Clean Room Production
I have a solid experience with quality assurance of production in classified clean room - class 7 + 8 according to ISO 14644 and ISO 14698.
It is important to build a clean room correctly from the beginning, as it is both difficult and expensive to change afterwards.
If you are planning to build a new clean room or renovate an existing clean room, I can help you with:
- Requirements for supplier(s) of clean room and evaluation
- Critical eyes on interior design, airlocks and workflows including review of drawings
- Requirements for shielding etc. of ongoing production
- Check that clean room is established according to specified requirements
- Requirements for validation of clean room including review and approval of report
- Requirements for continuous monitoring of particles and bio-contamination
- Hygiene and health requirements for staff working in clean room
- Requirements for clothing, washing, replacement etc.
- Requirements for cleaning the clean room and validation of the cleaning process
- Requirements for compressed air according to ISO 8573