What does modularity offer in the digitization of industrial production?

Dividella is working with Medipak Systems sister companies to find new answers to the question of what does modularity offer in the digitization of industrial production.

Digitization, including the use of big data and interconnectivity has considerable potency in generating sustainable competitive advantages for the pharma industry, particularly in embracing Industry 4.0 design philosophies.

However, to take maximum advantage of ‘smart’ technologies means embracing a modular approach at every level from design concepts to engineering, construction and processes. This is essential to fully exploit the connectivity and data-sharing that are inherent parts of the Industry 4.0 concept and its Pharma 4.0 derivative.

Modularity in the digitization of industrial production

Essentially, modularity offers advantages in the move to digitized pharma production by promoting greater interconnectivity, interoperability, data-sharing and information transparency, allowing much higher levels of technical support and decentralized decision-making.

Dividella is part of a wider modular Medipak Systems group ecosystem of related skills and competences in which Dividella combines process and machinery expertise with Rondo, Werum IT Solutions, Fargo Automation, Mediseal and Seidenader, using latest information and communications technologies. This concerted move towards a digitized Industry 4.0 future provides a wider range of innovative solutions on materials and packaging together with easier upgrade and expansion paths.

Industry 4.0

Industry 4.0 is the fourth revolution in production, following on from mechanization, mass production and computerized automation. It describes the adoption of data exchange and artificial intelligence (AI) in manufacturing technologies leveraging ‘cloud’ stored data, cognitive and cyber-physical computing and the Internet of Things (IoT).

Industry 4.0 creates smart factories that are structured on modular lines, employing cyber-physical systems to monitor physical processes, creating virtual models of physical processes and decentralizing decision-making. Cyber-physical systems can intercommunicate in real time over IoT, allowing participants to offer and share internal and cross-organizational services across the whole value chain.

To harness Industry 4.0 advantages, solutions must obey four basic principles:

1. Interoperability: As devices, sensors, platforms and people become increasingly able to interconnect and share data via the Internet and IoT, it becomes possible to add further levels of automation. Interoperability depends on modularity.
2. Information transparency: The ability of information systems to create virtual models by combining digital plant systems with real time sensor data to create higher-value content. This requires interconnectivity, a further benefit of modular design.
3. Technical assistance: both in ability to aggregate and visualize information to solve urgent problems and also create cyber physical systems that can take on problematic tasks.
4. Decentralized decisions: Cyber physical systems that are able to make decisions and perform tasks autonomously, only delegating to humans in exceptional circumstance.

Pharma 4.0

“Pharma 4.0” applies Industry 4.0 concepts to revolutionize and transform the pharmaceutical industry, from outflowing goods to feedback of real-time patient data. It is part of an overall trend to more individualized therapies that creates ever-greater need for quality data and diverse formats. With this comes more pressure to make smarter use of data to avoid production bottlenecks in a Just in Time (JIT) world.

The trend towards personalized therapies requires a shift from in flexible mass production to manufacturing individually tailored products. This transformation depends on changing the perception of data and content in three main areas:

• Moving away from paper: Many so-called ‘state-of-the-art’ execution systems still rely of paper-based processing for GxP record keeping. Pharma 4.0 means handling GxP- compliant documentation as data in new electronic formats.
• Merging data: GxP relevant records will increasingly be defined by application, making the differentiation between GxP or non-GxP less relevant and requiring greater security for non- GxP areas.
• Global collaboration: The goal is to free content and data from company silos to allow them to be securely shared among virtual teams that can be quickly changed and reconfigured.

Dividella modular and digitized solutions

Dividella presented several Pharma 4.0 solutions at Interpack 2017 in Dusseldorf.

Smart Device: A Dividella NeoTOP x TopLoad syringe packaging machine was controlled and monitored remotely via a Smart Device. With the aid of the device, multiple production units can be scheduled, coordinated and controlled in parallel. The solution, based on HTLM 5, is compatible with all systems and mobile terminals.

Condition Monitoring & Predictive Analytics: Dividella also presented a prototype solution for remote monitoring status of the NeoTOP x, using data captured in real time and applying algorithms to generate forecasts in which critical changes are predicted/detected and corrective interventions scheduled before failures occur.

Smart Packaging: Product personalization and product security can be taken to new levels using smart communication of the pack with the patient and communication with the machines in the production process. In addition to the actual product, consumers can request additional services via the package, which also communicates with the packaging machine to control settings for individual, personalized products. These solutions use NFC chip technology developed by Rondo.

Plug & Produce: Vertical integration (creation of a standardized interface between production machines and control system) is fundamental in implementing Pharma 4.0 solutions. Plug & Produce, developed by Werum, is like connecting USB devices, making it possible to ‘plug and play’ systems or packaging machines within the overall networked system.

Enterprise Manufacturing Intelligence (EMI): EMI can improve product quality (process stability) and productivity (process efficiency) by supervising production almost in real time. Processes can be continuously verified applying production data to support decision-making. The customer can make better-informed decisions on process stability and process efficiency, to enhance both quality and productivity.

About Dividella

Swiss-based parenteral packaging specialist Dividella has built up an impressive reputation across the global pharmaceutical industry for the quality and effectiveness of its TopLoad cartoning machines. This success has been established on a holistic approach that recognizes that machine and pack design go hand in hand.

Dividella’s production units at Grabs in Switzerland exclusively design and manufacture machines for packaging pharmaceutical products, with total focus on the specific requirements of parenteral pack products, i.e. liquid pharmaceuticals that are packaged in syringes, flasks, vials, auto-injectors and the like. These are highly sensitive products that demand thoroughly developed solutions.

Dividella works in close consultation with its customers to develop optimal specific packaging concepts.