In the Pharma and Life Science sector, and in general in regulated environments, data integrity is an essential value. iFIX, the HMI solution developed by GE-Digital and supported in Italy by ServiTecno, allows IMA Active to have a single engine for the interfaces of the machines of its entire portfolio.

Pharmaceuticals, cosmetics, food, tea, coffee: the IMA group for 60 years – since 1961 to be precise – designs and manufactures automatic machines for processing and packaging of all these products, and today is undisputed leader In this compound.
The company, whose name derives from the acronym of Industria Macchine Automatiche, is based in the heart of the Packaging Valley, the advanced mechanics and industrial automation cluster of Emilia Romagna. Since the XNUMXs, IMA has achieved continuous growth thanks to operations on the market, but also and above all to constant research and development of innovative technological solutions that the market appreciates.

 

Flexibility and reliability as a value

For a company that unites organic growth and acquisitions (only in the last 2 years, between 2018 and 2019, the Emilian Group acquired 82,5% of Tissue Machinery Company, 70% of Ciemme, 60% of Perfect Pack, and took over the majority of Atop, leader world in the automation sector for the production of electric motors for E-traction) it is essential to be able to use a ecosystem of partners who are able to support the company in its proposal value added.

In the sectors to which IMA addresses there are many complexities and critical issues to be addressed – and very different from each other – and all of them must be given a solid and reliable solution, which guarantees the highest quality and compliance of the final product. For this the partners must guarantee IMA not only proven technologies, But also a high quality support and most importantly, reliable over the long term. Suffice it to say that customers often turn to IMA in the after-sales phase even tens of years after the original purchase, both for maintenance activities and for those "revamping" operations that allow these machines to stay in top condition. step with the continue technological transformation and to reduce downtime and operator training time less and less specialized. It is no coincidence that one of IMA's inspiring slogans is: 'Different markets. A single flexibility on a global scale'.

The pharmaceutical sector and the experience of IMA Active

in Life Science and Pharma sectors the Emilian company operates today with four brands: IMA Active, IMA Life, IMA Safe and IMA BFB.
IMA Active, in particular, designs, develops and manufactures machines for the production of solid oral forms, while IMA Life takes care of drugs liquids and lyophilisates.
In these areas "The times that mark the activities are often not short: everything must be planned and then proceeds in the order of months and even years", points out Marco Minardi, Automation Manager of IMA Active. “In our sector, for example, it takes more than a year between the order of the machine and the first product ready for the patients, especially due to the regulations that govern the sector. Vision, strategies and actions are therefore necessarily medium and long-term, and with a view to an expected life for machines and systems of 15 or 20 years, having and being able to count on solid partners is a very important value: in our case, such evaluations have a significant impact”.

In the past, the IMA Group used custom technological platforms for the various machines in the Pharma and Food sectors. Then in the pharmaceutical sector, the Emilian group made some acquisitions, including those of BOC Edwards, with plants in the Netherlands and the United States, and Zanchetta of Lucca, both companies that used the platform iFIX as an HMI solution.
Subsequently, the idea was born in IMA Active of creating a new HMI solution that could be used on all the machines in its articulated portfolio, which guaranteed brand recognition and a high standard of usability and interface solidity.
“With the continuous growth of the IMA Group, the industrialization of processes has become very important. Just to give an example, in our division alone we manage 28 families of machines for product processing and treatment, each of which has various sizes and a considerable degree of customization".

 

“When we choose the solutions to use for our automations, we always carry out a 360-degree, holistic assessment of the technology, the product and its resources: the specific technical potentials are obviously the basis, but the related services and long-term support Mark Minardi.

 

The choice of iFIX, the intelligent interface between the machine and the users

It is in this framework that the collaboration between the IMA Group, GE Digital and ServiTecno (a company that distributes and supports GE Digital software in Italy), reaches a turning point: after an intense process of analysis of the solutions on the market, In fact, IMA Active decides to focus on iFIX as a pillar to build the Kortex Max SCADA-HMI platform.
“The interface is the way in which the machine communicates with the operator: it is therefore a strategic element in the overall design of a product. It always has been, but it is even more so today, with the advent of mechatronics and the increase in the engineering complexity of machines. All these conditions determined the need to find an adequate, flexible and efficient product, which led us to choose iFIX as the technological basis on which to develop our platform which we called Kortex Max with reference to the concepts of 'cerebral cortex and maximum usability', which are two essential characteristics of the system”.

In the choice of the GE Digital – ServiTecno tandem, the assessment of the characteristics of the product and the profile of the two partners played a fundamental role. “In our choices – underlines Minardi – we look for both updated technology and the reliability of the supplier, its ability to support us, and what ServiTecno does is a fundamental value for us: it helps us to solve the technical and technological problems that inevitably arise they present following us in the various activities and this is for us a value at least equal to the technological specifications”.
And so today, within the IMA Group, the two divisions IMA Active (specialized in machinery and solutions for the production of oral solids) and IMA Life (specialized in the liquid drug sector), having partially overlapping characteristics and needs, are both standardized on the iFIX platform.
"The fact of converging activities on a single platform also allows us to manage resources in production peaks in a flexible way, allocating them dynamically on orders, precisely because of the choice of a common platform", underlines Minardi.

