Pharma 4.0 is not only about serialisation
24/01/2019 Rockwell Automation
Recently we have seen great changes taking place in the pharmaceutical sector. Despite a particularly complex normative system, this is proving to be one of the sectors that has reacted best to the challenges of digitalisation.One example of this dynamic approach is Molteni Farmaceutici, which has found the ideal supplier in Rockwell Automation to support it in the process of development and to help take it into the age of Pharma 4.0.
The history of Molteni began in Florence back in 1892, when Alfredo Alitti, a pioneer of the pharmaceutical industry, founded a company that was destined to become a giant, specialising in pain therapy, anesthesiology and the treatment of addictions.
Vocation for innovation
Tiziano Petrucciani, Quality and Technological Development manager of Molteni Farmaceutici, tells us about the company's vocation for innovation, starting with the site in Scandicci, the company's flagship production plant. "The Scandicci factory, just outside Florence, is Molteni's headquarters. It was opened in 1962 and is the site where all the production is carried out, with manufacturing processes fully complying with Good Manufacturing Practices (GMP). The pharmaceutical forms produced at the factory in Scandicci are essentially sterile liquids packaged in glass phials and plastic phialoids, oral solutions in glass bottles, nasal spray solutions and topical forms in aluminum tubes (anesthetic gels)."
Over time, the factory has been equipped with highly automated production plant and IT systems able to manage, monitor and control the process, but what drove Molteni to invest in innovation? "The springboard was the need to increase process efficiency and effectiveness, but entry into Elite, issue of the Basket Bonds and the recently approved Industrial Plan, also played an important role. Mandatory normative compliance can become an incentive.
"It is a known fact that we operate in a highly regulated sector," he continues. "In addition, since Molteni handles mostly products based on narcotic active ingredients, it has to constantly align its procedures to ensure compliance of the Quality System within the requirements of Good Manufacturing Practices, with the procedures for managing narcotic products, in compliance with the national regulations (Presidential Decree 309/90 and subsequent amendments and additions) and international regulations on these types of products. A lean approach is always possible however, even in a sector where transformations are slow due to the very nature of the production processes. But the key to implementing all this is employee training. Without this, transformation at the operating level would be practically impossible."
From IT to OT, the technologies equired
Some of the Industry 4.0 technologies have proved more useful than others in dealing with the particular criticalities of a production system like that of Molteni.
"Recently, we integrated all the main company processes in the new SAP ERP system, giving the Molteni system greater robustness and safety. We also invested extensively in company compliance and re-engineered the company processes, and in April 2017 we obtained renewal of the ISO 9001 certification in compliance with the new 2015 regulation.
"Many important Industry 4.0 investments have been made in the Manufacturing and Quality areas," he continues. "For example, we have introduced a "safe" centralised management system for the data generated during the analytical Quality Control processes and a packaging line supervision system based on SCADA and on software for logging and processing the data coming from the production lines.
"One of the most important investments for Molteni," he adds, "has been the investment aimed at meeting the standards imposed by the new EU Falsified Medicines Directive. This was when we began working with Rockwell Automation, who proposed a solution based on the modular Rockwell Software® PharmaSuite® platform, comprising a dedicated module for managing serialisation."
Serialisation and anti-counterfeiting
The EU Falsified Medicines Directive establishes that by February 2019, drug manufacturing firms must apply on every package, verify and transmit the unique identifier, printed both in alphanumerical and coded form in a two-dimensional Data Matrix code. The Marketing Authorisation Holders will also be required to send the serialisation data of their pharmaceutical products to the database or European Hub.
The Rockwell Automation solution supported Molteni in achieving this type of process, which includes, among other things, a constant exchange of data between the machines, the production lines and the site's software platform, which manages the production lines and also between the site of the Marketing Authorisation Holder and the European Hub.
"The PharmaSuite MES platform supplied by Rockwell Automation for managing the pharmaceutical packaging serialisation system at the factory in Scandicci, is modular, flexible and scalable," explains Petrucciani. "It not only handles contingent needs relating to the European drug serialisation regulations, but can also support further technological developments. The introduction of this type of platform has obviously entailed extensive enlargement of the company IT infrastructure, which is now able to support complex processes."
PharmaSuite offers a complete solution that includes both interfacing with the production devices, and communication with the central repositories of the authorities, defining an architecture composed of five levels: Unit controller (level 1), Line controller (level 2), Site controller (level 3), SAP-Sms (level 4) and the Central database (level 5).
"Thanks to the IT upgrade and the interfacing of the MES platform with other company systems - such as the new SAP management system - and the system for editing and centralised management of packaging line label layouts, we believe we have laid the foundation for a number of very important future technological developments, in collaboration with Rockwell Automation. We already have some ideas in the pipeline. Two examples are the introduction of a new Manufacturing Intelligence system for monitoring the efficiency of the lines (performance analysis with KPI, production monitoring, maintenance management) and the Electronic Batch Record."
Implementation of the pilot line
The serialisation process in Molteni Farmaceutici involves three packaging levels: cartoning machine, case-packer machine and pallet package. The pilot project for the implementation of PharmaSuite was carried out on Line 12 for secondary packaging of Nasal Spray products.
For more information, please contact:
Rockwell Automation Ltd
Elena Popova - Marketing Communications UK and Ireland
Tel: +44 1908 627889
Email: EPopova@ra.rockwell.com
Web: www.rockwellautomation.co.uk
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