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Körber Case Study: Ferring Pharmaceuticals implements eBR electronic batch recording with a new MES system
The Pharma Consulting experts from Körber have helped reproductive medicine and maternal health leader Ferring Pharmaceuticals to transform its ways of working at its production facility in Kiel, Germany, implementing a manufacturing execution system (MES) including electronic Batch Recording (eBR).
The project was motivated by the benefits that Ferring has realized from introducing MES at other sites.
Process Landscape® modelling
With experienced Consulting experts from Körber, incorporated onto its Project Team, Ferring started by reviewing its workflows and processes to prepare them for the digital transformation.
The new proposed processes were summarized, visualized, and shared using Körber Process Landscape®, a standardized tool that helps customers to achieve target processes much faster and more easily by obtain a clear view of them. This was done for each section of the visual inspection area, namely manual, semi-automatic, and automatic inspections. The process steps were analyzed, among others, by directly walking the shop floor and clarifying open points with the operators. This helped to identify misinterpretations that had resulted from recent changes and helped to clarify the processes.
Simplification and optimization
Final clarifications and decisions were made in meetings that included all process stakeholders. By doing so, the team was able to identify process simplifications and process optimization opportunities. As a result of this harmonization exercise, the number of process steps was tremendously reduced, and the complexity optimized.
With the optimal-designed recipes in place, the system supports operators when entering the data. Immediate feedback is provided in order to guide them through the complex production processes. As a beneficial side effect, all calculations and most of the test steps can be executed automatically, massively reducing human errors and greatly simplifying review of the batch documentation over previous paper-based processes.
A clear asset in the project was Körber’s modular approach. Following the ISA 88 recommendations, directives, the project team used a clustering process, combining the different process steps to a set of building blocks that could then be arranged to make up the process recipe.
Since each building block was prevalidated, regulatory compliance becomes much easier, with each change to process only requiring specific validation for any new characteristics. Therefore the overall validation effort decreases drastically. The project team was able to reuse approximately 70 – 80 % of the blocks in different recipes by applying this modular approach.
Through automatic checks and calculations in the eBR, the review effort for the electronic records was significantly reduced compared to the paper-based documentation. The quality of the batch reports increased concurrently. Now, all recipes are managed and executed in the manufacturing execution system for the visual inspection.
The implementation of eBR at Kiel is a further milestone on Ferring Pharmaceuticals’ path to digital manufacturing and paperless production as per the Pharma 4.0 vision.
Customer benefits identified include up to 25% reduction in batch deviations with all typical batch documentation errors eliminated, cutting required documentation time during production by between 25% and 40%, reducing average time required for Batch Record review, and cutting 15 minutes off the typical time required for each visual inspection batch.
These savings are just for Ferring’s visual inspection area. As the production processes in other areas are far more complex, even greater benefits are expected as use of eBR rolls out to the other production areas at Kiel. These roll-outs to the other areas are planned for the next few years and will also be supported by the Pharma Consulting experts.
Drawing on Körber experience
Project Owner for Ferring Pharmaceuticals in Kiel was the company’s Associate Director of MES Management, Hartwig Hönerloh, who commented:
“For our colleagues it is a tremendous change to introduce electronic Batch Recording. With the support from Körber, we were able to identify and realize process optimizations. If you put your trust in Körber’s experts, you can draw on twenty plus years of MES and process know-how. We are looking forward to continue working together on the introduction in the other areas.”
Körber Consulting Team Lead Tim Meyer added: “It was and is a pleasure to work with such a dedicated team, which drove the project to a quick completion. In addition, we were able to clearly demonstrate the benefits to the customer which led to an overall success.”
Körber is an international technology group with around 10,000 employees and more than 100 locations worldwide.
Körber turns entrepreneurial thinking into customer success to shape technological change, offering inspirational products, solutions and services in five Business Areas: Digital, Pharma, Supply Chain, Tissue and Tobacco.
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As a leading pharma consulting expert that works in personal partnership with its customers, Körber possesses deep understanding of specific process and regulatory challenges of pharmaceutical, biotech, and medical devices manufacturers and how to optimize manufacturing processes by developing tailor-made solutions for customers’ individual needs and time requirements.
Consulting experts from the business unit Pharma at Körber offer a broad portfolio of services that include machine qualification, manufacturing execution systems, or validation.
To ensure customers remain competitive, Körber’s industry-leading experts connect them to the future by consulting on innovations like digital maturity, augmented reality solutions, small batches and targeted treatment.
About Ferring Pharmaceuticals
Headquartered at Saint-Prex in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives.
The company has been developing treatments for mothers and babies for more than half a century and now identifies, develops and markets innovative products in the areas of reproductive medicine and maternal health, urology and gastroenterology.
Ferring markets its treatments in 110 countries, employing some 6,500 people in 56 countries
Learn more at: https://www.ferring.com
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