Medical Device Manufacturing

Within six Class 7 Cleanrooms

Europlaz assembly line

Cleanroom Facilities

  • Six ISO Class 7 cleanrooms covering over 15,000 sq ft
  • Cleanrooms certified to ISO 14644 for airborne particulate
  • 24 injection moulding machines from 10 to 300 Tonne

With an ISO Class 7 Cleanroom classification on all our cleanrooms, they are specifically designed for processing class I and class II medical devices, equipment and pharmaceutical products.

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

Cleanroom Solutions

On offer within cleanroom facilities are complete medical device 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
cleanroom solutions
Validation

Cleanroom Quality Control

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

We are a registered FDA Equipment Manufacturing Establishment (Reg. No. 3004180226)

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

in house automation

In House Automation

Europlaz can design, source and commission automation equipment to complete critical assembly tasks and verify the completion of that task.

Where there are production efficiencies to be gained, we will work with you to drive down costs and increase output.

Typical equipment used includes integrated vision systems, SCARA, 6-axis and cartesian robots. We can provide test stations ranging from a simple process test to full device testing with a verifying data record of each test.

Our automation capabilities include:

  • Expert knowledge of high-speed automation
  • Established automation supply chain
  • In-house designing, machining, programming and system construction
  • Development of custom assembly stations and custom test stations
  • 100% device verification systems
  • Lab-based “Proof of Concept” activities
  • Scale-up automation from development through full production
Please contact us to discuss your requirements or if you have any questions.

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