A key focus of the pharmaceutical market today is to achieve even greater flexibility during production. Xtrema is the answer that IMA Life gives to the world of aseptic filling. Its design features a great flexibility offered thanks to the integration of modular equipment, providing the adaptability and customization that pharmaceutical companies need when developing new production concepts

Monica Cervellati

State-of-the-art constructive details coupled with consolidated and worldwide re-known filling technology, make the New Xtrema Series the latest technological breakthrough in aseptic filling. Designed with a modern modular concept, Xtrema gives the possibility to actively manage the production process, by tailoring the different machine phases to the actual production needs. Xtrema F2000 is an in-line filling & stoppering machine with continuous motion positive in-line transport system.The machine is suitable for filling liquid solutions into cylindrical vials and for insertion of rubber stoppers and can handle all vial sizes in the SVP range: from 0.25 to 100 ml. Xtrema, in its top of the range version, features a dual potential with the possibility of selecting the vial transport motion according to the productive needs of the moment: the machine can move at continuous motion with a very accurate 100% IPC of all vials filled at the highest speed available on the market: 400 vpm. The selection from continuous to alternate motion is automatic by HMI. The transport system is linear and positive and allows the treatment of vials in “multi-pocket dowels”, which allocate several vials, reducing, in this way the number of dowels to be changed over. To fulfil the latest cGMP regulations and requirements for isolation integration, all mechanical movements should not come in-and-out the grey area, in order not to contaminate the product being processed and to reduce the risk of leaks. The IMA Life anthropomorphic robotized nozzle carrier fully responds to this design requirement similar to the human body motions, the fluid of the movement ensures as well, no vibrations and gentle handling of the vials. The Total IPC system for distributed volume is based on the dual potentiality offered by the machine to fill at high-speed and simultaneously achieve 100% check-weighing sampling, in the same batch, still at 400 vpm. The IPC system removes the vials in batches from the conveyor system for tare and gross check-weighing and then feeds the vials back into the empty dowels. If a deviation in the filling volume is detected, the PC feedback software automatically adjusts the filling volume. The Total IPC Check is of course also available on the intermittent motion machines up to 400 vpm. A so called Periodic Check can also be achieved, on this machine version,when it’s necessary to check only a pre-defined number of vials (typically at batch start and at batch end). The number of vials to check is entered directly on the HMI. During the rest of the production the machine works at the highest speed. A Statistical IPC is available on the continuous motion machines. In this case the machine carries out a vial sampling by removing one vial at a time and feeding it back after the check-weighing.  During the weight detection the machine moves at the highest speed.