A new microdosing machine is a high-tech solution for filling cytostatic powders into vials
The recently launched robotic microdosing machine, the Macofar MicroRobot 50, is specially designed for filling potent and cytostatic medicines, for example for treating cancer and auto-immune diseases. The technology is particularly suited for dosing sticky or hygroscopic pharmaceutical powders with irregular shapes. It can also be used to fill sterile liquids. For high containment applications up to level OEB 5, it can be supplied with isolator technology. Alternatively, it can be configured with cRABS or oRABS for non-cytotoxic products.
During the production process, three anthropomorphic robots transport the vials under an isolator to the dosing, stoppering and capping stations. Since the robots work independently of specific formats, the product change times are significantly shorter. The servo-driven transfer system generally reduces the concentration of particles in critical areas and with it the risk of contamination. Furthermore, thanks to the clearly structured system concept, the MicroRobot 50 is readily accessible and easy to clean. The robotic grippers can be equipped with cleaning guns in order to validate the cleaning processes.
This new filling technology weighs each vial individually twice
The new solution achieves a maximum total output of 50 vials per minute including 100% in-process weight control; in other words, each vial is individually weighed both before and after filling. If necessary, the filling volume is adjusted automatically. Numerous control systems ensure a reliable process and a very low waste rate with these high-priced medicines. If a stopper is missing, for example, the filled vial is fed back to the station in question, where the process is repeated, rather than simply removed. The same applies to missing caps; in case of missing rubber stopper/alu cap, the robot will go back to stoppering station/alu capping station to correctly close the vials, reducing rejections.The remaining quantity of the batch has been reduced to a minimum in the dosing station, so that product loss is virtually zero.
The ultra-compact machine is less than 4m long and was designed with ergonomic principles in mind. All product contact parts are extremely small and lightweight. The use of components that are easy to remove and install was likewise a development priority. Access to the machine is via glove ports and RTP systems. The isolator features a built-in VHP generator for bio decontamination.
This is the first Romaco Macofar robotic filling and closing machine specifically designed to fit under isolation technology.
It equipped with two closing stations, the first one for rubber stoppers and the second one for alu-caps. It also offers maximum accuracy when handling higroscopic powders.
There is a high level of inertisation thanks to gassing points located on the robots’ arms, in the powder hopper and in the filling needles.
Washing can be performed by means of robot, creating a validated cleaning process.
Filling technology feedback
The MicroRobot 50 unites the powder expertise of Romaco Macofar with Truking isolator technology. This robotic microdosing machine represents the first joint development project by the two pharmaceutical machinery specialists from Italy and China. Feedback so far has been altogether positive: orders for the MicroRobot 50 have already been received from two Asian pharmaceutical producers.