Process Skid For GMP-Compliant Manufacture of Nanoparticles

Related Vendors

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Glatt Ingenieurtechnik GmbH

Italvacuum, Srl

GMP Guidelines Must Be Followed

For pharmaceutical production a wide array of certificates are needed to ensure that everything functions properly and that there is no risk to patients through defective production or contamination. Moreover, in a commercial installation for the manufacture of medicines for human use, different safety precautions are required from those applying for experimental production in a laboratory. GMP guidelines must be followed before the production platform can be used to make tablets or injection compositions for commercial use.

How To Chose The Right Partner

Accordingly, only companies with the necessary pharmaceutical industry knowledge, experience, and expertise came into question, and M+W could offer precisely this combination. Since 1912 M+W has been at the forefront when it comes to advanced engineering development and design solutions. “As chemists we needed a plant constructor who could speak our language, was familiar with the industry and able to provide the necessary know-how,” explains Dr. Elke Horstkotte, project manager at Leon-Nanodrugs.

“The designer had to know what was involved in order to bring the project to a successful conclusion. This not only meant having a thorough understanding of industry requirements but also being able to independently come up with solutions to challenges and then design the periphery. In M+W we have found precisely that partner.”

In January 2016, Leon-Nanodrugs awarded the tender to M+W. Thereafter, M+W engineers, designers and software experts at the company’s Stuttgart headquarter set about building in-house the first commercially viable large-scale MJR platform for pharmaceutical nanoparticle production.

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