Introduction

As pharmaceutical manufacturing continues to evolve, the industry is looking for new ways to strengthen quality, improve efficiency and ensure reliable supply without compromising patient safety. At the upcoming European Biomanufacturing Summit in Düsseldorf, these challenges will be at the heart of discussions among leading biomanufacturing and pharmaceutical professionals.

Among the speakers is Julia Wiesner, Site Head of Technical Operations at Merz in Dessau, who brings more than 15 years of pharmaceutical industry experience and expertise in sterile drug manufacturing. Ahead of the summit, Julia shares her perspective on the growing role of automated visual inspection in sterile drug manufacturing, from improving consistency and throughput to harnessing data and new technologies such as AI.

Could you begin with a brief introduction about yourself, and an overview of your responsibilities as Site Head of Technical Operations at Merz?

I am Julia Wiesner, Site Head of Technical Operations at Merz in Dessau. I hold a Ph.D. in Chemistry and have more than 15 years of experience in the pharmaceutical industry. My responsibilities include Quality Control, Quality Assurance, CMO Operations and several production teams across the value chain, from drug substance manufacturing through sterile filling and lyophilization to visual inspection and secondary packaging. My team focuses on ensuring reliable supply, high quality standards and sustainable operational performance.

What are the key challenges in sterile drug production today, and how is automated visual inspection helping manufacturers address them? 

Main objectives of sterile drug production are patient safety, GMP compliance, and reliable supply considering rising demand and increasing regulatory requirements. Key challenges include contamination and particulate control, process variability and the detection of small or rare defects across large batch sizes within complex product matrices (e.g. lyophilizates). Automated visual inspection helps by applying controlled and repeatable inspection conditions to every unit. It supports consistent defect detection at higher throughput and generates valuable data for identifying trends, investigating potential root causes and continuously improving manufacturing processes.

How do automated inspection technologies improve product quality, consistency and efficiency compared with traditional manual inspection approaches?

Manual inspection remains valuable, particularly for unusual or complex defects, but it is repetitive and can be influenced by operator fatigue and individual judgement. Automated systems apply predefined inspection parameters consistently across high production volumes. They can reduce operator-related variability, increase throughput and generate objective defect and image data.

The greatest benefit comes from combining automation with human expertise, using technology for standardized inspection while qualified specialists provide oversight, assess atypical findings and support continuous process improvement.

 “Automated visual inspection enables consistent defect detection while generating valuable data for process improvement.” 

What considerations are most important when implementing automated visual inspection systems within existing sterile manufacturing environments? 

Implementation begins with understanding the product, container-closure system, relevant defect classes and expected detection capability. Difficult-to-inspect products, including lyophilized products, can increase false-reject rates and the number of borderline or gray-zone units requiring further assessment and manual visual inspection effort. The system must also fit the material flow, equipment, IT infrastructure and pharmaceutical quality system. Cross-functional teams should address recipe development, qualification and validation, data integrity, maintenance and training. Performance targets must balance patient safety, reliable defect detection, operational robustness and an acceptable false-reject rate. 

How do you ensure automated inspection processes meet regulatory expectations while maintaining high standards for patient safety and product integrity? 

“Patient safety is always the top priority, supported by robust validation and continuous performance monitoring.”

Patient safety is always the top priority. We apply a risk-based lifecycle approach covering defect classification, user requirements, qualification, validation and continued performance monitoring. Automated inspection must demonstrate detection of known, relevant defects under representative conditions and perform at least as well as the qualified manual method. This includes representative defect standards and challenge sets, controlled inspection recipes, acceptance sampling after 100% inspection, and documented trending. Hardware, software and parameter changes are assessed through the pharmaceutical quality system, with traceability, quality oversight and change control.

What role do data analytics, machine learning, and digital technologies play in improving inspection accuracy and operational decision-making?

Data analytics can transform inspection results into valuable process knowledge. Image libraries, defect classification and trend analysis help identify recurring patterns that may be linked to filling, lyophilization, crimping or component quality. Machine learning can potentially improve differentiation between true defects and acceptable product variation, reducing false rejects while maintaining sensitivity. In a GMP environment, however, these technologies require controlled data, robust validation and clear lifecycle governance. They should support expert decision-making while accountability remains within the quality system.

“Operational excellence is not achieved by speed alone, but by balancing detection, stability and continuous learning.”

How do you manage the integration of new automation technologies with existing manufacturing processes and quality systems?

We manage technology integration as a cross-functional change program rather than simply an equipment project. We first assess the current process, interfaces and risks, then define requirements, responsibilities and acceptance criteria. Production, Quality, Engineering and OT/IT are involved, supported where appropriate by external expertise. Qualification, validation, training and data integrity are built into the implementation plan. A phased approach, using technical studies, representative product trials and structured performance reviews, supports robust integration into established manufacturing processes and the pharmaceutical quality system.

What impact do automated visual inspection solutions have on reducing variability, improving throughput and supporting operational excellence? 

Automated visual inspection can reduce variability by applying the same controlled conditions and decision parameters to every unit. It can increase throughput, support capacity growth and allow skilled employees to focus more on process evaluation and improvement. The resulting defect and performance data also enables more effective trending, investigations and preventive actions. Operational excellence is not achieved by speed alone. It requires the right balance between reliable defect detection, stable processes, appropriate false-reject as well as “gray” unit levels and continuous data-driven learning.

Looking ahead, what innovations or technologies do you believe will have the greatest impact on the future of sterile drug manufacturing? 

I expect the greatest impact to come from combining advanced automation, machine vision and integrated manufacturing data. AI-supported inspection may improve defect classification, while robotics and increasingly closed systems can reduce manual intervention in sterile processes. Predictive analytics and digital twins may help manufacturers understand process behavior and identify risks earlier. However, innovation must remain connected to pharmaceutical fundamentals: contamination control, process understanding, robust validation and qualified people. The most valuable technologies will be those that measurably strengthen patient safety and supply reliability.

Which aspect of the European Biomanufacturing Summit are you most looking forward to? 

I am particularly looking forward to exchanging practical experiences with colleagues facing similar challenges in sterile manufacturing. Automated visual inspection is not only a technology topic. It connects quality, operations, engineering, digitalization and regulatory strategy. I hope the roundtable will enable an open discussion about both the opportunities and the practical challenges, including validation, false rejects, gray units, data use and organizational readiness. I am also interested in learning how other companies are translating new technologies into robust and sustainable manufacturing solutions. 

Conclusion

Julia’s perspective highlights an important theme that will run throughout the European Biomanufacturing Summit: the future of manufacturing is not simply about adopting new technologies; but about using them in ways that deliver meaningful improvements in quality, efficiency and patient safety.

As industry leaders come together in Düsseldorf, the summit provides an opportunity to exchange practical experiences, explore emerging technologies and discuss how innovation can be translated into robust, sustainable manufacturing operations. For Julia, that exchange is particularly valuable — bringing together quality, operations, engineering and digital expertise to shape the future of sterile manufacturing.

Register now: biomaneurope.com