One of the main responsibilities of the pharmaceutical industry is to ensure the quality and safety of its products, which is why rigorous controls at all stages of the production process have been implemented, in order to provide not only effective, safe and quality medicines, but also proof that they are effective and safe.

One of these processes is inspection, which plays a crucial role in carrying out these controls. This process can be carried out manually, by qualified personnel, or automatically, by machinery installed and qualified to carry out this process.

Compared to the manual inspection process, automatic inspection uses computerized and mechanized systems to carry out the inspection processes in an automated manner, i.e. without human intervention. This method offers advantages such as:

• Greater speed and efficiency when carrying out the inspection, which increases the overall performance of the production process.
• Increased accuracy and consistency, reducing the number of errors that can be made during the process.
• Saving resources by reducing the number of people involved in the overall process.
• Increased objectivity of the process as we eliminate biases that human inspectors themselves may have.
• Increased traceability, as the machinery stores data generated from the inspection process that can help trace products in the event of problems or defects at any stage of the supply chain.

However, despite the fact that the automatic inspection process can offer great automatic inspection process may offer great advantages over manual inspection, we must not forget factors that also However, we must not forget about factors that can also can also affect the the incorporation of these techniques to our process, such as:

• Initial costs, as both the machinery and its installation and qualification involve large investments.
• Related to this previous point, the speed of start-up, as the arrival of new machinery at a production plant involves carrying out processes that may delay the start of operations, such as the qualification or even hiring of personnel with previous experience dealing with the same or similar machinery.
• Difficulty in adapting to changes that may occur, both in terms of products and new requirements for an existing product. 

In addition, although part of the inspection process is indeed carried out automatically, the independence of the use of trained manual inspection personnel is not total: all automatic inspection processes require human verification to assess that each batch has been correctly inspected by the machinery, and that the machinery has not had any faults or maladjustments that could jeopardise the robustness of the process.

All these factors must be taken into account when deciding which method is the most appropriate. In addition, factors such as the volume of production and the type of product must also be taken into account when deciding between one type of inspection and another.

THE FUTURE IS NOW: IA AND THE INTERNET OF THINGS IN INSPECTION

Although automatic inspection machinery has great results and is, nowadays, widely used in production processes, it is still evolving. The companies in charge of providing this equipment are in continuous development processes to improve them, both in terms of operation and performance.

These improvements involve both the optimisation of existing functionalities and the incorporation of new technologies, which make it possible to increase the performance, precision and efficiency of automatic inspection, and can solve current problems such as the lack of flexibility when making changes to the equipment.

Some of the most innovative technical improvements that are being implemented in inspection machinery for the pharmaceutical industry are artificial intelligence (AI) and the internet of things (IoT).

As for the advantages of incorporating these improvements, their main function is to remedy current shortcomings such as the lack of flexibility in adapting to changes or the identification and classification of defects that until now could be overlooked in both automatic and manual inspection.

This is the case of the incorporation of AI machine learning mechanism such as ‘Deep Learning’, which has the potential to reduce the amount of false rejects produced by the machine by accurately identifying recurring patterns and/or deviations, and whose operation has already been tested in production lines.

On the other hand, we can also find equipment that employs IoT tools. The Internet of Things(IoT) involves the creation of a network of interconnected equipment and platforms, which allows the connection and exchange of information in real-time and facilitates management and monitoring tasks. In terms of its application within the inspection of pharmaceuticals, this tool can facilitate the collection and analysis of data from the process in real-time, which would allow us to improve the efficiency and effectiveness of the inspection.

PHARMA 4.0, WHAT TO EXPECT

The implementation of these types of tools, AI and IoT, among others, are a further step in what is known as the Fourth Industrial Revolution or Industry 4.0, which aims to integrate these new smart technologies into organisations, people and assets.

As we have already seen, the incorporation and development of these tools is already underway, and it is to be expected that in the future more and more equipment will offer us these tools. However, despite all the problems that these technologies can help to cover, the implementation and changeover to these systems must always go hand in hand with a correct execution of the installations of this equipment. As innovative as it may seem, and as much as these tools can offer, we must always take into account the regulations and standards of the pharmaceutical industry when working with new functionalities.

This implies that we must not only have the enthusiasm to always want to be involved in a process of continuous improvement, but also the willingness to carry out all the changes and the outlay that this entails so that our production process is in order.

Helena Gómez
Life Sciences Consultant at ALTEN Belgium