HARKE HK-701R Oxygen Transmission Rate (OTR) Tester
| Brand | HARKE |
|---|---|
| Model | HK-701R |
| Principle | Vacuum Method (ASTM D3985, ISO 15105-2) |
| Test Range | 0.007–190,000 cm³/m²·24h·0.1MPa |
| Resolution | 0.001 cm³/m²·24h·0.1MPa |
| Sample Count | 1–3 independent stations |
| Vacuum Resolution | 0.1 Pa |
| Temperature Control Range | 5–95 °C |
| Temperature Accuracy | ±0.1 °C |
| Humidity Control Range | 0% RH, 2–98.5% RH, 100% RH (optional humidity generator) |
| Humidity Accuracy | ±1% RH |
| Max Sample Thickness | ≤5 mm (customizable) |
| Sample Size | ≥150 mm × 94 mm or circular |
| Effective Test Area | 48 cm² |
| Test Gases | O₂, N₂, CO₂, air, He (user-supplied gas source) |
| Test Pressure Range | −0.1 to +0.1 MPa |
| Gas Supply Pressure | 0.3–1.0 MPa |
| Gas Inlet Port | Ø8 mm |
| Dimensions (L×W×H) | 730 × 510 × 350 mm |
| Power Supply | AC 220 V, 50 Hz |
| Net Weight | 63 kg |
Overview
The HARKE HK-701R Oxygen Transmission Rate (OTR) Tester is a precision-engineered instrument designed for quantitative determination of oxygen permeation through polymeric films, laminates, foils, and other packaging barrier materials under controlled temperature and humidity conditions. It operates on the vacuum method—compliant with ASTM D3985 (oxygen transmission rate of plastic film and sheeting) and ISO 15105-2 (gas transmission rate—part 2: coulometric detection)—where a test specimen separates two chambers: a high-purity oxygen environment on the upstream side and a high-vacuum downstream side. Oxygen molecules permeating through the sample are carried by a carrier gas stream to a coulometric sensor, which provides real-time, linear response proportional to O₂ flux. This principle ensures high reproducibility and traceable measurement of OTR, diffusion coefficient (D), solubility coefficient (S), and permeability coefficient (P = D × S), all derived from time-lag analysis and steady-state flux evaluation.
Key Features
- Triple independent test stations enable parallel evaluation of up to three specimens under identical or individually programmed environmental conditions—enhancing throughput without compromising inter-station comparability.
- High-resolution vacuum system with 0.1 Pa resolution supports precise low-flux measurements down to 0.007 cm³/m²·24h·0.1MPa, critical for evaluating ultra-high-barrier substrates such as SiOx-coated PET or AlOx multilayer films.
- Wide thermal control range (5–95 °C) with ±0.1 °C stability enables Arrhenius-based activation energy studies and accelerated shelf-life modeling per ISO 2556 and ASTM F1249 protocols.
- Modular humidity integration allows optional installation of a certified humidity generator, supporting standardized RH setpoints (2–98.5% RH, plus dry and saturated extremes) with ±1% RH accuracy—essential for assessing moisture-sensitive barrier systems like EVOH or PVDC blends.
- Rigid aluminum alloy frame and sealed chamber architecture minimize thermal drift and external contamination, ensuring long-term calibration integrity in regulated QC laboratories.
- Gas compatibility extends beyond O₂ to N₂, CO₂, air, and He—facilitating comparative permeability profiling and validation of selective barrier performance across multiple gases per ISO 14663.
Sample Compatibility & Compliance
The HK-701R accommodates flat specimens up to 5 mm thick and ≥150 mm × 94 mm (or equivalent circular format), with a defined test area of 48 cm². Its clamping mechanism ensures uniform sealing pressure and eliminates edge leakage—a common source of error in gravimetric or manometric methods. The system meets mechanical and electrical safety requirements per IEC 61010-1 and is compatible with GLP/GMP documentation workflows. Data acquisition supports audit-ready timestamped records, including environmental setpoints, vacuum decay curves, sensor response profiles, and calculated coefficients—all exportable in CSV or PDF formats. When paired with validated humidity modules, it satisfies USP and FDA 21 CFR Part 11 compliance requirements for electronic records and signatures when deployed with appropriate IT controls.
Software & Data Management
HARKE’s proprietary OTRControl v3.x software provides intuitive instrument control, real-time permeation curve visualization, and automated calculation of OTR, D, S, and P values per ISO 15105-1/2 and ASTM F1249 Annex A1. Each test session generates a structured metadata log containing operator ID, sample ID, environmental history, sensor calibration status, and pass/fail flags against user-defined acceptance criteria. Raw sensor voltage traces and pressure transients are retained for reprocessing. Export functions support direct integration into LIMS environments via ODBC or REST API endpoints. All data files include embedded digital signatures and immutable hash verification to meet ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Applications
- Quality control of pharmaceutical blister lidding foils and cold-forming aluminum/PVC laminates per EP 3.2.1 and USP .
- Development and validation of food packaging structures—including retort pouches, vacuum-sealed meat trays, and modified atmosphere packaging (MAP) films.
- Accelerated aging studies correlating OTR shifts with thermal/hygrometric stress exposure.
- Benchmarking of nanocomposite, plasma-deposited, or metallized barrier coatings versus industry reference standards.
- Regulatory submission support for FDA 510(k), EU MDR Annex I, and China NMPA Class II/III packaging dossiers.
FAQ
What standards does the HK-701R comply with?
It conforms to ASTM D3985, ISO 15105-2, ISO 2556, ASTM F1249 (for high-barrier films), and ISO 14663 for multi-gas permeability assessment.
Can the instrument measure gases other than oxygen?
Yes—N₂, CO₂, air, and He are supported; sensor configuration and calibration must be adapted per gas-specific diffusion kinetics and detection sensitivity.
Is humidity control built-in or optional?
Humidity generation is an optional module; standard configuration includes dry (0% RH) and saturated (100% RH) capability, with intermediate RH levels requiring the add-on generator.
How is leak integrity verified before testing?
The system performs automated vacuum hold tests and real-time leak rate quantification using pressure decay algorithms—results are logged and flagged if exceeding 0.5 Pa/min threshold.
What sample preparation tools are recommended?
HARKE supplies certified die-cutting kits (150 mm × 94 mm rectangular and 100 mm diameter circular) with tungsten-carbide blades to ensure burr-free edges and consistent thickness profile across specimens.
