HARKE HK-R3 Aluminum Foil Composite Film Gas Permeability Tester
| Brand | HARKE |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Manufacturer |
| Country of Origin | Domestic (China) |
| Model | HK-R3 |
| Pricing | Upon Request |
Overview
The HARKE HK-R3 Aluminum Foil Composite Film Gas Permeability Tester is a precision-engineered instrument designed for quantitative evaluation of gas barrier performance in multilayer flexible packaging materials—particularly aluminum foil–based laminates widely used in pharmaceutical blister packs, food vacuum pouches, and high-barrier medical device packaging. It operates on the differential pressure (manometric) method per ISO 15105-1, ASTM D1434, and GB/T 1038, where a controlled pressure gradient is established across a conditioned test specimen sealed between two isolated chambers. The lower chamber (test side) is maintained under high vacuum while the upper chamber (high-pressure side) is pressurized with the test gas (e.g., O₂, N₂, CO₂, or air). Gas molecules permeate through the film driven by the partial pressure difference, and their accumulation in the low-pressure chamber is measured continuously via high-stability capacitance manometers. Real-time pressure rise data are processed to calculate gas transmission rate (GTR), permeability coefficient (P), diffusion coefficient (D), and solubility coefficient (S), all traceable to NIST-calibrated reference standards.
Key Features
- Triple independent test chambers enable concurrent, fully isolated measurements of up to three specimens—identical or dissimilar—maximizing throughput without cross-contamination or thermal interference.
- Precise environmental control: ±0.1 °C temperature uniformity and ±1 % RH stability across a programmable range of 5–40 °C and 0–90 % RH, supporting accelerated aging simulations and regulatory-compliant condition validation.
- Dual-mode test logic: Selectable proportional control or fuzzy logic algorithms ensure robust convergence during transient permeation phases—critical for low-permeability Al-foil composites exhibiting long lag times.
- Scalable measurement range: Configurable vacuum manifold and pressure transducer options extend detection limits from 1000 cm³/m²·day·atm (moderate barrier), eliminating need for manual range switching.
- Temperature-dependent modeling: Built-in Arrhenius data fitting engine computes activation energy (Eₐ) and extrapolates permeability values at non-tested temperatures (e.g., 2°C or 40°C), supporting ICH Q1A stability protocols.
- Hazardous gas compatibility: Optional system modifications—including explosion-proof solenoid valves, stainless-steel gas pathways, and leak-tight dual-seal chamber design—support safe testing of flammable (e.g., H₂) or toxic (e.g., SO₂) gases under OSHA and ATEX-aligned configurations.
- Fully automated operation: Integrated PLC and PC-based controller execute sequence steps—including vacuum evacuation, pressure equilibration, real-time monitoring, and end-of-test validation—without operator intervention.
Sample Compatibility & Compliance
The HK-R3 accommodates circular specimens up to Ø100 mm (standard Ø97 mm test area) with thicknesses ranging from 20 µm to 500 µm, including metallized PET/Al/PE laminates, SiOₓ-coated films, and AlOₓ nanocomposite structures. All wetted surfaces are electropolished 316L stainless steel or PTFE-lined to prevent catalytic degradation of sensitive barrier layers. The system complies with ISO/IEC 17025 documentation requirements for calibration traceability, supports GLP/GMP audit trails (including user authentication, electronic signatures, and 21 CFR Part 11–compliant data integrity logs), and meets EU Regulation (EC) No. 1935/2004 for food-contact material testing.
Software & Data Management
HARKE PermeaSoft v4.2 provides ISO 15105–aligned calculation modules, real-time permeation curve visualization, multi-parameter regression analysis (Fickian/non-Fickian diffusion modeling), and automated report generation in PDF/CSV/XLSX formats. Raw sensor data are stored with full metadata (operator ID, ambient conditions, calibration timestamps, chamber seal integrity logs). The software includes built-in validation protocols for system suitability (e.g., standard film verification per ASTM F2622), drift monitoring, and uncertainty budgeting per GUM (JCGM 100:2008). RS232 and optional Ethernet interfaces enable seamless integration into LIMS or MES environments.
Applications
- Quality release testing of aluminum-laminated pouches for sterile pharmaceuticals (USP , EP 3.2.1)
- Accelerated shelf-life prediction for retortable food packaging under elevated T/RH conditions
- R&D screening of novel barrier coatings (e.g., Al₂O₃ ALD, DLC) on polymer substrates
- Regulatory submission support for FDA 510(k) and MDR Annex II technical documentation
- Supplier qualification audits requiring reproducible O₂TR/CO₂TR data per ISTA 3A and ASTM D4332
FAQ
What gases can be tested with the standard HK-R3 configuration?
Standard configuration supports O₂, N₂, CO₂, and air. Other gases require hardware modification and safety review.
Is calibration traceable to national standards?
Yes—certified reference films (NIST-traceable O₂TR standards) are supplied; annual calibration certificates include uncertainty budgets per ISO/IEC 17025.
Can the system operate unattended overnight?
Yes—automated shutdown, pressure safety interlocks, and email/SMS alert triggers ensure secure extended-duration testing.
What sample preparation tools are included?
Standard kit includes stainless-steel die cutter (Ø97 mm), vacuum grease, quantitative filter paper, and vacuum pump oil conditioner.
Does the software support multi-language UI and 21 CFR Part 11 compliance?
PermeaSoft v4.2 offers English, German, and Chinese UI; Part 11 mode enables role-based access, audit trail export, and electronic signature workflows.
