Cleanroom Medical Device Assembly

 

Europlaz has three cleanrooms specialising in sterile medical device assembly and packaging. Cleanroom processes are tailored to meet individual customer needs.

      medical device packaging - sterile medical packaing within a cleanroom

Each device is tested as a complete working part and packed ready for end distribution.

If necessary, components can be externally sourced and assembled by Europlaz.

          Medical Device Assembly - Cleanroom medical moulding - clean room assembly

Typical assembly operations include:

  • Ultrasonic weldingHot Wire Welding
  • Hot Plate welding
  • Ultra Sonic Welding/Cleaning
  • Adhesive & UV bonding

 

Europlaz carries out both cleanroom assembly and non-cleanroom assembly operations.

Facilities:

  Cleanroom
1
Cleanroom
2
Cleanroom
3
Year built 1998 2003 2010
Sq. Foot 5000 3000 4000
Class 7 Yes Yes Yes
ISO 14644-1 Yes Yes Yes
ISO 13485 Yes Yes Yes
Injection Molding machines 11 0 1
Assembly No Yes Yes
Packaging No Yes Yes
CE Marking No Yes Yes
Ultra-sonic Welding No Yes Yes
Automatic assembly No Yes Yes
Manual Assembly No Yes Yes

All cleanroom manufacture is fully QC audited to ensure regulation compliance.

As well as Manual, semi-automatic and fully automatic assembly our cleanrooms are equipped for cleanroom injection moulding and sterile packaging.

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