How Stevanato’s digital twins cut pharma manufacturing costs

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Riccardo Butta, a leader at Stevanato Group, delves into how cutting-edge digital twin technology, advanced data management, and AI-driven systems are transforming manufacturing efficiency and quality in the pharmaceutical sector.

From reducing operational costs to enhancing patient outcomes, Stevanato Group is at the forefront of digital transformation in pharma.

Digital Twin Technology: How has the implementation of digital twin technology at Stevanato Group enhanced your manufacturing processes? Can you share specific examples of how it has reduced risks and costs?

Data management and AI are integral to the manufacturing processes at Stevanato Group, and by introducing digital twins, we’ve been able to introduce the real-time simulation and optimization of workflows. During the inspection process, digital twins enable the testing of different product recipes virtually, minimizing the need for physical trials and reducing downtime and saving costs. Additionally, this technology facilitates more precise performance characterization, leading to fewer required validation batches during process performance qualification (PPQ). The result is a streamlined production cycle that improves efficiency and agility while enhancing product quality through continuous monitoring and predictive analytics. These innovations embody the principles of Pharma 4.0, driving the industry toward a more interconnected, data-driven future.

Data Management: In what ways has advanced data management contributed to improving quality and productivity within Stevanato Group? How do you ensure data integrity and security, especially when dealing with sensitive pharmaceutical information?

Stevanato Group offers primary container traceability, which has several benefits, including uniquely coded containers with machine-readable 2D barcodes that improve production efficiency and quality by providing insight into each stage of the manufacturing process.

To ensure data integrity and security, especially when handling sensitive pharmaceutical information, Stevanato Group employs robust data management practices that comply with all regulatory standards. This is seamlessly integrated into existing operations, ensuring that the integrity of the containers remains intact while also meeting all requirements. This comprehensive approach safeguards sensitive data while enhancing operational efficiency and product quality.

Patient Outcomes: Can you elaborate on how digitalization initiatives at Stevanato Group directly contribute to better patient outcomes? Are there any recent success stories or case studies that highlight this impact?

Digitalization initiatives at Stevanato Group significantly enhance patient outcomes by improving the quality and efficiency of pharmaceutical manufacturing. For instance, utilizing digital twins simulates inspection processes, allowing for fine-tuning of parameters and real-time adjustments without interrupting production. This capability results in a reduction in time to market, ensuring that critical medications reach patients faster.

A particular use case involves the implementation of Stevanato Group Vision AI, a secure, cloud-based platform that leverages deep learning to enhance inspection performance. This has led to higher detection rates and minimized false rejections, directly contributing to the delivery of safer, higher-quality products. Furthermore, robust data management practices eliminate silos, enabling detailed root cause analysis and continuous process optimization.

Cost Reduction Strategies: What specific digital tools or processes have been most effective in reducing operational costs at Stevanato Group? How do you balance cost-saving measures with maintaining high quality and safety standards?

To balance cost-saving measures with high quality and safety standards, Stevanato Group prioritizes data-driven decision-making. Robust data management systems provide real-time insights, enabling detailed root cause analysis and proactive adjustments to processes. By continuously monitoring and optimizing production parameters, Stevanato Group ensures that cost efficiencies do not compromise product integrity. This integrated approach allows for sustainable cost reductions while upholding the highest regulatory and quality standards.

Quality Assurance: How has technology helped in maintaining or even improving the quality assurance processes at Stevanato Group? Are there any new technologies you're exploring to further enhance product quality?

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Digital Twin technology enables proactive adjustments that maintain high quality production standards. Additionally, the Stevanato Group Vision AI platform utilizes deep learning algorithms to improve inspection accuracy, significantly increasing defect detection rates while minimizing false rejections to ensure products meet stringent quality standards before reaching the market.

Challenges in Digitalization: What were some of the challenges Stevanato Group faced when integrating digital solutions into your operations? How did you overcome these challenges, and what lessons were learned?

In integrating digital solutions, Stevanato Group has overcome several challenges such as maintaining data integrity and complying with strict regulatory requirements. As we implemented Digital Twin and

 AI-driven systems, we encountered challenges in standardizing data management practices across different manufacturing stages. Ensuring that digital tools interacted harmoniously with existing equipment also required significant technical expertise and iterative fine-tuning.

We adressed these challenges by setting up strong data management systems to support real-time monitoring and quick adjustments. Stevanato Group Vision AI helped us standardize data practices and maintain consistent quality. Additionally, Digital Twin technology allowed us to test and solve potential issues virtually before applying changes in the actual production process.

We learned that taking small steps with digital upgrades made it easier for our teams to adjust. Ongoing training was key to helping everyone get confident with new technology. Encouraging collaboration across departments also improved communication and made it easier to align with regulations. Overall, being flexible and proactive helped us navigate the digital transformation successfully.

Industry Trends: What are some key industry trends in digitalization within the pharmaceutical and life sciences sectors that you believe will shape the future? How is Stevanato Group positioning itself to stay ahead of these trends?

The dramatic increase in investment in digital technologies—from less than $1 billion in 2015 to over $7 billion in 2021 (McKinsey & Company) —reflects the urgency for companies to adapt quickly to market needs, optimize manufacturing processes, and improve drug access, quality, and safety.

We are positioning ourselves to stay ahead of these trends by fully embracing AI across the supply chain, particularly in areas like automatic visual inspection. This technology not only detects minute particle defects but also enhances overall product quality and compliance, ultimately ensuring that life-saving drugs are safe for patients. Furthermore, we are exploring the potential of AI to enable personalized medicine by analyzing genetic patterns, which can lead to more tailored treatment options with fewer side effects.

Future Innovations: What upcoming technological innovations are you most excited about, and how do you see them impacting Stevanato Group's operations and the broader pharmaceutical industry?

I’m particularly excited about AI and digital twin innovation, as they represent transformative shifts in the pharmaceutical manufacturing landscape and are already experiencing the benefits of our SG Vision AI platform. This not only improves product quality but also drives significant cost savings for our customers.

Strategic Vision: How does digitalization fit into Stevanato Group's long-term strategic vision? What are your goals for the next 5-10 years in terms of leveraging technology to drive business growth and improve patient care?

Digitalization is central to Stevanato Group's long-term strategic vision, as it empowers us to enhance operational efficiency, improve product quality, and innovate our service offerings. Over the next 5-10 years, we aim to leverage technology to drive business growth and significantly improve patient care. Our goals include expanding the use of AI and machine learning across our manufacturing processes to increase automation and enhance inspection accuracy. By continuing to develop advanced solutions like our SG Vision AI and Inspection Digital Twin, we intend to optimize production workflows, reduce time to market, and minimize waste, ultimately leading to more reliable and safer pharmaceutical products.

Ultimately, our vision is to create a fully integrated, digitally connected environment that supports personalized medicine and better patient outcomes. By prioritizing digital transformation, we remain at forefront of innovation in the pharmaceutical industry.