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.

General


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.

Technical Specifications


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

Operating Characteristics


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

Material Compatibility


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

Physical Characteristics


Compact footprint
Modular Design
Control panel type
Siemens PLC and HMI

Custom Options


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