Without data integrity there is no product

There are several technical characteristics of iFIX that led IMA to choose it as the pillar of its operator interfaces.
The first, essential point to address when adopting a technology in the pharmaceutical field is the management of Data Integrity (see box). And here the experience accumulated by GE Digital in over thirty years of product development makes the difference. "In the Lifescience and Pharma world iFIX has always been a recognized and recognizable player, its reputation was therefore a tangible value", underlines Minardi.
In a regulated sector such as pharmaceuticals, the data is essential: “Without the data, the lot must be thrown away”Minardi effectively sums it up.

GE iFIX also integrates GE Proficy Historian as well, a process data historicizer appreciated by the market. “Proficy Historian plays a central role for the qualification of process data and for keeping track of Data integrity, of which data traceability is a part, for both regulatory and process engineering purposes to optimize parameters and improve quality and repeatability of operations”, underlines Minardi.
iFIX and proficy Historian also allow for good integration with the relational database and to contextualize the information collected and archived over time, also for the purpose of alarming production systems.
Another added value of iFIX is its modularity and adaptability in relation to machine and line architectures, characteristics which determine how the machines are offered to the customer in terms of integration with the plant floor and with the architecture of management systems. iFIX natively supports all the main standards in use in the pharmaceutical sector, thus making it relatively simple for IMA to propose a solution that integrates easily into all scenarios.
An example that goes in this direction is also the support of the Terminal Server architecture. “With the increasingly strong integration between the OT and IT world, the use of the Scada iFIX system in the Client-Server version with multiclient is functional and valuable, for example for customers who need to install our machines between two environments different or to improve general ergonomics”Minardi explains.
Since, as we said, IMA Active produces a considerable variety of solutions, another added value of iFIX appreciated by Minardi is the possibility of obtaining automation of the configuration of the Scada system: "As regards the generation of the interface for the single of machine, iFIX allows us to reflect the configuration chosen by the customer, automatically generating an interface that includes all and only the features that are needed”.

 

 

A look into the future

La caution and the guarantee of the final result in the pharmaceutical world they are fundamental and come before any innovation. The speed of adoption of the novelties must also be reckoned with delivery times ranging from 8 to 24 months. However, this does not mean that innovations are not evaluated, on the contrary. “We have a specific agreement with ServiTecno: at each iFIX revision they provide us with a pre-analysis on the impact of the changeover in our specific case; then follow test sessions, evaluation and verification of the various operational steps, and a verification of the real effectiveness of the updating and development of the systems". Although operating with longer timescales than other industrial sectors, e “since we can never afford mistakes of any kind, for which, as mentioned, operational caution must always be maximum, the renewal and improvement of systems and solutions is in any case on the agenda, both as regards the 'hard' technological components ', the machinery, the operational 'muscles' of production, both as regards the control and software part”.

The next step of this fruitful collaboration which continues to innovate and always guarantee, at the same time, maximum reliability, quality and compliance, will be a “further strengthening of the path with GE Digital and ServiTecno – anticipates the Automation Manager of IMA Active – for a collaboration that goes well beyond the final product, and necessarily brings together product and operational support in every phase and every evolution of production systems". Another possible area of ​​development concerns frontier technologies such as Data Analytics and Intelligence Artificial. “The IMA Group is also moving with interest and attention in this field: if there is an interesting product, we immediately take it into consideration”, remarked the Automation manager. “These are technologies and solutions that must be highly customized, according to the specific needs to be satisfied, and for this very reason the availability of the technological and digital partner must be total. The goal is always very concrete: we must give the end customer a very strong and tangible added value".

The qualities of data in the pharmaceutical sector

In a highly regulated production environment such as the pharmaceutical one, the quality and integrity of data are critical elements because they are closely related to human health.
La Data Integrity (data integrity) can be defined, in relation to data management, as the ensuring that a data set is handled correctly during the process of production and in relation to all operational areas (production, laboratories and warehouses).
To be considered complete, data must meet several criteria throughout its lifecycle. There Food and Drug Administration (the US agency responsible for controls on the food and pharmaceutical sectors) provides for the so-called ALCOA fee, an acronym that derives from the initials of the five qualities that i must have data collected that is to be Attributable, Legible, Contemporary (recorded simultaneously), Original and Accurate.
In addition have also been defined the CCEA criteria (or Alcoa plus), according to which the data must also be Consistent, Complete, Accurate and Recoverable.
It is evident that software technologies that natively support and manage these requirements in a standardized way (such as GE Digital's Proficy Historian) can be of great support in the system validation process.
GE Proficy Historian, for example, allows through its collector system to generate data records already associated with identifiers (e.g. product and lot) and time stamps (time stamps) and to send them, in a secure and encrypted manner, to the archiving server. The data record, once generated, cannot be modified except for codified procedures and is completely compatible with the reference legislation.

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