Assess the process to be contained within the space. While it might be convenient to house all phases of your process within a cleanroom, the size, hence cost, of the facility will immediately begin to grow. Identify those processes that must be conducted within a clean environment and limit this first clean area to only those process machines, WIP storage, materials, etc. necessary to support those processes.
Lay out the clean facility incorporating people and material flow and integrate it into the other, non-clean areas of the manufacturing facility that relate to the clean area. After careful consideration it may turn out that only a small percentage of the floor space needs to be cleanroom rated with the majority of the square footage being a “controlled environment,” that is, conditioned and maintained but not HEPA/ULPA filtered, and having only a modest air exchange rate.
Developing a “clean workspace” mindset is a challenge for those accustomed to working in an uncontrolled lab environment, however if cleanliness is critical to the end product the discipline associated with working clean is vital. A gowning protocol should be established, as should a janitorial protocol. By using cleanroom garments, you are protecting the product from the people. By regularly cleaning the cleanroom, in a meticulous manner, the debris that is inevitable in a workspace, and that in turn may become a product contaminant, is removed.
