WHAT IS A CLEAN ROOM? It’s a closed environment where “clean” or “aseptic” work is carried out.It has a “regulated” atmosphere . It has low particle count with “predefined limits” . It is designed to generate less particles . It is designed to remove generated particles Why Clean Room? To protect the Product from contaminants Head space is a portion of the Clean Room environment. CONTAMINANTS: What contaminants should be kept out? Physical - dust, dirt, fibre, grit, glass, lint, Chemical - organic, inorganic, vapours, fumes, smoke Biological - bacteria, fungi, virus, spores, pollen, endotoxins, human cells Energies - heat, light, sound, static, magnetic, electricity, radiation Sources of contamination - All inputs to the “Clean Room” are sources of contamination Material - RM, PM, lubricants, cleaning agents disinfectant Machines - wear & tear of moving parts, rust, peel-off, emissions People - sweat, breath, saliva, hair, cells, Air - can brin...
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