Robot-Assisted Sterile Processes in Pharmacy Drives for Use in Fill-Finishing Systems

Related Vendors

FAULHABER Drive Systems

SIMTOS (Seoul International Machine Tool Show)

With Azzurra, Pharma Integration offers fully automated systems for the safe production of medicines. Brushless Faulhaber motors enable precise and gentle filling and capping in a sterile environment. With their smooth design, they meet the highest hygiene requirements of the pharmaceutical industry and ensure reliable, error-free processes.

For medicines to be safe for patients, they must be manufactured, filled and packaged in a sterile environment—a demanding process that must run smoothly and efficiently. This is especially true for injectable drugs, such as vital preparations, where any delay or error can have serious consequences. Strict controls, specialized equipment and careful packaging processes must ensure the integrity and safety of these sensitive medicines.

Three Fully Automated Variants for the Fill-Finish Process

Medicines available on the market must be reliably produced and continuously supplied. This requires the right production and packaging systems. However, research and the production of small batches also require automated systems that ideally resemble real production as closely as possible in order to be able to make reliable statements about the quality criteria of the final products as early as the research and development phase. For this purpose, the Italian company Pharma Integration from Siena develops innovative systems for the fill-finishing process, i.e. the filling and closing of small-volume medicines. The Italian company's Azzurra filling system relies on fully automated processes in which robots take over all work steps instead of humans. This leads to precise and reliable results, offers absolute repeat accuracy and is also extremely productive. The compact, scalable system is currently available in three versions:

Gallery

Gallery with 9 images

• Azzurra Micro is a compact monoblock solution, i.e. all the important components, e.g. for filling, capping and inspection, are integrated in one module. Two robot modules are installed under an isolator, i.e. a closed protective environment with sterile conditions. This variant is ideal for small series production, particularly for research and development, clinical studies, personalized medicine and cell and gene therapies.
• The next largest variant is the Azzurra Small. It is also a monoblock solution under an isolator, but with four robot modules. It was developed for commercial production. The system offers the same level of automation and flexibility as Azzurra Micro, but with increased capacity.
• The third variant, Azzurra FAB, has been specially developed for longer production campaigns and is suitable for large-scale industrial production. The monoblock solution functions as a miniaturized cleanroom structure with four robot modules. Thanks to their flexibility and variability, the three machine variants are suitable for both niche products and mass production and adapt to the different requirements of the pharmaceutical industry.

Drives for Reliable Filling And Secure Capping

A lot is in motion within the system: The handling of tubs and nests, i.e. the special containers in which vials, syringes or cartridges are brought into the machine, requires drive solutions, as do various steps in the filling process, the subsequent capping of the respective vials and many other processes. Smooth, jerk-free transportation is required as well as high precision for the filling tasks and low noise levels from the drives so that employees in the surrounding area are not disturbed. At the same time, applications in the medical and pharmaceutical sectors place high hygiene requirements on the components used. Drives such as the brushless motors of the BX4 family from Faulhaber enable the movement and operation of various key components involved in the different phases of the fill-finish process. The drives are ideal for use in clean rooms or sterile production environments thanks to their smooth design, which avoids gaps and recesses where dirt could accumulate. The fact that the drive does not have any glued components is also an advantage under hygienically demanding conditions. A special drive variant with specifications for the medical sector is also available. The drives also impress in terms of reliability and service life. The drives also have extremely low vibration and noise levels. Faulhaber motors are also used to close the containers. In this important production step, they ensure that containers are closed correctly and consistently.

Environmental Monitoring System

In addition to the systems for the fill-finish process, the Italians also offer an environmental monitoring system (BioCapt Single-Use Microbial Impactor AutoM). This is a device for active airborne microbial sampling, which was specially developed for robot-supported production environments and is also used in the systems in the Azzurra series. The environmental monitoring system uses actuators to move plates for environmental monitoring, which is critical to maintaining sterile conditions in pharmaceutical manufacturing.

The powerful Faulhaber motors ensure reliable movement in all the areas of application described and thus make a significant contribution to the overall functionality of the Azzurra system. Their compact size and precise control options, for example with the MC3603 motion controller (Fig. 5), enable several critical processes to be realized efficiently within the limited space of the machine. This makes the system powerful and reliable all round.

Additive Manufacturing in production processes

New Methods, Breakthroughs and Applications