HARKE HK-O2 Oxygen Transmission Rate Tester

Overview

The HARKE HK-O₂ Oxygen Transmission Rate (OTR) Tester is a precision-manufactured gas permeability instrument engineered for quantitative determination of oxygen permeation through packaging materials and rigid containers under controlled temperature and humidity conditions. It operates on the vacuum (manometric) measurement principle: a test specimen separates two chambers — one evacuated, the other containing the test gas (typically O₂ or air). As oxygen molecules permeate through the material, pressure rise in the low-pressure side is measured continuously via high-sensitivity capacitance manometers. This real-time pressure change, combined with calibrated volume and temperature data, enables calculation of OTR according to Fick’s first law of diffusion. The system supports both film and container configurations, delivering traceable, reproducible results aligned with regulatory expectations for barrier performance validation in pharmaceutical, food, medical device, and advanced material development laboratories.

Key Features

• Triple-specimen testing station with automated averaging — improves statistical robustness and throughput without manual intervention.
• Independent dual environmental control: programmable temperature range (5–95 °C, optional heated/cooled chamber) and multi-level relative humidity conditioning (0%, 35–90%, 100% RH) with ±1% RH accuracy — critical for evaluating moisture-dependent barrier behavior.
• High-resolution manometric detection: 0.001 cm³/m²·d for films and 0.00001 cm³/pkg·d for containers — suitable for ultra-high-barrier materials such as Al-coated PET, SiOₓ-coated films, and multilayer coextrusions.
• Modular gas handling architecture: compatible with O₂, N₂, CO₂, He, H₂, hydrocarbons (CH₄, C₃H₈, C₄H₁₀), and NH₃ — requires user-supplied certified gas sources; hazardous gas configurations must be specified prior to shipment per IEC 60079 and local safety regulations.
• Carrier gas delivery system with mass-flow-controlled 99.999% N₂ sweep (0–200 mL/min) ensures stable baseline and minimizes boundary layer effects during dynamic permeation analysis.
• Stainless steel 1/8″ fluidic interface and sealed vacuum manifold — designed for long-term integrity, minimal outgassing, and compatibility with GLP-compliant maintenance logs.

Sample Compatibility & Compliance

The HK-O₂ accommodates flat films (≥150 mm × 94 mm or circular), laminates, foils, coated papers, and rigid or semi-rigid containers (≤Φ120 mm × 400 mm height). Materials routinely evaluated include aluminum foil composites, PVDC-coated LDPE, PET/PVDC coextrusions, pharmaceutical blister lidding (PVC, cold-forming aluminum), biodegradable PLA films, battery separators, aerospace polymer membranes, and synthetic skin analogs. All measurements adhere strictly to internationally harmonized test protocols: GB/T 1038 (China), ISO 15105-1 (plastics — determination of gas transmission rate — part 1: constant volume, variable pressure method), ISO 2556 (gas transmission — manometric method), ASTM D1434 (standard test method for determining gas permeability characteristics), JIS K7126-1 (Japanese Industrial Standard), and YBB00082003 (Chinese pharmaceutical packaging standard). Instrument design supports audit readiness for FDA 21 CFR Part 11–enabled software environments and GMP/GLP documentation workflows.

Software & Data Management

The HK-O₂ integrates with HARKE’s proprietary OTRControl™ software (Windows-based), providing full parameter scripting, real-time permeation curve visualization, automatic OTR calculation per ISO 15105-1 Annex A, and export of raw pressure/time datasets in CSV and PDF formats. Audit trails record operator ID, method version, calibration timestamps, environmental setpoints, and pass/fail status against user-defined acceptance criteria. Data encryption, electronic signatures, and role-based access control align with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Optional 21 CFR Part 11 compliance package includes digital certificate management, biometric login support, and immutable archive generation.

Applications

This instrument serves as a primary tool for R&D and QC laboratories assessing oxygen barrier integrity across regulated and industrial sectors. In pharmaceutical packaging, it validates shelf-life predictions for sterile barrier systems (e.g., IV bags, vial stoppers, pouches) per USP . In food packaging, it correlates OTR values with lipid oxidation kinetics in snack, meat, and dairy products. For emerging applications, it characterizes O₂ permeability in solid-state battery separators, fuel cell membranes, and bioresorbable wound dressings where oxidative stability dictates functional lifetime. Its capacity to test diverse gases also supports research into selective gas separation membranes and controlled-atmosphere packaging (CAP) system design.

FAQ

Does the HK-O₂ require external gas cylinders for operation?
Yes — users must supply certified O₂ (for test gas) and 99.999% high-purity N₂ (as carrier gas). Regulators and stainless steel tubing must comply with ISO 8573-1 Class 1 for particulate and hydrocarbon content.
Can the system test flammable or toxic gases such as hydrogen or ammonia?
Yes — but only with pre-approved hazardous gas configuration, including explosion-proof solenoid valves, leak-tested manifolds, and integrated gas sensors. Notification during quotation stage is mandatory.
Is temperature and humidity control internal or external?
Both chambers feature integrated Peltier-based thermal regulation and saturated salt/steam-based RH generation. No external climatic chamber is required for standard operating ranges.
What sample preparation tools are recommended?
HARKE supplies optional die-cutting kits (film), container sealing fixtures (for pouches/bottles), and vacuum degassing stations to eliminate trapped air — all documented in the IQ/OQ validation protocol.
How is calibration verified?
NIST-traceable reference films (e.g., certified Mylar® standards) are used for periodic verification. Certificate of Calibration includes uncertainty budgets per ISO/IEC 17025 requirements.