Labthink C330H Water Vapor Transmission Rate (WVTR) Tester – Electrolytic Sensor-Based Permeation Analyzer
| Brand | Labthink |
|---|---|
| Model | C330H |
| Testing Principle | Electrolytic (Coulometric) Moisture Detection |
| Standards Compliance | ISO 15106-3, ASTM F3299, GB/T 21529, YBB 00092003-2015 |
| Test Range | 0.005–50 g/(m²·day) |
| Resolution | 0.001 g/(m²·day) |
| Repeatability | ±0.005 g/(m²·day) or ±2%, whichever is greater |
| Temperature Control | 10–55 °C (±0.2 °C) |
| Humidity Control | 5–90 %RH (±1 %RH), optional 100 %RH |
| Test Chambers | 3 independent |
| Sample Area | 50 cm² |
| Max Sample Size | 108 mm × 108 mm |
| Max Thickness | ≤3 mm |
| Packaging Test Capacity | up to 3 L (optional) |
| Carrier Gas | 99.999% high-purity N₂ (user-supplied) |
| Inlet Pressure | ≥0.28 MPa (40.6 psi) |
| Gas Interface | 1/8″ stainless steel tubing |
| Data Management | DataShield™ audit-trail-enabled software |
| Regulatory Support | Optional 21 CFR Part 11 compliance package |
| GMP Computer System Validation Support | Optional |
Overview
The Labthink C330H Water Vapor Transmission Rate (WVTR) Tester is a precision-engineered electrolytic permeation analyzer designed for quantitative determination of water vapor transmission through polymeric films, laminates, coated papers, pharmaceutical blister foils, medical device packaging, photovoltaic encapsulants, and rigid or flexible packaging components. It operates on the fundamental principle of coulometric moisture detection—based on Faraday’s law—where water vapor diffusing across a test specimen is carried by dry nitrogen carrier gas to an electrolytic sensor. The sensor quantifies water concentration via charge accumulation proportional to molecular water content, enabling trace-level sensitivity and high metrological integrity. Developed in strict accordance with ISO 15106-3 (Electrolytic Detection Method), ASTM F3299, and relevant Chinese pharmacopoeial standards (YBB 00092003-2015), the C330H delivers traceable, reproducible WVTR data essential for barrier validation, shelf-life modeling, regulatory submissions, and quality control in GxP environments.
Key Features
- Patented Electrolytic Sensor Technology: Labthink-developed coulometric moisture sensor with sub-microgram water detection capability; exhibits long-term stability (>12 months calibration interval under routine use), low drift (<0.5% signal variation over 72 h), and intrinsic linearity across full dynamic range.
- Tri-Chamber Integrated Test Block: A thermodynamically optimized, single-body aluminum manifold housing three independent test cells. Each chamber features dedicated PID-controlled temperature regulation and real-time RH monitoring—eliminating cross-talk and ensuring true parallelism per ISO 5725 and ICH Q5C requirements.
- Spatial 3D Thermal Uniformity System: Dual-zone air circulation with laminar flow profiling maintains ±0.2 °C temperature homogeneity across all sample surfaces and sensor paths—critical for minimizing boundary-layer artifacts in low-permeability measurements.
- Automated Environmental Control: Fully integrated humidity generation and conditioning system delivers stable RH setpoints from 5% to 90% RH (±1% RH accuracy); optional saturated steam module enables 100% RH testing for high-moisture applications.
- 12-inch Windows 10 Touch Interface: Industrial-grade panel PC with Intel Core i5 processor, SSD storage, and native USB/Ethernet/Wi-Fi connectivity; preloaded with Labthink’s proprietary test execution engine supporting both guided wizard mode and advanced parameter scripting.
Sample Compatibility & Compliance
The C330H accommodates flat specimens up to 108 mm × 108 mm and 3 mm thick—including monolayer films, coextrusions, metallized PET, SiOx/AlOx-coated substrates, paperboard laminates, and Tyvek® composites. For package-level evaluation, optional 3-liter test chambers support pouches, trays, vials, and syringes under controlled headspace conditions. All hardware and firmware comply with electromagnetic compatibility (EMC) directives (IEC 61326-1), electrical safety (IEC 61010-1), and mechanical design standards (ISO 12100). The system architecture supports full GMP-aligned validation documentation packages—including IQ/OQ/PQ protocols—and integrates seamlessly into enterprise quality management systems (QMS) via standardized OPC UA and RESTful API interfaces.
Software & Data Management
DataShield™ is a validated, audit-trail-enabled software platform compliant with FDA 21 CFR Part 11 requirements when configured with electronic signatures, role-based access control, and immutable record retention. It provides automated calculation of WVTR (g/m²·day), permeance (g·mm/m²·day·kPa), and diffusion coefficient (cm²/s), with uncertainty propagation per GUM (JCGM 100:2018). Raw sensor output, environmental logs, and calibration history are stored in encrypted SQLite databases with SHA-256 hashing. Export formats include CSV, PDF reports (with digital signature), XML for LIMS integration, and direct SQL push to corporate data warehouses. Optional computer system validation (CSV) services include risk assessment (ICH Q9), traceability matrices, and change control documentation.
Applications
- Barrier qualification of pharmaceutical blister lidding foils and cold-form foil according to USP <671> and Ph. Eur. 5.3.
- Stability-indicating WVTR monitoring for biologics primary packaging under accelerated aging protocols (ICH Q1A).
- Photovoltaic backsheet permeation screening per IEC 61215-2 MQT10 and UL 1703 Annex D.
- Food packaging shelf-life modeling using Arrhenius-based permeability extrapolation.
- Regulatory dossier preparation for FDA 510(k), MDR Annex II, and China NMPA registration dossiers.
- Root cause analysis of delamination, blooming, or sterility failure linked to moisture ingress pathways.
FAQ
What measurement principle does the C330H employ?
It uses coulometric electrolytic detection per ISO 15106-3: water vapor permeating the specimen is swept by dry nitrogen to an electrolytic cell where H2O is decomposed into H2 and O2; the resulting current is directly proportional to water mass flow.
Can the C330H test both flat materials and intact packages?
Yes—standard configuration supports films and sheets; optional large-volume test fixtures enable package-level testing up to 3 L capacity under defined internal/external humidity gradients.
Is 21 CFR Part 11 compliance available as a factory option?
Yes—fully documented Part 11 readiness package includes electronic signatures, audit trail configuration, and system validation support files.
What carrier gas specifications are required?
99.999% pure nitrogen with inlet pressure ≥0.28 MPa (40.6 psi); dew point < −70 °C recommended to prevent baseline interference.
How is temperature and humidity uniformity verified across chambers?
Each chamber contains a calibrated Pt100 RTD and capacitive RH sensor; system self-verifies thermal/hygrometric uniformity during startup and every 24 h via embedded reference checks.
