Solutions

We have a solution for everything – and more importantly: they can all be connected through our unique Körber Ecosystem. In our current seven areas of expertise, we are at your disposal with our comprehensive know-how.

All Solutions

Software solutions

With our 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. With our holistic understanding and use of digitalization, you remain future-proof and combine digital innovation with sustainability.

Overview Software solutions

PAS-X: Much more than MES

PAS-X includes different suites such as MES Suite, Intelligence Suite, Content Suite, and Services Suite.

Handling systems

Looking for perfectly designed production lines that reduce operational complexity, can adapt quickly to changes in the pharmaceutical industry and work seamlessly with your software and machinery? 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.

Overview Handling systems

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 AI-supported, high-performance machines and semi-automatic machines to laboratory units and inspection applications for in-process control. As thought leaders in the field, we always make sure that machines and software speak the same language.

Overview Inspection

Machine finder

Go directly to our machines

Filter according to the criteria you are concerned about.

Remote Service Tool Körber Xpert View

Support whenever and whereever you need it. Reduce your downtime and improve your production quality with Körber Xpert View.

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. Our ecosystem approach ensures that all machines, software, and other components operate harmoniously and perform at the highest level.

Overview Packaging machines

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

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.

Overview Packaging solutions

From development to market readiness

Körber offers Packaging Qualification Services from a single source.

Expansion of production capacities in the packaging sector

Körber increases its secondary packaging capacities to meet rising demand and ensure security of supply.

Aseptic processing

Consulting

Our experts will advise you during the analysis of your requirements, show you optimization potential and support you during the implementation of projects in all areas of the pharmaceutical, biotech and medical device industry. Our aim is to achieve holistic optimization for your factory of excellence.

Overview Consulting

Services

You need help with a specific product or have questions about one of our areas of expertise? Körber is your forward-looking navigator to excellence. We provide data-led, proactive advice and services to improve what is needed to scale and evolve towards your factory of excellence.

All Services

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Blog

Can you support quality metrics without MES? Get ready to be graded on a curve!

The Food and Drug Administration Safety and Innovation Act (FDASIA) provides the FDA the ability to conduct electronic inspections and target on-site inspections based on metrics. The agency intends to request quality metrics data reports from the industry for a one-year period in electronic format through the FDA Electronic Submissions Gateway (ESG). Analysis of these data – such as the number of lots attempted of a product or the number of specification-related rejected lots of a product, etc. – would be used to grade companies on a curve and to provide them a “grade”, representing their fit on a curve. The FDA would direct resources to those companies who are on the lower end of the curve.

Risk-based inspection schedule

The FDA intends to open the ESG in January 2018 to receive voluntary submissions of data generated in 2017. It expects to begin data analysis when the portal is closed and publish initial findings on its website. The results of the voluntary phase will be evaluated and the FDA will then initiate a notice and comment the rulemaking under its existing statutory authority to develop a mandatory quality metrics reporting program.

According to the latest published guidance, quality metrics data will be used to:

Establish a signal detection program as one factor in identifying establishments and products that may pose significant risk to consumers
Identify situations in which there may be a risk of drug supply disruption
Improve the effectiveness of establishment inspections
Improve FDA’s evaluation of drug manufacturing and control operations

The guidance document specifically states that the FDA is continuing to encourage the adoption of emerging technologies and will request comments on implementing new technology while maintaining a robust quality metrics program.

The FDA’s e-inspections program based on quality metrics is a key step in its objective to encourage the industry to implement state-of-the-art, innovative quality management systems that drive the industry to focus on improving product quality, rather than simply ensuring compliance to regulatory requirements.

MES is the key to support quality metrics

To show regulators their commitment to quality, most companies will be forced to discontinue the use of paper batch records in favor of electronic batch record systems and MES. The integration of MES with complimentary systems like QMS, PLM and LIMS will play a key role in achieving a single source of truth to support quality metrics reporting.