Automation Robotics: Tool for The Medicine of Tomorrow

A guest post by Federico Fumagalli*

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The introduction of robotics into manufacturing plants benefits both products and staff, delivering greater operational flexibility, safety, quality and process efficiency compared to what traditional mechanical solutions allow. However, the price to achieve this is a reduction in production rates.

Steriline's robotic nest filling machine.
Steriline's robotic nest filling machine.
(Source: Steriline )

The industrial robot is a fully programmable mechatronic component with an extremity that can be moved within a specified working volume, allowing it to assume an arbitrary orientation. Because of this ability, in analogy with what the human arm does with the hand, industrial robots are often called ‘arms’.

In this context, ‘component’ means that the robot can be purchased on the market ready-to-use, while ‘programmable’ means that it can perform any task described by the software through its programming language. However, this higher flexibility comes with lower speed in terms of achieving output targets. Robots can take longer than humans to handle and adapt to materials (syringes, vials, bags, cartridges, etc.) or use them in the required combinations. The limits of robotic production capacity are even more marked if compared with the limits of standard mechanical solutions.

Flexibility is given by the introduction of external sensors that gather information from the field in real time; this is very important for developers who write programmes that allow manipulators to react autonomously according to the inputs they receive, for example if the production cycle changes or non-conformities are detected. These features are obviously lacking in standard solutions.

The external sensors mentioned above are primarily the cameras that can capture images of the operating environment. These images, processed with appropriate algorithms, allow the robot to perform complex tasks such as picking up single parts from a pile rather than detecting the conformity of the grasped part. In addition, MEMS (Micro Electro Mechanical Systems) sensors, made with techniques typical of the electronics industry, allow for real-time monitoring of many physical quantities at a very low cost and in limited dimensions.

The above is generally true for automation in manufacturing and therefore, albeit with some important differences, in the pharmaceutical sector.

Robotics in the pharmaceutical context

The peculiarities of the pharmaceutical sector are linked to the need to use strict and monitored operating procedures in a clean or sterile environment. Robotics, integrated inside isolators, is the safest processing and containment solution available for the pharmaceutical market and Steriline has been a pioneer in these kind of applications since 2014.

Industrial robots allow process improvements in the pharmaceutical sector, dealing with the most varied tasks as they can be directly involved in some drug-production operations. Above all, they are used in primary and secondary packaging operations.

In order to be used in primary packaging, especially when operating in the presence of drugs that have not yet been packaged, robots must guarantee a very high level of cleanliness and sterility as required by cGMP to ensure product quality.

This means that, first of all, they must have ‘cleanroom’ characteristics, i.e. they must be designed in such a way as to not release any contaminants into the environment. Furthermore, they must have smooth and easily sanitized external surfaces, with no roughness, edges and protrusions in which bacteria could attach and proliferate, for example.

Finally, when robots are called upon to operate inside isolators and therefore in totally sterile conditions, their external surface must be resistant to decontamination treatments, which are usually very aggressive. Specifically, it is about resistance to vaporized hydrogen peroxide (VHP), intense UV radiation rather than high temperature given by moist or dry heat sterilization.

The robotic systems find their natural positioning in the medium productivity range, especially if products are changed frequently.

If the robots are appropriately programmed and the machine is properly designed, product changes can essentially be managed automatically, with obvious advantages such as reduced set-up times, the maintenance of sterility within the plant and therefore machine downtimes.

However, it should be emphasized that the introduction of robots is only a necessary condition to obtain the results described, as an inaccurate design and approximate programming can completely nullify the advantages.

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The above is very important and serves as a warning that robots are a necessary but not sufficient means to achieve the much-needed flexibility that is introduced into the system only as a consequence of adequate design and programming.

The robotic vial filling solution under isolator.
The robotic vial filling solution under isolator.
(Source: Steriline )

Sensors to gather information from the field

While robots can change their behavior based on an external input (for example the production recipe), it is far more interesting that they are able to change their behavior in real time based on inputs coming from the ‘field’. These inputs are collected directly by sensors capable of monitoring the production process and providing the robot with the necessary information so that it can appropriately modify its behavior. The sensors involved are vision sensors and gravimetric measurement systems.

The vision systems are responsible for verifying that the parts that the robots must grasp are correctly positioned but, above all, they allow process monitoring to guarantee compliance of the parts. They check that the container is intact before being filled, that the cap has been inserted correctly, that the capping process guarantees the seal of the container, etc. In Steriline’s Robotic 3D Control Picking Solution for example, a combination of 3D vision sensors and an Infrared Stereoscopic vision system detects the position and the orientation of caps, allowing the robotic arms to autonomously generate the best trajectory to pick them up correctly.

Gravimetric systems, which are nothing more than weight scales, verify that the containers are filled with the right quantity of drug, remaining within the allowed limits.

Vision systems and gravimetric sensors represent the basic sensors that enable a robotic machine to react to non-compliance without requiring operator intervention. This is of course true only if the appropriate action plan has been included in the design phase and correctly implemented in the software programming phase.

Federico Fumagalli, Chief Commercial Officer at Steriline.
Federico Fumagalli, Chief Commercial Officer at Steriline.
(Source: Steriline )

Accurate and flexible manufacturing systems for customized therapies

The adoption of robotics throughout the pharmaceutical industry is growing. One of the reasons is that Advanced Therapy Medicinal Products (ATMPs) are growing exponentially and so is the need for extremely accurate and flexible manufacturing systems. Robotics meets both requirements, making robot deployment preferable to more traditional aseptic fill/finish systems.

Indeed, customized drugs cannot be produced by standard mechanical systems. That is why the most common solution currently is to manually produce these drugs, which are required in particular by oncology therapies, starting from standard packs, directly in hospital pharmacies. However, this is a significant commitment as it means transforming hospital pharmacies from logistics centres to production plants.

Robotics, assisted by numerous sensors, currently represents the only possibility for effectively meeting this need, which is characterized by unit batch production with the doses that will be prescribed each time by medical personnel, creating infinite recipes to prepare more accurate individual drugs.

This is the case of Steriline’s Intelligent Compounding System, a software-controlled system that compounds patient-specific or batch intravenous medication doses into the appropriate final containers in a controlled environment. It is based on isolator technology and includes a bio-decontamination system with vaporized hydrogen peroxide (H2O2) sterilization technology and state-of-the-art automation and robotics.

A challenge to overcome: awareness and training

A big challenge to overcome in the past five years was raising awareness inside the industry of the availability of developing technologies to assist with process automation in compounding environments. The workforce needs to gain knowledge and become familiar with these kinds of systems to work comfortably with them. The staff must gain a deep understanding of the system and how it works.

Robotics is quite a new approach, especially for compounding centres, where trust needs to be gained. Hence, one should begin by educating the people so that they can appreciate the purpose of robotic automation and, once they believe in its purpose, they can become more familiar and comfortable with it.

A lot of the workforce today is becoming more aware of this kind of automation, so hospitals, compounding centres and manufacturers all share in the responsibility to provide the staff with dedicated training so that they can gain the appropriate knowledge.

* The author is Chief Commercial Officer at Steriline

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