Labthink C206H Oxygen Transmission Rate (OTR) Analyzer
| Brand | Labthink |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | OEM/ODM Manufacturer |
| Country of Origin | China |
| Model | C206H |
| Price Range | USD 14,000 – 98,000 |
| Test Principle | Isobaric Coulometric Sensor Method (ASTM D3985 Compliant) |
| Test Range | 0.02–200 cc/(m²·day) @ 50 cm² (standard) |
| optional MASK areas | 5 cm² (0.2–2000 cc/(m²·day)) and 1 cm² (1–10,000 cc/(m²·day)) |
| Resolution | 0.0001 cc/(m²·day) |
| Repeatability | ±0.02 cc/(m²·day) or ±1%, whichever is greater |
| Temperature Range | 15–50 °C (standard) |
| Temp. Stability | ±0.15 °C |
| Humidity Range | 0% RH, 5–90% RH ±2% RH |
| Test Chambers | 6 independent chambers |
| Chamber Area | 50 cm² (standard) |
| Sample Size | 11.2 cm × 11.2 cm |
| Max. Sample Thickness | 3 mm |
| Gas Supply | ≥99.999% N₂, ≥99.5% O₂ (user-supplied) |
| Inlet Pressure | ≥280 kPa (40.6 PSI) |
| Interface | 1/8" stainless steel tubing |
| Dimensions | 600 × 490 × 660 mm |
| Power | 120 VAC ±10% / 60 Hz OR 220 VAC ±10% / 50 Hz |
| Weight | 100 kg |
Overview
The Labthink C206H Oxygen Transmission Rate (OTR) Analyzer is an isobaric, coulometric-sensor-based instrumentation system engineered for high-precision, high-throughput measurement of oxygen permeation through polymeric films, laminates, foils, and rigid sheets. It operates on the fundamental principle of oxygen diffusion across a barrier material under controlled temperature and relative humidity conditions, with oxygen molecules transported across the specimen into a nitrogen carrier stream and quantified via a trace-level electrochemical sensor. This method aligns strictly with ASTM D3985 (“Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor”), as well as ASTM F1307, ISO 15105-2, GB/T 19789, GB/T 31354, DIN 53380-3, JIS K7126-2-B, and YBB 00082003-2015—ensuring global regulatory acceptability for packaging validation in pharmaceutical, food, medical device, and electronics industries.
Key Features
- Six independent test chambers, each with a standardized 50 cm² active area—triple the throughput of conventional single- or dual-chamber OTR analyzers—enabling concurrent, statistically independent measurements of six specimens under identical environmental conditions.
- ppb-level coulometric oxygen sensor developed in-house by Labthink, delivering a detection limit as low as 0.02 cc/(m²·day), with threefold extended service life versus legacy sensors and zero calibration requirement due to absolute signal output.
- Rainbow Bridge™ test chamber architecture incorporating 360° circumferential gas recirculation and precision thermal mass control, achieving ±0.15 °C temperature stability across all chambers during dynamic testing.
- Integrated high-accuracy capacitive humidity sensor within each chamber, enabling real-time logging of RH profiles synchronized with OTR calculation—critical for evaluating moisture-dependent barrier performance (e.g., PVDC, EVOH, or hydrophilic coatings).
- Automated sample clamping mechanism ensuring uniform sealing pressure and eliminating operator-induced variability; combined with motorized lid actuation and audible/visual status alerts for process integrity monitoring.
- Embedded industrial-grade computing platform running Windows OS on a 12-inch capacitive touchscreen interface—immune to external malware, supporting audit-ready data storage, deterministic I/O timing, and deterministic firmware execution per IEC 62443-3-3 security guidelines.
Sample Compatibility & Compliance
The C206H accommodates a broad spectrum of flexible and semi-rigid packaging materials, including but not limited to biaxially oriented polypropylene (BOPP), polyester (PET), polyethylene (PE), polyamide (PA), ethylene-vinyl alcohol (EVOH) coextrusions, aluminum foil laminates, metallized films, paper-plastic composites, siliconized rubber sheets, and thin-gauge metal foils (e.g., Al, Cu). Specimen thickness is supported up to 3 mm, with maximum dimensions of 11.2 cm × 11.2 cm. All test protocols adhere to Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) frameworks. Optional CFR 21 Part 11-compliant software modules provide electronic signatures, audit trails, role-based access control, and immutable data archiving—fully traceable for FDA, EMA, PMDA, and NMPA submissions.
Software & Data Management
Control and analysis are executed via Labthink’s proprietary OTR-Studio™ software suite, compliant with ISO/IEC 17025:2017 data integrity requirements. The platform supports automated method setup—including temperature ramping, RH profiling, and multi-step conditioning sequences—as well as real-time curve visualization, statistical outlier detection (Dixon’s Q-test), and customizable report generation (PDF, CSV, XML). Raw sensor voltage, flow rate, chamber temperature/humidity, and calculated OTR values are timestamped at ≤1-second intervals and stored locally in encrypted binary format. Optional DataShield™ module enables hardware-enforced write-once-read-many (WORM) archival to external NAS or SAN infrastructure, satisfying long-term retention mandates under EU Annex 11 and USP .
Applications
- Pharmaceutical primary packaging: blister foil lidding, cold-form foil, sachets, and child-resistant pouches—validating shelf-life predictions per ICH Q5C and Q1A(R2).
- Food packaging: modified atmosphere packaging (MAP) films, vacuum-sealed trays, and retort pouches—supporting compliance with FDA 21 CFR §177 and EU Regulation (EC) No 1935/2004.
- Medical device packaging: sterile barrier systems (SBS) per ISO 11607-1, including Tyvek®/polyester pouches and thermoformed trays.
- Emerging applications: encapsulation films for OLED displays, photovoltaic backsheet materials, and lithium-ion battery separator films—where ultra-low OTR (<0.1 cc/m²·day) correlates directly with functional lifetime.
FAQ
What standards does the C206H comply with?
ASTM D3985, ASTM F1307, ISO 15105-2, GB/T 19789, GB/T 31354, DIN 53380-3, JIS K7126-2-B, and YBB 00082003-2015.
Is the instrument suitable for high-barrier materials with OTR below 0.1 cc/(m²·day)?
Yes—the ppb-class coulometric sensor and optimized nitrogen purge path enable reliable quantification down to 0.02 cc/(m²·day) at standard 50 cm² area.
Can humidity be controlled independently per chamber?
No—humidity is uniformly regulated across all six chambers via a centralized saturated salt/temperature-controlled vapor generator, ensuring inter-chamber comparability per ISO 15105-2 Annex A.
Does the system support 21 CFR Part 11 compliance out-of-the-box?
CFR 21 Part 11 functionality is available as an optional validated software package (Order Code: C206H-CFR11), including electronic signatures, audit trail export, and user permission hierarchy.
What gas purity specifications are required for operation?
Carrier nitrogen must be ≥99.999% pure; oxygen for reference side must be ≥99.5% pure. Compressed air (if used for auxiliary functions) requires ≥550 kPa inlet pressure and oil/water filtration per ISO 8573-1 Class 2:2:2.
