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Responding to the recently published GMP Annex 1 notes whereby risks linked with sterility assurance must be minimized during material transfer and be supported by high capability transfer technology, IMA's Nebula accomplishes this, especially in terms of speed.
6-log decontamination is achieved over the entire packaging 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. 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.
Nebula can be connected to aseptic fill-finish plants to enhance their performance. Operational flexibility is significantly improved by avoiding the complexity involved in changeover procedures and drastically reducing the machine’s sensibility to packaging make-up and material. Moreover, in face of the increasingly stringent regulations defined in Annex 1, Nebula provides a valid means of guaranteeing excellent sterility assurance.