The new IMA decontamination tunnel eliminates debagging inside the aseptic zone

In pharmaceutical production, maintaining the highest standards of sterility is non-negotiable. When it comes to aseptic processing and freeze-drying, a revolutionary solution has emerged: NEBULA, the high-speed decontamination tunnel from IMA Life. Read along to learn more about its features, advantages, and the paradigm shift it brings to the industry.

Unprecedented sterility assurance

NEBULA’s core is its hyper-speed decontamination technology.

Adopting an unparalleled approach, NEBULA ensures 100% sterility of Ready-To-Use (RTU) material as it seamlessly integrates with IMA Life aseptic fill-finish lines. NEBULA eliminates debagging inside the aseptic zone, as everything in the tunnel is sterilized. This means that your trays with vials or syringes can be debagged before the processing, then the trays are placed in the tunnel, the trays and RTU are sterilized, and they continue through the tunnel to the filling line.
In alignment with the recent GMP Annex 1 guidelines, which emphasize minimizing risks associated with sterility assurance during material transfer, NEBULA stands out.

NEBULA highlights in focus

Seamless connectivity:
NEBULA isn’t just a standalone solution; it seamlessly connects to aseptic fill-finish lines, enhancing their overall performance.
Compliance with Annex 1 guidelines:
In the face of increasingly stringent regulations outlined in Annex 1, NEBULA is a reliable solution for ensuring excellent sterility assurance.
Layout-friendly:
NEBULA’s impact on layout is minimal, allowing for easy integration into existing production setups.

Advantages:

With NEBULA the debagging process is altered, as debagging takes place outside the aseptic zone.
NEBULA facilitates the entry of RTU material into isolators at an extraordinary pace, achieving hyper-speed decontamination.
The entire external packaging surface undergoes a precise 6-log decontamination process. This is made possible through the aerodynamic containment of highly concentrated vapor phase hydrogen peroxide (HC-VPHP).
The tunnel prioritizes safety with chamber pressure management, ensuring the operators’ well-being and maintaining the cleanroom’s sterility. No hydrogen peroxide circulates within the isolator or outside NEBULA.
The design enables the continuous, high-speed introduction of RTU material, reaching up to six tubs or trays per minute.

An exciting innovation for sterility assurance

In the pursuit of perfection in pharmaceutical production, IMA Life NEBULA emerges as a game-changer. When looking at the complexities of sterile material transfer, NEBULA not only meets but exceeds expectations. Its hyper-speed decontamination technology, coupled with seamless integration and compliance with industry guidelines, positions NEBULA at the forefront, offering unmatched sterility and operational excellence.

For more details on NEBULA please contact us by following the link below.