Not For Human Use Fill and Finish Services

De-risk R&D and improve commercialization efficiency with NFHU fill & finish

Developing new injectable drug products and installing automation often requires thousands to millions of filled containers, where only critical-to-quality attributes such as dimensions, materials, functionality, and weight matter. Stevanato Group’s NFHU (Not For Human Use) fill & finish services, also known as non-GMP fill & finish, help biopharma companies obtain representative samples without the burden of GMP. This approach helps prevent delays in drug production while supporting earlier testing, reducing risk, and accelerating time to market.

Using NFHU fill & finish for product development

By identifying fill & finish challenges early, you can avoid costly rework such as repeated validation or reformulation. Our NFHU services allow you to have commercially-representative samples in both small and large quantities, earlier, and easier than using manual or GMP fill & finish lines. This approach allows you to:

De-risk machineability of the drug product and the containers, especially for viscous formulations, suspensions, coated plungers, or vacuum stoppering
Optimize container and device specifications, including plunger position, headspace, and fill volume for an easier transfer to your commercial final fill & finish line
De-risk the selection of the drug container and closure by using more commercially-representative samples for earlier comparison and stability testing
Reduce sample-cost for new test methods, sterilization cycles, and package testing

Using NFHU Fill & Finish for manufacturing

When ordering new automation equipment, manufacturers need test samples (filled containers) to run-in and mechanically test the equipment before Factory Acceptance Testing (FAT) and through Site Acceptance Testing (SAT). For example, use cases include assembling autoinjector/pen injectors, prefilled syringes that include finger-flanges or plunger rods, inspecting and/or labeling filled containers, and any final sterilization or packaging. A high-speed line running at 600 parts per minute will use almost 300,000 parts over an eight-hour test run.

Our NFHU fill & finish is a dedicated service instead of pausing GMP lines or using demonstration units at fill & finish equipment manufacturers. Boost your efficiency:

Reduce Total Cost of Ownership (TCO) when ordering new automation or assembling demonstration devices with more price-appropriate test samples
Minimize and maintain the equipment installation schedule with faster lead-times and easier scheduling without interrupting GMP production.
Allow new fill & finish lines and related new assembly, inspection, or labeling equipment to be installed in parallel.

Compatible with multiple brands and manufacturers
Sites in Boston, U.S., and Piombino Dese, Italy
Formats include syringe, cartridge, and vial
Fill media include water, placebo, and drug
Analytical testing and device assembly upon request

Why choose Stevanato Group?

As an integrated solution provider, Stevanato Group is familiar with drug containers, drug delivery devices, automation engineering, and analytical services. We are present throughout the product development and commercial life cycle and understand how NFHU test samples are beneficial and where companies struggle.

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NFHU Fill & Finish Services

De-risk R&D and improve commercialization efficiency with NFHU fill & finish

NFHU fill & finish key features