laboratories in food, pharmaceutical, medical device, and flexible packaging industries, the instrument enables rapid method development, robust process validation, and full regulatory traceability. Its architecture supports both film- and container-mode testing without hardware reconfiguration, reducing downtime between sample types and facilitating seamless integration into GMP-aligned workflows.
Key Features
- Dual independent 50 cm² test cells for parallel or comparative analysis—increasing throughput by up to 100% versus single-cell systems
- Integrated coulometric oxygen sensor with NIST-traceable calibration, delivering long-term stability and <0.25 cc/m²·day repeatability
- Automated barometric pressure compensation: real-time local atmospheric pressure measurement and automatic normalization of OTR data to sea-level standard (101.325 kPa)
- Intuitive 10.1-inch capacitive touchscreen interface with guided workflow navigation—no specialized training required for routine operation
- Full sequence automation: auto-load, seal, equilibrate, measure, purge, and report generation—including customizable pass/fail logic per test
- Remote access via secure HTTPS interface; compatible with enterprise IT infrastructure and firewall-compliant network deployment
- Modular environmental control: direct coupling with external temperature/humidity chambers (e.g., 85 °C / 85 %RH per IEC 60068-2-30)
Sample Compatibility & Compliance
The OX-TRAN® Model 2/12 accommodates flat films (up to 10.8 cm × 10.8 cm), laminates, coated foils, and rigid or semi-rigid containers (up to 3 L volume). Optional fixtures enable testing of pouches, blister packs, vials, and syringes. All test protocols comply with globally recognized standards including ASTM F2622 (for high-barrier films), ASTM D3985 (for general-purpose films), and ISO 15105-2. Instrument firmware supports 21 CFR Part 11-compliant audit trails, electronic signatures, and user-access tiering—enabling compliance with FDA, EMA, and PMDA regulatory expectations for analytical instrumentation used in product release testing.
Software & Data Management
TruTest™ software provides validated, version-controlled operation with embedded SOP management, electronic lab notebook (ELN) export (PDF/A-2, CSV, XML), and configurable reporting templates aligned with internal QA requirements. All raw sensor signals, environmental logs, and metadata (operator ID, timestamp, cell ID, calibration history) are stored in an encrypted SQLite database with immutable records. Data integrity safeguards include write-once storage, checksum verification, and automated backup to network drives or cloud repositories. The system supports LIMS integration via ASTM E1384-compliant HL7 messaging or RESTful API endpoints.
Applications
- Barrier performance qualification of pharmaceutical blister lidding foils and cold-form foil
- Accelerated aging studies for sterile barrier systems per ISO 11607-1
- Comparative OTR screening of biodegradable films (PLA, PHA, cellulose derivatives)
- Process validation of vacuum-sealed food packaging lines
- Stability-indicating testing of oxygen-sensitive injectables in Type I glass vials with elastomeric closures
- Supplier qualification of aluminum oxide (AlOx) and silicon oxide (SiOx) coated PET substrates
FAQ
Does the OX-TRAN® Model 2/12 require daily sensor recalibration?
No—coulometric sensors exhibit intrinsic zero-drift stability and are calibrated per ASTM D3985 using certified reference films; typical recalibration intervals are every 6–12 months depending on usage frequency.
Can the instrument test samples at 85 °C / 85 %RH?
Yes—when connected to an externally controlled climatic chamber meeting IEC 60068-2-30, the system maintains precise thermal and hygral control during dynamic OTR measurement.
Is container-mode testing limited to specific geometries?
No—custom gasket kits and adaptable sealing fixtures support irregular shapes, including tubs, trays, and molded plastic containers, provided internal volume does not exceed 3 L.
How is data integrity ensured during multi-shift operations?
Each test session generates a cryptographically signed audit trail containing operator credentials, environmental setpoints, raw sensor output, and final calculated OTR—fully compliant with ALCOA+ principles.
What maintenance is required beyond sensor calibration?
Routine tasks include quarterly purge gas filter replacement, annual leak verification per ASTM F1306, and biannual verification of temperature/humidity sensor accuracy using NIST-traceable references.
