Vaporized hydrogen peroxide decontamination chamber
Ensure aseptic material safety with a decontamination chamber designed for rapid vaporized hydrogen peroxide treatment and precise humidity control, achieving significant bio-burden reduction in GMP processes.
Decontaminates Aseptic Materials in Pharmaceutical Settings
The VHP DC-A Decontamination Chamber Atmospheric from STERIS is a state-of-the-art solution designed for aseptic material decontamination in pharmaceutical and biopharmaceutical environments. This chamber excels with its non-condensing vaporized hydrogen peroxide technology, achieving a 6-log reduction in bio-burden, crucial for GMP-regulated processes. Its operation consists of three phases: Pre-Conditioning to dehumidify and lower particulate levels, VHP Decontamination for effective sterilization, and Post-Conditioning to safely aerate and remove residual VHP gases.
Ideal for decontaminating vial stopper bags, wrapped components, and syringes, this equipment seamlessly integrates into production lines, enhancing process efficiency. Operated via a Siemens PLC and HMI, it boasts configurable parameters suited for various loads, ensuring adaptability and ease of integration. The decontamination chamber offers significant energy efficiency, employing very low hydrogen peroxide consumption, while maintaining user safety through thorough risk analysis.
Certified for GMP compliance by TÜV SÜD Germany, the VHP DC-A supports pharmaceutical manufacturers by providing comprehensive contamination control inline with industry standards. Its independent system design simplifies installation and validation, while customization options and engineering support ensure alignment with specific production requirements.
Benefits
- Ensures GMP compliance and bio-burden reduction, critical for pharmaceutical safety standards.
- Increases operational efficiency with a short decontamination cycle.
- Reduces operating costs with low hydrogen peroxide consumption.
- Enhances user safety with comprehensive risk analysis and automated controls.
- Simplifies integration with an independent design and configurable system parameters.
- Applications
- Biopharmaceuticals,Gmp regulated pharmaceuticals,Pharmaceutical manufacturing,Aseptic material decontamination
- End products
- Vial stopper bags,Sterile medical packaging,Syringes,Wrapped components
- Steps before
- Pre-Conditioning,Dehumidification,Particulate Reduction,Pre-Sterilization
- Steps after
- Post-Conditioning,VHP Aeration,Bioburden Reduction,GMP Compliance Verification
- Input ingredients
- vial stopper bags,wrapped components,syringes,aseptic material packages,pre-sterilized material packages
- Output ingredients
- decontaminated vial stopper bags,decontaminated wrapped components,decontaminated syringes,sterilized material packages,bio burden reduced by 6-log
- Market info
- Steris Finn-Aqua is known for manufacturing high-quality steam sterilizers and water purification systems, specializing in clean utilities for pharmaceutical and biotech industries. Their equipment is recognized for reliability and meeting stringent industry standards.
- Decontamination Phases
- Pre-Conditioning,VHP Decontamination,Post-Conditioning
- Automation
- Siemens PLC-controlled
- Cycle Time
- Short cycle time
- Bioburden Reduction
- 6-log reduction
- Hydrogen Peroxide Consumption
- Very low
- Post-Conditioning Process
- VHP gas converted to water and oxygen
- Particulate Reduction
- Yes
- Control Panel Type
- Siemens HMI
- Safe Opening
- When VHP concentration reaches a safe level
- Working mechanism
- VHP Decontamination
- Integrated steps
- Pre-Conditioning,VHP Decontamination,Post-Conditioning
- Automation level
- PLC-controlled
- Changeover time
- Short cycle time
- Safety measures
- Extensive risk analysis
- Installation type
- Independent system
- Biological compatibility
- Compatible with pharmaceutical and aseptic materials
- Corrosive resistance (e.g. acids)
- Low hydrogen peroxide consumption
- Cleanability
- Able to ensure a 6-log reduction of bio-burden
- GMP Compliance
- TÜV SÜD Germany
- Compact footprint
- Modular Design
- Control panel type
- Siemens PLC and HMI
- Control panel type
- Simatic Siemens PLC
- Integration possibilities
- Configurable parameters for various loads
- Safety features
- Extensive risk analysis for operator safety
- Cycle phases
- Pre-Conditioning,VHP Decontamination,Post-Conditioning