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NEBULA
High-speed Decontamination Tunnel
Responding to the GMP Annex 1 notes, whereby risks linked to sterility assurance must be minimised during material transfer and supported by high-capability transfer technology, Nebula accomplishes what no other solution has done before.
Responding to the GMP Annex 1 notes, whereby risks linked to sterility assurance must be minimised during material transfer and supported by high-capability transfer technology, Nebula accomplishes what no other solution has done before.
Hyperspeed decontamination technology
Adopting an unprecedented approach to ensuring 100% sterility of RTU material as it enters and transits isolated production lines, Nebula is a high-speed decontamination tunnel which integrates seamlessly with IMA LIFE aseptic fill-finish lines. 6-log decontamination is achieved over the entire external packaging surface using aerodynamic containment of highly concentrated vapour phase hydrogen peroxide (HC-VPHP), while material crosses the tunnel in a matter of seconds. This allows for continuous, high-speed tub introduction, up to six per minute.
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Production Plant
IMA Life
NEBULA Highlights
1.
High-speed transfer technology ensuring 100% sterility of Ready-To-Use material as it enters the isolator
2.
6-log decontamination achieved over the entire external packaging surface
3.
Maximum safety for both operator and cleanroom by chamber pressure management, avoiding any hydrogen peroxide circulation within the isolator and outside NEBULA
4.
Continuous, high-speed RTU introduction, up to six tubs/trays per minute: alternative solution to eBeam, pulsed light and NO2 technologies
5.
Easy size and RTU size changeover: independent of packaging
6.
Easy connection to aseptic fill-finish plants to enhance their performance
7.
Excellent sterility assurance according to Annex 1 guidelines
8.
Minimal impact on layout
The tunnel is comprised of a series of chambers in which pressure is managed to ensure maximum safety for both operator and cleanroom, avoiding hydrogen peroxide circulation within the isolator.
- Technical Data
- Machine Layout
| NEBULA TECHNICAL DATA |
|
| Features | Dimensions |
| Decontamination Tunnel Dimensions (Cleanroom) | 3.7 m (L) x 0.9 m (W) x 1.5 (H) + inlet/outlet piping up to the ceiling |
| Power supply & Ventilation Skid 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 (W) x 2 m (H) |
| Cabinet H2O2 Solutions (Cleanroom/Technical Area) | 1,2 m (L) x 0.5 m (W) x 1.6 m (H) |
| Ready-To-Use Tub/Trays | 3-4” tubs (standard Nebula), 6” tubs, vial trays (to be requested) |
| Outlet H2O2 catalyser | included |
| Output | Up to 6 RTU/min (max speed @ 30sec 6-log decontamination time) |
| Expected 35% H2O2 solution consumption in production | 6 l/hr |
| H2O2 storage | 2x20L tank – 35% aqueous hydrogen peroxide solution high purity – low residues |
| Requested Utilities |
Ventilation Inlet Airflow: 450 m3/h from technical area |
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