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- 12/04/2018

Pharmaceutical production and Industry 4.0: MG2 solutions for the maximum reliability

Chimica Oggi-Chemistry Today

Machines located in the most different places, which communicate thanks to a network connection by registering the production data in a centralized file to improve process performances as far as both efficiency and quality are concerned. Industry 4.0 is a technological paradigm which MG2 decided to integrate since 2009 to its production process. It makes it possible to collect production data of capsule fillers, by analysing them both under the historical aspect and in real time. By focusing on planned preventive maintenance, efficiency and production effectiveness, a watchful eye is always kept on the future. Internet, sensors and connected machines, cutting-edge experimental technologies such as increased reality and 3D print: at MG2 everything is aimed at being at the customer side. The above, but not only, is what Marco Bellentani, Product Manager and Validation Manager, is reporting us starting from MG2 approach to Industry 4.0.

“Starting from 90’s, MG2 has been cooperating with its customers to improve collection, analysis and sharing of production data to mainly evaluate both quality and efficiency of its machines working process. To MG2, Industry 4.0 particularly means machines network integration to customers supervision systems, by centralizing data collection thanks to safe protocols, thus guaranteeing their integrity. The wide data availability allows to carry out analysis to understand the process and improve it both as far as quality and efficiency are concerned. Network integration makes it possible for the machine to receive from the centralized system the necessary input information to start a new batch. Industry 4.0 also represents the possibility to create a connection between the machine and MG2 headquarters to start the remote assistance. Finally, to MG2 Industry 4.0 represents industrial internet, which allows to supervise production in real time, thus getting an exact picture of what machines are doing, both individually and as a group”.

Industry 4.0 and big data: how does MG2 apply this innovation?

Big data and analytics concept applied to MG2 turns into in the collection of production data by a massive approach from all machines: a unique centralized archive. The added value granted by the Big Data consists in the possibility of carrying out large-scale analysis for example on the last 6 months/1 year. There is the actual opportunity to either observe the trend or compare the performances of different machines to find the best one, analyse it and repeat it on all the other machines. To this purpose MG2 developed different software modules to communicate with the most different data filing systems such as ORACLE and Microsoft SQL Server”

What happens if the customer wants to have a picture in real time of the machine during production?

“What we are talking about is the monitoring in real time function, thanks to which some key process indicators allow to check the machines at any time, by connecting themselves to a mode being recognized all over the world as the standard industrial connection: the OPC Server. Contrary to large-scale analysis, monitoring in real time allows to focus on the present situation to be immediately informed on the system performances. In case any abnormality occurs, the operator is informed by means of an alarm code on the laptop included in the equipment. He can thus promptly react, thus allowing the machine to operate again in the best production condition as soon as possible. Big data and monitoring in real time are then meant to reach considerably different results”.

What is the customer approach in the analysis of data?

“Typically, our customer can run the data analysis in two ways. He can utilize the tool developed by MG2, which allows him to visualize advanced analysis, from any computer being connected to the network, by drawing data directly from either the machine or the centralized archives, but he can also choose to use independently his own archive by creating his own analysis, trends, diagrams, groups and comparisons. The latter is exactly the case of a multinational pharmaceutical German company which has been practicing this paradigm on different MG2 machines, also installed in different production sites, since before the existence of Industry 4.0. We are talking about the halfway the 90’s: they can be really defined as forerunner. In the year 2000, the same above-mentioned company also developed a WEB platform allowing to consult online the data collected from all machines. To MG2, these experiences come from far, boosted by customers who already were strongly conscious of the big potentialities aimed at better understanding both their own process and their information system. This made it possible for them to withdraw from a single datum to projecting themselves towards a wider perspective where they found MG2 as an open partner having the suitable competences for this purpose.

All the above principles are connected to informatic safety. What standard are put in place to protect data of both MG2 and its customers?

“Each connection function is designed to guarantee high information safety. Let’s think about the utilization of database being protected from external accesses, about the OPC industrial standard, which is recognized all over the world, and which last evolution, the UA OPC, introduces (differently from the previous versions) a better safety management with a high cybersecurity level: cryptography and advanced management of the profiles to access to the network. This technology is used both to provide information and receive information in real time. Of course, the receipt of information from the outside, for example to open a new batch, requires much higher safety and control levels to avoid that incorrect information reach the machine thus affecting the process. We also can offer a remote assistance service, included in the integration process between supplier and customer. In such case we utilize a safe connection, being in internet, in that we need to connect ourselves from our site in Pianoro to the machine in the production site which can be in India, Argentina, Australia, or anywhere. In this case we utilize the VPN technology, by creating via internet a direct and safe connection based on data cryptography between MG2 network and the customer network. Hence, we can talk about vertical and horizontal integration between the supplier and the customer, while clearly keeping in mind that we must observe connections safety.

How do you face data integrity theme?

“’Data integrity is an essential requirement to always have complete and available information. Integrity is ensured on the one side by the management and the control of the accesses to the machine, and on the other side thanks to the adoption of a database, recognized on a worldwide level, to register all information: MG2 chose SQL Server di Microsoft, a strong point, in that it is an industrial rooted technology adopted all over the world. This theme is naturally connected to the records management and the electronic signatures. MG2 machines comply with 21 CFR Part 11 regulation, which is the reference regulation for the pharmaceutical industry since the years 2000’s. Another important subject for the data integrity is data backup. MG2 applies the backup system integrated in the Microsoft SQL Server; data are then transferred to a centralized server of the customer, where the single files coming from the different machines are included: these files are created with a frequency which can be decided by the customer.

In terms of relation between supplier and customer what are MG2 benefits?
“An important aspect of the integration between customer and supplier, which has been an MG2 reality for more than 10 years is the online availability of both machine and spare parts documentation. If our customers need to send some information related to the machine, they connect to internet by means of a common browsing device, such as either a tablet or a mobile phone and they can consult the documentation, ask for quotations, forward spare parts orders, the whole of this by a simple click, under a guided mode, thus excluding any possible mistake. This is a particularly useful service also for sales agents, who can see all the documentation referring to the customers of their sales area, to see an overview of all the installed machines, but also to have a tool which creates a link between the agent and the customer. In real time, 24 hours a day, data are updated, available and they can be either shared or utilized”.

What does MG2 see in its informatic future?

“The cloud is a hypothesis for the future. It will be possible to collect in the cloud some non-confidential data coming from our machines installed all over the world. These data will be useful not only for MG2, but also for the customer. Under the producer point of view, the analysis of these Big Data will ease the continuous improvement process of the single machine models. As per the customer, it will allow a proactive approach regarding both maintenance and the performance improvement of the single machines.

This application, together with the others, such as the augmented reality and the 3D printing, will be projects for the near future”.