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Quality assurance and regulatory affairs

TRUSTED EXPERTISE

With ​more than 20 years of ​manufacturing expertise, Promepla provides high-quality manufacturing and assembly services for the medical, pharmaceutical, and healthcare industries.

CLEANROOM

Our 3,500 m² of ISO Class 8 cleanroom facilities (certified to ISO 14644​), with optional ISO Class 7 environments, are ​designed for ​the assembly ​of complex single-use medical devices. Continuous environmental and microbiological monitoring ensures the highest standards of quality, safety, and product ​integrity.

Precision manufacturing in certified cleanroom environments

Cleanroom Manufacturing & Assembly

Cleanroom Manufacturing & Assembly

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ISO 8 clean rooms

3500m²

dedicated professionals

450

injection moulding machines

27

extrusion lines

7

Techniques and Processes

  • High-precision injection moulding and mould manufacturing

  • Thermoplastic extrusion

  • Solvent bonding, UV and epoxy gluing

  • Ultrasonic and hot plate welding

  • Manual and customised assembly

  • Overmoulding, flaring, tipping, pad printing, hole drilling

Plastic Materials

  • Polyolefins

  • PVC and PVC-free

  • Polyamids

  • Polycarbonate

  • Polysulfones

  • High-end PEEK

  • TPEs

  • Elastomers and silicones

  • BPA-free

Our capabilities

  • 3,500 m² ISO 8 cleanrooms

  • 27 injection moulding machines

  • 4 overmoulding machines

  • 7 extrusion lines

  • 1 compounding machine

  • 6 US welding machines

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