Contamination sources that find their way into your cleanroom can be broadly classified into two categories. Those originating from the physical plant and those from processes/human actions.
The first category includes the HVAC design, including the cleanroom components like flooring, wall, and ceiling materials, as well as tool installation and venting.
The second more variable category comprises human actions taken to maintain mechanical systems. Specifically, it means those actions required to maintain mechanical systems, process controls, and cleaning and housekeeping protocols and measurements. It also includes the selection of support materials like gowns, gloves, wipes and shoe covers and operators.
The biggest variable is your operators. Don’t forget your cleaning and housekeeping personnel.
Thoroughly cleaning your cleanroom floors should be part of your overall cleaning protocol. And acceptable particulate and bacterial/microbial counts should be part of your cleaning protocol.
Develop a daily and weekly cleaning schedule. And determine who will take of this, when, and how frequently measurements will be taken.
Various ISO classes determine acceptable contamination levels as follows:
Many industries must control to smaller particles than 0.5 microns. They may also control for bacterial and other microbial components. Contamination of a cleanroom is expensive when it causes products to be scrapped, research to be done over, or expensive equipment to fail.
The information supplied in this article is for guidance only. Not all cleanrooms will use the same procedures. Follow your specific cleanroom or company procedural manual before this guide.
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