Requirements for polishing inside equipment in clean rooms
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I am currently working on the design of a cleanroom of class 300,000, used for the production of active pharmaceutical ingredients. There is a crystallization tank installed in the clean area, and it is required that both the interior and exterior of this tank be polished. However, I could not find any specifications regarding the polishing of the interior surface. I am wondering what level of smoothness is required to meet the standards; I would appreciate any advice from everyone.
300,000 levels are not considered high. I remember there are relevant regulations in GMP; it seems to be Ra0.8μm (grade 8). The polished surface on the inner wall of the crystallization tank should meet this standard, while welds and transition areas need to meet a standard one level lower. However, there is also a requirement of 0.2μm (grade 10)