Hand-made seams in the white room by the production team

Shaping achieves the final device, thanks to numerous processes:

Cutting

  • Laser cutting (2D programming machine)
  • Thermal cutting (hot pen, heated blade)
  • Ultrasound cutting
  • Cold cutting, manual or machinal
     

 

Assembly

Assembly can be done :

  • by semi-automatic or automatic machine sewing
  • by manual sewing
  • by ultrasound soldering
  • by thermal soldering
  • by high frequency soldering
  • by glueing (silicone glue or cyanoacrylate)
  • by crimping
     

 

There also are specific processes like:

  • splicing to assemble the braids
  • machine embroidery
  • thermal shaping
  • thermal treatments (steriliser or high temperature oven)
     

 

Besides actual manufacture, three other processes are applied and proposed in the production cycle of the implantable medical devices. They are the following:

 

Cleaning

Depending on the materials, cleaning is done by ether oiling or in propanol baths.

 

Control

Checks are carried out in all the manufacturing stages. The final visual check of the aspect and presence of particles, and dimensional, is carried out in constant luminosity.

 

Packaging, labelling, conditioning

The products are conditioned in the white room in double packaging, in Tyvek bags or blisters, before going over to the final conditioning, that includes the boxing, labelling and inclusion of the leaflet.

 

Sterilisation

Cousin Biotech carries out the sterilisation of the devices by gamma irradiation or ethylene oxide.

 

Manufacture takes completely place in clean rooms, in a controlled environment, on more than 1200 m2 (category ISO 8 to ISO 6), from braiding to conditioning.

The processes used are all validated according to the strictest norms in terms of qualification. The references used are ISO 13485 and 21 CFR Part 820 (FDA).