Labthink C230H Oxygen Transmission Rate (OTR) Tester for Packaging Materials
| Brand | Labthink |
|---|---|
| Model | C230H |
| Origin | Shandong, China |
| Manufacturer Type | Direct Manufacturer |
| Origin Category | Domestic (China) |
| Price Range | USD 14,000 – 85,000 |
| Test Principle | Coulometric Sensor + Isobaric Method (ASTM D3985) |
| Test Range | 0.01–200 cm³/(m²·day) |
| Resolution | 0.001 cm³/(m²·day) |
| Repeatability | ±0.01 cm³/(m²·day) or ±2%, whichever is greater |
| Temperature Control | 10–55 °C (±0.2 °C) |
| Humidity Control | 0% RH, 5–90% RH (±1% RH), 100% RH |
| Test Chambers | 3 independent |
| Sample Area | 50 cm² (standard) |
| Max. Sample Size | 108 mm × 108 mm |
| Max. Thickness | ≤3 mm |
| Package Testing Capacity | up to 3 L (optional) |
| Carrier Gas | ≥99.999% N₂, ≥0.28 MPa (40.6 psi) |
| Interface | 1/8″ stainless steel tubing |
| Data Compliance | Optional 21 CFR Part 11, GMP-compliant audit trail, DataShield™ secure data management |
Overview
The Labthink C230H Oxygen Transmission Rate (OTR) Tester is an isobaric, coulometric-sensor-based instrumentation system engineered for precise and reproducible measurement of oxygen permeation through packaging materials and finished packages. It operates on the principle of oxygen diffusion across a barrier under controlled temperature and humidity conditions, with oxygen molecules transported by a high-purity nitrogen carrier gas stream to a trace-level coulometric oxygen sensor. The resulting electrical current—proportional to oxygen concentration—is converted into quantitative OTR values in accordance with ASTM D3985, ASTM F1307, ASTM F1927, ISO 15105-2, GB/T 19789, GB/T 31354, DIN 53380, JIS K7126-2-B, and YBB 00082003-2015. Designed for laboratories requiring regulatory-grade data integrity, the C230H supports both flat film/sheet testing and package-level evaluation (up to 3 L), making it suitable for quality control, R&D, and stability studies across pharmaceutical, food, medical device, photovoltaic, and personal care industries.
Key Features
- Tri-chamber integrated test block: Patented monolithic design employing advanced thermodynamic and fluid dynamic modeling to minimize inter-chamber variance in temperature, humidity, and gas flow—ensuring high inter-test consistency.
- Independent environmental monitoring: Each test chamber equipped with dedicated high-accuracy temperature and relative humidity sensors (±0.2 °C, ±1% RH), enabling real-time feedback control and validation of test conditions per ASTM E2060 and ISO 17785.
- Automated climate conditioning: Fully programmable temperature (10–55 °C) and humidity (0%, 5–90%, or 100% RH) control without manual intervention; ramp-and-soak profiles supported.
- Flexible test configuration: Simultaneous evaluation of three identical specimens (for statistical robustness per ISO 5725) or three distinct materials under identical environmental parameters—ideal for comparative barrier screening.
- 12-inch Windows 10 touchscreen interface: Industrial-grade tablet with embedded high-performance processor; supports both guided automatic mode and advanced manual mode for granular parameter control, including flow rate, dwell time, and sensor stabilization thresholds.
- DataShield™ secure architecture: Role-based access control, cryptographic hashing of raw data files, immutable audit trails, and export compatibility with CSV, PDF, XML, and LIMS-ready formats.
Sample Compatibility & Compliance
The C230H accommodates rigid and flexible polymeric films, laminates, coated papers, aluminum foils, blister packs, pouches, bottles, and trays. Standard test area is 50 cm² (108 mm × 108 mm max sample size; ≤3 mm thickness). Optional package test fixtures enable headspace analysis of sealed containers up to 3 L volume using internal nitrogen purge methodology per ASTM F1307. All hardware and firmware comply with electromagnetic compatibility (EMC) directives (IEC 61326-1) and functional safety standards (IEC 61508). When configured with optional CFR 21 Part 11 modules, the system delivers electronic signatures, audit logs, and user permission hierarchies required for FDA-regulated environments. Validation documentation—including IQ/OQ/PQ templates, uncertainty budgets per GUM (JCGM 100), and metrological traceability to NIST SRMs—is available upon request.
Software & Data Management
The embedded Labthink OTR Control Suite provides full lifecycle data governance—from method definition and calibration verification to report generation and archival. Calibration routines include zero-gas (N₂) and span-gas (known O₂ concentration) validation with auto-recording of drift and sensitivity coefficients. All test sequences are timestamped and digitally signed. DataShield™ enforces write-once-read-many (WORM) storage policies, prevents unauthorized modification, and supports TLS 1.2 encrypted network transmission. Integration with enterprise systems is enabled via OPC UA, RESTful API, or direct SQL database connectivity. For GLP/GMP compliance, optional modules deliver electronic signature workflows, change control logs, and periodic review reports aligned with Annex 11 and ALCOA+ principles.
Applications
- Pharmaceutical packaging: Quantifying OTR of blister lidding foils, cold-forming sheets, and HDPE/PP bottles to ensure shelf-life prediction per ICH Q5C and USP .
- Food packaging development: Evaluating barrier performance of multilayer 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 peel-open trays per ISO 11607-1.
- PV encapsulant R&D: Assessing long-term oxidative stability of EVA, POE, and silicone-based encapsulants exposed to damp heat (85 °C/85% RH).
- Regulatory submission support: Generating auditable datasets for FDA 510(k), PMDA, and EMA dossier submissions where material characterization is mandated.
FAQ
What standards does the C230H comply with?
The instrument meets ASTM D3985 (film), ASTM F1307 (packages), ASTM F1927 (high-barrier), ISO 15105-2, GB/T 19789, GB/T 31354, JIS K7126-2-B, and YBB 00082003-2015.
Can the C230H test both flat films and finished packages?
Yes—standard configuration supports film/sheet testing; optional package test kits enable OTR measurement of rigid and flexible containers up to 3 L volume.
Is 21 CFR Part 11 compliance available?
Yes—optional software and hardware modules provide full electronic record and signature functionality, including audit trail, role-based access, and data encryption.
What carrier gas is required?
≥99.999% high-purity nitrogen at minimum inlet pressure of 0.28 MPa (40.6 psi); gas source is user-supplied.
How is measurement repeatability verified?
Repeatability is validated per ISO 5725-2 using certified reference materials; typical performance is ±0.01 cm³/(m²·day) or ±2%, whichever is greater, under controlled lab conditions.
Does the system support remote monitoring and data export?
Yes—via Ethernet/Wi-Fi, with support for CSV, PDF, XML, and database exports; optional integration with LIMS and MES platforms is available.
