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Innovative Inhaler Platform

Injection-Molded Assembly for an Innovative Inhaler Platform

The elaera® mesh inhaler platform from Activoris is designed to simplify the administration of many medications. The medical technology specialist, with its development center in Munich, created a sophisticated design in a compact format for this purpose. 1zu1scale is contributing three assemblies comprising a total of 8 injection-molded components ready for series production, including three complex two-component parts.

Activoris came to us with the final 3D-printed prototype and the CAD drawings for the injection molding design. The high technical quality of the design made it much easier for us to implement series production. The data was perfectly prepared; there were no material buildup issues. This allowed us to jointly resolve all potential weak points right after the first sample parts were produced.

Lukas Dilsky,Project Manager Tooling & Injection Molding

Compact, One-Piece Housing

The elaera® mesh inhaler platform from Activoris enables the simple and spatially flexible administration of modern biopharmaceuticals. With this handy device, the medical technology manufacturer offers a versatile solution for inhaled aerosol therapy. 1zu1scale manufactures a total of eight high-quality injection-molded components for the three elements of the housing, including three two-component parts. They come together to form a compact device with a practical snap-fit mechanism and the highest precision for dosing. With the complete system cast as a single unit, Activoris is now entering the validation phase for future regulatory approval.

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Components

8 injection-molded components, including three two-component components made of PP and TPE

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Properties

Precise and stable visible components, three two-component components

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Scaling

Up to 100,000 units for testing and studies in the coming years

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Additional Services

Aluminum molds for fast and cost-effective injection molding production

SCALE: One Process, many Advantages

Sketch

Exemplary Preliminary Work

  • Activoris provided process-optimized CAD drawings
  • A 3D-printed prototype illustrated form and function
  • The quality and reliability of 1zu1scale as a game-changer in the development process

Check

Parts on the Table

  • Joint definition of requirements during an in-person meeting on-site
  • Rapid tooling: Molds and first parts ready in four months
  • Suggestions for improvements to fine-tune the design

Approve

Rapid Validation

  • Quality difference: Components impress right away
  • Few iterations until the final design
  • Switch to softer TPE material; pins stabilize the snap-fit mechanism

Launch

Small-batch production for studies

  • Injection molding with aluminum molds for rapid validation
  • Fully functional small batch for initial test rounds after six months
  • Aluminum molds allow for minor adjustments with minimal effort

Execute

Scaling at the push of a button

  • Gradual production from 500 to 100,000 units per year can be implemented immediately
  • Professional setup by 1zu1scale for further scaling without interruption
  • Option for steel molds, ISO 13485 certification, and ISO Class 8 cleanroom

Simple Solutions for Complex Challenges

Quality Guaranteed: Activoris made the right choice by switching to 1zu1scale. It took just six months from the first meeting to a robust small-batch production run. Even complex two-component parts, as well as moving snap-fit and locking mechanisms, were resolved quickly and pragmatically thanks to 1zu1scale’s expertise. Three perfectly coordinated assemblies form an easy-to-use, ergonomic, and robust housing. With this, Activoris is now taking the next step toward market approval.

In medical technology in particular, development projects require manufacturing partners that are flexible, fast, and at the same time ensure quality. With 1zu1scale, we have found a partner that very professionally combines rapid tooling, cleanroom manufacturing, and ISO 13485-compliant processes.

Axel Fischer,Managing Director of Activoris Medizintechnik GmbH

Questions & Answers

It is used for the inhalation of biopharmaceutical active ingredients, thereby enabling patient-friendly therapy.

The cartridge containing the active ingredient is secured in the movable interchangeable component. The base component regulates the aerosol dosage. Using the nebulizer head, the patient simply triggers the delivery by inhaling. All three components come together to form a compact unit.

8 parts ranging in size from 3 to 8.5 centimeters, including three two-component parts made of PP and TPE.

The 8 components are manufactured using a total of 11 aluminum molds.

6 months. Activoris approached 1zu1scale with a mature design and a 3D-printed prototype. The assembly was optimized through just a few iterations.

High precision, quality, and stability. Three interconnected assemblies form a long chain of tolerances; the accuracy of the two-component parts in the nebulizer head affects dosing, and daily use requires stable moving structures.

Activoris is moving into validation with the final components and, starting in 2027, will begin the test phase with small-scale production runs of up to 5,000 units in preparation for clinical trials. As part of the regulatory approval process, demand could rise to as many as 100,000 units per year.

Project Managers

From idea to series: The people behind the project.

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