Labthink C230H Tri-Chamber Isostatic Oxygen Permeation Analyzer for Bottles and Rigid Packaging
| Brand | Labthink |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | Labthink-C230H |
| Price Range | USD 14,000 – 70,000 |
| Test Principle | Isostatic (Equal-Pressure) Method with Coulometric Oxygen Sensor |
| Standards Compliance | ASTM D3985, ASTM F1307, ASTM F1927, GB/T 19789, GB/T 31354, DIN 53380, JIS K7126-2-B, YBB 00082003-2015 |
| Test Range (Film) | 0.01–200 cm³/(m²·day) |
| Test Range (Package) | 0.00005–1 cm³/(pkg·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. Package Volume | 3 L |
| Sample Size | 108 mm × 108 mm |
| Max. Sample Thickness | ≤3 mm |
| Carrier Gas | ≥99.999% N₂, inlet pressure ≥0.28 MPa (40.6 psi) |
| Gas Interface | 1/8″ stainless steel tubing |
| Optional Modules | DataShield™ Data Integrity System, CFR 21 Part 11 Compliance Package, GMP Computer System Validation Support, Package Testing Kit |
Overview
The Labthink C230H Tri-Chamber Isostatic Oxygen Permeation Analyzer is a precision-engineered instrument designed for quantitative determination of oxygen transmission rate (OTR) across flexible films, rigid sheets, and intact packaging containers—including bottles, jars, pouches, and blister packs. It operates on the isostatic (equal-pressure) principle in accordance with ASTM D3985, where oxygen diffuses through a conditioned specimen under controlled temperature and humidity, while a stream of ultra-high-purity nitrogen carries permeated O₂ molecules to a coulometric sensor for real-time electrochemical quantification. This method ensures high sensitivity, long-term sensor stability, and minimal baseline drift—critical for regulatory-grade barrier performance validation in pharmaceutical primary packaging, sterile medical device trays, and shelf-life-critical food packaging.
Key Features
- Tri-chamber parallel testing architecture: Three thermally and hygroscopically isolated test cells enable simultaneous evaluation of identical replicates (per ASTM standard requirements for statistical validity) or three distinct materials under identical environmental conditions—reducing inter-test variability and accelerating throughput.
- Patented integrated test block: Engineered using computational fluid dynamics (CFD) and thermodynamic modeling, the monolithic test manifold minimizes cross-chamber thermal gradients, flow asymmetry, and humidity distribution variance—achieving <±0.2 °C temperature uniformity and <±1% RH humidity consistency across all chambers.
- Independent chamber-level environmental monitoring: Each test cavity incorporates dedicated platinum resistance thermometer (PRT) and capacitive RH sensors, enabling closed-loop feedback control and real-time deviation logging—essential for GLP/GMP audit trails.
- Automated climate conditioning: Integrated Peltier-based heating/cooling and ultrasonic humidification/dehumidification systems maintain setpoint accuracy without manual intervention over extended test durations (up to 168 h).
- 12-inch industrial touch interface: Running Windows 10 IoT Enterprise with Intel Core i5 processor, the system supports both guided auto-test workflows and advanced manual parameter tuning—enabling compliance with research protocols requiring custom ramp profiles or multi-step conditioning sequences.
Sample Compatibility & Compliance
The C230H accommodates flat specimens up to 108 mm × 108 mm and ≤3 mm thickness, as well as 3D packages up to 3 L internal volume—including PET bottles, aluminum-laminated sachets, HDPE pharmaceutical containers, and thermoformed trays. Its mechanical clamping system ensures uniform sealing pressure without deformation-induced measurement artifacts. The analyzer is validated per ISO/IEC 17025:2017 general requirements for competence of testing laboratories and supports full traceability to NIST-traceable gas standards. Regulatory alignment includes FDA 21 CFR Part 11 (with optional electronic signature and audit trail module), EU Annex 11, and Chinese YBB 00082003-2015 for pharmaceutical packaging verification.
Software & Data Management
DataShield™ is Labthink’s proprietary data integrity framework, compliant with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). It enforces role-based access control, immutable audit logs, electronic signatures, and automated backup to network drives or cloud repositories (AWS S3, Azure Blob). Raw sensor outputs, environmental logs, and calculated OTR values are stored in vendor-neutral CSV and XML formats, with optional export to LIMS via HL7 or ASTM E1384 interfaces. All software modules undergo annual cybersecurity penetration testing and support TLS 1.2+ encrypted communications for remote diagnostics and firmware updates.
Applications
- Pharmaceutical packaging qualification per USP and EP 3.2.1 for oxygen-sensitive biologics and lyophilized products
- Accelerated shelf-life prediction modeling using Arrhenius-based OTR temperature dependence analysis
- Comparative barrier layer optimization studies for multilayer coextruded films (e.g., EVOH, PVDC, SiOx-coated PET)
- Validation of sterilization-induced barrier degradation in Tyvek®-lidded trays
- Regulatory submission dossiers supporting FDA 510(k), MDR Annex II, and NMPA Class III medical device registrations
- QC release testing of blister foil laminates per ASTM F1927 and ISO 15105-2
FAQ
What gas purity is required for carrier nitrogen?
Ultra-high-purity nitrogen ≥99.999% (5.0 grade) is mandatory; impurities >1 ppm O₂ or H₂O will compromise sensor baseline stability and measurement accuracy.
Can the C230H test aluminum cans or glass vials?
Yes—provided the container geometry allows hermetic sealing against the test head gasket and internal volume does not exceed 3 L. Custom fixtures are available for non-standard shapes.
Is calibration traceable to national standards?
All factory calibrations use NIST-traceable certified permeation standards (e.g., polyethylene reference films with certified OTR values at 23 °C/0% RH), documented in the Certificate of Calibration supplied with each instrument.
Does the system support unattended overnight operation?
Yes—integrated power-fail recovery, automatic error logging, and email/SNMP alerting ensure uninterrupted 24/7 testing cycles with zero operator presence required.
How is data integrity enforced during remote access?
Remote sessions operate over authenticated VPN tunnels with session time-outs, keystroke logging, and dual-factor authentication; no local data caching occurs on client devices.
