Cleanroom/controlled area

For high-grade medical and pharmaceutical plastic components

Plastic moulding in its purest form

WAREMA Kunststofftechnik Reinraum Sauberraum

It goes without saying that our cleanroom complies with ISO standard 14644 class 7 and is GMP C-certified. This means that we have a completely isolated and enclosed space specially designed for manufacturing plastic parts for your medical devices and pharmaceutical components. Temperature, positive pressure and humidity are constantly monitored. Our cleanroom concept also includes the bioburden and particle monitoring.

The controlled area is the area before the cleanroom and is also equipped with a high-grade air flowbox. This enables us to meet your individual requirements while ensuring high quality and cost-effectiveness.

We offer injection moulding of thermoplastic components as well as subassemblies and finished products. Depending on your requirements, this can be done manually or with the help of our custom-designed finishing machines.

WAREMA Kunststofftechnik Reinraum Sauberraum

Range of products and services

  • State-of-the art machines using single and multi-component injection moulding
  • 6-axis robot for safe parts handling
  • Proprietary special machines with camera recognition for automated feeding of insert components
  • Transfer systems for further automated test and assembly steps
  • 3D laser marking under cleanroom conditions
  • Individual product labelling
  • UDI-compliant labelling – machine readable and in plain text
  • From hand-made individual components to fully automated series production
  • Customer-specific solutions implemented by our in-house mechanical engineering department
  • Assembly in a controlled area and under cleanroom conditions
  • From bulk to individual packaging
  • Packaging of medical and pharmaceutical products in customer-specific hard and soft blisters
  • Sealing of blisters with Tyvek or other medical films
  • Customer-specific labelling
  • Contract sterilisation
  • Ethylene oxide sterilisation
  • Parametric batch release
Peter Ragusa, WAREMA Kunststofftechnik

I always enjoy working with my highly committed team on new and increasingly demanding customer projects in our state-of-the-art cleanroom.

Peter Ragusa, WAREMA Kunststofftechnik
Interested in working with us on a project?
Production Cleanroom
Peter Ragusa
+49 9391 20-9941
WAREMA Kunststofftechnik Kontakt

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competent & reliable advice.

Interested in working with us on a project? We look forward to hearing from you!

WAREMA Kunststofftechnik Standort Deutschland
WAREMA Kunststofftechnik und Maschinenbau Standort Ungarn Gyál