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Integration between robotics and isolators for safe and waste-free drug production
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Integration between robotics and isolators for safe and waste-free drug production
by Alessandro Bignami
The flexibility and safety of the pharmaceutical process are the guidelines by which Steriline’s most advanced technologies are gaining ground, including for example, the integration between robotics and isolators. To understand more about the advantages and potential of robotic solutions and sub-insulator lines, we interviewed two technicians highly specialized in these technologies at the company’s headquarters in Como, Italy. Mario Fusi is the Director of Design & Technology and Roberto Campagnoli is the Robotic Software Engineer at ISS (Innovative Security Solutions), a spin-off of the Polytechnic of Milan, located in Lomazzo (CO) and controlled by Steriline, a company consolidated in the production of complete lines for sterile filling of injectable products serving pharmaceutical companies around the world.
What requests do you receive the most from robotic technology users?
Roberto Campagnoli: “The main factor is the great flexibility of production. Robotics can meet extremely specific needs. Customers are fascinated by the functioning and potential of robots, but they still know little about them. This does not surprise me, considering that they have been used in the pharmaceutical industry for no more than 15 years. Therefore, it is important to explore with industries the possibilities that this technology offers, also looking at future needs. With robots, it is possible to program large production cycles aimed above all at reducing processing waste: an absolute priority for pharmaceutical companies, which sometimes deal with expensive and high-value products. In fact, the possible repeatability of operations is highly appreciated, which in case of errors are automatically repeated without incurring product waste. It should also be remembered that the robot can modify some parts of the machine to accommodate a change in shape. ISS and Steriline are even developing a project that provides for the automatic assembly and replacement of volumetric pumps in an aseptic environment.”
In the area of isolators, what are the most common needs?
Mario Fusi: “The trend is first and foremost to install complete production lines under an insulator, with the consequent increase in demand for our solutions. The main objective is to minimize the effects of human intervention in the processing of the drug, starting with the risk of contamination. The integration of the isolator with robotic technology allows us to create a protected environment with practically only the presence of an external operator. The result of this decrease in interaction between person and product ensures greater safety for both and consequently a better quality of the product, as required. The issue of safety for operators is increasingly central and challenging, since the treated products are in many cases highly active, or involve viruses or hazardous substances processed in research laboratories.”
You are achieving significant results in the area of gene and cell therapies. What are your peculiarities from a supplier’s point of view highly technological like Steriline?
Fusi: “These are high value-added applications for small batches and limited and customized productions. The installation of an isolator simplifies first and foremost the design of the environment where the processing takes place, since it allows, up to class C, not to have to work in a clean room, avoiding the complications that this entails in the management of a site. In addition, installation and testing operations are greatly accelerated. In fact, in a few hours the internal sterilization of the equipment is carried out mainly through the use of hydrogen peroxide steam or other solutions that are slowly established. The ease of cleaning and sterilization of the isolator allows for quick and safe exchange of the product to be handled, avoiding risks of cross-contamination. These are all important characteristics not only for gene and cell therapy lines, but also in high-volume lines. In small productions, it is above all the robotic part that really makes the difference.”
For what reasons, above all?
Campagnoli: “Firstly, because robots allow complex manipulations and safe management of very expensive products, where waste must be reduced to a minimum and the container and the final medicine must be safeguarded. Due to their flexibility, robots prove to be optimal solutions, for example in the case of productions that require limited volumes and use RTU (Ready-To-Use) containers, for example in the laboratories of research centres and large industries. From the management of the pre-sterilized container, in this case all operations take place within the equipment, automatically, without the need to integrate it with a Washer or a depyrogenation tunnel”. Fusi: “The integrity and aesthetics of the containers are also fully preserved. For example, scratches, marks and imperfections on glass bottles are avoided, since there is no friction between them. There are countries, such as Japan, where even an aesthetic defect of this type, perhaps almost imperceptible to others, is not accepted and leads to the disposal of the product”.
