New ISO class7 Cleanroom Promolding

In this ‘state of the art’ cleanroom we produce and assemble medical products, from disposables and commodities to technically high-quality products.

Products for the medical industry require a clean working environment. In the ISO class 7 cleanroom we can guarantee a clean injection molding and assembly process under ISO 14644 standardized conditions.

Production technology

There are 2 injection molding machines at the cleanroom:

  • Full electric with 80 ton capacity (ENGEL E-motion 170/75 TL)
  • 2K hybrid with 300 ton capacity (ENGEL EVC 440H / 300 CO)

Assembly

The assembly is partially robotized with an automated warehouse system. Separate product components, air and liquid tight, can be connected with a laser welding machine.

Cleanroom - Promolding

The ISO 14644 standard: table

deeltjes/m³
Klasse 0,1 µm 0,2 µm 0,3 µm 0,5 µm 1 µm 5 µm
ISO 1 10 2
ISO 2 100 24 10 4
ISO 3 1000 237 102 35 8
ISO 4 10 000 2370 1020 352 83
ISO 5 100 000 23 700 10 200 3520 832 29
ISO 6 1 000 000 237 000 102 000 35 200 8320 293
ISO 7 352 000 83 200 2930
ISO 8 3 520 000 832 000 29 300
ISO 9 35 200 000 8 320 000 293 000

“The conditions under which you can develop medical instruments are very strict. Inspections also. Especially for invasive use. The final product must be thoroughly tested for contamination. In the new cleanroom the chance of this has been reduced to a minimum and optimally stabilized.”

Menco Verduin – Manager Director Promolding.

Do you have products that need to be produced in a clean room?

Feel free to contact us. You can also call us: 070 3074730.

 

Download here the leaflet for more information.

Leaflet Cleanroom Promolding