Labthink C360H Gravimetric Water Vapor Transmission Rate Tester
| Brand | Labthink |
|---|---|
| Model | C360H |
| Testing Principle | Gravimetric (Weight Gain/Loss Method) |
| Standards Compliance | ASTM E96, ASTM D1653, ISO 2528, GB/T 1037, GB/T 16928, TAPPI T464, DIN 53122-1, YBB00092003-2015 |
| Test Stations | 12 |
| Temperature Range | 20–55 °C ±0.2 °C |
| Humidity Range | 10–90 %RH ±1 %RH |
| Sample Diameter | Φ74 mm |
| Max. Sample Thickness | ≤3 mm |
| Effective Test Area | 33 cm² |
| WVTR Range (Weight Loss Mode) | up to 10,000/n g/(m²·day) or 645/n g/(100 in²·day), n = 1–12 |
| WVTR Range (Weight Gain Mode) | up to 1200 g/(m²·day) or 77 g/(100 in²·day) per station |
| Carrier Gas | Compressed Air (≥0.6 MPa) |
| Gas Drying | Long-life desiccant module (no cartridge replacement, >20,000 h service life) |
| Humidification | Internal fog-free steam generator |
| Airflow Control | Automated, real-time regulated |
| Data Management | DataShield™ secure audit trail system |
| Regulatory Options | Optional 21 CFR Part 11 compliance package, GMP-compliant computer system validation support |
Overview
The Labthink C360H Gravimetric Water Vapor Transmission Rate (WVTR) Tester is an engineered solution for precise, reproducible measurement of water vapor permeation through packaging and barrier materials. It operates on the gravimetric principle—quantifying mass change over time in sealed test cups containing either desiccant (weight gain mode) or distilled water (weight loss mode)—under rigorously controlled environmental conditions. This method directly aligns with internationally recognized standards including ASTM E96 (desiccant and water methods), ISO 2528, GB/T 1037, and YBB00092003-2015, ensuring regulatory acceptability across pharmaceutical, food, medical device, and personal care industries. The system’s dual-mode capability enables accurate characterization of both high-barrier films (e.g., AlOx-coated PET, SiOx-laminates) and highly permeable substrates (e.g., nonwovens, paperboard), eliminating the need for instrument reconfiguration or method switching between material classes.
Key Features
- Twelve independent test stations with synchronized environmental control, enabling parallel evaluation of multiple samples or replicates under identical conditions—critical for statistical validity and throughput efficiency.
- Advanced thermal-fluid chamber architecture featuring 3D spatial temperature uniformity (<±0.2 °C) and laminar, feedback-regulated airflow—minimizing boundary layer effects and enhancing measurement stability.
- Fog-free, internally generated humidity control (10–90 %RH ±1 %RH) coupled with a maintenance-free desiccant drying module (>20,000 h operational lifetime, no consumable replacements required).
- Integrated 12-inch Windows 10 touchscreen interface with industrial-grade processor, supporting both automated routine testing and advanced manual parameter tuning for R&D applications.
- Real-time dynamic compensation algorithms adjust for ambient drift, cup geometry, and diffusion kinetics—optimizing test duration and result fidelity across the full WVTR range (from 10,000 g/m²·day).
- Modular DataShield™ data management system with encrypted local storage, configurable user roles, electronic signatures, and full audit trail generation compliant with ALCOA+ principles.
Sample Compatibility & Compliance
The C360H accommodates rigid and flexible planar specimens up to 3 mm thick and 74 mm in diameter—including polymer films (PE, PP, PET, PVDC), metallized laminates, coated papers, aluminum foils, medical-grade nonwovens, and pharmaceutical blister sealants. Its standardized 33 cm² test area ensures direct comparability with published literature and regulatory submissions. All operational protocols adhere to GLP and GMP expectations where applicable. Optional qualification packages support IQ/OQ/PQ documentation, and the system can be configured with 21 CFR Part 11-compliant electronic records and signature functionality—including role-based access control, immutable audit logs, and password-protected method locking.
Software & Data Management
Control and analysis are executed via Labthink’s proprietary WinWVTR software, built on a deterministic real-time kernel for sub-second weight sampling resolution. The platform supports customizable test templates, automatic pass/fail threshold evaluation against specification limits, and export to CSV, PDF, XML, and LIMS-compatible formats. DataShield™ implements AES-256 encryption at rest and in transit, with configurable retention policies and tamper-evident hashing of raw sensor streams. Network integration includes Ethernet (RJ45), Wi-Fi (802.11ac), and optional OPC UA server for MES/SCADA interoperability. All software modules undergo annual cybersecurity vulnerability assessment and are validated per IEC 62304 Class B requirements.
Applications
- Pharmaceutical packaging: Quantifying moisture ingress into blister packs, sachets, and cold-form foil to ensure drug stability and shelf-life prediction per ICH Q5C guidelines.
- Food packaging development: Evaluating barrier performance of retort pouches, vacuum-sealed trays, and modified atmosphere packaging (MAP) films under accelerated aging conditions.
- Medical device sterilization packaging: Validating microbial barrier integrity of Tyvek®-based pouches and peelable lids per ISO 11607-1.
- Regulatory dossier preparation: Generating GLP-compliant reports for FDA 510(k), EU MDR Annex I, and PMDA submissions requiring WVTR traceability and uncertainty budgets.
- Quality control laboratories: Routine lot-release testing with automated calibration verification, drift monitoring, and SPC charting integrated into enterprise QMS platforms.
FAQ
What standards does the C360H comply with?
ASTM E96 (Procedure A & B), ASTM D1653, ISO 2528, GB/T 1037, GB/T 16928, TAPPI T464, DIN 53122-1, and YBB00092003-2015.
Can the system test both high- and low-barrier materials without hardware modification?
Yes—the dual-mode gravimetric design and adaptive environmental control enable seamless transition between ultra-low WVTR (5,000 g/m²·day) measurements using the same test chamber and sensors.
Is the drying system truly maintenance-free?
The integrated desiccant module uses regenerative solid-state sorbents with >20,000 hours of continuous operation—no cartridge swaps, no downtime, and no recalibration required during service life.
How is data integrity ensured for regulated environments?
With optional 21 CFR Part 11 configuration, the system provides electronic signatures, audit trails with hash-verified records, role-based permissions, and system-generated certificates of analysis meeting FDA and EMA expectations.
Does the instrument support remote monitoring and integration with lab informatics systems?
Yes—via native Ethernet/Wi-Fi connectivity, RESTful API, and OPC UA protocol support, enabling bidirectional communication with LIMS, ELN, and MES platforms without third-party middleware.
