Ultra Pouch Roll for Steam and VH2O2 Low-Temperature Sterilization
Manufacturer: SPS Medical
Country of Origin: France
The ULTRA Pouch Roll, developed by SPS Medical, is a high-performance, reinforced Sterile Barrier System (SBS) designed to meet the rigorous demands of Central Sterile Supply Departments (CSSDs). Engineered specifically for the packaging of heavy, bulky reusable medical devices (RMD) and surgical trays, it serves as a robust alternative to traditional envelope-type wrapping systems. This packaging solution is scientifically validated for compatibility with both Steam and Hydrogen Peroxide low-temperature sterilization processes, providing a versatile and secure barrier for critical medical instrumentation.
Features:
- Dual-Material Composition: The roll features a unique hybrid design consisting of one porous polyolefin synthetic side and one blue-tinted transparent film side, facilitating both sterilization agent penetration and easy content identification.
- Enhanced Perforation Resistance: Utilizing an innovative reinforced porous web, the ULTRA material offers significantly higher resistance to perforation and tearing compared to conventional paper/film packaging, making it ideal for sharp or heavy orthopedic loan sets.
- Aseptic Opening Performance: The specialized "Peel" film ensures a high-quality, fiber-free opening (no defibration), which eliminates the risk of particle emission when transferring devices to the sterile field.
- Integrated Process Indicators: Includes a Steam sterilization indicator printed within the film structure (intrafilm print) to provide clear visual confirmation of processing while preventing ink contact with the medical devices.
- Superior Seal Integrity: Engineered with high seal strength to considerably reduce the risk of bursting during the pressure fluctuations of the sterilization cycle, thereby minimizing the need for costly reprocessing.
- Validated Sterility Maintenance: The system is tested to maintain sterility for up to 12 months under hospital storage conditions, ensuring long-term safety for stored instrumentation.
- Regulatory Compliance: Fully complies with international standards EN 868-5 and EN ISO 11607-1.
- Resource Efficiency: The adaptable pouch format reduces overall packaging waste compared to standard wrap methods by optimizing the material volume used for various tray sizes.
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