Labthink C403H Tri-Chamber Oxygen & Water Vapor Transmission Rate Tester
| Brand | Labthink |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | Direct Manufacturer |
| Region | Domestic (China) |
| Model | C403H |
| Price Range | USD 28,000 – 115,000 |
| OTR Range | 0.01–200 cc/(m²·day) @ 50 cm² |
| WVTR Range | 0.005–40 g/(m²·day) @ 50 cm² |
| OTR Resolution | 0.0001 cc/(m²·day) |
| WVTR Resolution | 0.0001 g/(m²·day) |
| OTR Repeatability | ±0.01 cc/(m²·day) or ±1%, whichever is greater |
| WVTR Repeatability | ±0.005 g/(m²·day) or ±2%, whichever is greater |
| Temperature Range | 15–50 °C (optional 5–60 °C) |
| Temp Stability | ±0.05 °C |
| RH Range | 0–90 %RH ±2% |
| Test Chambers | 3 independent |
| Standard Test Area | 50 cm² |
| Sample Thickness Limit | ≤3 mm |
| Sample Size | 112 mm × 112 mm |
| Carrier Gas | ≥99.999% N₂, ≥99.5% O₂ |
| Inlet Pressure | ≥280 kPa |
| Power | 120 VAC ±10% / 60 Hz or 220 VAC ±10% / 50 Hz |
| Dimensions (W×D×H) | 600 × 500 × 700 mm |
| Net Weight | 100 kg |
Overview
The Labthink C403H Tri-Chamber Oxygen & Water Vapor Transmission Rate (OTR/WVTR) Tester is an engineered solution for quantitative barrier performance evaluation of flexible packaging materials used in pharmaceutical, food, medical device, and high-reliability electronics applications. It operates on two orthogonal, standardized measurement principles: coulometric oxygen detection per ASTM D3985 and ASTM F1307, and infrared moisture detection per ASTM F1249 and ISO 15106-2. This dual-sensor architecture enables simultaneous, traceable quantification of molecular transport kinetics—oxygen diffusion through polymer matrices and water vapor permeation across hydrophilic/hydrophobic laminates—under tightly controlled temperature and relative humidity conditions. The instrument is purpose-built for regulatory-grade testing environments requiring compliance with pharmacopoeial standards including YBB 00082003-2015 (OTR) and YBB 00092003-2015 (WVTR), as well as global norms such as GB/T 19789, GB/T 26253, DIN 53380-3, and JIS K7126-2-B.
Key Features
- Tri-chamber parallel testing architecture: Three physically isolated test cells, each with a standard 50 cm² exposure area, enable concurrent analysis of three specimens under identical environmental conditions—eliminating inter-run variability and accelerating statistical validation per ISO 5725 and ICH Q5C.
- ppb-level coulometric O₂ sensor: Labthink’s proprietary long-life coulometric cell delivers sub-ppb baseline stability and a functional lower detection limit of 0.01 cc/(m²·day), with service life exceeding three times that of conventional electrochemical sensors.
- Non-consumptive infrared H₂O sensor: Patented optical detection technology ensures zero drift over extended operation, maintaining resolution down to 0.0001 g/(m²·day) without calibration gas consumption or sensor replacement cycles.
- 360° convective thermal management: Precision air circulation system maintains temperature uniformity within ±0.05 °C across all chambers—critical for Arrhenius-based shelf-life modeling and accelerated aging correlation studies.
- Automated environmental control: Integrated high-accuracy RH and temperature sensors feed real-time feedback to PID-controlled humidification and heating subsystems, enabling stable setpoint maintenance at any point between 5–60 °C and 0–90 %RH (±2%).
- Industrial-grade embedded computing: Onboard hardened industrial PC running Windows OS eliminates external computer dependencies, mitigating cybersecurity risks and ensuring data integrity compliant with FDA 21 CFR Part 11 requirements when equipped with optional CFR21Part11 module.
Sample Compatibility & Compliance
The C403H accommodates rigid and flexible sheet/film substrates up to 3 mm thickness and 112 mm × 112 mm dimensions—including multilayer coextrusions, metallized PET/PE laminates, AlOx-coated films, PVDC-coated paperboards, foil-laminated blister foils, and silicone-rubber composites. Its mechanical clamping mechanism ensures consistent edge sealing without compression-induced microcracking or delamination artifacts. All operational parameters—including flow rates, pressure differentials, and sensor response timing—are traceably aligned to the measurement uncertainty budgets defined in ISO/IEC 17025:2017. Validation documentation supports IQ/OQ/PQ protocols for GMP-regulated laboratories and GLP-compliant contract research organizations.
Software & Data Management
Labthink’s proprietary TestMate™ software provides full lifecycle test management—from method definition and parameter scheduling to raw signal visualization, statistical outlier detection (per Grubbs’ test), and automated report generation in PDF/A-1a format. Audit trails record user actions, parameter changes, and calibration events with time-stamped digital signatures. Optional DataShield™ module enforces role-based access control, encrypted local storage, and tamper-evident electronic records meeting ALCOA+ principles. Export formats include CSV, XML, and ASTM E1482-compliant data exchange schema for LIMS integration.
Applications
- Pharmaceutical primary packaging qualification: Blister foil OTR verification against USP , moisture ingress assessment of desiccant-containing bottles, and stability-indicating barrier validation per ICH Q1A(R2).
- Medical device sterile barrier systems: ISO 11607-1 compliance testing of Tyvek®/polyethylene pouches and peel-open trays under accelerated aging protocols.
- Food packaging shelf-life modeling: Correlation of OTR/WVTR values with lipid oxidation (peroxides, hexanal) and microbial growth endpoints.
- PV encapsulant screening: Quantitative comparison of ethylene-vinyl acetate (EVA) vs. polyolefin elastomer (POE) films for moisture-induced potential-induced degradation (PID) mitigation.
- Regulatory submission support: Generation of test reports acceptable to EMA, PMDA, Health Canada, and ANVISA for marketing authorization dossiers.
FAQ
What standards does the C403H comply with for pharmaceutical packaging testing?
The instrument is configured to meet YBB 00082003-2015 (OTR), YBB 00092003-2015 (WVTR), USP , and ASTM D3985/F1249—fully supporting comparative testing required for drug master file (DMF) submissions.
Can the system operate under low-humidity conditions relevant to dry-powder inhaler (DPI) packaging?
Yes. The RH control range extends to 0% RH with optional desiccant-based drying modules, enabling validation of ultra-low moisture transmission for hygroscopic APIs.
Is third-party calibration certification available?
Labthink provides NIST-traceable calibration certificates issued by CNAS-accredited laboratories, including uncertainty budgets per ISO/IEC 17025 Annex A.4.
How is data integrity ensured during long-duration tests (e.g., 30-day WVTR runs)?
Continuous memory mirroring, cyclic redundancy checksums on all acquired data points, and automatic recovery from power interruption ensure no loss of time-series integrity—even across multi-week experiments.
Does the system support custom test methods beyond ASTM/ISO standards?
Yes. TestMate™ allows creation of user-defined protocols with programmable ramp profiles, dynamic RH/temperature sequences, and conditional termination logic—validated per GAMP5 Category 4 software classification.
