Isolator for Vphp decontamination testing
Ensure precise decontamination analysis and stringent monitoring of hydrogen peroxide levels in pharmaceutical and biotech production environments, with a robust isolator designed for sterile and safe processing of sensitive materials.
Monitors and Controls VPHP Decontamination Processes
The VPHP Decontamination Testing Isolator from Comecer is designed to ensure precise decontamination in medical and pharmaceutical settings. This isolator excels by integrating a vapor phase hydrogen peroxide (VPHP) generator with advanced sensors for monitoring hydrogen peroxide concentration, temperature, and humidity. It works by maintaining positive pressure within the chamber, which assures sterility throughout the decontamination process. Applications span a variety of settings from pharmaceutical production of sterile injectable drugs to RADIOPHARMACEUTICALS and aseptic compounding of cell and gene therapies. It supports comprehensive testing, monitoring, and desorption analysis, crucial for maintaining compliance with safety and environmental standards. The isolator facilitates easy integration with existing laboratory setups and is manually operable, ideal for bench-top operations. Equipped with sophisticated detection technology, it monitors even low concentrations of hydrogen peroxide (<3 ppb), making it a suitable choice for ensuring safety and quality in highly sensitive production environments.
Benefits
- Maintains sterility with positive pressure isolation, ensuring contamination-free environments.
- Provides precise VPHP concentration monitoring, enhancing safety and regulatory compliance.
- Enables accurate detection of low hydrogen peroxide levels, ensuring thorough decontamination.
- Facilitates integration into existing lab setups, minimizing setup time and operational disruptions.
- Supports versatile applications across pharmaceuticals, biotech, and radiopharmaceuticals, broadening its use case scope.
- Applications
- Aseptic compounding,Medical devices,Radiopharmaceuticals,Pharmaceutical products,Cell and gene therapy products
- End products
- Sterile injectable drugs,Implantable medical devices,Car-t cell therapies,Radiolabeled monoclonal antibodies,Parenteral nutrition solutions
- Steps before
- Steps after
- Sterilization,Monitoring,Recording,Desorption tests
- Input ingredients
- materials for decontamination,pharmaceutical materials
- Output ingredients
- decontaminated materials,H2O2 residues,analysis data
- Market info
- Comecer is known for manufacturing advanced containment and isolation systems, particularly in the pharmaceutical and nuclear medicine sectors, with expertise in custom-engineered equipment, ensuring high safety and compliance standards.
- Air flow velocity
- Probe used for measurement
- H2O2 concentration detection
- High sensitivity sensor
- Temperature and humidity sensor
- Integrated measurement
- H2O2 trend detection
- Maximum level sensor
- H2O2 low concentration detection
- Minimum level sensor
- Photo-catalytic action
- Photocatalyst included
- Moisture control
- Dehumidifier present
- Chamber pressure
- Positive pressure with respect to the laboratory
- Primary usage
- Decontamination via VPHP
- Desorption test capability
- Inside chamber
- Microbial monitoring
- Connection for particle and microbiological counter
- Chamber configuration
- Pre-chamber and main chamber
- Decontamination generator
- VPHP generator equipped
- Temperature sensor
- Included
- Humidity sensor
- Included
- Internal shelves
- Available
- Internal sliding tray
- For easy material movement
- Glovesystem
- Speedy Glovesystem
- Glove spreaders
- Available
- Airflow control
- 0.1–2 m/s
- Positive pressure operation
- Yes
- Automation level
- Manual / PLC / SCADA
- Cleaning method
- CIP / Manual
- Batch vs. continuous operation
- Batch
- Desorption Testing
- Material Compatibility
- Decontamination Cycle Control
- Programmable
- Glove system
- Speedy Glovesystem
- Internal shelves
- Yes
- Internal sliding tray
- Yes
- Connection for counters
- Particle and microbiological
- Dehumidifier
- Yes
- Photocatalyst
- Yes
- Control panel type
- HMI / Touchscreen