Labthink C360M Gravimetric Water Vapor Transmission Rate (WVTR) Tester
| Brand | Labthink |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | Direct Manufacturer |
| Model | C360M |
| Test Principle | Gravimetric (ASTM E96 / GB 1037 compliant) |
| Test Modes | Gain-Weight & Loss-Weight |
| Test Stations | 6 independent chambers |
| Temperature Range | 15–55 °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 (Loss-Weight) | up to 10,000/n g/(m²·day) [n = 1–6] |
| WVTR Range (Gain-Weight) | up to 1200 g/(m²·day) per station |
| Carrier Gas | Compressed air (≥0.6 MPa) |
| Drying System | Core-free, 20,000-hour service life |
| Humidification | Fog-free internal humidifier |
| Data Management | DataShield™ audit-trail-enabled software |
| Regulatory Compliance Options | 21 CFR Part 11, GMP-compliant computer system validation support |
Overview
The Labthink C360M Gravimetric Water Vapor Transmission Rate (WVTR) Tester is a precision-engineered instrument designed for quantitative determination of water vapor permeation through packaging and barrier materials under controlled environmental conditions. It operates on the gravimetric principle—measuring mass change over time in sealed test cups containing either desiccant (loss-weight mode) or distilled water (gain-weight mode), as specified in ASTM E96, GB/T 1037, ISO 2528, and other internationally recognized standards. The system is optimized for high reproducibility across low-, medium-, and high-barrier materials—including co-extruded IV bag films, pharmaceutical blister lidding, sterile barrier systems, flexible food pouches, and medical-grade nonwovens. Its six independently controlled test chambers enable parallel evaluation of multiple samples under identical or differentiated climate conditions, significantly improving throughput while maintaining traceable metrological integrity.
Key Features
- Six independent test chambers with fully autonomous temperature, humidity, and airflow control—enabling concurrent multi-condition testing without cross-chamber interference.
- Advanced thermal-fluidic chamber design ensures uniform temperature distribution (±0.2 °C) and laminar, adjustable air velocity across all test positions—critical for minimizing edge effects and enhancing measurement stability.
- Fog-free, self-regulating humidification system and core-free desiccant drying module (rated for >20,000 hours continuous operation) eliminate maintenance downtime and ensure long-term calibration consistency.
- Integrated 12-inch Windows 10 touchscreen interface with industrial-grade processor supports both automated routine testing and advanced parameter scripting for research-grade method development.
- Real-time environmental monitoring and dynamic compensation algorithms adjust for ambient drift, enabling accurate WVTR quantification even for ultra-low-permeability materials (<0.01 g/(m²·day)).
- Modular hardware architecture allows seamless integration with enterprise LIMS, ERP, or QMS platforms via Ethernet (wired/wireless) and supports optional 21 CFR Part 11-compliant electronic signatures and audit trails.
Sample Compatibility & Compliance
The C360M accommodates flat, flexible specimens up to 3 mm thick and 74 mm in diameter—including multilayer co-extruded films, aluminum-laminated foils, polymer-coated papers, spunbonded polypropylene, and hydrophilic/hydrophobic nonwovens used in IV solution bags and sterile medical packaging. All test configurations comply with regulatory requirements for pharmaceutical and medical device packaging validation per YBB00092003-2015, USP , and ISO 11607-1. Optional GMP-compliant computer system qualification packages include IQ/OQ documentation, user access control matrices, and electronic record retention protocols aligned with FDA and EMA expectations.
Software & Data Management
DataShield™ software provides full lifecycle data governance—from test setup and real-time curve visualization to statistical analysis (mean, SD, RSD, confidence intervals) and automated report generation in PDF, CSV, or XML formats. All data entries are timestamped, user-attributed, and immutable post-acquisition. Audit trail functionality logs every action—including parameter changes, result overrides, and user logins—with SHA-256 hashing for forensic integrity verification. The platform supports configurable electronic signatures, role-based permissions, and scheduled backups to network drives or cloud repositories meeting HIPAA and GDPR storage criteria.
Applications
- Pharmaceutical packaging: Validation of moisture barrier performance for parenteral drug containers, lyophilized vial stoppers, and cold-chain transport pouches.
- Medical device packaging: WVTR assessment of Tyvek®-based sterile barrier systems and peelable lid stocks per ISO 11607-2.
- Food packaging R&D: Comparative evaluation of biopolymer films, metallized PET, and nanocomposite laminates for shelf-life modeling.
- Regulatory submission support: Generation of GLP-compliant datasets for ANDA, NDA, and MDR technical files.
- Quality control laboratories: Routine batch release testing of incoming film rolls and final packaged goods per ASTM D1653 and TAPPI T464.
FAQ
What standards does the C360M comply with?
The instrument conforms to ASTM E96 (both desiccant and water methods), GB/T 1037, ISO 2528, DIN 53122-1, TAPPI T464, and YBB00092003-2015. Optional validation packages extend compliance to 21 CFR Part 11 and EU Annex 11.
Can the C360M test ultra-high-barrier materials?
Yes—the system’s low-drift weighing mechanism, stabilized thermal environment, and adaptive algorithmic correction enable reliable measurement down to 0.005 g/(m²·day), suitable for AlOx- or SiOx-coated substrates and PVD-deposited barrier films.
Is humidity control truly fog-free?
Yes—integrated ultrasonic humidification with condensate management eliminates visible mist, preventing localized condensation on samples or sensor surfaces that could compromise accuracy.
How is data integrity ensured during extended tests?
Continuous environmental logging, dual-redundant weight acquisition, and cryptographic hash anchoring of raw data streams ensure traceability and prevent tampering—even during unattended 30-day permeation studies.
Does Labthink provide installation qualification (IQ) support?
Yes—factory-certified engineers deliver on-site IQ/OQ/ PQ services, including environmental mapping, balance calibration traceability to NIST standards, and SOP alignment with client quality systems.
