Products for the medical industry require a clean manufacturing environment. In our ISO class 7 cleanroom we guarantee a clean injection molding and assembly process under ISO 14644 standardized conditions.
Production technology
Our cleanroom injection moulding machines are:
- Full electric with 80 ton clamping force (ENGEL E-motion 170/75 TL)
- 2K hybrid with 300 ton clamping force (ENGEL EVC 440H / 300 CO)
Assembly
The assembling is partially robotized and is fed by an automated warehouse system. Several parts are laser welded together to ensure air and liquid tightness.
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 are allowed to manufacture medical instruments are very strict. As inspections are. Especially where it concerns products for invasive use. The final product must be thoroughly tested on functionality as well as on contamination level. In our cleanroom we have taken care of all relevant regulations to ensure minimal contaminations and optimal stabilized processes.”
Bastiaan Meulblok – COO Promolding.
Curious whether your parts need clean room manufacturing?
Feel free to contact us, by mail welcome@promolding.nl or phone: +3170 3074730.
Download here the leaflet for more information.
