GBPI N500-P Gas Permeability Tester for Pharmaceutical and Food Packaging
| Brand | GBPI |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | Domestic (China) |
| Model | N500-P |
| Price Range | USD 14,000 – 70,000 |
| Testing Gases | O₂, CO₂, N₂ |
| Measurement Range | 0.02–50,000 cm³/(m²·24h·0.1 MPa), extendable to 600,000 cm³/(m²·24h·0.1 MPa) |
| Test Accuracy | 0.001 cm³/(m²·24h·0.1 MPa) |
| Temperature Control Range | 15–60 °C |
| Temperature Stability | ±0.1 °C |
| Vacuum Level | <20 Pa |
| Vacuum Resolution | 0.01 Pa |
| Test Pressure Range | −0.1 to +0.1 MPa |
| Gas Supply Pressure | 0.2–0.8 MPa |
| Gas Inlet Port | 1/8″ push-to-connect fitting |
| Effective Test Area | 50.24 cm² |
| Specimen Diameter | Φ110 mm |
| Max. Specimen Thickness | ≤2 mm |
| Chamber Capacity | 1 test chamber |
| Dimensions | 680 × 560 × 340 mm |
| Weight | 70 kg |
| Power Consumption | 1000 W |
| Electrical Supply | AC 220 V, 50 Hz |
| Compliance Standards | GB/T 1038–2000, ISO 2556:1974, ISO 15105-1:2007, ASTM D1434, YBB 00082003–2015, JIS K7126-1:2006 |
Overview
The GBPI N500-P Gas Permeability Tester is a precision-manufactured differential-pressure (manometric) instrument engineered for the quantitative determination of gas transmission rates—specifically oxygen (O₂), carbon dioxide (CO₂), and nitrogen (N₂)—through polymeric films, laminates, foils, and rigid packaging containers. It operates on the fundamental principle of measuring the steady-state diffusion flux of a test gas across a conditioned specimen under controlled temperature and pressure differentials, in strict accordance with gravimetric and manometric methodologies defined in ISO 15105-1 and ASTM D1434. Designed for regulated environments, the N500-P delivers traceable, reproducible permeation data essential for quality assurance in pharmaceutical primary packaging (e.g., blister lidding, pouches, vial stoppers), food packaging (e.g., vacuum-sealed trays, modified-atmosphere packaging films), and high-barrier functional materials such as solar backsheet films and medical transdermal patches.
Key Features
- High-resolution vacuum system with real-time monitoring down to 0.01 Pa, enabling precise control of upstream/downstream pressure differentials required for low-permeability measurements (e.g., aluminum-coated PET or SiOₓ barrier films).
- Electromagnetic stepwise temperature control system maintaining ±0.1 °C stability across 15–60 °C, critical for evaluating Arrhenius-dependent permeation behavior per ISO 2556 and USP <671>.
- ARM-based embedded control architecture supporting autonomous operation—no external PC required—featuring a 7-inch color touchscreen interface with intuitive workflow navigation and real-time graphical display of pressure, differential pressure, temperature, and cumulative gas transmission.
- Multi-mode measurement capability: selectable High/Medium/Low Barrier modes automatically optimize sensor range and integration time, ensuring optimal signal-to-noise ratio for materials spanning 0.02 to 600,000 cm³/(m²·24h·0.1 MPa).
- GMP-compliant software architecture aligned with Annex 11 and FDA 21 CFR Part 11 requirements, including role-based user access (Administrator, Operator, Reviewer), full audit trail logging (system, method, and run-level), electronic signatures, and immutable data storage.
- Modular hardware design with field-replaceable pressure sensors, vacuum pumps, and gas manifolds—minimizing downtime and simplifying preventive maintenance per ISO/IEC 17025 calibration intervals.
Sample Compatibility & Compliance
The N500-P accommodates flat specimens up to Φ110 mm and ≤2 mm thick—including monolayer plastics (LDPE, PP), metallized films (AlOx, SiOx), coextrusions, rubber sheets, ceramic substrates, and laminated pharmaceutical foils. With optional fixture kits, it extends to rigid and semi-rigid packaging formats: plastic bottles (up to 500 mL volume), sealed pouches, thermoformed trays, and shallow bowls. All testing adheres to internationally harmonized standards: GB/T 1038–2000 (Chinese national standard), ISO 2556:1974 (gas transmission through plastic film), ISO 15105-1:2007 (differential pressure method), ASTM D1434 (standard test method for gas transmission rate), YBB 00082003–2015 (Chinese pharmaceutical packaging standard), and JIS K7126-1:2006 (Japanese industrial standard). Certified reference materials (CRM) traceable to NIM (National Institute of Metrology, China) are supplied for routine instrument verification.
Software & Data Management
Pre-installed GBPI PermeaSoft™ v3.2 provides complete lifecycle data governance—from method creation and parameter validation to automated report generation and long-term archival. Test methods are version-controlled and password-protected; each run logs operator ID, timestamp, environmental conditions, raw sensor outputs, and calculated permeability values. Reports comply with GLP/GMP documentation requirements and export natively to PDF, Excel (.xlsx), and CSV formats. Database queries support retrospective analysis by material lot, test date, operator, or specification limit. All data modifications trigger an immutable audit record—including who changed what, when, and why—ensuring full ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) compliance.
Applications
- Pharmaceutical packaging validation: O₂ transmission rate (OTR) of cold-form blister lidding foil, HDPE bottle caps, and peelable pouch seals per USP <671> and ICH Q5C.
- Food packaging shelf-life modeling: CO₂ permeability of MAP (modified atmosphere packaging) films used in meat, cheese, and ready-to-eat meals.
- Barrier layer development: Quantitative evaluation of SiOₓ, AlOₓ, and nanocomposite coatings on PET and PP substrates.
- Medical device packaging: Sterility maintenance assessment of Tyvek® lids and thermoformed trays via accelerated aging correlation studies.
- Emerging applications: Water vapor interference correction in OTR testing, dual-gas sequential permeation for multi-layer laminate deconvolution, and permeation kinetics under dynamic humidity gradients.
FAQ
What gases can the N500-P measure?
The instrument is configured for O₂, CO₂, and N₂ permeation testing using certified gas cylinders and calibrated mass flow controllers. Custom configurations for He, H₂, or CH₄ are available upon request and subject to sensor compatibility validation.
Does the system support container testing?
Yes—optional volumetric fixtures enable direct OTR measurement of rigid and semi-rigid containers (e.g., PET bottles, aluminum cans, CPET trays) per ASTM F2622 and ISO 15105-2, with integrated purge-and-fill protocols to eliminate headspace interference.
How is calibration traceability ensured?
Each unit ships with GBW(E)130541/2 certified reference standards issued by China’s National Administration of Metrology. Users perform periodic verification using these SRMs; calibration certificates conform to ISO/IEC 17025 and include uncertainty budgets.
Is remote monitoring supported?
The embedded Ethernet port enables secure remote access via TLS-encrypted web interface for real-time status viewing, method upload/download, and diagnostic log retrieval—without compromising firewall integrity or audit trail integrity.
What regulatory documentation is provided?
Factory acceptance test (FAT) reports, IQ/OQ documentation templates, 21 CFR Part 11 readiness assessment, and EU Annex 11 gap analysis are included. Full validation support packages are available under separate service agreement.
