How can it happen that I, as manufacturing, have received a state of the art cleanroom facility but constantly face problems with the cleanliness of the FP, customer feedback, audit results, in process measures, etc.? What kind of contradiction is this? After more than 2 decades of operating experience and more than a decade of experience as a supplier, I can say that this is not surprising, it is unfortunately a common difficulty.
Cleanrooms are designed according to ISO regulations (level specified in URS), they are built and validated to the given level but always in a state of rest, empty. After installation and commissioning of machinery and equipment, it is assumed that the facility still meets the initial standard level. This is wrong, cleanrooms should be set up taking into account the activity(s) inside.
While I was responsible for manufacturing in such facilities, we did not even determine the final layout and material flow before ordering the cleanroom, not even mentioning the cases when we change the mfg technology, raw materials or the manufactured product in an existing cleanroom.
All these circumstances could result in imperfect laminar air flow, inadequate management of local contamination sources, overcrowded material transfer points, traffic jams at staff entry points during shift changes, insufficient space to store semi-finished products in progress or items awaiting rework or quality control sampling, etc.
The good news is that there are a lot of tricks and subtle solutions to compensate for the shortcomings. I am going to detail these in the upcoming posts.
In the meantime, check:
www.wipesforindustry.com, www.suntechungary.hu, www.gekatex.com