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A machine that comprehensively combines several types of robotics and technology. A machine that uses data for process control and optimization, as well as predictive maintenance. And which will be highly flexible for use in applications that have not yet been identified.
With this project, the medicines are no longer individually itemized but the system must be able to handle them all, from liquid to viscous, active- and high potent active ingredients, potentially sensitive to oxidation or aggressive, and possibly lyophilisates in the future, too. The medicines are both very expensive and of high quality. Therefore, yield functions such as refilling and redosing had to be provided, as did highly flexible processes. Three container types are definitely planned for the start of production. Pre-filled syringes, vials and cartridges in a total of ten formats – all of which should be delivered to the grippers and transport systems with virtually no work involving changing the format. Here, the solution is robotics: Systems from three manufacturers, including Optima, were installed, but without any kinematic information. All robotic functions were programmed and automated exclusively in-house at Optima Pharma, in other words united under a common control. The Acopostrak system has been used as an oval conveyor for the first time. Combined with a six-armed robot, Optima Pharma has developed an elegant solution that automatically compensates for any potential gaps that may arise from product rejects. This means that every tub is ultimately filled with the maximum number of 100 % tested pre-filled syringes. The same six-armed robot is also found at the beginning of the process chain for both removing the Tyvek foil and for denesting.
Thanks to centralized programming by the experts at Optima Pharma, all the robot systems are arranged on one level at the highest level of the control architecture. As a result, the integration of the robotics is completely transparent because there are no subsystems. This dispenses with interface issues and the "drawer-in-a-drawer-in-a-drawer..." principle. Here, the integration in the control architecture and coordination for the virtualization of the computer performance would barely be possible with third-party manufacturers. One example is predicting and programming the interception of processing errors to prevent them from propagating into numerous system sections. A system with subsystems would simply be pushed to its limits here. Another factor to consider is that it can already be seen that, in the future, multi-product systems will be adapted to new requirements more often. If the pharmaceutical company has only one contact in the area of programming, and this contact is responsible for all system areas, then the new functionality will most likely be just as efficient as the old. New certifications for changed processes from a centralized point are also simpler to realize than would be possible if they are decentralized.
Process Analytical Technologies (PAT) are included: More comprehensive process controls are used than before, but in particular, it is the recognition and evaluation of fluctuations and trends that lead to the greatest efficiency. Even a preview of wearing components can prevent unplanned system outages in the future. Features that are, to date, unique, such as the inspection of sealing surfaces on the mouth of the object, also enhance functionality. In addition, data for pneumatic pressure, temperature, and current consumption are continuously captured by sensors and evaluated. Trending and algorithm functions show, for example, if there are deviations in the wall thicknesses of flanged caps or a motor is beginning to wear.
The fact that this system offers maximum flexibility is also due to functions beyond the robotics. The first thing to mention here is the combi-fill module. Two peristaltic pump systems (for large and small volumes) and a ceramic rotary piston system for aggressive media are permanently installed in the system. There is also a system combined with a fill level sensor especially for cartridges. For format changes, just a few steps – primarily outside of the transport system – are enough, and after a decontamination cycle, the system is ready for new assignments.
With special start-up and empty run modes, re-dosing-onrequest, re-capping, and re- stoppering, the pharmaceutical company is able to use a medicine to the last drop. The system is also designed for the processing of high potent pharmaceutical ingredients. Among other things, a specific pressure zone concept, the washdown model, and an external washing machine for vials and cartridges are responsible for this. Robotics is the magic word for allegedly simple, flexible solutions. More precisely, cross-system programming, digitalization and PAT have been used to combine the robotics in one, highly efficient, complete system. Another welcome effect is the "breaking out" of a purely linear arrangement of functions. The machine layout results in many new possibilities for optimal usage of space. The system will be delivered to the customer in July 2020.
