Customization Instead of New Development: How nextaro® Was Adapted to a Specific Drug Application

Not every drug has the same requirements for a transfer device. This is precisely where the advantages of an established, modular product platform become clear.

For a pharmaceutical customer, sfm developed a customized version of the globally approved nextaro® product family. The key challenge was the filter: the filter used in the standard version was not suitable for the customer’s specific drug. Due to the characteristics of the active ingredient, the standard filter would not have allowed the drug to be administered as intended.

Instead of developing an entirely new transfer device, sfm was able to build on the modular design of the nextaro® platform. As part of a preliminary project, sfm manufactured several versions with nominal filter ratings ranging from 30 µm to 100 µm. sfm initially evaluated these versions using established standard test methods. The customer then tested the different filter options with its drug under conditions relevant to the intended application.

Based on these tests, the customer selected the filter best suited to its specific application. In addition to technical performance, the customer considered the specific method of administration and frequency of use. Based on a positive benefit-risk assessment, the customer determined that the version with the larger nominal filter rating offered advantages for its application.

Following the selection, sfm initiated the formal development and regulatory approval process. sfm manufactured the required samples using production tooling and validated processes and performed design verification with a statistically relevant number of test samples. The verification also included artificially aged products to support a five-year shelf life.

In parallel, sfm updated the design history documentation, risk management documentation, and Technical Documentation in accordance with the MDR. The new version was subsequently incorporated into the existing regulatory product platform. In the United States, the existing 510(k) was expanded to include the new version. As a result, the new nextaro® 20/20 vented 72 µm nominal Filter version has the corresponding regulatory approvals for both Europe and the United States.

Thanks to the high degree of standardization within the nextaro® platform, sfm was able to complete the entire process in approximately four months. Accelerated aging alone, performed to verify the five-year shelf life, required slightly more than three months.

This example illustrates the approach behind nextaro®: as much standardization as possible and as much customization as necessary.

The modular product design makes it possible to adapt individual functional components to the requirements of a specific drug without having to develop an entirely new transfer device. For pharmaceutical companies, this can significantly shorten the path from a specific product requirement to an approved transfer solution.