Insulator-integrated bottling line for high production volumes
How does the integration between robot and isolator happen?
Fusi: “First of all, we need to develop a global machine concept from the perspective of the requirements of the pharmaceutical factories where it will be installed. From a mechanical point of view, the robot must be able to reach all the points required by the application without ever ‘covering’ the process areas and open containers, since the products must be reached directly by the filtered air that guarantees their sterility. In this case, the 3D simulation helps to understand, with more than 95% fidelity, what the robot’s movements will be.”
Is the revision of GMP Annex 1 for the production of sterile medicines driving the demand for your Isolators?
Fusi: “The effect on the increase in demand is undeniable. The revised Annex 1 is an important step because it puts an end to practices that have hitherto been, at least in some cases, tolerated. Operators’ access to machines must now comply with much more restrictive rules, also for RABS. This leads to definitively overcoming resistance to insulators, which were seen as less accessible and limiting freedom of movement. Given the same working conditions, the insulator remains the safest and most advantageous solution at the moment, even if it requires a greater initial investment”.
What do you think will be the next technological steps for robotics and isolators?
Campagnoli: “Robotics, in reality, is a recent technology that still has a lot of potential to be explored. The challenge will be to bring it to machines and applications that are even more complex than those created so far. At ISS we also focus on the instrumentation to be implemented in conjunction with the robots. I am thinking, for example, of visual inspection systems with cameras, which allow you to make another leap in quality in production control, being able to see in real time, for example, the level of the liquid inside the individual syringe or the position of the caps on the bottles. Once again, the goal is absolute ‘zero waste.'”
Fusi: “Visual inspection will certainly have an important impact also in relation to the insulator. This, in turn, will lead to less and less physical involvement of the operator. We are already thinking about insulators without gloves and, therefore, without any human intervention. On the procedural side, much work is being done to optimize sterilization cycles, which must be increasingly safe and shorter, especially in continuous and mass production, where speed is a crucial variable.”
Did Covid leave any signs?
Fusi: “During the pandemic, times were so difficult that the general preference was for the installation of RABS. But now that delivery methods have more or less returned to normalcy, pharmaceutical manufacturers almost always opt for the isolator. This confirms that this is an important technology trend and destined to further drive Steriline’s growth.”
In October last year, STERILINE participated in the CPhI Barcelona fair. Commercial director Federico Fumagalli expressed himself positively about the experience: “We can say that we are definitely satisfied with the quality and quantity of customers served in Barcelona. The level of visitor participation has reached or even exceeded that of other major trade fairs typically held in Germany.”
In the specific field of insulators and technologies, Fumagalli explains that “orders are now coming in for complete filling lines in insulators from all over the world. Demand in the Middle East is increasing significantly, both in terms of the number of offers and in terms of the quality of the machines ordered. For robotic applications, the greatest interest comes from more mature markets, such as North America and Europe, but also from advanced Asian countries, such as South Korea and Taiwan. In 2023, orders received from North America are almost exclusively for robotic applications!”
What is less effervescent at this stage, stresses the manager, is the European market “due to the large investments made in the Covid period to increase vaccine production capacity, but also due to inflation and high interest rates”.
From a technological point of view, Steriline’s solutions continue to point towards the goal of zero waste. “Talking to some customers, it was found that the value of the single bottle sold, produced by machines with this philosophy, is extremely high: we are talking about tens of thousands of euros”, specifies Fumagalli. “Therefore, each bottle reprocessed by the machine, instead of being discarded, representing, therefore, a cost, assumes an important value that can be translated into revenue”.
Interesting prospects, even at the national level, are offered by the market for CGT, gene and cell therapies, which are increasingly used against diseases such as cancer and rare pathologies: “In Italy, the CGT sector is growing. As far as the outside world is concerned, we have already received a good number of requests for this type of preparation from both Europe and North America. These are robotic applications in insulators with a high degree of automation.”
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