QKTester WVTR-C1 Cup Method Water Vapor Transmission Rate Tester for YBB00102005-2015 Tri-Layer Co-Extruded IV Bags
| Brand | QKTester |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | WVTR-C1 |
| Test Range | 0.1–10,000 g/m²·24h |
| Test Accuracy | 0.01 g/m²·24h |
| Temperature Range | 10°C–55°C (±0.1°C to ±0.5°C) |
| Humidity Range | 10%RH–90%RH (±1%RH to ±2%RH) |
| Air Velocity | 0.5–2.5 m/s |
| Test Area | 33.18 cm² |
| Specimen Diameter | Φ72–Φ74 mm |
| Test Stations | 1–3 |
| Dimensions | 450×500×550 mm to 850×890×520 mm |
| Power Supply | AC 220 V, 50 Hz |
| Standards Compliance | GB/T 1037, GB/T 16928, ISO 2528, ASTM E96, ASTM D1653, TAPPI T464, DIN 53122-1, JIS Z0208, YBB00092003-2015 |
Overview
The QKTester WVTR-C1 Cup Method Water Vapor Transmission Rate (WVTR) Tester is a precision-engineered gravimetric instrument designed specifically for compliance-driven permeation testing of flexible packaging materials used in pharmaceutical and medical device applications. It operates on the cup (or gravimetric) method—defined in ISO 2528 and ASTM E96—as a primary standard for determining water vapor transmission through films, laminates, and co-extruded structures under controlled environmental conditions. The system is calibrated and validated for use with tri-layer co-extruded intravenous (IV) solution bags conforming to Chinese Pharmacopoeia standard YBB00102005-2015, enabling quantitative assessment of moisture barrier integrity critical to sterility maintenance, drug stability, and shelf-life validation. By establishing a defined humidity gradient across a conditioned specimen sealed over a desiccant-filled cup, the instrument measures minute mass changes over time using high-resolution analytical weighing, then computes WVTR in g/m²·24h per standardized calculation protocols.
Key Features
- High-stability gravimetric measurement system featuring dual-range load cells with resolution down to 0.01 g/m²·24h, traceable to national metrological standards;
- Independent temperature and humidity control chambers with PID-regulated air circulation (0.5–2.5 m/s), ensuring uniform conditioning across all test stations;
- Multi-station configuration (1–3 stations) supporting parallel testing for statistical robustness and throughput efficiency in QC laboratories;
- Automated cup lifting and positioning via servo-controlled linear actuators, eliminating operator-induced mechanical disturbance during weighing cycles;
- GMP-compliant software architecture with multi-level user authentication, full audit trail, electronic signatures, and 21 CFR Part 11-ready data handling;
- Integrated ISP firmware update capability enabling remote parameter calibration, protocol revision, and regulatory-aligned feature deployment without hardware intervention.
Sample Compatibility & Compliance
The WVTR-C1 accommodates flat, non-porous specimens up to 3 mm thickness and 74 mm diameter—including multilayer polyolefin-based IV bag films, aluminum foil laminates, PVDC-coated substrates, and sterilization-grade Tyvek® composites. Its test area of 33.18 cm² aligns with ISO 2528 and ASTM E96 requirements for representative sampling. All operational parameters and reporting outputs are fully traceable to pharmacopeial and industrial standards: YBB00092003-2015 (China Pharmacopoeia, Method I), GB/T 1037 and GB/T 16928 (Chinese National Standards), ASTM D1653 (for coated films), TAPPI T464 (paperboard applications), and DIN 53122-1 (German standard for sheet materials). Validation documentation supports GLP and GMP audits, including IQ/OQ/PQ templates and uncertainty budgets per ISO/IEC 17025 guidelines.
Software & Data Management
The embedded Windows-based control interface provides real-time graphical monitoring of mass drift, environmental stability, and test progression. Raw weight data are timestamped at configurable intervals (1–60 min), automatically corrected for buoyancy and thermal drift, and processed using ISO 2528 Annex A algorithms. Reports export natively to Excel (.xlsx) with embedded metadata (operator ID, calibration certificate numbers, chamber logs), support PDF watermarking for controlled document distribution, and integrate with LIMS via OPC UA or CSV batch upload. Audit trails record every action—including method edits, result overrides, and user logins—with immutable SHA-256 hashing. Cloud synchronization (optional) enables cross-site data harmonization while maintaining local data sovereignty per GDPR and HIPAA-aligned storage policies.
Applications
- Quality release testing of YBB00102005-2015-compliant IV bags for water vapor barrier performance prior to sterilization and filling;
- Accelerated aging studies correlating WVTR shifts with accelerated storage conditions (e.g., 40°C/75%RH per ICH Q1A);
- Comparative evaluation of alternative film formulations during packaging material qualification;
- Stability protocol development for biologics and lyophilized products requiring strict moisture ingress limits;
- Regulatory submission support for FDA IND/NDAs, EMA CTD Module 3, and NMPA registration dossiers;
- Routine QC verification of incoming roll stock and finished pouches in contract manufacturing organizations (CMOs).
FAQ
What regulatory standards does the WVTR-C1 directly support?
The instrument is pre-configured for YBB00092003-2015 (Pharmacopoeia of the People’s Republic of China), ISO 2528, ASTM E96, and GB/T 1037, with method templates and report formats aligned to each.
Can the system validate against USP <671> or EP 2.6.18?
While not a direct compendial instrument, its gravimetric methodology satisfies the scientific basis of USP <671> and EP 2.6.18 for permeation assessment when operated within specified environmental tolerances and validated per laboratory SOPs.
Is third-party calibration certification included?
Yes—each unit ships with NIST-traceable calibration certificates for temperature, humidity, and mass sensors, plus a full validation dossier compliant with ISO/IEC 17025 requirements.
How is data integrity ensured during extended tests (e.g., 7+ days)?
Continuous environmental logging, redundant power backup (UPS-compatible), automatic error recovery after interruption, and cryptographic audit trail hashing ensure end-to-end data fidelity without manual intervention.
Does the system support custom test profiles beyond standard methods?
Yes—the software allows creation of user-defined environmental ramps, multi-step RH transitions, and variable weighing intervals, subject to internal validation and change control procedures.
