The Vaporized Hydrogen Peroxide (VHP) passbox represents a critical investment in the infrastructure of cleanrooms and sterile environments. As such, selecting the right model involves careful consideration of various specifications to ensure compliance, effectiveness, and suitability for the intended application. This article reviews key specifications that distinguish the leading models of VHP passboxes in the industry.
Sterilization Efficacy
- Log Reduction Rate: Top models offer a 6-log or greater reduction of microbial life, adhering to the most stringent sterility assurance levels.
- Cycle Validation: Inbuilt systems for real-time monitoring and validation of the sterilization cycle parameters.
Build Quality and Materials
- Construction: Stainless steel 316L or equivalent offering superior corrosion resistance.
- Doors: Single or double-door configurations with tempered glass for visibility and durability.
- Gaskets and Seals: Silicon or other advanced materials ensuring air-tight seals resistant to VHP exposure.
Functional Capabilities
- VHP Compatibility: Compatibility with VHP generators and the ability to withstand the oxidative effects of VHP over prolonged periods.
- Air Filtration: Integrated HEPA/ULPA filtration systems for maintaining partical-free internal environments post-sterilization.
- Control Systems: Programmable logic controllers (PLCs) with touch screen interfaces for cycle customization.
- Decontamination Features: Inclusion of UV-C lights or additional decontamination technologies as supplementary sanitation measures.
Safety and Monitoring
- Leak Detection: Advanced leak detection systems that provide instant alerts in case of VHP leaks.
- Safety Locks: Mechanisms to prevent passbox opening during sterilization, ensuring operator safety and integrity of the sterile environment.
- Interlock System: Electromechanical or magnetic door interlocks that prevent both doors from being opened simultaneously.
- Audible Alarms and Indicators: Alarms for end-of-cycle notification and error alerts, including LED status indicators.
Technical Specifications
- Interior Dimensions: Varied options to accommodate specific transfer loads.
- Pass Through Capacity: Rated capacity for transfer volume and weight, ensuring device longevity.
- Operational Temperature Range: Broad functional temperature ranges for versatile applications.
Connectivity and Data Management
- Data Ports: USB or other connectivity options for data logging and transfer.
- Network Compatibility: Wi-Fi or ethernet options for integration into existing network infrastructures for monitoring and compliance tracking.
Compliance and Certification
- Industry Standards: Compliance with ISO, EU GMP, FDA, and other relevant industry standards for cleanroom equipment.
- Certifications: Possession of necessary certifications like CE marking, ensuring the product meets the legislative requirements within its category.
Maintenance and Support
- User Maintenance: User-serviceable parts for easy cleaning and filter replacement.
- Technical Support: Comprehensive after-sale support including installation, operation training, and on-going maintenance services.
- Warranty: Inclusion of a manufacturer’s warranty covering parts and labor.
Conclusion
When evaluating VHP passbox models, it is imperative to consider the specifications that align with your operational needs and regulatory requirements. The leading models on the market today are designed to offer high-performance sterilization, ensure safety, and enhance usability while providing robust data management and compliance features. Careful consideration of these specifications will result in a wise investment that supports and enhances the sterility of critical processes.
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