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Manufacturer-independent calibration expertise

Process safety in Life Sciences

Thanks to the engineering services from Endress+Hauser, it was possible to ensure high quality and compliance with legal requirements in pharmaceutical production even before initial production. This guarantees patient safety and profitability for WuXi Biologics customers.

mobile flow calibration in a clean room ©Endress+Hauser

The results

  • Manufacturer-independent calibration of various process parameters at a total of around 250 measuring points

  • Calibration tools for flow calibration tailored to customers' individual needs

  • On-site calibration by Endress+Hauser engineers

Christian Rämsch, Head of Engineering at WuXi Biologics

Our experience so far is that our concerns are always dealt with quickly and execution is always handled with a high degree of flexibility, meaning that all of our requests could always be met.

Christian Rämsch, Head of Engineering
WuXi Biologics Germany

Life sciences is one of the most strictly regulated industries. This is because safety is absolutely vital here, as patients are always the top priority. For this reason, the quality of the products has to be accurately documented at every single stage of the production process - with trust in the measurement technology used being a key requirement.

The challenge

Another important consideration is that the efficiency of the process is a critical factor for the manufacturer. Any incremental improvement in measurement accuracy can equate to enormous cost savings for customers - for example when dosing and filling very expensive pharmaceutical products worth millions of Euros per kilogram. Investing in optimal calibration of the system therefore offers advantages both in the short and long term.

The solution

In just five weeks, WuXi Biologics and Endress+Hauser managed to ensure the high quality of the produced biologics and compliance with legal requirements when manufacturing pharmaceuticals – even before the start of the first production batch. Many different critical parameters were calibrated in line with GMP in the project phase. The calibration of around 250 measuring points with measuring instruments from different manufacturers presented a unique challenge.

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