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With our PAS-X Manufacturing Execution System (MES) and software solutions for Analysis, Track & Trace, Networked Factories, and Intelligent Packaging, we are the world's leading supplier and partner to the pharmaceutical and biotech industries.

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Online, Nov. 22nd - 26th, 2021
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Handling

Handling

We are specialists for complete handling systems for pharmaceutical and medical products. Our solutions are decisive in the field of contactless and safe transport of e.g. glass syringes.

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Inspection

Inspection

As the world's leading inspection expert, we develop solutions for the pharmaceutical and biotech industries. Our range of products extends from high-performance machines and semi-automatic machines to laboratory units and inspection applications for in-process control.

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Packaging materials

Packaging materials

As long-standing specialists, we develop packaging solutions for innovative and high-quality secondary pharmaceutical packaging made of cardboard. We offer you solutions for counterfeit protection, standard folding boxes and much more.

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Packaging materials

Packaging materials

The demands on pharmaceutical packaging are high: it should be forgery-proof and childproof, but also compact and sustainable. Find out here how we make packaging future-proof.

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About us

We at Körber in the Pharmaceuticals business area are the people to contact when it comes to pharmaceutical products. As a leading system provider, we advise our customers from the development and production to the inspection and packaging of their products.

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Christian Wölbeling

Blog

ISPE and Werum make pharma manufacturers ready for Industrie 4.0

Together with key organizations within the ISPE DACH framework, Werum Solutions promotes the foundation of the Special Interest Group (SIG) “Pharma 4.0”. The goal is to provide best practice implementation methodologies, approaches and practical examples to apply new Industrie 4.0 technologies in pharmaceutical and biopharmaceutical production environments according to the current GMP and ICH guidelines. Divided into subgroups, experts are currently evaluating the topics “Plug & Produce” and “Holistic Production Control Strategy”.

In the “Plug & Produce” subgroup, Werum is contributing to the development of an integration standard which connects the ISA S95 levels 3 and 2, each vertically and horizontally, supporting an open message oriented communication concept based on common standards like OPC-UA. The standard has to meet all GxP-specific requirements, e.g. for data integrity, and needs to allow a simplified implementation and lifecycle approach for pharmaceutical manufacturing equipment. Werum’s new standardized messaged-based interface constitutes the technical basis for the Plug & Produce solution.

“Holistic Production Control Strategy” deals with the question of how ICH guidelines can be implemented into pharmaceutical production considering the enhanced technical capabilities of Industrie 4.0. Experts are working on a best practice methodology to show pharma manufacturers how submission documents from process development can be moved to commercial production via technology transfer and scale-up. In this context, MES such as Werum’s PAS-X can assure a flexible and robust production control strategy design and execution, meeting quality and compliance requirements.

ISPEThe global ISPE GAMP “Data Integrity” SIG is working on the creation of a Good Practice Guide for practical implementation of data integrity in all holistic production control strategy areas. Werum is leading the MES chapter for this guide.

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