Our holistic approach to assembly process design

Assembling drug delivery devices takes deep technical, operational, and regulatory know-how – like ours. Learn more about how we develop robust, efficient, and scalable processes that integrate seamlessly into your aseptic filling program.

Assembly process design

Key steps in our process design approach

Step 1
Defining your product profile

As early as possible, we’ll work with you to identify drug characteristics, regulatory frameworks, and project parameters that may influence processes and methods.

Step 2
Aligning product and patient

Once we’ve created a detailed product assessment, we’ll combine it with your target patient profile to identify user-centric criteria for our device and component selections.

Step 3
Mapping your life cycle goals

Before we start production, we’ll collaborate on a forward-thinking process plan that accounts for shifting market requirements, alternate device formats, changing batch sizes, and more.

Primary packaging influences process design
Technical foresight

Key factors in assembly process design

At the start of your project, we’ll pinpoint important components of your product profile that will guide our process development approach, including:

  • Primary packaging: Syringe or cartridge features that can have an important impact on key assembly steps
  • Drug substance properties: Fluid properties (like concentration and viscosity) that can influence fill volume, device selection, and more
  • Secondary packaging: How your target packaging configuration may be impacted by your product’s container
Process planning for device assembly projects
Process planning

Key priorities at every step

When you’re launching your product in a delivery device, you need a manufacturing partner like Vetter – one that can predict complexities and proactively integrate device assembly into your overall manufacturing program.

We know exactly what to focus on at each critical phase:

  • Development: Defining key components of your selected device, establishing processes, and rigorously testing feasibility
  • Validation: Identifying process risks, clinical evaluation, and process qualification and documentation
  • Commercial transfer: Finalize processes and transfer to commercial production
Picture that symbolizes 2 people talking over pharmaceutical compliance topics
Regulatory support

Compliance & combination products

Device-based injection systems need to navigate many evolving regulatory pathways on their way to market. Our team of experts is here to help you prepare for each relevant authority, their review processes, and compliance requirements – at launch, in new markets, and beyond.

Device Assembly and Secondary Packaging contact

Connect with us

Looking for the right device assembly and packaging strategy for your injectable product? Reach out to our team of experts to discuss how we can support you.

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