Nebula Aseptic Processing

Machine overview

Hyperspeed decontamination technology.

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.
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. 

Production plant

IMA Life

Machine highlights

  1. 100% sterility 

    High-speed transfer technology ensuring 100% sterility of Ready-To-Use material as it enters the isolator.

  2. 6-log decontamination

    6-log decontamination achieved over the entire external packaging surface.

  3. Operating safety

    Maximum safety for both operator and cleanroom by chamber pressure management, avoiding any hydrogen peroxide circulation within the isolator and outside NEBULA.

  4. Continuous processing 

    Continuous, high-speed RTU introduction, up to six tubs/trays per minute: alternative solution to eBeam, pulsed light and NO2 technologies.

  5. Seamless integration

    Easy connection to aseptic fill-finish plants to enhance their performance.

  6. Sterility assurance

    Excellent sterility assurance according to Annex 1 guidelines.

  7. Layout friendly

    Minimal impact on layout.

  8. Size changeover

    Easy size and RTU size changeover: independent of packaging.

Maximum safety

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.

Machine details

Machine video trailer

Inlet of RTU components

Internal overview with components

Internal side view with components

Internal pass-through port

Nebula overview

Technical information

NEBULA TECHNICAL DATA
FeaturesDimensions
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/trays3-4” tubs (standard Nebula),  6” tubs, vial trays (to be requested)
Outlet H₂O₂ catalyserincluded
OutputUp to 6 RTU/min (max speed @ 30sec 6-log decontamination time)
Expected 35% H₂O₂ solution consumption in production6 l/hr
H₂O₂ storage2x20L tank – 35% aqueous hydrogen peroxide solution high purity – low residues
Requested utilities

Ventilation inlet airflow: 450 m3/h from technical area
Compressed air: 10 Nm3/h @ 8 bar
Cold water for UTA: 2.5 m3/h @ 7°C
Industrial steam: 10 Kg/h @ 5 bar

NEBULA CAMPAIGN LAUNCH

NEBULA is the ultimate hyperspeed decontamination tunnel that integrates seamlessly with IMA Life aseptic fill-finish lines.
Discover its exceptional efficiency.

Promo video

Enhancing the performance of advanced robotics, the INJECTA 36 raises the bar for high-speed production of Ready-To-Use components.

Integrated lines

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