ETHOXY-9000: Ethylene Oxide Residual Analyzer

Overview
The ETHOXY-9000 quantifies residual ethylene oxide (EtO) in medical devices, textiles, and packaging using gas chromatography (GC) with mass spectrometry (MS) detection. Critical for ensuring compliance with ISO 10993-7 and ASTM F2100, it guarantees material safety for sensitive applications like sterilized healthcare products.

Karakteristik Utama

1. High-Sensitivity GC-MS: Detects EtO concentrations as low as 0.1 ppm with ±1% accuracy, suitable for trace analysis.
2. Automated Sampling: Robotic arms handle sample injection, reducing human error and improving throughput.
3. Multi-Media Compatibility: Analyzes solids, liquids, and gases with customizable temperature programs (50–300°C).
4. Compliance Automation: Preloaded ISO/ASTM protocols generate reports with pass/fail criteria and data traceability.

Applications

• Medical Devices: Certify sterilized equipment (e.g., surgical tools, implants) for FDA/CE compliance.
• Pharmaceuticals: Validate EtO residuals in drug packaging and delivery systems.
• Textiles: Test flame-retardant fabrics treated with EtO-based chemicals.

Konformitas
ISO 10993-7, ASTM F2100, EN 1422.

Optional Add-Ons

• Headspace autosamplers for volatile organic compounds (VOCs).
• Real-time data integration with LIMS (Laboratory Information Management Systems).
• Custom methods for niche compounds (e.g., chlorofluorocarbons).

Konklusi
The ETHOXY-9000 ensures material safety and regulatory compliance by delivering precise EtO residual analysis, critical for healthcare and industrial applications.