High-speed decontamination tunnel for pharmaceutical Rtu material
Ensure 100% sterility of ready-to-use materials with a high-speed tunnel that achieves 6-log decontamination in seconds, seamlessly integrating into aseptic lines for continuous, efficient operations.
The NEBULA from IMA Group is a high-speed decontamination tunnel designed to solve sterility challenges in biopharmaceutical and pharmaceutical industries. Utilizing aerodynamic containment of highly concentrated vapour phase hydrogen peroxide, it achieves 6-log decontamination of RTU materials, such as pre-filled syringes and sterile vials, as they transit isolated production lines. Key to its operation is the seamless integration with IMA LIFE aseptic fill-finish lines, allowing continuous high-speed introduction of up to six tubs per minute. The tunnel’s design features pressure-managed chambers for operator and cleanroom safety, avoiding hydrogen peroxide circulation outside NEBULA. Compact at 3.7 meters in length, it requires 35% hydrogen peroxide solution, with a 6 liters per hour consumption rate, and offers easy size changeover independent of packaging. Compliance with GMP Annex 1 provides excellent assurance of sterility, and minimal layout impact ensures simplified production line integration.
Benefits
- Ensures 100% sterility, complying with stringent GMP standards.
- Increases production speed with continuous high-speed RTU introduction.
- Enhances safety by preventing hydrogen peroxide exposure outside the tunnel.
- Facilitates integration with existing systems, boosting aseptic process efficiency.
- Enables flexible operations with easy changeovers and minimal layout impact.
- Applications
- Biopharmaceuticals,Ready-to-use (rtu) material,Pharmaceutical packaging,Aseptic fill-finish products
- End products
- Sterile liquid doses in vials,Sterile ampoules,Sterilized infusion bags,Pre-filled syringes,Sterile iv drug bags,Sterile vials,Aseptic eye drop containers
- Steps before
- Material preparation,RTU tub/tray loading,Pre-decontamination inspection
- Steps after
- Sterility assurance,Aseptic filling,Packing,Testing,Quality control
- Input ingredients
- RTU material,tubs,trays,vial trays
- Output ingredients
- sterilised RTU material,sterilised tubs,sterilised trays,sterilised vial trays
- Speed
- Up to 6 RTU/min
- Decontamination Time
- 30 sec for 6-log decontamination
- Decontamination Type
- Hydrogen Peroxide VPHP
- Dimensions (Cleanroom)
- 3.7 m (L) x 0.9 m (W) x 1.5 m (H)
- Dimensions (Technical Area)
- 2.3 m (L) x 1.2 m (W) x 2.8 m (H)
- AHU Dimensions (Technical Area)
- 2.0 m (L) x 0.8 m (W) x 2 m (H)
- H2O2 Solution Consumption
- 6 l/hr
- H2O2 Storage
- 2x20L tank – 35% aqueous
- Ventilation Inlet Airflow
- 450 m3/h
- Compressed Air
- 10 Nm3/h @ 8 bar
- Cold Water for UTA
- 2.5 m3/h @ 7°C
- Industrial Steam
- 10 Kg/h @ 5 bar
- Working Mechanism
- High-speed decontamination using HC-VPHP
- Integrated Steps
- Sterility assurance during transfer
- Batch vs Continuous Operation
- Inline Continuous
- Changeover Time
- Easy size and RTU size changeover
- Automation Level
- PLC-controlled
- CIP/SIP
- N/A (not described)
- Cleaning Method
- N/A (not described)
- Material Transfer
- High-speed tub introduction
- Connection to Process
- Seamless integration with IMA LIFE aseptic lines
- Corrosive resistance (e.g. acids)
- Yes
- GMP Compliance
- Annex 1 guidelines
- Machine footprint
- 3.7 m (L) x 0.9 m (W) x 1.5 m (H)
- Piping
- Inlet/outlet piping up to the ceiling
- Power supply,Ventilation Skid Dimensions
- 2.3 m (L) x 1.2 m (W) x 2.8 m (H)
- AHU Dimensions
- 2.0 m (L) x 0.8 m (W) x 2 m (H)
- Cabinet H2O2 Solutions
- 1.2 m (L) x 0.5 m (W) x 1.6 m (H)
- Ready-To-Use Tub/Trays Size
- 3-4” tubs
- 6” tubs
- Vial trays
- Integration with aseptic fill-finish lines
- Seamless integration with IMA LIFE aseptic fill-finish lines
- Changeover capabilities
- Easy size and RTU size changeover
- Custom RTU sizes
- 3-4” tubs,6” tubs,vial trays (to be requested)
- Market info
- IMA is known for its expertise in manufacturing automated packaging machines and solutions, particularly for the pharmaceutical, cosmetics, food, tea, and coffee industries, offering innovative, high-quality equipment and comprehensive customer service.