Cleanroom injection molding

Specialized manufacturing of plastic components, part of our design-to-manufacture service for drug delivery devices, single-use medical devices, instruments and kits. 

Fast-track commercialization with integrated cleanroom injection molding

Small, complex and lightweight plastic components are enabling new clinical techniques, improved ergonomics, and more efficient supply chains.   

Our global medical-grade cleanroom injection molding and assembly capabilities are an integrated part of our end-to-end medical device CDMO operating model, purpose built for low-mid volumes and high complexity product mixes.  

It means we can help innovators mold and assemble components at low volume, then scale with confidence – without compromising speed, compliance, or process control requirements.  

It’s an important aspect of how Ensera’s flexible, modular approach supports the complete lifecycle of combination, surgical and medical device manufacturing from concept through commercialization and next-generation product development. 

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Expertise

A smoother transition from design through manufacture

We consider cleanroom injection molding, assembly, and packing as one continuous process, for a seamless transition at each stage.

Underpinned by DfM, DfA, prototyping, tooling and validation geared to the specific challenges of high-mix, low-volume delivery, our proven approach enables you to:  

  • Run multiple batches with full traceability 
  • Handle changeovers with minimal downtime 
  • Manage complex product variants and materials 
  • Support fluctuating demand 
  • Maintain validated, repeatable processes across multiple geographies 
  • Deep plastics material knowledge Commodity, engineered and high-performance resins for 1k, 2k, insert and overmolding processes
  • Specialists in programs under 100k units per year For specialized surgical and drug delivery procedures
  • Class 8 cleanrooms on 3 continents FDA-inspected and ISO 13485 audited
  • Wrap-around services Component design, DfM, DfA, prototyping, tooling, metrology, assembly, overprinting, validation
Talk to us about your cleanroom injection molding challenge
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Process

Ensera cleanroom injection molding in numbers

Designed to support programs where conventional high-volume molders struggle: 

  • 100+ validated molding programs  
  • 29 machines | 10-280T | Arburg 
  • Single shot and 2k capability 
  • Insert and overmolding  
  • Tight tolerances and highly complex parts 
  • Single cavity and bridge tooling to support DfM, DfA and early-stage validation 
  • Scalable transition to multi-cavity commercial tooling 
  • Expertise in commodity, engineered and high-performance resin materials, including Polycarbonate, ABS, Polyamide, PET, PMMA, and polymers such as PEEK and PPS 
  • Scientific molding (RJG) with eDART in-cavity pressure monitoring  
  • In-house metrology: CT scanning | optical and CMM measurement 
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Device categories our cleanroom injection molding supports

  • Drug delivery

    Components and sub-assemblies

  • Minimally invasive surgical (MIS) devices and assemblies

    Single-use, multi-component Class II and Class III devices

  • Single-use instruments

    Orthopedic procedure kits for spine and T&E surgery in ambulatory settings

  • Enabling technologies

    Single-use medical devices for robotic-assisted surgery

  • Sports medicine

    Kits for soft tissue surgery

  • Orthobiologics

    Bone cement single-use delivery systems

Discover how we can support your single-use medical device manufacturing needs
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Wrap around services for cleanroom injection molding

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Looking to accelerate industrialization for innovative drug delivery devices, surgical instruments, kits and enabling technologies using plastic components?

Talk to Ensera about cleanroom injection molding as part of our design-to-manufacture project lifecycle support.  

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