GDP-C Gas Permeability Tester (Oxygen Transmission Rate Analyzer)
| Origin | Germany |
|---|---|
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | GDP-C |
| Pricing | Available Upon Request |
Overview
The GDP-C Gas Permeability Tester is a precision-engineered instrument designed for quantitative determination of oxygen transmission rate (OTR) and general gas permeability through flexible packaging materials, films, foils, laminates, and coated substrates. It operates on the fundamental principle of pressure-rise measurement in a controlled diffusion cell, leveraging the physical behavior of gases under defined partial pressure gradients across a test specimen. Unlike gravimetric or coulometric methods, the GDP-C employs a highly sensitive piezoresistive pressure transducer to monitor minute pressure increases in the downstream (low-pressure) chamber as gas molecules permeate through the sample—enabling direct, real-time quantification of gas flux without reliance on carrier gas streams or electrochemical sensors. The system supports both dry and humidified test conditions, with optional humidity control via a saturated salt solution or wet-glass-disk configuration in the high-pressure chamber, allowing compliance with regulatory requirements for moisture-dependent barrier evaluation (e.g., pharmaceutical blister packaging under accelerated stability conditions).
Key Features
- Triple-mode permeation testing: time-lag analysis (Barrer method), steady-state pressure-rise, and controlled-flow gas introduction for low-volume or hazardous gas applications
- Piezoresistive pressure sensing technology (replacing legacy U-tube manometers) delivering enhanced resolution, linearity, and long-term drift stability
- Integrated temperature-controlled test chamber maintained at 23 °C ± 0.5 °C per DIN 53536 and ASTM E1434–82 specifications
- Modular electrical architecture: independent power supplies for GDP-C main unit (230 V, 50 Hz, 50 W), host PC (230 V, 50 Hz, 250 W), and external display monitor (230 V, 50 Hz, 300 W)
- Compact footprint (48 × 34 × 50 cm) and lightweight design (22 kg without PC), facilitating integration into QC laboratories with space constraints
- Full compliance with international standard test methodologies—including DIN 53536 for plastic films and ASTM E1434–82 for oxygen transmission rate determination
Sample Compatibility & Compliance
The GDP-C accommodates circular specimens up to 97 mm in diameter, suitable for monolayer polymers (e.g., PET, PE, PP), metallized films, aluminum foil composites, and multilayer laminates used in food, pharmaceutical, and medical device packaging. Its dual-chamber diffusion cell enables strict adherence to ISO 15105-2 (plastics—film and sheeting—determination of gas transmission rate—part 2: atmospheric pressure method) and supports GLP-compliant documentation when paired with validated software. Humidity-controlled testing satisfies USP requirements for moisture-vapor-sensitive dosage forms and aligns with ICH Q5C stability protocol expectations for barrier integrity under varying RH conditions.
Software & Data Management
Acquisition and analysis are performed via dedicated Windows-based software that records pressure vs. time profiles at user-defined intervals (down to 1 s resolution). The software calculates OTR values in mL/(m²·day·bar), generates time-lag plots for diffusion coefficient (D) and solubility coefficient (S) derivation per Barrer formalism, and exports data in CSV and PDF formats. Audit trail functionality supports 21 CFR Part 11 readiness when deployed in regulated environments; electronic signatures, user access levels, and change logs are configurable per GMP Annex 11 guidance.
Applications
- Quality control of sterile barrier systems for Class II/III medical devices
- Development and validation of high-barrier packaging for oxygen-sensitive pharmaceuticals (e.g., lyophilized biologics, nitroglycerin tablets)
- Comparative assessment of coating efficacy (SiOx, AlOx) on polymer substrates
- Accelerated aging studies correlating OTR shifts with thermal/humidity stress exposure
- Supplier qualification and incoming material inspection per ISO 11607-1
FAQ
Does the GDP-C comply with FDA or EU MDR requirements for packaging validation?
Yes—the instrument’s measurement traceability, documented calibration procedures, and software audit capabilities support compliance with FDA 21 CFR Part 11 and EU MDR Annex I essential requirements for packaging performance verification.
Can the GDP-C measure gases other than oxygen?
Yes—while optimized for O2, it is fully compatible with nitrogen, carbon dioxide, and argon when configured with appropriate gas handling accessories and reference standards.
Is temperature control limited to 23 °C?
The base configuration maintains 23 °C ± 0.5 °C per DIN/ASTM standards; optional environmental chambers (not included) enable testing at 38 °C/90% RH or other ICH-relevant conditions.
What is the minimum detectable OTR value?
The system achieves reliable detection down to 0.5 mL/(m²·day·bar) under standard test conditions, verified using certified reference films traceable to NIST SRM 1474.
How is humidity introduced during wet-gas testing?
A calibrated wet-glass-disk assembly is placed in the upstream chamber, generating a stable vapor pressure environment; relative humidity is indirectly controlled via temperature-equilibrated saturated salt solutions per ISO 4887.
