In the upcoming years, Digital Transformation will allow companies to gain market leadership and to be increasingly proactive towards international customers. Digital Transformation must necessarily consist of a Business Process Analysis and Reengineering, an Organizational Change Management, an IT infrastructure reorganization and a proper KPI setup. This is the challenge” says Edoardo Collalto – CEO, K2innovation.

DIGITAL TRANSFORMATION FOR LIFE SCIENCE & PHARMA 

The opportunities that digital transformation can hold for life sciences organizations are manifold, from improving financial operations, supply and production chains, to developing new products and services, to engaging in a different way with customers and patients. While many companies have begun to explore the benefits that digital technologies can offer, many still have to make consistent, sustained and bold moves to harness the new capabilities. Only about 20% of biopharmaceutical companies are digitally maturing. Companies that are further ahead differ from those in the early stages of digital maturity in how they apply digital, improve know-how, collaborate and facilitate change. More mature companies adopt the BIM approach to manage the design, development and subsequent maintenance of new plants or the most important revamping.

VIRTUAL FAT (FACTORY ACCEPTANCE TEST)

Remote virtual validation is a very important application. Here, Fedegari’s team of engineers is physically on the site where the production system will be installed visualizing the machine or system in a virtual environment. Fedegari’s team stays on-site and connects to the customer location. People can then virtually join without going to the physical installation site. This allows more experts to analyze the product and eventually the process while reducing the time and costs associated with traveling and other physical visits expenses.

AR FOR VALIDATION, MAINTENANCE AND TRAININGS

AR is also applicable to virtual validation. Instead of navigating in a completely virtual environment,  it superimposes virtual elements onto the real-world environment,  allowing the user to check and anticipate any insertion and connection discrepancies. Therefore, this technology is more applicable to virtual validation when a combination of simulation and sensor data is superimposed on a real-world manufacturing system.  The information that technicians need to repair a machine can be projected directly onto the part they are dealing with. This speeds up the maintenance process, eliminating the need for the technician to consult instruction manuals and tables. It also guides the technician through the procedure, reducing the likelihood of errors and helping to train inexperienced staff members. By incorporating virtual validation with AR, engineers can walk along the physical and real production floor and observe a large amount of augmented information from their simulations.

ABOUT FEDEGARI

Over the years, Fedegari has diversified its production, developing customized solutions up and downstream of its sterilizers, bio-decontamination units, isolators and washers for the bio/pharmaceutical market. A unique characteristic of Fedegari is the extreme verticalization of the company, which has always refused the idea of assembling sophisticated process machines with standard components (COTS) designed for multiple applications, building everything in-house. This has allowed, after many years of field experience, to control technology through in-depth knowledge of the machines and processes and the constant innovation of its products. Today Fedegari delivers turnkey solutions, assisting the customer from the design phase to the validation of the process itself.

ABOUT K2INNOVATION

K2innovation is a privately owned consultancy firm, incorporated in Italy in 2011. It brings more than 20 years of experience in analyzing product development and manufacturing processes for world-class companies and leading Product Lifecycle Management (PLM) projects with different technologies. K2innovation is independent, not affiliated to any software vendor and has extensively worked in several industry segments, from aerospace & defense to automotive, from industrial equipment to fashion & retail with customers like Avio, Benetton, Bottega Veneta, Bticino (Legrand Group), Bvlgari Accessori understanding and improving their industrial processes. K2innovation has all its offices in Italy, the headquarter is located in Torino and its branches are located in Milano, Firenze and Jesi.