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Software solutions

Software solutions

With our Werum PAS-X MES - on premise or cloud-based - and our 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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Handling systems

Handling systems

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 machines

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 machines

Packaging machines

We are a leading supplier of packaging machines for liquid and solid pharmaceutical and medical products. With our blister, sachet and stick packaging machines we offer solutions for primary packaging. Our side and topload cartoners set standards worldwide for secondary packaging.

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K.Pak Topload Case Packer

Introducing our latest solution from Körber; the K.Pak Topload Case Packer! Created specifically for the pharmaceutical industry, the K.Pak solution provides operator-friendly machines to complete any production line. Our solution focuses on innovative technology, high-quality design and expert handling and packaging of your product. It’s time to start connecting the dots with Körber!

Packaging solutions

Packaging solutions

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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Consulting

Consulting

Our experts will advise you during the analysis of your requirements, show you optimisation potential and support you during the implementation of projects in all areas of the pharmaceutical, biotech and medical device industry.

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Blog

Strategic organization of MBR design

Ensuring the quality of MBR design is critical to successful MES, and, as such, the end-goal of creating high-quality MBRs must guide the entire production and review process.

Successful MBR design requires a structured approach:

Production process analysis

The production processes to be modeled in MBRs should be analyzed. This includes taking into account the requirements of stakeholders (e.g. production and QA), and the boundary conditions of other systems (e.g. ERP order structure). The result of this analysis will include the production process, structured into MBRs (e.g. bulk production, packaging), its unit operations (e.g. weighing, granulation, filling) and process steps. Such steps may include ‘assemble granulator,’ ‘granulation run,’ ‘post-run-activities,’ or ‘yield operations.’

From design outline to detailed design

The production process analysis described above leads to a design outline which can then serve as a table-of-contents for the future MBR (and batch record report). The content of the MBRs can then be translated into detailed design in manageable portions. In between each step, it’s advisable for MBR designers and future users to review progress since any changes having to be made later in the design process will require great effort. It’s advisable to keep the MBR executable, so incremental, periodic changes can be made and tested straight away.

Design styles and naming conventions should be defined early and applied throughout the design process. Predefined solutions from best-practice process libraries (such as Werum’s Content packages), and parts of already completed MBR designs or prototypes (e.g. from a fit phase) may be used to accelerate the detailed design.

Finalization

In the final stage, the focus switches from functional principles and important parts to open details. All details, including instructions, signatures and activities are added to the MBR. The scale up of the number of MBRs (e.g. duplicating) is dependent upon the similarity of the MBRs and the overall MBR design concept, but should happen before the product specific finalization.

Throughout these phases, Werum’s “Design as a Service” package provides comprehensive and best-practice solutions for the cost-effective creation of lean, high-quality and streamlined MBRs. For speedy and efficient creation, a globally oriented design team, leveraging offshore resources can be utilized.

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