A complete Contract Medical Manufacturing Resource

Cleanroom Manufacture

Medical Device Manufacturing within ISO Class 7 Cleanrooms

Cleanroom Facilities

  • Four 10,000 (ISO class 7) cleanrooms over 15,000 sq ft
  • Cleanrooms certified to ISO 14644 for airborne particulate
  • 22 injection moulding machines from 10 to 300 Tonne

Cleanrooms are specifically designed for processing class 1 and class 11 medical devices, equipment and pharmaceutical products.

Routine air pressure, micro-organism and airborne particulate monitoring ensure standards are maintained at all times.

On offer within cleanroom facilities are complete assembly, injection moulding and packaging solutions. Including:

  • High cavitation, fast cycle
  • Over moulding
  • Optical moulding
  • Thermal moulding
  • Manual, semi-automatic and fully automatic assembly
  • Ultrasonic welding
  • Hot Plate welding
  • Hot-wire welding
  • Adhesive & UV bonding
  • Multi-colour pad printing
  • Ultrasonic cleaning
  • Aseptic Filling
  • CE Marking
  • Blister packaging
  • Pouch sealing (roller and bar)
  • Label production (including custom bar codes)
  • Packaging validation

Quality control is of the highest standard at Europlaz; all manufacture is compliant with ISO 13485:2003 and BS EN ISO 9001-2008.

Registered FDA Equipment Manufacturing Establishment (Reg. No. 3004180226)

Europlaz is able to tailor solutions dependent on your specific requirements.

Please contact us to discuss your requirements or if you have any questions.