Dry powder inhaler

The project required Sovrin to design and implement a bespoke ISO 14644 Class 7 cleanroom manufacturing cell capable of integrating precision injection moulding, automated assembly, quality control, packaging and traceability within a controlled medical manufacturing environment.

The customer’s key requirement was speed without compromising quality. Sovrin responded by fast-tracking capital investment, developing the production cell in-house and achieving production readiness within six months.

Project Highlights

• Dedicated ISO 14644 Class 7 cleanroom constructed
• Production cell designed in-house by Sovrin
• In-line injection moulding and assembly
• Annual capacity of 6.5 million devices
• Five new Fanuc injection moulding machines installed
• Multi-impression tooling
• Four compact six-axis robot take-out systems
• Anti-static cooling conveyors
• Gravimetric blending
• Automated assembly and palletising
• Bespoke packaging
• 24/7 production capability
• Production-ready within six months
• First supplier to market by a considerable margin

The Manufacturing Challenge

The dry powder inhaler project required a manufacturing partner capable of rapidly scaling production while maintaining the repeatability, cleanliness and process control expected within regulated medical device manufacturing.

The customer required high-volume validated production in the shortest possible timeframe. This meant the manufacturing process could not rely on isolated operations or fragmented supply chain partners. Instead, the project required a purpose-built cleanroom manufacturing cell that could integrate moulding, handling, assembly, packaging and quality control into one efficient production flow.

For a respiratory drug delivery device, manufacturing consistency is critical. Component quality, assembly repeatability, controlled handling and process validation all influence the ability to deliver reliable device performance at scale.

Sovrin’s Solution

Sovrin designed and built a bespoke production cell within a newly constructed ISO 14644 Class 7 cleanroom. The cell was developed to combine high-precision injection moulding with automated handling, assembly and palletising, creating an efficient end-to-end manufacturing process for the dry powder inhaler device.

The project included the installation of five new Fanuc injection moulding machines, multi-impression tooling, compact six-axis robotic take-out systems, anti-static cooling conveyors and gravimetric blending. These technologies were selected to support repeatable high-volume production while maintaining control over material handling, cycle times and component consistency.

By integrating moulding and assembly within the same controlled manufacturing environment, Sovrin reduced process complexity, improved production flow and supported full manufacturing traceability.

Cleanroom Injection Moulding and Assembly

The dry powder inhaler manufacturing cell was developed around in-line injection moulding and assembly. This approach allowed moulded components to move efficiently through the production process with controlled handling and reduced reliance on external processing steps.

Sovrin’s cleanroom manufacturing capabilities supported the customer’s requirement for a scalable, high-quality production platform. Cycle times were optimised and harmonised across the cell to support an annual capacity of 6.5 million devices.

The combination of precision moulding, robotic handling, automated assembly, bespoke packaging and 24/7 production provided the customer with a robust manufacturing solution for regulated drug delivery device production.

Speed to Market

One of the defining achievements of the project was the speed of execution. Sovrin fast-tracked the required capital investment and delivered a production-ready manufacturing cell within six months.

Working in collaboration with the customer’s triple-source strategy, Sovrin became the first supplier to market by a considerable margin. This demonstrated Sovrin’s ability to respond quickly to complex medical device manufacturing requirements while maintaining the quality and process discipline required for validated production.

Medical Device Industrialisation Expertise

This project demonstrates Sovrin’s capability to support medical device industrialisation, particularly where customers require rapid scale-up from production planning into validated manufacture.

Sovrin’s role extended beyond component moulding. The project required manufacturing engineering, cleanroom planning, tooling strategy, automation, assembly integration, cycle-time optimisation, packaging and ongoing 24/7 production support.

For medical device and pharmaceutical customers, this integrated approach can reduce supply chain complexity and improve control over quality, traceability and production timelines.

Relevant Manufacturing Capabilities

This project brought together several of Sovrin’s core medical device manufacturing capabilities:

• Medical device injection moulding
• Cleanroom manufacturing
• Automated assembly
• Robotic handling
• Multi-impression tooling
• Bespoke production cell design
• Validation and qualification support
• Medical device packaging
• High-volume 24/7 production
• Drug delivery device manufacturing support

Why This Project Matters

The dry powder inhaler case study demonstrates Sovrin’s ability to deliver high-volume medical device manufacturing within a demanding timeframe.

By combining cleanroom injection moulding, automation, assembly and packaging in a dedicated ISO Class 7 production cell, Sovrin provided the customer with a scalable manufacturing solution capable of supporting regulated drug delivery device production.

The result was a production-ready system delivered in six months, with Sovrin becoming the first supplier to market under the customer’s triple-source manufacturing strategy.

Frequently Asked Questions

Does Sovrin manufacture dry powder inhaler components?

Yes. Sovrin has supported the high-volume manufacture of dry powder inhaler devices, including cleanroom injection moulding, assembly, automation, packaging and production scale-up.

What cleanroom classification was used for this project?

The dry powder inhaler manufacturing cell was built within a dedicated ISO 14644 Class 7 cleanroom environment.

What production capacity was achieved?

The production cell was designed to support an annual capacity of 6.5 million devices.

Did Sovrin provide both moulding and assembly?

Yes. The manufacturing solution integrated in-line injection moulding and assembly within a controlled cleanroom production cell.

Can Sovrin support high-volume medical device production?

Yes. Sovrin supports high-volume medical device manufacturing, including 24/7 production, automated assembly, robotic handling and scalable cleanroom manufacturing solutions.

Discuss a Drug Delivery Manufacturing Project

Sovrin Medical Plastics supports medical device and pharmaceutical customers requiring cleanroom injection moulding, automated assembly, validated production and scalable manufacturing solutions for regulated healthcare and drug delivery applications.

Contact our team to discuss your next medical device manufacturing project.